Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Notices 3471 

also recommends that microbiological 

information be obtained in at least one 

of the controlled studies. This draft 

guidance discusses patient-reported 

outcome instruments for assessing 

clinical response, and the use of time to 

resolution as a possible approach to 

assessing the primary endpoint in 

clinical studies. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 

acute bacterial otitis media. 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This draft guidance refers to 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 

0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001; and 

the collections of information referred to 

in the guidance Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees have been 

approved under 0910–0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Please note that in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: January 11, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–835 Filed 1–17–08; 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. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (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: Ryan White HIV/ 

AIDS Program Core Medical Services 

Waiver Application Requirements 

(OMB No. 0915–0307): Extension 

Title XXVI of the Public Health 

Service (PHS) Act, as amended by the 

Ryan White HIV/AIDS Treatment 

Modernization Act of 2006 (Ryan White 

HIV/AIDS Program) requires that 

grantees expend 75 percent of Parts A, 

B, and C funds on core medical services, 

including antiretroviral drugs, for 

individuals with HIV/AIDS identified 

and eligible under the legislation, 

effective fiscal year 2007. In order for 

grantees under Parts A, B, and C to be 

exempted from the 75 percent core 

medical services requirement, they must 

request and receive a waiver from 

HRSA, as required in the Act. 

Grantees must submit a waiver 

request with the annual grant 

application containing the information 

and documentation which will be 

utilized by HRSA in making 

determinations regarding waiver 

requests. 

The estimated annual burden is as 

follows: 

Application Number of 

respondents 

Responses 

per respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Waiver Request ................................................................... 20 1 20 6.5 130 

Total .............................................................................. 20 ........................ 20 ........................ 130 

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: January 14, 2008. 

Caroline Lewis, 

Associate Administrator for Management. 

[FR Doc. E8–879 Filed 1–17–08; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 


rwilkins on PROD1PC63 with NOTICES
3472 Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Notices 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Human 

Genome Research Institute Initial Review 

Group, Genome Research Review Committee. 

Date: March 6, 2008. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIH/NHGRI Twinbrook Conference 

Room, 5635 Fisher’s Lane, Suite 4076, MSC 

9306, Bethesda, MD 20852 (Telephone 

Conference Call). 

Contact Person: Rudy Pozzatti, PhD., 

Scientific Review Officer, Office of Scientific 

Review, National Human Genome Research 

Institute, National Institutes of Health, 

Bethesda, MD 20892, (301) 402–0838. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel, SEP ZHG1 HGR–P (M1). 

Date: March 7, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 

Double Tree Name Changed, 1750 Rockville 

Pike, Rockville, MD 20852. 

Contact Person: Rudy O. Pozzatti, PhD., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, 5635 Fishers Lane, Suite 4076, MSC 

9306, Rockville, MD 20852, (301) 402–0838, 

pozzattr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS). 

Dated: January 11, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–160 Filed 1–17–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Biodefense Therapeutics. 

Date: February 11–13, 2008. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Ellen S. Buczko, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 310–451–2676, 

ebuczko1@niaid.nih.gov. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Microbiology and Infectious Diseases 

B Subcommittee. 

Date: February 13–14, 2008. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Georgetown, 2101 

Wisconsin Avenue, NW., Washington, DC 

20007. 

Contact Person: Gary S. Madonna, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892, 301–496–3528, gm12w@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 11, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–156 Filed 1–17–08: 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in section 552b(c)(4) 

and 552b(c)(6), Title 5 U.S.C., as 

amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel. 

Date: February 15, 2008. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Rebecca Wagenaar Miller, 

PhD, Scientific Review Officer, Scientific 

Review Branch, National Inst of Dental & 

Craniofacial Research, National Institutes of 

Health, 45 Center Dr. Rm 4AN 32G, Bethesda, 

MD 20892, (301) 594–0652, 

rwagenaa@mail.nih.gov. 

Name of Committee: NIDCR Special Grants 

Review Committee. 

Date: February 21–22, 2008. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Raj K Krishnaraju, PhD, 

MS, Scientific Review Officer, Scientific 

Review Branch, National Inst of Dental & 

Craniofacial Research, National Institutes of 

Health, 45 Center Dr. Rm 4AN 32J, Bethesda, 

MD 20892, (301) 594–4864, 

kkrishna@nidcr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: January 11, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 08–157 Filed 1–17–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 


rwilkins on PROD1PC63 with NOTICES