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HHS/CDC RIN: 0920-AA80 Publication ID: Fall 2021 
Title: ●Requirement for Proof of Vaccination or Other Proof of Immunity Against Quarantinable Communicable Diseases 
Abstract:

This Interim Final Rule (IFR) will amend current regulations to permit CDC to require proof of vaccination or other proof of immunity against quarantinable communicable diseases. When CDC exercises this authority, persons arriving at a U.S. port of entry will be required to provide proof of immunity against quarantinable communicable diseases or proof of having been fully vaccinated against quarantinable communicable diseases. Additionally, as a condition of controlled free pratique under 42 CFR 71.31(b), carriers destined for the United States must also comply with requirements of any order issued pursuant to the IFR. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 71   
Legal Authority: secs. 215 and 311 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 216, 243)    sec. 361 to 369, PHS Act, as amended (42 U.S.C. 264 to 272)   
Legal Deadline:  None

Statement of Need:

In response to the COVID-19 pandemic, CDC is amending current regulations to require proof of vaccination or other proof of immunity against quarantinable communicable diseases for persons arriving at a U.S. port of entry.

Summary of the Legal Basis:

HHS/CDC is promulgating this rule under sections 215 and 311 of the Public Health Service Act, as amended (42 U.S.C. 216, 243); section 361 to 369, PHS Act, as amended (42 U.S.C 264 to 272).

Alternatives:

An alternative considered would allow non-U.S. nationals to submit accurate contact information, complete post-arrival testing, and self-quarantine after arrival in the United States in lieu of the vaccination requirement.

Anticipated Costs and Benefits:

HHS/CDC believes it is likely that this rulemaking will be determined to be economically significant under EO 12866.

Risks:

This rulemaking addresses the risk of introduction of communicable diseases by international travelers into the United States.  By implementing this rulemaking, CDC can reduce the risk of importation of new COVID-19 variants into the United States.  This rulemaking is expected to increase the number of travelers who are fully vaccinated upon arrival and reduce the number of international travelers arriving while infected.

Timetable:
Action Date FR Cite
Interim Final Rule  12/00/2021 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, Local, State 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Ashley C. Altenburger JD
Public Health Analyst
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS: H 16-4,
Atlanta, GA 30307
Phone:800 232-4636
Email: dgmqpolicyoffice@cdc.gov