Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68, 10685-10686 [2015-04121]

Download as PDF Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices Washington, DC 20405. ATTN: Ms. Hada Flowers/IC 3090–0080, Contract Financing Final Payment; (GSA Form 1142, Release of Claims). Instructions: Please submit comments only and cite Information Collection 3090–0080, Contract Financing Final Payment; (GSA Form 1142, Release of Claims), in all correspondence related to this collection. All comments received will be posted without change to https:// www.regulations.gov, including any personal and/or business confidential information provided. SUPPLEMENTARY INFORMATION: A. Purpose The General Services Administration Acquisition Regulation (GSAR) clause 552.232–72 requires construction and building services contractors to submit a release of claims before final payment is made to ensure contractors are paid in accordance with their contract requirements and for work performed. GSA Form 1142, Release of Claims is used to achieve uniformity and consistency in the release of claims process. B. Annual Reporting Burden Respondents: 2000. Responses per Respondent: 1. Hours per Response: .10. Total Burden Hours: 200. mstockstill on DSK4VPTVN1PROD with NOTICES C. Public Comment Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0080, Contract Financing Final Payment; (GSA Form 1142, Release of Claims), in all correspondence. Dated: February 24, 2015. Jeffrey A. Koses, Director, Office of Acquisition Policy, Office of Government-wide Policy. [FR Doc. 2015–04116 Filed 2–26–15; 8:45 am] BILLING CODE 6820–61–P VerDate Sep<11>2014 18:05 Feb 26, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb–3. On February 6, 2015, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves enterovirus D68 (EV–D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV–D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. DATES: The determination and declaration are effective February 6, 2015. FOR FURTHER INFORMATION CONTACT: Karen Mason, Centers for Disease Control and Prevention, 1600 Clifton Road MS–A34, Atlanta, GA 30333, Telephone (404) 639–1297 (this is not a toll free number). SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product. Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (‘‘CBRN’’) agent or agents; (2) the identification of a material threat by PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 10685 the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act 1 sufficient to affect national security or the health and security of United States citizens living abroad; (3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a CBRN agent or agents; or (4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents.2 Based on any of these four determinations, the Secretary of HHS may then declare that circumstances exist that justify the EUA, at which point the FDA Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FD&C Act are met. The Centers for Disease Control and Prevention (CDC), HHS, requested that the FDA, HHS, issue an EUA for new in vitro diagnostics for detection of EV–D68 to allow the Department to take preparedness measures based on information currently available about the EV–D68. The determination of a significant potential for a public health emergency, and the declaration that circumstances exist justifying emergency use of new in vitro diagnostics for detection of EV–D68 by the Secretary of HHS, as described below, enable the FDA Commissioner to issue an EUA for in vitro diagnostics for detection of EV–D68 for emergency use under section 564 of the FD&C Act. II. Determination by the Secretary of Health and Human Services On February 6, 2015, pursuant to section 564 of the FD&C Act, I determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and 1 42 U.S.C. 247d–6b amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, Public Law 113– 5, the Secretary may make determination of a public health emergency, or a significant potential for a public health emergency, under section 564 of the FD&C Act. The Secretary is no longer required to make a determination of a public health emergency in accordance with section 319 of the PHS Act, 42 U.S.C. 247d, to support a determination or declaration made under section 564 of the FD&C Act. 2 As E:\FR\FM\27FEN1.SGM 27FEN1 10686 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices security of United States citizens living abroad and that involves EV–D68. III. Declaration of the Secretary of Health and Human Services Also on February 6, 2015, on the basis of my determination of a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves EV–D68, I declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV–D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Notice of the EUAs issued by the FDA Commissioner pursuant to this determination and declaration will be provided promptly in the Federal Register as required under section 564 of the FD&C Act. Dated: February 6, 2015. Sylvia M. Burwell, Secretary. [FR Doc. 2015–04121 Filed 2–26–15; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https:// www.dhhs.gov/ohrp/sachrp/mtgings/ index.html. SUMMARY: The meeting will be held on Tuesday, March 24, 2015, from 8:30 a.m. until 5:00 p.m. and Wednesday, March 25, 2015, from 8:30 a.m. until 4:30 p.m. ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, Maryland 20852. FOR FUTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP), or mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:05 Feb 26, 2015 Jkt 235001 Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240–453–8141; fax: 240–453–6909; email address: SACHRP@hhs.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The meeting will open to the public at 8:30 a.m., on Tuesday, March 24. Following opening remarks from Dr. Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, Dr. Botkin and invited speakers will discuss issues surrounding the use of newborn dried bloodspots in research. The Subpart A Subcommittee (SAS) report will follow; SAS will discuss draft recommendations on the research uses of newborn dried bloodspots and the Newborn Screening Saves Lives Reauthorization Act of 2014. SAS was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment. In the afternoon of March 24, the Subcommittee on Harmonization (SOH) will present their report; SOH was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/ or coordination. SOH will present recommendations on the research use of ‘‘big data’’ and the intersection of the HHS and FDA regulations. On March 25, the SOH will discuss the return of individual research results with special considerations regarding HIPAA and CLIA; this will be followed by presentation of SOH recommendations on the FDA draft guidance ‘‘General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biologics.’’ The meeting will adjourn at 4:30 p.m. March 25, 2015. Time for public comment sessions will be allotted both days. Public attendance at the meeting is limited to space available. Individuals PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify one of the designated SACHRP points of contact at the address/phone number listed above at least one week prior to the meeting. Pre-registration is required for participation in the on-site public comment session; individuals may preregister the day of the meeting. Individuals who would like to submit written statements should email or fax their comments to SACHRP at SACHRP@hhs.gov at least five business days prior to the meeting. Dated: February 23, 2015. Jerry Menikoff, Executive Secretary, Secretary’s Advisory Committee on Human Research Protections, Director, Office for Human Research Protections. [FR Doc. 2015–04120 Filed 2–26–15; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–1696 and CMS– 10417] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to SUMMARY: E:\FR\FM\27FEN1.SGM 27FEN1

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[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10685-10686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Determination and Declaration Regarding Emergency Use of New In 
Vitro Diagnostics for Detection of Enterovirus D68

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Secretary of Health and Human Services (HHS) is issuing 
this notice pursuant to section 564 of the Federal Food, Drug, and 
Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 6, 2015, the 
Secretary determined that there is a significant potential for a public 
health emergency that has a significant potential to affect national 
security or the health and security of United States citizens living 
abroad and that involves enterovirus D68 (EV-D68). On the basis of this 
determination, she also declared that circumstances exist justifying 
the authorization of emergency use of new in vitro diagnostics for 
detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to 
the terms of any authorization issued under that section.

DATES: The determination and declaration are effective February 6, 
2015.

FOR FURTHER INFORMATION CONTACT: Karen Mason, Centers for Disease 
Control and Prevention, 1600 Clifton Road MS-A34, Atlanta, GA 30333, 
Telephone (404) 639-1297 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Under Section 564 of the FD&C Act, the Commissioner of the Food and 
Drug Administration (FDA), acting under delegated authority from the 
Secretary of HHS, may issue an Emergency Use Authorization (EUA) 
authorizing (1) the emergency use of an unapproved drug, an unapproved 
or uncleared device, or an unlicensed biological product; or (2) an 
unapproved use of an approved drug, approved or cleared device, or 
licensed biological product. Before an EUA may be issued, the Secretary 
of HHS must declare that circumstances exist justifying the 
authorization based on one of four determinations: (1) A determination 
by the Secretary of Homeland Security that there is a domestic 
emergency, or a significant potential for a domestic emergency, 
involving a heightened risk of attack with a chemical, biological, 
radiological, or nuclear (``CBRN'') agent or agents; (2) the 
identification of a material threat by the Secretary of Homeland 
Security pursuant to section 319F-2 of the Public Health Service (PHS) 
Act \1\ sufficient to affect national security or the health and 
security of United States citizens living abroad; (3) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to United States military forces of attack with a CBRN agent or 
agents; or (4) a determination by the Secretary that there is a public 
health emergency, or a significant potential for a public health 
emergency, that affects, or has a significant potential to affect 
national security or the health and security of United States citizens 
living abroad, and that involves a CBRN agent or agents, or a disease 
or condition that may be attributable to such agent or agents.\2\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 247d-6b
    \2\ As amended by the Pandemic and All-Hazards Preparedness 
Reauthorization Act, Public Law 113-5, the Secretary may make 
determination of a public health emergency, or a significant 
potential for a public health emergency, under section 564 of the 
FD&C Act. The Secretary is no longer required to make a 
determination of a public health emergency in accordance with 
section 319 of the PHS Act, 42 U.S.C. 247d, to support a 
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------

    Based on any of these four determinations, the Secretary of HHS may 
then declare that circumstances exist that justify the EUA, at which 
point the FDA Commissioner may issue an EUA if the criteria for 
issuance of an authorization under section 564 of the FD&C Act are met. 
The Centers for Disease Control and Prevention (CDC), HHS, requested 
that the FDA, HHS, issue an EUA for new in vitro diagnostics for 
detection of EV-D68 to allow the Department to take preparedness 
measures based on information currently available about the EV-D68.
    The determination of a significant potential for a public health 
emergency, and the declaration that circumstances exist justifying 
emergency use of new in vitro diagnostics for detection of EV-D68 by 
the Secretary of HHS, as described below, enable the FDA Commissioner 
to issue an EUA for in vitro diagnostics for detection of EV-D68 for 
emergency use under section 564 of the FD&C Act.

II. Determination by the Secretary of Health and Human Services

    On February 6, 2015, pursuant to section 564 of the FD&C Act, I 
determined that there is a significant potential for a public health 
emergency that has a significant potential to affect national security 
or the health and

[[Page 10686]]

security of United States citizens living abroad and that involves EV-
D68.

III. Declaration of the Secretary of Health and Human Services

    Also on February 6, 2015, on the basis of my determination of a 
significant potential for a public health emergency that has a 
significant potential to affect national security or the health and 
security of United States citizens living abroad and that involves EV-
D68, I declared that circumstances exist justifying the authorization 
of emergency use of new in vitro diagnostics for detection of EV-D68 
pursuant to section 564 of the FD&C Act, subject to the terms of any 
authorization issued under that section.
    Notice of the EUAs issued by the FDA Commissioner pursuant to this 
determination and declaration will be provided promptly in the Federal 
Register as required under section 564 of the FD&C Act.

    Dated: February 6, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-04121 Filed 2-26-15; 8:45 am]
BILLING CODE 4150-37-P
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