22752 Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices 

Application No. Drug Applicant 

NDA 16–636 NARCAN (naloxone hydrocholoride (HCl)) Injection, 0.02 mg/mL, 0.4 mg/mL, and 1 mg/ 

mL 

Endo Pharmaceuticals, Inc., 100 Painters Dr., 

Chadds Ford, PA 19317 

NDA 16–929 FUDR (floxuridine) Injection, 500 mg/vial Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 

NDA 18–538 LOZOL (indapamide) Tablets, 1.25 mg and 

2.5 mg 

Sanofi-Aventis U.S., 55 Corporate Blvd., P.O. 

Box 5925, Bridgewater, NJ 08807 

NDA 18–821 REGLAN (metaclopramide HCl) Oral Solution, equivalent to (EQ) 5 mg base/5 mL A.H. Robins Co., c/o Wyeth-Ayerst Research, 

P.O. Box 8299, Philadelphia, PA 19101– 

8299 

NDA 18–831 TRACRIUM (atracurium besylate) Injection, 

10 mg/mL 

Hospira, Inc. 

NDA 18–831 TRACRIUM (atracurium besylate) Preservative Free Injection, 10 mg/mL Do. 

NDA 19–080 PROSOM (estazolam) Tablets, 1 mg and 2 

mg 

Abbott Laboratories, 200 Abbott Park Rd., D– 

491, AP30–1E, Abbott Park, IL 60064– 

6157 

NDA 20–397 ZANAFLEX (tizanidine HCL) Tablets, EQ 2 

mg base 

Acorda Therapeutics, 15 Skyline Dr., Hawthorne, NY 10532 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: May 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–11217 Filed 5–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0189] 

Guidance for Industry: Animal Generic 

Drug User Fees and Fee Waivers and 

Reductions; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document for 

industry (#199) entitled ‘‘Animal 

Generic Drug User Fees and Fee Waivers 

and Reductions.’’ The purpose of this 

document is to provide guidance to 

industry on the Animal Generic Drug 

User Fee Act of 2008 (AGDUFA). FDA 

is issuing this final guidance document 

for immediate implementation 

consistent with the agency’s good 

guidance practices (GGPs). Interested 

persons may submit comments on 

agency guidances at any time. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine, Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance document 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

David Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: dnewkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 14, 2008, AGDUFA (Public 

Law 110–316) was enacted. AGDUFA 

amends the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) and 

requires FDA to assess and collect user 

fees for certain applications, products, 

and sponsors. It also requires the agency 

to grant a waiver from or a reduction of 

fees in certain circumstances. Under 

section 741(d) of the FD&C Act, when 

certain conditions are met, FDA will 

waive or reduce fees for generic new 

animal drugs intended solely to provide 

for a minor use or minor species 

indication. 

The purpose of the guidance 

document is to provide guidance on the 

types of fees FDA is authorized to 

collect under AGDUFA and how to 

request waivers and reductions of these 

fees. It describes the types of fees, the 

type of fee waiver or reduction 


pwalker on PROD1PC71 with NOTICES
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. 


pwalker on PROD1PC71 with NOTICES