10744 Federal Register / Vol. 74, No. 47 / Thursday, March 12, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Objective Work Plan (OWP), 

Objective Progress Report (OPR) and 

Project Abstract. 

OMB No.: 0980–0204. 

Description: Content changes are 

being made to the OPR 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 

standardized format will allow ANA to 

report results across all its program 

areas and flag grantees that may need 

additional training and/or technical 

assistance to successfully implement 

their projects. 

Following are content changes being 

made within specific sections of the 

OPR form: 

Objective Work Plan Udate Section: 

Adding 1st through 4th Quarter 

(Q1,Q2,Q3,Q4) results for Activities 

within each Objective. The grantee can 

continue to add to this form each 

quarter (rather than on to a new form), 

reflecting cumulative results throughout 

the project period rather than just the 

quarter. 

Financial Section: Add 2 Questions: 

(1) Provide details on any income 

generated as a result of ANA project 

activities; (2) Provide details on any 

changes made to the budget during the 

reporting period. 

Native American Youth and Elder 

Opportunities Section: Add Question: 

(1) Request details on any 

intergenerational activities between 

grandparents and their grandchildren. 

Finally, add a new section (last 

section) to the form: 

Project Sustainability: (1) Request 

details on the grantee’s intention to 

continue the project benefits and/or 

services after the project period has 

ended. 

End of Content Changes to the OPR. 

No changes are being made to the 

OWP or to the Project Abstract (below). 

The information collected by the 

OWP is needed to properly administer 

and monitor the Administration for 

Native Americans (ANA) programs 

within the Administration for Children 

and Families (ACF). The OWP assists 

applicants in describing their projects’ 

objectives and activities, and also assists 

independent panel reviewers, ANA staff 

and the ANA Commissioner during the 

review and funding decision process. 

The Project Abstract provides crucial 

information in a concise format that is 

utilized by applicants, independent 

reviewers, ANA staff and the ANA 

Commissioner. 

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

Project Abstract ............................................................................................. 500 1 0 .50 250 

Estimated Total Annual Burden 

Hours: 2,850. 

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: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 6, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–5283 Filed 3–11–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0228] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PROFENDER 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

PROFENDER and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

animal drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 


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