The Federal Register

Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Risk Factors for Birth Defects,

Fri, Dec 15 2006 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:

Time and Date: 12 p.m.2 p.m., January 23, 2007 (Closed).

Place: Teleconference.

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 [[Page 75553]]

Office, CDC, pursuant to Public Law 92463.

Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to ``Risk Factors for Birth Defects,'' RFA DD 07001.

Contact Person for More Information: Christine Morrison, Ph.D., Scientific Review Administrator, Office of Public Health Research, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.3098.

The Director, Management Analysis and Services Office, has been de

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Dec 15 2006 11:00:00 GMT

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

Fri, Dec 15 2006 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Dec 15 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Dec 15 2006 11:00:00 GMT

Drug Products Containing Quinine; Enforcement Action Dates

Fri, Dec 15 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such products or their shipment in interstate commerce. Drug products containing quinine, quinine sulfate, and any other salt of quinine are new drugs that require approved applications. One firm has an approved application to market a drug product containing quinine sulfate to treat malaria; this product has been designated an orphan drug product. Other manufacturers who wish to market a drug product containing quinine, quinine sulfate, or any other salt of quinine must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA); consideration of any such applications will be subject to the rights of the current NDA holder under the Orphan Drug Act.

International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World

Fri, Dec 15 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 12 to 16, 2007. This notice is issued under the Controlled Substances Act.

Notice of Program Exclusions

Fri, Dec 15 2006 11:00:00 GMT

Important Announcement: This is the final publication of the Office of Inspector General's (OIG) monthly exclusion actions in the Federal Register. Downloadable files of exclusion actions taken each month are available on the OIG's Web site. In addition, the Web site has a downloadable data file and an online searchable database containing all exclusion actions currently in effect. This data is called the List of Excluded Individuals/Entities (LEIE) and is located at http://oig.hhs.gov. Click on EXCLUSIONS DATABASE to access the LEIE and other important information about the OIG's exclusion program.

Program Exclusions: November 2006. During the month of November 2006, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusions is imposed, no program payment is made to anyone for any items or services (other than an emergency ite

National Institute of Dental & Craniofacial Research; Notice of Meeting

Fri, Dec 15 2006 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 a meeting of the National Advisory Dental and Craniofacal Research Council.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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/or contract proposals 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 and/or contracts proposals, the disclosure of which would constitute a clearly unwarra

National Institute of Dental and Craniofacial Research; Notice of Closed Meetings

Fri, Dec 15 2006 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 552(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 Institute of Dental and Craniofacial Research Special Emphasis Panel, 0722, Review PAR05101
Institutional Dental Research Training Program.

Date: January 9, 2007.

Time: 8 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814.

Contact Person: Lynn M. King

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

Fri, Dec 15 2006 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: National Outcome Measures (NOMs) for Consumers Receiving Mental Health ServicesNEW

The mission of SAMHSA's Center for Mental Health Services (CMHS) is to treat mental illnesses by promoting mental health and by preventing the development or worsening of mental illness when possible. Congress created CMHS to bring new hope to adults who have serious mental illnesses and to children with serious emotional disorders.

The purpose of this proposed data activity is to promote the use of consistent measures among CMHS grantees and contractors funded through the Program of Regional and National Significance (PRNS) and Children's Mental Health Initiati

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Dec 15 2006 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