61502 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

need for AMR surveillance with a 

forward-look toward sustainable 

solutions through global collaboration 

and evidence-based approaches. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: The 

World Health Organization 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing one award 

of $847,500 (total costs including 

indirect costs) in fiscal year (FY) 2010 

in support of this project. Subject to the 

availability of funds and successful 

performance, 2 additional years 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 2 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. 2010–24903 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–0495] 

Cooperative Agreement With the Pan 

American Health Organization for the 

Development of an Information Hub for 

Medical Products and Related 

Regulatory Processes and Systems in 

the Americas Region 

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 to award a 

cooperative agreement to the Pan 

American Health Organization (PAHO) 

for the development of an information 

hub in the areas of medical products 

and related regulatory processes and 

systems (e.g., including drugs, biologics, 

vaccines, medical devices, and other 

medical products as appropriate) in the 

region of the Americas. 

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 

to award a cooperative agreement to the 

PAHO for the development of an 

information hub in the areas of medical 

products and related regulatory 

processes and systems (e.g., including 

drugs, biologics, vaccines, medical 

devices, and other medical products as 

appropriate) in the region of the 

Americas. 

B. Research Objectives 

• The development of an online 

database (e.g., Web-based) in English 

and Spanish for a series of countries 

providing: 

Æ Overview of the regulated sector 

including description and specific 

data relating to the medical 

products and related regulatory 

processes and systems market; 

Æ Structural overview of the national 

regulatory process(es) including 

information relating to national 

entities participating in the 

regulatory process; 

Æ Data presented by specific 

regulatory areas (for example, 

biologics, vaccines, drugs, medical 

devices) on processes relating to 

product registration, licensing 

(manufacturer, wholesaler and 

pharmacy/vendor), quality control 

assessment and postmarketing 

surveillance; 

Æ Data presented on other regulatory 

areas such as clinical trials and 

supply chains; 

Æ Key regulations governing the areas 

of medical products and related 

regulatory processes and systems 

(e.g., including drugs, biologics, 

vaccines, medical devices, and 

other medical products as 

appropriate) per country and/or 

links to sources where such 

information is available. 

Æ Data collected and presented in 

such a way that ensures consistency 

of terminology, consistency in data 

collection methods, and robustness, 

comprehensiveness, and 

comparability of data. 

• The establishment of information 

exchange mechanisms with the active 

participation of national regulatory 

agencies (NRAs) in the region of the 

Americas that facilitates the process by 

which the information hub and database 

is populated with information that is 

reviewed and maintained in an up-todate and continual basis. 

Æ A detailed mechanism to maintain 

and update the hub information is 

developed detailing the 

responsibilities of PAHO and its 

Members States in keeping the data 

and information contained therein 

relevant, up-to-date, and 

comprehensive to encompass the 

future growth and complexity in the 

areas of medical products and 

related regulatory processes and 

systems. 

• As appropriate, PAHO would work 

to align or link the information hub with 

other ongoing global initiatives of the 

World Health Organization (WHO) or its 

regional offices in regulatory aspects 

relating to medical products and related 

regulatory processes and systems. 

• As appropriate, PAHO would work 

to enable effective linkage(s) of the 

information hub with other ongoing 

initiatives in regulatory aspects relating 

to medical products and related 

regulatory processes and systems 

including harmonization efforts, such as 

the Pan American Network for Drug 

Regulatory Harmonization (PANDRH), 

the ICH Global Cooperation Group; the 

Global Health Task Force on Health 

Technologies; the Asia-Pacific 

Economic Cooperation (APEC) 

harmonization efforts, and other 

relevant efforts and initiatives as 

appropriate. 

• The utilization of the data and 

information contained within the 

information hub by NRAs to enable 

harmonized approaches, standards and 

guidelines for regulatory systems. It will 

support evidence-based decisionmaking 

by NRAs and regulated industry sectors, 

facilitate the exchange of timely and 

accurate data, and promote transparency 

of regulated approaches and efforts. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES