Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal; Correction, 60017 [2017-27164]
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
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section to consider safety and occupational
health-related grant applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
NIOSH, 1095 Willowdale Road, Morgantown,
WV 26506, (304) 285–5976; nturner@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–27165 Filed 12–15–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) announces an
opportunity for commercial
manufacturers to work with CDC’s
National Center for Immunization and
Respiratory Diseases (NCIRD) on the
validation of pertussis serological kits
prior to submission to the Food and
Drug Administration (FDA) for
marketing authorization. CDC is
interested in the development of an
assay that is an Immunoglobulin G (IgG)
anti-pertussis toxin (PT) enzyme-linked
immunosorbent assay (ELISA),
calibrated to an international reference
standard (such as FDA Reference
Standard Lot #3, World Health
Organization (WHO) International
Standard 06/140, or equivalents). The
ELISA will be used for in vitro
serological diagnosis of pertussis in
clinical cases of selected age groups.
CDC will be able to provide guidance,
materials, and evaluation support for
the manufacturer; however, the
manufacturer will be responsible for
submitting a premarket submission to
FDA with adequate information,
including any analytical or clinical data
needed to support the submission, to
demonstrate to FDA that FDA can grant
marketing authorization to the product.
DATES: CDC is accepting information
through June 18, 2018.
ADDRESSES: You may submit
information by any of the following
methods:
• Email: PertussisDL@cdc.gov.
• Mail: Lucia Tondella, National
Center for Immunization and
SUMMARY:
Board of Scientific Counselors,
National Center for Injury Prevention
and Control (BSC, NCIPC); Notice of
Charter Renewal; Correction
Notice is hereby given of a change in
the Charter Renewal of the Board of
Scientific Counselors, National Center
for Injury Prevention and Control (BSC,
NCIPC), Notice of Charter Renewal
which was published in the Federal
Register on November 24, 2017, Volume
82, Number 225, page 55843.
The name of the committee should
read as follows: Board of Scientific
Counselors, National Center for Injury
Prevention and Control (BSC, NCIPC)
and the Summary section should read as
follows:
SUMMARY: This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Board of
Scientific Counselors, National Center
for Injury Prevention and Control (BSC,
NCIPC), Centers for Disease Control and
Prevention, Department of Health and
Human Services, has been renewed for
a 2-year period through November 5,
2019.
FOR FURTHER INFORMATION CONTACT:
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
Centers for Disease Control and
Prevention
Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Deputy Associate Director for
Science, NCIPC, CDC, 4770 Buford
Highway NE, Mailstop F–63, Atlanta,
GA 30341, Telephone (770) 488–1430.
Email address: GCattledge@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
Jkt 244001
[FR Doc. 2017–27164 Filed 12–15–17; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
17:53 Dec 15, 2017
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Invitation to Manufacturers of
Pertussis Serological Kits
BILLING CODE 4163–18–P
VerDate Sep<11>2014
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
PO 00000
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60017
Respiratory Diseases, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mail Stop D–11,
Atlanta, GA 30329.
FOR FURTHER INFORMATION CONTACT:
For Technical Questions: Lucia
Tondella, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Stop D–11, Atlanta, GA 30329. Phone:
404–639–1239, Email: PertussisDL@
cdc.gov.
For Business Questions: Jason
Cloward, Technology Transfer Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Stop E–51, Atlanta, GA 30329. Phone:
404–639–2679, Email: wnv3@cdc.gov.
SUPPLEMENTARY INFORMATION: CDC’s
National Center for Immunization and
Respiratory Diseases (NCIRD), Division
of Bacterial Diseases (DBD), Meningitis
and Vaccine Preventable Diseases
Branch (MVPDB) has lead technical
responsibility for research, development
and evaluation of diagnostic assays for
their application in epidemiologic
studies of pertussis. CDC uses
epidemiologic, laboratory, clinical, and
biostatistical sciences to control and
prevent bacterial infectious disease such
as pertussis. CDC also conducts applied
research in a variety of settings, and
translates the findings of this research
into public health practice.
CDC is working closely with the
Council of State and Territorial
Epidemiologists (CSTE) to consider
including serology as an appropriate
diagnostic tool for confirming a
pertussis case. Serology can be very
useful for diagnosing pertussis in
adolescents and adults during the later
phases of disease when the current
accepted diagnostic methods, culture
and PCR, are no longer reliable.
Sensitive and specific quantitative
seroassays have been developed and are
routinely used for diagnosis of pertussis
world-wide; however, FDA marketing
authorization is necessary before these
seroassays can be made commercially
available as in vitro diagnostics in the
United States. To date, no quantitative
pertussis serology kits are commercially
available in the United States for
diagnostic use.
Interested manufacturers that may
have candidate products are invited to
contact CDC to discuss potential
opportunities for collaboration. At a
minimum, discussions with CDC should
include the following information for
each candidate product:
a. Product package insert or detailed
instructions for use.
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[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Page 60017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Board of Scientific Counselors, National Center for Injury
Prevention and Control (BSC, NCIPC); Notice of Charter Renewal;
Correction
Notice is hereby given of a change in the Charter Renewal of the
Board of Scientific Counselors, National Center for Injury Prevention
and Control (BSC, NCIPC), Notice of Charter Renewal which was published
in the Federal Register on November 24, 2017, Volume 82, Number 225,
page 55843.
The name of the committee should read as follows: Board of
Scientific Counselors, National Center for Injury Prevention and
Control (BSC, NCIPC) and the Summary section should read as follows:
SUMMARY: This gives notice under the Federal Advisory Committee Act of
October 6, 1972, that the Board of Scientific Counselors, National
Center for Injury Prevention and Control (BSC, NCIPC), Centers for
Disease Control and Prevention, Department of Health and Human
Services, has been renewed for a 2-year period through November 5,
2019.
FOR FURTHER INFORMATION CONTACT: Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Deputy Associate Director for Science, NCIPC, CDC, 4770
Buford Highway NE, Mailstop F-63, Atlanta, GA 30341, Telephone (770)
488-1430. Email address: [email protected].
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2017-27164 Filed 12-15-17; 8:45 am]
BILLING CODE 4163-18-P
