
[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Page 15617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Determining the Need for and Content of Environmental Assessments 
for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or 
Microbial Products; Guidance for Industry: 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 document entitled ``Determining the Need for and 
Content of Environmental Assessments for Gene Therapies, Vectored 
Vaccines, and Related Recombinant Viral or Microbial Products; Guidance 
for Industry'' dated March 2015. The guidance document provides 
investigational new drug application (IND) sponsors and applicants for 
a biologics license application (BLA) or a supplement to a BLA (BLA 
supplement), 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 you can expect once an 
EA is filed. The guidance announced in this notice finalizes the draft 
guidance of the same title dated June 2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 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 guidance document.
    Submit electronic comments on the 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 document entitled 
``Determining the Need for and Content of Environmental Assessments for 
Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or 
Microbial Products; Guidance for Industry'' dated March 2015. The 
guidance document provides IND sponsors and applicants for a BLA or a 
BLA supplement, 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 you can expect once an EA is filed. The guidance supplements the 
guidance entitled ``Guidance for Industry: Environmental Assessment of 
Human Drug and Biologics Applications'' dated July 1998 (July 27, 1998, 
63 FR 40127) (1998 Guidance) and supersedes the recommendations for 
GTVVs in section IV.B.1 ``Assessing Toxicity to Environmental 
Organisms'' in the 1998 Guidance. The guidance announced in this notice 
finalizes the draft guidance of the same title dated June 2014.
    In the Federal Register of June 20, 2014 (79 FR 35361), FDA 
announced the availability of the draft guidance of the same title 
dated June 2014. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. There 
were no changes to the guidance except for one correction to a 
technical error regarding influenza taxonomy. The guidance announced in 
this notice finalizes the draft guidance dated June 2014.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. 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 in 21 CFR part 25 have been approved under 
OMB control number 0910-0322; the collections of 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

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06686 Filed 3-23-15; 8:45 am]
BILLING CODE 4164-01-P


