Document ID: FDA-2007-D-0367-0061
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff;  Availability: Impact-Resistant Lense; Questions and Answers
Posted Date: 2010-09-02T04:00Z

[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]               
[Page 53971-53972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se10-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0367]

 
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 guidance entitled ``Impact-Resistant Lenses: 
Questions and Answers.'' This 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: Submit either electronic or written comments on this guidance at 
any time. General comments on agency guidance documents are welcome at 
any time.

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, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66. rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. 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, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4622, Silver Spring, MD 20993-0002, 301-796-5848.

SUPPLEMENTARY INFORMATION:

I. Background

    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 21 CFR 801.410(d)(2). This guidance answers 
questions for manufacturers, importers, and testing laboratories on 
such topics as test procedures, lens testing apparatus, record 
maintenance, and exemptions to testing. This document also contains 
more detailed and updated discussions of (1) lens blanks, (2) semi-
finished, finished, and plano lenses, and (3) import entry inspections.
    The draft version of this document was announced in the Federal 
Register of October 26, 2007 (72 FR 60862). Interested persons were 
invited to comment by January 24, 2008. FDA received numerous comments 
from laboratories, trade associations, retail establishments, and 
consumers surrounding three main issues. FDA further clarified the 
definition of ``manufacturer'' according to the Quality System 
regulation (21 CFR 820.3(o)). Additionally, based on data provided in 
the comments, FDA eliminated a question regarding the salability of 
plastic prescription lenses tested as part of a statistical sample. FDA 
also modified several questions which had indicated that the testing of 
all lenses had to be done after edging to clarify that all plastic 
prescription lenses and glass over-the-counter lenses could be tested 
in either ``un-cut finished'' or ``finished'' form.
    This guidance supersedes ``Impact-Resistant Lenses: Questions and 
Answers'' (FDA 87-4002), issued September 1987.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

[[Page 53972]]

requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 dsmica@fda.hhs.gov 
to receive an electronic copy of the document or send a fax request to 
301-847-8149 to receive a hard copy. Please use the document number 
(23) to identify the guidance you are requesting. A search capability 
for all CDRH guidance documents is available at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
default.htm. Guidance documents are also available at http://
www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: August 27, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-21908 Filed 9-1-10; 8:45 am]
BILLING CODE 4160-01-S