E7-8780. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for a draft guidance entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” FDA published a notice of availability of the draft guidance in the Federal Register of October 31, 2006 (71 FR 63774). The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices, if the device is reclassified. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls)

DATES:

Submit written or electronic comments on the draft guidance by June 7, 2007.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Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device” to the Division of Small Manufacturers, International, and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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 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:

David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 31, 2006 (71 FR 63728), FDA published a proposed rule to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). In the same issue of the Federal Register (71 FR 63774), FDA published a notice of availability of a draft guidance document entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls if they were reclassified. FDA invited interested persons to comment on the proposed rule and on the draft guidance document by January 29, 2007.

Two companies requested FDA to extend the comment period on the proposed rule by 90 days because the proposal presented complex medical and scientific issues that required the company to assemble a team of many different specialties in order to prepare their comments. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on the proposed rule for 30 days. Because the issues presented by the guidance document are intertwined with those presented by the proposed rule, FDA is reopening the comment period on the guidance document for the same period.

II. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled “Class II Special Controls Document: Absorbable Hemostatic Device,” you may either send an e-mail request to [e-mail] 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 1558 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 submissions, 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 are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets.

III. Request for Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance 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: April 25, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.