80 FR 10685 - Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range		10685-10686
FR Document		2015-04121

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.

Federal Register, Volume 80 Issue 39 (Friday, February 27, 2015)

[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10685-10686]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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\
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    \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.
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    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]
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Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10685

Washington, DC 20405. ATTN: Ms. DEPARTMENT OF HEALTH AND the Secretary of Homeland Security
Hada Flowers/IC 3090–0080, Contract HUMAN SERVICES pursuant to section 319F–2 of the Public
Financing Final Payment; (GSA Form Health Service (PHS) Act 1 sufficient to
1142, Release of Claims). Determination and Declaration affect national security or the health and
Regarding Emergency Use of New In security of United States citizens living
Instructions: Please submit comments
Vitro Diagnostics for Detection of abroad; (3) a determination by the
only and cite Information Collection
Enterovirus D68 Secretary of Defense that there is a
3090–0080, Contract Financing Final
Payment; (GSA Form 1142, Release of AGENCY: Office of the Secretary, military emergency, or a significant
Department of Health and Human potential for a military emergency,
Claims), in all correspondence related to
Services. involving a heightened risk to United
this collection. All comments received
States military forces of attack with a
will be posted without change to http:// ACTION: Notice.
CBRN agent or agents; or (4) a
www.regulations.gov, including any
SUMMARY: The Secretary of Health and determination by the Secretary that
personal and/or business confidential there is a public health emergency, or a
information provided. Human Services (HHS) is issuing this
notice pursuant to section 564 of the significant potential for a public health
SUPPLEMENTARY INFORMATION: Federal Food, Drug, and Cosmetic emergency, that affects, or has a
(FD&C) Act, 21 U.S.C. 360bbb–3. On significant potential to affect national
A. Purpose security or the health and security of
February 6, 2015, the Secretary
The General Services Administration determined that there is a significant United States citizens living abroad, and
potential for a public health emergency that involves a CBRN agent or agents, or
Acquisition Regulation (GSAR) clause
that has a significant potential to affect a disease or condition that may be
552.232–72 requires construction and
national security or the health and attributable to such agent or agents.2
building services contractors to submit Based on any of these four
a release of claims before final payment security of United States citizens living
abroad and that involves enterovirus determinations, the Secretary of HHS
is made to ensure contractors are paid may then declare that circumstances
in accordance with their contract D68 (EV–D68). On the basis of this
determination, she also declared that exist that justify the EUA, at which
requirements and for work performed. point the FDA Commissioner may issue
GSA Form 1142, Release of Claims is circumstances exist justifying the
authorization of emergency use of new an EUA if the criteria for issuance of an
used to achieve uniformity and authorization under section 564 of the
consistency in the release of claims in vitro diagnostics for detection of
EV–D68 pursuant to section 564 of the FD&C Act are met. The Centers for
process. Disease Control and Prevention (CDC),
FD&C Act, subject to the terms of any
B. Annual Reporting Burden authorization issued under that section. HHS, requested that the FDA, HHS,
DATES: The determination and
issue an EUA for new in vitro
Respondents: 2000. declaration are effective February 6, diagnostics for detection of EV–D68 to
Responses per Respondent: 1. 2015. allow the Department to take
preparedness measures based on
Hours per Response: .10. FOR FURTHER INFORMATION CONTACT: information currently available about
Total Burden Hours: 200. Karen Mason, Centers for Disease the EV–D68.
Control and Prevention, 1600 Clifton The determination of a significant
C. Public Comment Road MS–A34, Atlanta, GA 30333, potential for a public health emergency,
Telephone (404) 639–1297 (this is not a and the declaration that circumstances
Public comments are particularly toll free number).
invited on: Whether this collection of exist justifying emergency use of new in
SUPPLEMENTARY INFORMATION: vitro diagnostics for detection of
information is necessary and whether it
will have practical utility; whether our I. Background EV–D68 by the Secretary of HHS, as
estimate of the public burden of this described below, enable the FDA
Under Section 564 of the FD&C Act, Commissioner to issue an EUA for in
collection of information is accurate, the Commissioner of the Food and Drug
and based on valid assumptions and vitro diagnostics for detection of
Administration (FDA), acting under EV–D68 for emergency use under
methodology; ways to enhance the delegated authority from the Secretary
quality, utility, and clarity of the section 564 of the FD&C Act.
of HHS, may issue an Emergency Use
information to be collected. Authorization (EUA) authorizing (1) the II. Determination by the Secretary of
Obtaining Copies of Proposals: emergency use of an unapproved drug, Health and Human Services
Requesters may obtain a copy of the an unapproved or uncleared device, or On February 6, 2015, pursuant to
information collection documents from an unlicensed biological product; or (2) section 564 of the FD&C Act, I
the General Services Administration, an unapproved use of an approved drug, determined that there is a significant
Regulatory Secretariat (MVCB), 1800 F approved or cleared device, or licensed potential for a public health emergency
Street NW., Washington, DC 20405, biological product. Before an EUA may that has a significant potential to affect
telephone (202) 501–4755. Please cite be issued, the Secretary of HHS must national security or the health and
OMB Control No. 3090–0080, Contract declare that circumstances exist
Financing Final Payment; (GSA Form justifying the authorization based on 1 42 U.S.C. 247d–6b
1142, Release of Claims), in all one of four determinations: (1) A 2 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
mstockstill on DSK4VPTVN1PROD with NOTICES

correspondence. determination by the Secretary of
5, the Secretary may make determination of a public
Homeland Security that there is a
Dated: February 24, 2015. health emergency, or a significant potential for a
domestic emergency, or a significant public health emergency, under section 564 of the
Jeffrey A. Koses, potential for a domestic emergency, FD&C Act. The Secretary is no longer required to
Director, Office of Acquisition Policy, Office involving a heightened risk of attack make a determination of a public health emergency
of Government-wide Policy. in accordance with section 319 of the PHS Act, 42
with a chemical, biological, radiological, U.S.C. 247d, to support a determination or
[FR Doc. 2015–04116 Filed 2–26–15; 8:45 am] or nuclear (‘‘CBRN’’) agent or agents; (2) declaration made under section 564 of the FD&C
BILLING CODE 6820–61–P the identification of a material threat by Act.

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10686 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices

security of United States citizens living Julia Gorey, J.D., Executive Director, who plan to attend and need special
abroad and that involves EV–D68. SACHRP; U.S. Department of Health assistance, such as sign language
and Human Services, 1101 Wootton interpretation or other reasonable
III. Declaration of the Secretary of
Parkway, Suite 200, Rockville, accommodations, should notify one of
Health and Human Services
Maryland 20852; 240–453–8141; fax: the designated SACHRP points of
Also on February 6, 2015, on the basis 240–453–6909; email address: contact at the address/phone number
of my determination of a significant SACHRP@hhs.gov. listed above at least one week prior to
potential for a public health emergency SUPPLEMENTARY INFORMATION: Under the the meeting. Pre-registration is required
that has a significant potential to affect authority of 42 U.S.C. 217a, Section 222 for participation in the on-site public
national security or the health and of the Public Health Service Act, as comment session; individuals may pre-
security of United States citizens living amended, SACHRP was established to register the day of the meeting.
abroad and that involves EV–D68, I provide expert advice and Individuals who would like to submit
declared that circumstances exist recommendations to the Secretary of written statements should email or fax
justifying the authorization of Health and Human Services, through their comments to SACHRP at
emergency use of new in vitro the Assistant Secretary for Health, on SACHRP@hhs.gov at least five business
diagnostics for detection of EV–D68 issues and topics pertaining to or days prior to the meeting.
pursuant to section 564 of the FD&C associated with the protection of human Dated: February 23, 2015.
Act, subject to the terms of any research subjects. Jerry Menikoff,
authorization issued under that section. The meeting will open to the public
Executive Secretary, Secretary’s Advisory
Notice of the EUAs issued by the FDA at 8:30 a.m., on Tuesday, March 24. Committee on Human Research Protections,
Commissioner pursuant to this Following opening remarks from Dr. Director, Office for Human Research
determination and declaration will be Jerry Menikoff, Executive Secretary of Protections.
provided promptly in the Federal SACHRP and OHRP Director, and Dr. [FR Doc. 2015–04120 Filed 2–26–15; 8:45 am]
Register as required under section 564 Jeffrey Botkin, SACHRP Chair, Dr. BILLING CODE 4150–36–P
of the FD&C Act. Botkin and invited speakers will discuss
Dated: February 6, 2015. issues surrounding the use of newborn
Sylvia M. Burwell,
dried bloodspots in research. The DEPARTMENT OF HEALTH AND
Subpart A Subcommittee (SAS) report HUMAN SERVICES
Secretary.
will follow; SAS will discuss draft
[FR Doc. 2015–04121 Filed 2–26–15; 8:45 am]
recommendations on the research uses Centers for Medicare & Medicaid
BILLING CODE 4150–37–P of newborn dried bloodspots and the Services
Newborn Screening Saves Lives
[Document Identifier: CMS–1696 and CMS–
Reauthorization Act of 2014. SAS was 10417]
DEPARTMENT OF HEALTH AND established by SACHRP in October 2006
HUMAN SERVICES and is charged with developing Agency Information Collection
Meeting of the Secretary’s Advisory recommendations for consideration by Activities: Proposed Collection;
Committee on Human Research SACHRP regarding the application of Comment Request
Protections subpart A of 45 CFR part 46 in the
current research environment. AGENCY: Centers for Medicare &
AGENCY: Office of the Assistant In the afternoon of March 24, the Medicaid Services, HHS.
Secretary for Health, Office of the Subcommittee on Harmonization (SOH) ACTION: Notice.
Secretary, Department of Health and will present their report; SOH was
established by SACHRP at its July 2009 SUMMARY: The Centers for Medicare &
Human Services.
meeting and charged with identifying Medicaid Services (CMS) is announcing
ACTION: Notice. an opportunity for the public to
and prioritizing areas in which
SUMMARY: Pursuant to Section 10(a) of regulations and/or guidelines for human comment on CMS’ intention to collect
the Federal Advisory Committee Act, subjects research adopted by various information from the public. Under the
U.S.C. Appendix 2, notice is hereby agencies or offices within HHS would Paperwork Reduction Act of 1995 (the
given that the Secretary’s Advisory benefit from harmonization, PRA), federal agencies are required to
Committee on Human Research consistency, clarity, simplification and/ publish notice in the Federal Register
Protections (SACHRP) will hold a or coordination. SOH will present concerning each proposed collection of
meeting that will be open to the public. recommendations on the research use of information (including each proposed
Information about SACHRP and the full ‘‘big data’’ and the intersection of the extension or reinstatement of an existing
meeting agenda will be posted on the HHS and FDA regulations. collection of information) and to allow
SACHRP Web site at: http:// On March 25, the SOH will discuss 60 days for public comment on the
www.dhhs.gov/ohrp/sachrp/mtgings/ the return of individual research results proposed action. Interested persons are
index.html. with special considerations regarding invited to send comments regarding our
HIPAA and CLIA; this will be followed burden estimates or any other aspect of
DATES: The meeting will be held on this collection of information, including
by presentation of SOH
Tuesday, March 24, 2015, from 8:30 recommendations on the FDA draft any of the following subjects: (1) The
a.m. until 5:00 p.m. and Wednesday, guidance ‘‘General Clinical necessity and utility of the proposed
March 25, 2015, from 8:30 a.m. until
mstockstill on DSK4VPTVN1PROD with NOTICES

Pharmacology Considerations for information collection for the proper
4:30 p.m. Pediatric Studies for Drugs and performance of the agency’s functions;
ADDRESSES: Fishers Lane Conference Biologics.’’ The meeting will adjourn at (2) the accuracy of the estimated
Center, Terrace Level, 5635 Fishers 4:30 p.m. March 25, 2015. Time for burden; (3) ways to enhance the quality,
Lane, Rockville, Maryland 20852. public comment sessions will be utility, and clarity of the information to
FOR FUTHER INFORMATION CONTACT: Jerry allotted both days. be collected; and (4) the use of
Menikoff, M.D., J.D., Director, Office for Public attendance at the meeting is automated collection techniques or
Human Research Protections (OHRP), or limited to space available. Individuals other forms of information technology to

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Document Created: 2015-12-18 13:14:59
Document Modified: 2015-12-18 13:14:59

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		Notices
Action		Notice.
Dates		The determination and declaration are effective February 6, 2015.
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).
FR Citation		80 FR 10685