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  • 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
  • 5. 64455 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations limit the issuance of these certifications 2. Comment: One commenter requests its public domestic authorities permit that the rule be changed to require solely to instances where there is a birthparent(s) and the child to meet prospective adoptive parent(s) who have showing of exceptional need or if the with the prospective adoptive parent(s) been granted custody for purpose of child would be traveling. We have then this contact would be permitted. adoption by the country of origin (in deleted § 97.5(3) that required parties to As for the question about the photo- incoming cases) to complete adoptions submit a signed statement explaining listing service, unless State law in the United States. the need for such a certification. prohibits photo-listings of children Response: The Department is not eligible for adoption, States may 4. Comment: One commenter is modifying the rule as requested. continue to post information about such concerned that countries of origin Although the prospective adoptive children on the federally-funded expect copies of the Article 23 parent(s) failure to finalize the adoption national Web site. 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 final adoption order in the United States Convention Compliance in an Incoming 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 the Convention for support. Occurs in the United States adoption was granted in the country of Response: The Department believes origin. Moreover, this rule relates to 1. Comment: Two commenters are that its rule on Convention Article 23 certifications of adoptions pursuant to concerned that the certification certifications is consistent with the the Convention. procedure in § 97.5 means that Convention provisions cited and We nevertheless share the adoptions of children immigrating to the implements the Convention. commenter’s concern about adoptions United States (incoming cases) that are Specifically, as noted above, the IAA that are not finalized. The Department completed in the United States (as does not require that families finalize currently has experience with a few receiving country) after the country of the adoptions or notify the Department such cases in which the prospective origin granted custody for purposes of when the adoptions are final. We will adoptive parent(s) are granted custody adoption are not entitled to recognition use all other available means to obtain for purpose of adoption in the country under Convention Article 23. information on the final adoption of the of origin, bring the child to the United Response: Article 23 of the child for the child’s country of origin, States, and never finalize the adoption. Convention requires other Convention including relying on 22 CFR 96.50(h)(2), The family is typically intact and the countries to recognize an adoption that which requires accredited agencies, child is benefiting from an ongoing has been certified as having been made temporarily accredited agencies, and permanent placement so there is no in accordance with the Convention by approved persons, to notify the basis for the State to remove the child. the competent authority of the State of Department of the finalization of the Yet, there is no final adoption, the child the adoption. If custody for purpose of adoption within thirty days of the entry does not acquire U.S. citizenship under adoption is granted in a Convention of the final adoption order. We believe The Child Citizenship Act, and remains country of origin and the prospective that through 22 CFR 96.50(h)(2) a legal permanent resident, subject to adoptive parent(s) subsequently obtain a combined with the final rule in deportation under certain limited final adoption decree in a State court, § 97.5(e), making clear that the State circumstances. Similarly, the child does the adoption is entitled to recognition court final adoption decree may serve as not have all the additional benefits of a under the Convention, provided that the the Convention Article 23 certification, full legal parent-child relationship. State court decree is based on a the United States will fulfill its Despite these issues, there is no current 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 Regulatory Review that the grant of custody of the child 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 This rule, through which the determination that the requirements of continue our outreach and Department provides for Article 17 of the Convention have been communication efforts to stress to implementation of the Convention, met. This is true regardless of whether families and adoption service which focuses on issuance of the parent(s) or child apply for the provider(s) the critical importance of documents to facilitate cross-border additional certification under § 97.5 finalizing the adoption in both recognition of adoptions done under the because, as pointed out by the Convention and non-Convention cases. Convention, involves a foreign affairs commenters, the recognition of the 3. Comment: Some commenters function of the United States and adoption takes place by operation of law request that the rule be changed to therefore pursuant to 5 U.S.C. 553(a)(1) with or without subsequent certification mandate that the Department always is not subject to the procedures required by the Department. The U.S. adoption issue a certification under § 97.5 after by 5 U.S.C. 553 and 554. Nonetheless, would necessarily be recognized in all the parent(s) complete the final the Department published the proposed U.S. territory, but if the parent(s) or adoption in the United States. One rule and received public comment on it. other persons need documentation to commenter was concerned that a person 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. In accordance with the Regulatory Response. The Department is not may seek the certification as outlined in Flexibility Act, 5 U.S.C. 601–612, and modifying the rule in response to this § 97.5. In addition, they may rely on the Executive Order 13272, Section 3(b), the request. The Department cannot issue a State court adoption order. We have pwalker on PRODPC60 with RULES Department of State has evaluated the certification under 97.5 absent a request added a paragraph to § 97.5 to make effects of this rule on small entities and because it has no means to know when clear that the final State court order has determined and hereby certifies that a State court issues an adoption decree. shall constitute the certification under this rule would not have a significant However, the intent of § 97.5 was not to Article 23 of the Convention. VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 6. 64456 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations collection requirements imposed on State level, as discussed in the preamble economic impact on a substantial to the proposed rule on accreditation number of small entities. ‘‘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 defined in section 3(11) of the IAA to Regulatory Enforcement Fairness Act of 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 of information contained in an not result in an annual effect on the implications beyond those created by electronic or physical document, an economy of $100 million or more, a the IAA and the Convention, and the electronic collection of data, a major increase in costs or prices, or Department has been careful in this rule photograph, an audio or video tape, or significant adverse effects on to defer to State authorities whenever any other information storage medium competition, employment, investment, possible consistent with Convention of any type whatever that contains productivity, or innovation, or on the and IAA mandates. We also envision information about a specific past, ability of United States-based significant outreach and consultation current, or prospective Convention companies to compete with foreign- with appropriate State authorities in the adoption (regardless of whether the based companies in domestic and implementation of any regulation on adoption was made final) that has been export markets. this topic. preserved in accordance with section D. The Unfunded Mandates Reform Act F. Executive Order 12866: Regulatory 401(a) by the Secretary of State or the of 1995 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 conducted in accordance with the Section 4 of UFMA, 2 U.S.C. 1503, subject to the review procedures set Convention and the IAA. Upon receipt, excludes regulations necessary for forth in Executive Order 12866. In these information collections would be implementation of treaty obligations. addition, the Department is exempt subject to the preservation requirements This rule falls within this exclusion from Executive Order 12866 except to set forth in 22 CFR part 98 to implement because it would implement the the extent it is promulgating regulations section 401(a) of the IAA. Accordingly, Convention. In any event, this rule in conjunction with a domestic agency the Department has concluded that the would not result in the expenditure by that are significant regulatory actions. PRA would not apply to information State, local, or tribal governments, in the The Department of State, however, collected from the public under this aggregate, or by the private sector, of provided the proposed rule to OMB for rule, for the purpose of determining $100 million or more in any year. comment and incorporated its entitlement to a Hague Adoption Moreover, because this rule would not comments. The Department is not Certificate or Hague Custody significantly or uniquely affect small submitting the final rule to OMB, but Declaration, or a certification of governments, section 203 of the UFMA, has reviewed it to ensure consistency Convention compliance pursuant to 2 U.S.C. 1533, does not require with the regulatory philosophy and § 97.5, because such documents would preparation of a small government principles set forth in Executive Order agency plan in connection with it. be collected for use as Convention 12866. records. E. Executive Order 13132: Federalism G. Executive Order 12988: Civil Justice The Department intends, nonetheless, Reform A rule has federalism implications to consider carefully how to minimize under Executive Order 13132 if it has The Department has reviewed this the burden on the public of information substantial direct effects on the States, rule in light of sections 3(a) and 3(b)(2) collections contained in this rule as on the relationship between the national of Executive Order 12988 to eliminate such collections, in particular the government and the States, or on the ambiguity, minimize litigation, establish required application form, continue to distribution of power and clear legal standards, and reduce be developed. responsibilities among the various burden. The Department has made every 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 Adoption and foster care; Order 12988. to require consultations or to warrant International agreements; Reporting and H. The Paperwork Reduction Act (PRA) the preparation of a federalism summary recordkeeping requirements. of 1995 impact statement under section 6 of pwalker on PRODPC60 with RULES Accordingly, the Department adds I Under the Paperwork Reduction Act Executive Order 13132. new part 97 to title 22 of the CFR, (PRA), 42 U.S.C. 3501 et seq., agencies The Convention and the IAA do, chapter I, subchapter J, to read as are generally required to submit to OMB however, address issues that previously for review and approval information had been regulated primarily at the follows: VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 7. 64457 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations (f) Terms defined in 22 CFR 96.2 have identity, adoptability, background, PART 97—ISSUANCE OF ADOPTION social environment, family history, the meaning given to them therein. CERTIFICATES AND CUSTODY medical history (including that of the DECLARATIONS IN HAGUE § 97.2 Application for a Hague Adoption child’s family), and any special needs of CONVENTION ADOPTION CASES Certificate or a Hague Custody Declaration the child. (Outgoing Convention Case). Sec. (b) Transmission of Child Data. A (a) Once the Convention has entered 97.1 Definitions. 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 the birth mother or the birth father if 97.3 Requirements Subject to Verification apply to the Secretary for a Hague these identities may not be disclosed in an Outgoing Convention Case. Adoption Certificate or a Hague Custody under applicable State law, transmit to 97.4 Issuance of a Hague Adoption Declaration. Any other interested person a foreign authorized entity the Certificate or a Hague Custody may also make such application, but background study, proof that the Declaration (Outgoing Convention Case). such application will not be processed 97.5 Certification of Hague Convention necessary consents have been obtained, unless such applicant demonstrates that Compliance in an Incoming Convention 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 proceeding, as determined by the Authority: Convention on Protection of 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 Domestic Placement. Reasonable efforts Intercountry Adoption Act of 2000, 42 U.S.C. Secretary: pursuant to 22 CFR 96.54 must be made 14901–14954. (1) A completed application form in to actively recruit and make a diligent such form as the Secretary may search for prospective adoptive § 97.1 Definitions. prescribe, with any required fee; parent(s) to adopt the child in the As used in this part: (2) An official copy of the order of the United States and a timely adoptive (a) Adoption Court means the State adoption court finding that the child is placement in the United States not court with jurisdiction over the eligible for adoption and that the found. adoption or the grant of custody for (d) Preparation and Transmission of adoption or proposed adoption is in the purpose of adoption. Home Study. A U.S. authorized entity child’s best interests and granting the (b) U.S. Authorized Entity means a must receive from a foreign authorized adoption or custody for purposes of public domestic authority or an agency entity a home study on the prospective adoption; or person that is accredited or adoptive parent(s) prepared in (3) An official copy of the adoption temporarily accredited or approved by accordance with the laws of the court’s findings (either in the order an accrediting entity pursuant to 22 CFR receiving country, under the granting the adoption or custody for part 96, or a supervised provider acting responsibility of a foreign Central purposes of adoption or separately) under the supervision and Authority, foreign accredited body, or verifying, in substance, that each of the responsibility of an accredited agency or public foreign authority, that includes: requirements of § 97.3 has been temporarily accredited agency or (1) Information on the prospective complied with or, if the adoption court approved person. adoptive parent(s)’ identity, eligibility, has not verified compliance with a (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 Central Authority or other competent § 97.3 Requirements Subject to Verification in an Outgoing Convention an outgoing case (where the child is authority of the receiving country must Case. emigrating from the United States to 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 pwalker on PRODPC60 with RULES adoption has been granted in the United temporarily accredited agency, or public basis as the adopting parent(s). (f) Consent by Foreign Authorized States in accordance with the domestic authority must complete or Entity. A foreign authorized entity or Convention and, except as provided in approve a child background study that competent authority must declare that it § 97.4(b), the IAA. includes information about the child’s VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1
  • 8. 64458 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations that the prospective adoptive parent(s) (c) If a person seeking the certification consents to the adoption, if its consent is necessary under the law of the are eligible and suited to adopt and the described in paragraph (a) of this relevant foreign country for the adoption court’s determinations that the section fails to submit all the adoption to become final. child is eligible for adoption, that the documentation and information (g) Guardian Counseling and Consent. requirements in paragraphs (c) and (g) of required pursuant to paragraph (b) of Each person, institution, and authority this section have been met, and that an this section within 120 days of the (other than the child) whose consent is intercountry adoption is in the child’s Secretary’s request, the Department may necessary for the adoption must be best interests, provided that this consider the request abandoned. counseled as necessary and duly (d) The Secretary may issue the prohibition on contacts shall not apply informed of the effects of the consent certification if the Secretary, in the if the relevant State or public domestic (including whether or not an adoption Secretary’s discretion, is satisfied that authority has established conditions will terminate the legal relationship the adoption was made in compliance under which such contact may occur between the child and his or her family with the Convention. The Secretary may and any such contact occurred in of origin); must freely give consent decline to issue a certification, accordance with such conditions. expressed or evidenced in writing in the including to a party to the adoption, in (k) Improper financial gain. No one required legal form without any the Secretary’s discretion. A may derive improper financial or other inducement by compensation of any certification will not be issued to a non- gain from an activity related to the kind; and consent must not have been party requestor unless the requestor adoption, and only costs and expenses subsequently withdrawn. If the consent demonstrates that the certification is (including reasonable professional fees of the mother is required, it may be needed to obtain a legal benefit or for of persons involved in the adoption) given only after the birth of the child. purposes of a legal proceeding, as may be charged or paid. (h) Child Counseling and Consent. As determined by the Secretary in the appropriate in light of the child’s age § 97.4 Issuance of a Hague Adoption Secretary’s discretion. Certificate or a Hague Custody Declaration and maturity, the child must be (e) A State court’s final adoption (Outgoing Convention Case). counseled and informed of the effects of decree, when based upon the certificate (a) Once the Convention has entered the adoption and the child’s views must issued by a consular officer pursuant to into force for the United States, the be considered. If the child’s consent is 22 CFR 42.24(j), certifying that the grant Secretary shall issue a Hague Adoption required, the child must also be of custody of the child has occurred in Certificate or a Hague Custody counseled and informed of the effects of compliance with the Convention, or Declaration if the Secretary, in the granting consent, and must freely give upon its determination that the Secretary’s discretion, is satisfied that consent expressed or evidenced in requirements of Article 17 of the the adoption or grant of custody was writing in the required legal form Convention have been met constitutes made in compliance with the without any inducement by the certification of the adoption under Convention and the IAA. compensation of any kind. Article 23 of the Convention. (i) Authorized Entity Duties. A U.S. (b) If compliance with the Convention § 97.6–97.7 [Reserved] authorized entity must: can be certified but it is not possible to (1) Ensure that the prospective certify compliance with the IAA, the Dated: October 12, 2006. adoptive parent(s) agree to the adoption; Secretary personally may authorize Maura Harty, (2) Agree, together with a foreign issuance of an appropriately modified Assistant Secretary, Bureau of Consular authorized entity, that the adoption may Hague Adoption Certificate or Hague Affairs, Department of State. proceed; Custody Declaration, in the interests of [FR Doc. E6–18507 Filed 11–1–06; 8:45 am] (3) Take all appropriate measures to justice or to prevent grave physical ensure that the transfer of the child BILLING CODE 4710–06–P harm to the child. takes place in secure and appropriate § 97.5 Certification of Hague Convention circumstances and, if possible, in the Compliance in an Incoming Convention company of the adoptive parent(s) or the DEPARTMENT OF THE TREASURY Case Where Final Adoption Occurs in the prospective adoptive parent(s), and United States. Internal Revenue Service arrange to obtain permission for the (a) Once the Convention has entered child to leave the United States; and into force for the United States, any 26 CFR Parts 1 and 301 (4) Arrange to keep a foreign person may request the Secretary to authorized entity informed about the [TD 9295] certify that a Convention adoption in an adoption process and the measures incoming case finalized in the United RIN 1545–BF98 taken to complete it, as well as about the States was done in accordance with the progress of the placement if a AJCA Modifications to the Section Convention. probationary period is required; to 6011, 6111, and 6112 Regulations (b) Persons seeking such a return the home study and the child certification must submit the following background study to the authorities that Internal Revenue Service (IRS), AGENCY: documentation: forwarded them if the transfer of the Treasury. (1) A copy of the certificate issued by child does not take place; and to be ACTION: Final and temporary a consular officer pursuant to 22 CFR consulted in the event a new placement regulations. 42.24(j) certifying that the granting of or alternative long-term care for the custody of the child has occurred in SUMMARY: This document contains child is required. compliance with the Convention; (j) Contacts. Unless the child is being temporary and final regulations under (2) An official copy of the adoption adopted by a relative, there may be no sections 6011, 6111, and 6112 of the court’s order granting the final adoption; contact between the prospective Internal Revenue Code that modify the pwalker on PRODPC60 with RULES and adoptive parent(s) and the child’s rules relating to the disclosure of birthparent(s) or any other person who (3) Such additional documentation reportable transactions and the list has care of the child prior to the and information as the Secretary may maintenance requirements. These competent authority’s determination request at the Secretary’s discretion. regulations affect taxpayers VerDate Aug<31>2005 16:15 Nov 01, 2006 Jkt 211001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:FRFM02NOR1.SGM 02NOR1