1. Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations 64451
to compete effectively in a global a generic copy of Fort Dodge Animal (2) Indications for use. As a
environment. Health’s, Division of Wyeth’s ROBINUL- preanesthetic agent.
This Statement of Policy has been V (glycopyrrolate), approved under (3) Limitations. Federal law restricts
developed as a means for the NADA 101–777. The ANADA is this drug to use by or on the order of
Commission to respond flexibly to the approved as of October 2, 2006, and the a licensed veterinarian.
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
Policy Statement as necessary in light [FR Doc. E6–18444 Filed 11–1–06; 8:45 am]
summary.
of, the ongoing evolution of cross-border In accordance with the freedom of BILLING CODE 4160–01–S
electronic direct access and information provisions of 21 CFR part
intermediation in order to ensure that it 20 and 21 CFR 514.11(e)(2)(ii), a
does not adversely affect U.S. cash and summary of safety and effectiveness DEPARTMENT OF STATE
futures markets, market participants and data and information submitted to
customers, as well as the consumers support approval of this application 22 CFR Part 97
affected by those foreign market may be seen in the Division of Dockets [Public Notice 5602]
transactions. Management (HFA–305), Food and Drug
RIN 1400–AC19
Issued in Washington, DC, on October 27, Administration, 5630 Fishers Lane, rm.
2006 by the Commission. 1061, Rockville, MD 20852, between 9 Intercountry Adoption—Department
Eileen A. Donovan, a.m. and 4 p.m., Monday through Issuance of Certifications in Hague
Acting Secretary of the Commission.
Friday. Convention Adoption Cases
FDA has determined under 21 CFR
[FR Doc. E6–18513 Filed 11–1–06; 8:45 am] AGENCY: Department of State.
25.33(a)(1) that this action is of a type
BILLING CODE 6351–01–P
that does not individually or ACTION: Final rule.
cumulatively have a significant effect on
the human environment. Therefore, SUMMARY: The Department of State (the
DEPARTMENT OF HEALTH AND neither an environmental assessment Department) is issuing a final rule to
HUMAN SERVICES nor an environmental impact statement implement the certification and
is required. declaration provisions of the 1993
Food and Drug Administration This rule does not meet the definition Hague Convention on Protection of
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Children and Co-operation in Respect of
21 CFR Part 522 it is a rule of ‘‘particular applicability.’’ Intercountry Adoption (the Convention)
Therefore, it is not subject to the and the Intercountry Adoption Act of
Implantation or Injectable Dosage
congressional review requirements in 5 2000 (the IAA) with respect to adoption
Form New Animal Drugs;
U.S.C. 801–808. and custody proceedings taking place in
Glycopyrrolate
the United States, after review of public
List of Subjects in 21 CFR Part 522 comments received in response to the
AGENCY: Food and Drug Administration,
HHS. Animal drugs. Department’s June 16, 2006 issuance of
ACTION: Final rule. I Therefore, under the Federal Food, a proposed rule. This final rule governs
Drug, and Cosmetic Act and under the application process for Hague
SUMMARY: The Food and Drug authority delegated to the Commissioner Adoption Certificates and Hague
Administration (FDA) is amending the of Food and Drugs and redelegated to Custody Declarations in cases involving
animal drug regulations to reflect the Center for Veterinary Medicine, 21 emigration of a child from the United
approval of an abbreviated new animal CFR part 522 is amended as follows: States. It also establishes a process for
drug application (ANADA) filed by IVX seeking certification, for purposes of
Animal Health, Inc. The ANADA PART 522—IMPLANTATION OR Article 23 of the Convention, that an
provides for veterinary prescription use INJECTABLE DOSAGE FORM NEW adoption done in the United States
of glycopyrrolate solution as an ANIMAL DRUGS following a grant of custody in a
injectable preanesthetic agent in dogs Convention country of origin was done
I 1. The authority citation for 21 CFR
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
I 2. Revise § 522.1066 to read as 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 § 522.1066 Glycopyrrolate. FOR FURTHER INFORMATION CONTACT: For
Administration, 7500 Standish Pl., (a) Specifications. Each milliliter of further information, contact Anna Mary
Rockville, MD 20855, 301–827–0169, e- solution contains 0.2 milligram Coburn at 202–736–9081. Hearing- or
mail: john.harshman@fda.hhs.gov. glycopyrrolate. speech-impaired persons may use the
SUPPLEMENTARY INFORMATION: IVX (b) Sponsors. See Nos. 000856 and Telecommunications Devices for the
Animal Health, Inc., 3915 South 48th 059130 in § 510.600(c) of this chapter. Deaf (TDD) by contacting the Federal
Street Ter., St. Joseph, MO 64503, filed (c) Conditions of use in dogs and Information Relay Service at 1–800–
ANADA 200–365 that provides for cats—(1) Amount. 5 micrograms per 877–8339.
veterinary prescription use of pound of body weight (0.25 milliliter
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SUPPLEMENTARY INFORMATION:
Glycopyrrolate Injectable as a per 10 pounds of body weight) by
preanesthetic agent in dogs and cats. intravenous, intramuscular, or I. Background
IVX Animal Health, Inc.’s subcutaneous injection in dogs or by The Convention is a multilateral
Glycopyrrolate Injectable is approved as intramuscular injection in cats. treaty that provides a framework for the
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2. 64452 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations
adoption of children habitually resident parties to recognize adoptions, if the are governed mainly by State law, when
in one country party to the Convention adoption is certified by the country of the IAA has expressly imposed such
by persons habitually resident in adoption as having been made in Convention requirements. Finally, the
another country party to the accordance with the Convention. This Department has changed the title of the
Convention. It was developed under the final rule also establishes a separate, proposed rule to clarify that the rule
auspices of the intergovernmental discretionary, procedure pursuant to covers both incoming and outgoing case
organization known as the Hague which the Department may certify that certifications. The title change is not
Conference on Private International Law an incoming case finalized in the United indicative of any substantive changes to
(the Hague Conference). States (i.e., a case in which custody was the final rule.
The United States signed the granted abroad but the adoption was
Convention on March 31, 1994, and the Section 97.1 Definitions
done by a U.S. court) was done in
President subsequently transmitted the accordance with the Convention. The No comments on the definitions were
Convention to the Senate for its advice Department may issue this certification received, and no changes to 97.1 have
and consent. On September 20, 2000, if an issue arises concerning recognition been made. One commenter did
the Senate gave its advice and consent of the adoption pursuant to Article 23 recommend that throughout the rule the
to the ratification of the Convention of the Convention. term ‘‘adoptable’’ child be removed
and, at about the same time, Congress Further background on the because, according to the commenter,
enacted the implementing legislation for Convention and the IAA is provided in the term has historically implied that
the Convention—the Intercountry the Preamble to the Proposed Rule on children are a marketable commodity.
Adoption Act (the IAA), Public Law Issuance of Hague Convention Although the Convention itself uses the
106–279, 42 U.S.C. 14901–14952. Certificates and Declarations in term ‘‘adoptable’’ despite similar
Consistent with U.S policy on Convention Adoption Cases, Section I, objections at the time of drafting, we
ratification of treaties and the Senate’s 71 FR 34857–34858 (June 16, 2006); the have changed the word ‘‘adoptable’’ to
advice and consent to ratification, the Preamble to the Final Rule on the ‘‘eligible for adoption’’ whenever
United States will not ratify the Accreditation and Approval of Agencies possible.
Convention until the United States is and Persons under the IAA, Section I Section 97.2 Application for a Hague
able to carry out its obligations under and II, 71 FR 8064–8066 (February 15, Adoption Certificate (HAC) or a Hague
the Convention. (See Senate Declaration 2006); and the Preamble to the Proposed
Custody Declaration (HCD) (Outgoing
for Convention Article 22(2) (146 Cong. Rule on the Accreditation of Agencies
Case)
Rec. S8866 (daily ed. Sept. 20, 2000). and Approval of Persons under the
Although this final rule is effective in 30 Intercountry Adoption Act of 2000, 1. Comment: Some commenters are
days, parties are not required to comply Sections III and IV, 68 FR 54065–54073 concerned about how long the process
with the provisions of 22 CFR part 97 (September 15, 2003). to obtain a HAC or a HCD will take and
until the Convention enters into force that any delays could negatively affect
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 final rule establishes procedures This section provides a detailed recommends that specific timeframes be
for issuing certifications in Convention discussion of comments received on the added to the rule, such as requiring the
adoptions involving the emigration of a proposed rule and describes changes Department to issue a HAC or HCD in
child from the United States (outgoing made to the proposed rule. Three three business days, to ensure that
cases) and for seeking certifications general points should be kept in mind families who had traveled to adopt a
regarding adoptions in incoming cases. in reading this discussion. First, we child living the United States did not
In response to its issuance of the refer generally to actions of the have to wait too long for a HAC or HCD
proposed rule, the Department received ‘‘Department’’ pursuant to the rule. The once the relevant State court issued the
insightful public comments that are rule itself refers to actions of the final adoption decree or custody decree.
posted on the Department’s Web site at ‘‘Secretary,’’ as the official named in the Response: We agree that the HAC or
http://www.travel.state.gov. The IAA, but the day-to-day exercise of the HCD should be swiftly issued. The
Department is issuing the rule as final Secretary’s functions has been delegated Department, however, is not including a
with minor changes, taking into account (Delegation of Authority 261, 68 FR specific timeframe in the rule. Our goal
the comments received. 56372, September 30, 2003) to the nonetheless is to issue a HAC or HCD
Section 303(c) of the IAA gives the Assistant Secretary for Consular Affairs. as soon as possible, provided the
Department responsibility for issuing an Second, this rule directly imposes supporting documentation required
official certification that a child resident Federal requirements on State courts to under § 96.3 has been submitted.
in the United States has been adopted, the extent consistent with the IAA. 2. Comment: One commenter urges
or a declaration that custody for the Specifically, the IAA assigns to State the Department to accept all materials,
purpose of adoption has been granted, courts with jurisdiction over matters of including applications and supporting
in accordance with the Convention and adoption, or custody for purpose of documents by fax or e-mail, and to
the IAA. The IAA assigns to State courts adoption, the responsibility for encourage other Central Authorities
with jurisdiction over matters of receiving and verifying documents (CAs) to do the same. The commenter
adoption, or custody for purposes of required under the Convention, making also asks that the Department encourage
adoption, the responsibility for certain determinations required of the the CAs of receiving countries to
receiving and verifying documents country of origin by the Convention, provide any necessary approvals within
required under the Convention, making and determining that the placement is 24 hours of request, noting that the
certain determinations required of the in the best interests of the child. In Netherlands issues approvals within 24
country of origin by the Convention, keeping with current U. S. domestic law hours.
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and determining that the placement is and philosophy of treaty application in Response: The Department intends to
in the best interests of the child. With the context of a federalist system, we accept applications and supporting
certain limited exceptions, the have imposed the Convention materials via fax and e-mail to the
Convention requires all Convention requirements on outgoing cases, which extent practicable. We will encourage
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3. Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations 64453
other CAs to accept communications by or HCD may be issued. The conform with the Convention and the
fax and e-mail as well. We also plan to Department’s goal is to provide a HAC IAA, as implemented through § 97.3,
urge other CAs to act expeditiously to or HCD to any party to the adoption or and issue a HAC or HCD without
send any necessary approvals to custody proceeding who may need it to adjudicating the application.
relevant State courts for a Hague obtain recognition and acceptance of the We understand that some parties to
outgoing case. adoption decree or custody for purpose intercountry adoptions may be unaware
3. Comment: One commenter requests of adoption decree from other of the Convention and the IAA and
that fee payments be permitted by credit Convention countries or from U.S. consequently may not submit to the
card submission via Internet, phone, or authorities. State court the information the court
fax. 7. Comment: Some commenters needs to make the findings required
Response: If a fee is charged for request clarification of the application under § 97.3. The Department plans to
issuance of a HAC or HCD, we will process for HACs and HCDs. In continue its extensive outreach efforts to
make the methods of payment easy and particular, commenters want to know if inform interested persons about the
consistent with other federal agency a HAC or HCD is automatically issued Convention, the IAA, and the applicable
requirements covering payment of fees. even if no party applies. Similarly, other regulations. To date, we have conducted
4. Comment: One commenter asks commenters believe that the Department numerous outreach events with State
which part of the Department will be should always issue a HAC or HCD after court judges, public domestic
responsible for issuing HACs and HCDs a State court grants an adoption or authorities, and adoption service
and where its office will be located. custody for purpose of adoption decree. providers.
Response: The Office of Children’s Others are concerned that many parties 8. Comment: One commenter suggests
Issues in the Bureau of Consular Affairs will be unaware that for outgoing cases that the Department is withholding
will issue HACs and HCDs out of its involving Convention adoptions, the recognition of the State court adoption
central office in Washington, DC. receiving country is obligated not to or custody decree if it declines to issue
5. Comment: One commenter asks permit the child’s entry unless the the HAC or HCD.
what type of training will be provided Department (as CA of the country of Response. By verifying compliance
to the staff responsible for adjudicating origin) has issued a HAC or HCD for the with § 97.3 before issuing a HAC or
applications for HACs or HCDs and child. HCD, the Department is acting in
requests information on how this Response: Unless there is an accordance with Article 23 of the
function will be staffed. application from a party or other Convention. The Department’s
Response: The Department plans to interested person, in accordance with verification that all steps in the
train the Office of Children’s Issues case § 97.2(a), the Department will not sua adoption and/or custody process
officers thoroughly by using Foreign sponte issue a HAC or HCD. The complied with the Convention, the IAA,
Affairs Manual (FAM) materials and Department must be notified, via the and the regulations implementing the
formal classroom training. With respect application process, for the HAC or HCD IAA ensures that U.S. children leaving
to staffing, we do not yet know the to be issued. We expect that the the United States are protected in
number of outgoing cases and thus adoption service provider working with accordance with the Convention.
cannot determine how many officers the family would inform the prospective 9. Comment: One commenter requests
will be assigned this critical CA adoptive parent(s) of any necessary that the rule include language on the
function. requirements, including the need for a legal effect of a HAC or HCD similar to
6. Comment: One commenter requests HAC or HCD. In any case, a party or the language in Section 302(b) of the
clarification of the parties that may interested person may apply for a HAC IAA with respect to incoming cases (i.e.,
apply for a HAC or HCD and asks or HCD at any time. cases in which a child is immigrating to
specifically whether birthparent(s) may Once a party applies for a HAC or the United States).
apply for a HAC or HCD. The HCD, the Department, in its role as CA, Response: Article 23 of the
commenter also asks whether the must adjudicate the request to Convention requires other Convention
citizenship of the adoptive parent(s) or determine if the child has been adopted countries to recognize an adoption that
prospective adoptive parent(s) will or custody of the child for purposes of has been certified by the competent
affect their ability to obtain a HAC or a adoption has been granted in authority of the State of the adoption.
HCD. accordance with the Convention and Therefore, Convention countries must
Response: The adoptive parent(s) or (except as provided in § 97.4(b)) the recognize any adoption for which the
prospective adoptive parent(s), who will IAA. Specifically, section 303(c) of the Department has issued a HAC.
be habitual residents of the receiving IAA provides that the Department shall Including a requirement in U.S.
country and typically will not be U.S. issue a HAC or HCD on receipt and regulations is therefore unnecessary. In
citizens, will most likely be the parties verification of the required material and addition, the United States has no
to apply for a HAC or a HCD. Despite information. The Department may thus authority to regulate the receiving
being non-U.S. citizen adoptive not issue a HAC or HCD for all cases. countries.
parent(s) or prospective adoptive The rule mirrors the IAA statutory As for the HCD, Article 19 of the
parent(s), they will be able to apply for requirements and is not changed in Convention provides that the transfer of
and obtain a HAC or HCD. The rule response to the comment. The parties the child to the receiving country may
states that ‘‘any party’’ to an adoption or must first apply to a State court to make be carried out only if the requirements
custody proceeding may apply for a the needed findings, all derived from of Article 17 have been satisfied. The
HAC or HCD; thus, if a birthparent was the Convention or the IAA, so that the HCD demonstrates to the receiving
a party to the adoption or custody proceeding is Hague-compliant. The country that the United States, as the
proceeding, he or she may apply for a Department then reviews the State court country of origin, has agreed that the
HAC or HCD. Likewise, the adopted findings to adjudicate the application child may be entrusted to the
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child may apply for a HAC or HCD. If before issuing a HAC or HCD. The prospective adoptive parent(s) and that
various parties to the adoption or Department may not assume that every the adoption may proceed in the
custody proceeding apply for HACs or adoption or custody for purpose of receiving country. The Department
HCDs, more than one copy of the HAC adoption case will automatically expects that the receiving countries will
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4. 64454 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations
recognize the HCD as evidence that the 4. Comment: One commenter asks if contacts may occur in States which
Article 17 requirements have been met. the provision in 97.3(f), which limits expressly permit such contacts and
In any event, as noted, the United States contacts between the prospective prescribe the conditions under which
may not regulate another Convention adoptive parent(s) and the child’s such contacts may occur.
country. birthparent(s) or any other person who 5. Comment: Another commenter asks
has care of the child before the if States that allow ‘‘open adoptions’’ in
Section 97.3 Requirements Subject to adoption, prevents birthparent(s) from which the birthparent(s) and
Verification in an Outgoing Convention identifying prospective adoptive prospective adoptive parents(s) meet
Case parent(s) via such methods as reviewing and establish a trusting relationship
1. Comment: Several commenters parent profiles provided by an attorney before the adoption must change their
request that the reasonable efforts for the prospective adoptive parent(s), laws. The commenter notes that
requirement to locate a placement for or provided by an attorney for the oftentimes the open contacts continue
the child in the United States in birthparent(s), or provided by an throughout the child’s life and that
§ 97.3(c) not apply when birthparent(s) agency, or made available online. The current psychological research supports
directly identify prospective parent(s) commenter also asks if birthparent(s) the conclusion that such bonds are
outside the United States. One may identify prospective adoptive beneficial to the adoptee in the long-
commenter suggests that such contacts parent(s) via referrals from non-relatives run.
be permitted as long as an accredited, or by responding to advertisements Response: These regulations do not
temporarily accredited, or approved placed in newspapers. require States to change their laws with
adoption service provider is involved in Response: Section 97.3(j) implements respect to contacts. As discussed above,
the case. the requirements in Article 29 of the pre-birth contacts are permitted in
Response: This provision cross- Convention. Article 29’s prohibition on Convention cases if they are allowed by
references 22 CFR 96.54(a), which prior contact applies unless the the relevant State law or public
specifically excludes from the adoption takes place within a family or domestic authority and the contacts
reasonable efforts requirement cases in the contact is in compliance with the occurred in accordance with required
which the birthparent(s) have identified conditions established in the country of conditions.
origin, in this case the United States. For 6. Comment: One commenter asks if
specific prospective adoptive parent(s)
this reason, § 97.3(j) permits contacts the no direct contacts provision of the
or in other special circumstances
when a ‘‘relevant State or public rule applied to the U.S. government-
accepted by the State court.
domestic authority has established sponsored http://www.AdoptUSKids.org
2. Comment: One commenter photo listing service. The commenter
recommends that the rule specify more conditions under which such contact
may occur and any such contact explains that public domestic
clearly the steps that must be completed authorities put a photo and information
for a reasonable efforts finding to be occurred in accordance with such
conditions.’’ The answers to the about a child eligible for adoption
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 A State or a public domestic authority permanent family placement) on the
96.54(a), which sets forth the placement may establish conditions on direct web-based service and families from all
standards in outgoing cases, including contacts between birthparent(s) and over the world may express an interest
the reasonable efforts requirement. prospective adoptive parent(s). If such in the child to the public domestic
Specifically, reasonable efforts to find a conditions are set, then contacts that authority, submit a home study, and
timely placement for the child in the comply with those conditions may then social workers for the public
United States include: (1) Disseminating occur. If a State has no laws or domestic authority determine if a
information on the child and his or her conditions on direct contacts, then such referral and subsequent match are in the
availability for adoption through print, contacts may not occur because the best interests of the child. If so, then the
media, and internet resources designed Convention intends that such contacts public domestic authority undertakes
to communicate with potential be either barred or subject to regulation. the subsequent steps to complete an
prospective adoptive parent(s) in the If these principles are applied to the adoption, including in some cases,
United States; (2) Listing information commenter’s questions, then the answer supervising meetings with the
about the child on a national or State to what direct contacts are permitted birthparent(s), the child, and the
adoption exchange or registry for at least will necessarily depend on the State prospective adoptive parent(s).
sixty calendar days after the birth of the where the birthparent(s) are residing. If Response: Public domestic authorities
child; (3) Responding to inquiries about the State where the birthparent(s) reside must comply with 22 CFR part 97. As
adoption of the child; and (4) Providing permits them to review prospective discussed above, contacts are generally
a copy of the child background study to adoptive parent(s) profiles before the prohibited, unless the relevant State or
potential U.S. prospective adoptive referral or adoption or consider non- public domestic authority has
parent(s). relative referrals, then the practice is not established conditions under which
3. Comment: One commenter objects per se prohibited, but must comply with such contact may occur and any such
to the sixty-day period for listing any specific State requirements, such as contact occurred in accordance with
information about the child on a those on who may present the such conditions. Presumably, because
national or State adoption exchange or information (attorney for prospective the public domestic authority is
registry because research shows that adoptive parent(s) or birthparent(s) or coordinating the adoption, it has
delays in placement negatively impact a adoption service provider). If State established procedures on the contacts.
child’s emotional well-being. requirements are completely silent, then If the conditions for the contacts have
Response: This comment goes to 22 direct contact practices are not allowed. been enumerated, then the contacts may
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CFR part 96 and was addressed in the Likewise, if the State permits continue even for Hague cases as long
context of that rule. Part 96 is now a birthparent(s) to locate prospective as the contacts comply with the
final rule and no longer open for adoptive parent(s) through media such procedures that the public domestic
comment. as newspapers or Web sites, then such authority established. Thus, if a State or
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5. Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations 64455
its public domestic authorities permit 2. Comment: One commenter requests limit the issuance of these certifications
birthparent(s) and the child to meet that the rule be changed to require solely to instances where there is a
with the prospective adoptive parent(s) prospective adoptive parent(s) who have showing of exceptional need or if the
then this contact would be permitted. been granted custody for purpose of child would be traveling. We have
As for the question about the photo- adoption by the country of origin (in deleted § 97.5(3) that required parties to
listing service, unless State law incoming cases) to complete adoptions submit a signed statement explaining
prohibits photo-listings of children in the United States. the need for such a certification.
eligible for adoption, States may Response: The Department is not 4. Comment: One commenter is
continue to post information about such modifying the rule as requested. concerned that countries of origin
children on the federally-funded Although the prospective adoptive expect copies of the Article 23
national Web site. parent(s) failure to finalize the adoption certification to be sent in every case
is problematic, the IAA does not require where the adoption is completed by a
Section 97.5 Certification of Hague prospective adoptive parent(s) to obtain
Convention Compliance in an Incoming final adoption order in the United States
a final adoption decree in a U.S. State and cite Articles 7, 20, and 23, and of
Convention Case Where Adoption court when only custody for purpose of
Occurs in the United States the Convention for support.
adoption was granted in the country of
origin. Moreover, this rule relates to Response: The Department believes
1. Comment: Two commenters are that its rule on Convention Article 23
concerned that the certification certifications of adoptions pursuant to
the Convention. certifications is consistent with the
procedure in § 97.5 means that Convention provisions cited and
adoptions of children immigrating to the We nevertheless share the
commenter’s concern about adoptions implements the Convention.
United States (incoming cases) that are Specifically, as noted above, the IAA
completed in the United States (as that are not finalized. The Department
currently has experience with a few does not require that families finalize
receiving country) after the country of the adoptions or notify the Department
origin granted custody for purposes of such cases in which the prospective
adoptive parent(s) are granted custody when the adoptions are final. We will
adoption are not entitled to recognition use all other available means to obtain
under Convention Article 23. for purpose of adoption in the country
of origin, bring the child to the United information on the final adoption of the
Response: Article 23 of the States, and never finalize the adoption. child for the child’s country of origin,
Convention requires other Convention The family is typically intact and the including relying on 22 CFR 96.50(h)(2),
countries to recognize an adoption that child is benefiting from an ongoing which requires accredited agencies,
has been certified as having been made permanent placement so there is no temporarily accredited agencies, and
in accordance with the Convention by basis for the State to remove the child. approved persons, to notify the
the competent authority of the State of Yet, there is no final adoption, the child Department of the finalization of the
the adoption. If custody for purpose of does not acquire U.S. citizenship under adoption within thirty days of the entry
adoption is granted in a Convention The Child Citizenship Act, and remains of the final adoption order. We believe
country of origin and the prospective a legal permanent resident, subject to that through 22 CFR 96.50(h)(2)
adoptive parent(s) subsequently obtain a deportation under certain limited combined with the final rule in
final adoption decree in a State court, circumstances. Similarly, the child does § 97.5(e), making clear that the State
the adoption is entitled to recognition not have all the additional benefits of a court final adoption decree may serve as
under the Convention, provided that the full legal parent-child relationship. the Convention Article 23 certification,
State court decree is based on a Despite these issues, there is no current the United States will fulfill its
certificate issued by a consular officer authority or new authority in the IAA Convention obligations.
pursuant to 22 CFR 42.24(j) certifying granting the Department or the
that the grant of custody of the child Regulatory Review
Department of Homeland Security
occurred in compliance with the (DHS) the authority to compel A. Administrative Procedures Act
Convention or on the court’s finalization of the adoption. We plan to
determination that the requirements of continue our outreach and This rule, through which the
Article 17 of the Convention have been communication efforts to stress to Department provides for
met. This is true regardless of whether families and adoption service implementation of the Convention,
the parent(s) or child apply for the provider(s) the critical importance of which focuses on issuance of
additional certification under § 97.5 finalizing the adoption in both documents to facilitate cross-border
because, as pointed out by the Convention and non-Convention cases. recognition of adoptions done under the
commenters, the recognition of the 3. Comment: Some commenters Convention, involves a foreign affairs
adoption takes place by operation of law request that the rule be changed to function of the United States and
with or without subsequent certification mandate that the Department always therefore pursuant to 5 U.S.C. 553(a)(1)
by the Department. The U.S. adoption issue a certification under § 97.5 after is not subject to the procedures required
would necessarily be recognized in all the parent(s) complete the final by 5 U.S.C. 553 and 554. Nonetheless,
U.S. territory, but if the parent(s) or adoption in the United States. One the Department published the proposed
other persons need documentation to commenter was concerned that a person rule and received public comment on it.
show that the Convention adoption requesting the certification must show a B. Regulatory Flexibility Act/Executive
finalized in the United States was done need for it, including a showing that the Order 13272: Small Business
in accordance with the Convention, they child would be traveling overseas.
may seek the certification as outlined in Response. The Department is not In accordance with the Regulatory
§ 97.5. In addition, they may rely on the modifying the rule in response to this Flexibility Act, 5 U.S.C. 601–612, and
State court adoption order. We have request. The Department cannot issue a Executive Order 13272, Section 3(b), the
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added a paragraph to § 97.5 to make certification under 97.5 absent a request Department of State has evaluated the
clear that the final State court order because it has no means to know when effects of this rule on small entities and
shall constitute the certification under a State court issues an adoption decree. has determined and hereby certifies that
Article 23 of the Convention. However, the intent of § 97.5 was not to this rule would not have a significant
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6. 64456 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations
economic impact on a substantial State level, as discussed in the preamble collection requirements imposed on
number of small entities. to the proposed rule on accreditation ‘‘persons’’ as defined in the PRA.
and approval of agencies and persons, Section 503(c) of the IAA, however,
C. Small Business Regulatory
appearing at 68 FR 54064, 54069–54070. exempts from the PRA any information
Enforcement Fairness Act of 1996
In recognition of this fact, section 503(a) collection ‘‘for purposes of sections 104,
This rule is not a major rule as of the IAA contains a specific provision 202(b)(4), and 303(d)’’ of the IAA ‘‘or for
defined by 5 U.S.C. 804 for purposes of limiting preemption of State law to use as a Convention record as defined’’
congressional review of agency those State law provisions inconsistent in the IAA. Convention record is
rulemaking under the Small Business with the Convention or the IAA, and
Regulatory Enforcement Fairness Act of defined in section 3(11) of the IAA to
only to the extent of the inconsistency. mean ‘‘any item, collection, or grouping
1996, Pub. L. 104–121. The rule would This rule does not create new federalism
not result in an annual effect on the of information contained in an
implications beyond those created by
economy of $100 million or more, a electronic or physical document, an
the IAA and the Convention, and the
major increase in costs or prices, or Department has been careful in this rule electronic collection of data, a
significant adverse effects on to defer to State authorities whenever photograph, an audio or video tape, or
competition, employment, investment, possible consistent with Convention any other information storage medium
productivity, or innovation, or on the and IAA mandates. We also envision of any type whatever that contains
ability of United States-based significant outreach and consultation information about a specific past,
companies to compete with foreign- with appropriate State authorities in the current, or prospective Convention
based companies in domestic and implementation of any regulation on adoption (regardless of whether the
export markets. this topic. adoption was made final) that has been
preserved in accordance with section
D. The Unfunded Mandates Reform Act F. Executive Order 12866: Regulatory
of 1995 401(a) by the Secretary of State or the
Review
Attorney General.’’ Information
Section 202 of the Unfunded This rule, through which the collections imposed on persons
Mandates Reform Act of 1995 (UFMA), Department provides for pursuant to this rule would relate
Pub. L. 104–4; 109 Stat. 48; 2 U.S.C. implementation of the Convention, directly to specific Convention
1532, generally requires agencies to which focuses on issuance of adoptions (whether final or not), insofar
prepare a statement, including cost- documents to facilitate cross-border as collections would be used by the
benefit and other analyses, before recognition of adoptions done under the Department in its determination of
proposing any rule that may result in an Convention, pertains to a foreign affairs whether a Convention adoption, or a
annual expenditure of $100 million or function of the United States; therefore, grant of custody for purposes of a
more by State, local, or tribal pursuant to section 3(d)(2) of the Convention adoption, has been
governments, or by the private sector. Executive Order 12866, this rule is not
Section 4 of UFMA, 2 U.S.C. 1503, conducted in accordance with the
subject to the review procedures set
excludes regulations necessary for Convention and the IAA. Upon receipt,
forth in Executive Order 12866. In
implementation of treaty obligations. these information collections would be
addition, the Department is exempt
This rule falls within this exclusion subject to the preservation requirements
from Executive Order 12866 except to
because it would implement the the extent it is promulgating regulations set forth in 22 CFR part 98 to implement
Convention. In any event, this rule in conjunction with a domestic agency section 401(a) of the IAA. Accordingly,
would not result in the expenditure by that are significant regulatory actions. the Department has concluded that the
State, local, or tribal governments, in the The Department of State, however, PRA would not apply to information
aggregate, or by the private sector, of provided the proposed rule to OMB for collected from the public under this
$100 million or more in any year. comment and incorporated its rule, for the purpose of determining
Moreover, because this rule would not comments. The Department is not entitlement to a Hague Adoption
significantly or uniquely affect small submitting the final rule to OMB, but Certificate or Hague Custody
governments, section 203 of the UFMA, has reviewed it to ensure consistency Declaration, or a certification of
2 U.S.C. 1533, does not require with the regulatory philosophy and Convention compliance pursuant to
preparation of a small government principles set forth in Executive Order § 97.5, because such documents would
agency plan in connection with it. 12866. be collected for use as Convention
E. Executive Order 13132: Federalism records.
G. Executive Order 12988: Civil Justice
A rule has federalism implications Reform The Department intends, nonetheless,
under Executive Order 13132 if it has to consider carefully how to minimize
The Department has reviewed this
substantial direct effects on the States, the burden on the public of information
rule in light of sections 3(a) and 3(b)(2)
on the relationship between the national collections contained in this rule as
of Executive Order 12988 to eliminate
government and the States, or on the ambiguity, minimize litigation, establish such collections, in particular the
distribution of power and clear legal standards, and reduce required application form, continue to
responsibilities among the various burden. The Department has made every be developed.
levels of government. This rule will not reasonable effort to ensure compliance List of Subjects in 22 CFR Part 97
have such effects, and therefore does not with the requirements in Executive
have sufficient federalism implications Order 12988. Adoption and foster care;
to require consultations or to warrant International agreements; Reporting and
the preparation of a federalism summary H. The Paperwork Reduction Act (PRA)
recordkeeping requirements.
impact statement under section 6 of of 1995
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Executive Order 13132. Under the Paperwork Reduction Act I Accordingly, the Department adds
The Convention and the IAA do, (PRA), 42 U.S.C. 3501 et seq., agencies new part 97 to title 22 of the CFR,
however, address issues that previously are generally required to submit to OMB chapter I, subchapter J, to read as
had been regulated primarily at the for review and approval information follows:
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7. Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations 64457
PART 97—ISSUANCE OF ADOPTION (f) Terms defined in 22 CFR 96.2 have identity, adoptability, background,
CERTIFICATES AND CUSTODY the meaning given to them therein. social environment, family history,
DECLARATIONS IN HAGUE medical history (including that of the
§ 97.2 Application for a Hague Adoption child’s family), and any special needs of
CONVENTION ADOPTION CASES Certificate or a Hague Custody Declaration
(Outgoing Convention Case).
the child.
Sec. (b) Transmission of Child Data. A
97.1 Definitions. (a) Once the Convention has entered U.S. authorized entity must conclude
97.2 Application for a Hague Adoption into force for the United States, any that the child is eligible for adoption
Certificate or a Hague Custody party to an outgoing Convention and, without revealing the identity of
Declaration (Outgoing Convention Case). adoption or custody proceeding may
97.3 Requirements Subject to Verification the birth mother or the birth father if
apply to the Secretary for a Hague these identities may not be disclosed
in an Outgoing Convention Case.
97.4 Issuance of a Hague Adoption
Adoption Certificate or a Hague Custody under applicable State law, transmit to
Certificate or a Hague Custody Declaration. Any other interested person a foreign authorized entity the
Declaration (Outgoing Convention Case). may also make such application, but background study, proof that the
97.5 Certification of Hague Convention such application will not be processed necessary consents have been obtained,
Compliance in an Incoming Convention unless such applicant demonstrates that and the reason for its determination that
Case Where Final Adoption Occurs in a Hague Adoption Certificate or Hague the proposed placement is in the child’s
the United States. Custody Declaration is needed to obtain best interests, based on the home study
97.6–97.7 [Reserved]. a legal benefit or for purposes of a legal and child background study and giving
Authority: Convention on Protection of proceeding, as determined by the due consideration to the child’s
Children and Co-operation in Respect of Secretary in the Secretary’s discretion. upbringing and his or her ethnic,
Intercountry Adoption (done at The Hague, (b) Applicants for a Hague Adoption religious, and cultural background.
May 29, 1993), S. Treaty Doc. 105–51 (1998); Certificate or Hague Custody (c) Reasonable Efforts to find
1870 U.N.T.S. 167 (Reg. No. 31922 (1993)); Declaration shall submit to the
Intercountry Adoption Act of 2000, 42 U.S.C.
Domestic Placement. Reasonable efforts
14901–14954.
Secretary: pursuant to 22 CFR 96.54 must be made
(1) A completed application form in to actively recruit and make a diligent
§ 97.1 Definitions. such form as the Secretary may search for prospective adoptive
As used in this part: prescribe, with any required fee; parent(s) to adopt the child in the
(a) Adoption Court means the State (2) An official copy of the order of the United States and a timely adoptive
court with jurisdiction over the adoption court finding that the child is placement in the United States not
adoption or the grant of custody for eligible for adoption and that the found.
purpose of adoption. adoption or proposed adoption is in the (d) Preparation and Transmission of
(b) U.S. Authorized Entity means a child’s best interests and granting the Home Study. A U.S. authorized entity
public domestic authority or an agency adoption or custody for purposes of must receive from a foreign authorized
or person that is accredited or adoption; entity a home study on the prospective
temporarily accredited or approved by (3) An official copy of the adoption adoptive parent(s) prepared in
an accrediting entity pursuant to 22 CFR court’s findings (either in the order accordance with the laws of the
part 96, or a supervised provider acting granting the adoption or custody for receiving country, under the
under the supervision and purposes of adoption or separately) responsibility of a foreign Central
responsibility of an accredited agency or verifying, in substance, that each of the Authority, foreign accredited body, or
temporarily accredited agency or requirements of § 97.3 has been public foreign authority, that includes:
complied with or, if the adoption court (1) Information on the prospective
approved person.
has not verified compliance with a adoptive parent(s)’ identity, eligibility,
(c) Foreign Authorized Entity means a and suitability to adopt, background,
particular requirement in § 97.3,
foreign Central Authority or an family and medical history, social
authenticated documentation showing
accredited body or entity other than the environment, reasons for adoption,
that such requirement nevertheless has
Central Authority authorized by the ability to undertake an intercountry
been met and a written explanation of
relevant foreign country to perform adoption, and the characteristics of the
why the adoption court’s verification of
Central Authority functions in a children for whom they would be
compliance with the requirement
Convention adoption case. qualified to care;
cannot be submitted; and
(d) Hague Adoption Certificate means (2) Confirmation that a competent
(4) Such additional documentation
a certificate issued by the Secretary in authority has determined that the
and information as the Secretary may
an outgoing case (where the child is prospective adoptive parent(s) are
request at the Secretary’s discretion.
emigrating from the United States to eligible and suited to adopt and has
(c) If the applicant fails to submit all
another Convention country) certifying ensured that the prospective adoptive
of the documentation and information
that a child has been adopted in the parent(s) have been counseled as
required pursuant to paragraph (b)(4) of
United States in accordance with the necessary; and
this section within 120 days of the
Convention and, except as provided in (3) The results of a criminal
Secretary’s request, the Secretary may
§ 97.4(b), the IAA. background check.
consider the application abandoned.
(e) Hague Custody Declaration means (e) Authorization to Enter. The
a declaration issued by the Secretary in § 97.3 Requirements Subject to Central Authority or other competent
an outgoing case (where the child is Verification in an Outgoing Convention authority of the receiving country must
emigrating from the United States to Case. declare that the child will be authorized
another Convention country) declaring (a) Preparation of Child Background to enter and reside in the receiving
that custody of a child for purposes of Study. An accredited agency, country permanently or on the same
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adoption has been granted in the United temporarily accredited agency, or public basis as the adopting parent(s).
States in accordance with the domestic authority must complete or (f) Consent by Foreign Authorized
Convention and, except as provided in approve a child background study that Entity. A foreign authorized entity or
§ 97.4(b), the IAA. includes information about the child’s competent authority must declare that it
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