Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices 3609 

commercial poultry industry from the 

introduction of highly pathogenic avian 

influenza H5N1, these actions have the 

added benefit of mitigating the risk of 

human exposure to the virus. Because 

the USDA/APHIS import restrictions 

adequately address risks to human 

health, HHS/CDC is announcing the 

intent to lift its embargo against imports 

of birds and unprocessed bird products 

from those same countries and solicits 

comments on this proposal. All of the 

bird embargoes that are currently in 

force under USDA regulations will 

remain in force. HHS/CDC will work 

closely with USDA/APHIS to monitor 

the international situation regarding 

HPAI H5N1 outbreaks and will take 

additional action if it identifies human 

health risks that are not adequately 

contained by USDA regulatory actions. 

DATES: Written comments must be 

received on or before February 20, 2009. 

Comments received after January 21, 

2009 will be considered to the extent 

possible. 

ADDRESSES: You may submit written 

comments to the following address: 

Division of Global Migration and 

Quarantine, Centers for Disease Control 

and Prevention, U.S. Department of 

Health and Human Services, Attn: 

Rescission Notice, 1600 Clifton Road, 

NE., MS E–03, Atlanta, Georgia 30333. 

You may submit written comments 

electronically via the Internet at the 

following Address: http:// 

regulations.gov, or via e-mail to 

DGMQpubliccomments@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Stacy M. Howard, Division of Global 

Migration and Quarantine, Centers for 

Disease Control and Prevention, U.S. 

Department of Health and Human 

Services, 1600 Clifton Road, NE., MS 

E–03, Atlanta, Georgia 30333; telephone 

404–498–1600. 

SUPPLEMENTARY INFORMATION: 

Background 

On February 4, 2004, the Centers for 

Disease Control and Prevention (CDC) 

within the U.S. Department of Health 

and Human Services issued an order to 

ban immediately the import of all birds 

(Class: Aves) from specified countries, 

subject to limited exemptions for 

returning pet birds of U.S. origin and 

certain processed bird-derived products. 

HHS/CDC took this step because birds 

from these countries can potentially 

infect humans with avian influenza 

(influenza A/[H5N1]). Countries affected 

by the February 4, 2004, order included 

Cambodia, Indonesia, Japan, Laos, 

People’s Republic of China (including 

Hong Kong Special Administrative 

Region [SAR]), South Korea, Thailand, 

and Vietnam. This order was further 

amended on March 10, 2004, to lift the 

embargo of birds and bird products from 

the Hong Kong SAR because of the 

documented control of the outbreak 

there and the absence of highly 

pathogenic avian influenza H5N1 cases 

in Hong Kong’s domestic bird 

populations. Following the 

documentation of highly pathogenic 

avian influenza H5N1 in commercial 

birds in additional countries, HHS/CDC 

issued amendments to the February 4, 

2004, order that added these countries 

to its embargo: Malaysia on September 

28, 2004; Kazakhstan, Romania, Russia, 

Turkey, and Ukraine on December 29, 

2005; Nigeria on February 8, 2006; India 

on February 22, 2006; Egypt on 

February 27, 2006; Niger on March 2, 

2006; Albania, Azerbaijan, Cameroon, 

and Burma (Myanmar) on March 15, 

2006; Israel on March 20, 2006; 

Afghanistan on March 21, 2006; Jordan 

on March 29, 2006; Burkina Faso on 

April 10, 2006; Pakistan on April 10, 

2006; Gaza, the West Bank, and the 

Ivory Coast (Coˆte d’Ivoire) on April 28, 

2006; Sudan on May 16, 2006; Djibouti 

on June 2, 2006; and Kuwait on 

February 28, 2007. 

The HHS/CDC February 4, 2004, order 

and subsequent amendments have 

complemented simultaneous actions 

taken by the Animal and Plant Health 

Inspection Service (APHIS) within the 

U.S. Department of Agriculture (USDA). 

USDA/APHIS amended its regulations 

to prohibit or restrict the importation of 

birds, poultry, and unprocessed birds 

and poultry products from regions that 

have reported the presence of highly 

pathogenic avian influenza H5N1 in 

poultry. See 9 CFR 93.101, 93.201, 94.6, 

& 95.30. As the United Nations Food 

and Agriculture Organization and the 

World Organization for Animal Health 

(OIE) have confirmed additional cases of 

highly pathogenic avian influenza 

(H5N1) in commercial birds, USDA/ 

APHIS has added additional countries 

and regions to its ban. 

HHS/CDC believes that the actions 

taken to date by USDA/APHIS 

adequately mitigate the human health 

risks associated with birds and 

unprocessed bird products imported 

from the countries of concern, and that 

the HHS/CDC order of February 4, 2004, 

and subsequent amendments are no 

longer needed. HHS/CDC announces its 

intent to lift its embargo of birds and 

unprocessed bird products from 

specified countries to ensure a more 

coordinated federal response to the 

control of highly pathogenic avian 

influenza H5N1. 

Dated: January 9, 2009. 

Julie Louise Gerberding, 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–1029 Filed 1–16–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: ACF–IV–E–1 Foster Care and 

Adoption Assistance Financial 

Reporting Form. 

OMB No.: 0970–0205. 

Description: State agencies administer 

the Foster Care and Adoption 

Assistance Programs under Title IV–E of 

the Social Security Act. The 

Administration for Children and 

Families provides Federal funding at the 

rate of 50 percent for most of the 

administrative costs and at other rates 

for other specific categories of costs as 

detailed in Federal statutes and 

regulations. This form is submitted 

quarterly by each State to estimate the 

funding needs for the upcoming fiscal 

quarter and to report expenditures for 

the fiscal quarter just ended. The 

information collected in this report is 

used by this agency to calculate 

quarterly Federal grant awards and to 

enable oversight of the financial 

management of the programs. 

Part 3 of this form had also been used 

to collect semiannual budget 

projections. In response to the 

publication of the Federal Register 

Notice on October 10, 2008, comments 

from the ACF budget office indicated 

that this information is now available 

from other sources and the information 

previously collected on Part 3 is no 

longer needed. We are, therefore, 

deleting Part 3 of this form. 

Respondents: State agencies 

(including the District of Columbia and 

Puerto Rico) administering the Foster 

Care and Adoption Assistance programs 

under Title IV–E of the Social Security 

Act. 

mstockstill on PROD1PC66 with NOTICES

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