Advisory Committees; Filing of Annual Reports, 135-136 [E6-22450]

Download as PDF Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices enhanced with self-sufficiency services for low-income families who have young children or are expecting in Kansas and Missouri. Materials for follow-up surveys for each of these sites were previously submitted to OMB and were approved. The purpose of this submission is to add physiological measures to the follow-up effort to the Rhode Island study. Respondents: The respondents to this component of the Rhode Island followup survey will be low-income parents and their children from the Rhode Island site currently participating in the HtE Project. As described in the prior OMB submission, these parents are Medicaid recipients between the ages of 18 and 45 receiving Medicaid through 135 the managed care provider United Behavioral Health (UBH) in Rhode Island who meet study criteria with regard to their risk for depression. Children are the biological, adopted, and step-children of these parents, between the ages of 1 and 18 years of age. ANNUAL BURDEN ESTIMATES Instrument Number of respondents RI 15–month, parent physiological component. RI 15–month, young child physiological component. RI 15–month, youth physiological component. Estimated Total Annual Burden Hours 400 rwilkins on PROD1PC63 with NOTICES VerDate Aug<31>2005 19:02 Dec 29, 2006 Jkt 211001 8 242 Dated: December 22, 2006. Robert Sargis, Reports Clearance Officer. [FR Doc. 06–9940 Filed 12–29–06; 8:45 am] 8 160 Additional Information Copies of the proposed collection may be obtained by writing to The Administration for Children and Families, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. BILLING CODE 4184–01–M Average burden hours per response Number of responses per respondent 8 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Filing of Annual Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2006. ADDRESSES: Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301–827– 6860. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee Oversight and Management Staff (HF– 4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app. 1) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2005 through September 30, 2006. Center for Biologics Evaluation and Research: Allergenic Products Advisory PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 5 minutes or .08 hrs. 5 minutes or .08 hrs. 5 minutes or .08 hrs. ......................... Total burden hours 266.66 106.66 161.33 534.65 Committee Blood Products Advisory Committee Cellular, Tissue, and Gene Therapies Advisory Committee Vaccines and Related Biological Products Advisory Committee Center for Drug Evaluation and Research: Nonprescription Drugs Advisory Committee Anesthetic and Life Support Drugs Advisory Committee Center for Devices and Radiological Health: Medical Devices Advisory Committee (consisting of reports for General and Plastic Surgery Devices Panel, Obstetrics and Gynecology Devices Panel, Ophthalmic Devices Panel, Orthopaedic and Rehabilitation Devices Panel, and Radiological Devices Panel) National Center for Toxicological Research: Science Advisory Board to the National Center for Toxicological Research Annual reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday, at the following locations: 1. The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., rm. 133, Washington, DC; and 2. The Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. E:\FR\FM\03JAN1.SGM 03JAN1 136 Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices Dated: December 22, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–22450 Filed 12–29–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N–0573] Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of, and is requesting comment on, a draft risk assessment on animal cloning. FDA’s Center for Veterinary Medicine (CVM) developed this draft risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of, and is requesting comment on, a proposed risk management plan for animal clones and their progeny. The proposed risk management plan takes into account the risks identified in the draft risk assessment and sets out proposed measures that FDA might use to manage those risks. In addition, FDA is announcing availability of draft guidance for industry #179 for public comment. This draft guidance describes FDA’s recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed. DATES: Submit written or electronic comments on the draft risk assessment document, the proposed risk management plan, and the draft guidance for industry by April 3, 2007. FDA will accept comments, data, and information after the deadline, but to ensure consideration by the agency in any final documents, comments must be received by this date. Comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft risk assessment, proposed risk management plan, or the draft guidance for industry to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food VerDate Aug<31>2005 19:02 Dec 29, 2006 Jkt 211001 and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send a selfaddressed, adhesive label to assist that office in processing your request. Submit written comments on the draft risk assessment, proposed risk management plan, or draft guidance for industry to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–453–6842, email: clones@cvm.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In July 2001, FDA’s CVM issued an update on livestock cloning (available at https://www.fda.gov/cvm/CVM_Updates/ clones.htm) and indicated its intention to work with stakeholders to assess potential risks presented by cloning food-producing animals. It also requested that companies voluntarily refrain from introducing animal clones, their progeny, or their food products (such as milk or meat) into the human or animal food supply, pending completion of the risk assessment process. The public participation phase of this process begins with the release of draft documents entitled ‘‘Animal Cloning: A Draft Risk Assessment,’’ ‘‘Animal Cloning: Proposed Risk Management Plan for Clones and Their Progeny,’’ and ‘‘Draft Guidance for Industry #179: Use of Edible Products From Animal Clones or Their Progeny for Human Food or Animal Feed.’’ Among the goals of our draft risk assessment were the determination of whether somatic cell nuclear transfer (SCNT), the process used to produce the clones being considered in the risk assessment, poses any unique risks to animals involved in cloning relative to other assisted reproductive technologies, and whether foods derived from animal clones or their progeny pose consumption risks greater than those posed by foods derived from their conventional counterparts. It specifically does not consider risk issues that may be posed by genetically engineered animals. The draft risk assessment has been peer reviewed in accordance with the Office of Management and Budget’s Information Quality Peer Review Bulletin. The peer reviewers’ comments PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 and the agency’s response to them are posted on the Internet with the draft risk assessment (see the Electronic Access section of this document). The proposed risk management plan describes proposed measures that the agency might use to address animal health and food consumption risks identified in the draft risk assessment that are within the agency’s purview. It also describes the agency’s plans with regard to issues that are not within the agency’s authority to manage (e.g., ethics) regarding animal cloning. The draft guidance for industry describes FDA’s recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply. FDA will consider information received during the comment period in its preparation of a final risk assessment. To that end, FDA requests that any producers or breeders of clones who have additional data on the health of the clones or their progeny or composition of food products (i.e., meat or milk) derived from clones or their progeny share those data with us. Additionally, the agency reiterates that the release of these draft documents does not affect its request to industry to continue to refrain from introducing food products from clones and their progeny into the marketplace. II. Significance of Guidance The draft guidance for industry is a level 1 draft guidance that is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency’s current thinking on the topic. The draft guidance document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft risk assessment document, the proposed risk management plan, and the draft guidance for industry. For convenience in reviewing the comments, FDA requests that comments be separately identified as to which document they address. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this E:\FR\FM\03JAN1.SGM 03JAN1

Agencies

[Federal Register Volume 72, Number 1 (Wednesday, January 3, 2007)]
[Notices]
[Pages 135-136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Filing of Annual Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2006.

ADDRESSES: Copies are available from the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, 301-827-6860.

FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee 
Oversight and Management Staff (HF-4), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app. 1) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2005 through September 30, 2006.
Center for Biologics Evaluation and Research:
    Allergenic Products Advisory Committee
    Blood Products Advisory Committee
    Cellular, Tissue, and Gene Therapies Advisory Committee
    Vaccines and Related Biological Products Advisory Committee
Center for Drug Evaluation and Research:
    Nonprescription Drugs Advisory Committee
    Anesthetic and Life Support Drugs Advisory Committee
Center for Devices and Radiological Health:
    Medical Devices Advisory Committee (consisting of reports for 
General and Plastic Surgery Devices Panel, Obstetrics and Gynecology 
Devices Panel, Ophthalmic Devices Panel, Orthopaedic and Rehabilitation 
Devices Panel, and Radiological Devices Panel)
National Center for Toxicological Research:
    Science Advisory Board to the National Center for Toxicological 
Research
    Annual reports are available for public inspections between 9 a.m. 
and 4 p.m., Monday through Friday, at the following locations:
    1. The Library of Congress, Madison Bldg., Newspaper and Current 
Periodical Reading Room, 101 Independence Ave. SE., rm. 133, 
Washington, DC; and
    2. The Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.


[[Page 136]]


    Dated: December 22, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-22450 Filed 12-29-06; 8:45 am]
BILLING CODE 4160-01-S

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