[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 570-571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-33293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0636]
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of Antibodies to Borrelia
Burgdorferi; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry and Food and Drug Administration Staff; Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for the
Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this
draft guidance to provide industry and agency staff with
recommendations for studies to establish the analytical and clinical
performance of in vitro
[[Page 571]]
diagnostic devices (IVDs) intended for the detection of antibodies to
Borrelia burgdorferi. These devices are used to aid in the diagnosis of
Lyme disease. This draft guidance is not final nor is it in effect at
this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 5, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff; Establishing the Performance Characteristics
of In Vitro Diagnostic Devices for the Detection of Antibodies to
Borrelia burgdorferi'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Prasad Rao, Center for Devices and
Radiological Health Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5508, Silver Spring, MD 20993-0002, 301-796-6203.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance recommends studies for establishing the
performance characteristics of in vitro diagnostic devices for the
detection of antibodies to B. burgdorferi in human serum, plasma, and
blood. These devices are used to aid in the diagnosis of Lyme disease.
This document does not apply to B. burgdorferi nucleic acid
amplification assays. A manufacturer who intends to market an in vitro
device for the detection of antibodies to B. burgdorferi must conform
to the general controls of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and, unless exempt, obtain premarket clearance or approval
prior to marketing the device.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent the Agency's current thinking on establishing
the performance characteristics of in vitro diagnostic devices for the
detection of antibodies to B. burgdorferi. 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 requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Draft Guidance for Industry and Food and Drug Administration Staff;
Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies to Borrelia burgdorferi,'' you
may either send an e-mail request to [email protected] to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a hard copy. Please use the document number 1721 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807 subpart E have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 801 and 21 CFR 809.10 have been approved
under OMB control number 0910-0485; the collections of information in
21 CFR part 812 have been approved under OMB control number 0910-0078;
the collections of information in 42 CFR 493.15 have been approved
under OMB control number 0910-0598; the collections of information 21
CFR 50.23 have been approved under OMB control number 0910-0586 and the
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-33293 Filed 1-4-11; 8:45 am]
BILLING CODE 4160-01-P