[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finalizes the draft guidance of the same title dated July 2014.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]
 BILLING CODE 4164-01-P