Notice2024-01584
Best Practices for Food and Drug Administration Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products; Final Document; Availability
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Published
January 26, 2024
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 document entitled "Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products." The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its internet website best practices for certain postmarketing drug safety surveillance activities. This final document sets forth risk-based principles for FDA's conduct of ongoing postmarketing safety surveillance for human drug products and human biological products, in part, to address the Cures Act requirements. This document finalizes the draft document entitled "Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff" that was issued on November 7, 2019.
Full Text
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<title>Federal Register, Volume 89 Issue 18 (Friday, January 26, 2024)</title>
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[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5240-5241]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01584]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3768]
Best Practices for Food and Drug Administration Staff in the
Postmarketing Safety Surveillance of Human Drug and Biological
Products; Final Document; 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 document entitled ``Best Practices for FDA
Staff in the Postmarketing Safety Surveillance of Human Drug and
Biological Products.'' The 21st Century Cures Act (Cures Act), enacted
on December 13, 2016, requires that FDA make publicly available on its
internet website best practices for certain postmarketing drug safety
surveillance activities. This final document sets forth risk-based
principles for FDA's conduct of ongoing postmarketing safety
surveillance for human drug products and human biological products, in
part, to address the Cures Act requirements. This document finalizes
the draft document entitled ``Best Practices in Drug and Biological
Product Postmarket Safety Surveillance for FDA Staff'' that was issued
on November 7, 2019.
DATES: The announcement of the final document is published in the
Federal Register on January 26, 2024.
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-2019-N-3768 for ``Best Practices for FDA Staff in the Postmarketing
Safety Surveillance of Human Drug and Biological Products.'' 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 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 document to the
Division of Drug Information, Center for Drug
[[Page 5241]]
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002 or 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 document.
FOR FURTHER INFORMATION CONTACT: Sara Camilli, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3486, Silver Spring, MD 20993-0002, 301-
796-4203, <a href="/cdn-cgi/l/email-protection#8cdfedfeeda2cfede1e5e0e0e5cceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="5e0d3f2c3f701d3f33373232371e383a3f7036362d70393128">[email protected]</span></a>; or James Myers, 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 final document entitled
``Best Practices for FDA Staff in the Postmarketing Safety Surveillance
of Human Drug and Biological Products.''
Title IX, section 915 of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) added section 505(r) to
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(r)),
requiring FDA to prepare a summary analysis of the adverse drug
reaction reports received for a drug by 18 months after approval or
after use of the drug by 10,000 individuals, whichever is later. The
analysis includes identification of any new risks not previously
identified, potential new risks, or known risks reported in unusual
number.
Section 3075 of the Cures Act (Pub. L. 114-255) amended section
505(r)(2)(D) of the FD&C Act to eliminate the requirement for summary
analyses for drugs as required by FDAAA. In place of the summary
analyses, section 3075 amended section 505(r)(2)(D) of the FD&C Act to
include the requirement that FDA make publicly available on its
internet website best practices for drug safety surveillance activities
for drugs approved under section 505 of the FD&C Act or section 351 of
the Public Health Service Act (PHS Act).
Section 3075 of the Cures Act also amended section 505(k)(5) of the
FD&C Act to strike ``bi-weekly screening,'' in subparagraph (A), and
insert ``screenings''; it also added the requirement that FDA make
publicly available on its internet website guidelines, developed with
input from experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, that detail best
practices for drug safety surveillance using the Adverse Event
Reporting System.
The final document entitled ``Best Practices for FDA Staff in the
Postmarketing Safety Surveillance of Human Drugs and Biological
Products'' sets forth risk-based principles for FDA's conduct of
ongoing postmarketing safety surveillance for human drug products and
human biological products to address the Cures Act requirements.
Although section 3075 of the Cures Act only references drugs approved
under section 505 of the FD&C Act or section 351 of the PHS Act, the
document additionally discusses other products, including
nonprescription drug products, compounded drug products, and
homeopathic products. The document also includes a high-level overview
of other drug safety surveillance data sources, tools, methods, and
activities that extend beyond use of FDA's adverse event reporting
systems, as well as regulatory and other actions that can be taken in
response to identified safety signals. These additional topics are
included to provide context and a general overview of FDA's safety
surveillance process.
This document finalizes the draft document entitled ``Best
Practices in Drug and Biological Product Postmarket Safety Surveillance
for FDA Staff,'' issued on November 7, 2019 (84 FR 60094). FDA
considered comments received on the draft document as the document was
finalized. Changes from the draft to the final document include: (1)
document title revised to emphasize this document's focus on
postmarketing safety surveillance and to clarify that this document
only refers to human drug and biological products that are regulated by
FDA, as this document does not refer to animal drugs regulated by FDA;
(2) additional content to distinguish between the use of the terms
adverse event and adverse reaction; (3) clarification of products that
generally are subject to more extensive monitoring and types of safety
information for focus; (4) addition of a description of the FDA Adverse
Event Reporting System Public Dashboard; (5) revisions to the content
on medication errors, for clarity; (6) revisions to the section on the
pregnant population to align with the most recently issued documents
pertaining to clinical trials and postapproval pregnancy safety
studies; (7) inclusion of citations referencing the Sentinel System;
(8) revisions to the description of the process for signal evaluation
and documentation, including addition of a reference to the Center for
Drug Evaluation and Research's ``Manual of Policies and Procedures for
Collaborative Identification, Evaluation, and Resolution of a Newly
Identified Safety Signal''; (9) inclusion of an expanded discussion of
product labeling changes; and (10) additional content regarding Drug
Safety Communications. Editorial changes were made to improve clarity.
II. Electronic Access
Persons with access to the internet may obtain the document at
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-office-surveillance-and-epidemiology">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-office-surveillance-and-epidemiology</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01584 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P
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