Invitation to Manufacturers of Pertussis Serological Kits, 60017-60018 [2017-27189]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
Study Section business and for the study
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
Frm 00018
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\18DEN1.SGM
18DEN1
60018
Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
b. Detailed information to determine
if the product is calibrated to a
recognized standard.
c. Detailed summary of data
demonstrating suitable analytical and
clinical test characteristics (i.e.
precision, linearity, accuracy,
sensitivity/specificity, etc.).
Any collaborations that result from
these conversations will require that
manufacturers enter into an appropriate
agreement prior to the transfer of any
material to or from CDC. Sample
agreements may be viewed at the
following website: https://www.cdc.gov/
od/science/technology/techtransfer/
researchers/formsagreements/
index.htm.
All information submitted to CDC will
be kept confidential as allowed by
relevant federal law, including the
Freedom of Information Act (5 U.S.C.
552) and the Trade Secrets Act (18
U.S.C. 1905).
Dated: December 13, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2017–27189 Filed 12–15–17; 8:45 am]
BILLING CODE 4163–18–P
Food and Drug Administration
[Docket No. FDA–2017–D–6752]
Information Requests and Discipline
Review Letters Under the Generic Drug
User Fee Amendments; Draft Guidance
for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Information Requests and Discipline
Review Letters Under GDUFA.’’ This
draft guidance explains how FDA will
issue and use an information request
(IR) and/or a discipline review letter
(DRL) during the review of an original
abbreviated new drug application
(ANDA).
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by February 16, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
VerDate Sep<11>2014
17:53 Dec 15, 2017
Jkt 244001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Electronic Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–6752 for ‘‘Information Requests
and Discipline Review Letters Under
GDUFA.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Philip Bonforte, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1668,
Silver Spring, MD 20993–0002, 240–
402–9871, philip.bonforte@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Information Requests and Discipline
Review Letters Under GDUFA.’’
Under the first iteration of the Generic
Drug User Fee Amendments of 2012
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60017-60018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Invitation to Manufacturers of Pertussis Serological Kits
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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: [email protected].
Mail: 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.
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: [email protected].
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: [email protected].
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.
[[Page 60018]]
b. Detailed information to determine if the product is calibrated
to a recognized standard.
c. Detailed summary of data demonstrating suitable analytical and
clinical test characteristics (i.e. precision, linearity, accuracy,
sensitivity/specificity, etc.).
Any collaborations that result from these conversations will
require that manufacturers enter into an appropriate agreement prior to
the transfer of any material to or from CDC. Sample agreements may be
viewed at the following website: https://www.cdc.gov/od/science/technology/techtransfer/researchers/formsagreements/index.htm.
All information submitted to CDC will be kept confidential as
allowed by relevant federal law, including the Freedom of Information
Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905).
Dated: December 13, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-27189 Filed 12-15-17; 8:45 am]
BILLING CODE 4163-18-P
