[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25278-25280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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draft guidance entitled ``Providing Submissions in Electronic Format--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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
    <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 https://www.regulations.gov 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

[[Page 25279]]

https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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