[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Pages 68820-68821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20030]


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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Draft Guidance for Industry and Food and Drug Administration 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comment period on the draft guidance entitled ``Commercially 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 FDA announced the availability of this draft guidance in 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persons additional time to review and submit comments on the draft 
guidance, FDA has decided to extend the comment period.

DATES: Submit written or electronic comments on this draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Commercially Distributed Analyte Specific 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    Submit written comments concerning this draft guidance to the 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://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 [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.

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]
BILLING CODE 4160-01-S