**SUPPORTING STATEMENT**

# Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses

OMB No. 0910-0182

1.  **[Circumstances Making the Collection of Information
    Necessary]{.underline}**

> The Food and Drug Administration (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)) (Attachment 1)
> to regulate medical devices. A copy of the legal authority, 21 USC
> 351, 352, and 371(a), for this information collection is attached.

FDA implements provisions of the act through the Code of Federal
Regulations 21 CFR Parts 801.410(e) and 801.410(f) (Attachment 2). FDA
is requesting an extension of OMB Clearance No. 0910-0182 for the
information requirements in 21 CFR 801.410(e) and (f).

## 21 CFR 801.410(e) -- Recordkeeping

> Requires that records of sale or distribution of all impact-resistant
> lenses, including eyeglasses and sunglasses, be kept for a period of
> three years.

## 21 CFR 801.410(f) -- Recordkeeping

> Requires that results of impact tests and description of the test
> method and apparatus be kept for a period of three years.

The regulation is designed to protect the eyeglass wearer from potential
eye injury resulting from shattering of ordinary eyeglass lenses and
requires that eyeglasses and sunglasses be fitted with impact-resistant
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. According to the Vision Council of America, 60% of the
population, or 161 million Americans, wear prescription eyewear; 81%
have eyeglasses, 3% have contact lenses only and 16% have both
eyeglasses and contact lenses.

2.  **[Purpose and Use of the Information]{.underline}**

> The regulation requires that the lenses be rendered impact-resistant
> and capable of withstanding the impact test referred to as the
> "referee test" in the regulation. A lens manufacturer is required to
> render lenses impact-resistant and to keep results of the test,
> records of sale or distribution of all impact-resistant lenses for
> three years. These records are valuable to FDA when investigating
> complaints (i.e., eye injury complaints). If records were not
> maintained by the manufacturers, FDA investigations would be made more
> difficult to conduct and ultimately the public would not have the
> necessary protection from substandard eyeglasses.

3.  **[Use of Information Technology and Burden Reduction]{.underline}**

FDA is always open to improved technology, and while no legal avenues
exist to reduce the burden, the agency implemented a regulation on
August 20, 1997 (21 CFR, Part 11) that allows firms to utilize, on a
routine basis, electronic recordkeeping technologies. The recordkeeping
requirement is not viewed as an additional burden since manufacturers
(to include initial distributors/importers) normally maintain invoices,
shipping documents, records of sale or distribution and records relating
to testing. FDA routinely inspects these documents/records, whether they
be hardcopy or electronic, during the course of inspections of the
manufacturers. Importers routinely maintain certificates of testing as
appropriate. Because this collection deals primarily with recordkeeping
maintained at the manufacturers' site, no provisions have been made to
allow this collection to conform to the requirements of the Government
Paperwork Elimination Act (GPEA) by October 2003.

**4. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}**

> There is no duplication of data or sources since each manufacturer
> keeps their data. In the course of an investigation, FDA must go to
> the appropriate manufacturer and obtain the necessary data. The
> required information associated with this regulation is not available
> in any other form or from any other source.

**5. [Impact on Small Businesses or Other Small Entities]{.underline}**

> The requirements set forth in this regulation do not fall
> disproportionately on small businesses. As it is not possible to
> provide exemption or reduced requirements for small businesses without
> seriously compromising the important objectives of the regulation,
> efforts were made to minimize the burdens on all persons affected.
> These minimal burdens are imposed on all manufacturers and importers
> without regard to size or any other characteristic.
>
> The Division of Small Manufacturers Assistance in the Center for
> Devices and Radiological Health will provide technical assistance, on
> request, to small businesses. They will assist in identifying ways
> firms can meet the subject requirements so that it is not unduly
> burdensome.

**6. [Consequences of Collecting the Information Less
Frequently]{.underline}**

> Firms subject to this regulation are not required to submit the
> written records to FDA. They may use any appropriate technology to
> maintain these records. FDA normally reviews, and may copy, records
> during inspections of the manufacturers, including initial
> distributors/importers and holders of records, such as certificates
> for impact resistance, testing, testing records, etc. The
> manufacturers are required to have the records available to FDA for
> reviews on an "as needed" basis. There is no prescribed frequency. If
> records were not maintained by the firms, FDA
> inspections/investigations of complaints from users would be more
> difficult, if not impossible, to conduct. Ultimately the public would
> not have the necessary protection from substandard eyeglasses.

**7. [Special Circumstances relating to the Guidelines of 5 CFR
1320.5]{.underline}**

> There are no special circumstances requiring the maintenance of
> information in a manner inconsistent with 5 CFR 1320.6.

**8. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}**

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 the 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 No. 0910-0182).

**9. [Explanation of Any Payment or Gift to Respondents]{.underline}**

> This regulation does not provide any payment or gift to respondents.

**10. [Assurance of Confidentiality Provided to
Respondent]{.underline}**

> FDA adheres to 21 CFR Part 20 in determining whether information may
> be made available for public disclosure (such as sexual behavior and
> attitudes, religious beliefs, etc.)

**11. [Justification for Sensitive Questions]{.underline}**

> There are no requirements for the maintenance of information regarding
> matters that are commonly considered private.

**12. [Estimates of Hour Burden Including Annualized Hourly
Costs]{.underline}**

> There is no burden estimated for maintaining sale or distribution
> records under Section 21 CFR 801.410(e) since firms are retaining
> their records beyond the three-year period as a normal and customary
> business practice for reasons of product liability. This section,
> therefore, has been removed from the hourly recordkeeping burden chart
> below.
>
> The Vision Council of America
> ([www.visionsite.org](http://www.visionsite.org/)) provided sales
> figures that were used to estimate burden for this collection.
> Beginning in 1998, the vision industry has experienced a steady but
> declining growth rate of 2.6% for the distribution of lenses. It is
> 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. The following sales figures
> were developed based on the above assumptions:
>
> Year Sales %Change Eyeglass Shipments (Millions)
>
> 1998 15.8 +2.6% 84.51
>
> 1999 16.2 +2.6% 86.7
>
> 2000 16.6 +2.6% 89.0
>
> By also assuming that the glass/plastic lenses-produced ratio remained
> as in previous years (22% glass and 78% plastic), that glass lenses
> must be tested individually, and only 5% of the plastic lenses must be
> tested, then 23,070,000 lenses should be tested. This figure was
> derived by taking 22% of 89 million glass lenses (19,600,000) and
> adding it to 5% of the remaining plastic lenses (5% 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 and record 1,200 tests per hour. It is
> estimated that the total burden for this collection is 19,225 hours,
> which is calculated by dividing the total records figure (23,070,000)
> by test per hour (1,200). The hours per recordkeeper is calculated by
> dividing the total number of hours (19,225) by the number of
> manufacturers (30).
>
> The expected respondents to this collection are manufacturers of
> impact-resistant lenses.

+----------+-------------+-------------+---------+------------+------+
| # Estim  |             |             |         |            |      |
| ated Ann |             |             |         |            |      |
| ual Reco |             |             |         |            |      |
| rdkeepin |             |             |         |            |      |
| g Burden |             |             |         |            |      |
+----------+-------------+-------------+---------+------------+------+
| CFR      | No. of      | Annual      | Total   | Hours per  | T    |
| Section  | Re          | Frequency   | Annual  | Re         | otal |
|          | cordkeepers | of          | Records | cordkeeper | H    |
|          |             | Re          |         |            | ours |
|          |             | cordkeeping |         |            |      |
+----------+-------------+-------------+---------+------------+------+
| 80       | 30          | 769,000     | 23      | 641        | 19   |
| 1.410(f) |             |             | ,070,00 |            | ,225 |
+----------+-------------+-------------+---------+------------+------+

> There are no Capital Costs or Operating Costs associated with this
> collection.

**13. [Estimate of Other Total Annual Cost Burden to Respondents or
Recordkeepers]{.underline}**

In 1999, the FDA contacted the Optical Manufacturers Association in an
effort to gather data relative to industry burden. OMA did not believe
there were additional cost burdens due to these regulations.
Additionally, in year 2000 we contacted the Vision Council of America in
an effort to assess the current data relative to industry burden. As a
result of reviewing their (Vision Council of America) web site, it
appears that the industry burden remains constant for this product.
There is no capital cost and no operational cost burden. A lens
manufacturer (includes initial distributor/importers) is required to
keep impact-resistant testing results, records of sale or distribution
of all impact-resistant lenses for three years. The recordkeeping is not
viewed as an additional burden. Therefore, the burden to the firms
estimated at 0 hours.

14. **[Annualized Cost to Federal Government]{.underline}**

There are no anticipated costs to the Federal Government since these
records need not be submitted to FDA but, rather, they are maintained by
the lens manufacturers (also includes initial distributors/importers as
ordinary and customary practice.

**15. [Explanation for Program Changes or Adjustments]{.underline}**

The annual burden has changed from the prior submissions due to
increased market availability of plastic lenses, and consumer demand for
eyewear, particularly those fitted with plastic lenses. The increase in
the number of total burden hours is due to the 2.6% growth trend
reflected in item 12.

**16[. Plans for Tabulation and Publication and Project Time
Schedule]{.underline}**

There are no plans to publish this information for statistical use.

**17. [Reason(s) Display of OMB Expiration Date is
Inappropriate]{.underline}**

We are not requesting that the OMB Expiration Date not be displayed as
part of this information collection. There are no forms used with this
collection and therefore there is no frequently reproduced stock.

**18. [Exceptions to Certification for Paperwork Reduction Act
Submissions]{.underline}**

We are not seeking exceptions to the Certification statement outlined in
item 19.

B.  **Collection of Information Employing Statistical Methods**.

There are no statistical methods being employed in this collection of
information.

##### List of Attachments to Supporting Statement

### Attachment 1- Federal Food, Drug, and cosmetic Act, section 501, 502, 503, 701, & 702

> Attachment 2- 21 CFR Parts 801.410(e) & 801.410 (f)

Attachment 3 - Federal Register 60 Day notice \[Date\] (xx FR xxxxx).