[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32928-32929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1747]
Risk Evaluation and Mitigation Strategies: Modifications and
Revisions; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Risk
Evaluation and Mitigation Strategies: Modifications and Revisions.''
This guidance provides information on how FDA will define and process
submissions for modifications and revisions of risk evaluation and
mitigation strategies (REMS), as well as information on what types of
changes to approved REMS will be considered modifications or revisions
of the REMS. The guidance also provides instructions to application
holders related to procedures for submission of REMS modifications and
revisions to FDA as well as different timeframes for FDA's review of
and action on such changes. The definitions of REMS modifications and
revisions apply to all types of REMS. This guidance updates the
guidance of the same name, issued April 7, 2015, including finalizing
the portion that sets forth the submission procedures for REMS
revisions.
DATES: The announcement of the guidance is published in the Federal
Register on July 10, 2019.
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-2014-D-1747 for ``Risk Evaluation and Mitigation Strategies:
Modifications and Revisions.'' 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/FR2015-09-18/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 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 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: Vaishali Jarral, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6480, Silver Spring, MD 20993-0002, 301-
796-4248; or Stephen Ripley, Center for
[[Page 32929]]
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 ``Risk Evaluation and Mitigation Strategies: Modifications and
Revisions.'' This guidance provides information on what types of
changes to approved REMS will be considered modifications of the REMS
and what types of changes will be considered revisions. (See section
505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355-1(h)).) This guidance also provides information on how REMS
modifications and revisions should be submitted to FDA and how FDA
intends to review and act on these submissions.
If FDA determines that a REMS is necessary to ensure that the
benefits of a drug outweigh its risks, FDA is authorized to require a
REMS for such drugs under section 505-1 of the FD&C Act.\1\ Section
505-1(g) and (h) of the FD&C Act include provisions for the assessment
and modification of an approved REMS. Section 505-1(h) of the FD&C Act
requires FDA to review and act on proposed minor modifications, as
defined in guidance, within 60 days.\2\ It also requires FDA to
establish, through guidance, that ``certain modifications'' can be
implemented following notification to FDA. (See section 505-
1(h)(2)(A)(iv) of the FD&C Act.) In addition, FDA is required to review
and act on REMS modifications to conform the REMS to approved safety
labeling changes, or to a safety labeling change that FDA has directed
the application holder to make pursuant to section 505(o)(4) of the
FD&C Act within 60 days. (See section 505-1(h)(2)(A)(iii) of the FD&C
Act.) Finally, section 505-1(g)(4)(A) of the FD&C Act specifies that
proposed REMS modifications no longer require submission of a REMS
assessment; instead, proposed modifications must include an adequate
rationale for the proposed changes.
---------------------------------------------------------------------------
\1\ Section 505-1 of the FD&C Act applies to applications for
prescription drugs submitted under subsection 505(b) (i.e., new drug
applications) or (j) (i.e., abbreviated new drug applications) of
the FD&C Act (21 U.S.C. 355(b) or (j), respectively) and
applications under section 351 of the Public Health Service Act
(i.e., biologics license applications).
\2\ See section 505-1(h)(2)(A)(ii) of the FD&C Act. Section
1132(c) of the Food and Drug Administration Safety and Innovation
Act also provides that FDA will issue guidance that, for purposes of
section 505-1(h)(2)(A) of the FD&C Act, describes the types of
modifications to approved risk evaluation and mitigation strategies
that are considered to be minor modifications of such strategies.
---------------------------------------------------------------------------
This guidance updates the guidance of the same name, issued April
7, 2015 (80 FR 18629), and finalizes the portion that sets forth the
submission procedures for REMS revisions. FDA carefully considered all
comments received, including comments on the submission procedures
portion, and revised the guidance as appropriate.
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 ``Risk Evaluation and Mitigation Strategies:
Modifications and Revisions.'' 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. This guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This final 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). REMS
modifications are submitted to FDA as supplements to approved new drug
applications (NDAs) under 21 CFR 314.70 and for abbreviated new drug
applications (ANDAs) under 21 CFR 314.97, and for approved biologics
license applications (BLAs) under 21 CFR 601.12. Burden hours for NDAs
and ANDAs are approved by OMB under control number 0910-0001, and for
BLAs under control number 0910-0338. REMS revisions are submitted to
FDA as application correspondence and are also approved by OMB under
control numbers 0910-0001 and 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
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: July 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14663 Filed 7-9-19; 8:45 am]
BILLING CODE 4164-01-P