[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Notices]
[Pages 60862-60863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0364]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Impact-Resistant Lenses: Questions and Answers; 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availability of the draft guidance entitled ``Impact-Resistant Lenses: 
Questions and Answers.'' This draft guidance document answers 
manufacturer, importer, and consumer questions on impact-resistant 
lenses, including questions on test procedures, lens testing apparatus, 
record maintenance, and exemptions to testing.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 24, 2008.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled``Impact-Resistant Lenses: Questions and Answers'' 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    Submit written comments concerning this draft guidance to the 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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: John Stigi, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-3150.

SUPPLEMENTARY INFORMATION:

I. Background

    Eyeglasses and sunglasses are medical devices and are subject to 
device regulations, including Sec.  801.410 (21 CFR 801.410). This 
draft guidance document revises the original guidance document entitled 
``Impact-Resistant Lenses: Questions and Answers'' (FDA 87-4002), 
issued September 1987. This draft guidance document also contains 
detailed and updated discussions of the following: (1) Lens blanks; (2) 
semi-finished, finished, and plano lenses; and (3) import entry 
inspections.
    To reduce the number of eye injuries, eyeglasses and sunglasses 
must be fitted with impact-resistant lenses capable of withstanding the 
impact test described under Sec.  801.410(d)(2). This draft guidance 
answers questions for manufacturers, importers, and testing 
laboratories on such topics as test procedures, lens testing apparatus, 
record maintenance, and exemptions to testing.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on impact-
resistant lenses. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Impact-Resistant Lenses: 
Questions and Answers,'' you may either send an e-mail 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 (23) 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.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 801.109 have been approved under 
OMB Control No. 0910-0485; the collections of information in 21 CFR 
807.87 have been approved under OMB Control No. 0910-0120; and the 
collections of information in 21 CFR part 820 have been approved under 
OMB Control No. 0910-0073.

V. 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.

[[Page 60863]]

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: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21122 Filed 10-25-07; 8:45 am]
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