50482 Federal Register / Vol. 76, No. 157 / Monday, August 15, 2011 / Notices 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–20614 Filed 8–12–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Objective Work Plan (OSP), 

Objective Progress Report (OPR) and 

Project Abstract. 

OMB No. 0980–0204. 

Description: Content changes are 

being made to the OPR and OWP only. 

The information in the OPR is being 

collected on a quarterly basis to monitor 

the performance of grantees and better 

gauge grantee progress. The OWP is 

utilized by applications when they 

submit their proposals and then by 

grantees to monitor their projects once 

awarded. ANA has reworded and 

renumbered the OPR questions to allow 

for better flow and clarity. The majority 

of content being requested from the 

grantees is the same and has not 

changed. 

OPR: Following are content changes 

being made: 

Objective Work Plan Update: Content 

is the same. Questions 1 and 2 were 

originally questions 3 and 4 on the 

previous OPR. ANA has also reduced 

the number of objectives under this 

section to 3. ANA is also separating out 

the current status of expected results 

and the current status of expected 

benefits. This will match ANA’s revised 

OWP. 

Partnerships and Leveraged 

Resources: Content is the same. 

Questions 3 and 4 were originally part 

of questions 11–13. The leveraged 

resources table under question 4 has 

been reformatted to allow for easier data 

collection. 

Impact indicator: The content 

requested in this section is similar to the 

previous OPR with some additional 

information being requested. Question 5 

was originally captured under question 

11 of the previous OPR. ANA has added 

additional fields to this section: 

Tracking mechanism, pre-grant status, 

and three-year target to align with 

ANA’s funding opportunity 

announcement. Questions 5a and 5b are 

new and ask the grantee for the status 

of the impact indicator at the end of 

each budget period. This information 

was captured quantitatively in the 

previous OPR. 

Native American Youth and Elder 

Opportunities: Content is the same. 

Questions 6 and 6a were originally 

questions 14 and 14a on the previous 

OPR. 

Staffing: Content is the same. 

Questions 7 and 7a were originally 

question 16 on the previous OPR. 

Question 7b was originally question 15 

on the previous OPR. ANA has added 

one field to this table: Type of position. 

Challenges: Content is the same. 

Questions 8 and 9 were originally 

questions 1 and 5 on the previous OPR. 

For question 9 ANA has added a table 

to capture information that was 

previously provided in a narrative 

format. Questions 10 and 11 were 

originally questions 2 and 6 on the 

previous OPR. 

Project Sustainability: Content is the 

same. Questions 12 and 13 were 

originally questions 18 and 17 on the 

previous OPR. 

Financial: The content requested in 

this section is similar to the previous 

OPR with some additional information 

being requested. Questions 14 and 16a 

were originally questions 9, 10, and 7 on 

the previous OPR. Question 17 is a new 

question. This question will not require 

the grantee to conduct additional work 

as they will be able to respond to this 

question utilizing the required OPR and 

425 forms. Question 18 was originally 

question 8 on the previous OPR. 

Four additional questions have been 

added that are specific to a special 

initiative ANA is funding this year. 

These questions are only to be filled out 

by the Asset for Independence Grantees. 

OWP: ANA has reformatted the OWP 

(content is same). ANA has added a 

field for applicants to include problem 

statement identified in grant 

application; has separated the results 

and benefits expected to align with 

ANA’s funding opportunity 

announcement. ANA is no longer 

requesting data on non-personnel hours. 

On the previous OWP ANA requested 

applicants to provide the position 

responsible for each activity. This title 

has changed to ‘position performing the 

activity’ and applicants will be asked to 

identify the lead person in one cell and 

other support in a second cell. 

Project Abstract: ANA is no longer 

managing this form. Grants.gov has 

taken control of this form and will 

submit any additional requests for this 

submission. 

Respondents: Tribal Government, 

Native non-profit organizations, Tribal 

Colleges & Universities. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

OWP ................................................................................................ 500 1 3 1,500 

OPR ................................................................................................. 275 4 1 1,100 

Estimated Total Annual Burden 

Hours: 2,600. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 


srobinson on DSK4SPTVN1PROD with NOTICES
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