Invitation to Manufacturers of Pertussis Serological Kits, 60017-60018 [2017-27189]

Download as PDF 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]


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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.

-----------------------------------------------------------------------

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