[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as it merely removes a provision from the CFR that is obsolete.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]
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