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Federal Register / Vol. 72, No.

1 / Wednesday, January 3, 2007 / Notices 135

enhanced with self-sufficiency services Respondents: The respondents to this the managed care provider United
for low-income families who have component of the Rhode Island follow- Behavioral Health (UBH) in Rhode
young children or are expecting in up survey will be low-income parents Island who meet study criteria with
Kansas and Missouri. and their children from the Rhode regard to their risk for depression.
Materials for follow-up surveys for Island site currently participating in the Children are the biological, adopted,
each of these sites were previously HtE Project. As described in the prior and step-children of these parents,
submitted to OMB and were approved. OMB submission, these parents are between the ages of 1 and 18 years of
The purpose of this submission is to add Medicaid recipients between the ages of age.
physiological measures to the follow-up
18 and 45 receiving Medicaid through
effort to the Rhode Island study.

ANNUAL BURDEN ESTIMATES


Average burden
Number of responses
Instrument Number of respondents hours per re- Total burden hours
per respondent sponse

RI 15–month, parent physiological compo- 400 8 5 minutes or .08 266.66


nent. hrs.
RI 15–month, young child physiological 160 8 5 minutes or .08 106.66
component. hrs.
RI 15–month, youth physiological compo- 242 8 5 minutes or .08 161.33
nent. hrs.
Estimated Total Annual Burden Hours ......................... 534.65

Additional Information DEPARTMENT OF HEALTH AND Committee


Copies of the proposed collection may HUMAN SERVICES Blood Products Advisory Committee
be obtained by writing to The Cellular, Tissue, and Gene Therapies
Food and Drug Administration
Administration for Children and Advisory Committee
Families, Office of Information Services, Advisory Committees; Filing of Annual Vaccines and Related Biological
370 L’Enfant Promenade, SW., Reports Products Advisory Committee
Washington, DC 20447, Attn: ACF Center for Drug Evaluation and
Reports Clearance Officer. All requests AGENCY: Food and Drug Administration,
HHS. Research:
should be identified by the title of the Nonprescription Drugs Advisory
information collection. E-mail address: ACTION: Notice.
Committee
infocollection@acf.hhs.gov. SUMMARY: The Food and Drug Anesthetic and Life Support Drugs
OMB Comment Administration (FDA) is announcing Advisory Committee
OMB is required to make a decision that, as required by the Federal Center for Devices and Radiological
concerning the collection of information Advisory Committee Act, the agency has Health:
between 30 and 60 days after filed with the Library of Congress the
Medical Devices Advisory Committee
publication of this document in the annual reports of those FDA advisory
(consisting of reports for General
Federal Register. Therefore, a comment committees that held closed meetings
and Plastic Surgery Devices Panel,
during fiscal year 2006.
is best assured of having its full effect Obstetrics and Gynecology Devices
if OMB receives it within 30 days of ADDRESSES: Copies are available from
Panel, Ophthalmic Devices Panel,
publication. Written comments and the Division of Dockets Management Orthopaedic and Rehabilitation
recommendations for the proposed (HFA–305), Food and Drug Devices Panel, and Radiological
Administration, 5630 Fishers Lane, rm. Devices Panel)
information collection should be sent
1061, Rockville, MD 20852, 301–827–
directly to the following: Office of National Center for Toxicological
6860.
Management and Budget, Paperwork Research:
Reduction Project, Fax: 202–395–6974, FOR FURTHER INFORMATION CONTACT:
Science Advisory Board to the
Attn: Desk Officer for the Theresa L. Green, Advisory Committee National Center for Toxicological
Administration for Children and Oversight and Management Staff (HF– Research
Families. 4), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, Annual reports are available for
Dated: December 22, 2006. 301–827–1220. public inspections between 9 a.m. and
Robert Sargis, 4 p.m., Monday through Friday, at the
SUPPLEMENTARY INFORMATION: Under
following locations:
Reports Clearance Officer. section 10(d) of the Federal Advisory
[FR Doc. 06–9940 Filed 12–29–06; 8:45 am] Committee Act (5 U.S.C. app. 1) and 21 1. The Library of Congress, Madison
CFR 14.60(d), FDA has filed with the Bldg., Newspaper and Current
BILLING CODE 4184–01–M
Library of Congress the annual reports Periodical Reading Room, 101
for the following FDA advisory Independence Ave. SE., rm. 133,
committees that held closed meetings Washington, DC; and
rwilkins on PROD1PC63 with NOTICES

during the period October 1, 2005 2. The Division of Dockets


through September 30, 2006. Management (HFA–305), Food and
Center for Biologics Evaluation and Drug Administration, 5630 Fishers
Research: Lane, rm. 1061, Rockville, MD
Allergenic Products Advisory 20852.

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136 Federal Register / Vol. 72, No. 1 / Wednesday, January 3, 2007 / Notices

Dated: December 22, 2006. and Drug Administration, 7519 Standish and the agency’s response to them are
Randall W. Lutter, Pl., Rockville, MD 20855. Send a self- posted on the Internet with the draft risk
Associate Commissioner for Policy and addressed, adhesive label to assist that assessment (see the Electronic Access
Planning. office in processing your request. section of this document).
[FR Doc. E6–22450 Filed 12–29–06; 8:45 am] Submit written comments on the draft The proposed risk management plan
BILLING CODE 4160–01–S risk assessment, proposed risk describes proposed measures that the
management plan, or draft guidance for agency might use to address animal
industry to the Division of Dockets health and food consumption risks
DEPARTMENT OF HEALTH AND Management (HFA–305), Food and Drug identified in the draft risk assessment
HUMAN SERVICES Administration, 5630 Fishers Lane, rm. that are within the agency’s purview. It
1061, Rockville, MD 20852. Submit also describes the agency’s plans with
Food and Drug Administration electronic comments to http:// regard to issues that are not within the
[Docket No. 2003N–0573] www.fda.gov/dockets/ecomments. See agency’s authority to manage (e.g.,
the SUPPLEMENTARY INFORMATION section ethics) regarding animal cloning.
Draft Animal Cloning Risk for electronic access to the documents. The draft guidance for industry
Assessment; Proposed Risk describes FDA’s recommendations
FOR FURTHER INFORMATION CONTACT:
Management Plan; Draft Guidance for regarding the introduction of edible
Larisa Rudenko, Center for Veterinary
Industry; Availability products from animal clones and their
Medicine (HFV–100), Food and Drug
progeny into the food and feed supply.
AGENCY: Food and Drug Administration, Administration, 7500 Standish Pl.,
FDA will consider information received
HHS. Rockville, MD 20855, 240–453–6842, e-
during the comment period in its
ACTION: Notice. mail: clones@cvm.fda.gov.
preparation of a final risk assessment.
SUPPLEMENTARY INFORMATION: To that end, FDA requests that any
SUMMARY: The Food and Drug
I. Background producers or breeders of clones who
Administration (FDA) is announcing the
have additional data on the health of the
availability of, and is requesting In July 2001, FDA’s CVM issued an clones or their progeny or composition
comment on, a draft risk assessment on update on livestock cloning (available at of food products (i.e., meat or milk)
animal cloning. FDA’s Center for http://www.fda.gov/cvm/CVM_Updates/ derived from clones or their progeny
Veterinary Medicine (CVM) developed clones.htm) and indicated its intention share those data with us. Additionally,
this draft risk assessment to evaluate the to work with stakeholders to assess the agency reiterates that the release of
health risks to animals involved in the potential risks presented by cloning these draft documents does not affect its
process of cloning and to evaluate the food-producing animals. It also request to industry to continue to refrain
food consumption risks that may result requested that companies voluntarily from introducing food products from
from edible products derived from refrain from introducing animal clones, clones and their progeny into the
animal clones or their progeny. FDA is their progeny, or their food products
also announcing the availability of, and marketplace.
(such as milk or meat) into the human
is requesting comment on, a proposed or animal food supply, pending II. Significance of Guidance
risk management plan for animal clones completion of the risk assessment The draft guidance for industry is a
and their progeny. The proposed risk process. The public participation phase level 1 draft guidance that is being
management plan takes into account the of this process begins with the release issued consistent with FDA’s good
risks identified in the draft risk of draft documents entitled ‘‘Animal guidance practices regulation (21 CFR
assessment and sets out proposed Cloning: A Draft Risk Assessment,’’ 10.115). The draft guidance represents
measures that FDA might use to manage ‘‘Animal Cloning: Proposed Risk the agency’s current thinking on the
those risks. In addition, FDA is Management Plan for Clones and Their topic. The draft guidance document
announcing availability of draft Progeny,’’ and ‘‘Draft Guidance for does not create or confer any rights for
guidance for industry #179 for public Industry #179: Use of Edible Products or on any person and will not operate
comment. This draft guidance describes From Animal Clones or Their Progeny to bind FDA or the public. Alternative
FDA’s recommendations regarding the for Human Food or Animal Feed.’’ methods may be used as long as they
use of edible products from animal Among the goals of our draft risk satisfy the requirements of the
clones and their progeny in human food assessment were the determination of applicable statutes and regulations.
or in animal feed. whether somatic cell nuclear transfer
DATES: Submit written or electronic (SCNT), the process used to produce the III. Comments
comments on the draft risk assessment clones being considered in the risk Interested persons may submit to the
document, the proposed risk assessment, poses any unique risks to Division of Dockets Management (see
management plan, and the draft animals involved in cloning relative to ADDRESSES) written or electronic
guidance for industry by April 3, 2007. other assisted reproductive comments regarding the draft risk
FDA will accept comments, data, and technologies, and whether foods derived assessment document, the proposed risk
information after the deadline, but to from animal clones or their progeny management plan, and the draft
ensure consideration by the agency in pose consumption risks greater than guidance for industry. For convenience
any final documents, comments must be those posed by foods derived from their in reviewing the comments, FDA
received by this date. Comments on conventional counterparts. It requests that comments be separately
agency guidance documents are specifically does not consider risk identified as to which document they
welcome at any time. issues that may be posed by genetically address. Submit a single copy of
ADDRESSES: Submit written requests for engineered animals. electronic comments or two paper
rwilkins on PROD1PC63 with NOTICES

single copies of the draft risk The draft risk assessment has been copies of any mailed comments, except
assessment, proposed risk management peer reviewed in accordance with the that individuals may submit one paper
plan, or the draft guidance for industry Office of Management and Budget’s copy. Comments are to be identified
to the Communications Staff (HFV–12), Information Quality Peer Review with the docket number found in
Center for Veterinary Medicine, Food Bulletin. The peer reviewers’ comments brackets in the heading of this

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