The Federal Register

Submission for OMB Review; Comment Request

Fri, Jul 11 2008 11:00:00 GMT

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. This project will gather important information that will be useful for improving social services delivery approaches for working with individuals in couple relationships. The proposed collection will consist of a telephone survey and inhome observation of lowincome couples. These data collection efforts will examine sources of conflict and assess decisionmaking processes among lowincome couplesespecially in relation to issues directly addressed by social service programs (e.g., employment, housing, etc.)

Respondents: Lowincome couples.
Annual Burden Estimates

Submission for OMB Review; Comment Request

Fri, Jul 11 2008 11:00:00 GMT

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 survey (OMB No. 09700335) that is examining the organizational and partnership capacitybuilding experienced by organizations funded under the CEY program. The proposed information collection will allow indepth examination of a select number of lead organizations and their partners. Information collection will be through onsite observations of organizations and partnerships and structured discussions with key staff, using uniform protocols. Pilot testing will be conducted at two sites to ensure that the protocols and observations are valid and reliable. Onsite information collection will occur three times: Near the beginning, at the midpoint, and at the

2007-0650)

Fri, Jul 11 2008 11:00:00 GMT

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.

Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration

Fri, Jul 11 2008 11:00:00 GMT

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 drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDArecommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA.

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

Fri, Jul 11 2008 11:00:00 GMT

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 and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

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

Fri, Jul 11 2008 11:00:00 GMT

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 failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that condoms imported to the United States do not have defects that could compromise their effectiveness and present a health hazard to consumers who rely on condoms for protection from sexually transmitted diseases as well as for contraception.

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

Fri, Jul 11 2008 11:00:00 GMT

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 examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that medical gloves imported to the United States meet FDA's minimum acceptable quality criteria and do not have defects that could compromise their effectiveness and pose a health hazard to healthcare professionals and patients who rely on medical gloves for protection from blood and fluidborne pathogens.

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

Fri, Jul 11 2008 11:00:00 GMT

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 are convening this workshop at the present time because FDA has observed a recent increase in the number of reports of transfusiontransmitted babesiosis, thus warranting additional discussion to address this blood safety issue. The public workshop will feature presentations and roundtable discussions led by experts from academic institutions, government, and industry.

Date and Time: The public workshop will be held on September 12, 2008, from 7:30 a.m. to 5:30 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894.

Contact Person: R

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

Fri, Jul 11 2008 11:00:00 GMT

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, therefore, encourages nominations of qualified candidates from these groups.

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

Fri, Jul 11 2008 11:00:00 GMT

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 line from the top, ``c[dash]mails'' should read ``e[dash]mails''

3. On the same page, in the same column, in the first full paragraph, in the second line, ``11[dash]IS'' should read ``IHS''.

4. On page 36335, in the second column, under the fourth bullet, in the fifth line, ``DUO'' should read ``DGO''.

5. On the same page, in the third column, in the 13th line from the bottom, ``DNIP'' should read ``DNP''.

6. On page 36336, in the third column, under the 3. Indirect Costs heading, in the fifth line, ``Part 1127'' should read ``Part II27''.

7. On the same page, in the same column, under the same heading, in the same line, ``IIHS'' shoul

Tribal Self-Governance Program; Planning Cooperative Agreement

Fri, Jul 11 2008 11:00:00 GMT

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 the program is to award cooperative agreements that provide planning resources to Tribes interested in participating in the Tribal SelfGovernance Program (TSGP) as authorized by Title V, Tribal SelfGovernance Amendments of 2000 of the Indian SelfDetermination and Education Assistance Act of Public Law (Pub. L.) 93638, as amended. There is limited competition under this announcement because the authorizing legislation restricts eligibility to Tribes that meet specific criteria (Refer to Section III.1.A., Eligible Applicants in this announcement). The TSGP is designed to promote selfdetermination by allowing Tribes to assume more control of Indian Health

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

Fri, Jul 11 2008 11:00:00 GMT

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 discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBIPatient Oriented Research (K23, 24, and 25's) Career Enhancement Awards.

Date: July 2122, 2008.

Time: 7:30 a.m. to 5:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Crystal City Courtyard Marriott, 2899 Jefferson Davis Highway, Arlington, VA 22202.

Con

Center for Substance Abuse Prevention; Notice of Meeting

Fri, Jul 11 2008 11:00:00 GMT

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 administrative, legislative and program developments.

The meeting will also include the review, discussion, and evaluation of grant applications. Therefore a portion of the meeting will be closed to the public as determined by the Administrator, SAMHSA, and in accordance with Title 5 U.S.C. 552b(c)(6) and 5 U.S.C. App. 2, Section 10(d).

Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the CSAP National Advisory Council Designated Federal Official, Tia Haynes (see contact information below), to make arrangements to attend, to comment or to request special accommodations for persons

Center for Substance Abuse Treatment; Notice of Meeting

Fri, Jul 11 2008 11:00:00 GMT

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 reviewed by Initial Review Groups. Therefore, the meeting will be closed to
[[Page 39978]]
the public as determined by the Administrator, SAMHSA, in accordance with Title 5 U.S.C. 552b(c)(6) and 5 U.S.C. App. 2, Section 10(d).

Substantive program information, a summary of the meeting and a roster of Council members may be obtained as soon as possible after the meeting, either by accessing the SAMHSA Committee Web site at www.nac.samhsa.gov, or by contacting CSAT National Advisory Council's Designated Federal Official, Ms. Cynthi