Agency Information Collection Activities: Proposed Collection; Comment Request

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.

-----------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

No. of Annual Frequency Total Annual Hours per

21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours

----------------------------------------------------------------------------------------------------------------

801.410(f)..... 30 590,000 17,700,000 492 14,760

----------------------------------------------------------------------------------------------------------------

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