[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32309-32310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14868]



[[Page 32309]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0081]


Testing of Retroviral Vector-Based Human Gene Therapy Products 
for Replication Competent Retrovirus During Product Manufacture and 
Patient Follow-up; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Testing of Retroviral 
Vector-Based Human Gene Therapy Products for Replication Competent 
Retrovirus During Product Manufacture and Patient Follow-up; Draft 
Guidance for Industry.'' The draft guidance document provides sponsors 
of retroviral vector-based human gene therapy products recommendations 
regarding the testing for replication competent retrovirus (RCR) during 
the manufacture of retroviral vector-based products, and during follow-
up monitoring of patients who have received retroviral vector-based 
products. Recommendations include the identification and amount of 
material to be tested, and general testing methods. In addition, 
recommendations are provided on monitoring patients for evidence of 
retroviral infection after administration of retroviral vector-based 
gene therapy products. The draft guidance, when finalized, is intended 
to supersede the document entitled ``Guidance for Industry: 
Supplemental Guidance on Testing for Replication Competent Retrovirus 
in Retroviral Vector Based Gene Therapy Products and During Follow-up 
of Patients in Clinical Trials Using Retroviral Vectors,'' dated 
November 2006. The draft guidance, when finalized, is also intended to 
supplement the documents entitled ``Long Term Follow-Up After 
Administration of Human Gene Therapy Products; Draft Guidance for 
Industry'' and ``Chemistry, Manufacturing, and Control Information for 
Human Gene Therapy Investigational New Drug Applications; Draft 
Guidance for Industry,'' when these draft guidance documents are 
finalized.

DATES: Submit either electronic or written comments on the draft 
guidance by October 10, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for Written/Paper 
Submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-1999-D-0081 for ``Testing of Retroviral Vector-Based Human Gene 
Therapy Products for Replication Competent Retrovirus During Product 
Manufacture and Patient Follow-up; Draft Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301,

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Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Testing of Retroviral Vector-Based Human Gene Therapy Products for 
Replication Competent Retrovirus During Product Manufacture and Patient 
Follow-up; Draft Guidance for Industry.'' The draft guidance document 
provides sponsors of retroviral vector-based human gene therapy 
products recommendations regarding the testing for RCR during the 
manufacture of retroviral vector-based products, and during follow-up 
monitoring of patients who have received retroviral vector-based 
products. Recommendations are also provided for RCR testing during 
manufacture, including identification and amount of material to be 
tested, and general testing methods. In addition, recommendations are 
provided on monitoring patients for evidence of retroviral infection 
after administration of retroviral vector-based gene therapy products. 
The draft guidance, when finalized, is intended to supersede the 
document entitled ``Guidance for Industry: Supplemental Guidance on 
Testing for Replication Competent Retrovirus in Retroviral Vector Based 
Gene Therapy Products and During Follow-up of Patients in Clinical 
Trials Using Retroviral Vectors,'' dated November 2006. The draft 
guidance, when finalized, is also intended to supplement the ``Long 
Term Follow-Up After Administration of Human Gene Therapy Products; 
Draft Guidance for Industry'' and ``Chemistry, Manufacturing, and 
Control Information for Human Gene Therapy Investigational New Drug 
Applications; Draft Guidance for Industry,'' when these draft guidance 
documents are finalized. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of these other two draft 
guidance documents.
    This 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 testing of 
retroviral vector-based human gene therapy products for replication 
competent retrovirus during product manufacture and patient follow-up. 
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. This 
guidance is not subject to Executive Order 12866.

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; and the collections of information in 21 
CFR part 601 have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14868 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P