Agency Information Collection Activities; Submission for OMB Review; Comment Request

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