Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 24013 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–12023 Filed 5–21–09; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0299] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Agency Information Collection 

Request. 60-Day Public Comment 

Request. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed information collection request 

for public comment. Interested persons 

are invited to send comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including any of the following subjects: 

(1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. To obtain copies of 

the supporting statement and any 

related forms for the proposed 

paperwork collections referenced above, 

e-mail your request, including your 

address, phone number, OMB number, 

and OS document identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the OS Paperwork Clearance Officer 

at the above e-mail address within 60- 

days. 

Proposed Project: Adolescent Family 

Life Care and Prevention End of Year 

Report Templates (Revision) OMB No. 

0990–0299, Office of Adolescent 

Pregnancy Programs (OAPP). 

Abstract: OAPP is proposing to revise 

the current OMB approved Adolescent 

Family Life Care and Prevention End of 

Year Report Templates. The current 

OMB approval is applicable through 

May 31, 2009. All AFL grantees are 

required by their Notice of Grant 

Awards to submit an end of year report 

once per year. The current End of Year 

Report templates provide a degree of 

standardization across the AFL grantees, 

allowing for more complete data 

collection by OAPP for program 

assessment. 

OAPP is also proposing to consolidate 

0990–0300–AFL Prevention Project End 

of Year Report Template ICR and 0990– 

0299–AFL Care and Prevention End of 

Year Report Templates ICR. After the 

approval by OMB on 0990–0299 ICR, 

OAPP will eliminate 0990–0300. This 

action will reduce the redundancy 

across ICRs and lessen the number of 

burden hours reported by including 

both templates under one ICR (0990– 

0299). 

The original title will be changed to 

Adolescent Family Life End of the Year 

Report Template. 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms 

(if necessary) 

Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

End of Year Report Templates (program and evaluation for prevention and 

care grants) .................................................................................................. 65 1 65 4,225 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–12014 Filed 5–21–09; 8:45 am] 

BILLING CODE 4150–30–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Decision To 

Evaluate a Petition To Designate a 

Class of Employees for the University 

of Rochester in Rochester, NY, To Be 

Included in the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees for the University of 

Rochester in Rochester, New York, to be 

included in the Special Exposure Cohort 

under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. The initial 

proposed definition for the class being 

evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: University of Rochester. 

Location: Rochester, New York. 

Job Titles and/or Job Duties: 

Laboratory Technicians who worked in 

the University of Rochester Atomic 

Energy Project laboratory building. 

Period of Employment: September 1, 

1943 through June 19, 1945. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–12007 Filed 5–21–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10185 and 

CMS–10141] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

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


erowe on PROD1PC63 with NOTICES
24014 Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements and Supporting 

Regulations under 42 CFR 423.505; 

Form Number: CMS–10185 (OMB#: 

0938–0992); Use: Title I, Part 423, 

§ 423.514 describes CMS’ regulatory 

authority to establish requirements for 

Part D sponsors. It is noted that each 

Part D plan sponsor must have an 

effective procedure to develop, compile, 

evaluate, and report to CMS, its 

enrollees, and the general public, at the 

times and in the manner that CMS 

requires, statistics in the following 

areas: (1) The cost of its operations; (2) 

The availability of utilization of its 

services; (3) The availability, 

accessibility; and acceptability of its 

services; (4) Information demonstrating 

that the Part D plan sponsor has a 

fiscally sound operation; and (5) other 

matters that CMS may require. 

Subsection 423.505 of the Medicare 

Prescription Drug Modernization and 

Modernization Act establishes as a 

contract provision that Part D Sponsors 

must comply with the reporting 

requirements for submitting drug claims 

and related information to CMS. Data 

collected via Medicare Part D Reporting 

Requirements will be an integral 

resource for oversight, monitoring, 

compliance and auditing activities 

necessary to ensure quality provision of 

the Medicare Prescription Drug Benefit 

to beneficiaries. Please see the 

supporting documentation, ‘‘Revisions 

to 2nd Draft of CY 2010 Part D 

Reporting Requirements’’ document to 

view a list of current changes. 

Frequency: Reporting—yearly, quarterly 

and semi-annually; Affected Public: 

Business or other for-profit; Number of 

Respondents: 4,526; Total Annual 

Responses: 380,184; Total Annual 

Hours: 157,450. (For policy questions 

regarding this collection contact Alice 

Lee-Martin at 410–786–4578. For all 

other issues call 410–786–1103.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Benefit Plan Program: 

Use: Part D plans use the information 

discussed to comply with the eligibility 

and associated Part D participating 

requirements. CMS will use this 

information to approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to plans, and to ensure that 

correct information is disclosed to 

enrollees, both potential and current 

enrollees. Form Number: CMS–10141 

(OMB#: 0938–0964); Frequency: 

Reporting—quarterly, semi-annually 

and yearly; Affected Public: Business or 

other for-profits and Individuals or 

households; Number of Respondents: 

19,937,772; Total Annual Responses: 

38,152,764; Total Annual Hours: 

34,730,676. (For policy questions 

regarding this collection contact 

Eugenia Mattison-Gibson at 410–786– 

2564. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

E-mail your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on June 22, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: May 15, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–11939 Filed 5–21–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0307] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; INTELENCE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

INTELENCE 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 

human 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 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 


erowe on PROD1PC63 with NOTICES