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64451
                                                       Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

                                                                                                                                                       (2) Indications for use. As a
                                                                                              a generic copy of Fort Dodge Animal
                                      to compete effectively in a global
                                                                                                                                                    preanesthetic agent.
                                                                                              Health’s, Division of Wyeth’s ROBINUL-
                                      environment.
                                         This Statement of Policy has been                                                                             (3) Limitations. Federal law restricts
                                                                                              V (glycopyrrolate), approved under
                                      developed as a means for the                                                                                  this drug to use by or on the order of
                                                                                              NADA 101–777. The ANADA is
                                      Commission to respond flexibly to the                                                                         a licensed veterinarian.
                                                                                              approved as of October 2, 2006, and the
                                      challenges posed by the ongoing                         regulations are amended in 21 CFR                       Dated: October 23, 2006.
                                      evolution in electronic access to global                522.1066 to reflect the approval and a                Stephen F. Sundlof,
                                      markets. The Commission will continue                   current format. The basis of approval is
                                                                                                                                                    Director, Center for Veterinary Medicine.
                                      to monitor carefully, and review the                    discussed in the freedom of information
                                                                                                                                                    [FR Doc. E6–18444 Filed 11–1–06; 8:45 am]
                                      Policy Statement as necessary in light                  summary.
                                                                                                                                                    BILLING CODE 4160–01–S
                                                                                                 In accordance with the freedom of
                                      of, the ongoing evolution of cross-border
                                                                                              information provisions of 21 CFR part
                                      electronic direct access and
                                                                                              20 and 21 CFR 514.11(e)(2)(ii), a
                                      intermediation in order to ensure that it
                                                                                                                                                    DEPARTMENT OF STATE
                                                                                              summary of safety and effectiveness
                                      does not adversely affect U.S. cash and
                                                                                              data and information submitted to
                                      futures markets, market participants and
                                                                                                                                                    22 CFR Part 97
                                                                                              support approval of this application
                                      customers, as well as the consumers
                                                                                              may be seen in the Division of Dockets
                                      affected by those foreign market                                                                              [Public Notice 5602]
                                                                                              Management (HFA–305), Food and Drug
                                      transactions.
                                                                                                                                                    RIN 1400–AC19
                                                                                              Administration, 5630 Fishers Lane, rm.
                                        Issued in Washington, DC, on October 27,
                                                                                              1061, Rockville, MD 20852, between 9
                                      2006 by the Commission.                                                                                       Intercountry Adoption—Department
                                                                                              a.m. and 4 p.m., Monday through                       Issuance of Certifications in Hague
                                      Eileen A. Donovan,
                                                                                              Friday.                                               Convention Adoption Cases
                                      Acting Secretary of the Commission.
                                                                                                 FDA has determined under 21 CFR
                                      [FR Doc. E6–18513 Filed 11–1–06; 8:45 am]                                                                                Department of State.
                                                                                              25.33(a)(1) that this action is of a type             AGENCY:
                                      BILLING CODE 6351–01–P
                                                                                              that does not individually or                                   Final rule.
                                                                                                                                                    ACTION:
                                                                                              cumulatively have a significant effect on
                                                                                                                                                    SUMMARY: The Department of State (the
                                                                                              the human environment. Therefore,
                                      DEPARTMENT OF HEALTH AND                                                                                      Department) is issuing a final rule to
                                                                                              neither an environmental assessment
                                      HUMAN SERVICES                                                                                                implement the certification and
                                                                                              nor an environmental impact statement
                                                                                                                                                    declaration provisions of the 1993
                                                                                              is required.
                                      Food and Drug Administration                                                                                  Hague Convention on Protection of
                                                                                                 This rule does not meet the definition
                                                                                                                                                    Children and Co-operation in Respect of
                                                                                              of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
                                      21 CFR Part 522                                                                                               Intercountry Adoption (the Convention)
                                                                                              it is a rule of ‘‘particular applicability.’’
                                                                                                                                                    and the Intercountry Adoption Act of
                                                                                              Therefore, it is not subject to the
                                      Implantation or Injectable Dosage
                                                                                                                                                    2000 (the IAA) with respect to adoption
                                                                                              congressional review requirements in 5
                                      Form New Animal Drugs;
                                                                                                                                                    and custody proceedings taking place in
                                                                                              U.S.C. 801–808.
                                      Glycopyrrolate
                                                                                                                                                    the United States, after review of public
                                                                                              List of Subjects in 21 CFR Part 522                   comments received in response to the
                                                 Food and Drug Administration,
                                      AGENCY:
                                                                                                Animal drugs.                                       Department’s June 16, 2006 issuance of
                                      HHS.
                                                                                                                                                    a proposed rule. This final rule governs
                                                                                              I Therefore, under the Federal Food,
                                                Final rule.
                                      ACTION:
                                                                                                                                                    the application process for Hague
                                                                                              Drug, and Cosmetic Act and under
                                      SUMMARY: The Food and Drug                                                                                    Adoption Certificates and Hague
                                                                                              authority delegated to the Commissioner
                                      Administration (FDA) is amending the                                                                          Custody Declarations in cases involving
                                                                                              of Food and Drugs and redelegated to
                                      animal drug regulations to reflect                                                                            emigration of a child from the United
                                                                                              the Center for Veterinary Medicine, 21
                                      approval of an abbreviated new animal                                                                         States. It also establishes a process for
                                                                                              CFR part 522 is amended as follows:
                                      drug application (ANADA) filed by IVX                                                                         seeking certification, for purposes of
                                                                                              PART 522—IMPLANTATION OR
                                      Animal Health, Inc. The ANADA                                                                                 Article 23 of the Convention, that an
                                                                                              INJECTABLE DOSAGE FORM NEW
                                      provides for veterinary prescription use                                                                      adoption done in the United States
                                                                                              ANIMAL DRUGS
                                      of glycopyrrolate solution as an                                                                              following a grant of custody in a
                                      injectable preanesthetic agent in dogs                                                                        Convention country of origin was done
                                                                                                1. The authority citation for 21 CFR
                                                                                              I
                                      and cats.                                                                                                     in accordance with the Convention.
                                                                                              part 522 continues to read as follows:
                                      DATES: This rule is effective November                                                                        DATES: This rule is effective December 4,
                                                                                                  Authority: 21 U.S.C. 360b.
                                      2, 2006.                                                                                                      2006. Information about the date the
                                                                                                2. Revise § 522.1066 to read as
                                                                                              I                                                     Convention will enter into force is
                                      FOR FURTHER INFORMATION CONTACT: John
                                                                                              follows:                                              provided in 22 CFR 96.17.
                                      K. Harshman, Center for Veterinary
                                      Medicine (HFV 104), Food and Drug                                                                             FOR FURTHER INFORMATION CONTACT: For
                                                                                              § 522.1066    Glycopyrrolate.
                                      Administration, 7500 Standish Pl.,                                                                            further information, contact Anna Mary
                                                                                                (a) Specifications. Each milliliter of
                                      Rockville, MD 20855, 301–827–0169, e-                                                                         Coburn at 202–736–9081. Hearing- or
                                                                                              solution contains 0.2 milligram
                                      mail: john.harshman@fda.hhs.gov.                                                                              speech-impaired persons may use the
                                                                                              glycopyrrolate.
                                                                                                                                                    Telecommunications Devices for the
                                      SUPPLEMENTARY INFORMATION: IVX                            (b) Sponsors. See Nos. 000856 and
                                                                                                                                                    Deaf (TDD) by contacting the Federal
                                      Animal Health, Inc., 3915 South 48th                    059130 in § 510.600(c) of this chapter.
                                                                                                                                                    Information Relay Service at 1–800–
                                                                                                (c) Conditions of use in dogs and
                                      Street Ter., St. Joseph, MO 64503, filed
                                                                                                                                                    877–8339.
                                                                                              cats—(1) Amount. 5 micrograms per
                                      ANADA 200–365 that provides for
                                                                                              pound of body weight (0.25 milliliter
                                      veterinary prescription use of
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                                                                                                                                                    SUPPLEMENTARY INFORMATION:
                                                                                              per 10 pounds of body weight) by
                                      Glycopyrrolate Injectable as a
                                                                                                                                                    I. Background
                                                                                              intravenous, intramuscular, or
                                      preanesthetic agent in dogs and cats.
                                                                                              subcutaneous injection in dogs or by
                                      IVX Animal Health, Inc.’s                                                                                        The Convention is a multilateral
                                                                                              intramuscular injection in cats.
                                      Glycopyrrolate Injectable is approved as                                                                      treaty that provides a framework for the


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64452            Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

                                                                                                                                                    are governed mainly by State law, when
                                                                                              parties to recognize adoptions, if the
                                      adoption of children habitually resident
                                                                                                                                                    the IAA has expressly imposed such
                                                                                              adoption is certified by the country of
                                      in one country party to the Convention
                                                                                                                                                    Convention requirements. Finally, the
                                                                                              adoption as having been made in
                                      by persons habitually resident in
                                                                                                                                                    Department has changed the title of the
                                                                                              accordance with the Convention. This
                                      another country party to the
                                                                                                                                                    proposed rule to clarify that the rule
                                                                                              final rule also establishes a separate,
                                      Convention. It was developed under the
                                                                                                                                                    covers both incoming and outgoing case
                                                                                              discretionary, procedure pursuant to
                                      auspices of the intergovernmental
                                                                                                                                                    certifications. The title change is not
                                                                                              which the Department may certify that
                                      organization known as the Hague
                                                                                                                                                    indicative of any substantive changes to
                                                                                              an incoming case finalized in the United
                                      Conference on Private International Law
                                                                                                                                                    the final rule.
                                                                                              States (i.e., a case in which custody was
                                      (the Hague Conference).
                                         The United States signed the                         granted abroad but the adoption was
                                                                                                                                                    Section 97.1 Definitions
                                      Convention on March 31, 1994, and the                   done by a U.S. court) was done in
                                                                                                                                                       No comments on the definitions were
                                      President subsequently transmitted the                  accordance with the Convention. The
                                                                                                                                                    received, and no changes to 97.1 have
                                      Convention to the Senate for its advice                 Department may issue this certification
                                                                                                                                                    been made. One commenter did
                                      and consent. On September 20, 2000,                     if an issue arises concerning recognition
                                                                                                                                                    recommend that throughout the rule the
                                      the Senate gave its advice and consent                  of the adoption pursuant to Article 23
                                                                                                                                                    term ‘‘adoptable’’ child be removed
                                      to the ratification of the Convention                   of the Convention.
                                                                                                                                                    because, according to the commenter,
                                                                                                 Further background on the
                                      and, at about the same time, Congress
                                                                                                                                                    the term has historically implied that
                                                                                              Convention and the IAA is provided in
                                      enacted the implementing legislation for
                                                                                                                                                    children are a marketable commodity.
                                                                                              the Preamble to the Proposed Rule on
                                      the Convention—the Intercountry
                                                                                                                                                    Although the Convention itself uses the
                                                                                              Issuance of Hague Convention
                                      Adoption Act (the IAA), Public Law
                                                                                                                                                    term ‘‘adoptable’’ despite similar
                                                                                              Certificates and Declarations in
                                      106–279, 42 U.S.C. 14901–14952.
                                                                                                                                                    objections at the time of drafting, we
                                                                                              Convention Adoption Cases, Section I,
                                      Consistent with U.S policy on
                                                                                                                                                    have changed the word ‘‘adoptable’’ to
                                                                                              71 FR 34857–34858 (June 16, 2006); the
                                      ratification of treaties and the Senate’s
                                                                                                                                                    ‘‘eligible for adoption’’ whenever
                                                                                              Preamble to the Final Rule on the
                                      advice and consent to ratification, the
                                                                                                                                                    possible.
                                                                                              Accreditation and Approval of Agencies
                                      United States will not ratify the
                                                                                              and Persons under the IAA, Section I
                                      Convention until the United States is                                                                         Section 97.2 Application for a Hague
                                                                                              and II, 71 FR 8064–8066 (February 15,
                                      able to carry out its obligations under                                                                       Adoption Certificate (HAC) or a Hague
                                                                                              2006); and the Preamble to the Proposed
                                      the Convention. (See Senate Declaration
                                                                                                                                                    Custody Declaration (HCD) (Outgoing
                                                                                              Rule on the Accreditation of Agencies
                                      for Convention Article 22(2) (146 Cong.
                                                                                                                                                    Case)
                                                                                              and Approval of Persons under the
                                      Rec. S8866 (daily ed. Sept. 20, 2000).
                                                                                                                                                       1. Comment: Some commenters are
                                                                                              Intercountry Adoption Act of 2000,
                                      Although this final rule is effective in 30
                                                                                                                                                    concerned about how long the process
                                                                                              Sections III and IV, 68 FR 54065–54073
                                      days, parties are not required to comply
                                                                                                                                                    to obtain a HAC or a HCD will take and
                                                                                              (September 15, 2003).
                                      with the provisions of 22 CFR part 97
                                                                                                                                                    that any delays could negatively affect
                                      until the Convention enters into force
                                                                                              II. Section-by-Section Discussion of                  a child waiting for an adoptive
                                      for the United States (three months after
                                                                                              Comments                                              placement. One commenter
                                      the United States ratifies it).
                                                                                                 This section provides a detailed                   recommends that specific timeframes be
                                         This final rule establishes procedures
                                                                                              discussion of comments received on the                added to the rule, such as requiring the
                                      for issuing certifications in Convention
                                                                                              proposed rule and describes changes                   Department to issue a HAC or HCD in
                                      adoptions involving the emigration of a
                                                                                              made to the proposed rule. Three                      three business days, to ensure that
                                      child from the United States (outgoing
                                                                                              general points should be kept in mind                 families who had traveled to adopt a
                                      cases) and for seeking certifications
                                                                                              in reading this discussion. First, we                 child living the United States did not
                                      regarding adoptions in incoming cases.
                                                                                              refer generally to actions of the                     have to wait too long for a HAC or HCD
                                      In response to its issuance of the
                                                                                              ‘‘Department’’ pursuant to the rule. The
                                      proposed rule, the Department received                                                                        once the relevant State court issued the
                                                                                              rule itself refers to actions of the
                                      insightful public comments that are                                                                           final adoption decree or custody decree.
                                                                                              ‘‘Secretary,’’ as the official named in the              Response: We agree that the HAC or
                                      posted on the Department’s Web site at
                                                                                              IAA, but the day-to-day exercise of the               HCD should be swiftly issued. The
                                      http://www.travel.state.gov. The
                                                                                              Secretary’s functions has been delegated              Department, however, is not including a
                                      Department is issuing the rule as final
                                                                                              (Delegation of Authority 261, 68 FR                   specific timeframe in the rule. Our goal
                                      with minor changes, taking into account
                                                                                              56372, September 30, 2003) to the                     nonetheless is to issue a HAC or HCD
                                      the comments received.
                                                                                              Assistant Secretary for Consular Affairs.
                                         Section 303(c) of the IAA gives the                                                                        as soon as possible, provided the
                                                                                              Second, this rule directly imposes
                                      Department responsibility for issuing an                                                                      supporting documentation required
                                                                                              Federal requirements on State courts to
                                      official certification that a child resident                                                                  under § 96.3 has been submitted.
                                                                                              the extent consistent with the IAA.
                                      in the United States has been adopted,                                                                           2. Comment: One commenter urges
                                                                                              Specifically, the IAA assigns to State
                                      or a declaration that custody for the                                                                         the Department to accept all materials,
                                                                                              courts with jurisdiction over matters of
                                      purpose of adoption has been granted,                                                                         including applications and supporting
                                                                                              adoption, or custody for purpose of
                                      in accordance with the Convention and                                                                         documents by fax or e-mail, and to
                                                                                              adoption, the responsibility for
                                      the IAA. The IAA assigns to State courts                                                                      encourage other Central Authorities
                                                                                              receiving and verifying documents
                                      with jurisdiction over matters of                                                                             (CAs) to do the same. The commenter
                                                                                              required under the Convention, making
                                      adoption, or custody for purposes of                                                                          also asks that the Department encourage
                                                                                              certain determinations required of the
                                      adoption, the responsibility for                                                                              the CAs of receiving countries to
                                                                                              country of origin by the Convention,
                                      receiving and verifying documents                                                                             provide any necessary approvals within
                                                                                              and determining that the placement is
                                      required under the Convention, making                                                                         24 hours of request, noting that the
                                                                                              in the best interests of the child. In
                                      certain determinations required of the                                                                        Netherlands issues approvals within 24
                                                                                              keeping with current U. S. domestic law
                                      country of origin by the Convention,                                                                          hours.
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                                                                                                                                                       Response: The Department intends to
                                                                                              and philosophy of treaty application in
                                      and determining that the placement is
                                                                                                                                                    accept applications and supporting
                                                                                              the context of a federalist system, we
                                      in the best interests of the child. With
                                                                                                                                                    materials via fax and e-mail to the
                                                                                              have imposed the Convention
                                      certain limited exceptions, the
                                                                                                                                                    extent practicable. We will encourage
                                                                                              requirements on outgoing cases, which
                                      Convention requires all Convention


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64453
                                                       Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

                                                                                                                                                    conform with the Convention and the
                                                                                              or HCD may be issued. The
                                      other CAs to accept communications by
                                                                                                                                                    IAA, as implemented through § 97.3,
                                                                                              Department’s goal is to provide a HAC
                                      fax and e-mail as well. We also plan to
                                                                                                                                                    and issue a HAC or HCD without
                                                                                              or HCD to any party to the adoption or
                                      urge other CAs to act expeditiously to
                                                                                                                                                    adjudicating the application.
                                                                                              custody proceeding who may need it to
                                      send any necessary approvals to
                                                                                                                                                      We understand that some parties to
                                                                                              obtain recognition and acceptance of the
                                      relevant State courts for a Hague
                                                                                                                                                    intercountry adoptions may be unaware
                                                                                              adoption decree or custody for purpose
                                      outgoing case.
                                                                                                                                                    of the Convention and the IAA and
                                         3. Comment: One commenter requests                   of adoption decree from other
                                                                                                                                                    consequently may not submit to the
                                      that fee payments be permitted by credit                Convention countries or from U.S.
                                                                                                                                                    State court the information the court
                                      card submission via Internet, phone, or                 authorities.
                                                                                                                                                    needs to make the findings required
                                                                                                 7. Comment: Some commenters
                                      fax.
                                         Response: If a fee is charged for                                                                          under § 97.3. The Department plans to
                                                                                              request clarification of the application
                                      issuance of a HAC or HCD, we will                                                                             continue its extensive outreach efforts to
                                                                                              process for HACs and HCDs. In
                                      make the methods of payment easy and                                                                          inform interested persons about the
                                                                                              particular, commenters want to know if
                                      consistent with other federal agency                                                                          Convention, the IAA, and the applicable
                                                                                              a HAC or HCD is automatically issued
                                      requirements covering payment of fees.                                                                        regulations. To date, we have conducted
                                                                                              even if no party applies. Similarly, other
                                         4. Comment: One commenter asks                                                                             numerous outreach events with State
                                                                                              commenters believe that the Department
                                      which part of the Department will be                                                                          court judges, public domestic
                                                                                              should always issue a HAC or HCD after
                                      responsible for issuing HACs and HCDs                                                                         authorities, and adoption service
                                                                                              a State court grants an adoption or
                                      and where its office will be located.                                                                         providers.
                                                                                              custody for purpose of adoption decree.
                                         Response: The Office of Children’s                                                                           8. Comment: One commenter suggests
                                                                                              Others are concerned that many parties
                                      Issues in the Bureau of Consular Affairs                                                                      that the Department is withholding
                                                                                              will be unaware that for outgoing cases
                                      will issue HACs and HCDs out of its                                                                           recognition of the State court adoption
                                                                                              involving Convention adoptions, the
                                      central office in Washington, DC.                                                                             or custody decree if it declines to issue
                                                                                              receiving country is obligated not to
                                         5. Comment: One commenter asks                                                                             the HAC or HCD.
                                                                                              permit the child’s entry unless the
                                      what type of training will be provided                                                                          Response. By verifying compliance
                                                                                              Department (as CA of the country of
                                      to the staff responsible for adjudicating                                                                     with § 97.3 before issuing a HAC or
                                                                                              origin) has issued a HAC or HCD for the
                                      applications for HACs or HCDs and                                                                             HCD, the Department is acting in
                                                                                              child.
                                      requests information on how this                                                                              accordance with Article 23 of the
                                                                                                 Response: Unless there is an
                                      function will be staffed.                                                                                     Convention. The Department’s
                                                                                              application from a party or other
                                         Response: The Department plans to                                                                          verification that all steps in the
                                                                                              interested person, in accordance with
                                      train the Office of Children’s Issues case                                                                    adoption and/or custody process
                                                                                              § 97.2(a), the Department will not sua
                                      officers thoroughly by using Foreign                                                                          complied with the Convention, the IAA,
                                                                                              sponte issue a HAC or HCD. The
                                      Affairs Manual (FAM) materials and                                                                            and the regulations implementing the
                                                                                              Department must be notified, via the
                                      formal classroom training. With respect                                                                       IAA ensures that U.S. children leaving
                                                                                              application process, for the HAC or HCD
                                      to staffing, we do not yet know the                                                                           the United States are protected in
                                                                                              to be issued. We expect that the
                                      number of outgoing cases and thus                                                                             accordance with the Convention.
                                                                                              adoption service provider working with
                                                                                                                                                      9. Comment: One commenter requests
                                      cannot determine how many officers                      the family would inform the prospective
                                                                                                                                                    that the rule include language on the
                                      will be assigned this critical CA                       adoptive parent(s) of any necessary
                                                                                                                                                    legal effect of a HAC or HCD similar to
                                      function.                                               requirements, including the need for a
                                         6. Comment: One commenter requests                                                                         the language in Section 302(b) of the
                                                                                              HAC or HCD. In any case, a party or
                                      clarification of the parties that may                                                                         IAA with respect to incoming cases (i.e.,
                                                                                              interested person may apply for a HAC
                                      apply for a HAC or HCD and asks                                                                               cases in which a child is immigrating to
                                                                                              or HCD at any time.
                                      specifically whether birthparent(s) may                                                                       the United States).
                                                                                                 Once a party applies for a HAC or
                                                                                                                                                      Response: Article 23 of the
                                      apply for a HAC or HCD. The                             HCD, the Department, in its role as CA,
                                                                                                                                                    Convention requires other Convention
                                      commenter also asks whether the                         must adjudicate the request to
                                                                                                                                                    countries to recognize an adoption that
                                      citizenship of the adoptive parent(s) or                determine if the child has been adopted
                                                                                                                                                    has been certified by the competent
                                      prospective adoptive parent(s) will                     or custody of the child for purposes of
                                                                                                                                                    authority of the State of the adoption.
                                      affect their ability to obtain a HAC or a               adoption has been granted in
                                                                                                                                                    Therefore, Convention countries must
                                      HCD.                                                    accordance with the Convention and
                                         Response: The adoptive parent(s) or                                                                        recognize any adoption for which the
                                                                                              (except as provided in § 97.4(b)) the
                                      prospective adoptive parent(s), who will                                                                      Department has issued a HAC.
                                                                                              IAA. Specifically, section 303(c) of the
                                      be habitual residents of the receiving                                                                        Including a requirement in U.S.
                                                                                              IAA provides that the Department shall
                                      country and typically will not be U.S.                                                                        regulations is therefore unnecessary. In
                                                                                              issue a HAC or HCD on receipt and
                                      citizens, will most likely be the parties                                                                     addition, the United States has no
                                                                                              verification of the required material and
                                      to apply for a HAC or a HCD. Despite                                                                          authority to regulate the receiving
                                                                                              information. The Department may thus
                                      being non-U.S. citizen adoptive                                                                               countries.
                                                                                              not issue a HAC or HCD for all cases.
                                                                                                                                                      As for the HCD, Article 19 of the
                                                                                                 The rule mirrors the IAA statutory
                                      parent(s) or prospective adoptive
                                                                                                                                                    Convention provides that the transfer of
                                                                                              requirements and is not changed in
                                      parent(s), they will be able to apply for
                                                                                                                                                    the child to the receiving country may
                                                                                              response to the comment. The parties
                                      and obtain a HAC or HCD. The rule
                                                                                                                                                    be carried out only if the requirements
                                                                                              must first apply to a State court to make
                                      states that ‘‘any party’’ to an adoption or
                                                                                                                                                    of Article 17 have been satisfied. The
                                                                                              the needed findings, all derived from
                                      custody proceeding may apply for a
                                                                                                                                                    HCD demonstrates to the receiving
                                                                                              the Convention or the IAA, so that the
                                      HAC or HCD; thus, if a birthparent was
                                                                                                                                                    country that the United States, as the
                                                                                              proceeding is Hague-compliant. The
                                      a party to the adoption or custody
                                                                                                                                                    country of origin, has agreed that the
                                                                                              Department then reviews the State court
                                      proceeding, he or she may apply for a
                                                                                                                                                    child may be entrusted to the
                                                                                              findings to adjudicate the application
                                      HAC or HCD. Likewise, the adopted
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                                                                                                                                                    prospective adoptive parent(s) and that
                                                                                              before issuing a HAC or HCD. The
                                      child may apply for a HAC or HCD. If
                                                                                                                                                    the adoption may proceed in the
                                                                                              Department may not assume that every
                                      various parties to the adoption or
                                                                                                                                                    receiving country. The Department
                                                                                              adoption or custody for purpose of
                                      custody proceeding apply for HACs or
                                                                                                                                                    expects that the receiving countries will
                                                                                              adoption case will automatically
                                      HCDs, more than one copy of the HAC


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64454            Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

                                                                                                                                                    contacts may occur in States which
                                                                                                4. Comment: One commenter asks if
                                      recognize the HCD as evidence that the
                                                                                                                                                    expressly permit such contacts and
                                                                                              the provision in 97.3(f), which limits
                                      Article 17 requirements have been met.
                                                                                                                                                    prescribe the conditions under which
                                                                                              contacts between the prospective
                                      In any event, as noted, the United States
                                                                                                                                                    such contacts may occur.
                                                                                              adoptive parent(s) and the child’s
                                      may not regulate another Convention
                                                                                                                                                       5. Comment: Another commenter asks
                                                                                              birthparent(s) or any other person who
                                      country.
                                                                                                                                                    if States that allow ‘‘open adoptions’’ in
                                                                                              has care of the child before the
                                      Section 97.3 Requirements Subject to                                                                          which the birthparent(s) and
                                                                                              adoption, prevents birthparent(s) from
                                      Verification in an Outgoing Convention                                                                        prospective adoptive parents(s) meet
                                                                                              identifying prospective adoptive
                                      Case                                                                                                          and establish a trusting relationship
                                                                                              parent(s) via such methods as reviewing
                                                                                                                                                    before the adoption must change their
                                                                                              parent profiles provided by an attorney
                                         1. Comment: Several commenters
                                                                                                                                                    laws. The commenter notes that
                                                                                              for the prospective adoptive parent(s),
                                      request that the reasonable efforts
                                                                                                                                                    oftentimes the open contacts continue
                                                                                              or provided by an attorney for the
                                      requirement to locate a placement for
                                                                                                                                                    throughout the child’s life and that
                                                                                              birthparent(s), or provided by an
                                      the child in the United States in
                                                                                                                                                    current psychological research supports
                                                                                              agency, or made available online. The
                                      § 97.3(c) not apply when birthparent(s)
                                                                                                                                                    the conclusion that such bonds are
                                                                                              commenter also asks if birthparent(s)
                                      directly identify prospective parent(s)
                                                                                                                                                    beneficial to the adoptee in the long-
                                                                                              may identify prospective adoptive
                                      outside the United States. One
                                                                                                                                                    run.
                                                                                              parent(s) via referrals from non-relatives
                                      commenter suggests that such contacts
                                                                                                                                                       Response: These regulations do not
                                                                                              or by responding to advertisements
                                      be permitted as long as an accredited,
                                                                                                                                                    require States to change their laws with
                                                                                              placed in newspapers.
                                      temporarily accredited, or approved
                                                                                                                                                    respect to contacts. As discussed above,
                                                                                                Response: Section 97.3(j) implements
                                      adoption service provider is involved in
                                                                                                                                                    pre-birth contacts are permitted in
                                                                                              the requirements in Article 29 of the
                                      the case.
                                                                                                                                                    Convention cases if they are allowed by
                                                                                              Convention. Article 29’s prohibition on
                                         Response: This provision cross-
                                                                                                                                                    the relevant State law or public
                                                                                              prior contact applies unless the
                                      references 22 CFR 96.54(a), which
                                                                                                                                                    domestic authority and the contacts
                                                                                              adoption takes place within a family or
                                      specifically excludes from the
                                                                                                                                                    occurred in accordance with required
                                                                                              the contact is in compliance with the
                                      reasonable efforts requirement cases in
                                                                                                                                                    conditions.
                                                                                              conditions established in the country of
                                      which the birthparent(s) have identified
                                                                                                                                                       6. Comment: One commenter asks if
                                                                                              origin, in this case the United States. For
                                      specific prospective adoptive parent(s)
                                                                                                                                                    the no direct contacts provision of the
                                                                                              this reason, § 97.3(j) permits contacts
                                      or in other special circumstances
                                                                                                                                                    rule applied to the U.S. government-
                                                                                              when a ‘‘relevant State or public
                                      accepted by the State court.
                                                                                                                                                    sponsored http://www.AdoptUSKids.org
                                                                                              domestic authority has established
                                         2. Comment: One commenter                                                                                  photo listing service. The commenter
                                                                                              conditions under which such contact
                                      recommends that the rule specify more                                                                         explains that public domestic
                                                                                              may occur and any such contact
                                      clearly the steps that must be completed                                                                      authorities put a photo and information
                                                                                              occurred in accordance with such
                                      for a reasonable efforts finding to be                                                                        about a child eligible for adoption
                                                                                              conditions.’’ The answers to the
                                      made by the State court.                                                                                      (usually a child or sibling group that has
                                                                                              commenter’s questions thus depend on
                                         Response: As noted above, this                                                                             been waiting a long time for a
                                                                                              local law and regulations.
                                      provision cross-references 22 CFR                                                                             permanent family placement) on the
                                                                                                A State or a public domestic authority
                                      96.54(a), which sets forth the placement                                                                      web-based service and families from all
                                                                                              may establish conditions on direct
                                      standards in outgoing cases, including                                                                        over the world may express an interest
                                                                                              contacts between birthparent(s) and
                                      the reasonable efforts requirement.                                                                           in the child to the public domestic
                                                                                              prospective adoptive parent(s). If such
                                      Specifically, reasonable efforts to find a                                                                    authority, submit a home study, and
                                                                                              conditions are set, then contacts that
                                      timely placement for the child in the                                                                         then social workers for the public
                                                                                              comply with those conditions may
                                      United States include: (1) Disseminating                                                                      domestic authority determine if a
                                                                                              occur. If a State has no laws or
                                      information on the child and his or her                                                                       referral and subsequent match are in the
                                                                                              conditions on direct contacts, then such
                                      availability for adoption through print,                                                                      best interests of the child. If so, then the
                                                                                              contacts may not occur because the
                                      media, and internet resources designed                                                                        public domestic authority undertakes
                                                                                              Convention intends that such contacts
                                      to communicate with potential                                                                                 the subsequent steps to complete an
                                                                                              be either barred or subject to regulation.
                                      prospective adoptive parent(s) in the                                                                         adoption, including in some cases,
                                                                                                If these principles are applied to the
                                      United States; (2) Listing information                                                                        supervising meetings with the
                                                                                              commenter’s questions, then the answer
                                      about the child on a national or State                                                                        birthparent(s), the child, and the
                                                                                              to what direct contacts are permitted
                                      adoption exchange or registry for at least                                                                    prospective adoptive parent(s).
                                                                                              will necessarily depend on the State
                                      sixty calendar days after the birth of the                                                                       Response: Public domestic authorities
                                                                                              where the birthparent(s) are residing. If
                                      child; (3) Responding to inquiries about                                                                      must comply with 22 CFR part 97. As
                                                                                              the State where the birthparent(s) reside
                                      adoption of the child; and (4) Providing                                                                      discussed above, contacts are generally
                                                                                              permits them to review prospective
                                      a copy of the child background study to                                                                       prohibited, unless the relevant State or
                                                                                              adoptive parent(s) profiles before the
                                      potential U.S. prospective adoptive                                                                           public domestic authority has
                                                                                              referral or adoption or consider non-
                                      parent(s).                                                                                                    established conditions under which
                                                                                              relative referrals, then the practice is not
                                         3. Comment: One commenter objects                                                                          such contact may occur and any such
                                                                                              per se prohibited, but must comply with
                                      to the sixty-day period for listing                                                                           contact occurred in accordance with
                                                                                              any specific State requirements, such as
                                      information about the child on a                                                                              such conditions. Presumably, because
                                                                                              those on who may present the
                                      national or State adoption exchange or                                                                        the public domestic authority is
                                                                                              information (attorney for prospective
                                      registry because research shows that                                                                          coordinating the adoption, it has
                                                                                              adoptive parent(s) or birthparent(s) or
                                      delays in placement negatively impact a                                                                       established procedures on the contacts.
                                                                                              adoption service provider). If State
                                      child’s emotional well-being.                                                                                 If the conditions for the contacts have
                                                                                              requirements are completely silent, then
                                                                                                                                                    been enumerated, then the contacts may
                                                                                              direct contact practices are not allowed.
                                         Response: This comment goes to 22
pwalker on PRODPC60 with RULES




                                                                                                                                                    continue even for Hague cases as long
                                                                                              Likewise, if the State permits
                                      CFR part 96 and was addressed in the
                                                                                                                                                    as the contacts comply with the
                                                                                              birthparent(s) to locate prospective
                                      context of that rule. Part 96 is now a
                                                                                                                                                    procedures that the public domestic
                                                                                              adoptive parent(s) through media such
                                      final rule and no longer open for
                                                                                                                                                    authority established. Thus, if a State or
                                                                                              as newspapers or Web sites, then such
                                      comment.


                                 VerDate Aug<31>2005   16:15 Nov 01, 2006   Jkt 211001   PO 00000   Frm 00016   Fmt 4700   Sfmt 4700   E:FRFM02NOR1.SGM   02NOR1
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs

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Legal Highs From Herbs

  • 1. 64451 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations (2) Indications for use. As a a generic copy of Fort Dodge Animal to compete effectively in a global preanesthetic agent. Health’s, Division of Wyeth’s ROBINUL- environment. This Statement of Policy has been (3) Limitations. Federal law restricts V (glycopyrrolate), approved under developed as a means for the this drug to use by or on the order of NADA 101–777. The ANADA is Commission to respond flexibly to the a licensed veterinarian. approved as of October 2, 2006, and the challenges posed by the ongoing regulations are amended in 21 CFR Dated: October 23, 2006. evolution in electronic access to global 522.1066 to reflect the approval and a Stephen F. Sundlof, markets. The Commission will continue current format. The basis of approval is Director, Center for Veterinary Medicine. to monitor carefully, and review the discussed in the freedom of information [FR Doc. E6–18444 Filed 11–1–06; 8:45 am] Policy Statement as necessary in light summary. BILLING CODE 4160–01–S In accordance with the freedom of of, the ongoing evolution of cross-border information provisions of 21 CFR part electronic direct access and 20 and 21 CFR 514.11(e)(2)(ii), a intermediation in order to ensure that it DEPARTMENT OF STATE summary of safety and effectiveness does not adversely affect U.S. cash and data and information submitted to futures markets, market participants and 22 CFR Part 97 support approval of this application customers, as well as the consumers may be seen in the Division of Dockets affected by those foreign market [Public Notice 5602] Management (HFA–305), Food and Drug transactions. RIN 1400–AC19 Administration, 5630 Fishers Lane, rm. Issued in Washington, DC, on October 27, 1061, Rockville, MD 20852, between 9 2006 by the Commission. Intercountry Adoption—Department a.m. and 4 p.m., Monday through Issuance of Certifications in Hague Eileen A. Donovan, Friday. Convention Adoption Cases Acting Secretary of the Commission. FDA has determined under 21 CFR [FR Doc. E6–18513 Filed 11–1–06; 8:45 am] Department of State. 25.33(a)(1) that this action is of a type AGENCY: BILLING CODE 6351–01–P that does not individually or Final rule. ACTION: cumulatively have a significant effect on SUMMARY: The Department of State (the the human environment. Therefore, DEPARTMENT OF HEALTH AND Department) is issuing a final rule to neither an environmental assessment HUMAN SERVICES implement the certification and nor an environmental impact statement declaration provisions of the 1993 is required. Food and Drug Administration Hague Convention on Protection of This rule does not meet the definition Children and Co-operation in Respect of of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 21 CFR Part 522 Intercountry Adoption (the Convention) it is a rule of ‘‘particular applicability.’’ and the Intercountry Adoption Act of Therefore, it is not subject to the Implantation or Injectable Dosage 2000 (the IAA) with respect to adoption congressional review requirements in 5 Form New Animal Drugs; and custody proceedings taking place in U.S.C. 801–808. Glycopyrrolate the United States, after review of public List of Subjects in 21 CFR Part 522 comments received in response to the Food and Drug Administration, AGENCY: Animal drugs. Department’s June 16, 2006 issuance of HHS. a proposed rule. This final rule governs I Therefore, under the Federal Food, Final rule. ACTION: the application process for Hague Drug, and Cosmetic Act and under SUMMARY: The Food and Drug Adoption Certificates and Hague authority delegated to the Commissioner Administration (FDA) is amending the Custody Declarations in cases involving of Food and Drugs and redelegated to animal drug regulations to reflect emigration of a child from the United the Center for Veterinary Medicine, 21 approval of an abbreviated new animal States. It also establishes a process for CFR part 522 is amended as follows: drug application (ANADA) filed by IVX seeking certification, for purposes of PART 522—IMPLANTATION OR Animal Health, Inc. The ANADA Article 23 of the Convention, that an INJECTABLE DOSAGE FORM NEW provides for veterinary prescription use adoption done in the United States ANIMAL DRUGS of glycopyrrolate solution as an following a grant of custody in a injectable preanesthetic agent in dogs Convention country of origin was done 1. The authority citation for 21 CFR I and cats. in accordance with the Convention. part 522 continues to read as follows: DATES: This rule is effective November DATES: This rule is effective December 4, Authority: 21 U.S.C. 360b. 2, 2006. 2006. Information about the date the 2. Revise § 522.1066 to read as I Convention will enter into force is FOR FURTHER INFORMATION CONTACT: John follows: provided in 22 CFR 96.17. K. Harshman, Center for Veterinary Medicine (HFV 104), Food and Drug FOR FURTHER INFORMATION CONTACT: For § 522.1066 Glycopyrrolate. Administration, 7500 Standish Pl., further information, contact Anna Mary (a) Specifications. Each milliliter of Rockville, MD 20855, 301–827–0169, e- Coburn at 202–736–9081. Hearing- or solution contains 0.2 milligram mail: john.harshman@fda.hhs.gov. speech-impaired persons may use the glycopyrrolate. Telecommunications Devices for the SUPPLEMENTARY INFORMATION: IVX (b) Sponsors. See Nos. 000856 and Deaf (TDD) by contacting the Federal Animal Health, Inc., 3915 South 48th 059130 in § 510.600(c) of this chapter. Information Relay Service at 1–800– (c) Conditions of use in dogs and Street Ter., St. Joseph, MO 64503, filed 877–8339. cats—(1) Amount. 5 micrograms per ANADA 200–365 that provides for pound of body weight (0.25 milliliter veterinary prescription use of pwalker on PRODPC60 with RULES SUPPLEMENTARY INFORMATION: per 10 pounds of body weight) by Glycopyrrolate Injectable as a I. Background intravenous, intramuscular, or preanesthetic agent in dogs and cats. subcutaneous injection in dogs or by IVX Animal Health, Inc.’s The Convention is a multilateral intramuscular injection in cats. Glycopyrrolate Injectable is approved as treaty that provides a framework for the VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 2. 64452 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations are governed mainly by State law, when parties to recognize adoptions, if the adoption of children habitually resident the IAA has expressly imposed such adoption is certified by the country of in one country party to the Convention Convention requirements. Finally, the adoption as having been made in by persons habitually resident in Department has changed the title of the accordance with the Convention. This another country party to the proposed rule to clarify that the rule final rule also establishes a separate, Convention. It was developed under the covers both incoming and outgoing case discretionary, procedure pursuant to auspices of the intergovernmental certifications. The title change is not which the Department may certify that organization known as the Hague indicative of any substantive changes to an incoming case finalized in the United Conference on Private International Law the final rule. States (i.e., a case in which custody was (the Hague Conference). The United States signed the granted abroad but the adoption was Section 97.1 Definitions Convention on March 31, 1994, and the done by a U.S. court) was done in No comments on the definitions were President subsequently transmitted the accordance with the Convention. The received, and no changes to 97.1 have Convention to the Senate for its advice Department may issue this certification been made. One commenter did and consent. On September 20, 2000, if an issue arises concerning recognition recommend that throughout the rule the the Senate gave its advice and consent of the adoption pursuant to Article 23 term ‘‘adoptable’’ child be removed to the ratification of the Convention of the Convention. because, according to the commenter, Further background on the and, at about the same time, Congress the term has historically implied that Convention and the IAA is provided in enacted the implementing legislation for children are a marketable commodity. the Preamble to the Proposed Rule on the Convention—the Intercountry Although the Convention itself uses the Issuance of Hague Convention Adoption Act (the IAA), Public Law term ‘‘adoptable’’ despite similar Certificates and Declarations in 106–279, 42 U.S.C. 14901–14952. objections at the time of drafting, we Convention Adoption Cases, Section I, Consistent with U.S policy on have changed the word ‘‘adoptable’’ to 71 FR 34857–34858 (June 16, 2006); the ratification of treaties and the Senate’s ‘‘eligible for adoption’’ whenever Preamble to the Final Rule on the advice and consent to ratification, the possible. Accreditation and Approval of Agencies United States will not ratify the and Persons under the IAA, Section I Convention until the United States is Section 97.2 Application for a Hague and II, 71 FR 8064–8066 (February 15, able to carry out its obligations under Adoption Certificate (HAC) or a Hague 2006); and the Preamble to the Proposed the Convention. (See Senate Declaration Custody Declaration (HCD) (Outgoing Rule on the Accreditation of Agencies for Convention Article 22(2) (146 Cong. Case) and Approval of Persons under the Rec. S8866 (daily ed. Sept. 20, 2000). 1. Comment: Some commenters are Intercountry Adoption Act of 2000, Although this final rule is effective in 30 concerned about how long the process Sections III and IV, 68 FR 54065–54073 days, parties are not required to comply to obtain a HAC or a HCD will take and (September 15, 2003). with the provisions of 22 CFR part 97 that any delays could negatively affect until the Convention enters into force II. Section-by-Section Discussion of a child waiting for an adoptive for the United States (three months after Comments placement. One commenter the United States ratifies it). This section provides a detailed recommends that specific timeframes be This final rule establishes procedures discussion of comments received on the added to the rule, such as requiring the for issuing certifications in Convention proposed rule and describes changes Department to issue a HAC or HCD in adoptions involving the emigration of a made to the proposed rule. Three three business days, to ensure that child from the United States (outgoing general points should be kept in mind families who had traveled to adopt a cases) and for seeking certifications in reading this discussion. First, we child living the United States did not regarding adoptions in incoming cases. refer generally to actions of the have to wait too long for a HAC or HCD In response to its issuance of the ‘‘Department’’ pursuant to the rule. The proposed rule, the Department received once the relevant State court issued the rule itself refers to actions of the insightful public comments that are final adoption decree or custody decree. ‘‘Secretary,’’ as the official named in the Response: We agree that the HAC or posted on the Department’s Web site at IAA, but the day-to-day exercise of the HCD should be swiftly issued. The http://www.travel.state.gov. The Secretary’s functions has been delegated Department, however, is not including a Department is issuing the rule as final (Delegation of Authority 261, 68 FR specific timeframe in the rule. Our goal with minor changes, taking into account 56372, September 30, 2003) to the nonetheless is to issue a HAC or HCD the comments received. Assistant Secretary for Consular Affairs. Section 303(c) of the IAA gives the as soon as possible, provided the Second, this rule directly imposes Department responsibility for issuing an supporting documentation required Federal requirements on State courts to official certification that a child resident under § 96.3 has been submitted. the extent consistent with the IAA. in the United States has been adopted, 2. Comment: One commenter urges Specifically, the IAA assigns to State or a declaration that custody for the the Department to accept all materials, courts with jurisdiction over matters of purpose of adoption has been granted, including applications and supporting adoption, or custody for purpose of in accordance with the Convention and documents by fax or e-mail, and to adoption, the responsibility for the IAA. The IAA assigns to State courts encourage other Central Authorities receiving and verifying documents with jurisdiction over matters of (CAs) to do the same. The commenter required under the Convention, making adoption, or custody for purposes of also asks that the Department encourage certain determinations required of the adoption, the responsibility for the CAs of receiving countries to country of origin by the Convention, receiving and verifying documents provide any necessary approvals within and determining that the placement is required under the Convention, making 24 hours of request, noting that the in the best interests of the child. In certain determinations required of the Netherlands issues approvals within 24 keeping with current U. S. domestic law country of origin by the Convention, hours. pwalker on PRODPC60 with RULES Response: The Department intends to and philosophy of treaty application in and determining that the placement is accept applications and supporting the context of a federalist system, we in the best interests of the child. With materials via fax and e-mail to the have imposed the Convention certain limited exceptions, the extent practicable. We will encourage requirements on outgoing cases, which Convention requires all Convention VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 3. 64453 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations conform with the Convention and the or HCD may be issued. The other CAs to accept communications by IAA, as implemented through § 97.3, Department’s goal is to provide a HAC fax and e-mail as well. We also plan to and issue a HAC or HCD without or HCD to any party to the adoption or urge other CAs to act expeditiously to adjudicating the application. custody proceeding who may need it to send any necessary approvals to We understand that some parties to obtain recognition and acceptance of the relevant State courts for a Hague intercountry adoptions may be unaware adoption decree or custody for purpose outgoing case. of the Convention and the IAA and 3. Comment: One commenter requests of adoption decree from other consequently may not submit to the that fee payments be permitted by credit Convention countries or from U.S. State court the information the court card submission via Internet, phone, or authorities. needs to make the findings required 7. Comment: Some commenters fax. Response: If a fee is charged for under § 97.3. The Department plans to request clarification of the application issuance of a HAC or HCD, we will continue its extensive outreach efforts to process for HACs and HCDs. In make the methods of payment easy and inform interested persons about the particular, commenters want to know if consistent with other federal agency Convention, the IAA, and the applicable a HAC or HCD is automatically issued requirements covering payment of fees. regulations. To date, we have conducted even if no party applies. Similarly, other 4. Comment: One commenter asks numerous outreach events with State commenters believe that the Department which part of the Department will be court judges, public domestic should always issue a HAC or HCD after responsible for issuing HACs and HCDs authorities, and adoption service a State court grants an adoption or and where its office will be located. providers. custody for purpose of adoption decree. Response: The Office of Children’s 8. Comment: One commenter suggests Others are concerned that many parties Issues in the Bureau of Consular Affairs that the Department is withholding will be unaware that for outgoing cases will issue HACs and HCDs out of its recognition of the State court adoption involving Convention adoptions, the central office in Washington, DC. or custody decree if it declines to issue receiving country is obligated not to 5. Comment: One commenter asks the HAC or HCD. permit the child’s entry unless the what type of training will be provided Response. By verifying compliance Department (as CA of the country of to the staff responsible for adjudicating with § 97.3 before issuing a HAC or origin) has issued a HAC or HCD for the applications for HACs or HCDs and HCD, the Department is acting in child. requests information on how this accordance with Article 23 of the Response: Unless there is an function will be staffed. Convention. The Department’s application from a party or other Response: The Department plans to verification that all steps in the interested person, in accordance with train the Office of Children’s Issues case adoption and/or custody process § 97.2(a), the Department will not sua officers thoroughly by using Foreign complied with the Convention, the IAA, sponte issue a HAC or HCD. The Affairs Manual (FAM) materials and and the regulations implementing the Department must be notified, via the formal classroom training. With respect IAA ensures that U.S. children leaving application process, for the HAC or HCD to staffing, we do not yet know the the United States are protected in to be issued. We expect that the number of outgoing cases and thus accordance with the Convention. adoption service provider working with 9. Comment: One commenter requests cannot determine how many officers the family would inform the prospective that the rule include language on the will be assigned this critical CA adoptive parent(s) of any necessary legal effect of a HAC or HCD similar to function. requirements, including the need for a 6. Comment: One commenter requests the language in Section 302(b) of the HAC or HCD. In any case, a party or clarification of the parties that may IAA with respect to incoming cases (i.e., interested person may apply for a HAC apply for a HAC or HCD and asks cases in which a child is immigrating to or HCD at any time. specifically whether birthparent(s) may the United States). Once a party applies for a HAC or Response: Article 23 of the apply for a HAC or HCD. The HCD, the Department, in its role as CA, Convention requires other Convention commenter also asks whether the must adjudicate the request to countries to recognize an adoption that citizenship of the adoptive parent(s) or determine if the child has been adopted has been certified by the competent prospective adoptive parent(s) will or custody of the child for purposes of authority of the State of the adoption. affect their ability to obtain a HAC or a adoption has been granted in Therefore, Convention countries must HCD. accordance with the Convention and Response: The adoptive parent(s) or recognize any adoption for which the (except as provided in § 97.4(b)) the prospective adoptive parent(s), who will Department has issued a HAC. IAA. Specifically, section 303(c) of the be habitual residents of the receiving Including a requirement in U.S. IAA provides that the Department shall country and typically will not be U.S. regulations is therefore unnecessary. In issue a HAC or HCD on receipt and citizens, will most likely be the parties addition, the United States has no verification of the required material and to apply for a HAC or a HCD. Despite authority to regulate the receiving information. The Department may thus being non-U.S. citizen adoptive countries. not issue a HAC or HCD for all cases. As for the HCD, Article 19 of the The rule mirrors the IAA statutory parent(s) or prospective adoptive Convention provides that the transfer of requirements and is not changed in parent(s), they will be able to apply for the child to the receiving country may response to the comment. The parties and obtain a HAC or HCD. The rule be carried out only if the requirements must first apply to a State court to make states that ‘‘any party’’ to an adoption or of Article 17 have been satisfied. The the needed findings, all derived from custody proceeding may apply for a HCD demonstrates to the receiving the Convention or the IAA, so that the HAC or HCD; thus, if a birthparent was country that the United States, as the proceeding is Hague-compliant. The a party to the adoption or custody country of origin, has agreed that the Department then reviews the State court proceeding, he or she may apply for a child may be entrusted to the findings to adjudicate the application HAC or HCD. Likewise, the adopted pwalker on PRODPC60 with RULES prospective adoptive parent(s) and that before issuing a HAC or HCD. The child may apply for a HAC or HCD. If the adoption may proceed in the Department may not assume that every various parties to the adoption or receiving country. The Department adoption or custody for purpose of custody proceeding apply for HACs or expects that the receiving countries will adoption case will automatically HCDs, more than one copy of the HAC VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 4. 64454 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations contacts may occur in States which 4. Comment: One commenter asks if recognize the HCD as evidence that the expressly permit such contacts and the provision in 97.3(f), which limits Article 17 requirements have been met. prescribe the conditions under which contacts between the prospective In any event, as noted, the United States such contacts may occur. adoptive parent(s) and the child’s may not regulate another Convention 5. Comment: Another commenter asks birthparent(s) or any other person who country. if States that allow ‘‘open adoptions’’ in has care of the child before the Section 97.3 Requirements Subject to which the birthparent(s) and adoption, prevents birthparent(s) from Verification in an Outgoing Convention prospective adoptive parents(s) meet identifying prospective adoptive Case and establish a trusting relationship parent(s) via such methods as reviewing before the adoption must change their parent profiles provided by an attorney 1. Comment: Several commenters laws. The commenter notes that for the prospective adoptive parent(s), request that the reasonable efforts oftentimes the open contacts continue or provided by an attorney for the requirement to locate a placement for throughout the child’s life and that birthparent(s), or provided by an the child in the United States in current psychological research supports agency, or made available online. The § 97.3(c) not apply when birthparent(s) the conclusion that such bonds are commenter also asks if birthparent(s) directly identify prospective parent(s) beneficial to the adoptee in the long- may identify prospective adoptive outside the United States. One run. parent(s) via referrals from non-relatives commenter suggests that such contacts Response: These regulations do not or by responding to advertisements be permitted as long as an accredited, require States to change their laws with placed in newspapers. temporarily accredited, or approved respect to contacts. As discussed above, Response: Section 97.3(j) implements adoption service provider is involved in pre-birth contacts are permitted in the requirements in Article 29 of the the case. Convention cases if they are allowed by Convention. Article 29’s prohibition on Response: This provision cross- the relevant State law or public prior contact applies unless the references 22 CFR 96.54(a), which domestic authority and the contacts adoption takes place within a family or specifically excludes from the occurred in accordance with required the contact is in compliance with the reasonable efforts requirement cases in conditions. conditions established in the country of which the birthparent(s) have identified 6. Comment: One commenter asks if origin, in this case the United States. For specific prospective adoptive parent(s) the no direct contacts provision of the this reason, § 97.3(j) permits contacts or in other special circumstances rule applied to the U.S. government- when a ‘‘relevant State or public accepted by the State court. sponsored http://www.AdoptUSKids.org domestic authority has established 2. Comment: One commenter photo listing service. The commenter conditions under which such contact recommends that the rule specify more explains that public domestic may occur and any such contact clearly the steps that must be completed authorities put a photo and information occurred in accordance with such for a reasonable efforts finding to be about a child eligible for adoption conditions.’’ The answers to the made by the State court. (usually a child or sibling group that has commenter’s questions thus depend on Response: As noted above, this been waiting a long time for a local law and regulations. provision cross-references 22 CFR permanent family placement) on the A State or a public domestic authority 96.54(a), which sets forth the placement web-based service and families from all may establish conditions on direct standards in outgoing cases, including over the world may express an interest contacts between birthparent(s) and the reasonable efforts requirement. in the child to the public domestic prospective adoptive parent(s). If such Specifically, reasonable efforts to find a authority, submit a home study, and conditions are set, then contacts that timely placement for the child in the then social workers for the public comply with those conditions may United States include: (1) Disseminating domestic authority determine if a occur. If a State has no laws or information on the child and his or her referral and subsequent match are in the conditions on direct contacts, then such availability for adoption through print, best interests of the child. If so, then the contacts may not occur because the media, and internet resources designed public domestic authority undertakes Convention intends that such contacts to communicate with potential the subsequent steps to complete an be either barred or subject to regulation. prospective adoptive parent(s) in the adoption, including in some cases, If these principles are applied to the United States; (2) Listing information supervising meetings with the commenter’s questions, then the answer about the child on a national or State birthparent(s), the child, and the to what direct contacts are permitted adoption exchange or registry for at least prospective adoptive parent(s). will necessarily depend on the State sixty calendar days after the birth of the Response: Public domestic authorities where the birthparent(s) are residing. If child; (3) Responding to inquiries about must comply with 22 CFR part 97. As the State where the birthparent(s) reside adoption of the child; and (4) Providing discussed above, contacts are generally permits them to review prospective a copy of the child background study to prohibited, unless the relevant State or adoptive parent(s) profiles before the potential U.S. prospective adoptive public domestic authority has referral or adoption or consider non- parent(s). established conditions under which relative referrals, then the practice is not 3. Comment: One commenter objects such contact may occur and any such per se prohibited, but must comply with to the sixty-day period for listing contact occurred in accordance with any specific State requirements, such as information about the child on a such conditions. Presumably, because those on who may present the national or State adoption exchange or the public domestic authority is information (attorney for prospective registry because research shows that coordinating the adoption, it has adoptive parent(s) or birthparent(s) or delays in placement negatively impact a established procedures on the contacts. adoption service provider). If State child’s emotional well-being. If the conditions for the contacts have requirements are completely silent, then been enumerated, then the contacts may direct contact practices are not allowed. Response: This comment goes to 22 pwalker on PRODPC60 with RULES continue even for Hague cases as long Likewise, if the State permits CFR part 96 and was addressed in the as the contacts comply with the birthparent(s) to locate prospective context of that rule. Part 96 is now a procedures that the public domestic adoptive parent(s) through media such final rule and no longer open for authority established. Thus, if a State or as newspapers or Web sites, then such comment. VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1