82 FR 60017 - Invitation to Manufacturers of Pertussis Serological Kits
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 241 (December 18, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 241 (December 18, 2017)
| Page Range | 60017-60018 | |
| FR Document | 2017-27189 |
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)] [Notices] [Pages 60017-60018] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60017
Study Section business and for the study meetings and other committee Respiratory Diseases, Centers for
section to consider safety and occupational management activities, for both the Disease Control and Prevention, 1600
health-related grant applications. Centers for Disease Control and Clifton Road NE, Mail Stop D–11,
For Further Information Contact: Nina Prevention and the Agency for Toxic Atlanta, GA 30329.
Turner, Ph.D., Scientific Review Officer,
NIOSH, 1095 Willowdale Road, Morgantown,
Substances and Disease Registry. FOR FURTHER INFORMATION CONTACT:
WV 26506, (304) 285–5976; nturner@cdc.gov. Elaine L. Baker, For Technical Questions: Lucia
The Director, Management Analysis and Director, Management Analysis and Services Tondella, National Center for
Services Office, has been delegated the Office, Centers for Disease Control and Immunization and Respiratory Diseases,
authority to sign Federal Register notices Prevention. Centers for Disease Control and
pertaining to announcements of meetings and [FR Doc. 2017–27164 Filed 12–15–17; 8:45 am] Prevention, 1600 Clifton Road NE, Mail
other committee management activities, for
BILLING CODE 4163–18–P Stop D–11, Atlanta, GA 30329. Phone:
both the Centers for Disease Control and
Prevention and the Agency for Toxic 404–639–1239, Email: PertussisDL@
Substances and Disease Registry. cdc.gov.
DEPARTMENT OF HEALTH AND For Business Questions: Jason
Elaine L. Baker, HUMAN SERVICES Cloward, Technology Transfer Office,
Director, Management Analysis and Services Centers for Disease Control and
Office, Centers for Disease Control and Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Prevention. Prevention
Stop E–51, Atlanta, GA 30329. Phone:
[FR Doc. 2017–27165 Filed 12–15–17; 8:45 am]
Invitation to Manufacturers of 404–639–2679, Email: wnv3@cdc.gov.
BILLING CODE 4163–18–P
Pertussis Serological Kits SUPPLEMENTARY INFORMATION: CDC’s
National Center for Immunization and
AGENCY: Centers for Disease Control and
DEPARTMENT OF HEALTH AND Respiratory Diseases (NCIRD), Division
Prevention (CDC), Department of Health
HUMAN SERVICES of Bacterial Diseases (DBD), Meningitis
and Human Services (HHS).
and Vaccine Preventable Diseases
ACTION: Notice.
Centers for Disease Control and Branch (MVPDB) has lead technical
Prevention SUMMARY: The Centers for Disease responsibility for research, development
Control and Prevention (CDC) within and evaluation of diagnostic assays for
Board of Scientific Counselors, the Department of Health and Human their application in epidemiologic
National Center for Injury Prevention Services (HHS) announces an studies of pertussis. CDC uses
and Control (BSC, NCIPC); Notice of opportunity for commercial epidemiologic, laboratory, clinical, and
Charter Renewal; Correction manufacturers to work with CDC’s biostatistical sciences to control and
National Center for Immunization and prevent bacterial infectious disease such
Notice is hereby given of a change in as pertussis. CDC also conducts applied
the Charter Renewal of the Board of Respiratory Diseases (NCIRD) on the
validation of pertussis serological kits research in a variety of settings, and
Scientific Counselors, National Center translates the findings of this research
for Injury Prevention and Control (BSC, prior to submission to the Food and
Drug Administration (FDA) for into public health practice.
NCIPC), Notice of Charter Renewal
marketing authorization. CDC is CDC is working closely with the
which was published in the Federal
interested in the development of an Council of State and Territorial
Register on November 24, 2017, Volume
assay that is an Immunoglobulin G (IgG) Epidemiologists (CSTE) to consider
82, Number 225, page 55843.
anti-pertussis toxin (PT) enzyme-linked including serology as an appropriate
The name of the committee should
immunosorbent assay (ELISA), diagnostic tool for confirming a
read as follows: Board of Scientific
calibrated to an international reference pertussis case. Serology can be very
Counselors, National Center for Injury
standard (such as FDA Reference useful for diagnosing pertussis in
Prevention and Control (BSC, NCIPC)
Standard Lot #3, World Health adolescents and adults during the later
and the Summary section should read as
Organization (WHO) International phases of disease when the current
follows:
Standard 06/140, or equivalents). The accepted diagnostic methods, culture
SUMMARY: This gives notice under the ELISA will be used for in vitro and PCR, are no longer reliable.
Federal Advisory Committee Act of serological diagnosis of pertussis in Sensitive and specific quantitative
October 6, 1972, that the Board of clinical cases of selected age groups. seroassays have been developed and are
Scientific Counselors, National Center CDC will be able to provide guidance, routinely used for diagnosis of pertussis
for Injury Prevention and Control (BSC, materials, and evaluation support for world-wide; however, FDA marketing
NCIPC), Centers for Disease Control and the manufacturer; however, the authorization is necessary before these
Prevention, Department of Health and manufacturer will be responsible for seroassays can be made commercially
Human Services, has been renewed for submitting a premarket submission to available as in vitro diagnostics in the
a 2-year period through November 5, FDA with adequate information, United States. To date, no quantitative
2019. including any analytical or clinical data pertussis serology kits are commercially
FOR FURTHER INFORMATION CONTACT: needed to support the submission, to available in the United States for
Gwendolyn H. Cattledge, Ph.D., demonstrate to FDA that FDA can grant diagnostic use.
M.S.E.H., Deputy Associate Director for marketing authorization to the product. Interested manufacturers that may
Science, NCIPC, CDC, 4770 Buford DATES: CDC is accepting information have candidate products are invited to
daltland on DSKBBV9HB2PROD with NOTICES
Highway NE, Mailstop F–63, Atlanta, through June 18, 2018. contact CDC to discuss potential
GA 30341, Telephone (770) 488–1430. ADDRESSES: You may submit opportunities for collaboration. At a
Email address: GCattledge@cdc.gov. information by any of the following minimum, discussions with CDC should
The Director, Management Analysis methods: include the following information for
and Services Office, has been delegated • Email: PertussisDL@cdc.gov. each candidate product:
the authority to sign Federal Register • Mail: Lucia Tondella, National a. Product package insert or detailed
notices pertaining to announcements of Center for Immunization and instructions for use.
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![60018 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
b. Detailed information to determine Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
if the product is calibrated to a Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
recognized standard. following way: Agency will review this copy, including
c. Detailed summary of data • Federal eRulemaking Portal: the claimed confidential information, in
demonstrating suitable analytical and https://www.regulations.gov. Follow the its consideration of comments. The
clinical test characteristics (i.e. instructions for submitting comments. second copy, which will have the
precision, linearity, accuracy, Comments submitted electronically, claimed confidential information
sensitivity/specificity, etc.). including attachments, to https:// redacted/blacked out, will be available
Any collaborations that result from www.regulations.gov will be posted to for public viewing and posted on
these conversations will require that https://www.regulations.gov. Submit
the docket unchanged. Because your
manufacturers enter into an appropriate both copies to the Dockets Management
comment will be made public, you are
agreement prior to the transfer of any Staff. If you do not wish your name and
solely responsible for ensuring that your
material to or from CDC. Sample contact information to be made publicly
comment does not include any
agreements may be viewed at the available, you can provide this
confidential information that you or a
following website: https://www.cdc.gov/ information on the cover sheet and not
third party may not wish to be posted,
od/science/technology/techtransfer/ in the body of your comments and you
such as medical information, your or
researchers/formsagreements/ must identify this information as
anyone else’s Social Security number, or
index.htm. ‘‘confidential.’’ Any information marked
confidential business information, such
All information submitted to CDC will as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
be kept confidential as allowed by that if you include your name, contact
relevant federal law, including the and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
Freedom of Information Act (5 U.S.C. identifies you in the body of your
552) and the Trade Secrets Act (18 of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
U.S.C. 1905). posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Dated: December 13, 2017. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Sandra Cashman, with confidential information that you 23389.pdf.
Executive Secretary, Centers for Disease do not wish to be made available to the Docket: For access to the docket to
Control and Prevention. public, submit the comment as a read background documents or the
[FR Doc. 2017–27189 Filed 12–15–17; 8:45 am] written/paper submission and in the electronic and written/paper comments
BILLING CODE 4163–18–P manner detailed (see ‘‘Written/Paper received, go to https://
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on any guidance at any time as follows: with a heading or cover note that states Drug User Fee Amendments of 2012
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Document Created: 2017-12-15 23:54:55
Document Modified: 2017-12-15 23:54:55
| 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 | CDC is accepting information through June 18, 2018. | |
| 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] | |
| FR Citation | 82 FR 60017 |
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