Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program, 62817-62818 [2016-21888]

Download as PDF 62817 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Rules and Regulations REGULATION FOR THE CONTROL OF ATMOSPHERIC POLLUTION AND PUERTO RICO LAWS Commonwealth effective date Puerto Rico regulation * * * EPA approval date * Comments * * * PUERTO RICO LAWS Act 1 (‘‘Puerto Rico Government Ethics Act of 2011’’), Chapter V, ‘‘Financial Reports’’. January 3, 2012 ........ September 13, 2016, [insert Federal Register citation]. Act 416 (Commonwealth of Puerto Rico’s ‘‘Environmental Public Policy Act’’), Title II, ‘‘On the Environmental Board,’’ Section 7, ‘‘Creating the Board; Members; Terms,’’ sections A. and D. September 22, 2004 September 13, 2016, [insert Federal Register citation]. ■ 4. Add § 52.2730 to read as follows: Lhorne on DSK30JT082PROD with RULES § 52.2730 Section 110(a)(2) infrastructure requirements. (a) 1997 8-hour ozone and the 1997 PM2.5 NAAQS—(1) Approval. Submittal from Puerto Rico dated November 29, 2006 and supplemented February 1, 2016, to address the CAA infrastructure requirements for the 1997 ozone and the 1997 PM2.5 NAAQS. This submittal satisfies the 1997 ozone and the 1997 PM2.5 NAAQS requirements of the Clean Air Act (CAA) 110(a)(2)(A), (B), (C) (with the exception of program requirements for PSD), (D)(i)(II) and (ii) (with the exception of program requirements related to PSD), (E), (F), (G), (H), (J) (with the exception of program requirements related to PSD), (K), (L), and (M). (2) Disapproval. Submittal from Puerto Rico dated November 29, 2006 and supplemented February 1, 2016, to address the CAA infrastructure requirements for the 1997 ozone and the 1997 PM2.5 NAAQS are disapproved for the following sections: 110(a)(2)(C) (PSD program only), (D)(i)(II), PSD program only), (D)(ii) (PSD program only) and (J) (PSD program only). These requirements are being addressed by § 52.2729 which has been delegated to Puerto Rico to implement. (b) 2008 ozone and the 2006 PM2.5 NAAQS—(1) Approval. Submittal from Puerto Rico dated January 22, 2013, supplemented February 1, 2016 to address the CAA infrastructure requirements for the 2008 ozone NAAQS and supplemented April 16, 2015 and February 1, 2016 to address the CAA infrastructure requirements for the 2006 PM2.5 NAAQS. This submittal satisfies the 2008 ozone and the 2006 VerDate Sep<11>2014 15:24 Sep 12, 2016 Jkt 238001 PM2.5 NAAQS requirements of the Clean Air Act (CAA) 110(a)(2)(A), (B), (C) (with the exception of program requirements for PSD), (D)(i)(II) and (ii) (with the exception of program requirements related to PSD), (E), (F), (G), (H), (J) (with the exception of program requirements related to PSD), (K), (L), and (M). (2) Disapproval. Submittal from Puerto Rico dated January 22, 2013 and supplemented April 16, 2015 and February 1, 2016, to address the CAA infrastructure requirements for the 2008 ozone and the 2006 PM2.5 NAAQS are disapproved for the following sections: 110(a)(2)(C) (PSD program only), (D)(i)(II) (PSD program only), (D)(ii) (PSD program only) and (J) (PSD program only). These requirements are being addressed by § 52.2729 which has been delegated to Puerto Rico to implement. (c) 2008 lead NAAQS—(1) Approval. Submittal from Puerto Rico dated January 31, 2013 and supplemented February 1, 2016, to address the CAA infrastructure requirements for the 2008 lead NAAQS. This submittal satisfies the 2008 lead NAAQS requirements of the Clean Air Act (CAA) 110(a)(2)(A), (B), (C) (with the exception of program requirements for PSD), (D)(i)(II) and (ii) (with the exception of program requirements related to PSD), (E), (F), (G), (H), (J) (with the exception of program requirements related to PSD), (K), (L), and (M). (2) Disapproval. Submittal from Puerto Rico dated January 31, 2013 and supplemented February 1, 2016, to address the CAA infrastructure requirements for the 2008 lead NAAQS are disapproved for the following PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 These provisions are intended to apply to any person subject to Clean Air Act section 128, 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. These provisions are intended to apply to any person subject to Clean Air Act section 128, 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. September 22, 2004 is the Commonwealth approval date. sections: 110(a)(2)(C) (PSD program only), (D)(i)(II) (PSD program only), (D)(ii) (PSD program only) and (J) (PSD program only). These requirements are being addressed by § 52.2729 which has been delegated to Puerto Rico to implement. [FR Doc. 2016–21326 Filed 9–12–16; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 102 RIN 0906–AA84 Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program Health Resources and Services Administration, HHS. ACTION: Direct final rule. AGENCY: 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 SUMMARY: E:\FR\FM\13SER1.SGM 13SER1 62818 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES 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 nnair@hrsa.gov. 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 VerDate Sep<11>2014 15:24 Sep 12, 2016 Jkt 238001 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] 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 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [WCB: WC Docket No. 12–375; FCC 16– 102] Rates for Interstate Inmate Calling Services Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Commission continues its reform of the inmate calling services (ICS) marketplace by responding to points raised in a petition filed by Michael S. Hamden, seeking reconsideration of certain aspects of the Commission’s 2015 ICS Order. Specifically, the Commission amends its rate caps to better allow ICS providers to recover costs incurred as a result of providing inmate calling services, including the costs of reimbursing facilities for any costs they may incur that are reasonably and directly related to the provision of service. The Order also clarifies the definition of ‘‘mandatory taxes and fees’’ and addresses other arguments raised by Mr. Hamden. DATES: The rules adopted in this document shall become effective December 12, 2016, except for the amendments to 47 CFR 64.6010(a) and (c), which shall become effective March 13, 2017. FOR FURTHER INFORMATION CONTACT: Gil Strobel, Wireline Competition Bureau, Pricing Policy Division at (202) 418– 1540 or at Gil.Strobel@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission Order on Reconsideration, released August 9, 2016. The full text of this document may be downloaded at the following internet address: https://apps.fcc.gov/ edocs_public/attachmatch/FCC-16102A1.docx This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104–13. SUMMARY: I. Executive Summary 1. In this order, we respond to the petition filed by Michael S. Hamden and amend our rate caps to improve the ability of providers to cover costs facilities may incur that are reasonably related to the provision of ICS. • The Commission is statutorily mandated to ensure ICS rates are just, fair, and reasonable and to promote access to ICS by inmates and their families and friends. In response to E:\FR\FM\13SER1.SGM 13SER1

Agencies

[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 nnair@hrsa.gov.

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