[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38161-38163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1032]
Risk Evaluation and Mitigation Strategy Logic Model: A Framework
to Link Program Design With Assessment; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``REMS Logic
Model: A Framework to Link Program Design With Assessment.'' The
guidance describes FDA's risk evaluation and mitigation strategy (REMS)
logic model. The REMS logic model is a framework that FDA recommends,
which provides applicants with a systematic, structured approach to the
design, implementation, and evaluation of a REMS. The aim of applying
the REMS logic model is to develop clear goals, objectives, and
strategies that align with the intended outcomes and to help applicants
of new drug applications (NDAs), biologics license applications (BLAs),
and abbreviated new drug applications (ANDAs) incorporate REMS
assessment planning into the design of a REMS. The principles in this
guidance apply to designing a REMS, developing a REMS assessment, and
modifying a REMS.
DATES: Submit either electronic or written comments on the draft
guidance by August 5, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2024-D-1032 for ``REMS Logic Model:
[[Page 38162]]
A Framework to Link Program Design With Assessment.'' 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 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 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Gita Toyserkani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1106, Silver Spring, MD, 20993-0002, 301-
796-1783, 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 draft guidance for industry
entitled ``REMS Logic Model: A Framework to Link Program Design With
Assessment.'' Section 505-1 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355-1) establishes FDA's REMS authority. A REMS
is a required risk management strategy that can include one or more
elements to ensure that the benefits of a drug outweigh its risks (see
section 505-1(a) of the FD&C Act). A REMS can include a Medication
Guide, a patient package insert, a communication plan, and certain
packaging and safe disposal technologies for a drug that poses a
serious risk of abuse or overdose. FDA also may require certain
elements to assure safe use as part of the REMS for drugs or biological
products (see section 505-1(f) of the FD&C Act).
A REMS, like other public health programs, involves a set of
activities or interventions to achieve an intended outcome. Program
evaluation is a systematic method of collecting, analyzing, and using
data to examine the effectiveness and efficiency of those programs and
to inform continuous program improvement. Several theories, frameworks,
and logic models have been used to guide both program design and
evaluation. In particular, logic models describe in detail how a
program or intervention operationally works to achieve benefits and
captures the logical flow and linkages that exist within the program or
intervention and its proximal and distal outcomes. Leveraging this type
of systematic approach is a critical aspect to the success and
effectiveness of programs.
In 2013, FDA received feedback from the Office of the Inspector
General (available at https://oig.hhs.gov/oei/reports/OEI-04-11-00510.asp) on the overall effectiveness of REMS. To address the
feedback, FDA convened a public meeting on REMS standardization (78 FR
30313, May 22, 2013) (meeting materials available at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/background-materials-rems-standardization-and-evalution-public-meeting). FDA
sought stakeholder input on using a commonly cited framework for
program planning and evaluation. FDA also encouraged applicants to
consider using healthcare program assessment frameworks to assess REMS
(see the draft guidance for industry entitled ``REMS Assessment:
Planning and Reporting'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rems-assessment-planning-and-reporting). FDA continued to explore and research the application of
theories, frameworks, and models to develop a systematic approach to
REMS design, implementation, and evaluation. Existing healthcare
program evaluation frameworks, together with stakeholder feedback and
FDA's research, informed the development of FDA's REMS logic model.
This draft guidance describes FDA's REMS logic model, which uses
common logic model principles adapted for use in a REMS and makes
explicit the scientific evidence, assumptions, and underlying logic
that support the program and the various processes behind it. The REMS
logic model provides applicants \1\ with a recommended systematic,
structured approach to design, implement, and evaluate a REMS. The REMS
logic model delineates the relationship between the goal, objectives,
strategies, and intended outcomes. The logic model includes the three
phases of a REMS life cycle: design, implement, and evaluate. Each
phase is further separated into two or more steps. Application of the
REMS logic model begins with the design phase (situation context,
program goal). The next phase is the implement phase (inputs,
activities, outputs). The last phase is the evaluate phase (outcome,
impact). The REMS logic model, although described in sequential steps,
is an iterative process that involves moving back and forth or toggling
between steps and phases to address uncertainties,
[[Page 38163]]
validating assumptions, incorporating new information, and refining the
program.
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\1\ For the purposes of the ``REMS Logic Model: A Framework to
Link Program Design With Assessment'' guidance, the term applicant
refers to sponsors of investigational new drug applications and
applicants of NDAs, BLAs, and ANDAs.
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This draft guidance is being issued to fulfill the performance
goals (available at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027) under the sixth
reauthorization of the Prescription Drug User Fee Act (PDUFA VII). This
REMS logic model guidance is the first in a series of planned guidances
for industry and FDA staff to optimize REMS design and improve the way
a REMS is assessed.
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 of FDA on ``REMS Logic
Model: A Framework to Link Program Design With Assessment.'' 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 for the submission of investigational new drug
applications have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 314 for the submission of new
drug applications and abbreviated new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 601 for the submission of biologics license
applications have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR part 208 pertaining to Medication
Guides for prescription drug and biological products have been approved
under OMB control number 0910-0393. The collections of information in
21 CFR 201.56 and 201.57 for the content and format requirements for
labeling of drugs and biologics have been approved under OMB control
number 0910-0572. The collections of information in 21 CFR part 316
regarding orphan drug product development are approved under OMB
control number 0910-0167. The collections of information pertaining to
Prescription Drug User Fee Program have been approved under OMB control
number 0910-0297.
III. Electronic Access
Persons with access to the internet may obtain the draft 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09928 Filed 5-6-24; 8:45 am]
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