[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52133-52135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0397]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on recordkeeping requirements for
manufacturers, importers, distributors, and retailers of impact-
resistant lenses, including eyeglasses and sunglasses.
DATES: Submit written comments on the collection of information by
December 5, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
[[Page 52134]]
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses--21 CFR
801.410(e) and (f)--(OMB Control Number 0910-0182)--Reinstatement
FDA has the statutory authority under sections 501, 502, and 701(a)
of the Federal Food, Drug, and Cosmetic Act (the 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.
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 have 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 since 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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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.
There are approximately 30 manufacturers of eyeglasses in the U.S.
Optical Manufacturers Association (OMA), 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.
Section 801.410(c)(1) states:
To protect the public more adequately from potential eye injury,
eyeglasses and sunglasses must be fitted with impact-resistant
lenses, except in those cases where the physician or optometrist
finds that such lenses will not fulfill the visual requirements of
the particular patient, directs in writing the use of other lenses,
and gives written notification thereof to the patient.
Optometrists in the Center of Devices and Radiological Health's Office
of Device Evaluation, FDA, have estimated that it should take a
physician or optometrist approximately 2 minutes to write up a
prescription and notification
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for nonimpact-resistant lenses. Because most prescription orders are
now filled by impact-resistant plastic lenses, and only one or two
orders for nonimpact-resistant lenses are estimated to be completed
annually, this de minimus burden is not included in the chart.
Dated: September 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26451 Filed 10-3-97 ; 8:45 am]
BILLING CODE 4160-01-F
