Notice2021-26699
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period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 10, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry," published in the Federal Register on September 30, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 86 Issue 235 (Friday, December 10, 2021)</title>
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[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70507-70508]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2307]
Real-World Data: Assessing Electronic Health Records and Medical
Claims Data To Support Regulatory Decision-Making for Drug and
Biological Products; Draft Guidance for Industry; Reopening of the
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the document entitled ``Real-World
Data: Assessing Electronic Health Records and Medical Claims Data to
Support Regulatory Decision-Making for Drug and Biological Products;
Draft Guidance of Industry,'' published in the Federal Register on
September 30, 2021. The Agency is taking this action to allow
interested persons additional time to submit comments.
DATES: FDA is reopening the comment period on the draft guidance
published September 30, 2021 (86 FR 54219). Submit either electronic or
written comments by January 24, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 24, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 24, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2020-D-2307 for ``Real-World Data: Assessing Electronic Health
Records and Medical Claims Data to Support Regulatory Decision-Making
for Drug and Biological Products; Draft Guidance for Industry.''
Received comments, those filed in a timely manner (see ADDRESSES), 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
[[Page 70508]]
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.
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#98fcf1f9f6f6fdb6e8f9eaf9f7f9f6d8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="9ffbf6fef1f1fab1effeedfef0fef1dff9fbfeb1f7f7ecb1f8f0e9">[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#017275647169646f2f7368716d6478416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="502324352038353e7e2239203c3529103634317e3838237e373f26">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 30,
2021 (86 FR 54219), FDA published a notice of availability with a 60-
day period to provide comments on the draft guidance entitled ``Real-
World Data: Assessing Electronic Health Records and Medical Claims Data
to Support Regulatory Decision-Making for Drug and Biological Products;
Draft Guidance of Industry.'' This draft guidance is intended to
provide sponsors, researchers, and other interested stakeholders with
considerations when proposing to use electronic health records or
medical claims data in clinical studies to support a regulatory
decision for effectiveness or safety. Interested persons were
originally given until November 29, 2021, to submit comments to the
docket. 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 until
January 24, 2022. The Agency believes that reopening the comment period
for 45 additional days allows adequate time for interested persons to
submit comments.
Dated: December 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26699 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P
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