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7746 Federal Register / Vol. 70, No.

30 / Tuesday, February 15, 2005 / Notices

Respondents: The respondents to Medicaid. These populations are at site, respondents will have completed a
these follow-up surveys will be low- heightened risk for all of the barriers more detailed baseline survey, which is
income individuals from the five states that cause people to be hard-to-employ. required to establish baseline measures
represented by the four sites currently Prior to these follow-up surveys, basic of depression and related conditions.
participating in the HtE Project: Kansas, demographic information for all survey
The annual burden estimates are
Missouri, New York, Pennsylvania and respondents will have been obtained
wherever possible from the existing detailed below, and the substantive
Rhode Island. Many will be current or
former TANF participants, and many automated systems or brief baseline content of each survey are detailed in
will be current or former recipients of information forms. In the Rhode Island the supporting statement.

ANNUAL BURDEN ESTIMATES


Number of Average burden
Number of Total burden
Instrument responses per hours per
respondents hours
respondent response

Rhode Island, 6–month ................................... 734 1 38 minutes or .63 hrs ..................................... 464.87
Rhode Island, 15–month ................................. 734 1 45 minutes or .75 hrs ..................................... 550.50
New York City, 12–month ............................... 1,000 1 32 minutes or .53 hrs ..................................... 533.33
Philadelphia, 12–month .................................. 750 1 25 minutes or .42 hrs ..................................... 312.50
Kansas/Missouri, 12–month ............................ 680 1 45 minutes or .75 hrs ..................................... 510.00

Estimated Total Annual Burden ACF, E-mail address: Abuse Prevention and Treatment Act
Hours. 2,371.20 Katherine_T._Astrich@omb.eop.gov. Amendments of 2003, provides
Dated: February 8, 2005 direction to the States and Territories to
Additional Information
Robert Sargis, accomplish the purposes of (1)
Copies of the proposed collection may supporting community-based efforts to
be obtained by writing to the Reports Clearance Officer.
develop, operate, expand and, where
Administration for Children and [FR Doc. 05–2825 Filed 2–14–05; 8:45 am]
appropriate, to network initiatives
Families. Office of Administration, BILLING CODE 4184–01–M
aimed at the prevention of child abuse
Office of Information Services, 370 and neglect and to support networks of
L’Enfant Promenade, SW., Washington, coordinated resources and activities to
DC 20447, Attn: ACF Reports Clearance DEPARTMENT OF HEALTH AND
HUMAN SERVICES better strengthen and support families to
Officer. All requests should be reduce the incidence of child abuse and
identified by the title of the information neglect; and (2) fostering an
collection. E-mail address: Administration for Children and
Families understanding, appreciation and
grjohnson@acf.hhs.gov. knowledge of diverse populations in
OMB Comment Proposed Information Collection order to be effective in preventing and
OMB is required to make a decision Activity; Comment Request Proposed treating child abuse and neglect. This
concerning the collection of information Projects: Program Instruction contains
between 30 and 60 days after information collection requirements that
Title: Community-Based Child Abuse
publication of this document in the are found in Pub. L. 108–36 at Sections
Prevention Program (CBCAP).
Federal Register. Therefore, a comment OMB No.: 0970–0155. 201, 202, 203, 205, 206, 207, and
is best assured of having its full effect Description: The Program Instruction, pursuant to receiving a grant award. The
if OMB receives it within 30 days of prepared in response to the enactment information submitted will be used by
publication. Written comments and of the Community-Based Grants for the the agency to ensure compliance with
recommendations for the proposed Prevention of Child Abuse and Neglect the statute, complete the calculation of
information collection should be sent (administratively known as the the grant award entitlement, and
directly to the following: Office of Community-Based Child Abuse provide training and technical
Management and Budget, Paperwork Prevention Program (CBCAP)), as set assistance to the grantee.
Reduction Project, Attn: Desk Officer for forth in Title II of Pub. L. 108–36, Child Respondents: State Government.

ANNUAL BURDEN ESTIMATES


Average bur-
Number of
Number of den Total burden
Instrument responses per
respondents hours per hours
respondent response

Application ....................................................................................................... 52 1 40 2,080


Annual Report .................................................................................................. 52 1 24 1,248

Estimated Total Annual Burden Families is soliciting public comment comments may be forwarded by writing
Hours 3,328 on the specific aspects of the to the Administration for Children and
In compliance with the requirements information collection described above. Families, Office of Information Services,
of Section 3506(c)(2)(A) of the Copies of the proposed collection of 370 L’Enfant Promenade, SW.,
Paperwork Reduction Act of 1995, the information can be obtained and Washington, DC 20447, Attn: ACF
Administration for Children and

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Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices 7747

Reports Clearance Officer. All requests Committee Oversight and Management comments on the draft guidance. Two
should be identified by the title of the Staff (HF–4), Food and Drug paper copies of mailed comments are to
information collection. E-mail: Administration, 5600 Fishers Lane, be submitted, except that individuals
grjohnson@acf.hhs.gov. Rockville, MD 20857. Submit written may submit one copy. Comments are to
The Department specifically requests comments on the draft guidance to the be identified with the docket number
comments on: (a) Whether the proposed Division of Dockets Management (HFA– found in brackets in the heading of this
collection of information is necessary 305), Food and Drug Administration, document. Received comments may be
for the proper performance of the 5630 Fishers Lane, rm. 1061, Rockville, seen in the Division of Dockets
functions of the agency, including MD 20852. Submit electronic comments Management between 9 a.m. and 4 p.m.,
whether the information shall have to http://www.fda.gov.dockets/ Monday through Friday.
practical utility, (b) the accuracy of the ecomments. See the SUPPLEMENTARY III. Electronic Access
agency’s estimate of the burden of the INFORMATION section for electronic
proposed collection of information; (c) access to the draft guidance document. Persons with access to the Internet
the quality, utility, and clarity of the may obtain the document at
FOR FURTHER INFORMATION CONTACT:
information to be collected; and (d) http://www.fda.gov/oc/advisory/
Linda Ann Sherman, Office of the
ways to minimize the burden of the default.htm in the policy and guidance
Commissioner (HF–4), Food and Drug
collection of information on section of FDA’s advisory committee
Administration, 5600 Fishers Lane,
respondents, including through the use Intranet Web site.
Rockville, MD 20857, 301–827–1220, e-
of automated collection techniques or mail: disclosure@oc.fda.gov. Dated: February 8, 2005.
other forms of information technology. William K. Hubbard,
SUPPLEMENTARY INFORMATION:
Consideration will be given to Associate Commissioner for Policy and
comments and suggestions submitted I. Background Planning.
within 60 days of this publication. FDA is announcing the availability of [FR Doc. 05–2822 Filed 2–14–05; 8:45 am]
Dated: February 8, 2005. a draft guidance document entitled BILLING CODE 4160–01–S
Robert Sargis, ‘‘The Open Public Hearing; FDA
Reports Clearance, Officer. Advisory Committee Meetings.’’
Guidance documents are prepared for DEPARTMENT OF HEALTH AND
[FR Doc. 05–2826 Filed 2–14–05; 8:45 am]
FDA staff, applicants/sponsors, and the HUMAN SERVICES
BILLING CODE 4184–01–M
public that describe the agency’s
Food and Drug Administration
interpretation of, or policy on, a
DEPARTMENT OF HEALTH AND regulatory issue. Every committee [Docket No. 2005D–0033]
HUMAN SERVICES meeting includes an OPH during which
interested persons may present relevant Draft Guidance for Industry on Internal
Food and Drug Administration information or views orally or in writing Radioactive Contamination—
21 CFR 14.25(a). The hearing is Development of Decorporation Agents;
[Docket No. 2005D–0042] Availability
conducted in accordance with 21 CFR
Draft Guidance on the Open Public 14.29. FDA encourages the participation AGENCY: Food and Drug Administration,
Hearing; Food and Drug from all public speakers in its HHS.
Administration Advisory Committee decisionmaking processes. The draft ACTION: Notice.
Meetings; Availability guidance is intended to answer more
fully questions about how (including SUMMARY: The Food and Drug
AGENCY: Food and Drug Administration, topics such as meeting logistics and Administration (FDA) is announcing the
HHS. administrative requirements) the public availability of a draft guidance for
ACTION: Notice. may participate at an OPH session. This industry entitled ‘‘Internal Radioactive
includes, but is not limited to, general Contamination—Development of
SUMMARY: The Food and Drug Decorporation Agents.’’ This draft
members of the public; individuals or
Administration (FDA) is announcing the spokespersons from the regulated document provides guidance to industry
availability of a draft guidance industry; consumer advocacy groups; on the development of decorporation
document entitled ‘‘The Open Public and professional organizations, agents for the treatment of internal
Hearing; FDA Advisory Committee societies, or associations. radioactive contamination when
Meetings.’’ This draft guidance is for This level 1 draft guidance is being evidence is needed to demonstrate the
members of the public who choose to issued consistent with FDA’s good effectiveness of the agents, but human
participate in the open public hearing guidance practices (21 CFR 10.115). The efficacy studies are unethical or
(OPH) session of an FDA advisory draft guidance, when finalized will infeasible. In such instances, the Animal
committee meeting. The draft guidance represent the agency’s current thinking Efficacy Rule may be invoked to
is intended to answer more fully on an FDA advisory committee open approve new medical products not
questions about how the public may public hearing. It does not create or previously marketed or new indications
participate at an OPH session, and it confer any rights for or on any person for previously marketed products.
includes topics such as meeting logistics and does not operate to bind FDA or the Specifically, this draft guidance
and administrative requirements. public. An alternative approach may be addresses chemistry, manufacturing and
DATES: Submit written or electronic used if such approach satisfies the controls (CMC) information; animal
comments on this draft guidance by requirements of the applicable statute efficacy, safety pharmacology, and
June 15, 2005. General comments on and regulations. toxicology studies; clinical
agency guidance documents are pharmacology, biopharmaceutics, and
welcome at any time. II. Comments human safety studies; and postapproval
ADDRESSES: Submit written requests for Interested persons may submit to the commitments.
single copies of the draft guidance to Division of Dockets Management (see DATES: Submit written or electronic
Linda Ann Sherman, Advisory ADDRESSES) written or electronic comments on the draft guidance by May

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