The Federal Register

Notice of Availability on Transforming Healthcare Quality Through Information Technology (THQIT)--Implementation

Tue, Dec 30 2003 11:00:00 GMT

This notices announces the availability of a Request for Applications (RFA) on Implementation grants to evaluate the effects of health information technology (HIT) on improving patient safety and quality of health care.

The objective of this RFA is to support organization and community wide implementation and diffusion of HIT and to assess the extent to which HIT contributes to measurable and sustainable improvement in patient safety, cost and overall quality of care. Research resulting from this RFA should inform AHRQ, providers, patients, payers, policymakers, and the public about how HIT can be successfully implemented in diverse health care settings and lead to safer and better health for all Americans.

Notice of Meetings

Tue, Dec 30 2003 11:00:00 GMT

In accordance with section 10(d) of the Federal Advisory Committee Act as amended (5 U.S.C., Appendix 2), the Agency for Healthcare Research and Quality (AHRQ) announces meetings of scientific peer review groups. The subcommittees listed below are part of the Agency's Health Services Research Initial Review Group Committee.

The subcommittee meetings will be closed to the public in accordance with the Federal Advisory Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C. 552b(c)(6). Grant applications are to be reviewed and discussed at these meetings. These discussions are likely to involve information concerning individuals associated with the applications, including assessments of their personal
qualifications to conduct their proposed projects. This information is exempt from mandatory disclosure under the abovecited statutes.

1. Name of Subcommittee: Health Care Research Training.

Date: January 2223, 2004 (Open from 8 a.m. to 8:15 a.m. on January 22 and closed for

Cooperative Agreement for Research on the Association Between Exposure to Media Violence and Youth Violence; Notice

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements to conduct methodologically sound research on how media violence affects youth violent behavior was published in the Federal Register on November 28, 2003, Volume 68, Number 229, pages 6682966834. The notice is amended as follows:

On page 66833, Column 3, Line 4 in the first paragraph after the ``AR25'' requirement, delete ``$250,000'' and replace with ``$500,000.''

Dated: December 19, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331835 Filed 122903; 8:45 am]
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National Organization Strategies for the Prevention, Early Detection and Control of Chronic Disease by Chief Elected

Tue, Dec 30 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: 04072.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates: Application Deadline: February 13, 2004. I. Funding Opportunity Description

Authority: This program is authorized under section 301(a) of the Public Health Service Act, (42 U.S.C. 241(a)).

Purpose: The purpose of the program is to support a national organization in the development and implementation of educational initiatives that can be used by chief elected officials in applying effective strategies to prevent and control cancer and other chronic diseases, chronic disease risk factors, and chronic disease health disparities in their cities. This program addresses the ``Healthy People 2010'' focus areas of: Tobacco Use; Physical Activity and Fitness; Nutrition and Overweight; Public Health Infrastructure; Oral Health; Arthritis; Osteoporosis and Chronic Back Conditions; Educational and CommunityBased Programs; Adolescent and School Health; Cancer; Di

Practices To Improve Training Skills of Home Visitors; Notice of Availability of Funds-Amendment

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreement to conduct a systematic examination of the impact of home visitor training and factors related to the implementation of an existing efficacious or effective home visiting program on family outcomes of child maltreatment and risk behaviors for youth violence was published in the Federal Register on December 1, 2003, Volume 68, Number 230, pages 6717167176. The notice is amended as follows: On page 67176, Column 1, Line 4, in the first paragraph after ``AR25'' requirement, delete ``$250,000'' and replace with ``$500,000.''

Dated: December 19, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331834 Filed 122903; 8:45 am]
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Capacity Building Assistance To Improve the Delivery and Effectiveness of HIV Prevention Services for Racial/Ethnic

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements for Capacity Building Assistance to Improve the Delivery and Effectiveness of HIV Prevention Services for Racial/ Ethnic Minority Populations was published in the Federal Register, Tuesday, December 2, 2003, Volume 68, Number 231, pages 6755867566. The notice is amended as follows:

Page 67558, second column, please do not include Arizona (AZ) in the South region; please do not include Arkansas (AK) in the West region, but do include AK in the South region.

Dated: December 22, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331974 Filed 122903; 8:45 am]
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HIV Prevention Projects for the Pacific Islands

Tue, Dec 30 2003 11:00:00 GMT

Announcement Type: New.

Funding Opportunity Number: 04069.

Catalog of Federal Domestic Assistance Number: 93.943.

Key Dates:

Application Deadline: February 2, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act, 42 U.S.C., 241 and 247b(k)(2).

Purpose: The purpose of the program is to support HIV prevention projects in the U.S. Affiliated Pacific Island Jurisdictions. HIV prevention programs in these jurisdictions face unique challenges and circumstances. These jurisdictions often lack sufficient resources, program infrastructure, and technical support to fully implement a comprehensive HIV prevention program and to ensure that critical prevention program components are implemented and sustained. These island nations deal with many challenging dynamics that include reaching and supporting prevention activities in locations separated by vast expanses of ocean, highly mobile pop

HIV Prevention Projects; Notice of Availability of Funds; Amendment

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements for HIV prevention projects was published in the Federal Register July 10, 2003, Volume 68, Number 132, pages 41138 41147. The notice is amended as follows:

On page 41138, first column, section ``A. Authority and Catalog of Federal Domestic Assistance Number,'' please amend the CFDA number from 93.943 to 93.340.

Dated: December 22, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331973 Filed 122903; 8:45 am]
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Grant for Injury Control Research Center; Notice of Availability of Funds-Amendment

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for a grant for an Injury Control Research Center (ICRC) was published in the Federal Register on November 26, 2003, Volume
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68, Number 228, pages 6644266447. The notice is amended as follows: On page 66447, Column 1, Section ``VI. Award Administration Information,'' on line 4 in the first paragraph after the ``AR25'' requirement, delete ``$250,000'' and replace with ``$500,000.''

Dated: December 19, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331838 Filed 122903; 8:45 am]
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Youth Violence Prevention Through Community-Level Change; Notice of Availability of Funds-Amendment

Tue, Dec 30 2003 11:00:00 GMT

A notice announcing the availability of fiscal year (FY) 2004 funds for Youth Violence Prevention Through CommunityLevel Change was published in the Federal Register on December 2, 2003, Volume 68, Number 231, pages 6745067455. The notice is amended as follows: On page 67453, Column 2, Section ``IV. Application and Submission Information,'' under 5. Funding Restrictions, at the end of the paragraph add the word ``None'' and move Funding Priority and Funding Preference to page 67450, Column 3, Section ``I. Funding Opportunity Description'' after Research Objectives.

Dated: December 19, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 0331839 Filed 122903; 8:45 am]
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Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Dec 30 2003 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Dec 30 2003 11:00:00 GMT

President's Committee for People With Intellectual Disabilities (PCPID): Notice of Meeting

Tue, Dec 30 2003 11:00:00 GMT

Revision of the Requirements for Spore-Forming Microorganisms

Tue, Dec 30 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore forming microorganisms. FDA is amending the regulations due to advances in facility, system, and equipment design and in sterilization technologies that will allow work with sporeforming microorganisms to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement for always using separate, dedicated facilities and equipment for work with sporeforming microorganisms is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. We are issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that we will receive any significant comments o

Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule

Tue, Dec 30 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with sporeforming microorganisms. FDA is proposing this amendment due to advances in facility, system, and equipment design and in sterilization technologies that would allow work with sporeforming microorganisms to be performed in multiproduct manufacturing areas. We are amending the regulations because the existing requirement for always using separate, dedicated facilities and equipment for work with spore forming microorganisms is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action b

Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision;

Tue, Dec 30 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This draft guidance provides recommendations for sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for generic clozapine products. This draft guidance is being issued because an earlier guidance on this topic published in November 1996 needed to be revised to
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reflect current agency recommendations. Because of significant potential adverse effects, the agency no longer recommends in vivo bioequivalence testing in healthy subjects.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Dec 30 2003 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (301) 4437978.

Protection and Advocacy for Individuals with Mental Illness (PAIMI) Final Rule, 42 CFR part 51(OMB No. 09300172Extension)These regulations meet the directive under 42 U.S.C. 10826(b) requiring the Secretary to promulgate final regulations to carry out the PAIMI Act. The regulations contain information collection requirements. The Act authorized funds to support activities on behalf of individuals with significant (severe) mental illness (adults) or emotional impairment (children/youth) (42 U.S.C. at 10802(4)). However, only entities designated by the governor of each State and six (6) territories (the American Indian Consortium, American Samoa, Guam, the Northern

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Dec 30 2003 11:00:00 GMT

Evaluation of the Buprenorphine Waiver: Longitudinal Patient SurveyNewThe Substance Abuse and Mental Health Services
Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT), is evaluating a program that permits officebased physicians to obtain Waivers from the requirements of the Narcotic Addict Treatment Act of 1974 (21 U.S.C. 823(g)). Under the Drug Addiction Treatment Act of 2000 (21 U.S.C. 823 (g)(2)), the Waiver Program permits qualifying physicians to prescribe and dispense buprenorphine, a schedule III narcotic drug recently approved by the FDA for the treatment of opiate addiction. Furthermore, the Dr