81 FR 62817 - Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 177 (September 13, 2016)

Page Range		62817-62818
FR Document		2016-21888

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.

Federal Register, Volume 81 Issue 177 (Tuesday, September 13, 2016)

[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Rules and Regulations]
[Pages 62817-62818]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Rules and Regulations 62817

REGULATION FOR THE CONTROL OF ATMOSPHERIC POLLUTION AND PUERTO RICO LAWS
Commonwealth
Puerto Rico regulation EPA approval date Comments
effective date

* * * * * * *

PUERTO RICO LAWS

Act 1 (‘‘Puerto Rico Government Ethics Act of January 3, 2012 ........ September 13, 2016, These provisions are intended to apply to any
2011’’), Chapter V, ‘‘Financial Reports’’. [insert Federal person subject to Clean Air Act section 128,
Register citation]. and are included in the SIP for the limited
purpose of satisfying the requirements of
Clean Air Act sections 110(a)(2)(E)(ii) and
128. January 3, 2012 is the Commonwealth
approval date.
Act 416 (Commonwealth of Puerto Rico’s September 22, 2004 September 13, 2016, These provisions are intended to apply to any
‘‘Environmental Public Policy Act’’), Title II, [insert Federal person subject to Clean Air Act section 128,
‘‘On the Environmental Board,’’ Section 7, Register citation]. and are included in the SIP for the limited
‘‘Creating the Board; Members; Terms,’’ purpose of satisfying the requirements of
sections A. and D. Clean Air Act sections 110(a)(2)(E)(ii) and
128. September 22, 2004 is the Common-
wealth approval date.

■ 4. Add § 52.2730 to read as follows: PM2.5 NAAQS requirements of the Clean sections: 110(a)(2)(C) (PSD program
Air Act (CAA) 110(a)(2)(A), (B), (C) only), (D)(i)(II) (PSD program only),
§ 52.2730 Section 110(a)(2) infrastructure
(with the exception of program (D)(ii) (PSD program only) and (J) (PSD
requirements.
requirements for PSD), (D)(i)(II) and (ii) program only). These requirements are
(a) 1997 8-hour ozone and the 1997 (with the exception of program being addressed by § 52.2729 which has
PM2.5 NAAQS—(1) Approval. Submittal requirements related to PSD), (E), (F), been delegated to Puerto Rico to
from Puerto Rico dated November 29, (G), (H), (J) (with the exception of implement.
2006 and supplemented February 1, program requirements related to PSD), [FR Doc. 2016–21326 Filed 9–12–16; 8:45 am]
2016, to address the CAA infrastructure (K), (L), and (M).
requirements for the 1997 ozone and the BILLING CODE 6560–50–P

1997 PM2.5 NAAQS. This submittal (2) Disapproval. Submittal from
satisfies the 1997 ozone and the 1997 Puerto Rico dated January 22, 2013 and
PM2.5 NAAQS requirements of the Clean supplemented April 16, 2015 and DEPARTMENT OF HEALTH AND
Air Act (CAA) 110(a)(2)(A), (B), (C) February 1, 2016, to address the CAA HUMAN SERVICES
(with the exception of program infrastructure requirements for the 2008
requirements for PSD), (D)(i)(II) and (ii) ozone and the 2006 PM2.5 NAAQS are 42 CFR Part 102
(with the exception of program disapproved for the following sections:
110(a)(2)(C) (PSD program only), RIN 0906–AA84
requirements related to PSD), (E), (F),
(G), (H), (J) (with the exception of (D)(i)(II) (PSD program only), (D)(ii)
Removing Outmoded Regulations
program requirements related to PSD), (PSD program only) and (J) (PSD
Regarding the Smallpox Vaccine Injury
(K), (L), and (M). program only). These requirements are
Compensation Program
(2) Disapproval. Submittal from being addressed by § 52.2729 which has
Puerto Rico dated November 29, 2006 been delegated to Puerto Rico to AGENCY: Health Resources and Services
and supplemented February 1, 2016, to implement. Administration, HHS.
address the CAA infrastructure (c) 2008 lead NAAQS—(1) Approval. ACTION: Direct final rule.
requirements for the 1997 ozone and the Submittal from Puerto Rico dated
1997 PM2.5 NAAQS are disapproved for January 31, 2013 and supplemented SUMMARY: This action removes the
the following sections: 110(a)(2)(C) (PSD February 1, 2016, to address the CAA outmoded regulations for the Smallpox
program only), (D)(i)(II), PSD program infrastructure requirements for the 2008 Vaccine Injury Compensation Program.
only), (D)(ii) (PSD program only) and (J) lead NAAQS. This submittal satisfies The program and its implementing
(PSD program only). These requirements the 2008 lead NAAQS requirements of regulation have been rendered obsolete
are being addressed by § 52.2729 which the Clean Air Act (CAA) 110(a)(2)(A), by the expiration of the Declaration
has been delegated to Puerto Rico to (B), (C) (with the exception of program Regarding Administration of Smallpox
implement. requirements for PSD), (D)(i)(II) and (ii) Countermeasures under the Smallpox
(b) 2008 ozone and the 2006 PM2.5 (with the exception of program Emergency Personnel Protection Act of
NAAQS—(1) Approval. Submittal from requirements related to PSD), (E), (F), 2003 and incorporation of the smallpox
Puerto Rico dated January 22, 2013, (G), (H), (J) (with the exception of countermeasure injury coverage under
supplemented February 1, 2016 to program requirements related to PSD), the Public Readiness and Emergency
address the CAA infrastructure (K), (L), and (M). Preparedness Act of 2005 and its
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requirements for the 2008 ozone (2) Disapproval. Submittal from authorization of the Countermeasures
NAAQS and supplemented April 16, Puerto Rico dated January 31, 2013 and Injury Compensation Program.
2015 and February 1, 2016 to address supplemented February 1, 2016, to DATES: This action is effective
the CAA infrastructure requirements for address the CAA infrastructure November 14, 2016 without further
the 2006 PM2.5 NAAQS. This submittal requirements for the 2008 lead NAAQS action, unless adverse comment is
satisfies the 2008 ozone and the 2006 are disapproved for the following received by October 13, 2016. If adverse

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62818 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Rules and Regulations

comment is received, HHS will publish Smallpox Countermeasures, which FEDERAL COMMUNICATIONS
a timely withdrawal of the rule in the expired on January 23, 2008. Vaccine COMMISSION
Federal Register. recipients and accidental vaccinia
FOR FURTHER INFORMATION CONTACT: contacts had 1 and 2 years, respectively, 47 CFR Part 64
Questions or comments regarding the to file a request for program benefits.
[WCB: WC Docket No. 12–375; FCC 16–
Smallpox Vaccine Injury Compensation The SVICP ended on January 23, 2010. 102]
Program should be directed to Narayan Alternatively, based on a credible risk
Nair, M.D., Acting Director, Division of that the threat of exposure to variola Rates for Interstate Inmate Calling
Injury Compensation Programs, virus, the causative agent of smallpox, Services
Healthcare Systems Bureau, HRSA, constitutes a public health emergency,
5600 Fishers Lane, Room 08N146B, the Secretary issued a Declaration (73 AGENCY: Federal Communications
Rockville, MD 20857, by phone at (301) FR 61869–61871) covering smallpox Commission.
443–5287, or by email at countermeasures under the Public ACTION: Final rule.
nnair@hrsa.gov. Readiness and Emergency Preparedness
Act of 2005 (PREP Act), with an SUMMARY: In this document, the
SUPPLEMENTARY INFORMATION: In Commission continues its reform of the
effective date of January 24, 2008. The
response to Executive Order 13563, Sec. PREP Act authorizes the establishment inmate calling services (ICS)
6(a), which urges agencies to ‘‘repeal’’ and administration of the marketplace by responding to points
existing regulations that are Countermeasures Injury Compensation raised in a petition filed by Michael S.
‘‘outmoded’’ from the Code of Federal Program, whose implementing Hamden, seeking reconsideration of
Regulations (CFR), HHS is removing 42 regulation, at 42 CFR part 110, is based certain aspects of the Commission’s
CFR part 102. Notice and comment are on the SVICP’s regulation and provides 2015 ICS Order. Specifically, the
not required for this rule, because it similar benefits. On December 9, 2015, Commission amends its rate caps to
affects agency organization, procedure, the PREP Act Declaration was amended better allow ICS providers to recover
or practice under 5 U.S.C. 553(b)(A). and republished (80 FR 76546–76553), costs incurred as a result of providing
Furthermore, HHS believes that there is extending the effective time period to inmate calling services, including the
good cause hereby to bypass notice and December 31, 2022, and deleting costs of reimbursing facilities for any
comment and proceed to a direct final obsolete language referring to SEPPA. costs they may incur that are reasonably
rule, pursuant to 5 U.S.C. 553 (b)(B). and directly related to the provision of
The action is non-controversial, as it Executive Order 12866 service. The Order also clarifies the
merely removes a provision from the This action does not meet the criteria definition of ‘‘mandatory taxes and
CFR that is obsolete. This rule poses no for a significant regulatory action as set fees’’ and addresses other arguments
new substantive requirements on the out under Executive Order 12866, and raised by Mr. Hamden.
public. Accordingly, HHS believes this review by the Office of Management and DATES: The rules adopted in this
direct final rule will not elicit any Budget has accordingly not been document shall become effective
significant adverse comments, but if required. December 12, 2016, except for the
such comments are received HHS will
Regulatory Flexibility Act amendments to 47 CFR 64.6010(a) and
publish a timely notice of withdrawal in
(c), which shall become effective March
the Federal Register. This action will not have a significant
13, 2017.
economic impact on a substantial
I. Background FOR FURTHER INFORMATION CONTACT: Gil
number of small entities. Therefore, the
The Smallpox Emergency Personnel regulatory flexibility analysis provided Strobel, Wireline Competition Bureau,
Protection Act of 2003 (SEPPA), (42 for under the Regulatory Flexibility Act Pricing Policy Division at (202) 418–
U.S.C. 239 et seq.) enacted on April 30, is not required. 1540 or at Gil.Strobel@fcc.gov.
2003, authorized the Secretary of the SUPPLEMENTARY INFORMATION: This is a
Department of Health and Human Paperwork Reduction Act summary of the Commission Order on
Services (the Secretary), through the This action does not affect any Reconsideration, released August 9,
establishment of the Smallpox Vaccine information collections. 2016. The full text of this document
Injury Compensation Program (SVICP), List of Subjects in 42 CFR Part 102 may be downloaded at the following
to provide benefits and/or compensation internet address: https://apps.fcc.gov/
to certain persons who sustained Biologics, Immunization, Public edocs_public/attachmatch/FCC-16-
covered injuries as a direct result of the health, Smallpox. 102A1.docx This document does not
administration of covered smallpox contain new or modified information
PART 102—[REMOVED]
countermeasures (including the collection requirements subject to the
smallpox vaccine) or as a result of ■ For reasons set out in the preamble, Paperwork Reduction Act of 1995
vaccinia contracted through accidental and under the authority at 5 U.S.C. 301, (PRA), Public Law 104–13.
vaccinia contact. The SVICP’s HHS amends 42 CFR chapter I by I. Executive Summary
implementing regulation was codified at removing part 102.
42 CFR part 102. 1. In this order, we respond to the
The SVICP provided compensation Dated: August 26, 2016. petition filed by Michael S. Hamden
for unreimbursed medical expenses James Macrae, and amend our rate caps to improve the
and/or lost employment income to Acting Administrator, Health Resources and ability of providers to cover costs
eligible individuals for covered injuries Services Administration. facilities may incur that are reasonably
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sustained as a direct result of the Approved: September 7, 2016. related to the provision of ICS.
smallpox vaccine or accidental vaccinia Sylvia M. Burwell, • The Commission is statutorily
inoculation, and/or death benefits to Secretary, Department of Health and Human mandated to ensure ICS rates are just,
certain survivors of these individuals. Services. fair, and reasonable and to promote
The Secretary did not extend SEPPA’s [FR Doc. 2016–21888 Filed 9–12–16; 8:45 am] access to ICS by inmates and their
Declaration Regarding Administration of BILLING CODE 4165–15–P families and friends. In response to

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Document Created: 2018-02-09 13:16:33
Document Modified: 2018-02-09 13:16:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Direct final rule.
Dates		This action is effective November 14, 2016 without further action, unless adverse comment is received by October 13, 2016. If adverse comment is received, HHS will publish a timely withdrawal of the rule in the Federal Register.
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]
FR Citation		81 FR 62817
RIN Number		0906-AA84
CFR Associated		Biologics; Immunization; Public Health and Smallpox