3056 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

III. Commentsuidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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 the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available 

for public examination 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.regulations.gov. 

Dated: January 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–919 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0510] 

Draft Guidance for Industry: 

Submission of Laboratory Packages 

by Accredited Laboratories; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Submission of 

Laboratory Packages by Accredited 

Laboratories.’’ The draft guidance 

document provides information and 

recommendations about accreditation 

standards for laboratories and the 

quality and type of data that accredited 

laboratories produce to support testing 

results submitted to FDA about the 

admissibility of detained articles offered 

for import. We are taking this action 

under a recommendation made by the 

President’s Interagency Working Group 

on Import Safety (Working Group). 

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 April 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Executive Operations (HFC–2), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857. 

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: 

Donna Porter, Division of Field Science 

(HFA–141), Office of Regulatory Affairs, 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7605. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Submission of Laboratory 

Packages by Accredited Laboratories.’’ 

The draft guidance is about 

accreditation standards for laboratories 

and about the quality and type of data 

that accredited laboratories should 

produce in support of testing results 

submitted to FDA pertaining to the 

admissibility of detained articles offered 

for import of all product types (i.e., 

biological products, drugs, devices, and 

food) that we regulate. FDA is taking 

this action under a recommendation 

made by the President’s Interagency 

Working Group on Import Safety 

(Working Group). The Working Group 

was to conduct a comprehensive review 

of the U.S. import system and identify 

ways to further increase the safety of 

imports entering the country, and it 

presented its initial findings to the 

President on September 10, 2007, in a 

report entitled ‘‘Protecting American 

Consumers Every Step of the Way: A 

Strategic Framework for Continual 

Improvement in Import Safety.’’ 

On November 6, 2007, the Working 

Group presented to the President its 

Import Safety Action Plan (Action Plan), 

which contains short- and long-term 

recommendations for continuing to 

improve the safety of imports entering 

the United States. The Action Plan 

recommended that FDA issue guidance 

that ‘‘would set standards for the 

sampling and testing of imported 

products, including the use of 

accredited laboratories submitting data 

to FDA to assist in evaluating whether 

an appearance of a violation may be 

resolved.’’ 

The issuance of the draft guidance is, 

therefore, consistent with the Action 

Plan and also consistent with FDA’s 

good guidance practices regulation (21 

CFR 10.115). The draft guidance, when 

finalized, will represent FDA’s current 

thinking on this topic. 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 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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. A copy of the draft guidance 

and received comments are available for 

public examination 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 draft guidance at either 

http://www.fda.gov/ora or http:// 

www.regulations.gov. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3057 

Dated: January 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–837 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0394] 

Guidance for Industry on Regulation of 

Genetically Engineered Animals 

Containing Heritable recombinant DNA 

Constructs; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the agency) is 

announcing the availability of a 

guidance for industry #187 entitled 

‘‘Regulation of Genetically Engineered 

Animals Containing Heritable 

recombinant DNA Constructs.’’ This 

guidance is intended to clarify FDA’s 

requirements and recommendations for 

producers and developers of genetically 

engineered (GE) animals and their 

products. The guidance describes how 

the new animal drug provisions of the 

Federal Food, Drug, and Cosmetic Act 

(the act) apply with respect to GE 

animals, including FDA’s intent to 

exercise enforcement discretion 

regarding requirements for certain GE 

animals. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Larisa Rudenko, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8247, 

e-mail: larisa.rudenko@hhs.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

19, 2008 (73 FR 54407), FDA published 

the notice of availability for a draft 

guidance entitled ‘‘Regulation of 

Genetically Engineered Animals 

Containing Heritable rDNA Constructs’’ 

giving interested persons until 

November 18, 2008, to comment on the 

draft guidance. FDA received numerous 

comments on the draft guidance. FDA 

reviewed and considered all comments 

and, in response, made several changes. 

In response to requests for greater 

transparency, the agency clarified its 

intent to hold public advisory 

committee meetings for GE animalrelated approvals and its intent to post 

statements of intent to exercise 

enforcement discretion over certain GE 

animals. In response to other comments, 

FDA clarified the scope of new animal 

drug application (NADA) approvals for 

GE animals and clarified its intent to 

work with other agencies should it 

receive a request for investigation or 

approval of a new animal drug in a GE 

wildlife animal ultimately intended for 

release into the wild. 

The guidance announced in this 

notice finalizes the draft guidance dated 

September 19, 2008. 

For the purpose of this guidance, FDA 

defines ‘‘genetically engineered (GE) 

animals’’ as those animals modified by 

recombinant DNA (rDNA) techniques, 

including progeny that contain the 

modification. The term GE animal can 

refer to both animals with heritable 

rDNA constructs and animals with nonheritable rDNA constructs (e.g., those 

modifications intended to be used as 

gene therapy). Although much of this 

guidance will be relevant to nonheritable rDNA constructs, and FDA 

intends to regulate non-heritable 

constructs in much the same way as 

described in this guidance for heritable 

constructs, this guidance only pertains 

to GE animals containing heritable 

rDNA constructs. We may issue a 

separate guidance on the regulation of 

GE animals bearing non-heritable 

constructs to discuss when those 

constructs would be under FDA 

jurisdiction and the kinds of 

information that would be relevant for 

FDA’s review. In this guidance, we will 

use the term ‘‘GE animal’’ to refer to GE 

animals with heritable rDNA constructs. 

For ease of reference, we sometimes 

refer to regulation of the article (the 

rDNA construct) in such GE animals as 

regulation of the GE animal. 

The Center for Veterinary Medicine 

(‘‘CVM’’, ‘‘we’’, ‘‘us’’, ‘‘our’’) has been 

working on applications submitted by 

developers of GE animals under the 

New Animal Drug provisions of the act 

(21 U.S.C. 321 et seq.). This guidance is 

intended to clarify these requirements 

and our recommendations for producers 

and developers (‘‘sponsors,’’ ‘‘you’’) of 

GE animals and their products. CVM 

will work closely with the other Centers 

at FDA that regulate pharmaceuticals or 

other medical products derived from 

biopharm animals to ensure that our 

oversight is complementary and not 

unnecessarily duplicative. Developers of 

GE animals should contact CVM early in 

the development of their GE animal; 

developers whose animals are already 

well under development also should 

contact CVM. We intend to issue 

additional guidance to describe more 

fully how various components of the 

New Animal Drug provisions of the act 

apply to biopharm animals and how 

CVM will implement them, the division 

of responsibilities between CVM and the 

other Centers regarding biopharm 

animals and products derived from 

them, and, more generally, how CVM 

and the other Centers will work 

interactively to regulate biopharm 

animals and their products. Developers 

of GE animals should come to CVM 

early in the process. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the topic. 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. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information 

have been approved under OMB Control 

Nos. 0910–0032, 0910–0045, 0910– 

0117, and 0910–0284. 

IV. 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 

mstockstill on PROD1PC66 with NOTICES