[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57452-57454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0283]
Postmarketing Studies and Clinical Trials--Implementation of
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Postmarketing Studies and Clinical Trials--Implementation of Section
505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' This draft
guidance revises the guidance for industry of the same name issued
April 1, 2011. The draft guidance is being revised to describe the
multiple factors that FDA considers, before requiring a postmarketing
study or clinical trial for the purposes described in the Federal Food,
Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of
the reports under the FD&C Act and the active postmarket risk
identification and analysis (ARIA) system available under the FD&C Act
to meet these purposes. The draft guidance is also being revised to
reflect certain provisions enacted under the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for
Patients and Communities Act as they relate to postmarketing studies
and clinical trials.
[[Page 57453]]
DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2009-D-0283 for ``Postmarketing Studies and Clinical Trials--
Implementation of Section 505(o)(3) of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for Industry; Availability.'' 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft 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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ayanna Augustus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20993-0002, 301-
796-3980; 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 announcing the availability of a draft guidance for industry
entitled, ``Postmarketing Studies and Clinical Trials--Implementation
of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.''
Section 505(o)(3) of the FD&C Act \1\ (21 U.S.C. 355(o)) authorizes
FDA to require certain postmarketing studies or clinical trials for
prescription drugs to obtain more information about a serious risk that
may be associated with a drug. In some cases, FDA may be concerned
about a serious risk that is potentially or known to be associated with
a drug but may not know enough about the risk to determine if or how to
address it, such as by describing the risk in labeling. Section
505(o)(3)(B) of the FD&C Act states that postmarketing studies and
clinical trials may be required for any or all of the following
purposes: (1) To assess a known serious risk related to the use of the
drug; (2) to assess signals of serious risk related to the use of the
drug; or (3) to identify an unexpected serious risk when available data
indicates the potential for a serious risk.
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\1\ Section 901 of Title IX of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85) amended the FD&C Act by
adding section 505(o).
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Prior to requiring a postmarketing study or clinical trial, FDA
must find that the reports under section 505(k)(1) of the FD&C Act and
the ARIA system \2\ made available under section 505(k)(3) of the FD&C
Act will not be sufficient to meet the purposes described in section
505(o)(3)(B) of the FD&C Act.\3\ Similarly, before requiring a
postmarketing clinical trial, FDA must find that a postmarketing study
will not be sufficient to meet the purposes
[[Page 57454]]
described in section 505(o)(3)(B) of the FD&C Act.\4\
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\2\ Section 505(k)(3) of the FD&C Act mandates that FDA
establish an active surveillance system for monitoring drugs, using
electronic data from healthcare information holders. The Sentinel
System draws on existing healthcare data from multiple sources to
actively monitor the safety of medical products. The ARIA system is
a subcomponent of the Sentinel System.
\3\ Section 505(o)(3)(D)(i) of the FD&C Act.
\4\ Section 505(o)(3)(D)(ii) of the FD&C Act.
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In April 2011, FDA issued a guidance describing how it would
implement section 505(o) of the FD&C Act. At that time, the ARIA system
was still in early development. The ARIA system is now officially
launched, and FDA must consider the system's sufficiency to meet the
purposes of section 505(o)(3)(B) of the FD&C Act to determine if a
postmarketing study or clinical trial is necessary. This draft guidance
revises the guidance for industry of the same name issued on April 1,
2011 (76 FR 18226). Significant changes from the 2011 version include
explaining how FDA considers the reporting under section 505(k)(1) of
the FD&C Act and the ARIA system when determining their sufficiency for
the purposes under section 505(o)(3)(B) of the FD&C Act. The guidance
is also being revised to provide examples of postmarketing requirements
under section 505(o)(3) of the FD&C Act to assess a potential reduction
in the expected effectiveness of a drug under certain circumstances.
FDA's authority to require these types of studies or trials was
clarified by a modification to the definition of adverse drug
experience at section 505-1(b)(1)(E) of the FD&C Act (21 U.S.C. 505-
1(b)(1)(E)) enacted under section 3041 of the SUPPORT Act (Pub. L. 115-
271).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking on implementation of
section 505(o)(3)(B) of the FD&C Act. 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
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The following collections of information for postmarketing reports
and clinical data in 21 CFR 314.50, 314.80, 314.81, 314.98, 314.430,
and 314.610(b), subpart I have been approved under OMB control number
0910-0001: (1) Preparing and submitting reports pertaining to safety,
postmarketing commitments and preparing and submitting spontaneous and
periodic reports, including active postmarket risk identification
(using electronic health care data) and any milestones or submissions
for which projected dates were specified as part of the postmarketing
commitment; (2) submitting a proposed timetable of the postmarketing
commitments; (3) preparing registries and submitting them when
appropriate; (4) designing meta-analyses to evaluate statistical
analyses of data; (5) preparing assay procedures; and (6) prepare a
plan or approach for approval an NDA when human efficacy studies are
not ethical or feasible.
The following collections of information for postmarketing studies
and clinical trials (including various patient populations) in 21 CFR
312.23 have been approved under OMB control number 0910-0014: (1)
Conducting in vitro laboratory tests and studies to compare pregnancy
incidence an pregnancy outcomes and/or child outcomes for patients
exposed to a drug; (2) submitting an introductory statement and general
investigational plan, including a drug's pharmacological class; and (3)
submitting protocols for drug safety and pharmacology and toxicology
information.
The collections of information in 21 CFR 310.305, 314.80, and
314.98 for submitting adverse event information to the FDA Adverse
Event Reporting System have been approved under OMB control numbers
0910-0230 and 0910-0291; the collections of information in 21 CFR
312.47 and 312.82 for submitting a meeting request to appeal the
conduct of a postmarketing study or clinical trial have been approved
under OMB control number 0910-0430 (and guidance for industry and
review staff entitled ``Formal Dispute Resolutions: Appeals Above the
Division Level'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm343101.pdf).
The following collection of information in Sec. 314.510 has been
approved under OMB control number 0910-0765: Requests for serious or
life-threatening diseases or conditions that may be granted accelerated
approval if FDA determines the product has an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit or on a
clinical endpoint that can be measured earlier than irreversible
morbidity or mortality or other clinical benefit.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23312 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P