[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Notices]
[Pages 70916-70917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1599]


Agency Information Collection Activities; Proposed Collection; 
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 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 extension 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 to 
insure public health and safety for manufacturers of impact-resistant 
lenses used in eyeglasses and sunglasses.

DATES: Submit written or electronic comments on the collection of 
information by January 29, 2001.

ADDRESSES: Submit written or electronic comments on the collection of 
information to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

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: 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 extension 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary

[[Page 70917]]

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 (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. Section 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. FDA estimates the burden of this collection of 
information as follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours
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801.410(f)         30                 769,000            23,070,00          .0008              18,456
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The Vision Council of America (www.visionsite.org) provided sales 
figures 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 (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) since firms are retaining their records 
as a normal and customary business practice for reasons of product 
liability.

    Dated: November 20, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30329 Filed 11-27-00; 8:45 am]
BILLING CODE 4160-01-F