Submission for OMB Review; Comment Request, 50483 [2011-20613]
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Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–20646 Filed 8–12–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Application Requirements for
the Low Income Home Energy
Assistance Program (LIHEAP)
Residential Energy Assistance Challenge
Program (REACH) Model Plan.
OMB No.: 0970–0348.
Description: States, including the
District of Columbia, Tribes, Tribal
organizations and Territories applying
for LIHEAP REACH funds must Submit
an annual application prior to receiving
Federal funds. The Human Services
Amendments of 1994 (Pub. L. 103–252)
amended the LIHEAP statute to add
Section 2607B, which established the
REACH program. REACH was funded
for the first time in FY 1996 and is
intended to: (1) Minimize health and
safety risks that result from high energy
burdens on low-income Americans; (2)
reduce home energy vulnerability and
prevent homelessness as a result of the
inability to pay energy bills; (3) increase
50483
the efficiency of energy usage by lowincome families, helping them achieve
energy self-sufficiency; and (4) target
energy assistance to individuals who are
most in need. The REACH Model Plan
clarifies the information being requested
and ensures the submission of all the
information required by statute. The
form facilitates our response to
numerous queries each year concerning
the information that should be included
in the REACH application. Submission
of a REACH application and use of the
REACH Model Plan is voluntary.
Grantees have the option to use another
format.
Respondents: State Governments,
Tribal governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per response
Total burden
hours
Reach model plan ............................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Instrument
51
1
72
3,672
Estimated Total Annual Burden
Hours: 3,672.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, 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: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–20613 Filed 8–12–11; 8:45 am]
BILLING CODE 4184–01–P
VerDate Mar<15>2010
16:05 Aug 12, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0577]
Draft Guidance for Industry and Food
and Drug Administration Staff; Factors
to Consider When Making Benefit-Risk
Determinations in Medical Device
Premarket Review; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Factors to Consider
When Making Benefit-Risk
Determinations in Medical Device
Premarket Review.’’ The
recommendations in this guidance are
intended to provide greater clarity on
FDA’s decisionmaking process with
regard to benefit-risk determinations in
the premarket review of medical
devices. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by November 14, 2011.
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of the draft guidance
document entitled ‘‘Factors to Consider
When Making Benefit-Risk
Determinations in Medical Device
Premarket Review’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8149. See
the SUPPLEMENTARY INFORMATION section
for information on electronic access to
the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: For
Devices Regulated by CDRH: Rachel
Turow, Center for Devices and
ADDRESSES:
E:\FR\FM\15AUN1.SGM
15AUN1
Agencies
[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Page 50483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20613]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Application Requirements for the Low Income Home Energy
Assistance Program (LIHEAP) Residential Energy Assistance Challenge
Program (REACH) Model Plan.
OMB No.: 0970-0348.
Description: States, including the District of Columbia, Tribes,
Tribal organizations and Territories applying for LIHEAP REACH funds
must Submit an annual application prior to receiving Federal funds. The
Human Services Amendments of 1994 (Pub. L. 103-252) amended the LIHEAP
statute to add Section 2607B, which established the REACH program.
REACH was funded for the first time in FY 1996 and is intended to: (1)
Minimize health and safety risks that result from high energy burdens
on low-income Americans; (2) reduce home energy vulnerability and
prevent homelessness as a result of the inability to pay energy bills;
(3) increase the efficiency of energy usage by low-income families,
helping them achieve energy self-sufficiency; and (4) target energy
assistance to individuals who are most in need. The REACH Model Plan
clarifies the information being requested and ensures the submission of
all the information required by statute. The form facilitates our
response to numerous queries each year concerning the information that
should be included in the REACH application. Submission of a REACH
application and use of the REACH Model Plan is voluntary. Grantees have
the option to use another format.
Respondents: State Governments, Tribal governments, Insular Areas,
the District of Columbia, and the Commonwealth of Puerto Rico.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Reach model plan.................... 51 1 72 3,672
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 3,672.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, 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-
7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-20613 Filed 8-12-11; 8:45 am]
BILLING CODE 4184-01-P