Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices 50483 

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 

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

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per response 

Total burden 

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 

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. 

SUMMARY: 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. 

ADDRESSES: 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 http:// 

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 


srobinson on DSK4SPTVN1PROD with NOTICES