Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket Nos. 00D-1086, 00D-1087, 00D-1088, 00D-1089, 00D-1090, and 00D-1091]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of six guidance documents. These six guidance documents are intended to serve as special controls for six devices that FDA has proposed previously to reclassify from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the 
                        **Federal Register**
                        , FDA is reopening the comment period on the proposed reclassification of the six devices and one other device. FDA is now inviting comment on these guidance documents because they were not available for comment at the time of the publication of the proposed reclassification (64 FR 12774, March 15, 1999).
 DATES: Submit written comments by July 18, 2000.
 ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the docket number for the appropriate guidance document found in the 
                        **SUPPLEMENTARY INFORMATION**
                         section. Submit written requests for single copies on a 3.5′′ diskette of one or more of these guidance documents to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels 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 documents.
 FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-2974.


SUPPLEMENTARY INFORMATION: I. Background In the 
                    **Federal Register**
                     of March 15, 1999, FDA published a proposed rule to reclassify 38 preamendments class III devices into class II and to establish special controls for these devices. FDA invited interested persons to comment on the proposed rule by June 14, 1999. FDA received one request to reopen the comment period for six devices. The request noted that FDA had not made the guidance documents that were proposed as special controls for these six devices available for comment through FDA's Good Guidance Practices (GGP's) (62 FR 8961, February 27, 1997). The request further noted that it was impossible to comment on the proposed reclassification without the guidance documents being available. Therefore, the requester asked that FDA extend the comment period until at least 90 days after the guidance documents are publicly available. FDA agreed with the request. FDA also identified three additional devices for which the agency had not issued the guidance documents proposed as special controls in accordance with the GGP policy. The agency is announcing the availability of the following six guidance documents (each with a separate docket number) for six of these nine devices. In the near future, FDA will announce the availability of two guidance documents that will address the other three devices. The six guidance documents, with their docket numbers, and Facts-on-Demand (FOD) numbers are as follows: Guidance document
Docket No.
FOD No.
21 CFR Section
Device nameGuidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.
00D-1086
372
870.3260
Pacemaker lead adaptor.Guidance Document for Vascular Prostheses 510(k) Submissions.
00D-1087
1357
870.3450
Vascular graft prosthesis of less than 6 millimeter diameter.Guidance for Annuloplasty Rings 510(k) Submissions.
00D-1088
1358
870.3800
Annuloplasty ring.Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.
00D-1089
1632
870.4230
Cardiopulmonary bypass defoamer.Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.
00D-1090
1622
870.4260
Cardiopulmonary bypass arterial line blood filter.Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.
00D-1091
1361
870.4360
Cardiopulmonary bypass oxygenators.
 These guidance documents represent the agency's current thinking on premarket notifications for these devices. These guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both. Under FDA's GGP policy, each of these guidance documents is a Level 2 guidance. 
                    ( print page 20996) II. Electronic Access In order to receive these guidance documents via your fax machine, call the CDRH FOD system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system and enter the document number listed above followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of these guidance documents may do so by using the Internet. 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 access to the Internet. Updated on a regular basis, the CDRH home page includes these guidance documents, device safety alerts, 
                    **Federal Register**
                     reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, mammography matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/​cdrh. These guidance documents are also available at http://www.fda.gov/​cdrh/​ODE. III. Comments Interested persons may submit to the Dockets Management Branch (address above) written comments regarding these guidance documents by July 18, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number for each guidance document as listed in the table in the 
                    **SUPPLEMENTARY INFORMATION**
                     section of this document. If you wish to comment on more than one guidance document, please submit your comments separately for each guidance document. The guidance documents and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 3, 2000. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health.


[FR Doc. 00-9710 Filed 4-18-00; 8:45 am] BILLING CODE 4160-01-F