SUPPORTING STATEMENT

**FOR**

**PERFORMANCE STANDARD FOR DIAGNOSTIC**

**X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS**

**0910-0564**

**A. Justification**

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

The Food and Drug Administration (FDA) intends to issue a final rule to
amend the performance standard for diagnostic x-ray systems and their
major components. Sections 532 through 542 of the Federal Food, Drug,
and Cosmetic Act (the act), (as amended by the Safe Medical Devices Act
of 1990) (21 U.S.C. 360ii through ss) (attachment 1) direct the
Secretary of the Department of Health and Human Services (the Secretary)
to establish and carry out an electronic product radiation control
program to protect the public from unnecessary radiation from electronic
products. Such a program shall include the development, issuance, and
administration of performance standards to control the emission of
electronic product radiation from electronic products.

The regulations issued under these authorities are established in the
Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J. A
mandatory radiation safety performance standard for diagnostic x-ray
systems was established and became effective in 1974. This standard is
in 21 CFR 1020.30 through 1020.33 (attachment 2). This performance
standard established numerous radiation safety related equipment
performance requirements and a requirement that manufacturers provide
certain radiation safety information in the user instructions or user
manuals that are provided to purchasers with the equipment. This
requirement is contained in 21 CFR 1020.30(h).

To account for recent technological changes and changes in the clinical
use of fluoroscopic x-ray equipment, FDA is proposing to amend the
performance standard to add requirements for additional radiation safety
related features on all fluoroscopic x-ray systems. To assure that
purchasers and users of fluoroscopic systems have safety related
information regarding these proposed new equipment features, FDA is also
proposing to require additional information related to these features
and operation of the equipment be included in the user instructions for
this equipment.

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

The information required to be provided by x-ray equipment manufacturers
in the user instructions is necessary to assure that purchasers of
diagnostic x-ray systems have all the information necessary to assure
safe and appropriate use of the equipment. The requirements assure that
purchasers have the minimum radiation safety related information
necessary for use of the equipment. Equipment performance requirements
alone, without adequate instructions, are not sufficient to assure safe
use of the complex systems that characterize modern fluoroscopic x-ray
systems. Users need complete and specific instructions regarding the
radiation safety features of the equipment to permit its proper use and
operation,

Users of fluoroscopic x-ray systems will use the information provided to
select appropriate modes of operation of the equipment and to understand
the patient radiation dose implications of selected operational
parameters.

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

There are no obvious means to apply information technology to reduce the
reporting burden.

Manufacturers already use many aspects of information technology in the
design, development and manufacturing of new models of fluoroscopic
x-ray systems. It is not possible to eliminate the need for adequate
user instructions for complex x-ray systems.

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

There is no other source of information regarding instructions for use
of specific models of diagnostic x- ray systems other than the
manufacturer of the equipment. It is not reasonable to anticipate other
sources of this information and FDA has not attempted to identify such
sources.

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

All manufacturers, regardless of size, currently provide user
instructions for fluoroscopic x-ray systems. The requirement for
manufacturers to provide the user information related to the new
equipment features will app1y to any manufacturer of diagnostic x-ray
systems. Because of the need for this safety related inforn1ation for
any fluoroscopic x-ray system, it is not feasible or reasonable to
modify the requirement for small businesses. Any manufacturer producing
fluoroscopic x-ray systems must provide appropriate and adequate safety
information for users of the equipment.

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

There is no frequency of information collection associated with the
requirement for specific information to be included in the user
instructions. Manufacturers must provide specific information for each
model of x-ray systems to the purchaser at the time of purchase. This
information will be developed and prepared as each new model of x-ray
system is introduced to the market.

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

There are no special circumstances requiring deviation from the
guidelines of 5 CPR 1320.5.

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

FDA is providing a 90-day comment period on the final rule. FDA
routinely consults with members of industry, government, and the public,
through the Teclu1ical Electronic, Product Radiation Safety Standards
Committee (TEPRSSC) and the Radiological Devices Panel. These are
permanent advisory committees established under sections 534(f) and
513(b) of the act. FDA is required to consult with the TEPRSSC before
adding or changing standards.

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

FDA is not offering any payment or gift to respondents for this
information collection.

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

The information to be provided is information that should be public
information and that is necessary for safe operation of fluoroscopic
x-ray systems.

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

The information required does not include questions about sexual
behavior, attitude, religious beliefs or any other matters that are
commonly considered private or sensitive in nature.

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

As described in the assessment of the cost impact of the proposed
amendment (attachment 4), it is estimated that that there are about 20
manufacturers of fluoroscopic x-ray systems who market in the U.S. Each
of these manufacturers is estimated to market about 10 distinct models
of fluoroscopic x-ray systems. Immediately following the effective date
of the proposed amendments, for each model of fluoroscopic x-ray system
that manufacturers continue to market, each manufacturer would have to
supplement the user instructions to include the additional information
required by the proposed amendments.

Manufacturers already develop, produce, and provide x-ray system user
manuals or instructions containing the information necessary to operate
the systems, as well as the specific information required to be provided
by the existing standard in current §1020.3O(h). Therefore, it is
assumed that no significant additional capital, operating, or
maintenance costs will occur to the manufacturers in connection with the
provision of the newly required information. The manufacturers already
have procedures and methods for developing and producing the user\'s
manuals, and the additional information required by the proposed
requirements is expected to only add a few printed pages to these
already extensive manuals or documents.

The burden that will occur to manufacturers from the new requirements
for information in the user\'s manuals will be the effort required to
develop, draft, review, and approve the new information. The information
or data to be contained within the new user instructions will already be
available to the manufacturers from their design, testing, validation,
or other product-development documents, The burden will consist of
gathering the relevant information from these documents and preparing
the additional instructions from this information.

It is estimated that about three weeks of professional staff time (120
hours) would be required to gather the required information for a single
model of an x-ray system. It is estimated that an additional six weeks
(240 hours) of professional staff time would be required to draft, edit,
design, layout, review, and approve the new portions of the user\'s
manual or information required by the proposed amendments. Hence FDA
estimates a total of 360 hours to prepare the new user information that
would be required for each model.

For a given manufacturer, FDA anticipates that every distinct model of
fluoroscopic system will not

require a separate development of this additional infotn1ation. Because
it is thought highly likely that several models of fluoroscopic x-ray
systems from a given manufacturer will share common design

aspects, it is anticipated that similar means for meeting the proposed
requirement for display of exposure time, air kerma rate, and cumulative
air kerma and the requirement for the last-image-hold feature will

exist on multiple models of a single manufacturer\'s products. Such
common design aspects for multiple

models will reduce the burden on manufacturers to develop new user
information. Hence the average time required to prepare new user
information for all of a manufacturer\'s models will be correspondingly
reduced. It is assumed that the applicability of the new user
information developed to multiple models

will reduce the average burden from the 360 hours to about 180 hours per
model under the assumption that each set of user information for a given
equipment feature design will be a applicable to at least two

different models of a manufacturer\'s fluoroscopic systems. Under this
assumption, the total estimated time for preparing the new user
information that would be required is 36,000 hours, as shown in Table 1.

In each succeeding year the burden will be less, as the reporting
requirement will apply only to the new models developed and introduced
by the manufacturers in that specific year. FDA assumes that every two
years each manufacturer will replace each of its models with a newer
model requiring new user

information. The multiple system applicability of this information js
accounted for by also assuming that each new model only requires 180
hours of effort to develop the required information. These assumptions
result in an estimated burden of 18,000 hours for each of the years
following the initial year of applicability of the proposed amendments,
as shown in Table 2

Table 1. \--Estimated Average Annual Reporting Burden for the First Year

+---------------+----------+----------+----------+----------+---------+
| 21 CFR        | No. of   | Annual   | Total    | Hours    | Total   |
| section       | res      | f        | annual   | per      | hours   |
|               | pondents | requency | r        | response |         |
|               |          | of       | esponses |          |         |
|               |          | response |          |          |         |
+---------------+----------+----------+----------+----------+---------+
| 1020          | 20       | 10       | 200      | 180      | 36,000  |
| .30(h)(5)&(6) |          |          |          |          |         |
|               |          |          |          |          |         |
| and           |          |          |          |          |         |
| 1020.32(j)(4) |          |          |          |          |         |
+---------------+----------+----------+----------+----------+---------+

1 There are no capital cost or operating and maintenance costs
associated with this information collection.

Table 2 -- Estimated Average Annual Reporting Burden for Second and
Following Years

+---------------+----------+----------+----------+----------+---------+
| 21 CFR        | No. of   | Annual   | Total    | Hours    | Total   |
| section       | res      | f        | annual   | per      | hours   |
|               | pondents | requency | r        | response |         |
|               |          | of       | esponses |          |         |
|               |          | response |          |          |         |
+---------------+----------+----------+----------+----------+---------+
| 1020          | 20       | 5        | 100      | 180      | 18,000  |
| .30(h)(5)&(6) |          |          |          |          |         |
|               |          |          |          |          |         |
| and           |          |          |          |          |         |
| 1020.32(i)(4) |          |          |          |          |         |
+---------------+----------+----------+----------+----------+---------+

2 There are no capital costs or operating and maintenance costs
associated with this information collection

From Bureau of Economic Analysis and Bureau of Labor Statistics
compensation inflators, the estimated hourly industry compensation rate
in NAICD 334517 (Irradiation Equipment) is about \$33 per hour. Using
this labor cost estimates indicates that the industry cost of this
information collection burden will be about \$1.2 million in year one,
then decreasing to \$0.6 million per year in subsequent years.

**13. [Estimate of the Other Total Annual Cost Burden to Respondent or
Record keepers]{.underline}**

There are no capital costs or operating/maintenance costs associated
with this information collection.

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

There will be no costs to the Federal government due to the requirements
for additional information to be provided in the user instructions.

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

This is a new collection.

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

There are no plans to publish the collection of information subject to
this clearance.

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

FDA is not requesting an exemption from the requirement to display the
OMB Expiration Date.

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

FDA is not requesting any exceptions from the certification requirement.

**B. [Collection of Information Employing Statistical
Methods.]{.underline}**

There are no plans to publish the information collected under the
provisions of this regulation for statistical use. The collection of
information for which FDA is seeking approval does not employ any
statistical methods.

# List of Attachments

1.  FD&C Act, Chapter V, Subchapter C

2.  21 CFR 1020.30-1020.33

3.  Assessment of the Impact of the Proposed Amendments to the
    Diagnostic X-ray Equipment Performance Standard addressing
    Fluoroscopic X-ray Systems, November 15, 2000.