52754 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

comments that yielded improvements to 

our data collection instrument, and we 

are therefore submitting a revised data 

collection form for emergency clearance. 

The definition of subsidized 

employment used for this collection is 

the same as the definition for the TANF 

program in general, given in 45 CFR 

261.2(c) and (d). This information will 

help the agency as well as the public 

better understand how jurisdictions are 

using the money they are awarded 

through the Emergency Fund. 

A voluntary information collection 

relating to the number of individuals in 

subsidized employment will serve 

several purposes. 

This information will demonstrate the 

impact of the program, help ACF to 

evaluate the effectiveness of this 

initiative, and provide information to 

aide in the transparency and 

accountability of jurisdictions receiving 

Recovery Act funds. This information 

will also allow the Administration to 

publicly communicate the impact and 

achievements of the program, and make 

future policy decisions on the basis of 

such knowledge. 

Respondents: State, territory, and 

tribal agencies administering the 

Temporary Assistance for Needy 

Families (TANF) Program that have 

received TANF Emergency Funds. 

Instrument 

Number of 

respondents 

(jurisdictions) 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Subsidized Employment Report OFA–200 ...................................................... 74 1 24 1,776 

Estimated Total Annual Burden 

Hours: We estimate the annualized cost 

of the hour burden to be $159,840. This 

figure is based on an estimated average 

hourly cost of $90 (including fringe 

benefits, overhead, and general and 

administrative costs) for the jurisdiction 

staff performing the work multiplied by 

the estimated 1,776 burden hours, 

calculated based on 74 jurisdictions 

applying for and receiving TANF 

Emergency Funds (all States and 

Territories, plus an estimated 20 tribes) 

If the TANF Emergency Fund is 

extended and jurisdictions report in FY 

2011, the jurisdiction would submit four 

additional responses and the total 

burden hours for FY 2011 would be 

7,104. 

Additional Information: ACF is 

requesting that OMB grant a 180-day 

approval for this information collection 

under procedures for emergency 

processing by September 13, 2010. A 

copy of this information collection, with 

applicable supporting documentation, 

may be obtained by calling the 

Administration for Children and 

Families, Reports Clearance Officer, 

Robert Saris at (202) 690–7275. 

Comments about the information 

collection described above should be 

directed to the Office of Information and 

Regulatory Affairs, Attn: OMB Desk 

Officer for ACF, Office of Management 

and Budget, Paperwork Reduction 

Project, 725 17th Street, NW., 

Washington, DC 20503; FAX: (202) 395– 

7285; e-mail: oirasubmission@ornb.eop.

gov. 

Dated: August 18, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–21203 Filed 8–26–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Assessing the 

Long-Term Impacts of the John E. 

Fogarty International Center’s 

Research and Training Programs 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the John E. 

Fogarty International Center, the 

National Institutes of Health has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on May 27, 2010 

(volume 75, number 102, page 29763) 

and allowed 60 days for public 

comment. One comment was received 

from a member of the public. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

Proposed Collection: Title: Assessing 

the Long-Term Impacts of the John E. 

Fogarty International Center’s Research 

and Training Programs. Type of 

Information Collection Request: New 

collection. Need and Use of Information 

Collection: This study will inform 

investment decisions and strategies 

employed by the Fogarty International 

Center for the purpose of strengthening 

biomedical research capacity in low and 

middle income countries. The primary 

objective of the study is to develop 

detailed case studies of the long-term 

impacts of Fogarty’s research and 

training programs on educational 

institutions located in low and middle 

income countries. The findings will 

provide valuable information 

concerning return on the Center’s 

investments over the past twenty years 

and effective strategies for promoting 

research capacity development in the 

future. Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Current and former NIH 

grantees; Current and former NIH 

trainees in countries of interest; Leaders 

and administrators at institutions of 

interest; Policy-makers and scientific 

leaders in countries of interest. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 

210 per year. Estimated Number of 

Responses per Respondent: 1. Average 

Burden Hours per Response: 1. 

Estimated Total Annual Burden Hours 

Requested: 290. The annualized cost to 

respondents is estimated at: $4,841. 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52755 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: Desk Officer for NIH. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Linda Kupfer, 

Fogarty International Center, National 

Institutes of Health, 16 Center Drive, 

Bethesda, MD 20892, or call non-tollfree number 301–496–3288, or e-mail 

your request, including your address to: 

Linda.Kupfer@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 23, 2010. 

Timothy J. Tosten, 

Executive Officer, John E. Fogarty 

International Center, National Institutes of 

Health. 

[FR Doc. 2010–21350 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0433] 

Draft Guidance for Industry on Acute 

Bacterial Skin and Skin Structure 

Infections: Developing Drugs for 

Treatment; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Acute Bacterial Skin 

and Skin Structure Infections: 

Developing Drugs for Treatment.’’ The 

purpose of this draft guidance is to 

assist clinical trial sponsors and 

investigators in the development of 

antimicrobial drugs for the treatment of 

acute bacterial skin and skin structure 

infections (ABSSSI), impetigo, and 

minor cutaneous abscesses. FDA’s 

thinking in this area has evolved in 

recent years, and this draft guidance, 

when finalized, will inform sponsors of 

the changes in the definitions of ABSSSI 

and the recommendations for clinical 

drug development. 

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 

either electronic or written comments 

on the draft guidance by November 26, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Joseph G. Toerner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Acute Bacterial Skin and Skin 

Structure Infections: Developing Drugs 

for Treatment.’’ The purpose of this draft 

guidance is to assist clinical trial 

sponsors and investigators in the 

development of antimicrobial drugs for 

the treatment of ABSSSI, impetigo, and 

minor cutaneous abscesses. This 

guidance revises the draft guidance 

regarding uncomplicated and 

complicated skin and skin structure 

infections published in 1998. The 

guidance also addresses the clinical 

development of new drugs to treat drugresistant bacterial pathogens implicated 

in ABSSSI, such as methicillin-resistant 

Staphylococcus aureus. 

The definitions of ABSSSI and the 

designs of ABSSSI clinical trials were 

discussed at a meeting of the AntiInfective Drugs Advisory Committee on 

November 18, 2008. In addition, other 

advisory committee meetings have 

focused on the development of specific 

drugs for this indication. As a result of 

these public discussions, as well as 

review of applications at FDA, the 

agency’s thinking in this area has 

evolved in recent years and this draft 

guidance informs sponsors of the 

changes in our recommendations. 

Specifically, the guidance defines the 

clinical disease entities and provides a 

justification for a noninferiority margin 

for the design of active-controlled 

clinical trials that can be used to 

provide evidence of efficacy for the 

treatment of ABSSSI. The guidance 

describes a new responder efficacy 

endpoint for noninferiority trials that is 

based on the historical studies used to 

justify the noninferiority margin. 

Currently, there are ongoing efforts in 

the scientific community to develop and 

evaluate new efficacy endpoints for 

ABSSSI. The guidance also defines the 

clinical disease entities of skin 

infections for which a superiority trial is 

recommended. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on developing drugs for the treatment of 

ABSSSI. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014 and the collections 

of information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES