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1. Submission for OMB Review; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

Title: Exploration of LowIncome Couples' DecisionMaking Processes.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Exploration of LowIncome Couples' Decision Making (CDM) Processes study.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

2. Submission for OMB Review; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

Proposed Project

Title: Communities Empowering Youth Evaluation Study.

OMB No. New Collection.

Description: The information collection activity proposed under this notice will obtain information about lead and partner organizations funded under the Communities Empowering Youth (CEY) program. The information collected will complement a

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

3. 2007-0650)

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration

NOTICES: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatDrug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability

NOTICES: Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability,

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination

NOTICES: Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Availability,

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Condoms.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of condoms from manufacturers/shippers whose condoms have
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination

NOTICES: Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Availability,

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of surgeons' and patient
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States; Public Workshop

NOTICES: Approaches to Reduce Risk of Transfusion-Transmitted Babesiosis in the United States,

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Approaches to Reduce the Risk of Transfusion Transmitted Babesiosis in the United States.'' The purpose of the public workshop is to discuss the risk and possible approaches to minimize the incidence of transfusiontransmitted babesiosis in the United States. We

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

9. Request for Nominations for Voting Members on Public Advisory Committee, Food Advisory Committee

NOTICES: Food Advisory Committee,

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (FAC), Center for Food Safety and Applied Nutrition (CFSAN).

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Office of Clinical and Preventive Services, Division of Nursing Services Nursing Program, Schools of Nursing

NOTICES: Competitive Continuation and New Grants Funding; Correction,

Correction

In notice document E814457 beginning on page 36333 in the issue of Thursday, June 26, 2008 make the following corrections:

1. On page 36333, in the second column, under the I. Funding Opportunity Description heading, in the eighth line, ``(AI/AN5)'' should read ``(AI/ANs)''.

2. On page 36334, in the third column, in the sixth

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Indian Health Service

11. Tribal Self-Governance Program; Planning Cooperative Agreement

NOTICES: Tribal Self-Governance Program; Planning Cooperative Agreement,

Announcement Type: New.

Funding Announcement Number: HHS2008IHSTSGP0002.

Catalog of Federal Domestic Assistance Number(s): 93.2 10.

Key Dates:

Application Deadline Date: August 15, 2008.

Review Date: August 2526, 2008.

Earliest Anticipated Start Date: September 1, 2008. I. Funding Opportunity Description

The purpose of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Indian Health Service

12. National Heart, Lung, and Blood Institute; Notice of Closed Meetings

NOTICES: National Heart, Lung, and Blood Institute,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

13. Center for Substance Abuse Prevention; Notice of Meeting

NOTICES: Center for Substance Abuse Prevention National Advisory Council,

Pursuant to Public Law 92463, notice is hereby given that the Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Prevention National Advisory Council will meet on July 29 and July 30, 2008.

A portion of the meeting will be open and will include discussion of the Center's policy issues, and current

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration

14. Center for Substance Abuse Treatment; Notice of Meeting

NOTICES: Center for Substance Abuse Treatment National Advisory Council,

Pursuant to Public Law 92463, notice is hereby given that the Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) National Advisory Council will meet on July 31, 2008 from 1 p.m. to 3 p.m. via teleconference.

The meeting will include discussion and evaluation of grant applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration

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