[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60094-60095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3768]


Best Practices in Drug and Biological Product Postmarket Safety 
Surveillance for Food and Drug Administration Staff; Draft Document; 
Availability; Establishment of Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; establishment of public docket; request 
for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to collect comments on a draft document 
that details best practices for drug safety surveillance entitled 
``Best Practices in Drug and Biological Product Postmarket Safety 
Surveillance for FDA Staff.'' The 21st Century Cures Act (Cures Act) 
was enacted on December 13, 2016, and requires that FDA make publicly 
available on its internet website best practices for drug safety 
surveillance activities. The draft document sets forth risk-based 
principles by which FDA conducts ongoing postmarketing safety 
surveillance for drug and biological products to address the Cures Act 
requirements. FDA is seeking public comment on the draft best practices 
in drug and biological product postmarket safety surveillance.

DATES: Submit either electronic or written comments on the draft 
document by January 6, 2020 to ensure that the Agency considers your 
comment on this draft document before it begins work on the final 
version.

ADDRESSES: You may submit comments 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 in Drug and Biological Product 
Postmarket Safety Surveillance for FDA Staff.'' 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.
     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

[[Page 60095]]

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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Eileen Wu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 3472, Silver Spring, MD 20993-0002, 301-796-2345, 
eileen.wu@fda.hhs.gov; 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 establishing a public docket to collect comments on a draft 
document entitled ``Best Practices in Drug and Biological Product 
Postmarket Safety Surveillance for FDA Staff.'' Title IX, section 915 
of the Food and Drug Administration Amendments Act of 2007 (FDAAA) 
added a new 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.
    The Cures Act (Pub. L. 114-255) was enacted on December 13, 2016, 
and has the goal of advancing medical product innovation, as well as 
ensuring patient access to safe and effective treatments as soon as 
possible. Section 3075 of the Cures Act 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'', as required by FDAAA, 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 draft document entitled ``Best Practices in Drug and Biological 
Product Postmarket Safety Surveillance for FDA Staff'' sets forth risk-
based principles by which FDA conducts ongoing postmarketing safety 
surveillance for drug and 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 draft document additionally provides a high-level 
discussion regarding other products, including over-the-counter 
monograph, compounded, and homeopathic drug products. The draft 
document also includes a high-level overview of other data sources, 
tools, and methods, as well as drug safety surveillance activities that 
extend beyond use of the Adverse Event Reporting System (and its 
successors). These additional topics are included to provide context 
and a general overview of FDA's safety surveillance process. FDA is 
seeking public comment on the draft best practices document before it 
begins work on the final version, which will be made publicly 
available.

II. Electronic Access

    Persons with access to the internet may obtain the draft document 
entitled ``Best Practices in Drug and Biological Product Postmarket 
Safety Surveillance for FDA Staff'' at https://www.fda.gov/media/130216/download.

    Dated: November 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24332 Filed 11-6-19; 8:45 am]
 BILLING CODE 4164-01-P


