Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61497 

TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

FDA Center No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Center for Food Safety and Applied Nutrition (Three different product categories) 

386 2 772 1.5 1,158 

247 47 11,609 2 23,218 

337 1 337 0.5 169 

Total 15,653 27,401 50,942 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25009 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–0477] 

Approval Pathway for Biosimilar and 

Interchangeable Biological Products; 

Public Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public hearing to obtain input on 

specific issues and challenges 

associated with the implementation of 

the Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act). The 

BPCI Act establishes an abbreviated 

approval pathway for biological 

products that are demonstrated to be 

‘‘highly similar’’ (biosimilar) to, or 

‘‘interchangeable’’ with, an FDAlicensed biological product. The 

purpose of this public hearing is to 

create a forum for interested 

stakeholders to provide input regarding 

the agency’s implementation of the 

statute. FDA will take the information it 

obtains from the public hearing into 

account in its implementation of the 

BPCI Act. 

DATES: The public hearing will be held 

November 2 and 3, 2010, from 8:30 a.m. 

to 4:30 p.m. Individuals who wish to 

present at the public hearing must 

register on or before October 11, 2010. 

Section III of this document provides 

attendance and registration information. 

Electronic or written comments will be 

accepted after the public hearing until 

December 31, 2010. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Building 

31, Rm. 1503, Silver Spring, MD 20993. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Room 1061, Rockville, MD 20852. 

Identify comments with the 

corresponding docket number found in 

brackets in the heading of this 

document. 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the public 

hearing (see Section VI of this 

document). 

A live webcast of this public hearing 

will be viewable at the following Web 

addresses on the days of the public 

hearing: http://www.fda.gov/Drugs/ 

NewsEvents/ucm221688.htm. A video 

record of the public hearing will be 

available at the same Web addresses for 

1 year. 

FOR FURTHER INFORMATION CONTACT: 

Sandra J. Benton, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993, 301–796– 

1042, FAX: 301–847–3529, E-mail: 

biosimilarspublicmtg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (Affordable 

Care Act) (Pub. L. 111–148). The 

Affordable Care Act contains a subtitle 

called the Biologics Price Competition 

and Innovation Act of 2009 (BPCI Act) 

that amends the Public Health Service 

Act (PHS Act) and other statutes to 

create an abbreviated approval pathway 

for biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed reference biological 

product (see sections 7001 through 7003 

of the BPCI Act). 

The objectives of the BPCI Act are 

conceptually similar to those of the 

Drug Price Competition and Patent 

Term Restoration Act of 1984 (Pub. L. 

98–417) (commonly referred to as the 

‘‘Hatch-Waxman Act’’), which 

established abbreviated pathways for 

the approval of drug products under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). The BPCI Act aligns with 

FDA’s longstanding policy of permitting 

appropriate reliance on what is already 

known about a drug, thereby saving 

time and resources and avoiding 

unnecessary duplication of human or 

animal testing. The implementation of 

an abbreviated approval pathway for 

biological products can present 

challenges given the scientific and 

technical complexities that may be 

associated with the larger and often 

more complex structure of biological 

products, as well as the processes by 

which such products are manufactured. 

Most biological products are produced 

in a living system such as a 

microorganism, or plant or animal cells, 

whereas small molecule drugs are 

typically manufactured through 

chemical synthesis. 

Section 351(k) of the PHS Act (42 

U.S.C. 262(k)), added by the BPCI Act, 

describes the general requirements for 

an application for a proposed biosimilar 

biological product and an application or 

a supplement for a proposed 

interchangeable biological product. 

A biological product may be 

demonstrated to be ‘‘biosimilar’’ to a 

biological reference product based upon 

data derived from analytical studies, 

animal studies, and a clinical study or 

studies if the product is shown to be 

highly similar to the reference product, 

notwithstanding minor differences in 

clinically inactive components, and if 

there are no clinically meaningful 

differences between the biological 

product and the reference product in 

terms of safety, purity and potency. 

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61498 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

To meet the higher standard of 

‘‘interchangeability,’’ a product must 

demonstrate that it can be expected to 

produce the same clinical result as the 

reference product in any given patient 

and, if the biological product is 

administered more than once to an 

individual, the risk in terms of safety or 

diminished efficacy of alternating or 

switching between the use of the 

biological product and the reference 

product is not greater than the risk of 

using the reference product without 

such alternation or switch. 

Interchangeable products may be 

substituted for the reference product by 

a pharmacist without the intervention of 

the prescribing health care provider. 

The BPCI Act also includes, among 

other provisions: A 12-year period of 

marketing exclusivity from the date of 

first licensure of the reference product, 

during which approval of a 351(k) 

application referencing that product 

cannot be made effective; an exclusivity 

period for the first biological product 

submitted in a 351(k) application that 

has been determined to be 

interchangeable with the reference 

product for any condition of use, during 

which a second or subsequent biological 

product may not be determined 

interchangeable to that reference 

product; and a transition provision for 

protein products that have been or will 

be approved under section 505 of the 

FD&C Act (21 U.S.C. 355) prior to March 

23, 2020. 

The BPCI Act also requires that FDA 

develop recommendations to present to 

Congress with respect to a user fee 

program for biosimilar and 

interchangeable biological products. 

Such recommendations must address 

the goals for the process of reviewing 

351(k) applications, and plans for 

meeting those goals, for fiscal years (FY) 

2013 to 2017. In developing such 

recommendations, FDA is required to 

consult with the Committee on Health, 

Education, Labor, and Pensions of the 

Senate; the Committee on Energy and 

Commerce of the House of 

Representatives; scientific and academic 

experts; healthcare professionals; 

representatives of patient and consumer 

advocacy groups; and regulated 

industry. 

The BPCI Act also establishes 

procedures for identifying and resolving 

patent disputes involving applications 

submitted under section 351(k) of the 

PHS Act; these procedures do not 

involve FDA and are not within the 

scope of this public hearing. 

II. Purpose and Scope of the Public 

Hearing 

The purpose of this part 15 hearing is 

to receive information and comments 

from a broad group of stakeholders, 

such as healthcare professionals, 

healthcare institutions, manufacturers of 

biomedical products, interested 

industry and professional associations, 

patients and patient associations, third 

party payers, current and prospective 

biological license application (BLA) and 

new drug application (NDA) holders, 

and the public, regarding 

implementation of the BPCI Act. 

To prepare to begin negotiations with 

regulated industry regarding a user fee 

program, FDA must identify which 

companies and trade associations would 

be affected by a user fee program for 

biosimilar and interchangeable 

biological products (i.e., a company 

likely to submit an application for 

approval of a biosimilar or 

interchangeable biological product). 

The purpose of this public hearing is 

to create a forum for interested 

stakeholders to provide input regarding 

the agency’s implementation of the 

statute concerning the following issues, 

among others: Scientific and technical 

factors related to a determination of 

biosimilarity or interchangeability; the 

type of information that may be used to 

support a determination of biosimilarity 

or interchangeability; development of a 

framework for optimal 

pharmacovigilance for biosimilar and 

interchangeable biological products; 

scope of the revised definition of a 

‘‘biological product’’; priorities for 

guidance development; scientific and 

technical factors related to reference 

product exclusivity; scientific and 

technical factors that may inform the 

agency’s interpretation of ‘‘product 

class’’ as it relates to available regulatory 

pathways for certain protein products 

during the 10-year transition period 

following enactment of the BPCI Act; 

and the establishment of a user fee 

program for biosimilar and 

interchangeable biological products. 

FDA is particularly interested in 

obtaining information and public 

comment on the following issues, 

although any comments on any issues 

related to biosimilar or interchangeable 

biological products are welcome. 

A. Biosimilarity 

Section 351(k) of the PHS Act as set 

forth in the BPCI Act requires, among 

other things, that an application for a 

proposed biosimilar product include 

information demonstrating that the 

proposed product is biosimilar to a 

reference product based upon data 

derived from: 

• Analytical studies that demonstrate 

that the biological product is highly 

similar to the reference product 

notwithstanding minor differences in 

clinically inactive components; 

• Animal studies (including the 

assessment of toxicity); and 

• A clinical study or studies 

(including the assessment of 

immunogenicity and pharmacokinetics 

or pharmacodynamics) that are 

sufficient to demonstrate safety, purity, 

and potency in one or more appropriate 

conditions of use for which the 

reference product is licensed. 

The BPCI Act provides that FDA may 

determine, at its discretion, that an 

element described previously is 

unnecessary in a 351(k) application. 

FDA seeks comments on the following 

issues: 

1. What scientific and technical 

factors should the agency consider in 

determining whether the biological 

product is highly similar to the 

reference product notwithstanding 

minor differences in clinically inactive 

components? 

2. What scientific and technical 

factors should the agency consider in 

determining the appropriate analytical, 

animal, and clinical study or studies to 

assess the nature and impact of actual 

or potential structural differences 

between the proposed biosimilar 

product and the reference product? 

3. What range of structural differences 

between a proposed biosimilar product 

and the reference product is consistent 

with the standard ‘‘highly similar’’ and 

may be acceptable in a 351(k) 

application if the applicant can 

demonstrate the absence of any 

clinically meaningful differences 

between the proposed biosimilar 

product and the reference product? 

4. Under what circumstances should 

the agency consider finding that animal 

studies or a clinical study or studies are 

‘‘unnecessary’’ for submission of a 351(k) 

application? 

B. Interchangeability 

Section 351(k)(4) of the PHS Act 

requires that an application for a 

proposed interchangeable product 

contain information sufficient to 

demonstrate: 

• The biological product is biosimilar 

to the reference product; and 

• The biological product can be 

expected to produce the same clinical 

result as the reference product in any 

given patient; and 

• For a biological product that is 

administered more than once to an 

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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61499 

individual, the risk in terms of safety or 

diminished efficacy of alternating or 

switching between use of the biological 

product and the reference product is not 

greater than the risk of using the 

reference product without such 

alternation or switch. 

FDA seeks input on the following 

issues related to interchangeability: 

1. What factors should the agency 

consider in determining whether a 

proposed interchangeable biological 

product can be ‘‘expected to produce the 

same clinical result as the reference 

product in any given patient?’’ 

2. What factors should the agency 

consider in evaluating the potential risk 

related to alternating or switching 

between use of the proposed 

interchangeable biological product and 

the reference product or among 

interchangeable biological products? 

C. Patient Safety and 

Pharmacovigilance 

The agency considers the safety of 

patients who are taking any medical 

products to be of paramount 

importance. To that end and to protect 

each individual patient, the agency is 

developing a framework for optimal 

pharmacovigilance for biosimilar and 

interchangeable products that is 

informed by our current experience and 

industry best practices. In the interest of 

patient safety and for the purpose of 

pharmacovigilance, the agency must be 

able to distinguish between a reference 

product, a related biological product 

that has not been demonstrated to be 

biosimilar, a biosimilar product, and an 

interchangeable product. 

FDA seeks comments on the following 

issues: 

1. What factors unique to proposed 

biosimilar or interchangeable biological 

products and their use should the 

agency consider in developing its 

pharmacovigilance program for such 

products? 

2. What approaches can be 

undertaken by the agency, industry, or 

health care community to ensure 

appropriate pharmacovigilance for 

biosimilar and interchangeable 

products? 

3. If each product were given a unique 

nonproprietary name, should a 

distinguishing prefix or suffix be added 

to the nonproprietary name for a related 

biological product that has not been 

demonstrated to be biosimilar, a 

biosimilar product, or an 

interchangeable product to facilitate 

pharmacovigilance? What factors should 

be considered to reduce any negative 

impact on the healthcare delivery 

system related to unique nonproprietary 

names for highly similar biological 

products? 

4. What safeguards should the agency 

consider to assist the healthcare 

community when prescribing, 

administering, and dispensing 

biological products to prevent unsafe 

substitution of biological products? 

5. What are some mechanisms that 

FDA may consider to communicate 

findings that a particular product is or 

is not biosimilar to or interchangeable 

with a given reference product? 

D. The Use of Supportive Data and 

Information 

The BPCI Act provides that an 

application for the licensure of a 

biosimilar or interchangeable product: 

Shall include publicly available 

information regarding the Secretary’s 

(Department of Health and Human 

Services) previous determination that 

the reference product is safe, pure, and 

potent; and may include any additional 

information in support of the 

application, including publicly 

available information with respect to the 

reference product or another biological 

product (section 351(k)(2)(A)(iii) of the 

PHS Act). 

The BPCI Act defines the term 

‘‘reference product’’ to mean ‘‘the single 

biological product licensed under 

[section 351(a)] against which a 

biological product is evaluated in an 

application submitted under [section 

351(k)].’’ Accordingly, section 351(k) 

requires that an applicant demonstrate 

biosimilarity to and or 

interchangeability with a reference 

product licensed by FDA (as 

distinguished from a biological product 

licensed by a foreign regulatory 

authority). 

The agency is aware that some 

prospective biosimilar sponsors have 

conducted animal and/or clinical 

studies to support regulatory approval 

in another jurisdiction using a non-U.S.- 

licensed biological product as a 

comparator. To avoid duplicative 

animal and human testing, sponsors 

may wish, to the extent permissible, to 

rely on these studies to support a 351(k) 

application. 

FDA seeks comments on the following 

issue: From a scientific perspective, to 

what extent, if any, should animal or 

clinical data comparing a proposed 

biosimilar product with a non-U.S.- 

licensed comparator product be used to 

support a demonstration of biosimilarity 

to a U.S.-licensed reference product? 

What type of bridging data or 

information would be needed to 

scientifically justify the relevance of the 

comparative data? 

E. Definition of a Biological Product 

The BPCI Act changes the statutory 

authority under which certain protein 

products will be regulated by amending 

the definition of ‘‘biological product’’ in 

section 351(i) of the PHS Act to include 

a protein (except any chemically 

synthesized polypeptide) before the 

phrase ‘‘or analogous product.’’ In light 

of the absence of scientific consensus on 

the distinction between the categories of 

‘‘protein’’ and ‘‘polypeptide’’ or 

‘‘peptide,’’ FDA may establish a 

regulatory definition of ‘‘protein’’ and 

‘‘any chemically synthesized 

polypeptide’’ to clarify the authority 

under which such products will be 

licensed and regulated and, to the extent 

possible, avoid the conflicting 

regulation of certain products (i.e., those 

that are manufactured through either 

synthetic and recombinant technology) 

under different authorities. 

FDA seeks comments on the following 

issues: 

1. What scientific and technical 

factors should FDA consider if it 

develops a regulatory definition for the 

category of ‘‘protein’’ (as distinguished 

from peptide or polypeptide)? 

2. What scientific and technical 

factors should FDA consider if it 

develops a regulatory definition for the 

category of ‘‘any chemically synthesized 

polypeptide’’? 

F. Guidances 

Although the issuance or nonissuance 

of guidance does not preclude 

submission or agency review of, or 

action on, a 351(k) application, we are 

interested in obtaining public input 

regarding priorities for issuing guidance 

documents for industry (see section 

351(k)(8) of the PHS Act). 

FDA seeks comments on the following 

issues: 

1. What types of guidance documents 

for industry should be a priority for the 

agency during the early period of 

implementation? 

2. Section 351(k)(8)(E) of the PHS Act 

permits the agency to indicate in a 

guidance document that the science and 

experience, as of the date of the 

guidance document, with respect to a 

product or product class (not including 

any recombinant protein) does not allow 

approval of a 351(k) application for such 

a product or product class. What 

scientific and technical factors should 

the agency consider in determining if 

the existing science and experience are 

sufficient to allow approval for a 

product or product class under section 

351(k) of the PHS Act? 

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61500 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

G. Exclusivity 

The BPCI Act provides for a 12-year 

period of marketing exclusivity from the 

date of first licensure of the reference 

biological product, during which 

approval of a 351(k) application cannot 

be made effective (see section 351(k)(7) 

of the PHS Act). The date of first 

licensure does not apply to a license for 

or approval of: 

• A supplement for the biological 

product that is the reference product; or 

• A subsequent application filed by 

the same sponsor or manufacturer of the 

biological product that is the reference 

product (or a related entity) for a change 

(not including a modification to the 

structure of the biological product) that 

results in a new indication, route of 

administration, dosing schedule, dosage 

form, delivery system, delivery device, 

or strength; or 

• A subsequent application filed by 

the same sponsor or manufacturer of the 

biological product that is the reference 

product (or a related entity) for a 

modification to the structure of the 

biological product that does not result 

in a change in safety, purity, or potency 

(see section 351(k)(7)(C) of the PHS 

Act). 

FDA seeks comments on the following 

issues: 

1. In light of the potential transfer of 

BLAs from one corporate entity to 

another and the complexities of 

corporate and business relationships, 

what factors should the agency consider 

in determining the types of related 

entities that may be ineligible for a 

period of 12-year exclusivity for a 

subsequent BLA? 

2. What factors should the agency 

consider in determining whether a 

modification to the structure of the 

licensed reference biological product 

results in a change in safety, purity, or 

potency, such that a subsequent BLA 

may be eligible for a second 12-year 

period of marketing exclusivity? 

H. Transition Provisions 

The BPCI Act requires that an 

application for a biological product, 

which now includes the category of 

‘‘protein (except any chemically 

synthesized polypeptide),’’ must be 

submitted under section 351 of the PHS 

Act, rather than under section 505 of the 

FD&C Act. However, the BPCI Act 

provides an exception for certain 

biological products that are in a 

‘‘product class’’ for which an application 

has been approved under section 505 of 

the FD&C Act prior to March 23, 2010. 

An application for a biological product 

in these product classes may be 

submitted under section 505 of the 

FD&C Act until March 23, 2020, unless 

there is another biological product 

licensed under section 351(a) of the PHS 

Act that could serve as the reference 

product for the application, if the 

application were submitted under 

section 351(k) of the PHS Act (see 

section 7002(e) of the BPCI Act). 

FDA seeks comments on the following 

issues: 

1. What scientific factors should FDA 

consider in defining and applying 

‘‘product class’’ for purposes of 

determining which applications for 

biological products may be submitted 

under the FD&C Act during the 10-year 

transition period? 

2. What scientific factors should FDA 

consider in determining whether 

another biological product approved 

under section 351(a) of the PHS Act 

could serve as the reference product for 

an application submitted under section 

351(k) of the PHS Act? 

I. User Fees 

The BPCI Act amends section 735 of 

the FD&C Act (21 U.S.C. 379g) to 

include 351(k) applications in the 

definition of a ‘‘human drug 

application’’ for the purposes of the 

prescription drug user fee provisions 

(see section 7002(f)(3) of the BPCI Act). 

The BPCI Act requires FDA to develop 

recommendations to present to Congress 

by January 15, 2012, for goals for the 

process of reviewing 351(k) 

applications, and plans for meeting 

those goals, for the first five fiscal years 

after FY 2012 (see section 7002(f)(3) of 

the BPCI Act). 

FDA seeks comments on the following 

issues: 

1. If the existing fee structure under 

the Prescription Drug User Fee Act 

(PDUFA) were to be considered as a 

model in establishing a user fee 

structure for applications and 

supplements for proposed biosimilar 

and interchangeable biological products, 

what factors and changes should FDA 

take into consideration, and why? 

2. What factors should FDA take into 

account when considering whether to 

recommend that user fees for biosimilar 

and interchangeable biological products 

should also be used to monitor safety 

after approval? 

In addition, FDA seeks to identify 

potential participants in any 

negotiations of user fee programs for 

biosimilar and interchangeable 

biological products, specifically 

companies that would be affected by 

such a user fee program and industry 

associations representing such 

companies. FDA requests that 

commenters identify these potential 

participants by sending to Biosimilars

UserFeeProgram@fda.hhs.gov the 

following information regarding any 

company that may be subject to a user 

fee program for biosimilar and 

interchangeable biological products, or 

any industry association representing 

such companies: The name of the entity; 

contact person; e-mail address; and a 

phone number. 

III. Attendance and Registration 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures and limited 

seating. Attendance is free and will be 

on a first-come, first-served basis. 

Individuals who wish to present at the 

public hearing must register by sending 

an e-mail to biosimilarspublicmtg@fda.

hhs.gov on or before October 11, 2010, 

and provide complete contact 

information, including name, title, 

affiliation, address, e-mail, and phone 

number. Those without e-mail access 

may register by contacting Sandra 

Benton (see FOR FURTHER INFORMATION

CONTACT). FDA has included questions 

for comment in section II of this 

document. You should identify the 

section and the number of each question 

you wish to address in your 

presentation, so that FDA can consider 

that in organizing the presentations. 

Individuals and organizations with 

common interests should consolidate or 

coordinate their presentations and 

request time for a joint presentation. 

FDA will do its best to accommodate 

requests to speak and will determine the 

amount of time allotted for each oral 

presentation, and the approximate time 

that each oral presentation is scheduled 

to begin. FDA will notify registered 

presenters of their scheduled times, and 

make available an agenda at http:// 

www.fda.gov/Drugs/NewsEvents/

ucm221688.htm approximately 2 weeks 

prior to the public hearing. Once FDA 

notifies registered presenters of their 

scheduled times, presenters should 

submit to FDA an electronic copy of 

their presentation to biosimilarspublic

mtg@fda.hhs.gov on or before October 

27, 2010. 

If you need special accommodations 

because of disability, please contact 

Sandra Benton, (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

A live Webcast of this public hearing 

will be viewable at the following Web 

addresses on the days of the public 

hearing: http://www.fda.gov/Drugs/

NewsEvents/ucm221688.htm. A video 

record of the public hearing will be 

available at the same Web addresses for 

one year. 

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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 

mstockstill on DSKH9S0YB1PROD with NOTICES