Notice2022-09065
Providing Submissions in Electronic Format-Postmarketing Safety Reports; Guidance for Industry; Availability
Primary source
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Published
April 28, 2022
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 "Providing Submissions in Electronic Format--Postmarketing Safety Reports." This guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drugs, biological products, and combination products. This guidance finalizes the revised draft guidance entitled "Providing Submissions in Electronic Format-- Postmarketing Safety Reports," issued in June 2014.
Full Text
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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25278-25280]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2001-D-0067]
Providing Submissions in Electronic Format--Postmarketing Safety
Reports; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, 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 ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports.'' This
guidance provides general information pertaining to electronic
submission of postmarketing safety reports (individual case safety
reports (ICSRs), attachments to ICSRs (ICSR attachments), and other
postmarketing safety reports) for certain human drugs, biological
products, and combination products. This guidance finalizes the revised
draft guidance entitled ``Providing Submissions in Electronic Format--
Postmarketing Safety Reports,'' issued in June 2014.
DATES: The announcement of the guidance is published in the Federal
Register on April 28, 2022.
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-2001-D-0067 for ``Providing Submissions in Electronic Format--
Postmarketing Safety Reports.'' 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
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<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; 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:
For information concerning human drug products: Suranjan De, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002,
240-402-0498.
For information concerning human biological products: 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 ``Providing Submissions in Electronic Format--Postmarketing
Safety Reports.'' This guidance provides general information pertaining
to electronic submission of postmarketing safety reports (ICSRs, ICSR
attachments, and other postmarketing safety reports) under the
following provisions:
<bullet> 21 CFR 314.80 and 314.98 (regarding products with approved
new drug applications (NDAs) and abbreviated new drug applications
(ANDAs), respectively, including combination products or drug
constituent parts with approved NDAs or ANDAs)
<bullet> 21 CFR 600.80 (regarding products with approved biologics
license applications (BLAs), including combination products or
biological product constituent parts with approved BLAs)
<bullet> 21 CFR part 4, subpart B (requiring additional reports for
combination products with approved NDAs, ANDAs, or BLAs)
<bullet> 21 CFR 310.305 (regarding prescription drug products
marketed for human use without approved NDAs or ANDAs, including
prescription drug products that are compounded by facilities registered
as outsourcing facilities under section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 353b))
<bullet> 21 CFR 329.100 and section 760 of the FD&C Act (21 U.S.C.
379aa) (regarding nonprescription drug products marketed for human use
without approved NDAs or ANDAs)
This guidance does not apply to the following: Vaccines, human
cells, tissues, and cellular tissue-based products regulated under
section 361 of the Public Health Service Act (42 U.S.C. 264), whole
blood or blood components, combination products with a drug or
biological product constituent part marketed under a device
application, or lot distribution reports.
On June 10, 2014, FDA published a final rule (79 FR 33072) to amend
its postmarketing safety reporting regulations for human drug and
biological products to require that persons subject to mandatory
reporting requirements submit safety reports in an electronic format
that the Agency can process, review, and archive. Elsewhere in the June
10, 2014, Federal Register (79 FR 33220), FDA announced the
availability of a revised draft guidance entitled ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports,'' which
revised and replaced the draft guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Postmarketing
Individual Case Safety Reports,'' issued on June 12, 2008 (73 FR
33436). The guidance announced in this current notice finalizes the
June 10, 2014, revised draft guidance of the same title. The Agency
considered comments on the draft guidance while finalizing the
guidance. Generally, we revised the draft guidance to update and
clarify topics, such as: (1) Options for transmitting reports in
electronic format; (2) the notification that submitters will receive
when FDA has received the electronic postmarketing safety report; (3)
requesting temporary waivers from the electronic submission
requirement; and (4) information on the receipt date of electronic
submissions in the case of submission failure.
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 ``Providing Submissions in Electronic
Format--Postmarketing Safety Reports.'' 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 pertaining to postmarketing reporting
of adverse drug experiences, including periodic and followup reports,
have been approved under OMB control number 0910-0001. The collections
of information in 21 CFR part 207 pertaining to registration of
producers of drugs and listing of drugs in commercial distribution have
been approved under OMB control number 0910-0045. The collections of
information in 21 CFR parts 310, 314, and 600 pertaining to
postmarketing reporting of adverse drug experiences for drugs subject
to an NDA have been approved under OMB control number 0910-0291
(MedWatch Forms FDA 3500, 3500A, and 3500B). The collections of
information in 21 CFR parts 310 and 314 pertaining to: (1)
Postmarketing reporting of adverse drug experiences for drugs without
approved
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NDAs and the collections of information and (2) the submissions
required by section 760 of the FD&C Act for nonprescription human drug
products marketed without an approved application have been approved
under OMB control number 0910-0230. The collections of information in
21 CFR part 600 for biological drug products have been approved under
OMB control number 0910-0308. The collections of information pertaining
to the electronic submission of adverse event reports in 21 CFR parts
310, 314, and 329 have been approved under OMB control number 0910-
0645. The collections of information pertaining to submissions required
for outsourcing facilities under section 503B of the FD&C Act have been
approved under OMB control number 0910-0800. The collections of
information in 21 CFR part 4 pertaining to postmarketing safety
information sharing by constituent part applicants for combination
products have been approved under OMB control number 0910-0834.
III. Electronic Access
Persons with access to the internet may obtain the 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: April 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09065 Filed 4-27-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 28, 2022.
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