The Federal Register

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): National Institute for

Wed, Jan 2 2008 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting.

Time and Date: 8:30 a.m.5:30 p.m., February 20, 2008 (Closed).

Place: Marriott Marina del Rey, 4100 Admiralty Way, Marian del Rey, CA 90292.

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Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ``National Institute for Occupational Safety and Health (NIOSH): Occupational Safety and Health Training Project Grants, PA PAR06484.''

Contact Person for More Information: Charles N. Rafferty, PhD, Assistant Director for Review and Policy, Office of Extramural Programs, Office of Extramural Coordination and

Mine Safety and Health Research Advisory Committee (MSHRAC): Meeting

Wed, Jan 2 2008 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee:

Time and Date:

8:45 a.m.5:15 p.m., January 22, 2008.

8:30 a.m.3:45 p.m., January 23, 2008.

Place: Hilton Garden Inn Pittsburgh/Southpointe, 1000 Corporate Drive, Canonsburg, PA 15317, telephone (724) 7435000, fax (724) 7435010.

Status: The meeting room accommodates approximately 50 people.

Purpose: This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2).

Matters To Be Discussed: The meeting will focus on Communications and Tracking, update on Refuge Alternatives Activities, Mine Ground Control Research, Dynamic Failures Proposal,

Center for Food Safety and Applied Nutrition; Statement of Organization, Functions, and Delegations of Authority

Wed, Jan 2 2008 11:00:00 GMT

Part D, Food and Drug Administration, Chapter DB, Office of Operations, Center for Food Safety and Applied Nutrition (DBF), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970, and 60 FR 56005, November 9, 1995; 64 FR 36361, July 6, 1999; and in pertinent part at 57 FR 54239) is amended to reflect the restructuring of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Operations (OO), Food and Drug Administration (FDA) as follows:

I. Under Chapter DB, Office of Operations, delete in its entirety, the ``Center for Food Safety and Applied Nutrition (DBF).

II. Establish a new Chapter DH, Center for Food Safety and Applied Nutrition (DH), under Part D to read as follows:

DF.10 Organization. The Center for Food Safety and Applied Nutrition, FDA is headed by the Director, Food Safety and Applied Nutrition, and includes the following organizational units: Office of the Ce

Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s,

Wed, Jan 2 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.'' The purpose of this guidance document is to recommend an
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interactive premarket review process for these submissions that is designed to expedite FDA's review of device applications while continuing to assure device safety and effectiveness, in accordance with the goals of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products

Wed, Jan 2 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (overthecounter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.

Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the

Wed, Jan 2 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' This draft guidance is intended to assist the dietary supplement industry in complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by the Center for Drug Evaluation and Research on labeling requirements for nonprescription (overthecounter) human drugs marketed without an approved
application, is announced elsewhere in this issue of the Federal Register.

Agency Information Collection Request. 60-Day Public Comment Request

Wed, Jan 2 2008 11:00:00 GMT

Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-Making

Wed, Jan 2 2008 11:00:00 GMT

On September 5, 2007, the Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services (HHS) issued a notice in the Federal Register (Vol. 72, No. 171, pages 5096650970) seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decisionmaking capacity who are potential subjects in research. A 90day comment period was established upon publication of that notice.

The purpose of this notice is to inform all interested parties that the comment period originally identified in the September 5, 2007 Federal Register has been extended for forty one days, in order to maximize the opportunity for interested individuals and organizations to provide information and comments to HHS on this topic.

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

Wed, Jan 2 2008 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 (240) 2761243. Proposed Project: 2008 National Survey of Mental Health Treatment Facilities (NSMHTF) (OMB No. 09300119)Revision

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Mental Health Services (CMHS) will conduct a 2008 NSMHTF. This national survey represents a redesign of the biennial Survey of Mental Health Organizations (SMHO) last conducted in 2004 under OMB No. 09300119. Instead of surveying each mental health organization as a whole, the 2008 NSMHTF will survey all of the mental health treatment locations. These separate mental health service locations are called facilities, in contrast to mental health organizations, which may inc

Agency Information Collection Activities: Proposed Collection; Comment Request

Wed, Jan 2 2008 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