Notices. Notice

11,209 words·~51 min read·/register/2007/06/21/07-3045

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Principal Deputy Assistant Secretary, Deputy Assistant Secretaries, Program Directors, Program Commissioners, Deputy Director/Commissioner, Office of Child Support Enforcement, and Staff Office Directors the following authority vested in me by the Secretary of Health and Human Services in the memorandum dated August 20, 1991, Delegations of Authority for Social Security Act Programs; 31 U.S.C. 1535; and HHS General Administrative Manual, Chapter 8-77.

(a)Authorities Delegated 1. Authority to administer approved cooperative research, experimental, pilot or demonstration projects under the provisions of sections 1110 and 1115 of the Social Security Act. 2. Authority to approve interagency agreements to procure, provide or exchange services, supplies or equipment.

(b)Limitations 1. The authority listed in #1 above shall be exercised under the condition that projects may be administered by the Office of Planning, Research and Evaluation (OPRE), by the program/staff office or jointly by OPRE with the program/staff office. 2. Where all or any part of an experimental, pilot, demonstration, or other project is wholly financed with Federal funds made available under sections 1110 or 1115 of the Social Security Act, without any State, local or other non-Federal financial participation, that project must be approved by the Secretary of Health and Human Services. 3. This delegation of authority does not include the authority to approve/disapprove projects under section 1115 of the Social Security Act or approve/disapprove waivers of State Plan requirements or costs that would not otherwise be included as expenditures under the provisions of section 1115(a)(1) and

(2)of the Social Security Act. 4. The authority to approve interagency agreements to procure, provide, or exchange services, supplies, or equipment requires the concurrence of the ACF Chief Financial Officer if it exceeds $250,000 (including amendments) within a fiscal year or if it requires the signature of the Assistant Secretary, ACF, or the Secretary of HHS.

(c)Effective Date This delegation is effective upon the date of signature.

(d)Effect on Existing Delegations As related to this delegation of authority, this delegation supersedes all previous delegations of authority involving the administration of the cross-program authorities delegated herein. I hereby ratify and affirm any actions taken by the Principal Deputy Assistant Secretary, Deputy Assistant Secretaries, Program Directors, Program Commissioners, Deputy Director/Commissioner, Office of Child Support Enforcement, and Staff Office Directors, which involved the exercise of the authority delegated herein prior to the effective date of this delegation. Dated: June 13, 2007. Daniel C. Schneider, Acting Assistant Secretary for Children and Families. [FR Doc. E7-12019 Filed 6-20-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0091] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 23, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number 0910-0541. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition (OMB Control Number 0910-0541)—Extension As an integral part of its decisionmaking process, FDA is obligated under the National Environmental Policy Act of 1969

(NEPA)to consider the environmental impact of its actions, including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, generally recognized as safe affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and health claims petitions. In 1997, FDA amended its regulations in part 25 (21 CFR part 25) to provide for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment (62 FR 40570, July 29, 1997). As a result of that rulemaking, FDA no longer routinely requires submission of information about the manufacturing and production of FDA-regulated articles. FDA also has eliminated the previously required Environmental Assessment

(EA)and abbreviated EA formats from the amended regulations. Instead, FDA has provided guidance that contains sample formats to help industry submit a claim of categorical exclusion or an EA to CFSAN. The guidance document entitled “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition” identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for FDA's own procedures in order to ensure full compliance with the purposes and provisions of NEPA. The guidance provides information to assist in the preparation of claims of categorical exclusion and EAs for submission to CFSAN. The following questions are covered in this guidance:

(1)What types of industry-initiated actions are subject to a claim of categorical exclusion?

(2)What must a claim of categorical exclusion include by regulation?

(3)What is an EA?

(4)When is an EA required by regulation and what format should be used?

(5)What are extraordinary circumstances? and

(6)What suggestions does CFSAN have for preparing an EA? Although CFSAN encourages industry to use the EA formats described in the guidance because standardized documentation submitted by industry increases the efficiency of the review process, alternative approaches may be used if these approaches satisfy the requirements of the applicable statutes and regulations. FDA is requesting the extension of OMB approval for the information collection provisions in the guidance. *Description of Respondents* : The likely respondents include businesses engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food. In the **Federal Register** of March 28, 2007 (72 FR 14581), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Burden Hours 25.32(i) 52 3 156 1 156 25.32(o) 1 1 1 1 1 25.32(q) 7 2 14 1 14 Total 171 171 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimates in table 1 of this document for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for § 25.32(i) and

(q)that the agency has received in the past 3 years. Please note that, in the past 3 years, there have been no submissions that requested an action that would have been subject to the categorical exclusion in § 25.32(o). To avoid counting this burden as zero, FDA has estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission. To calculate the estimate for the hours per response values, we assumed that the information requested in this guidance for each of these three categorical exclusions is readily available to the submitter. For the information requested for the exclusion in § 25.32(i), we expect that submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for attachment to the claim for categorical exclusion. We believe that this effort should take no longer than 1 hour per submission. For the information requested for the exclusions in § 25.32(o) and (q), the submitters will almost always merely need to copy existing documentation and attach it to the claim for categorical exclusion. We believe that collecting this information should also take no longer than 1 hour per submission. Dated: June 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11969 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0230] Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Processors That Export to the European Community AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of U.S. firms/processors exporting shell eggs, dairy products, game meat and game meat products to the European Community (the EC). DATES: Submit written or electronic comments on the collection of information by August 20, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Information From U.S. Processors That Export to the European Community (OMB Control Number 0910-0320)—Extension The EC is a group of 27 European countries that have agreed to harmonize their commodity requirements to facilitate commerce among member States. EC legislation for intra-EC trade has been extended to trade with non-EC countries, including the United States. For certain food products, including those listed in this document, EC legislation requires assurances from the responsible authority of the country of origin that the processor of the food is in compliance with applicable regulatory requirements. FDA requests information from processors that export certain animal-derived products (e.g., shell eggs, dairy products, game meat, game meat products, animal casings, and gelatin) to the EC. FDA uses the information to maintain lists of processors that have demonstrated current compliance with U.S. requirements and provides the lists to the EC quarterly. Inclusion on the list is voluntary. EC member countries refer to the lists at ports of entry to verify that products offered for importation to the EC from the United States are from processors that meet U.S. regulatory requirements. Products processed by firms not on the lists are subject to detention and possible refusal at the port. FDA requests the following information from each processor seeking to be included on the lists: 1. Business name and address; 2. Name and telephone number of person designated as business contact; 3. Lists of products presently being shipped to the EC and those intended to be shipped in the next 6 months; 4. Name and address of manufacturing plants for each product; and 5. Names and affiliations of any Federal, State, or local governmental agencies that inspect the plant, government-assigned plant identifier such as plant number, and last date of inspection. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Products No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Shell Eggs 10 1 10 0.25 3 Dairy 120 1 120 0.25 30 Game Meat and Meat Products 5 1 5 0.25 1 Animal Casings 5 1 5 0.25 1 Gelatin 3 1 3 0.25 1 Collagen 3 1 3 0.25 1 Total 37 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on the responses received over the past 3 years. We estimate that the annual reporting burden would be approximately 37 hours. The time to respond to the questions should take approximately 15 minutes using any of the technologies available to transmit the information. All of the information asked for should be readily available. No record retention is required. In previous years, FDA estimated that the agency's communication with trade associations and states resulted in a reporting burden of 520 hours. FDA no longer receives information from trade associations and states under this program. Accordingly, the proposed annual burden for this information collection has been reduced by 520 hours. Therefore, the proposed annual burden for this information collection is 37 hours. Dated: June 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11980 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0227] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for “Medical Devices Third-Party Review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).” DATES: Submit written or electronic comments on the collection of information by August 20, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act--Section 523, Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0375)—Extension Section 210 of FDAMA established section 523 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) of the act (21 U.S.C. 360) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices. Respondents to this information collection are businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Section 523 of the Act No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Requests for accreditation 1 1 1 24 24 510(k) reviews conducted by accredited third parties 14 24 336 40 13,440 Totals 13,464 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 Section 523 of the Act No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 510(k) reviews by third-party reviewers 14 24 336 10 3,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. I. Reporting A. Requests for Accreditation FDA now has approximately 8 years of experience with third-party reviews under section 523 of the act. Currently there are 11 active accredited third parties. FDA does not expect to receive more than 1 application for accreditation per year for a total of 14 accredited third parties, who will be conducting third-party reviews. B. 510(k) Reviews Conducted by Accredited Third Parties FDA has received 784 510(k)s with a third-party review since 2004. FDA estimates that over the next 3 years, they will accredit 1 third-party reviewer per year for a total of 14 third parties. Each third-party reviewer expects to review a total of 24 510(k) submissions per year for an annual total of 336 applications. II. Recordkeeping Third-party reviewers are required to keep records of their review of each submission. At the end of 3 years, the agency expects to have 14 accredited persons for review with each third party reviewing on average 24 510(k) applications per year. The agency anticipates approximately 336 annual submissions of 510(k)s for third-party review. Dated: June 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11981 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0223] Draft Guidance for Industry on Use of the Computer Crossmatch; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft document entitled “Guidance for Industry: “Computer Crossmatch” (Electronic Based testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)” dated June 2007. The draft guidance document provides recommendations to blood establishments consistent with current good manufacturing practice

(CGMP)for the use of a “computer crossmatch,” also called an “electronic crossmatch.” The computer crossmatch is an alternative to serologic crossmatch and may be used to demonstrate incompatibility between the donor's red blood cell type and the recipient's serum or plasma type. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by September 19, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled “Guidance for Industry: “Computer Crossmatch” (Electronic Based Testing for the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type)” dated June 2007. The draft guidance document provides recommendations consistent with CGMP for use of a “computer crossmatch” also called an “electronic crossmatch”. The computer crossmatch is an alternative to serologic crossmatch and may be used to demonstrate incompatibility between the donor's red blood cell type and the recipient's serum or plasma type. A final rule published in the **Federal Register** on August 6, 2001 (66 FR 40886) revised § 606.151(c) (21 CFR 606.151(c)) to allow either a serologic crossmatch or a computer crossmatch. Prior to September 5, 2001, a blood establishment could only use a computer crossmatch if FDA gave its written approval for the use of a computer crossmatch as an alternate procedure under § 640.120 (21 CFR 640.120). With this revision to § 606.151(c), an application to FDA to permit use of computer crossmatch as an alternative procedure under § 640.120 is no longer necessary. Licensed establishments that change procedures to implement computer crossmatch remain subject to § 601.12 (21 CFR 601.12). This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S. C. 3501-3520). The collections of information in 21 CFR 606.100(b) and 606.160 have been approved under OMB control number 0910-0116. The collections of information under § 601.12 have been approved under OMB control number 0910-0338. The collections of information under 21 CFR 606.171 have been approved under OMB control number 0910-0458. III. Comments The draft document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: June 13, 2007. Randall W. Lutter, Acting Deputy Commissioner for Policy. [FR Doc. E7-11998 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0108] Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a document entitled “Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs,” dated June 2007. The guidance document further explains the requirements and recommendations for the informed consent of donors of Source Plasma in plasmapheresis and immunization programs. The guidance document is designed to assist blood establishments that are planning to apply for licensure or revising their existing informed consent procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated April 2006. This guidance supersedes the draft guidance document entitled “Draft Reviewer's Guide: Informed Consent for Plasmapheresis/Immunization,” dated October 1995. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled “Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs,” dated June 2007. The guidance further explains the requirements in § 640.61 (21 CFR 640.61) and makes recommendations for the informed consent of donors of Source Plasma in plasmapheresis and immunization programs. The guidance discusses informed consent issues applicable to all Source Plasma donors, including describing the hazards of the procedures, the importance of affording the donor an opportunity to ask questions, and the potential consequences for the donor if the results of tests for communicable disease agents are reactive, positive, or outside of normal limits. The guidance also discusses additional informed consent issues for a donor who is participating in an immunization program. The information in the guidance will assist those establishments applying for licensure as well as those establishments that are revising their existing informed consent procedures. In the **Federal Register** of Thursday, April 27, 2006 (71 FR 24857), FDA announced the availability of the draft guidance of the same title dated April 2006. FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated April 2006. This guidance will supersede the draft guidance document entitled “Draft Reviewer's Guide: Informed Consent for Plasmapheresis/ Immunization,” dated October 1995. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in § 640.61 and 21 CFR 640.66 have been approved under OMB control number 0910-0116. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: June 13, 2007. Randall W. Lutter, Acting Deputy Commissioner for Policy. [FR Doc. E7-11997 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D-0005 (formerly 02D-0005)] International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability for comments of a revised draft guidance for industry (#143) entitled “Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms” (VICH GL30). This revised draft guidance, which updates a draft guidance on the same topic for which a notice of availability was published in the **Federal Register** of February 6, 2002 (the 2002 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document describes the specific data elements to be used for the submission and exchange of spontaneous adverse event reports

(AERs)between marketing authorization holders

(MAHs)and regulatory authorities (RAs). DATES: Submit written or electronic comments on the revised draft guidance by July 23, 2007, to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the revised draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft guidance document. Submit written comments on the revised draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Comments should be identified with the full title of the revised draft guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Lynn Post, Center for Veterinary Medicine, (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9062, e-mail: *lynn.post@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. VICH is a parallel initiative for veterinary medicinal products. VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH steering committee is composed of member representatives from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; the U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry and Fisheries. Four observers are eligible to participate in the VICH steering committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH steering committee meetings. II. Revised Draft Guidance on Controlled Lists of Terms In June 2006, the VICH steering committee agreed that a revised draft guidance entitled “Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms'' (VICH GL30), should be made available for public comment. The draft guidance is a revision of a guidance on the same topic for which a notice of availability was published in the **Federal Register** of February 6, 2002 (67 FR 5605). This revised draft guidance clarifies the 2002 guidance, adding information, and providing consistency with more recently published VICH guidances. This draft VICH guidance document describes the specific data elements to be used for the submission and exchange of spontaneous AERs between MAHs and RAs. Although the revised draft guidance includes, as Appendix A, a proposed list of terms, FDA prefers the list of terms maintained by the National Cancer Institute's *NCI Thesaurus* and would like to refer to the *NCI Thesaurus* in the final guidance. FDA invites comments regarding which list of terms (Appendix A or the *NCI Thesaurus* ) would be the best choice to further the goals set forth in this revised draft guidance. Since Appendix A was included in the revised draft guidance for discussion purposes only, it has not yet been formally considered within the VICH process. FDA expects that the list of terms included in Appendix A will be discussed by a task force chosen from the members of the VICH pharmacovigilance expert working group. III. Paperwork Reduction Act of 1995 This revised draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in section III of the revised draft guidance have been approved under OMB Control No. 0910-0284. IV. Significance of Guidance This draft document, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement. The draft VICH guidance (#143) is consistent with the agency's current thinking on this topic. This guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. V. Comments This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit written or electronic comments regarding this draft guidance document to the Division of Dockets Management (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VI. Electronic Access Electronic comments may also be submitted electronically on the Web site *http://www.fda.gov/dockets/ecomments* . Once on this Internet site, select Docket No. 2002D-0005 entitled “Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms” (VICH GL30), and follow the directions. Copies of the draft guidance document entitled “Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms” (VICH GL30) may be obtained on the Internet from the Center for Veterinary Medicine home page at *http://www.fda.gov/cvm* . Dated: June 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11996 Filed 6-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Geographic Composition of the Contract Health Service Delivery Areas (CHSDA) and Service Delivery Areas

(SDA)of the Indian Health Service AGENCY: Indian Health Service (IHS), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The purpose of this notice is to revise and update the list of Contract Health Service Delivery Areas (CHSDA) as defined in 42 CFR part 136, Subparts A-C and Service Delivery Areas

(SDA)as established by the Director, Indian Health Service

(IHS)administratively to effectuate the intent of Congress. This list replaces and supplements the FR notice dated January 10, 1984 (49 FR 1291) establishing CHSDAs and FR notice dated August 25, 1988 (53 FR 32460) establishing Health Service Delivery Areas (HSDAs). EFFECTIVE DATE: June 21, 2007. FOR FURTHER INFORMATION CONTACT: Hankie Ortiz, Director, Division of Regulatory Affairs, 801 Thompson Avenue, Rockville, Maryland 20852, telephone:

(301)443-1116. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: On September 16, 1987, the Department of Health and Human Services

(HHS)published new final regulations governing eligibility for the Indian Health Service

(IHS)services at 52 FR 35044. In the Fiscal Year 1988 Appropriations Act, Section 315, Public Law 100-202, Congress delayed implementation of the new regulations for one year and imposed a moratorium on the use of appropriated funds for implementation of the new regulations in subsequent fiscal years. In Section 719(a) ofthe Indian Health Care Amendments of 1988, Public Law 100-713, Congress directed that during the moratorium that IHS should provide services pursuant to the criteria for eligibility for such services that were in effect on September 15, 1987. Because the moratorium continues in effect, for the convenience of the public, the HHS republished the eligibility regulations in effect on September 15, 1987. These regulations appear re-designated in the Code of Federal Regulations at Title 42, Part 136, Subparts A-C. The regulations of September 16, 1987, that are under moratorium, provided that the IHS would designate and publish as a notice in the **Federal Register** specific geographic areas within the United States including Indian reservations and areas surrounding those reservations as Health Service Delivery Areas (HSDAs). The HSDAs are the geographic areas within which *direct* and *contract health services* may be made available by the IHS to eligible individuals who reside within the areas. In anticipation of the Congressional moratorium being lifted, the IHS on August 25, 1988 published at 53 FR 32460 a list of HSDAs. If the Congressional moratorium were lifted, the list was to be effective September 16, 1988 or such later date as may be estblished by Congress. Because the Congressional moratorium continues in effect, the HSDA list never became effective. As noted above, the IHS currently provides services under regulations in effect on September 15, 1987 and republished at 42 CFR Part 136, Subparts A-C. Subpart C defines a Contract Health Service Delivery Area (CHSDA) as the geographic area within which contract health services will be made available by the IHS to members of an identified Indian community who reside in the area. It should be clearly understood that residence within a CHSDA or Service Delivery Area

(SDA)by a person who is within the scope of the Indian health program, as set forth in 42 CFR 136.12, creates no legal entitlement to contract health services but only potential eligibility for services. Services needed but not available at an IHS/tribal facility are provided under the Contract Health Services

(CHS)program depending on the availability of funds, the person's relative medical priority, and the actual availability and accessibility of alternate resources in accordance with the regulations. The purpose of this FR notice is to revise and update the list of CHSDAs and SDAs as last published in 1984. The current eligibility regulations at 42 CFR 136.22(a)(1)-(5) defines certain CHSDAs by designating some States as CHSDAs and certain counties within a state as a CHSDA. In addition, Section 136.22(a)(6) provides that: With respect to all other reservations ( *i.e.* , other than those not specifically listed in 42 CFR 136.22(a)(1)-(5)) within the scope of the Indian health program, the CHSDA shall consist of a county which includes all or part of a reservation, and any county or counties which have a common boundary with the reservation. The counties included or excluded from the following list of CHSDAs were determined by applying the regulations at 42 CFR 136.22 except where otherwise provided for by regulations, public laws, or congressional action in the appropriations process. The list includes those CHSDAs as defined in the regulations at 42 CFR 136.22, including those CHSDAs designated as exceptions within the funded scope and exceptions provided by legislation. In addition, many of the newly recognized tribes do not have reservations and either Congress has legislatively designated counties to serve as SDAs or the Director, IHS exercised reasonable administrative discretion to designate SDAs to effectuate the intent of Congress for these tribes. The SDAs function as CHSDAs for the purposes of operating a CHS program pursuant to the ISDEAA, Pub. L. 93-638. Thus, the CHSDA list incorporates the SDAs that operate as CHSDAs for newly recognized tribes recognized as of the date of publication of this Notice. The CHSDA and SDA list has been modified and updated to include the name of the tribe, with the respective reservation in parenthesis underneath the name of the tribe, and/or the counties comprising the CHSDA or SDA. Any mistakes in the list of CHSDAs and SDAs should be brought to the attention of Hankie Ortiz, Director, Division of Regulatory Affairs, 801 Thompson Avenue, Rockville, Maryland 20852, telephone:

(301)443-1116. Any corrections of mistaken inclusions or exclusions of a county or counties in a CHSDA or SDA may be made administratively and included in a later FR notice. Redesignation of areas included or excluded from a CHSDA for reasons other than a mistake is governed by 42 CFR 136.22(b) and may be made by the Director, IHS. The CHSDA and SDA counties for all tribes and reservations within the funded scope of the IHS program are as follows: Contract Health Service Delivery Areas and Service Delivery Areas Tribe/Reservation County/State Ak Chin Indian Community (Ak Chin Indian Reservation) Pinal, AZ. Alabama-Coushatta Tribe Polk, TX. 1 Alaska Entire State. 2 Arapaho Tribe (Wind River Reservation) Hot Springs, WY, Fremont, WY, Sublette, WY. Aroostook Band of Micmac Aroostook, ME. 3 Assiniboine-Sioux Tribe (Fort Peck Reservation) Daniels, MT, McCone, MT, Richland, MT, Roosevelt, MT, Sheridan, MT, Valley, MT. Bad River Band of Lake Superior Chippewa (Bad River Reservation) Ashland, WI, Iron, WI. Bay Mills Indian Community (Bay Mills Reservation) Chippewa, MI. Blackfeet Tribe (Blackfeet Reservation) Glacier, MT, Pondera, MT. Bois Forte Band of Chippewa (Nett Lake Reservation) Itasca, MN, Koochiching, MN, St. Louis, MN. Brigham City Intermountain School Health Center ( 4 ). Bums Paiute Tribe (Bums Paiute Indian Colony) Harney, OR. California Entire State, except for the counties listed in footnote. 5 Catawba Indian Nation All Counties in SC, 13 Cabarrus, NC, Cleveland, NC, Gaston, NC, Mecklenburg, NC, Rutherford, NC, Union, NC. Cayuga Nation of New York Allegany, NY, 13 Cattaraugus, NY, Chautaugua, NY, Erie, NY, Warren, PA. Cheyenne River Sioux (Cheyenne River Reservation) Corson, SD, Dewey, SD, Haakon, SD, Meade, SD, Perkins, SD, Potter, SD, Stanley, SD, Sully, SD, Walworth, SD, Ziebach, SD. Chippewa-Cree Indians (Rocky Boy Reservation) Chouteau, MT, Hill, MT, Liberty, MT. Chitimacha Tribe St. Mary Parish, LA. Cocopah Tribe Yuma, AZ, Imperial, CA. Coeur D'Alene Tribe (Coeur D'Alene Reservation) Benewah, ID, Kootenai, ID, Latah, ID, Spokane, WA, Whitman, WA. Colorado River Indian Tribes (Colorado River Reservation) La Paz, AZ, Riverside, CA, San Bernardino, CA, Yuma, AZ. Confederated Salish & Kootenai Tribes (Flathead Reservation) Flathead, MT, Lake, MT, Missoula, MT, Sanders, MT. Confederated Tribes of Chehalis (Chehalis Reservation) Grays Harbor, WA, Lewis, WA, Thurston, WA. Confederated Tribes of Colville (Colville Reservation) Chelan, WA, 6 Douglas, WA, Ferry, WA, Grant, WA, Lincoln, WA, Okanogan, WA, Stevens, WA. Confederated Tribes of Coos, Lower Umpqua & Siuslaw Indians Coos, OR, 7 Curry, OR, Douglas, OR, Lane, OR, Lincoln, OR. Confederated Tribes of Goshute (Goshute Reservation) Nevada, Juab, UT, Toole, UT. Confederated Tribes of Grand Ronde (Grand Ronde Community) Polk, OR, 8 Washington, OR, Marion, OR, Yamhill, OR, Tillamook, OR, Multnomah, OR. Confederated Tribes of Siletz (Siletz Reservation) Benton, OR, 9 Clackamas, OR, Lane, OR, Lincoln, OR, Linn, OR, Marion, OR, Multnomah, OR, Polk, OR, Tillamook, OR, Washington, OR, Yam Hill, OR. Confederated Tribes of Umatilla (Umatilla Reservation) Umatilla, OR, Union, OR. Confederated Tribes of Warm Springs (Warm Springs Reservation) Clackamas, OR, Jefferson, OR, Linn, OR, Marion, OR, Wasco, OR. Confederated Tribes & Bands of Yakima Nation (Yakama Reservation) Klickitat, WA, Lewis, WA, Skamania, WA, 10 Yakima, WA. Coquille Tribe Coos, OR, 13 Curry, OR, Douglas, OR, Jackson, OR, Lane, OR. Coushatta Tribe Allen Parish, LA, Jefferson Davis, LA. Cow Creek Band of Umpqua Coos, OR, 11 Deshutes, OR, Douglas, OR, Jackson, OR, Josephine, OR, Klamath, OR, Lane, OR. Cowlitz Indian Tribe Clark, WA, 13 Cowlitz, WA, King, WA, Lewis, WA, Pierce, WA, Skamania, WA, Thurston, WA. Crow Tribe (Crow Reservation) Big Horn, MT, Carbon, MT, Treasure, MT, l4 Yellowstone, MT, Big Horn, WY, Sheridan, WY. Crow Creek Sioux Tribe (Crow Creek Reservation) Brule, SD, Buffalo, SD, Hand, SD, Hughes, SD, Hyde, SD, Lyman, SD, Stanley, SD. Eastern Band of Cherokee Indians (Cherokee Reservation) Cherokee, NC, Graham, NC, Haywood, NC, Jackson, NC, Swain, NC. Flandreau Santee Sioux Tribe Moody, SD. Fond du Lac Band of Chippewa (Fond du Lac Reservation) Carlton, MN, St. Louis, MN. Forest County Potawatomi Community Forest, WI, Marinette, WI, Oconto, WI. Fort Belknap Indian Community (Fort Belknap Reservation) Blaine, MT, Phillips, MT. Fort McDermitt Paiute and Shoshone (Fort McDermitt Reservation) Nevada, Malheur, OR. Fort McDowell Yavapai Nation (Fort McDowell Reservation) Maricopa, AZ. Fort Mojave Indian Tribe Nevada, Mohave, AZ, San Bernardino, CA. Gila River Indian Community (Gila River Reservation) Maricopa, AZ, Pinal, AZ. Grand Portage Band of Chippewa (Grand Portage Reservation) Cook, MN. Grand Traverse Band of Ottawa & Chippewa Antrim, MI, 15 Benzie, MI, Charlevoix, MI, Grand Traverse, MI, Leelanau, MI, Manistee, MI. Hannahville Indian Community Delta, MI, Menominee, MI. Haskell Indian Health Center Douglas, KS. l6 17 . Havasupai Tribe (Havasupai Reservation) Coconino, AZ. Ho-Chunk Nation of Wisconsin (Winnebago Tribe of Wisconsin) Adams, WI, 18 Clark, WI, Columbia, WI, Crawford, WI, Dane, WI, Eau Claire, WI, Houston, MN, Jackson, WI, Juneau, WI, La Crosse, WI, Marathon, WI, Monroe, WI, Sauk, WI, Shawano, WI, Vernon, WI, Wood, WI. Hoh Indian Tribe (Hoh Reservation) Jefferson, WA. Hopi Tribe Apache, AZ, Coconino, AZ, Navajo, AZ. Houlton Band of Maliseet Indians Aroostook, ME. 19 Hualapai Indian Tribe (Hualapai Reservation) Coconino, AZ, Mohave, AZ, Yavapai, AZ. Huron Potawatomi Inc. Allegan, MI, 13 Barry, MI, Branch, MI, Calhoun, MI, Kalamazoo, MI, Kent, MI, Ottawa, MI. Iowa Tribe Brown, KS, Doniphan, KS, Richardson, NE. Jamestown S'Klallam Tribe Clallam, WA, Jefferson, WA. Jena Band of Choctaw Indians Grand Parish, LA, 13 LaSalle Parish, LA, Rapides Parish, LA. Jicarilla Apache Nation (Jicarilla Apache Reservation) Archuleta, CO, Rio Arriba, NM, Sandoval, NM. Kaibab Band of Paiute (Kaibab Reservation) Coconino, AZ, Mohave, AZ, Kane, UT. Kalispel Indian Community (Kalispel Reservation) Pend Oreille, WA, Spokane, WA. Keweenaw Bay Indian Community (L'Anse Reservation) Baraga, MI, Houghton, MI, Ontonagon, MI. Kickapoo Tribe of Indians (Kickapoo Reservation) Brown, KS, Jackson, KS. Kickapoo Traditional Tribe of Texas Maverick, TX. 20 Klamath Indian Tribe Klamath, OR. 21 Kootenai Tribe Boundary, ID. Lac Courte Oreilles Band of Lake Superior Chippewa (Lac Courte Oreilles Reservation) Sawyer, WI. Lac du Flambeau Band of Lake Superior Chippewa (Lac du Flambeau Reservation) Iron, WI, Oneida, WI, Vilas, WI. Lac Vieux Desert Band of Lake Superior Chippewa Gogebic, MI. Leech Lake Band of Chippewa (Leech Lake Reservation) Beltrami, MN, Cass, MN, Hubbard, MN, Itasca, MN. Little River Band of Ottawa Indians Kent, MI, 22 Muskegon, MI, Newaygo, MI, Oceana, MI, Ottawa, MI, Manistee, MI, Mason, MI, Wexford, MI, Lake, MI. Little Traverse Bay Bands of Odawa Alcona, MI, 22 Alger, MI, Alpena, MI, Antrim, MI, Benzie, MI, Charlevoix, MI, Cheboygan, MI, Chippewa, MI, Crawford, MI, Delta, MI, Emmet, MI, Grand Traverse, MI, Iosco, MI, Kalkaska, MI, Leelanau, MI, Luce, MI, Mackinac, MI, Manistee, MI, Missaukee, MI, Montmorency, MI, Ogemaw, MI, Oscoda, MI, Otsego, MI, Presque Isle, MI, Schoolcraft, MI, Roscommon, MI, Wexford, MI. Lower Brule Sioux Tribe (Lower Brule Reservation) Brule, SD, Buffalo, SD, Hughes, SD, Lyman, SD, Stanley, SD. Lower Elwha Tribal Community (Lower Elwha Reservation) Clallam, WA. Lower Sioux Indian Community (Lower Sioux Reservation) Redwood, MN, Renville, MN. Lummi Tribe (Lummi Reservation) Whatcom, WA. Makah Indian Tribe (Makah Reservation) Clallam, WA. Mashantucket Pequot Tribe New London, CT. 23 Match-e-be-nash-she-wish Band of Pottawatomi Allegan, MI, 13 Barry, MI, Kalamazoo, MI, Kent, MI, Ottawa, MI. Menominee Indian Tribe Langlade, WI, Menominee, WI, Oconto, WI, Shawano, WI. Mescalero Apache Tribe (Mescalero Reservation) Chaves, NM, Lincoln, NM, Otero, NM Miccosukee Tribe Broward, FL, Collier, FL, Miami-Dade, FL. Mille Lacs Band of Chippewa (Mille Lacs Reservation) Aitkin, MN, Kanebec, MN, Mille Lacs, MN, Pine, MN. Mississippi Band of Choctaw Indians Attala, MS, Jasper, MS, 24 Jones, MS, Kemper, MS, Leake, MS, Neshoba, MS, Newton, MS, Noxubee, MS, Scott, MS, 25 Winston, MS. Mohegan Indian Tribe Fairfield, CT, Hartford, CT, Litchfield, CT, Middlesex, CT, New Haven, CT, New London, CT, Tolland, CT, Windham, CT. Muckleshoot Indian Tribe King, WA, Pierce, WA. Narragansett Indian Tribe Washington, RI. 26 Navajo Nation (Navajo Reservation) Apache, AZ, Bernalillo, NM, Cibola, NM, Coconino, AZ, Kane, UT, McKinley, NM, Montezuma, CO, Navajo, AZ, Rio Arriba, NM, Sandoval, NM, San Juan, NM, San Juan, UT, Socorro, NM, Valencia, NM. Nevada Entire State. 27 Nez Perce Tribe Clearwater, ID Idaho, ID, Latah, ID, Lewis, ID, Nez Perce, ID. Nisqually Indian Tribe (Nisqually Reservation) Pierce, WA, Thurston, WA. Nooksack Indian Tribe Whatcom, WA. Northern Cheyenne Tribe (Northern Cheyenne Reservation) Big Horn, MT, Carter, MT, 28 Rosebud, MT. Northwestern Band of Shoshone Nation (Washakie) Box Elder, UT. 29 Oglala Sioux Tribe (Pine Ridge Reservation) Bennett, SD, Cherry, NE, Custer, SD, Dawes, NE, Fall River, SD, Jackson, SD, Mellete, SD, Pennington, SD, Shannon, SD, Sheridan, NE, Todd, SD, Washabaugh, SD. Oklahoma Entire State. 30 Omaha Tribe Burt, NE, Cuming, NE, Monona, IA, Thurston, NE, Wayne, NE. Oneida Nation Chenango, NY, Cortland, NY, Herkimer, NY, Madison, NY, Oneida, NY, Onondaga, NY. Oneida Tribe of Indians Brown, WI, Outagamie, WI. Onondaga Nation Onondaga, NY. Paiute Indian Tribe of Utah Iron, UT, 31 Millard, UT, Sevier, UT, Washington, UT. Pascua Yaqui Tribe Pima, AZ. 32 Passamaquoddy Tribe Aroostook, ME, 33 Washington, ME. Passamaquoddy Pleasant Point South Washington, ME from Baring, ME North to Milbridge, ME, South and West to Alexander, ME. 34 Penobscot Tribe Aroostook, ME, Penobscot, ME. Poarch Band of Creek Indians Baldwin, AL, 35 Escambia, AL, Escambia, FL, Elmore, AL, Mobile, AL, Monroe, AL. Pokagon Band of Potawatomi Indians Allegan, MI, Berrien, MI, Cass, MI, Elkhart, IN, 13 Kosciusko, IN, La Porte, IN, Marshall, IN, St. Joseph, IN, Starke, IN, Van Buren, MI. Ponca Tribe (Northern) Boyd, NE, 36 Charles Mix, SD, Douglas, NE, Knox, NE, Lancaster, NE, Madison, NE. Port Gamble Indian Community Kitsap, WA. Prairie Band of Potawatomi Nation Jackson, KS. Prairie Island Indian Community (Prairie Island Reservation) Goodhue, MN. Pueblo of Acoma Cibola, NM. Pueblo of Cochiti Sandoval, NM, Sante Fe, NM. Pueblo of Jemez Sandoval, NM. Pueblo of Isleta Bernalillo, NM, Cibola, NM, Socorro, NM, Torrance, NM, Valencia, NM. Pueblo of Laguna Bemalillo, NM, Cibola, NM, Sandoval, NM, Valencia, NM. Pueblo of Nambe Santa Fe, NM. Pueblo of Picuris Taos, NM. Pueblo of Pojoaque Rio Arriba, NM, Santa Fe, NM. Pueblo of San Felipe Sandoval, NM. Pueblo of San Ildefonso Los Alamos, NM, Rio Arriba, NM, Sandoval, NM, Santa Fe, NM Pueblo of San Juan Rio Arriba, NM. Pueblo of Sandia Bernalillo, NM, Sandoval, NM. Pueblo of Santa Ana Sandoval, NM. Pueblo of Santa Clara Los Alamos, NM, Rio Arriba, NM, Sandoval, NM, Santa Fe, NM. Pueblo of Santo Domingo Sandoval, NM, Santa Fe, NM. Pueblo of Taos Colfax, NM, Taos, NM. Pueblo of Tesuque Santa Fe, NM. Pueblo of Zia Sandoval, NM. Puyallup Tribe King, WA, Pierce, WA, Thurston, WA. Quechan Tribe (Fort Yuma Indian Reservation) Yuma, AZ, Imperial, CA. Quileute Tribe (Quileute Reservation) Clallam, WA, Jefferson, WA Quinault Tribe (Ouinalt Reservation) Grays Harbor, WA, Jefferson, WA. Rapid City Pennington, SD. 37 Red Cliff Band of Lake Superior Band of Chippewa Bayfield, WI. Red Lake Band of Chippewa Indians (Red Lake Reservation) Beltrami, MN, Clearwater, MN, Koochiching, MN, Lake of the Woods, MN, Marshall, MN, Pennington, MN, Polk, MN, Roseau, MN. Rosebud Sioux Tribe (Rosebud Reservation) Bennett, SD, Cherry, NE, Gregory, SD, Lyman, SD, Mellette, SD, Todd, SD, Tripp, SD. Sac & Fox Tribe of the Mississippi in Iowa Tama, IA. Sac & Fox Nation of Missouri in Kansas & Nebraska Brown, KS, Richardson, NE. Saginaw Chippewa Indian Tribe (Isabella Reservation) Arenac, MI, 38 Clare, MI, Isabella, MI, Midland, MI, Missaukee, MI. St. Croix Chippewa Indians(St. Croix Reservation) Barron, WI, Burnett, WI, Pine, MN, Polk, WI, Washburn, WI. St. Regis Band of Mohawk Indians Franklin, NY, St. Lawrence, NY. Salt River Pima-Maricopa Indian Community (Salt River Reservation) Maricopa, AZ. Samish Indian Tribe Clallam, WA, 13 Island, WA, Jefferson, WA, King, WA, Kitsap, WA, Pierce, WA, San Juan, WA, Skagit, WA, Snohomish, WA, Whatcom, WA. San Carlos Apache Tribe (San Carlos Reservation) Apache, AZ Cochise, AZ, Gila, AZ, Graham, AZ, Greenlee, AZ, Pinal, AZ. San Juan Southern Paiute Tribe (Navajo Reservation) Coconino, AZ San Juan, UT. Santee Sioux (Santee Reservation) Bon Homme, SD, Knox, NE. Sauk-Suiattle Indian Tribe Snohomish, WA, Skagit, WA. Sault St. Marie Tribe of Chippewa Alger, MI, 39 Chippewa, MI, Delta, MI, Luce, MI, Mackinac, MI, Marquette, MI, Schoolcraft, MI. Seminole Tribe of Florida Broward, FL, Collier, FL, Glades, FL, Hendrv, FL. Seneca Nation Allegany, NY, Cattaraugus, NY, Chautaugua, NY, Erie, NY, Warren, PA. Shakopee Mdewakanton Sioux Community (Prior Lake) Scott, MN. Shoal Water Bay Tribe (Shoalwater Bay Reservation) Pacific, WA. Shoshone Tribe (Wind River Reservation) Hot Springs, WY, Fremont, WY, Sublette, WY. Shoshone-Bannock Tribe (Fort Hall Reservation) Bannock,ID, Bingham, ID, Caribou, ID, Lemhi, ID, 40 Power, ID. Shoshone-Paiute Tribe (Duck Valley Reservation) Nevada, Owyhee, ID. Sisseton-Wahpeton Sioux Tribe (Lake Traverse Reservation) Codington, SD, Day, SD, Grant, SD, Marshall, SD, Richland, ND, Roberts, SD, Sargent, ND, Traverse, MN. Skokomish Indian Tribe (Skokomish Reservation) Mason, WA. Skull Valley Band of Goshute Indians Tooele, UT. Snoqualmie Tribe King, WA, 13 Snohomish, WA, Pierce, WA, Island, WA, Mason, WA. Sokaogon Chippewa (Mole Lake) Forest, WI. Southern Ute Indian Tribe (Southern Ute Reservation) Archuleta, CO, La Plata, CO, Montezuma, CO, Rio Arriba, NM, San Juan, NM. Spirit Lake Tribe (Fort Totten) (Devil's Lake Sioux Reservation) Benson, ND, Eddy, ND, Nelson, ND, Ramsey, ND. Spokane Tribe (Spokane Reservation) Ferry, WA, Lincoln, WA, Stevens, WA. Squaxin Island Tribe (Squaxin Island Reservation) Mason, WA. Standing Rock Sioux Tribe Adams, ND, Campbell, SD, Corson, SD, Dewey, SD, Emmons, ND, Grant, ND, Morton, ND, Perkins, SD, Sioux, ND, Walworth, SD, Ziebach, SD. Stockbridge Munsee Community Menominee, WI, Shawano, WI. Stillaguamish Tribe Snohomish, WA. Suquamish Indian Tribe (Port Madison Reservation) Kitsap, WA. Swinomish Indians (Swinomish Reservation) Skagit, WA. Three Affiliated Tribes (Fort Berthold Reservation) Dunn, ND, Mercer, ND, McKenzie, ND, McLean, ND, Mountrail, ND, Ward, ND. Tohono O'odham Nation (Papago) Maricopa, AZ, Pima, AZ, Pinal, AZ. Tonawanda Band of Seneca Genesee, NY, Erie, NY, Niagara, NY. Tonto Apache Tribe of Arizona Gila, AZ. Trenton Service Unit Divide, ND, 41 McKenzie, ND, Williams, ND, Richland, MT, Roosevelt, MT, Sheridan, MT. Tulalip Tribes (Tulalip Reservation) Snohomish, WA. Tunica-Biloxi Indian Tribe Avoyelles, LA, Rapides, LA. 42 Turtle Mountain Band of Chippewa (See also, Trenton Service Unit) Rolette, ND. 43 Tuscarora Nation Niagara, NY. Upper Sioux Community (Upper Sioux Reservation) Chippewa, MN, Yellow Medicine, MN. Upper Skagit Indian Tribe Skagit, WA. Ute Indian Tribe (Uintah & Ouray Reservation) Carbon, UT, Daggett, UT, Duchesne, UT, Emery, UT, Grand, UT, Rio Blanco, CO, Summit, UT, Uintah, UT, Utah, UT, Wasatch, UT. Ute Mountain Tribe (Ute Mountain Reservation) Apache, AZ, La Plata, CO, Montezuma, CO, San Juan, NM, San Juan, UT. Wampangoag Tribe of Gay Head (Aquinnah) Dukes, MA. 12 Washoe Tribe of Nevada & California Entire State of NV, Entire State of CA, except for the counties listed in footnote. White Earth Band of Chippewa (White Earth Reservation) Becker, MN, Clearwater, MN, Mahnomen, MN, Norman, MN, Polk, MN. White Mountain Apache (Fort Apache Reservation) Apache, AZ, Coconino, AZ, Gila, AZ, Graham, AZ, Greenlee, AZ, Navajo, AZ. Winnebago Tribe Dakota, NE, Dixon, NE, Monona, IA, Thurston, NE, Wayne, NE, Woodbury, IA. Yankton Sioux Tribe Bon Homme, SD, Boyde, NE, Charles Mix, SD, Douglas, SD, Gregory, SD, Hutchinson, SD, Knox, NE. Yavapai-Apache Nation (Camp Verde Indian Reservation) Yavapai, AZ. Yavapai-Prescott Tribe (Yavapai Reservation) Yavapai, AZ. Ysleta Del Sur Pueblo of Texas El Paso, TX. 1 Zuni Tribe (Zuni Reservation) Apache, AZ, Cibola, NM, McKinley, NM, Valencia, NM. 1 Public Law 100-89, Restoration Act for Ysleta Del Sur and Alabama and Coushatta Tribes of Texas establishes service areas for “members of the tribe” by sections 101(3) and 105(a) for the Pueblo and sections 201(3) and 206(a) respectively. 2 Entire State of Alaska is included as a CHSDA by regulation (42 CFR 136.22(a)(1)). 3 Aroostook Band of Micmac was recognized by Congress on November 26, 1991 through the Aroostook Band of Micmac Settlement Act. Aroostook County was defined as the SDA. 4 Special programs established by Congress irrespective of the eligibility regulations. Eligibility for services at these facilities is based on the legislative history of the appropriation of funds for the particular facility, rather than the eligibility regulations and historically services have been provided at Brigham City (Pub. L. 88-358). 5 Entire State of California, excluding counties of Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura, is designated a CHSDA (25 U.S.C. 1680). 6 Historically part of the Coleville Service Unit population since 1970. 7 Members of the tribe residing in these counties were specified as eligible for Federal services and benefits without regard to the existence of a Federal Indian reservation (Pub. L. 98-481, and H. Rept. No. 98-904). 8 Grande Ronde Tribe of Oregon recognized by Pub. L. 98-165, signed into law on November 22, 1983, provides for eligibility in these six counties without regard to the existence of a reservation. 9 In order to carry out the Congressional intent of the Siletz Restoration Act, Pub. L. 95-195, as expressed in H. Report No. 95-623, at page 4, Siletz tribal members residing in these counties are eligible for contract health services. 10 Historically part of the Yakirna Service Unit population since 1979. 11 Cow Creek Band of Umpqua recognized by Pub. L. 97-391, signed into law on December 29, 1983. House Rept. No. 97-862 designates Douglas, Jackson, and Josephine Counties as a service area without regard to the existence of a reservation. The IRS later exercised administrative discretion to add Coos, Deshutes, Klamath and Lane counties to the service delivery area. 12 Members of the tribe residing in Martha's Vineyard [are] deemed to be living “on or near an Indian reservation” for the purposes of eligibility for Federal services (Sec. 12, Pub. L. 100-95). 13 This is a newly recognized tribe, as documented at 67 FR 46329, July 12, 2002. The counties listed were designated administratively as the SDA, to function as a CHSDA, for the purposes of the operating a CHS program pursuant to the ISDEAA, Pub. L. 93-638. 14 Historically part of Crow Service Unit population. 15 Historically part of the Grande Traverse Service Unit population since 1980. 16 Historically part of Kansas Service Unit since 1979. 17 Special programs established by Congress irrespective of the eligibility regulations. Eligibility for services at these facilities is based on the legislative history of the appropriation of funds for the particular facility, rather than the eligibility regulations and historically services have been provided at Haskell (H. Rept. No. 95-392). 18 The counties included in this CHSDA were designated by regulation (42 CFR 136.22(a)(5)). 19 Public Law 97-428 provides for eligibility in or around the Town of Houlton without regard to existence of a reservation. 20 Texas Band of Kickapoo was recognized by Pub. L. 97-429, signed into law on January 8, 1983.The Act provides for eligibility for Kickapoo tribal members residing in Maverick County without regard to the existence of a reservation. 21 Legislative history states that for the purpose of Federal services and benefits “members of the tribe residing in Klamath County shall be deemed to be residing in or near a reservation”. (Pub. L. 99-398, Sec. 2(2)). 22 The Little River Band of Ottawa Indians and the Little Traverse Bay Bands of Odawa Indians were recognized by Congress (Pub. L. 103-324, Sec. 4(b)(2)) and the listed counties were designated as the SDA, to function as a CHSDA, for the purposes of the operating a CHS program pursuant to the ISDEAA, Pub. L. 93-638. 23 Mashantucket Pequot Indian Claims Settlement Act, Pub. L. 98-134, signed into law on October 18, 1983, provides for a reservation in New London. 24 Choctaw Indians residing in Jasper and Noxubee Counties, MS, will continue to be eligible for contract health services. These two counties were inadvertently omitted from 42 CFR 136.22. 25 Historically part of the Choctaw Service Unit population since 1970. 26 Narragansett Indians recognized by Pub. L. 95-395, signed into law September 30, 1978. Lands in Washington County are now federally restricted and the Bureau of Indian Affairs considers them as the Narragansett Indian Reservation. 27 Entire State of Nevada is included as a CHSDA by regulation (42 CFR 136.22(a)(2)). 28 Historically part of the Northern Cheyenne Service Unit population since 1979. 29 Land of Box Elder County, Utah, taken into trust for the tribe in 1986. 30 Entire State of Oklahoma is included as a CHSDA by regulation (42 CFR 136.22(a)(3)). 31 Paiute Indian Tribe of Utah Reservation Act, Pub. L. 96-227, provides for the extension of services to these four counties without regard to the existence of a reservation. 32 Legislative history (H.R. Report No. 95-1021) to Pub. L. 95-375, Extension of Federal Benefits to Pascua Yaqui Indians, Arizona, expresses congressional intent that lands conveyed to the tribes pursuant to Act of October 8, 1964. (Pub. L. 88-350) shall be deemed a Federal Indian Reservation. 33 Included to carry out the intention of Congress to fund and provide contract health services to Penobscot and Passamaquoddy Indians in Aroostook County (Pub. L. 96-420; H. Rept. 96-1353). 34 Included to carry out the intention of Congress to fund and provide contract health services to Penobscot and Passamaquoddy Indians in Aroostook County (Pub. L. 96-420; H. Rept. 96-1353). 35 Counties in the Service Unit designated by Congress for the Poarch Band of Creek Indians (see H. Rept. 98-886, June 29, 1984; Cong. Record, October 10, 1984, Pg. H11929). 36 Ponca Restoration Act, Pub. L. 101-484, recognized members of the tribe residing in Boyd, Douglas, Knox, Madison or Lancaster counties of Nebraska or Charles Mix county of South Dakota shall be deemed to be residing on or near a reservation. 37 Special programs established by Congress irrespective of the eligibility regulations. Eligibility for services at these facilities is based on the legislative history of the appropriation of funds for the particular facility, rather than the eligibility regulations and historically services have been provided at Rapid City South Dakota Hospital (S. Rept. No. 1154, FY 1967 Interior Approp. 89th Cong. 2d Sess.). 38 Historically part of Isabella Reservation Area and Eastern Michigan Service Unit population since 1979. 39 The counties included in this CHSDA were designated by regulation (42 CFR 136.22(a)(4)). 40 Historically part of the Fort Hall Service Unit population since 1979. 41 The Secretary acting through the Service is directed to provide contract health services to Turtle Mountain Band of Chippewa Indians that reside in Trenton Service Area of Divide, Mackenzie, and Williams counties in the state of North Dakota and the adjoining counties of Riehl and, Roosevelt, and Sheridan in the state of Montana (Sec. 815, Pub. L. 94-437). 42 Historically part of the Tunica Biloxi Service Unit population since 1982. 43 The Secretary acting through the Service is directed to provide contract health services to Turtle Mountain Band of Chippewa Indians that reside in Trenton Service Area of Divide, Mackenzie, and Williams counties in the state of North Dakota and the adjoining counties of Richland, Roosevelt, and Sheridan in the state of Montana (Sec. 815, Pub. L. 94-437). Dated: May 11, 2007 Robert G. McSwaim, Deputy Director, Indian Health Service. [FR Doc. 07-3045 Filed 6-20-07; 8:45 am]

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