[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)]
[Notices]
[Page 52047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0852]
Design and Analysis of Shedding Studies for Virus or Bacteria-
Based Gene Therapy and Oncolytic Products; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a document entitled ``Design and Analysis of
Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic
Products; Guidance for Industry.'' The guidance document provides
sponsors of virus or bacteria-based gene therapy products (VBGT
products) and oncolytic viruses or bacteria (oncolytic products) with
recommendations on how to conduct shedding studies during preclinical
and clinical development. The guidance announced in this notice
finalizes the draft guidance of the same title dated July 2014.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 240-402-8010. 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 ``Design
and Analysis of Shedding Studies for Virus or Bacteria-Based Gene
Therapy and Oncolytic Products; Guidance for Industry.'' The guidance
provides sponsors of VBGT and oncolytic products with recommendations
on how to conduct shedding studies during preclinical and clinical
development. VBGT and oncolytic products are derived from infectious
viruses or bacteria. In general, these product-based viruses and
bacteria are not as infectious or as virulent as the parent strain of
virus or bacterium. Nonetheless, FDA is issuing this guidance because
the possibility that infectious product-based viruses and bacteria may
be shed by a patient raises safety concerns related to the risk of
transmission to untreated individuals. To understand the risk
associated with product shedding, sponsors should collect data in the
target patient population in clinical trials before licensure.
In the Federal Register of July 9, 2014 (79 FR 38908), FDA
announced the availability of the draft guidance of the same title. FDA
received a few comments on the draft guidance and those comments were
considered as the guidance was finalized. A summary of changes includes
reorganization of and within certain sections of the guidance, and
addition of new bullet points and information to address specific
questions raised in the comments and at the November 6, 2014, meeting
of the Cellular, Tissue, and Gene Therapies Advisory Committee. In
addition, editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance of the same title
dated July 2014.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on design and analysis of shedding studies for
virus or bacteria-based gene therapy and oncolytic products. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it 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 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 600 have been approved under OMB control number 0910-0308; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; and the collections of information in 21
CFR part 50 have been approved under OMB control number 0910-0755.
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: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21235 Filed 8-26-15; 8:45 am]
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