[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Pages 13769-13770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1599]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Use of Impact-Resistant Lenses in Eyeglasses 
and Sunglasses

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.

DATES: Submit written comments on the collection of information by 
April 6, 2001.

ADDRESSES: Submit written comment on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy 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 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 (OMB 
Control Number 0910-0182)--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(i)), every manufacturer or importer of a device 
intended for human use shall establish and maintain records. This 
regulation is designed to protect the eyeglass and sunglass wearer from 
potential eye injury resulting from shattering of ordinary eyeglass 
lenses, and it requires that eyeglasses and sunglasses be fitted with 
impact-resistant lenses. The regulation in Sec. 801.410(f) (21 CFR 
801.410(f)) requires that the results of impact tests and description 
of the test method and apparatus also be kept for a period of 3 years. 
These records are valuable to FDA when investigating eye injury 
complaints.
    The expected respondents to this collection are manufacturers of 
impact-resistant lenses.
    In the Federal Register of November 28, 2000 (65 FR 70916), the 
agency requested comments on the proposed collection of information. 
One comment was received. The comment stated the estimate seems to 
include only the time for testing, but omitted the cost of the 
materials and their disposal. It stated that the estimate did not 
explicitly address whether this testing is destructive in nature. These 
costs are material.
    FDA's attempt at addressing these issues was limited by the Vision 
Council of America's (VCA) reluctance to provide any more information 
than what had been included in FDA's original submission. VCA informed 
FDA that there was a restriction on information because VCA had 
promised their clients that they would not release certain data that 
was considered critical. Because of this limited amount of information 
from FDA's most reliable source (VCA), FDA was limited to the estimated 
burden that was included in the original submission (OMB control number 
0910-0182).
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                     Annual Frequency per
    21 CFR Section       No. of Recordkeepers           Recordkeeping            Total Annual Records       Hours per Recordkeeper        Total Hours
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        801.410(f)                        30                      769,000                 23,070,000                        .0008              19,225
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Due to an inadvertent error, the recordkeeping burden hours for Sec.  801.410(f) that appeared in a notice issued in the Federal Register of November
  28, 2000, were incorrect. Table 1 of this document contains the correct estimates.

     VCA provided sales figures (www.visionsite.org) that were used in 
estimating the burden for this collection. Beginning in 1998, a growth 
rate of 2.6 percent for the distribution of lenses began, and it was 
assumed that this growth rate continued in 1999 and 2000. This resulted 
in an increase in the number of eyeglasses shipped annually to 89 
million lenses shipped by year 2000.
    By also assuming that the glass/plastic lenses-produced ratio 
remained as in previous years (22 percent glass and 78 percent 
plastic), that glass lenses must be tested individually, and only 5 
percent of the plastic lenses must be tested, then 23,070,000 lenses 
should be tested. This figure was derived by taking 22 percent of 89 
million glass lenses (19,600,000) and adding it to 5 percent of the 
remaining plastic lenses (5 percent x 69,400,000 = 3,470,000).
    Next, divide the total tests (23,070,000) by 30 manufacturers to 
return the annual frequency of recordkeeping figure of 769,000. 
Previously, FDA and industry experts estimated that on average, each 
test could be completed and recorded in 3 seconds. Industry, therefore, 
could complete 1,200 tests per hour. Therefore, it is estimated that 
the total burden for this collection is 19,225 hours, which is 
calculated by taking the total records figure (23,070,000) and dividing 
it by tests per hour (1,200). The total hours was calculated by 
multiplying the total number of records

[[Page 13770]]

(23,070,000) and the hours per record (.0008).
    There is no burden estimated for maintaining sale or distribution 
records under Sec. 801.410(e) because firms are retaining their records 
as a normal and customary business practice for reasons of product 
liability.

    Dated: March 1, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-5472 Filed 3-6-01; 8:45 am]
BILLING CODE 4160-01-S