3610 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 

ANNUAL BURDEN ESTIMATES 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Form ACF–IV–E–1 .......................................................................................... 52 41 6 3,328 

Estimated Total Annual Burden 

Hours: 3,328. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: January 13, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–953 Filed 1–16–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0007] 

Draft Guidance for Industry on Animal 

Models--Essential Elements to 

Address Efficacy Under the Animal 

Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: FDA is announcing the 

availability of a draft guidance entitled 

‘‘Animal Models--Essential Elements to 

Address Efficacy Under the Animal 

Rule.’’ When human efficacy studies are 

neither ethical nor feasible, animal 

efficacy studies may be relied on under 

the Animal Rule to support approval or 

licensure of a drug or biological 

product. This guidance identifies and 

discusses the critical characteristics of 

an animal model that should be 

addressed when developing products 

for approval under the Animal Rule. 

The guidance is intended to help 

sponsors determine whether the model 

meets the requirements of the Animal 

Rule. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by March 23, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or Office 

of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 301–827–1800. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rosemary Roberts, Office of CounterTerrorism and Emergency 

Coordination, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3342, 

Mail Stop 3329, Silver Spring, MD 

20993, 301–796–2210 or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Animal Models--Essential Elements to 

Address Efficacy Under the Animal 

Rule.’’ The purpose of this draft 

guidance is to assist sponsors to identify 

the critical characteristics of an animal 

model that should be addressed when 

efficacy of an investigational product 

will be established under the ‘‘Animal 

Rule’’ (see 21 CFR 314.600; 21 CFR 

601.90). Critical characteristics include, 

but are not limited to, information 

regarding the natural history of the 

condition to be treated in humans and 

animals, the challenge agent, route of 

exposure to the challenge agent, and the 

timing of intervention with the study 

drug. Data from human experience with 

the etiologic agent or with the 

intervention, when available, may 

support applicability of the animal 

model. The information described in the 

draft guidance is relevant for any animal 

model being considered as a basis for 

establishing efficacy under the Animal 

Rule and is intended to help determine 

whether the model meets the 

requirements of the Animal Rule. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on animal models when addressing 

efficacy under the animal rule. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3611 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder.guidance/ 

index.htm, http://www.fda.gov/cber/ 

guidelines.htm or http:// 

www.regulations.gov. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–936 Filed 1–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0008] 

Draft Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Citizen Petitions and 

Petitions for Stay of Action Subject to 

Section 505(q) of the Federal Food, 

Drug, and Cosmetic Act.’’ The Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) added new provisions 

to the Federal Food, Drug, and Cosmetic 

Act (the act) addressing the agency’s 

treatment of certain citizen petitions 

and petitions for stay of agency action 

(collectively, petitions), as well as 

related applications. The draft guidance 

describes how FDA will determine if the 

new provisions apply to a particular 

petition and how FDA will determine if 

a petition would delay approval of a 

pending abbreviated new drug 

application (ANDA) or 505(b)(2) 

application. The draft guidance also 

describes how FDA will interpret the 

requirements that such petitions include 

a certification and that supplemental 

information or comments to such 

petitions include a verification. The 

draft guidance also addresses the 

relationship between the review of 

petitions and pending ANDAs and 

505(b)(2) applications for which the 

agency has not yet made a decision on 

approvability. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance, including comments 

regarding the proposed collection of 

information, by March 23, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Boocker, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Citizen Petitions and Petitions for Stay 

of Action Subject to Section 505(q) of 

the Federal Food, Drug, and Cosmetic 

Act.’’ The draft guidance provides 

information regarding FDA’s current 

thinking on interpreting section 914 of 

Title IX of FDAAA (Public Law 110–85). 

Section 914 of FDAAA added new 

section 505(q) to the act (21 U.S.C. 

355(q)) and governs certain citizen 

petitions and petitions for stay of agency 

action that request that FDA take any 

form of action related to a pending 

application submitted under section 

505(b)(2) or 505(j) of the act. The draft 

guidance describes FDA’s interpretation 

of section 505(q) of the act regarding 

how the agency will determine if: (1) 

The provisions of section 505(q) 

addressing the treatment of citizen 

petitions and petitions for stay of agency 

action (collectively, petitions) apply to a 

particular petition and (2) a petition 

would delay approval of a pending 

ANDA or a 505(b)(2) application. The 

draft guidance also describes how FDA 

will interpret the provisions of section 

505(q) requiring that: (1) A petition 

include a certification and (2) 

supplemental information or comments 

to a petition include a verification. 

Finally, the draft guidance addresses the 

relationship between the review of 

petitions and pending ANDAs and 

505(b)(2) applications for which the 

agency has not yet made a decision on 

approvability. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on citizen petitions and petitions for 

stay of action that are subject to section 

505(q) of the act. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

Federal agencies must obtain approval 

from the Office of Management and 

Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

mstockstill on PROD1PC66 with NOTICES