Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus, 37813-37816 [2018-16537]
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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
In addition, CERCLA provides ATSDR
with the authority to prepare
toxicological profiles for substances not
found on the SPL. CERCLA authorizes
ATSDR to establish and maintain
inventory of literature, research, and
studies on the health effects of toxic
substances (CERCLA Section
104(i)(1)(B)); to respond to requests for
health consultations (CERCLA Section
104(i)(4)); and to support the sitespecific response actions conducted by
the agency.
Availability
The Draft Toxicological Profiles are
available online at https://
www.atsdr.cdc.gov/ToxProfiles and at
www.regulations.gov, Docket No.
ATSDR–2015–0001.
Pamela I. Protzel Berman,
Director, Office of Policy, Partnerships and
Planning, Agency for Toxic Substances and
Disease Registry.
[FR Doc. 2018–16557 Filed 8–1–18; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Announce the Intent To Award an
Administrative Supplement
Announcing the Intent to Award
an Administrative Supplement for two
(2) Help America Vote Act (HAVA)
Training and Technical Assistance
(T/TA) grantees, the National Disability
Rights Network (NDRN) 90HAVA0001
and the National Federation of the Blind
(NFB) 90HAVA0002.
ACTION:
The Administration for
Community Living (ACL) announces the
intent to award an administrative
supplement to the current Help America
Vote Act (HAVA) Training and
Technical Assistance (T/TA) grantees
held by the National Disability Rights
Network (NDRN) and the National
Federation of the Blind (NFB). The
purpose of the HAVA programs are
designed to establish and improve
participation in the election process for
individuals with a full range of
disabilities. In each eligible state and
territory, seven percent of HAVA funds
are set aside for the Protection and
Advocacy Systems (P&As) to ensure that
individuals with disabilities have the
opportunity to participate in every step
of the voting process. After receiving
training and technical assistance, P&As
may inform others on the availability of
accessible voting equipment and its use.
The administrative supplement for FY
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SUMMARY:
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2018 will be in the amount of $122,721
bringing the total award for FY 2018 to
$462,590.
Program Name: Help America Vote
Act Training and Technical Assistance.
Recipients: National Disability Rights
Network (NDRN) and National
Federation of the Blind (NFB).
Period of Performance: The
supplement award will be issued for the
second year of the two-year project
period of September 1, 2018, through
August 30, 2019.
Total Award Amount: NDRN
$326,274 in FY 2018 NFB $136,316 in
FY2018.
Award Type: Administrative
Supplement.
Statutory Authority: This program is
authorized under Title II, Subtitle D,
Part 5 of HAVA 42 U.S.C. 15461–62,
Section 102 of the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000 (DD Act) (42 U.S.C. 15002).
Basis for Award: The additional
funding will not be used to begin new
projects. The funding will be used to
increase NDRN’s capacity building
efforts to provide training and technical
assistance to the Protection and
Advocacy Systems in the electoral
process and NFB will be able to attend
voting related conferences, conduct
voting outreach campaigns and translate
materials into Spanish.
FOR FURTHER INFORMATION CONTACT: For
further information or comments
regarding this program supplement,
contact Melvenia Wright, U.S.
Department of Health and Human
Services, Administration for
Community Living, Administration on
Disabilities, Administration on
Intellectual and Developmental
Disabilities: telephone (202) 795–7472;
email Melvenia.Wright@acl.hhs.gov.
Dated: July 26, 2018.
Lance Robertson,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2018–16561 Filed 8–1–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0126]
Revocation of Authorization of
Emergency Use of an In Vitro
Diagnostic Device for Detection of
Ebola Virus
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
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37813
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Zalgen Labs, LLC for the
ReEBOV Antigen Rapid Test. FDA
revoked this Authorization on May 18,
2018, under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as requested
by Zalgen Labs, LLC by letter dated
March 1, 2018. The revocation, which
includes an explanation of the reasons
for revocation, is reprinted in this
document.
DATES: The Authorization is revoked as
of May 18, 2018.
ADDRESSES: Submit written requests for
single copies of the revocation to the
Office of Counterterrorism and
Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a Fax number to which the
revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocation.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4336, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. On
February 24, 2015, FDA issued an EUA
to Corgenix, Inc. for the ReEBOV
Antigen Rapid Test, subject to the terms
of the Authorization. Notice of the
issuance of the Authorization was
published in the Federal Register on
June 5, 2015 (80 FR 32140), as required
by section 564(h)(1) of the FD&C Act. In
response to requests from Zalgen Labs,
LLC and Corgenix, Inc. to transfer
ownership of the EUA for the ReEBOV
Antigen Rapid Test from Corgenix, Inc.
to Zalgen Labs, LLC, FDA amended and
reissued the EUA to Zalgen Labs, LLC
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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
in its entirety on November 3, 2016.
Under section 564(g)(2), the Secretary of
Health and Human Services may revoke
an EUA if, among other things, the
criteria for issuance are no longer met or
other circumstances make such
revocation appropriate to protect the
public health or safety.
revoked the EUA for the ReEBOV
Antigen Rapid Test on May 18, 2018,
because the criteria for issuance were no
longer met and these circumstances
made such revocation appropriate to
protect the public health or safety.
II. EUA Revocation Request for an In
Vitro Diagnostic Device for Detection of
the Ebola Virus
An electronic version of this
document and the full text of the
revocation are available on the internet
at https://www.regulations.gov.
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Pursuant to a request from Zalgen
Labs, LLC on March 1, 2018, FDA
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III. Electronic Access
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IV. The Revocation
Having concluded that the criteria for
revocation of the Authorization under
section 564(g) of the FD&C Act are met,
FDA has revoked the EUA for Zalgen
Labs, LLC’s ReEBOV Antigen Rapid
Test. The revocation in its entirety
follows and provides an explanation of
the reasons for revocation, as required
by section 564(h)(1) of the FD&C Act.
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Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
37816
Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
[FR Doc. 2018–16537 Filed 8–1–18; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2657]
Advancing the Development of
Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Division of Pediatric and
Maternal Health, Office of Surveillance
and Epidemiology, and Office of
Pediatric Therapeutics, Food and Drug
Administration (FDA or the Agency) are
announcing a public workshop entitled
‘‘Advancing the Development of
Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance.’’ The
purpose of this 1-day workshop is to
provide a forum to gather information
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SUMMARY:
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on the latest developments in pediatric
pharmacovigilance from the perspective
of various stakeholders and to expand
the conversation to include the utility
and challenges of emerging
pharmacovigilance tools, including
specific challenges associated with
pediatric data tools.
DATES: The public workshop will be
held on Friday, September 14, 2018,
from 8 a.m. to 5 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDAWhite Oak Campus,
10903 New Hampshire Ave. Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
For
questions regarding the workshop,
contact Denise Pica-Branco, Center for
FOR FURTHER INFORMATION CONTACT:
PO 00000
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Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1732,
denise.picabranco@fda.hhs.gov; or
Meshaun Payne, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–6668,
meshaun.payne@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Drugs and biologics (products) receive
marketing approval only after
undergoing premarket review and upon
establishment of safety and efficacy
through adequate and well-controlled
clinical trials. Because all safety issues
related to a product may not be detected
in the premarket phase, FDA receives
and analyzes postmarket safety
information to determine if events
reported in the postmarketing period are
likely to be related to exposure to a
product. When FDA determines that
reported postmarketing events are likely
related to a product, FDA can introduce
labeling changes and other activities to
inform the professional and lay public.
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Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37813-37816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16537]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0126]
Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection of Ebola Virus
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA
revoked this Authorization on May 18, 2018, under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by
letter dated March 1, 2018. The revocation, which includes an
explanation of the reasons for revocation, is reprinted in this
document.
DATES: The Authorization is revoked as of May 18, 2018.
ADDRESSES: Submit written requests for single copies of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.
FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On February 24, 2015, FDA issued
an EUA to Corgenix, Inc. for the ReEBOV Antigen Rapid Test, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on June 5, 2015 (80
FR 32140), as required by section 564(h)(1) of the FD&C Act. In
response to requests from Zalgen Labs, LLC and Corgenix, Inc. to
transfer ownership of the EUA for the ReEBOV Antigen Rapid Test from
Corgenix, Inc. to Zalgen Labs, LLC, FDA amended and reissued the EUA to
Zalgen Labs, LLC
[[Page 37814]]
in its entirety on November 3, 2016. Under section 564(g)(2), the
Secretary of Health and Human Services may revoke an EUA if, among
other things, the criteria for issuance are no longer met or other
circumstances make such revocation appropriate to protect the public
health or safety.
II. EUA Revocation Request for an In Vitro Diagnostic Device for
Detection of the Ebola Virus
Pursuant to a request from Zalgen Labs, LLC on March 1, 2018, FDA
revoked the EUA for the ReEBOV Antigen Rapid Test on May 18, 2018,
because the criteria for issuance were no longer met and these
circumstances made such revocation appropriate to protect the public
health or safety.
III. Electronic Access
An electronic version of this document and the full text of the
revocation are available on the internet at https://www.regulations.gov.
IV. The Revocation
Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for Zalgen Labs, LLC's ReEBOV Antigen Rapid Test. The
revocation in its entirety follows and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.
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[GRAPHIC] [TIFF OMITTED] TN02AU18.007
Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16537 Filed 8-1-18; 8:45 am]
BILLING CODE 4164-01-C
