[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to Link Program Design With Assessment; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``REMS Logic 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DATES: Submit either electronic or written comments on the draft 
guidance by August 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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]
BILLING CODE 4164-01-P