80 FR 52047 - Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 166 (August 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 166 (August 27, 2015)
| Page Range | 52047-52047 | |
| FR Document | 2015-21235 |
[Federal Register Volume 80, Number 166 (Thursday, August 27, 2015)] [Notices] [Page 52047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21235] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 The guidance announced in this notice finalizes the draft guidance of the same title dated July 2014.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
![Federal Register / Vol. 80, No. 166 / Thursday, August 27, 2015 / Notices 52047
Contact Persons For Additional Hampshire Ave., Bldg. 71, Rm. 3128, editorial changes were made to improve
Information: Donna Pickett, Medical Systems Silver Spring, MD 20993–0002. Send clarity. The guidance announced in this
Administrator, Classifications and Public one self-addressed adhesive label to notice finalizes the draft guidance of the
Health Data Standards Staff, NCHS, 3311 assist the office in processing your same title dated July 2014.
Toledo Road, Hyattsville, Maryland 20782,
email dfp4@cdc.gov, telephone 301–458–
requests. The guidance may also be This guidance is being issued
4434 (diagnosis); Mady Hue, Health obtained by mail by calling CBER at 1– consistent with FDA’s good guidance
Insurance Specialist, Division of Acute Care, 800–835–4709 or 240–402–8010. See practices regulation (21 CFR 10.115).
CMS, 7500 Security Boulevard, Baltimore, the SUPPLEMENTARY INFORMATION section The guidance represents the current
Maryland 21244, email marilu.hue@ for electronic access to the guidance thinking of FDA on design and analysis
cms.hhs.gov, telephone 410–786–4510 document. of shedding studies for virus or bacteria-
(procedures). Submit electronic comments on the based gene therapy and oncolytic
The Director, Management Analysis and guidance to http://www.regulations.gov.
Services Office, has been delegated the
products. It does not establish any rights
Submit written comments to the for any person and is not binding on
authority to sign Federal Register notices
pertaining to announcements of meetings and
Division of Dockets Management (HFA– FDA or the public. You can use an
other committee management activities, for 305), Food and Drug Administration, alternative approach if it satisfies the
both the Centers for Disease Control and 5630 Fishers Lane, Rm. 1061, Rockville, requirements of the applicable statutes
Prevention, and the Agency for Toxic MD 20852. and regulations.
Substances and Disease Registry. FOR FURTHER INFORMATION CONTACT:
II. Paperwork Reduction Act of 1995
Catherine Ramadei, Tami Belouin, Center for Biologics
Acting Director, Management Analysis and
Evaluation and Research, Food and This guidance refers to previously
Services Office, Centers for Disease Control Drug Administration, 10903 New approved collections of information
and Prevention. Hampshire Ave., Bldg. 71, Rm. 7301, found in FDA regulations. These
[FR Doc. 2015–21160 Filed 8–26–15; 8:45 am] Silver Spring, MD 20993–0002, 240– collections of information are subject to
BILLING CODE 4160–18–P
402–7911. review by the Office of Management and
SUPPLEMENTARY INFORMATION: Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
I. Background
DEPARTMENT OF HEALTH AND 3520). The collections of information in
HUMAN SERVICES FDA is announcing the availability of 21 CFR part 312 have been approved
a document entitled ‘‘Design and under OMB control number 0910–0014;
Food and Drug Administration Analysis of Shedding Studies for Virus the collections of information in 21 CFR
or Bacteria-Based Gene Therapy and part 600 have been approved under
[Docket No. FDA–2014–D–0852]
Oncolytic Products; Guidance for OMB control number 0910–0308; the
Design and Analysis of Shedding Industry.’’ The guidance provides collections of information in 21 CFR
Studies for Virus or Bacteria-Based sponsors of VBGT and oncolytic part 601 have been approved under
Gene Therapy and Oncolytic Products; products with recommendations on how OMB control number 0910–0338; and
Guidance for Industry; Availability to conduct shedding studies during the collections of information in 21 CFR
preclinical and clinical development. part 50 have been approved under OMB
AGENCY: Food and Drug Administration, VBGT and oncolytic products are control number 0910–0755.
HHS. derived from infectious viruses or
ACTION: Notice. bacteria. In general, these product-based III. Comments
viruses and bacteria are not as infectious Interested persons may submit either
SUMMARY: The Food and Drug or as virulent as the parent strain of electronic comments regarding this
Administration (FDA or Agency) is virus or bacterium. Nonetheless, FDA is document to http://www.regulations.gov
announcing the availability of a issuing this guidance because the or written comments to the Division of
document entitled ‘‘Design and Analysis possibility that infectious product-based Dockets Management (see ADDRESSES). It
of Shedding Studies for Virus or viruses and bacteria may be shed by a is only necessary to send one set of
Bacteria-Based Gene Therapy and patient raises safety concerns related to comments. Identify comments with the
Oncolytic Products; Guidance for the risk of transmission to untreated docket number found in brackets in the
Industry.’’ The guidance document individuals. To understand the risk heading of this document. Received
provides sponsors of virus or bacteria- associated with product shedding, comments may be seen in the Division
based gene therapy products (VBGT sponsors should collect data in the of Dockets Management between 9 a.m.
products) and oncolytic viruses or target patient population in clinical and 4 p.m., Monday through Friday, and
bacteria (oncolytic products) with trials before licensure. will be posted to the docket at http://
recommendations on how to conduct In the Federal Register of July 9, 2014 www.regulations.gov.
shedding studies during preclinical and (79 FR 38908), FDA announced the
clinical development. The guidance availability of the draft guidance of the IV. Electronic Access
announced in this notice finalizes the same title. FDA received a few
draft guidance of the same title dated Persons with access to the Internet
comments on the draft guidance and may obtain the guidance at either http://
July 2014. those comments were considered as the www.fda.gov/BiologicsBloodVaccines/
DATES: Submit either electronic or guidance was finalized. A summary of GuidanceComplianceRegulatory
written comments on Agency guidances changes includes reorganization of and Information/Guidances/default.htm or
rmajette on DSK2VPTVN1PROD with NOTICES
at any time. within certain sections of the guidance, http://www.regulations.gov.
ADDRESSES: Submit written requests for and addition of new bullet points and
single copies of the guidance to the information to address specific Dated: August 21, 2015.
Office of Communication, Outreach and questions raised in the comments and at Leslie Kux,
Development, Center for Biologics the November 6, 2014, meeting of the Associate Commissioner for Policy.
Evaluation and Research (CBER), Food Cellular, Tissue, and Gene Therapies [FR Doc. 2015–21235 Filed 8–26–15; 8:45 am]
and Drug Administration, 10903 New Advisory Committee. In addition, BILLING CODE 4164–01–P
VerDate Sep<11>2014 15:08 Aug 26, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4703 Sfmt 9990 E:\FR\FM\27AUN1.SGM 27AUN1](https://thefederalregister.org/doc/80_FR_52213/page/1.svg)
Document Created: 2015-12-15 10:53:22
Document Modified: 2015-12-15 10:53:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 52047 |
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