Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs; Availability, 3057-3058 [E9-862]

Download as PDF Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices Dated: January 9, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–837 Filed 1–15–09; 8:45 am] Rockville, MD 20855, 240–276–8247, e-mail: larisa.rudenko@hhs.fda.gov. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–S In the Federal Register of September 19, 2008 (73 FR 54407), FDA published the notice of availability for a draft guidance entitled ‘‘Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs’’ giving interested persons until November 18, 2008, to comment on the draft guidance. FDA received numerous comments on the draft guidance.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 The guidance announced in this notice finalizes the draft guidance dated September 19, 2008.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. I. Background 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. 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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. mstockstill on PROD1PC66 with NOTICES ADDRESSES: FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., VerDate Nov<24>2008 19:02 Jan 15, 2009 Jkt 217001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 3057 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 E:\FR\FM\16JAN1.SGM 16JAN1 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 https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cvm or https:// 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. mstockstill on PROD1PC66 with NOTICES 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 VerDate Nov<24>2008 19:02 Jan 15, 2009 Jkt 217001 the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// 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 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 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 E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Pages 3057-3058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-862]


-----------------------------------------------------------------------

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 self-addressed 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 https://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 animal-related 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 non-heritable rDNA constructs (e.g., those 
modifications intended to be used as gene therapy). Although much of 
this guidance will be relevant to non-heritable 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

[[Page 3058]]

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 https://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/cvm or https://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

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