Notice2021-15645
Field Alert Report Submission: Questions and Answers; Guidance for Industry; Availability
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Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This guidance provides FDA's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA's recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions about FARs. This guidance finalizes the draft guidance of the same title issued on July 19, 2018.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39046-39047]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2326]
Field Alert Report Submission: Questions and Answers; Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Field
Alert Report Submission: Questions and Answers.'' This guidance
provides FDA's current thinking regarding the requirements for
submission of field alert reports (FARs) by applicants of new drug
applications (NDAs) and abbreviated new drug applications (ANDAs) and
outlines FDA's recommendations for FAR submissions to help improve
their consistency and relevancy. The guidance also addresses certain
frequently asked questions about FARs. This guidance finalizes the
draft guidance of the same title issued on July 19, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on July 23, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-2326 for ``Field Alert Report Submission: Questions and
Answers.'' 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
[[Page 39047]]
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, or to the Office of
Communication, Outreach and Development, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Mohamed Ghorab, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3141, Silver Spring, MD, 20993-0002, 240-
402-8940; 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Field Alert Report Submission: Questions and Answers.'' The
FAR regulations found in Sec. 314.81(b)(1) (21 CFR 314.81(b)(1)) and
21 CFR 314.98(b) establish an early warning system to help FDA fulfill
its responsibility to protect patient health. Under these regulations,
NDA and ANDA applicants must submit certain information to FDA about
distributed drug products regulated by the Center for Drug Evaluation
and Research or the Center for Biologics Evaluation and Research.
The guidance addresses the FAR submission requirements and focuses
on topics such as the incidents and possible/actual quality issues that
require submission of a FAR, the contents of the FAR, who submits the
FAR, and when, where, and how they should submit it. The guidance also
addresses followup and final FARs, which are not required under Sec.
314.81(b), and recommends their submission to inform FDA of the status
of root cause investigations and corrective actions taken, if any.
This guidance finalizes the draft guidance issued on July 19, 2018
(83 FR 34142). In response to public comments, FDA made minor editorial
changes and clarified that the FAR requirements apply to all products
under an NDA or ANDA, including positron emission tomography drugs,
designated medical gases, and combination products containing a drug
constituent part. Although not the focus of this guidance, FDA notes
that FAR requirements also apply to certain combination products under
21 CFR part 4, subpart B. For additional information about these
products, see the guidance for industry and FDA staff ``Postmarketing
Safety Reporting for Combination Products,'' available at <a href="https://www.fda.gov/media/111788/download">https://www.fda.gov/media/111788/download</a>, and the Postmarketing Safety
Reporting for Combination Products web page at <a href="https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products">https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products</a>. FDA may consider whether
additional adjustments are needed to guidance or FAR-related
instructions for biologics license applications or device applications
for combination products that contain a drug constituent part as the
Agency gains experience with safety reporting for such products.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Field Report Alert Submission.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the 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">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</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: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15645 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
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