[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Notices]
[Pages 21160-21161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-3028]


Draft Guidance for Industry; Premarket Approval Applications for 
In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV); 
Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV 
Infection, Hepatitis C, or Other HCV-Associated Disease; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Premarket Approval 
Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C 
Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring 
of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft 
Guidance for Industry and FDA.'' FDA is issuing this draft guidance to 
provide current recommendations about the design, data collection, and 
data analysis of studies that are important to the premarket approval 
application (PMA) process for in vitro diagnostic (IVD) devices 
pertaining to HCV. This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit written comments on the draft guidance by July 26, 2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Premarket Approval Applications for In 
Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): 
Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV 
Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance 
for Industry and FDA'' to the Division of Small Manufacturers 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 301-443-8818. Submit written 
comments on the draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for

[[Page 21161]]

information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Doria DuBois, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 12, 1998, FDA called a meeting of the Microbiology 
Devices Advisory Panel to obtain recommendations from the panel 
regarding scientific information necessary for premarket approval of 
tests for hepatitis viruses. Following the panel meeting and subsequent 
discussions between FDA and industry, FDA developed and published a 
draft guidance (See 64 FR 54902, October 8, 1999). FDA accepted public 
comments regarding the draft guidance until January 6, 2000. This 
second draft guidance incorporates those comments and replaces the 
October 8, 1999, draft guidance document.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on assays for detecting evidence of infection with HCV. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the applicable statutes and regulations.
    The agency has adopted good guidance practices (GGPs) and published 
the final rule, which set forth the agency's regulations for the 
development, issuance, and use of guidance documents (65 FR 56468, 
September 19, 2000). This draft guidance document is issued as a level 
1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Premarket Approval Applications for In Vitro 
Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays 
Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, 
Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for 
Industry and FDA'' via your fax machine, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt press 1 to 
order a document. Enter the document number (1353) followed by the 
pound sign (#). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. The CDRH 
home page may be accessed at http://www.fda.gov/cdrh. ``Premarket 
Approval Applications for In Vitro Diagnostic Devices Pertaining 
Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or 
Monitoring of HCV Infection or HCV-Associated Disease; Draft Guidance 
for Industry and FDA,'' will be available at http://www.fda.gov/cdrh/ode/guidance/1353.pdf. Updated on a regular basis, the CDRH home page 
also includes the civil money penalty guidance documents package, 
device safety alerts, Federal Register reprints, information on 
premarket submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by July 26, 2001. 
Two copies of any comments are to be submitted, except individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The guidance 
document and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 18, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-10528 Filed 4-26-01; 8:45 am]
BILLING CODE 4160-01-S