[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Rules and Regulations]
[Pages 62817-62818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 102

RIN 0906-AA84


Removing Outmoded Regulations Regarding the Smallpox Vaccine 
Injury Compensation Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: This action removes the outmoded regulations for the Smallpox 
Vaccine Injury Compensation Program. The program and its implementing 
regulation have been rendered obsolete by the expiration of the 
Declaration Regarding Administration of Smallpox Countermeasures under 
the Smallpox Emergency Personnel Protection Act of 2003 and 
incorporation of the smallpox countermeasure injury coverage under the 
Public Readiness and Emergency Preparedness Act of 2005 and its 
authorization of the Countermeasures Injury Compensation Program.

DATES: This action is effective November 14, 2016 without further 
action, unless adverse comment is received by October 13, 2016. If 
adverse

[[Page 62818]]

comment is received, HHS will publish a timely withdrawal of the rule 
in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Questions or comments regarding the 
Smallpox Vaccine Injury Compensation Program should be directed to 
Narayan Nair, M.D., Acting Director, Division of Injury Compensation 
Programs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 
08N146B, Rockville, MD 20857, by phone at (301) 443-5287, or by email 
at [email protected].

SUPPLEMENTARY INFORMATION:  In response to Executive Order 13563, Sec. 
6(a), which urges agencies to ``repeal'' existing regulations that are 
``outmoded'' from the Code of Federal Regulations (CFR), HHS is 
removing 42 CFR part 102. Notice and comment are not required for this 
rule, because it affects agency organization, procedure, or practice 
under 5 U.S.C. 553(b)(A). Furthermore, HHS believes that there is good 
cause hereby to bypass notice and comment and proceed to a direct final 
rule, pursuant to 5 U.S.C. 553 (b)(B). The action is non-controversial, 
as it merely removes a provision from the CFR that is obsolete. This 
rule poses no new substantive requirements on the public. Accordingly, 
HHS believes this direct final rule will not elicit any significant 
adverse comments, but if such comments are received HHS will publish a 
timely notice of withdrawal in the Federal Register.

I. Background

    The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), 
(42 U.S.C. 239 et seq.) enacted on April 30, 2003, authorized the 
Secretary of the Department of Health and Human Services (the 
Secretary), through the establishment of the Smallpox Vaccine Injury 
Compensation Program (SVICP), to provide benefits and/or compensation 
to certain persons who sustained covered injuries as a direct result of 
the administration of covered smallpox countermeasures (including the 
smallpox vaccine) or as a result of vaccinia contracted through 
accidental vaccinia contact. The SVICP's implementing regulation was 
codified at 42 CFR part 102.
    The SVICP provided compensation for unreimbursed medical expenses 
and/or lost employment income to eligible individuals for covered 
injuries sustained as a direct result of the smallpox vaccine or 
accidental vaccinia inoculation, and/or death benefits to certain 
survivors of these individuals. The Secretary did not extend SEPPA's 
Declaration Regarding Administration of Smallpox Countermeasures, which 
expired on January 23, 2008. Vaccine recipients and accidental vaccinia 
contacts had 1 and 2 years, respectively, to file a request for program 
benefits. The SVICP ended on January 23, 2010.
    Alternatively, based on a credible risk that the threat of exposure 
to variola virus, the causative agent of smallpox, constitutes a public 
health emergency, the Secretary issued a Declaration (73 FR 61869-
61871) covering smallpox countermeasures under the Public Readiness and 
Emergency Preparedness Act of 2005 (PREP Act), with an effective date 
of January 24, 2008. The PREP Act authorizes the establishment and 
administration of the Countermeasures Injury Compensation Program, 
whose implementing regulation, at 42 CFR part 110, is based on the 
SVICP's regulation and provides similar benefits. On December 9, 2015, 
the PREP Act Declaration was amended and republished (80 FR 76546-
76553), extending the effective time period to December 31, 2022, and 
deleting obsolete language referring to SEPPA.

Executive Order 12866

    This action does not meet the criteria for a significant regulatory 
action as set out under Executive Order 12866, and review by the Office 
of Management and Budget has accordingly not been required.

Regulatory Flexibility Act

    This action will not have a significant economic impact on a 
substantial number of small entities. Therefore, the regulatory 
flexibility analysis provided for under the Regulatory Flexibility Act 
is not required.

Paperwork Reduction Act

    This action does not affect any information collections.

List of Subjects in 42 CFR Part 102

    Biologics, Immunization, Public health, Smallpox.

PART 102--[REMOVED]

0
For reasons set out in the preamble, and under the authority at 5 
U.S.C. 301, HHS amends 42 CFR chapter I by removing part 102.

    Dated: August 26, 2016.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
    Approved: September 7, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-21888 Filed 9-12-16; 8:45 am]
 BILLING CODE 4165-15-P