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)

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.

[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]


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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.

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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