[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35361-35362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0663]


Draft Guidance for Industry: Determining the Need for and Content 
of Environmental Assessments for Gene Therapies, Vectored Vaccines, and 
Related Recombinant Viral or Microbial Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Determining the Need for and Content of Environmental Assessments for 
Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or 
Microbial Products'' dated June 2014. The draft guidance document 
provides investigational new drug application (IND) sponsors and 
applicants for a biologics license application (BLA), or a supplement 
to a BLA, with recommendations on considerations when assessing whether 
to submit an Environmental Assessment (EA) for gene therapies, vectored 
vaccines, and related recombinant viral or microbial products (GTVVs). 
The guidance also contains recommendations as to what information 
should be included in an EA and what sponsors and applicants can expect 
once an EA is filed. The guidance, when finalized, will supplement the 
guidance entitled ``Guidance for Industry: Environmental Assessment of 
Human Drug and Biologics Applications,'' dated July 1998 (1998 
Guidance) and will also supersede those recommendations for GTVVs in 
section IV.B.1 Assessing Toxicity to Environmental Organisms'' of the 
guidance.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 18, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. 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 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Determining the Need for and Content of 
Environmental Assessments for Gene Therapies, Vectored Vaccines, and 
Related Recombinant Viral or Microbial Products'' dated June 2014. The 
draft guidance document provides IND sponsors and applicants for a BLA, 
or a supplement to a BLA, with recommendations on considerations when 
assessing whether to submit an EA for GTVVs. The guidance also contains 
recommendations as to what information should be included in an EA and 
what sponsors and applicants can expect once an EA is filed. Products 
addressed in the guidance include all GTVVs, but not live-attenuated 
viral or microbial vaccines created by traditional methods such as 
serial passaging or recombinant protein-based vaccines. The guidance, 
when finalized, will supplement the 1998 Guidance, and will also 
supersede those recommendations for GTVVs in section IV.B.1 entitled 
``Assessing Toxicity to Environmental Organisms'' of the guidance.
    The draft guidance is being issued 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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 in 21 CFR part 25 have been approved under 
OMB control number 0910-0322; the collections of

[[Page 35362]]

information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; and the collections of information for 21 CFR part 
601 have been approved under OMB control number 0910-0338.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments 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, and will be posted to the docket 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14470 Filed 6-19-14; 8:45 am]
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