Notice2021-27521
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 21, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled "Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry" that appeared in the Federal Register on October 22, 2021. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 86 Issue 242 (Tuesday, December 21, 2021)</title>
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[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72248-72249]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27521]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0548]
Data Standards for Drug and Biological Product Submissions
Containing Real-World Data; Draft Guidance for Industry; Availability;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability entitled
``Data Standards for Drug and Biological Product Submissions Containing
Real-World Data; Draft Guidance for Industry'' that appeared in the
Federal Register on October 22, 2021. The Agency is taking this action
in response
[[Page 72249]]
to requests for an extension to allow interested persons additional
time to submit comments.
DATES: FDA is extending the comment period on the ``Data Standards for
Drug and Biological Product Submissions Containing Real-World Data;
Draft Guidance for Industry'' published October 22, 2021 (86 FR 58672).
Submit either electronic or written comments by February 4, 2022 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2021-D-0548 for ``Data Standards for Drug and Biological Product
Submissions Containing Real-World Data; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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.
FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-2500, <a href="/cdn-cgi/l/email-protection#dcb8b5bdb2b2b9f2acbdaebdb3bdb29cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="98fcf1f9f6f6fdb6e8f9eaf9f7f9f6d8fefcf9b6f0f0ebb6fff7ee">[email protected]</span></a>; or Stephen Ripley, 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, <a href="/cdn-cgi/l/email-protection#3a494e5f4a525f541448534a565f437a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="d1a2a5b4a1b9b4bfffa3b8a1bdb4a891b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 22, 2021, FDA published a notice
of availability with a 60-day comment period to provide comments on the
draft guidance entitled ``Data Standards for Drug and Biological
Product Submissions Containing Real-World Data: Draft Guidance for
Industry.'' FDA has received requests to extend the comment period to
allow sufficient time to develop and submit meaningful comments. FDA
has considered the requests and is extending the comment period for 45
days, until February 4, 2022. The Agency believes that a 45-day
extension allows adequate time for interested persons to submit
comments.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27521 Filed 12-20-21; 8:45 am]
BILLING CODE 4164-01-P
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