Employability skills, work experience presentation
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
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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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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.
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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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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
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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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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
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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.
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