Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 22753 

available, what information FDA 

recommends you submit in support of a 

request for a fee waiver or reduction, 

how to submit such a request, and 

FDA’s process for reviewing requests. 

FDA is issuing this level 1 final 

guidance document for immediate 

implementation consistent with FDA’s 

GGPs regulation (21 CFR 10.115). Prior 

public participation is not feasible 

because the guidance concerns statutory 

requirements that FDA must implement 

immediately. AGDUFA’s user fee 

provisions are already in effect, and it 

is essential for the agency to provide 

guidance on how to request fee waivers 

and reductions as quickly as possible. If 

FDA receives comments on this final 

guidance, it will review the comments 

and revise the guidance if appropriate. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s GGPs regulation 

(21 CFR 10.115). The guidance 

represents the agency’s current thinking 

on the fee waiver provisions of 

AGDUFA. It does not create or confer 

any rights for or on any person and will 

not operate to bind FDA or the public. 

Alternative methods may be used as 

long as they satisfy the requirements of 

the applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

FDA concludes that there are no 

collections of information under the 

Paperwork Reduction Act of 1995. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this guidance. 

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. A copy of the 

guidance and received comments are 

available for public examination in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

V. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either http:// 

www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: May 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11218 Filed 5–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

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 meeting of the 

National Cancer Advisory Board. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

A portion of the meeting 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 Cancer 

Advisory Board Subcommittee on Cancer 

Centers. 

Open: June 10, 2009, 6 p.m. to 7:30 p.m. 

Agenda: Discussion on Cancer Centers. 

Place: Bethesda Hyatt Regency Hotel, One 

Metro Center, Bethesda, MD 20814. 

Contact Person: Dr. Linda K. Weiss, 

Executive Secretary, NCAB Subcommittee on 

Cancer Centers, National Cancer Institute, 

National Institutes of Health, 6116 Executive 

Boulevard, Suite 700, Bethesda, MD 20892– 

8345, (301) 496–8531. 

Name of Committee: National Cancer 

Advisory Board. 

Open: June 11, 2009, 8 a.m. to 4 p.m. 

Agenda: Program reports and 

presentations; business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327. (301) 496–5147. 

Name of Committee: National Cancer 

Advisory Board. 

Closed: June 11, 2009, 4 p.m. to 

adjournment. 

Agenda: Review of grant applications. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Name of Committee: National Cancer 

Advisory Board. 

Open: June 12, 2009, 8:30 a.m. to 12 p.m. 

Agenda: Program reports and 

presentations; business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/ncab.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: May 5, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–11236 Filed 5–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 


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