[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Notices]
[Pages 231-232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0512]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
February 4, 1998.
ADDRESSES: Submit written comments on the collection of information to
Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk
Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance:
Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses--21 CFR
[[Page 232]]
801.410(c), (e), and (f)--(OMB Control Number 0910-0182)--Reinstatement
FDA has the statutory authority under section 501, 502, and 371(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, and
371(a)) to regulate medical devices. Section 801.410 (21 CFR 801.410)
requires that lenses be rendered impact-resistant and capable of
withstanding the impact test referred to as the ``referee test'' in the
regulation. Under Sec. 801.410(c)(1), eyeglasses and sunglasses must be
fitted with impact-resistant lenses except in cases where an
optometrist or physician finds that such lenses will not fulfill a
patient's visual requirements. In such cases, the optometrist or
physician must notify the patient in writing and specify in a written
prescription that nonimpact lenses be used in the patient's eyewear.
Under Sec. 801.410(e) and (f), manufacturers and distributors of
impact-resistant lenses, both eyeglasses and sunglasses, are required
to maintain certain records. Under Sec. 801.410(e) manufacturers,
distributors, retailers, and importers are required to maintain records
such as invoice(s), shipping documents, and records of sale or
distribution of all impact-resistant lenses, including finished
prescription eyeglasses and sunglasses, which shall be kept and
maintained for a period of 3 years. However, the names and addresses of
individuals purchasing nonprescription eyeglasses and sunglasses at the
retail level need not be kept and maintained by the retailer. Under
Sec. 801.410(f) any persons conducting ``referee'' (lens impact) tests
in accordance with Sec. 801.410(d) shall maintain the results thereof
and a description of the test method and of the test apparatus for a
period of 3 years.
These records are valuable to FDA when investigating complaints
(i.e., eye injury complaints). If records were not maintained, FDA
investigations would be made more difficult to conduct and ultimately
the public would not have the necessary protection from substandard
eyeglasses. The regulation is designed to protect the eyeglass wearer
from potential eye injury resulting from shattering of ordinary
eyeglass lenses. Examination of data available on the frequency of eye
injuries resulting from the shattering of ordinary crown glass lenses
indicates that the use of such lenses constitutes an avoidable hazard
to the eye of the wearer. Between 50 and 60 percent of the American
public wear prescription eye wear.
Firms subject to this regulation are not required to submit the
written records to FDA. FDA normally reviews and may copy records
during an inspection of the manufacturer. The manufacturers are
required to make the records available to FDA on an ``as needed''
basis.
Respondents to this collection of information are manufacturers,
importers, distributors, and retailers of impact-resistant sunglasses
and eyeglasses.
The burden of maintaining sale and/or distribution records, as
required by Sec. 801.410(e), is estimated at 0 hours because firms are
routinely retaining the records beyond the 3-year period for reasons of
routine business practice. Under 5 CFR 1320.3(b)(2), the time, effort,
and financial resources necessary to comply with a collection of
information are excluded from the burden estimate if the recordkeeping
needed to comply is usual and customary because it would occur in the
normal course of activities. Based on conversations with eye care
professionals, FDA also estimates that the burden under Sec. 801.410 is
virtually nil because very few prescriptions for nonimpact lenses are
written. Therefore, no estimate for this section has been included in
the chart.
FDA estimates the burden of this collection of information as
follows :
Table 1.--Estimated Annual Recordkeeping Burden
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Annual
21 CFR Section No. of Frequency of Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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801.410(f) 30 590,000 17,700,000 492 14,760
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There are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 30 manufacturers of eyeglasses in the U.S.
Optical Manufacturers Association, which represents 98 percent of the
domestic industry involved in lens manufacturing, and the association
has stated to FDA that the regulation does not impose a burden on their
members. This position is based on the fact that the recordkeeping and
testing requirements of the regulation represent minimum requirements
for a conscientious manufacturer.
Dated: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-72 Filed 1-2-98; 8:45 am]
BILLING CODE 4160-01-F
