Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61501 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, who 

will be accompanied by FDA senior 

management from the Office of the 

Commissioner and the Center for Drug 

Evaluation and Research. 

Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10, subpart C (21 CFR 

part 10, subpart C)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see section VI of this 

document). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

V. Request for Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

either electronic or written comments to 

the Division of Dockets Management 

(see ADDRESSES). It is only necessary to 

send one set of comments. It is no 

longer necessary to send two copies of 

mailed comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

VI. Transcripts 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management (see ADDRESSES) 

and on the Internet at http://www.

regulations.gov approximately 30 days 

after the public hearing. A transcript 

will also be made available in either 

hard copy or on CD–ROM, upon 

submission of a Freedom of Information 

request. Written requests are to be sent 

to Division of Freedom of Information 

(HFI–35), Office of Management 

Programs, Food and Drug 

Administration, 5600 Fishers Lane, 

Room 6–30, Rockville, MD 20857. 

Dated: September 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24853 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0496] 

Cooperative Agreement To Support 

Capacity Building Activities Through 

the World Health Organization Global 

Foodborne Infections Network 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to accept and consider a single 

source application to award a 

cooperative agreement to the World 

Health Organization (WHO) Advisory 

Group on Integrated Surveillance of 

Antimicrobial Resistance (AGISAR) and 

in support of the WHO Global 

Foodborne Infections Network (GFN) 

and to provide guidance to the WHO on 

a framework for the development of an 

international network to promote and 

enhance collaboration on harmonization 

and data sharing among countries with 

Antimicrobial Resistance (AMR) 

surveillance programs. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Program Contact: Patrick McDermott, 

Division of Animal and Food 

Microbiology, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Mod II, rm. 1505, Rockville, MD 

20855, 301–210–4213, FAX: 301– 

210–4685, email: 

Patrick.McDermott@fda.hhs.gov. 

Management Contact: Katherine C. 

Bond, Office of International 

Programs, Office of the 

Commissioner, FDA, 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, 

FDA, 5630 Fishers Lane (HFA–500), 

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–10–006] 

[Catalog of Federal Domestic Assistance 

Number(s): 93.103 https:// 

www.cfda.gov] 

A. Background 

The Food and Drug Administration 

(FDA) is announcing its intention to 

accept and consider a single source 

application for a cooperative agreement 

to the WHO GFN. This project 

represents a collaborative agreement 

between the WHO and FDA aimed at 

capacity building in laboratory based 

surveillance of foodborne pathogens and 

disease in developing regions to support 

AGISAR and GFN to enable FDA to 

realize its goal of developing an 

international database for human and 

animal isolates of foodborne pathogens 

and their susceptibility profiles. 

B. Research Objectives 

• Support WHO capacity building 

activities with member countries for 

AMR monitoring (development of AMR 

training modules for GFN training 

courses, and hosting of visiting scientist 

from developing countries). 

• Develop harmonized schemes for 

monitoring antimicrobial resistance in 

zoonotic and enteric bacteria to include 

appropriate sampling. 

• Promote information sharing on 

AMR (development of a global AMR 

databank). 

• Provide expert advice to WHO, and 

promote WHO and FDA collaborative 

work to advise WHO Member States on 

containment of AMR with a particular 

focus to Human Critically Important 

Antimicrobials. AGISAR should be the 

core advisory group to review criteria 

for ranking human and animal 

antimicrobials to be reviewed by WHO; 

and FDA’s resources could be used in 

support of AGISAR’s participation. 

• Support and advise WHO on 

selection of sentinel sites to be 

strategically identified around the globe 

and designing pilot projects to conduct 

integrated surveillance of antimicrobial 

resistance. 

• Promote development of 

standardized methods for monitoring 

antimicrobial use and work with 

member states for the implementation of 

these methods at the country-level. 

• Promote the development of 

published articles on the emergence of 

AMR threats and challenges, and the 

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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. 

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