[Federal Register Volume 71, Number 173 (Thursday, September 7, 2006)]
[Notices]
[Pages 52799-52800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7500]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0336]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Commercially Distributed Analyte Specific Reagents (ASRs): 
Frequently Asked Questions; 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availability of the draft guidance entitled ``Commercially Distributed 
Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' This 
guidance document is intended to clarify the regulations regarding ASRs 
and the role and responsibilities of ASR manufacturers.

DATES: Submit written or electronic comments on this draft guidance by 
December 6, 2006.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Commercially Distributed Analyte Specific Reagents 
(ASRs): Frequently Asked Questions'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Courtney C. Harper, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0490.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is providing this guidance in order to eliminate confusion 
regarding particular marketing practices among ASR manufacturers. ASRs 
are the building blocks of laboratory-developed tests and are defined 
and classified in a rule codified at Sec.  864.4020 (21 CFR 864.4020). 
With this draft guidance document, FDA seeks to advise ASR 
manufacturers that it views certain practices as being inconsistent 
with the marketing of an ASR, as defined in Sec.  864.4020. Some 
manufacturers have believed that when they combine a Class I ASR, which 
is exempt from premarket notification requirements under section 510(l) 
of the Federal Food, Drug, and Cosmetic Act (the act), (21 U.S.C. 
360(l)), with other products, or with instructions for use in a 
specific test, the product remains exempt because of the presence of an 
ASR. However, as explained in this draft guidance, when an ASR is 
marketed in certain ways, FDA views the product as no longer being an 
ASR within the meaning of Sec.  860.4020.

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 commercially 
distributed ASRs. 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

[[Page 52800]]

the Internet. To receive ``Commercially Distributed Analyte Specific 
Reagents (ASRs): Frequently Asked Questions, `` 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 240-276-3151 to receive a hard 
copy. Please use the document number 1590 to identify the guidance you 
are requesting.
    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. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 807.87 have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
809.10 and 809.30 (Sec.  809.30) have been approved under OMB control 
number 0910-0485; and the collections of information in 21 CFR 814.20 
have been approved under OMB control number 0910-0231.
    The draft guidance includes discussion of the restrictions on the 
sale, distribution, and use of ASRs (Sec.  809.30). Under this 
regulation, a laboratory that develops an in-house test using an ASR 
must add a disclaimer when reporting the test result to the 
practitioner (Sec.  809.30(e)). Advertising and promotional materials 
for ASRs must not make any statement regarding analytical or clinical 
performance (Sec.  809.30(d)(4)). In addition, the labeling for Class 
I, exempt ASRs must bear the statement, ``Analyte Specific Reagent. 
Analytical and performance characteristics are not established.'' Class 
II or III ASRs must bear the statement, ``Analyte Specific Reagent. 
Except as a component of the approved/cleared test (name of approved/
cleared test), analytical and performance characteristics are not 
established'' (Sec.  809.30(d)(2) and (d)(3)). The disclaimer and these 
statements do not constitute ``collections of information'' under the 
PRA. Rather, they are ``public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit to the Division of Dockets Managment 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Recieved comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: September 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7500 Filed 9-5-06; 4:00 pm]
BILLING CODE 4160-01-S