Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 71447 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

806.10 .................................................................................. 666 1 666 10 6,660 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

806.20 .................................................................................. 90 1 90 10 900 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Respondents to this collection of 

information are manufacturers and 

importers of medical devices. FDA 

reviewed reports of device corrections 

and removals submitted to the Agency 

for the previous 3 years as part of 

responding to the current request for 

approval of the information collection 

requirements for §§ 806.10 and 806.20. 

This information was obtained through 

the Agency’s voluntary recall provisions 

(i.e., 21 CFR part 7). The specific 

information requested was the total 

number of class I, II, and III recalls for 

the last 3 years. This information was 

obtained from the Agency’s Recall 

Enterprise System—a database of all 

recalls submitted to the Agency. 

This information is relevant since a 

§ 806.10 report is required for all class 

I and II recalls. Although class III recalls 

are not required to be submitted to FDA 

(by § 806.10) a record must be kept in 

the firm’s § 806.20 file. Therefore, the 

number of class I and II recalls can be 

used to estimate the maximum number 

of reports that are required to be 

submitted under § 806.10. Also, the 

recordkeeping burden can be estimated 

based upon the number of class III 

recalls, which are not required to be 

reported but must be retained in a 

§ 806.20 file. 

FDA has determined that estimates of 

the reporting burden for § 806.10 should 

be revised to reflect a projected 7.3 

percent increase (from the last PRA 

numbers) in reports submitted to FDA 

as class I and II. FDA also estimates the 

recordkeeping burden in § 806.20 

should be revised to reflect a reduction 

of 6.8 percent (from the last PRA 

numbers) in records filed and 

maintained under this section. The 

estimates of time needed to collect part 

806 information have not changed. 

Dated: November 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29520 Filed 11–22–10; 8:45 am] 

BILLING CODE 4160–01–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) Model 

Plan. 

OMB No.: 0970–0075. 

Description: States, including the 

District of Columbia, Tribes, Tribal 

Organizations and Territories applying 

for LIHEAP block grant funds must 

submit an annual application (Model 

Plan) that meets the LIHEAP statutory 

and regulatory requirements prior to 

receiving Federal funds. A detailed 

application must be submitted every 

three years. Abbreviated applications 

may be submitted in alternate years. 

There have been no changes in the 

Model Plan since the approval of the 

addition of the LIHEAP Program 

Integrity Assessment Supplement by the 

Office of Management and Budget 

earlier this year. 

Respondents: State, Local or Tribal 

Governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

LIHEAP Program Integrity Assessment and Plan ........................................... 216 1 1 216 

Detailed Model Plan ........................................................................................ 72 1 1 72 

Abbreviated Model Plan .................................................................................. 144 1 .33 47.5 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 335.5 

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71448 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 

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. 

Dated: November 18, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–29479 Filed 11–22–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Notice of Intent To Provide 

Supplemental Funding 

ACTION: Notice of intent to provide 

supplemental funding to the existing 

cooperative agreement (90AM3204) 

with the Administration on Aging and 

a request for a supplemental 

application. 

SUMMARY: The Administration on Aging 

is announcing the availability of 

supplemental grant funds for the 

support of the Senior Medicare Program 

(SMP). The goal of this supplemental is 

a program expansion for one award to 

include direct Medicare fraud 

prevention intervention activities in 

high risk areas. 

Funding Opportunity Title/Program 

Name: National Hispanic SMP 

(NHSMP). 

Announcement Type: Proposed 

program expansion. 

Funding Opportunity Number: 

Program Announcement No. HHS– 

2011–AoA–MP–1102. 

Statutory Authority: HIPAA of 1996 

(Pub. L. 104–191). 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.048 

Discretionary Projects. 

DATES: Key Dates: The deadline date for 

comments under this Program 

Announcement is December 23, 2010. 

Other Important dates: 

1. The supplemental application due 

date is November 29, 2010. 

2. The anticipated start date is 

December 2010. 

3. The opening date begins on the first 

day of publication of this notice. 

4. The expiration date is December 5, 

2010. 

I. Funding Opportunity Description 

Since September 2008 NHCOA has 

operated the NHSMP providing 

technical assistance to all SMP projects 

nation-wide pertaining to Hispanic 

community issues. The goal of the SMP 

program is to prevent or reduce the 

billions of dollars loss annually due to 

Medicare/Medicaid fraud, error and 

abuse. The Centers for Medicare & 

Medicaid Services data has revealed 

that Medicare fraud is rampant in the 

Hispanic community. Hispanic older 

adults are especially vulnerable to 

Medicare fraud due to social isolation 

from the general population due to a 

combination of linguistic and cultural 

factors. This goal of this program 

expansion is to target direct intervention 

activities in South Florida, especially 

Miami and Dade counties. Intervention 

activities must be relevant to the unique 

characteristics of the older Hispanic 

community designed to increase 

awareness of the SMP program and 

fraud prevention. 

II. Award Information 

A. Purpose of the Award: Health Care 

Fraud Prevention Program Expansion. 

B. Amount of the Award: $335,000. 

C. Project Period: December 1, 2010– 

May 31, 2011. 

III. Eligible Applicant 

The National Hispanic Council on 

Aging. 

IV. Evaluation Criteria 

A. Purpose and Need for Assistance— 

Weight: 20 Points 

Does the proposed project clearly and 

adequately describe the targeted 

population and document the need for 

intervention? 

B. Approach, Work Plan and 

Activities—Weight: 30 Points 

Does the proposal reflect a coherent 

and feasible approach for successfully 

addressing the identified problems? (10) 

Is the project work plan clear and 

comprehensive? (10) 

Does the applicant demonstrate 

experience in working with targeted 

population? (10) 

C. Project Outcomes, Evaluation and 

Dissemination—Weight: 20 Points 

Are the expected expansion benefits/ 

results clear and realistic? (10) 

Does the project expansion contain an 

evaluation component? (5) 

Will results be disseminated to AoA 

and other interested parties? (5) 

D. Level of Effort—Weight: 30 Points 

Does key staff have the background, 

experience to carry out their designated 

roles? (10) 

Are budget line items clearly 

delineated and consistent with work 

plan objectives? (10) 

Has the applicant demonstrated the 

organization’s capacity to implement 

the work plan? (10) 

V. Application and Submission 

Requirements 

A. SF 424—Application for Federal 

Assistance. 

B. SF 424A—Budget Information. 

C. Separate Budget Narrative/ 

Justification. 

D. SF 424B—Assurances. Note: Be 

sure to complete this form according to 

instructions and have it signed and date 

by the authorized representative (see 

item 18d on the SF 424). 

E. Lobbying Certification. 

F. Program narrative no more than 

five pages including the following 

items: 

• Summary/Abstract summary page 

• Expansion Proposal 

• Anticipated outcome(s) 

G. Work Plan. 

H. The application should be 

submitted through grants.gov using the 

funding opportunity #HHS–2011–AoA– 

MP–1102. 

VI. Application Review Information 

Three Federal Reviewers external to 

the Office of Elder Rights will score the 

application. 

VII. Agency Contact 

Direct inquiries regarding 

programmatic issues to U.S. Department 

of Health and Human Services, 

Administration on Aging, Office of 

Elder Rights, Washington, DC 20201, 

telephone: Barbara Dieker, (202) 357– 

0139; e-mail 

Barbara.Dieker@aoa.hhs.gov. 

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