[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,

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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

[[Page 52135]]

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