[Federal Register: September 7, 2006 (Volume 71, Number 173)]
[Notices]
[Page 52799-52800]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se06-59]
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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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of the draft guidance entitled ``Commercially Distributed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DATES: Submit written or electronic comments on this draft guidance by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Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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