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

3058 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

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. 

Submit electronic comments to http:// 

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

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

www.regulations.gov. 

Dated: January 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–862 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–0381] 

Guidance for Industry on Voluntary 

Third-Party Certification Programs for 

Foods and Feeds; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Voluntary Third-Party 

Certification Programs for Foods and 

Feeds.’’ This guidance describes the 

general attributes FDA believes a 

voluntary third-party certification 

program should have in order to help 

ensure its certification is a reliable 

reflection that the foods and feeds 

(hereinafter foods) from certified 

establishments meet applicable FDA 

requirements, as well as other 

certification criteria. 

DATES: Submit written or electronic 

comments on agency guidance 

documents at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4337, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. The 

guidance can also be obtained by mail 

by calling 301–796–4840. 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: 

Sharon Lindan Mayl, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4337, Silver Spring, 

MD 20993–0002, 301–796–4840. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Voluntary Third-Party Certification 

Programs for Foods and Feeds.’’ This 

guidance represents FDA’s current 

thinking on the certification process and 

describes the general attributes FDA 

believes a voluntary third-party 

certification program should have in 

order to provide FDA with confidence 

in its certification program. If FDA has 

such confidence, we may choose to 

recognize the program and provide 

incentives for establishments to obtain 

certification by recognized certification 

programs. Recognition in this context 

means that FDA has determined that 

certification may be a reliable reflection 

that the foods from an establishment 

certified by that certification body meet 

applicable FDA requirements, as well as 

other certification criteria. 

This guidance is intended as one of 

the steps in FDA’s future recognition of 

one or more voluntary third-party 

certification programs for particular 

product types. In the future, FDA (we) 

may issue guidance that addresses thirdparty certification programs in 

particular product areas. 

This guidance is issued in response to 

the recommendations contained in the 

Action Plan for Import Safety: A 

Roadmap for Continual Improvement 

(Action Plan) issued on November 6, 

2007, by the Interagency Working Group 

on Import Safety (Working Group) 

established by Executive Order 13439, 

as well as FDA’s Food Protection Plan 

released on the same date. Both those 

plans emphasize certification as a way 

to improve our capacity to verify the 

safety of products from a growing food 

establishment inventory, both domestic 

and foreign. 

In the Federal Register of April 2, 

2008 (73 FR 17989), FDA issued a 

document requesting comments on the 

use of third-party certification programs 

for foods and animal feeds. FDA 

received approximately 70 comments in 

response to that document. The 

comments were generally supportive of 

the use of third-party certification 

programs. Many encouraged FDA to 

recognize such programs as a way to 

increase participation and improve the 

safety and security of foods. 

On July 10, 2008, we announced the 

availability of a draft guidance for 

industry entitled ‘‘Voluntary ThirdParty Certification Programs for Foods 

and Feeds’’ (73 FR 39704). In response 

to the draft guidance, we received 19 

comments from a variety of sources, 

including trade associations, individual 

companies, standards development 

organizations, and other domestic and 

foreign Government agencies. These 

comments were considered as the 

guidance was finalized. 

Also on July 10, 2008, FDA issued a 

document announcing a pilot on 

Voluntary Third-Party Certification 

Programs for Imported Aquacultured 

Shrimp (73 FR 39705). We are currently 

in Phase II of the pilot in which we will 

conduct onsite audits of selected thirdparty certification bodies and targeted 

sampling of imported shrimp products. 

The goal of the pilot is to gather 

technical and operational information 

that will assist FDA in determining its 

infrastructure needs, as well as the 

process for evaluating third-party 

certification programs. Based on our 

experience with the pilot, we may make 

additional changes to the guidance 

being announced in this document. 

The guidance makes several changes 

from the draft guidance. For example, 

the section on verification that the 

establishment meets certification 

criteria no longer includes detailed 

criteria on specific safety and security 

systems. Instead, the guidance only 

recommends that the audit provide the 

certification body with reasonable 

assurance that the food or feed is safe 

and in compliance with certification 

criteria, which should include FDA 

requirements. As FDA recognizes thirdparty certification programs in 

particular product areas, FDA plans to 

provide additional guidance on specific 

certification criteria for those product 

areas. 

In order to help minimize confusion, 

the guidance uses terminology that is 

generally consistent with accepted 

international definitions, such as those 

used in documents by the International 

Organization for Standardization (ISO) 

and the Codex Alimentarius 

Commission (Codex). There may be 

some divergence, however, when uses 

of the terms by these organizations are 

inconsistent or when use of the 

internationally accepted terminology 

mstockstill on PROD1PC66 with NOTICES