61504 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

AZDONE (hydrocodone bitartrate and 

aspirin) Tablet, 5 mg/500 mg, is the 

subject of ANDA 89–420, held by 

Schwarz Pharma, Inc., and initially 

approved on January 25, 1988. AZDONE 

is indicated for the relief of moderate to 

moderately severe pain. AZDONE 

(hydrocodone bitartrate and aspirin) 

Tablet, 5 mg/500 mg is currently listed 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated June 

23, 2010 (Docket No. FDA–2010–P– 

0338), under 21 CFR 10.30, requesting 

that the Agency determine whether 

AZDONE (hydrocodone bitartrate and 

aspirin) Tablet, 5 mg/500 mg, was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

AZDONE (hydrocodone bitartrate and 

aspirin) Tablet, 5 mg/500 mg was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that AZDONE (hydrocodone 

bitartrate and aspirin) Tablet, 5 mg/500 

mg, was withdrawn for reasons of safety 

or effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of AZDONE 

(hydrocodone bitartrate and aspirin) 

Tablet, 5 mg/500 mg, from sale. We have 

also independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list AZDONE 

(hydrocodone bitartrate and aspirin) 

Tablet, 5 mg/500 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to AZDONE (hydrocodone bitartrate and 

aspirin) Tablet, 5 mg/500 mg, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: September 29, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–24902 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0497] 

Global Implementation of the 

Veterinary Medicinal Products 

Guidelines 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces its 

intention to accept and consider a single 

source application for a cooperative 

agreement to the World Organization for 

Animal Health (OIE). The OIE is the 

intergovernmental organization 

responsible for improving animal health 

worldwide and is recognized by the 

World Trade Organization (WTO) as a 

reference for international sanitary 

rules, with 175 Member Countries and 

Territories. The purpose of this 

agreement is to continue outreach that 

began in fiscal year (FY) 2009 to expand 

capacity building to support OIE’s 

services and activities that are needed to 

carry out OIE’s Veterinary International 

Conference on Harmonization (VICH) 

Global Outreach to disseminate and 

implement VICH guidelines at the 

country level. 

FOR FURTHER INFORMATION CONTACT: 

Program Contact: Merton V. Smith, 

Center for Veterinary Medicine 

(HFV–1), Food and Drug 

Administration, 7519 Standish Pl., 

rm. 177, Rockville, MD 20855, 240– 

276–9025, FAX: 240–276–9030, 

email: Merton.Smith@fda.hhs.gov. 

Management Contact: Katherine C. 

Bond, Office of the Commissioner, 

Food and Drug Administration, 

White Oak Bldg. 32, rm. 3300, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–8318, 

FAX: 301–595–5058, email: 

Katherine.Bond@fda.hhs.gov. 

Grants Contact: Kimberly Pendleton, 

Division of Acquisition and Grants 

(HFA–500), Food and Drug 

Administration, 5630 Fishers Lane, 

rm. 2104, Rockville, MD 20857, 

301–827–9363, FAX: 301–827– 

7101, email: 

kimberly.pendleton@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

contact Kimberly Pendleton. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–10–010 

Catalog of Federal Domestic Assistance 

Number(s): 93.103 https://www.cfda.gov 

A. Background 

FDA announces its intention to accept 

and consider a single source application 

for award of a cooperative agreement to 

the OIE in support of international 

technical capacity building activities 

that help to assure that U.S. imports of 

veterinary medicinal products are safe, 

effective, and of high quality and that 

food from treated animals is safe and 

wholesome; to assist foreign regulators 

in developing and using rigorous safety 

standards; to develop and foster 

mutually beneficial regulatory 

partnerships; and to leverage resources 

for capacity building through 

appropriate training and other activities. 

B. Research Objectives 

• Promote and enhance in OIE 

Members good veterinary governance, 

which includes the compliance of 

Veterinary Services with OIE 

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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61505 

international standards, as an 

instrumental and essential prerequisite 

to the establishment and effective 

implementation of adequate and 

appropriate legislation covering all 

aspects of products for veterinary use, 

including registration, quality control, 

distribution, monitoring of quantities 

and final use. 

• Develop and improve international 

and regional cooperation in the 

establishment and enforcement of 

legislation to harmonize the regulatory 

framework between OIE Member States 

so as to assist countries in need to 

effectively institute and maintain such 

mechanisms. 

• Encourage countries to allocate 

appropriate human and financial 

resources to veterinary services and 

laboratories to correctly implement the 

OIE standards and guidelines related to 

veterinary products and their control. 

• Enhance capacities of national focal 

points for OIE on matters related to 

veterinary products according to the 

suggested terms of reference and 

encourage his/her participation in 

training sessions and appropriate 

international gatherings and meetings. 

• Promote the responsible and 

prudent use of veterinary medicinal 

products, in particular of antimicrobials 

used in veterinary medicine, and the 

monitoring of the quantities used and 

potential existence or development of 

antimicrobial resistance in diseasecausing organisms affecting both 

humans and animals. 

• Actively encourage the recognition 

and application of the international 

recommendations, guidelines and tools 

developed by the OIE and adopted by 

the World Assembly of Delegates on 

veterinary products. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: The 

OIE. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing one award 

of $565,000 (total costs including 

indirect costs) in fiscal year (FY) 2010 

in support of this project. Subject to the 

availability of funds and successful 

performance, 1 additional year of 

support up to $565,000 per year will be 

available. 

B. Length of Support 

The support will be 1 year with the 

possibility of an additional year of 

noncompetitive support. Continuation 

beyond the first year will be based on 

satisfactory performance during the 

preceding year, receipt of a noncompeting continuation application and 

available Federal FY appropriations. 

Dated: September 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24905 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Members of the 

National Institutes of Health’s Senior 

Executive Service 2010 Performance 

Review Board (PRB) 

The National Institutes of Health 

(NIH) announces the persons who will 

serve on the National Institutes of 

Health’s Senior Executive Service 2010 

Performance Review Board. This action 

is being taken in accordance with Title 

5, U.S.C., 4314(c)(4), which requires that 

members of performance review boards 

be appointed in a manner to ensure 

consistency, stability, and objectivity in 

performance appraisals and requires 

that notice of the appointment of an 

individual to serve as a member be 

published in the Federal Register. 

The following persons will serve on 

the NIH Performance Review Board, 

which oversees the evaluation of 

performance appraisals of NIH Senior 

Executive Service (SES) members: 

Ms. Colleen Barros (Chair), Dr. Michael 

Gottesman, Ms. Lenora Johnson, Ms. 

Robin Kawazoe, Dr. Sally Rockey, Dr. 

Lawrence Tabak, Dr. Samir Zakhari. 

For further information about the NIH 

Performance Review Board, contact the 

Office of Human Resources, Workforce 

Relations Division, National Institutes of 

Health, Building 31, Room B3C07, 

Bethesda, Maryland 20892, telephone 

301–402–9203 (not a toll-free number). 

Dated: September 27, 2010. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. 2010–24929 Filed 10–4–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC)—Health Disparities 

Subcommittee (HDS) 

Correction: This notice was published 

in the Federal Register on September 1, 

2010, Volume 75, Number 169, page 

53703. A quorum of the subcommittee’s 

membership was not able to participate; 

therefore, the meeting was adjourned. 

The subcommittee will reconvene as 

follows: 

Time and Date: 2 p.m.–3 p.m., 

October 21, 2010. 

Place: Teleconference. 

Status: Open to the public. 

Teleconference access limited only by 

the availability of telephone ports. The 

public is welcome to participate during 

the public comment period, which is 

tentatively scheduled from 2:45 p.m. to 

2:50 p.m. To participate in the 

teleconference please dial (877) 394– 

7734 and enter conference code 

9363147. 

Purpose: The Subcommittee will 

provide recommendations for 

consideration to the ACD on strategic 

and other broad issues facing CDC. 

Matters To Be Discussed: Policy brief 

on health equity and social 

determinants of health; update on 

collaboration with the CDC Health 

Equity Workgroup; CDC Director’s 

Annual Health Disparity Report; and 

briefing on the realignment of the CDC 

Office of Minority Health and Health 

Disparities. Agenda items are subject to 

change as priorities dictate. 

Contact Person for More Information: 

Walter W. Williams, M.D., M.P.H., 

Designated Federal Officer, HDS, ACD, 

CDC, 1600 Clifton Road, NE., M/S E–67, 

Atlanta, Georgia 30333. Telephone (404) 

498–2310, E-mail: http:// 

www1@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: September 29, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–24911 Filed 10–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

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