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Notice

Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of comment period.

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The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799).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 To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period.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Submit written or electronic comments on this draft guidance by March 5, 2007.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Submit written requests for single copies of the draft guidance document entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions” to the Division of Small Manufacturers,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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.

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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.

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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 Start Printed Page 68821manufacturers 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://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.

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Dated: November 20, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-20030 Filed 11-27-06; 8:45 am]

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