The Federal Register

Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis,

Tue, Apr 7 2009 11:00:00 GMT

As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration (FDA)) are announcing a callfordata for safety and effectiveness information for sodium shale oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinseoff treatment for dandruff. We have reviewed a time and extent application (TEA) for SSOS and determined that it is eligible for consideration in our OTC drug monograph system. We will evaluate the submitted data and information to determine whether SSOS can be generally recognized as safe and effective (GRASE) as an OTC rinseoff treatment for dandruff.

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 23, 2009, from 8:30 a.m. to 5:30 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: James Swink, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402764050, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512625. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications that

Proposed Information Collection Activity; Comment Request

Tue, Apr 7 2009 11:00:00 GMT

Proposed Projects

Title: CrossSite Evaluation of the Infant Adoption Awareness Training Program for Projects Initially Funded in Fiscal Year 2006.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), Children's Bureau (CB), will conduct the CrossSite Evaluation of the Infant Adoption Awareness Training Program (IAATP). Title XII, Subtitle A, of the Children's Health Act of 2000 (CHA) authorizes the Department of Health and Human Services to make Infant Adoption Awareness Training grants available to national, regional, and local adoption organizations for the purposes of developing and implementing programs that train the staff of public and nonprofit private health service organizations to provide adoption information and referrals to pregnant women on an equal basis with all other courses of action included in nondirective counseling of pregnant women. Participants in the training include individuals who provide pregnancy or adoption information

Center for Scientific Review; Notice of Closed Meetings

Tue, Apr 7 2009 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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: Center for Scientific Review Special Emphasis Panel. Musculoskeletal Rehabilitation Sciences.

Date: April 14, 2009.

Time: 1 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: Daniel F. McDonald, PhD, Scientifi

Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review

Tue, Apr 7 2009 11:00:00 GMT

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``Guidance on the Genetic Information
Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and http://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRB) that review, nonexempt human subjects research involving genetic testing or coll

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Gastrointestinal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on May 19, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301589 5200.

Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001; FAX: 3018276776, email: Kristine.Khuc@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512538. Please

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Apr 7 2009 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 2761243.

Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniq

Agency Information Collection Activities; Proposed Collection; Comment Request; Semi-Annual and Final Reporting

Tue, Apr 7 2009 11:00:00 GMT

The Administration on Aging (AoA) 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 the information
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collection requirements relating to the continuation of an existing collection for Performance Progress Reports for Older Americans Act Title IV grantees.

Submission for OMB Review; Comment Request

Tue, Apr 7 2009 11:00:00 GMT

Title: Building Strong Families (BSF) Demonstration and Evaluation Impact Study Second Followup.

OMB No.: 09700304.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), anticipates continuing data collection for the 15month followup surveys of the Building Strong Families (BSF) Demonstration and Evaluation. Data collection will continue for an additional 6 months beyond the current date of expiration (July 31, 2009).

This data collection is a part of the BSF evaluation, which is an important opportunity to learn if welldesigned interventions can help lowincome couples develop the knowledge and relationship skills that research has shown are associated with healthy marriages. The BSF evaluation uses an experimental design that randomly assigns couples who volunteer to participate in BSF programs to a program or control group.

Materials for the original 15month data collection effort, previously submitted to OMB, c

National Human Genome Research Institute; Notice of Closed Meeting

Tue, Apr 7 2009 11:00:00 GMT

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

The meeting 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: Center for Inherited Disease Research Access Committee.

Date: April 30May 1, 2009.

Time: 7 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: Admiral Fell Inn, 888 South Broadway, Baltimore, MD 21231.

Contact Person: Camilla E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome Research Institute, National Insti

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Apr 7 2009 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

A Study of Primary and Secondary Prevention Behaviors Practiced Among FiveYear Survivors of Colorectal CancerNewNational Center for Chronic Disease Prevention and Control (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Colorectal cancer (CRC) is the third most prevalent cancer and the second leading cause of cancer death in both men and women in the Unite

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Gastrointestinal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on May 20, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301589 5200.

Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: Kristine.Khuc@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512538. Please

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Apr 7 2009 11:00:00 GMT

Proposed Information Collection Activity; Comment Request

Tue, Apr 7 2009 11:00:00 GMT

Proposed Projects:

Title: Head Start Grant Application and Budget Instruments.

OMB No.: 09700207.

Description: The Office of Head Start is proposing to renew, without changes, the Head Start Grant Application and Budget Instrument, which standardizes the grant application information that is requested from all Head Start and Early Head Start grantees applying for continuation grants. The application and budget forms are available in a passwordprotected, Webbased system. Completed applications can be transmitted electronically to Regional and Central Offices. The Administration for Children and Families believes that this application form makes the process of applying for Head Start program grants more efficient for applicants.

Respondents: Head Start and Early Head Start grantees. Annual Burden Estimates Number of Average burden Instrument

Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009

Tue, Apr 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2009.

For FY 2009, the generic new animal drug user fee rates are: $41,400 for each abbreviated application for a generic new animal drug; $3,005 for each generic new animal drug product; $56,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $42,265 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $28,175 for a generic new