Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 56595 

TABLE 2.—ESTIMATED REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG PRODUCTS1— 

Continued 

Category (21 CFR Section) 

Year(s) In Which Burdens Occur After 

June 30, 2006 

No. of Respondents 

No. of Responses per 

Respondent 

Total Responses Hours per 

Response Total Hours Total Capital Costs 

Burden associated with revised labeling for efficacy 

supplements for generic 

drug products (§ 201.57) 

Beginning year 3, 

continuing annually 

thereafter 

42 8 336 (for 

years 1–10) 

27 9,072 $2.5 million 

Total 112,952 Up to $8.3 

million 

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

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 17, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22731 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). To request a copy 

of the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office at (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Data Collection Tool 

for State Offices of Rural Health Grant 

Program: (New) 

The mission of the Office of Rural 

Health Policy (ORHP) is to sustain and 

improve access to quality care services 

for rural communities. In its authorizing 

language (Sec. 711 of the Social Security 

Act [42 U.S.C. 912]), Congress charged 

ORHP with ‘‘administer[ing] grants, 

cooperative agreements, and contracts to 

provide technical assistance and other 

activities as necessary to support 

activities related to improving health 

care in rural areas.’’ 

The State Offices of Rural Health 

Grant Program (SORH) is authorized by 

Section 338J of the Public Health 

Service Act (42 U.S.C. 254r). The 

purpose of SORH is to assist States in 

strengthening their rural health care 

delivery systems by helping to support 

a focal point for rural health within each 

State. The program provides funding for 

an institutional framework that links 

rural hospitals, providers and 

communities with State and Federal 

resources to help develop long term 

solutions to rural health problems. The 

average annual award for each State 

based grantee is $150,000. The law 

provides for a Federal-State partnership, 

requiring a State funding match of $3 for 

each $1 of Federal funding. Over the 

past 16 years, this program has 

leveraged in excess of $200 million in 

State matching funds for rural health. 

For SORH, program performance 

measures were drafted to provide data 

useful to the program and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act (GPRA) of 1993. ORHP seeks to 

collect information from grantees on 

their efforts to provide technical 

assistance to clients within their State. 

SORH grantees would be required to 

submit a Technical Assistance Report 

that includes: 1) The total number of 

technical assistance encounters 

provided directly by the grantee; and, 2) 

the total number of clients that received 

direct technical assistance from the 

grantee. Submission of the Technical 

Assistance Report would be done via email to ORHP no later than 30 days after 

the end of each twelve month budget 

period. 

The estimated average annual burden 

is as follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Technical Assistance Report ............................................... 50 1 50 12.5 625 

Total .............................................................................. 50 ........................ ........................ ........................ 625 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: September 22, 2008 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E8–22728 Filed 9–26–08; 8:45 am] 

BILLING CODE 4165–15–P 

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