[Federal Register Volume 65, Number 14 (Friday, January 21, 2000)]
[Notices]
[Pages 3462-3463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P-1720]


Approval of an Alternate Requirement of the User Labeling 
Requirements for Devices Containing Dry Natural Rubber that Contact 
Humans; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Approval of an Alternative 
Requirement of the User Labeling Requirements for Devices that Contain 
Dry Natural Rubber that Contact Humans.'' FDA granted a petition 
submitted by the Health Industry Manufacturers Association (HIMA), on 
behalf of in vitro diagnostic device (IVD) manufacturers, that 
requested a variance from placing the warning statement about dry 
natural rubber on the immediate IVD package (vial) label. FDA is 
announcing the availability of its response to HIMA's petition in order 
to inform affected manufacturers and the public.

ADDRESSES:  Submit written requests for single copies on a 3.5 diskette 
of the document entitled ``Approval of an Alternate Requirement of the 
User Labeling Requirements for Devices that Contain Dry Natural Rubber 
that Contact Humans'' to the contact person named below. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the alternative requirement document.

FOR FURTHER INFORMATION CONTACT:  John J. Farnham, Center for Devices 
and Radiological Health (HFZ-321), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20852, 301-594-4616.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 1997 (62 FR 51021), FDA 
issued a final rule, codified in 21 CFR Sec. 801.437(e), requiring 
labeling statements on medical devices containing dry natural rubber 
that are intended to contact or likely to contact humans. The rule 
became effective on September 30, 1998. On June 3, 1999, HIMA requested 
a variance for in vitro diagnostic products that have vial labels too 
small to accommodate the required statement. The petition said that 
manufacturers of the products could place the warning on the outer 
package, as well as on a package insert. On September 10, 1999, FDA 
issued a letter granting HIMA's petition.

II. Electronic Access

    In order to receive the document entitled ``Approval of an 
Alternative Requirement of the User Labeling Requirements for Devices 
that Contain Dry Natural Rubber that Contact Humans,'' via your fax 
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 
301-827-0111 from the touch-tone telephone. At the first

[[Page 3463]]

voice prompt press 1 to access the Division of Small Manufacturers 
Assistance (DSMA) Facts, at second voice prompt press 2, and then enter 
the document number (1148) followed by the pound sign (#). Then follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the alternative 
requirement may also do so using the Internet. CDRH maintains an entry 
on the Internet for easy access to information including text, graphic, 
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 
the ``Approval of an Alternative Requirement of the User Labeling 
Requirements for Devices that Contain Dry Natural Rubber that Contact 
Humans,'' 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, labeling matters, and 
other device-oriented information. The CDRH home page may be accessed 
at http://www.fda.gov/cdrh. The document entitled ``Approval of an 
Alternative Requirement of the User Labeling for Devices that Contain 
Dry Natural Rubber that Contact Humans'' will be available at http://www.fda.gov/cdrh.

    Dated: January 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-1409 Filed 1-20-00; 8:45 am]
BILLING CODE 4160-01-F