Document ID: FDA-2014-D-0852-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Design and Analysis of Shedding Studies for
Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Availability
Posted Date: 2014-07-09T04:00Z

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Page 38908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15991]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0852]

Draft Guidance for Industry: Design and Analysis of Shedding 
Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic 
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: 
Design and Analysis of Shedding Studies for Virus or Bacteria-Based 
Gene Therapy and Oncolytic Products'' dated July 2014. The draft 
guidance document provides sponsors of virus or bacteria-based gene 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.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 19, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 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 The draft guidance may also be 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Design and Analysis of Shedding Studies for 
Virus or Bacteria-Based Gene Therapy and Oncolytic Products'' dated 
July 2014. The draft guidance document provides sponsors of oncolytic 
and VBGT products with recommendations on how to conduct shedding 
studies during preclinical and clinical development. Oncolytic and VBGT 
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.
    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

    The 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 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

    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 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15991 Filed 7-8-14; 8:45 am]
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