NFID Comments on Department of Health and Human Services Request for Information on Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making
September 16, 2026
Cynthia Goss
Deputy Assistant Secretary for Planning and Evaluation (Health Policy)
Office of the Secretary
U.S. Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201
Re: Docket No. HHS-OS-2026-0332; RIN 0991-ZA62 — Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making
The National Foundation for Infectious Diseases (NFID) appreciates the opportunity to comment on the Department of Health and Human Services (HHS) Request for Information (RFI) regarding categories used in federal vaccine recommendations and the role of shared clinical decision-making (SCDM).
NFID is a nonprofit organization founded in 1973 and dedicated to educating and engaging the public, communities, and healthcare professionals about infectious diseases across the lifespan. NFID receives funding from multiple sources, including industry, and develops educational content independently under conflict-of-interest and firewall policies.
NFID shares HHS’s commitment to transparency, clarity, and public trust. The RFI raises important questions about how federal vaccine recommendation categories are understood and implemented, including their effects on clinician and patient comprehension, coverage, and clinical systems.
Because changes to federal vaccine recommendation categories require scientific, clinical, and implementation expertise and rigorous review, this RFI should inform, but not replace, the established Advisory Committee on Immunization Practices (ACIP) process for determining whether categories should be added, removed, renamed, or redefined.
Key NFID recommendations
- Use the established ACIP process to evaluate proposed changes to recommendation categories. Categories should communicate evidence-based clinical guidance clearly. Any proposed change should be evaluated against that purpose through the ACIP process, informed by the perspectives of those who use the recommendations.
- Require an access and implementation plan before making changes. Before adopting a change, HHS should assess and publicly explain its likely effects on access and implementation. It should also specify the support required to carry out the change and the measures that will be used to evaluate it.
1. Use the established ACIP process to evaluate proposed changes to recommendation categories
(Questions 1, 2, 4, 8, and 9)
Historically, U.S. vaccine recommendations have been made by the Director of the Centers for Disease Control and Prevention based on recommendations from independent experts serving on ACIP. Using an evidence-based framework, ACIP evaluates whether the available evidence demonstrates that the benefits of a vaccine outweigh its risks. Federal agencies, including CDC and the Food and Drug Administration, continue to monitor vaccine safety after approval and widespread use, and existing recommendations are reevaluated as new evidence becomes available.
Federal vaccine recommendations guide clinicians on which patients should be offered a vaccine, when it should be given, and when individualized clinical judgment is needed. Recommendation categories must therefore communicate that guidance accurately and clearly. ACIP has an established, rigorous, and transparent process for developing and revising evidence-based recommendations, and it should use that process to determine whether categories should be added, removed, renamed, or redefined.
The RFI cites confusion among clinicians and patients about both former Category B and current SCDM recommendations, along with inconsistent implementation in electronic health records and forecasting tools. These findings identify potential problems but do not establish that changing the category structure or terminology is the best solution. Clearer guidance and education about the existing framework may be equally or more effective. In evaluating the need for change, ACIP should seek input from healthcare professionals, patients, and parents to identify sources of confusion and assess whether proposed category names and definitions are clearly understood. This input should inform how categories are named and communicated, not substitute for ACIP’s scientific and clinical judgment about which categories are needed.
2. Require an access and implementation plan before adopting changes
(Questions 6, 12, 13, 17, and 18)
Access and implementation are direct and foreseeable consequences of how HHS structures and describes federal vaccine recommendation categories. HHS should anticipate and manage those consequences when considering changes to the framework. Changes in terminology or category structure should not reduce or destabilize access to vaccines that remain recommended.
Before adopting a new framework, HHS should assess and publicly explain its expected effects on insurance coverage and cost sharing, Vaccines for Children eligibility, vaccine injury compensation programs, state programs and laws that reference federal recommendation categories, pharmacy authority, standing orders, clinical decision-support systems, immunization information systems, and provider workflow. HHS should also evaluate whether intended audiences may interpret a proposed category as meaning that a vaccine is not recommended or available.
If HHS adopts a new framework, implementation support should be available when it takes effect. HHS should provide plain-language explanations of coverage, establish specifications for clinical and immunization systems, and support concise decision aids and provider education. Terminology changes should be limited, clearly explained, and communicated in a coordinated manner.
Before implementation, HHS should define and publish measures of success. Evaluation should address comprehension among healthcare professionals, patients, and parents; accurate implementation by clinical and immunization systems; access and coverage; and vaccine uptake. HHS should publish the results and revise the framework when evidence indicates that improvements are needed.
Additional considerations raised by the RFI
The RFI cites research, including international data, on the effects of compulsory vaccination policies. That evidence raises potentially legitimate public health questions about which approaches are most effective at achieving strong vaccination coverage and preventing disease in the United States. This inquiry, however, is distinct from how federal vaccine recommendation categories should be named and understood. Federal recommendations provide clinical guidance; they are not mandates. Requirements established by states, schools, employers, and other institutions are separate policy decisions made under their own authority.
Several questions in the RFI ask whether the term “shared clinical decision-making” creates confusion by implying that informed consent, patient choice, or individualized clinical judgment apply differently to vaccines in that category. Vaccination, like all medical care, requires informed consent regardless of how a recommendation is categorized. Before changing the terminology on this basis, HHS should determine whether this misunderstanding exists, whether SCDM contributes to it, and whether clearer guidance and education about the existing framework would be more effective than introducing another term.
The need for a more rigorous approach is illustrated by the RFI’s treatment of “individual-based decision-making” (IBDM). Federal communications have used IBDM as another name for SCDM since 2025 without clearly defining the term, yet the RFI now asks whether the two differ while also using them interchangeably. Asking the public to clarify terminology the federal government has already introduced and applied demonstrates the risk of adopting a term before defining and testing it: stakeholders are left to infer its meaning from how it is used, increasing rather than reducing confusion.
NFID therefore does not recommend specific category names or definitions in response to this RFI. Decisions about category structure, age distinctions, and timing of vaccination require detailed scientific and clinical review through the established ACIP process. The RFI may identify options for ACIP to examine, but it should not establish or redefine categories outside that process.
Conclusion
NFID supports evidence-based improvements that make federal vaccine recommendations easier to understand and implement. Any proposed change should proceed through the established ACIP process, be supported by HHS planning for effective implementation and continued access, and preserve the distinction between evidence-based scientific recommendations and separate policy decisions.
About the National Foundation for Infectious Diseases
Founded in 1973, the National Foundation for Infectious Diseases (NFID) is a non-profit 501(c)(3) organization dedicated to educating and engaging the public, communities, and healthcare professionals about infectious diseases across the lifespan. NFID has a 4-star rating from Charity Navigator and has earned a Platinum transparency seal from Candid/GuideStar. For more information, and to access trusted science-based resources on immunization for both healthcare professionals and the public, visit www.nfid.org.
Contact: communications@nfid.org
