[Federal Register: November 28, 2006 (Volume 71, Number 228)]
[Notices]
[Page 68820-68821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no06-57]
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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Draft Guidance for Industry and Food and Drug Administration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; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period on the draft guidance entitled ``Commercially
Distributed Analyte Specific Reagents (ASRs): Frequently Asked
Questions.'' FDA announced the availability of this draft guidance in
the Federal Register of September 7, 2006 (71 FR 52799). The initial
comment period closes on December 6, 2006. To provide interested
persons additional time to review and submit comments on the draft
guidance, FDA has decided to extend the comment period.
DATES: Submit written or electronic comments on this draft guidance by
March 5, 2007. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Commercially Distributed Analyte Specific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 240-276-3151. 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Submit written comments concerning this draft guidance to the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 Harper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0490, ext. 162.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is extending the comment period on the draft guidance
``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently
Asked Questions.'' This draft guidance is intended to help eliminate
confusion regarding particular marketing practices among ASR
manufacturers. With the draft guidance document, FDA seeks to advise
ASR
[[Page 68821]]
manufacturers that it views certain practices as being inconsistent
with the marketing of an ASR, as defined in Sec. 864.4020. As the draft
guidance document explains, 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.
FDA issued this draft guidance on September 7, 2006. The initial
comment period on the draft guidance closes on December 6, 2006, but at
the request of in vitro diagnostic device stakeholders, FDA has decided
to extend the comment period for an additional 90 days, until March 5,
2007.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Commercially Distributed Analyte
Specific Reagents (ASRs): Frequently Asked Questions,'' you may either
send an email 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
.
III. Comments
Interested persons may submit to the Division of Dockets Management
(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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20030 Filed 11-27-06; 8:45 am]
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