[Federal Register Volume 75, Number 170 (Thursday, September 2, 2010)]
[Notices]
[Pages 53971-53972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21908]
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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 [email protected]
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]
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