Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61503 

• As appropriate, explore with the 

WHO, the possibility of expanding this 

information hub to other WHO Regions. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: the 

PAHO. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing one award 

of $904,000 (total costs including 

indirect costs) in FY 2010 in support of 

this project. 

B. Length of Support 

The support will be 1 year with the 

possibility of an additional 3 years 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. 2010–24906 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–0494] 

Cooperative Agreement With the World 

Health Organization for a Plan to 

Develop a Global Integrated Food 

Safety Information Platform 

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 awarding a 

cooperative agreement to the World 

Health Organization (WHO), 

Department of Food Safety and 

Zoonoses, to develop a plan for a global 

integrated food safety information 

system or platform in partnership with 

the WHO Secretariat and the Member 

States. 

FOR FURTHER INFORMATION CONTACT: 

Management Contact: Katherine C. 

Bond, Office of International 

Programs, 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–10–009 

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 awarding a cooperative agreement to 

the WHO, Department of Food Safety 

and Zoonoses to develop a plan for a 

global integrated food safety information 

system or platform in partnership with 

the WHO Secretariat and the Member 

States. This project represents a 

collaborative agreement between WHO 

and FDA in support of global solutions 

to address food safety problems; global 

sharing of comparable food safety data 

and information; and improved global 

capacity for detection of and response to 

food safety threats through preventative 

controls, data and surveillance and riskbased approaches. 

B. Research Objectives 

• Outreach to parties who have 

information needs and information to 

share to ascertain their interests and to 

cultivate their support; 

• Engagement of all relevant parties 

in defining the goals and designing the 

system to maximize utilization and 

sustainability; 

• A timeline for development, design, 

pilot-testing, implementation and 

maintenance of a global integrated 

information platform; 

• A business plan that delineates the 

commitment, support and resources of 

the WHO Secretariat and relevant 

stakeholders essential to ensure full 

implementation and long-term 

sustainability; and 

• A clear articulation of the benefits, 

measurable outputs and impacts that 

would result from a WHO global 

integrated information platform to the 

global community, Member States and 

other relevant parties and stakeholders. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: The 

WHO. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing one award 

of $395,500 (total costs including 

indirect costs) in fiscal year (FY) 2010 

in support of this project. 

B. Length of Support 

The total project period for an 

application submitted in response to 

this funding opportunity may not 

exceed 1 year. 

Dated: September 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24904 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–P–0338] 

Determination That AZDONE 

(Hydrocodone Bitartrate and Aspirin) 

Tablet, 5 Milligrams/500 Milligrams, 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that AZDONE (hydrocodone bitartrate 

and aspirin) Tablet, 5 milligrams (mg)/ 

500 mg, was not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for hydrocodone 

bitartrate and aspirin tablet, 5 mg/500 

mg, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Livornese, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6306, 

Silver Spring, MD 20993–0002, 301– 

796–0719. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

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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 

mstockstill on DSKH9S0YB1PROD with NOTICES