[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5240-5241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 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 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, [email protected]; 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 
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-office-surveillance-and-epidemiology or https://www.regulations.gov.

    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