Notice2021-19403
International Council for Harmonisation Q12: Implementation Considerations for Food and Drug Administration-Regulated Products; Draft Guidance for Industry; Reopening of the Comment Period
Primary source
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Published
September 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the draft guidance for industry entitled "ICH Q12: Implementation Considerations for FDA-Regulated Products" published in the Federal Register of May 20, 2021. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 86 Issue 172 (Thursday, September 9, 2021)</title>
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[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50539-50540]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19403]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0166]
International Council for Harmonisation Q12: Implementation
Considerations for Food and Drug Administration-Regulated Products;
Draft Guidance for Industry; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
reopening the comment period for the draft guidance for industry
entitled ``ICH Q12: Implementation Considerations for FDA-Regulated
Products'' published in the Federal Register of May 20, 2021. FDA is
reopening the comment period to allow interested persons additional
time to submit comments.
DATES: FDA is reopening the comment period on the notice published May
20, 2021 (86 FR 27437). Submit either electronic or written comments by
October 12, 2021.
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 October 12, 2021. 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 October 12, 2021. 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<ls-thn-eq> 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-0166 for ``ICH Q12: Implementation Considerations for FDA-
Regulated Products; Draft Guidance for Industry; Reopening of the
Comment Period.'' 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 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
[[Page 50540]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002;
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; or
Office of Policy, Center for Devices and Radiological Health (CDRH),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, 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: Ashley Boam, CDER, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver
Spring, MD 20993-0002, 301-796-6341; Stephen Ripley, CBER, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911; or Andrew Yeatts, CDRH,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5510, Silver Spring, MD 20993-0002, 301-796-4539.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 20, 2021 (86 FR 27437), FDA
announced the availability of a draft guidance for industry entitled
``ICH Q12: Implementation Considerations for FDA-Regulated Products.''
Interested persons were originally given until July 19, 2021, to
comment on the draft guidance. However, the Agency believes that
reopening the comment period for an additional 30 days from the date of
publication of this notice will allow adequate time for interested
persons to submit comments without significantly delaying Agency
decision-making on these important issues.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19403 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P
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