[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Draft Guidance for Industry: Determining the Need for and Content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 The draft guidance document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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 18, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,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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