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Advisory Committee on Immunization Practices ,
Centers for Disease Control and Prevention (ACIP, CDC)
Recommendation Methodology Review Workgroup
Terms of Reference
UPDATED: January 21, 2026
PURPOSE
This document defines the activities, membership, and administrative requirements associated
with the establishment of a Recommendation Methodology Review Workgroup under the
Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention
(ACIP, CDC). ACIP utilizes subgroups of the Committee, known as Workgroups (WGs), to
develop options for presentation to the full ACIP parent committee during its public meetings to
facilitate discussion, deliberation , and development of recommendations. ACIP WGs are
intended to augment the effectiveness of ACIP. The direction, focus, and pace of both ACIP and
the individual WGs are guided by CDC and HHS policies and priorities, a s well as the need for
expert input to inform development of CDC immunization policy.
BACKGROUND
ACIP and its WGs address a wide range of issues related to U.S. immunization policies and
practices. Their work has primarily focused on three areas: (1) recommendations for specific
populations regarding the use or non -use of immunization products for particular infections or
diseases (target indications); (2) recommendations on the optimal timing, dosing, and intervals of
immunization products; and (3 ) recommendations on the coordinated use of multiple licensed
immunization products across different target indications within the overall immunization
schedule.
ACIP provides evidence -based recommendations to the CDC Director on immunization policy.
A critical initial step in ACIP WG activities and committee deliberations is the prospective
formulation of clear, well -defined policy questions and related hypotheses. Doing so requires
the use of an optimal and consistent framework to guide evidence review and decision -making.
TOPICS UNDER DISCUSSION
The WG will discuss topics that will address historical use and potential revisions to ACIP
frameworks ; policy questions and evidence assessment formulation ; vaccine timing, dosing and
scheduling considerations; implementation , economic , and resource considerations; uncertainty,
assumptions, and evidence gaps; and transparency and documentation.
DESCRI PTION of WORKGROUP ACTIVITIES
The following activities provide a framework for the Recommendation Methodology Review
Workgroup multi -year efforts , which may involve input from other Federal and private partners:
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• Assess the manner and the consistency of the use of existing frameworks that have been
adopted and used by ACIP and its workgroups to facilitate evidence assessment,
decision -making and recommendations – including Grading of Recommendations,
Assessment, Development and Evaluation ( GRADE ); and Evidence to Recommend ations
(EtR).
• Define Scope and Criteria – Establish decision criteria for evaluating processes for
developing discussion and presenting framing models that capture considerations related
to benefits, risks, uncertainties and ethics (to include rigor, transparency, usability,
adaptability, relevance, scalability, resource needs).
• Identify Relevant Models – Compile a comprehensive inventory of nationally and
internationally used evidence frameworks , as well as models and frameworks to assess
benefits, effectiveness, risk, safety , and uncertainty . This will include review of other
framework s used in public and private organizations responsible for high consequence
decision making (e.g., impacting lives and health of people)
• Conduct Systematic Evidence Scan – Review literature, guidelines, and organizational
methodologies to gather detailed information on each identified model.
• Assess Each Model Components – Evaluate (i) structure ; (ii) the way benefits, risks and
uncertainties are analyzed and presented; (iii) evidence appraisal methods ; (iv) discussion
and decision framing; (v) transparency ; (vi) reproducibility ; (vii) stakeholder -engagement
mechanisms, and other considerations.
• Engage Subject Matter Experts – Consult with internal and external experts for input on
findings and capture practical insights on model implementation.
• Identify Strengths, Limitations , and Gaps – Summarize benefits, constraints, and
contextual considerations for each model, including resource implications.
• Determine Ideal or Hybrid Model – Present the model (or combination of components
from multiple models) that best aligns with ACIP needs and broader system goals.
• Develop Summary Report – Prepare a concise report outlining methods, findings,
comparisons, and the final options .
• Present Findings – Deliver a briefing with options/findings , rationale, and proposed next
steps for adoption or further refinement at an upcoming ACIP meeting .
MEMBERSHIP
The Recommendation Methodology Review Workgroup is chaired by one of the ACIP members
appointed to serve as a Special Government Employee. The ACIP DFO or a designee will serve
as the Workgroup Lead (WGL) . The WGL and the ACIP DFO , in consultation with WG Chair ,
determine the WG’s membership , work priorities , and deliverables for presentation to the full
committee . Other federal staff (e.g., HHS leadership) and members of liaison representatives ,
and additional external subject matter experts may be invited to join workgroup meetings on an
ad hoc basis, to provide expertise as needed but will not participate as members of the
workgroup or participate in any deliberations or WG discussions .
Workgroup Membership : The Recommendation Methodology Review Workgroup is comp osed
of a WG Chair and up to 5 additional ACIP voting members given their professional, scientific,
and technical expertise ; and vested interest in ensuring the success of the ACIP meetings. They
are experts who are regarded as an authority or a practitioner of unique competence and skill by
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other persons in their profession or occupation. Upon request, HHS federal agencies named in
the ACIP charter may also appoint members to serve on WGs.
MEETINGS, ADMINISTRATION, and TIMELINES
1. Administrative Oversight : The WGL will work with the WG Chair to arrange meetings,
document meeting proceedings , and may provide presentations about the WG activities and
findings to the ACIP .
2. Meeting frequency and location : The Recommendation Methodology Review Workgroup will
meet on an as needed basis as determined by the WG Chair , WGL, and ACIP DFO . All
Recommendation Methodology Review Workgroup meetings are convened virtual ly via
teleconference.
3. Meeting structure : In addition to the WGL, at least two ACIP parent committee members (one of
whom serves as the Recommendation Methodology Review Workgroup Chair) must be present
at each meeting for a quorum . An agenda, relevant publications, and background documents will
be circulated as read ahead mat erial prior to each meeting.
4. Conflicts of Interest : N/A.
5. Confidentiality : The discussions of the Recommendation Methodology Review Workgroup may
include information that is unpublished, protected, privileged, or confidential . Discussions
within the workgroup will be kept confidential. Information of this nature must not be
disseminated, distributed, or copied to persons not authorized to receive such information. When
these types of information are distributed, the person/s presenting will identify the information as
such, so all members are duly informed; and written materials shall be clearly marked as such.
Unlike ACIP parent committee meetings, which are open to the public, Recommendation
Methodology Review Workgroup teleconferences are not subject to the open meeting
requirements of the Federal Advisory Committee Act or the GSA Final Rule ; data presented
during these meetings/teleconferences are often proprietary and should not be distributed to
people other than approved workgroup members.
6. CDC Staff Involvement : The CDC staff engaged in the ACIP Recommendation Methodology
Review Workgroup include the ACIP DFO and designee . Consultation or information al
presentations by CDC staff may be requested by the WG . CDC staff do not serve as members of
the Recommendation Methodology Review WG but may be asked to provide administrative
support and technical expertise to ACIP WGs, bringing subject matter expertise and current
professional focus in areas relevant to the goa ls of the WG. Consultation or informational
presentations by CDC staff will be transparent and evident to minimize the risk of, or the
appearance of, undue influence that would compromise the independence of the WG. The
ACIPDFO and WGL of the Recommen dation Methodology Review WG, in consultation with
the WG Chair, will monitor the interaction between the WG and the agency staff to ensure that
the WG activities and work products are appropriate and that there is not undue influence by the
CDC or by any special interest group on the activities or work products of the WG.
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7. Timelines : ACIP WGs are established when needed and terminated once the activities and work
products stated in the terms of reference have been completed and the WG’s charge has been
fulfilled .
8. Subject content : Findings and opinions of the Recommendation Methodology Review
Workgroup members will be discussed at ACIP meetings. Where applicable, t he
Recommendation Methodology Review Workgroup’s findings will be presented to the ACIP
parent committee for consideration for action (discussion, deliberation and decision , and
formulations of recommendations ).
9. Workgroup Meeting Summaries : Meeting minutes will be created to capture the information
gathered during each Recommendation Methodology Review Workgroup meeting and
teleconference.
10. Workgroup finding s: The Recommendation Methodology Review Workgroup will present
briefing documents, background materials, presentations to the ACIP parent committee for
consideration and deliberation in a public meeting. Final versions of all products /slides
presented at the ACIP parent committee meeting will be included in the committee’s official
records and uploaded into the Federal Advisory Committee Management Portal .
11. Workgroup Record Keeping : All CDC FACA committees, subcommittees, and WGs are subject
to the Federal Records Act. All records will be uploaded in the Federal Advisory Committee
Management Portal. The summary report of WG meeting activities and other WG documents
will become part of the ACIP’s official records as required by GENERAL RECORDS
SCHEDULE 6.2: Federal Advisory Committee Records .
RECORDKEEPING and REPORTING
The Workgroup will present findings/outcomes/observations to the ACIP parent committee for
discussion, deliberation, and potential adoption in an open public forum.