2020-08609. Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Extension of Comment Period  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry” that appeared in the Federal Register of January 30, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period on the notice published January 30, 2020 (85 FR 5445). Submit either electronic or written comments on the draft guidance by July 28, 2020, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2019-D-5392 for “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” 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.govinfo.gov/​content/​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 Start Printed Page 22741Development, Center for Biologics Evaluation and Research, 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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    FOR FURTHER INFORMATION CONTACT:

    Shruti Modi, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

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    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of January 30, 2020 (85 FR 5445), FDA published a notice with a 90-day comment period to request comments on the document entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry.” FDA is extending the comment period, in response to a request from a stakeholder, until July 22, 2020. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying publication of the final version of the guidance.

    II. Reference

    The following reference is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov.

    1. Email from Mr. Aleksandr Merenkov, Regulatory Intelligence Specialist, Regeneron Pharmaceuticals, Inc., to Jenifer Roe, Regulatory Counsel, Center for Biologics Evaluation and Research, FDA (March 26, 2020).

    II. Electronic Access

    Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances,, or https://www.regulations.gov.

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    Dated: April 16, 2020.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

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    [FR Doc. 2020-08609 Filed 4-22-20; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
04/23/2020
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability; extension of comment period.
Document Number:
2020-08609
Dates:
FDA is extending the comment period on the notice published January 30, 2020 (85 FR 5445). Submit either electronic or written comments on the draft guidance by July 28, 2020, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:
22740-22741 (2 pages)
Docket Numbers:
Docket No. FDA-2019-D-5392
PDF File:
2020-08609.Pdf
Supporting Documents:
» Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations Guidance for Industry
» Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability
» Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Extension of Comment Period
» Request for Extension of Comment Due Date from Regulatory Intelligence
» Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
» Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Availability