64451
                                                       Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2...
64452            Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

               ...
64453
                                                       Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2...
64454            Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations

               ...
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs
Legal Highs From Herbs
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Legal Highs From Herbs

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Legal Highs From Herbs

  1. 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. 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. 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. 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

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