National Indian Health Board, 55145-55146 [05-18653]

Download as PDF Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices comments regarding this document. 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 9, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–18655 Filed 9–19–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998D–0266] Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘PET Drug Products—Current Good Manufacturing Practice (CGMP).’’ Elsewhere in this issue of the Federal Register, we are issuing proposed regulations on CGMPs for positron emission tomography (PET) drug products. We are making the draft guidance available so that producers of PET drugs can better understand FDA’s thinking on CGMP compliance if the proposed regulations become final after notice-and-comment rulemaking. DATES: Submit written or electronic comments on the draft guidance by December 19, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 SUMMARY: VerDate Aug<31>2005 14:53 Sep 19, 2005 Jkt 205001 electronic comments to http:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Brenda Uratani, Center for Drug Evaluation and Research (HFD–320), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301–827–8941. SUPPLEMENTARY INFORMATION: I. Background On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (Modernization Act) (Public Law 105–115) into law. Section 121(c)(1)(A) of the Modernization Act directs us to establish appropriate approval procedures and CGMP requirements for PET drugs. Section 121(c)(1)(B) states that, in adopting such requirements, we must take due account of any relevant differences between not-for-profit institutions that compound PET drugs for their patients and commercial manufacturers of the drugs. Section 121(c)(1)(B) also directs us to consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists who make or use PET drugs as we develop PET drug CGMP requirements and approval procedures. We presented our initial tentative approach to PET drug CGMP requirements and responded to numerous questions and comments about that approach at a public meeting on February 19, 1999. In the Federal Register of September 22, 1999 (64 FR 51274), FDA published preliminary draft regulations on CGMP for PET drug products. FDA received comments on the preliminary draft regulations at another public meeting on the same subject on September 28, 1999. FDA made changes in the working draft in response to the public comments. In the Federal Register of April 1, 2002 (67 FR 15344), FDA published a preliminary draft proposed rule, in conjunction with the first draft guidance (67 FR 15404, April 1, 2002). FDA received written and oral comments on the preliminary draft proposed rule and the first draft guidance at a public meeting on May 21, 2002, and written comments after the May 2002 meeting, FDA has taken all comments into consideration in revising the preliminary draft proposed rule and the draft guidance. The draft guidance provides more details for discussion purposes on acceptable approaches to complying with the proposed PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 55145 regulations should they be published in final form. Elsewhere in this issue of the Federal Register, we are publishing a proposed rule on CGMP for PET drug products. We are making this draft guidance available so that PET drug producers can better understand FDA’s thinking on compliance with the proposed CGMP regulations if they become final after notice-and-comment rulemaking. We invite comments on whether the draft guidance would be a useful accompaniment to the proposed rule. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Two paper copies of mailed comments are to be submitted, 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. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/ index.htm, http://www.fda.gov/ohrms/ dockets/default.htm, or http:// www.fda.gov/cder/fdama under ‘‘Section 121—PET (Positron Emission Tomography).’’ Dated: September 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18509 Filed 9–15–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service National Indian Health Board Indian Health Service, HHS. Notice to supplement the singlesource cooperative agreement with the National Indian Health Board. AGENCY: ACTION: SUMMARY: The Indian Health Service (IHS) announces a supplement to the single-source cooperative agreement award to the National Indian Health Board (NIHB) for costs in providing advice and technical assistance to the IHS on behalf of federally recognized Tribes in the area of health care policy analysis and program development. The E:\FR\FM\20SEN1.SGM 20SEN1 55146 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices NIHB is a non-profit organization as described in section 501(c)(3) of the Internal Revenue Code. The mission of the IHS is to work in partnership with American Indian and Alaska Native people to raise their health to the highest level. Under the original cooperative agreement published in the Federal Register, 69 FR 11447, on March 10, 2004, the NIHB assists the IHS in carrying out its mission through access to a broad based consumer network involving the Areas Health Boards or Health Board representatives from each of the 12 IHS Areas. The NIHB communicates with these boards and with Tribes and Tribal organizations in order to raise health of AI/AN people to the highest level. NIHB also disseminates health care information which serves to improve and expand access for American Indians and Alaska Natives (AI/AN) Tribal Governments to all available health programs in the Department of Health and Human Services (HHS). The NIHB assists in the coordination of the Tribal consultation activities associated with formulating the IHS annual budget request. The program supplement to the single-source cooperative agreement is for $321,800 of non-recurring funding for use during the current budget period in effect from 01/01/2005 to 12/31/2005. The annual funding level of this singlesource cooperative agreement is approximately $230,000, subject to the availability of appropriations. Justification for Program Supplement The program supplement is issued under the authority of the Public Health Service Act, section 301(a) and is included under the Catalog of Federal Domestic Assistance number 93.933. This supplement funding is related to the original goals of the cooperative agreement and does not represent an expansion of activities outside of the present scope of work. The Federal Register Notice for the sole-source cooperative agreement award can be found in 69 FR 11447, published on March 10, 2004. The specific objectives and justifications for this program supplement are as follows: 1. Outreach and Education Within the AI/AN Community Concerning the Programs of the Centers for Medicare and Medicaid Services (CMS) We anticipate funding will be transferred through an inter-agency agreement between CMS and the IHS to supplement the NIHB cooperative agreement. the NIHB will inform and educated AI/AN beneficiaries on programs and opportunities that can be VerDate Aug<31>2005 14:53 Sep 19, 2005 Jkt 205001 accessed in CMS. The NIHB will dedicate one full day of its upcoming annual health conference (i.e., the 22nd Annual NIHB Consumer Conference in October 2005) to familiarize the anticipated 800 attendees with CMS and its programs. In addition the NIHB will provide expertise and assistance to he Tribal Technical Advisory Group (TTAG) with consultation efforts to ensure that Tribes have input in the development of both the CMS Tribal strategic plan and the CMS consultation policy for AI/AN’s. This supplement will benefit AI/AN’s by informing a AI/ AN’s of CMS programs established address health care needs of which they may not otherwise be aware. The benefit to the IHS is increased funding resources to the AI/AN beneficiaries. This effort is consistent with the NIHB’s goals of expanding the access to other programs of the HHS for AI/AN. 2. Enumeration of the Public Health Infrastructure in AI/AN Communities We anticipate funding will be transferred to the IHS from the CDC to conduct a study of the status of Tribal public health capacity in areas such as epidemiology disease surveillance, public health nursing, community environmental health, health education and promotion, and other preventative health capacities. A paucity of information exists about the prevention capacity available throughout the Tribal Public Health System (TPHS) which broadly includes Tribal health departments, health committees, service units, and services provided by Indian Health Boards. The study, which will be undertaken by the NIHB, will provide current and accurate date on the Tribal Public Health System and will serve as a foundation for public health workforce research, workforce development efforts and demonstration programs and discussions on the training needs of public health workers. This effort is consistent with the NIHB’s goal of providing advice and assistance in the areas of health care policy analysis and program development. 3. Support of the Activities of the Tribal Leader’s Diabetes Committee Efforts to prevent and combat diabetes and its complications have been major activities for the IHS over the last several years that have resulted in numerous positive accomplishments. A major reason for this success had been the active involvement of AI/AN Tribal Leadership in determining, with the IHS, how resources should be targeted, and ‘‘best practices’’ that can be replicated throughout the Indian Country. Funding through the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 supplement will enable the NIHB to provide support to the Tribal Leaders Diabetes Committees (TLDC), which provide advice and recommendations to the NIHB on the public health effort to prevent and control diabetes. This effort is consistent with the NIHB goals of providing advice and assistance in the areas of policy analysis and program development and in ensuring that health care advocacy is based on input from Tribal Government. Justification for Single Source: This project has been awarded on a noncompetitive, single-source basis. The NIHB is the only national AI/AN organization with health expertise that represents the interest of all federally recognized Tribes. Use of Cooperative Agreement: The program supplement to the original cooperative agreement has been awarded because of anticipated substantial programmatic involvement by IHS staff in the project. The substantial programmatic involvement includes the following: 1. The IHS staff will have approval over the hiring of key personnel as defined by regulation or provisions in the cooperative agreement. 2. The IHS will provide technical assistance to the NIHB as requested and attend and participate in all NIHB board meetings. FOR FURTHER INFORMATION CONTACT: Mr. Douglas Black, Director, Office of Tribal Programs, Office of the Director, Indian Health Service, 801 Thompson Avenue, Reyes Building, Suite 220, Rockville, Maryland 20852, (301) 443–1104. For grants information, contact Ms. Sylvia Ryan, Grants Management Specialist, Division of Grants Policy, 12300 Twinbrook Parkway, Suite 100, Rockville, Maryland 20852, (301) 443– 5204. Dated: September 13, 2005. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. 05–18653 Filed 9–19–05; 8:45 am] BILLING CODE 4165–16–M DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Submission for OMB Review; Comment Request Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, U.S. Department of Homeland Security. AGENCY: E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55145-55146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18653]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


National Indian Health Board

AGENCY: Indian Health Service, HHS.

ACTION: Notice to supplement the single-source cooperative agreement 
with the National Indian Health Board.

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SUMMARY: The Indian Health Service (IHS) announces a supplement to the 
single-source cooperative agreement award to the National Indian Health 
Board (NIHB) for costs in providing advice and technical assistance to 
the IHS on behalf of federally recognized Tribes in the area of health 
care policy analysis and program development. The

[[Page 55146]]

NIHB is a non-profit organization as described in section 501(c)(3) of 
the Internal Revenue Code. The mission of the IHS is to work in 
partnership with American Indian and Alaska Native people to raise 
their health to the highest level. Under the original cooperative 
agreement published in the Federal Register, 69 FR 11447, on March 10, 
2004, the NIHB assists the IHS in carrying out its mission through 
access to a broad based consumer network involving the Areas Health 
Boards or Health Board representatives from each of the 12 IHS Areas. 
The NIHB communicates with these boards and with Tribes and Tribal 
organizations in order to raise health of AI/AN people to the highest 
level. NIHB also disseminates health care information which serves to 
improve and expand access for American Indians and Alaska Natives (AI/
AN) Tribal Governments to all available health programs in the 
Department of Health and Human Services (HHS). The NIHB assists in the 
coordination of the Tribal consultation activities associated with 
formulating the IHS annual budget request.
    The program supplement to the single-source cooperative agreement 
is for $321,800 of non-recurring funding for use during the current 
budget period in effect from 01/01/2005 to 12/31/2005. The annual 
funding level of this single-source cooperative agreement is 
approximately $230,000, subject to the availability of appropriations.

Justification for Program Supplement

    The program supplement is issued under the authority of the Public 
Health Service Act, section 301(a) and is included under the Catalog of 
Federal Domestic Assistance number 93.933. This supplement funding is 
related to the original goals of the cooperative agreement and does not 
represent an expansion of activities outside of the present scope of 
work. The Federal Register Notice for the sole-source cooperative 
agreement award can be found in 69 FR 11447, published on March 10, 
2004. The specific objectives and justifications for this program 
supplement are as follows:

1. Outreach and Education Within the AI/AN Community Concerning the 
Programs of the Centers for Medicare and Medicaid Services (CMS)

    We anticipate funding will be transferred through an inter-agency 
agreement between CMS and the IHS to supplement the NIHB cooperative 
agreement. the NIHB will inform and educated AI/AN beneficiaries on 
programs and opportunities that can be accessed in CMS. The NIHB will 
dedicate one full day of its upcoming annual health conference (i.e., 
the 22nd Annual NIHB Consumer Conference in October 2005) to 
familiarize the anticipated 800 attendees with CMS and its programs. In 
addition the NIHB will provide expertise and assistance to he Tribal 
Technical Advisory Group (TTAG) with consultation efforts to ensure 
that Tribes have input in the development of both the CMS Tribal 
strategic plan and the CMS consultation policy for AI/AN's. This 
supplement will benefit AI/AN's by informing a AI/AN's of CMS programs 
established address health care needs of which they may not otherwise 
be aware. The benefit to the IHS is increased funding resources to the 
AI/AN beneficiaries. This effort is consistent with the NIHB's goals of 
expanding the access to other programs of the HHS for AI/AN.

2. Enumeration of the Public Health Infrastructure in AI/AN Communities

    We anticipate funding will be transferred to the IHS from the CDC 
to conduct a study of the status of Tribal public health capacity in 
areas such as epidemiology disease surveillance, public health nursing, 
community environmental health, health education and promotion, and 
other preventative health capacities. A paucity of information exists 
about the prevention capacity available throughout the Tribal Public 
Health System (TPHS) which broadly includes Tribal health departments, 
health committees, service units, and services provided by Indian 
Health Boards. The study, which will be undertaken by the NIHB, will 
provide current and accurate date on the Tribal Public Health System 
and will serve as a foundation for public health workforce research, 
workforce development efforts and demonstration programs and 
discussions on the training needs of public health workers. This effort 
is consistent with the NIHB's goal of providing advice and assistance 
in the areas of health care policy analysis and program development.

3. Support of the Activities of the Tribal Leader's Diabetes Committee

    Efforts to prevent and combat diabetes and its complications have 
been major activities for the IHS over the last several years that have 
resulted in numerous positive accomplishments. A major reason for this 
success had been the active involvement of AI/AN Tribal Leadership in 
determining, with the IHS, how resources should be targeted, and ``best 
practices'' that can be replicated throughout the Indian Country. 
Funding through the supplement will enable the NIHB to provide support 
to the Tribal Leaders Diabetes Committees (TLDC), which provide advice 
and recommendations to the NIHB on the public health effort to prevent 
and control diabetes. This effort is consistent with the NIHB goals of 
providing advice and assistance in the areas of policy analysis and 
program development and in ensuring that health care advocacy is based 
on input from Tribal Government.
    Justification for Single Source: This project has been awarded on a 
non-competitive, single-source basis. The NIHB is the only national AI/
AN organization with health expertise that represents the interest of 
all federally recognized Tribes.
    Use of Cooperative Agreement: The program supplement to the 
original cooperative agreement has been awarded because of anticipated 
substantial programmatic involvement by IHS staff in the project. The 
substantial programmatic involvement includes the following:
    1. The IHS staff will have approval over the hiring of key 
personnel as defined by regulation or provisions in the cooperative 
agreement.
    2. The IHS will provide technical assistance to the NIHB as 
requested and attend and participate in all NIHB board meetings.

FOR FURTHER INFORMATION CONTACT: Mr. Douglas Black, Director, Office of 
Tribal Programs, Office of the Director, Indian Health Service, 801 
Thompson Avenue, Reyes Building, Suite 220, Rockville, Maryland 20852, 
(301) 443-1104. For grants information, contact Ms. Sylvia Ryan, Grants 
Management Specialist, Division of Grants Policy, 12300 Twinbrook 
Parkway, Suite 100, Rockville, Maryland 20852, (301) 443-5204.

    Dated: September 13, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 05-18653 Filed 9-19-05; 8:45 am]
BILLING CODE 4165-16-M