SUPPORTING STATEMENT

**FOR**

**REPORTING AND RECORDKEEPING REQUIREMENTS AND**

**AVAILABILITY OF SAMPLE ELECTRONIC PRODUCT**

**FOR MANUFACTURERS AND**

**DISTRIBUTORS OF ELECTRONIC PRODUCTS**

**OMB No. 0910-0025**

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

> Sections 532 through 542 (21 U.S.C. 360ii through ss) (Attachment 1)
> of the Federal Food, Drug, and Cosmetic Act (the Act) 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. Section 532 of the act directs the Secretary to
> establish and carry out an electronic product radiation control
> program designed to protect the public health and safety from
> electronic radiation, and authorizes the Secretary to procure (by
> negotiation or otherwise) electronic products for research and testing
> purposes and to sell or otherwise dispose of such products. Section
> 534(g) directs the Secretary to review and evaluate industry testing
> programs on a continuing basis; and Sections 535(e) and (f) direct the
> Secretary to immediately notify manufacturers of, and assure
> correction of, radiation defects or noncompliance with performance
> standards. The authority for records and reports is contained in
> Sections in 537(b) -- (c) of the Act. Such program shall include the
> development, issuance, and administration of performance standards to
> control the emission of electronic product radiation from electronic
> products.
>
> The regulations promulgated under these authorities are listed in the
> Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J.
> Specifically, 21 CFR parts 1002 - 1010 (Attachment 2) specify
> information to be provided to the Food and Drug Administration (FDA),
> to users, and/or to be maintained in the event of an investigation of
> a safety concern or a product recall. Subchapter A regulations, 21 CFR
> 5.10(a)(3), 5.25(b), 5.35(a)(4), and 5.600 through 5.606 (Attachment
> 3), delegate administrative authorities to the FDA and Radiological
> Health (CDRH).
>
> The Center for Devices and Radiological Health (CDRH) also conducts
> laboratory compliance testing of products covered by regulations for
> product standards in 21 CFR Parts 1020, 1030, 1040, and 1050.
>
> The FDA is requesting from the Office of Management and Budget (OMB)
> that approval be extended for the information collection requirements
> contained in 21 CFR Parts 1002, 1003, 1004, 1005, 1010, 1020, 1030,
> 1040, and 1050. (See Attachment 4).
>
> Approval also is requested for the following forms:
>
> FDA Form 2579 "Report of Assembly of a Diagnostic X-ray System"
> (Attachment 5)
>
> FDA Form 2767 "Notice of Availability of Sample Electronic Product"
> (Attachment 6)
>
> FDA Form 2877 "Declaration for Imported Electronic Products Subject To
> Radiation Control Standards" (Attachment 7)
>
> FDA Form 3147 "Application For A Variance From 21 CFR 1040.11(c) For A
> Laser Light Show, Display, or Device" (Attachment 8)

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

> The information collections are either specifically called for in the
> Act or were developed to aid the Agency in performing its obligations
> under the Act. These requirements are placed upon manufacturers,
> importers, and assemblers of electronic products. The data reported to
> FDA and the records that are maintained allow FDA and the industry to
> make decisions and take actions, which protect the public from
> radiation hazards presented by electronic products. This information
> refers to the identification, location, operational characteristics,
> quality assurance programs for, and problem identification and
> correction of electronic products. The data provided to users and
> others are intended to encourage actions to reduce or eliminate
> radiation exposures.
>
> The reports are reviewed by FDA staff to determine product safety and
> adequacy of quality control testing. Potential and actual problems are
> resolved with the individual firm. The information supplied will be
> used by the FDA to locate and select sample products for conformance
> with regulations.
>
> Forms were designed to aid respondents in the submission of this
> information. In the event this information was not collected by FDA on
> forms, each manufacturer would have to respond in letter format with
> all the data now on FDA forms, requiring more time and expense on
> their part. FDA would also then require written notification from
> Winchester Engineering and Analytical Center (WEAC), detailing all
> products received, from whom, returned to whom, model and chassis
> numbers, etc. to assure that the Agency's information coincided with
> their products. These extra steps to obtain information now on a form
> would significantly increase the cost in man-hours and duplications to
> both federal and industry organizations. Testing an appropriate
> percentage of these products to protect the public would also be
> hindered by any slower progress in FDA's receipt of the information.
>
> The consequence of not obtaining the required information is that the
> public may unknowingly be exposed to unnecessary radiation hazards
> presented by electronic products. Without this information, FDA could
> not adequately make rational decisions and take appropriate actions to
> protect the public from these hazards as called for in the Act.

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

> The FDA is investigating several improved information technologies and
> methods to reduce the burden placed on manufacturers and assemblers,
> such as electronic transfer and optical storage of documents. The FDA
> is also currently investigating the usefulness and appropriateness of
> a more expedient means of processing the data from the forms approved
> for this collection.
>
> This collection's forms have been designed to provide the minimum
> needed information in order to process the testing of the product.
> Well-designed forms can eventually lead to creation of electronic
> submission systems for respondent use. The FDA is currently
> incorporating several other information technologies such as
> electronic transfer, fax and fax back systems, and the Internet to
> reduce the burden placed on manufacturers and importers.
>
> The FDA, partially on the advice of its reengineering team, is
> currently investigating allowing respondents to electronically submit
> data to allow easier reporting and reduced burden for this collection.
> In the past year, FDA has initiated a voluntary electronic submission
> pilot program to less than 10 respondents of this collection. This
> pilot has been designed to automatically edit-check for errors in
> on-line submissions, insure data integrity, and allow FDA staff to
> perform more easily trending and sampling analysis. The consensus of
> this project is that, if the pilot becomes standard FDA procedure,
> burden initially will increase. However, after the initial learning
> curve has passed, burden should be reduced significantly. If FDA is
> able to obtain sufficient funding to convert the present paper-based
> system to an electronic submission system similar to the one piloted,
> respondents should save significant amounts of hours and costs.
>
> The pilot reduced the number of supplements needed, and provided data
> often missing from paper submissions. FDA feels that respondent
> reporting burden will be reduced significantly, because of information
> gained from the pilot. In the pilot, it often took 25% more time to
> initially fill out the electronic submission application. However,
> when the second and subsequent reports were submitted electronically,
> it only took about one-fifth of the time to complete the submission as
> compared to a paper application. Because electronic submissions are
> currently under development at FDA and is not immediately ready to be
> used, FDA will submit an inventory correction worksheet when this
> pilot is implemented.
>
> These methods will be incorporated when CDRH satisfies technical and
> legal requirements such as data integrity for a regulated industry and
> comparability of data. The use of the FDA's optical scanning and
> retrieval system, IMAGE, is also being tested for use in reviewing
> medical device submissions, such as Investigational Device Exemption
> (IDE) applications, and larger use of IMAGE in the radiological health
> area may be a future option.

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

> The FDA is the only authorized Agency to control the radiation of
> electronic products. Therefore, these activities are not duplicated
> anywhere else. Those electronic products that are also medical devices
> may be subject to additional FDA regulations. In some cases there has
> been very little duplication of information and where there has been,
> exemptions have been granted so that the medical device reporting has
> precedence over electronic product reporting. Often, the documentation
> submitted to describe how radiation safety is assured through
> compliance with mandatory performance standards satisfies both medical
> device and electronic product reporting requirements simultaneously.
>
> There is no other similar information collected that can be used to
> carry out the enforcement of these regulations.

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

> Protection of public health requires periodic testing of radiation
> emitting products. Small businesses are not exempt from this
> information collection's requirements, and regulations and testing are
> equally applied to all firms, institutions, or individuals involved in
> conducting clinical investigations of non-medical products, regardless
> of the size of the organization. Efforts have been made to require the
> minimum amount of information possible for the Agency to make
> decisions and take actions to protect the public from radiation
> hazards presented by electronic products. Many of the FDA's
> recordkeeping requirements are part of normal records necessary for
> any business practice, and the disclosure information is typically
> included in the manuals that are provided with any manufactured
> product.
>
> FDA has acted to minimize the burden to any firm whose product
> undergoes additional government testing by requiring the manufacturer
> or importer to ship tested products directly to WEAC in Winchester,
> Massachusetts. The government pays all shipping and insurance charges.
>
> FDA also maintains a fax on demand system (FACTS) which provides firms
> with information pertaining to medical devices and radiological
> health. FDA reengineering teams have also suggested creation of a
> web-based electronic data system for the submission of required
> information and a link to a generic electronic mail account on the
> website to provide assistance regarding questions and problems with
> Radiological Health and electronic products to all firms, regardless
> of size.
>
> FDA also established the Division of Small Manufacturer's,
> International, and Consumer's Assistance (DSMICA), as required by the
> 1976 Amendments to the Act, to provide technical and other
> non-financial assistance to small firms, expressly to aid them in
> complying with the requirements of the Act. DSMICA participates in and
> presents conferences, workshops, and seminars on the application and
> interpretation of relevant regulations. They also consult with
> individual firms/sponsors, and develop and disseminate educational
> materials. Staff is available to respond to questions and a toll free
> telephone number was established to facilitate this communication
> link. Additional information on DSMICA may be obtained by and firm
> with internet access by logging onto the FDA's web site
> (http:\\\\www.fda.gov) and clicking on the Center for Devices and
> Radiological Health (CDRH) link.

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

> The frequency of the collection requirements depends on the device's
> date of introduction into commerce decided by the firm. In the event
> this information was not collected by FDA, each manufacturer would
> have to respond in letter format with all the data now collected on
> FDA forms, requiring more time and expense on their part. FDA would
> also require written notification from Winchester Engineering and
> Analytical Center (WEAC), detailing information such as all products
> received, from whom, returned to whom, model and chassis numbers, etc.
> to assure that FDA's information coincided with their products. These
> extra steps to obtain information now available on a form would
> significantly increase the cost in man-hours and duplications to both
> federal and industry organizations. If this information were obtained
> less frequently, fewer compliance tests could be completed, which
> could potentially result in endangering the public health through
> unnecessary exposure to electronic radiation. In the event that this
> product information was not provided to FDA in a timely manner, a
> hazard could go undetected and the risk to the public from unnecessary
> radiation would be increased significantly. If information was not
> provided to users, distributors, or assemblers at the time of
> possession of the product they may be unable to make rational
> decisions and take actions relating to safety. Because the initial
> product report required by 1040.10(a)(3)(i) is only submitted once by
> each firm, the chance of public health risk increases as the length of
> time extends from the date of introduction of the device.

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

> A few of the information collection requirements are inconsistent with
> that outlined in 5 CFR 1320.5 because immediate health hazards require
> immediate action and reporting must be prompt. If FDA and the affected
> industry or firm did not have access to this information, equipment
> could not be located quickly when a particular product or system is
> suspected of causing harm. If an entire model line is determined to be
> defective, the firm must be able to locate other installations of the
> defective units to eliminate additional hazards. For example, one of
> the collection requirements in this request is inconsistent with that
> outlined in 5 CFR 1320.5. Section 1020.30(d) requires the assembler of
> a diagnostic x-ray system to submit a report of assembly within two
> weeks of installation. This response time was agreed upon jointly by
> FDA and the manufacturers because it was felt that the two-week period
> was sufficient time to fill out and submit the Form FDA 2579 after
> completion of the assembly.
>
> Over the past several years, recordkeeping requirements have been
> significantly reduced, but the timeframe for maintaining these records
> (5 years) remains the same. These records are needed for significant
> risk products, and therefore are considered records pertaining to
> health which are not subject to the 3 year limit \[5 CFR 1320.5(f)\].
>
> If FDA did not possess this information, equipment could not be
> located quickly when a particular system is suspected of causing harm,
> and the protection of the public from significant health risks might
> be compromised.

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

> Notice has been published in the Federal Register on June 12, 2003 (68
> FR 35231) soliciting comments on this information collection prior to
> its submission to the Office of Management and Budget (OMB) as
> required by 5 CFR 1320.8(d) (see Attachment 9). No comments were
> received.
>
> In the past year (2002-2003), FDA staff began a pilot program to test
> electronic submission of some of the requirements of this information
> collection. Comments on this pilot were generally good, and most
> participants supported continuation of this project. If funding
> permits, CDRH will continue and expand electronic submission and
> reporting tools for its stakeholders.
>
> Some of the participants involved with the electronic submissions
> pilot included:
>
> Mr. Kevin Howard
>
> Regulatory Officer
>
> Ellex Medical Pty, LTD
>
> 82 Gilbert Street
>
> Adelaide SA 5000
>
> Australia
>
> Phone: 61-8-8104 5200
>
> Fax: 61-8-8104 5231
>
> Email: <kevin.howard@ellex.com.au>
>
> Mr. Robert T. Handren, Jr.
>
> Handren Associates, Inc.
>
> 5818 Princess Caroline Place
>
> Leesburg, FL 34748
>
> Phone: 352-314-8829
>
> Email: <rhandren@direcway.com>
>
> Mr. Alan L. Voss
>
> Regulatory Consultant
>
> A L Voss Associates
>
> 548 Raggio Court
>
> Angels Camp, CA 95222
>
> Phone: 209-736-9292
>
> Email: <alvoss@caltel.com>
>
> Ms. Anne Worden
>
> Acting VP Regulatory a& QA
>
> Lumenis, Inc.
>
> 2400 Condensa Street
>
> Santa Clara, CA 95051
>
> Phone: 408-764-3266
>
> Fax: 408-764-3934
>
> Email: <aworden@lumenis.com>
>
> Martha Murani, Assistant
>
> Phone: 408-764-3604
>
> Mr. Robert L. Turocy, CQA-BIO
>
> CT PMC Regulatory Affairs Manager
>
> Phillips Medical Systems
>
> 595 Miner Road
>
> Highland Heights, Ohio 44143
>
> Phone: 440-483-3528
>
> Fax: 440-483-2976
>
> Email: <robert.turocy@phillips.com>
>
> The FDA/CDRH's Office of Compliance staff also meets on a regular
> basis with consumer groups such as the Consumer Electronics
> Association to discuss topics relating to the regulation of electronic
> and radiological health industries.
>
> FDA also routinely consults with members of industry, government, and
> the public through the Technical Electronic Product Radiation Safety
> Standards Committee (TEPRSSC) and the Radiological Devices Panel
> (RDP). These committees are permanent advisory committees established
> under Sections 534(f) and 513(b) of the Act. FDA is required to
> consult with the TEPRSSC before establishment of or changes to
> standards, and the RDP advises FDA on use of radiation in the healing
> arts.
>
> Since this collection was last approved by OMB, FDA's Radiological
> Health Recordkeeping and Reporting reengineering team presented
> recommendations to Center management. The use of electronic
> submissions and tools to utilize those submissions were determined to
> assist both the public and FDA in improving both respondent and
> government burden.

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

> There is no payment or gift provided to respondents of this
> information collection.

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

> Section 537 of the Act states that the Secretary shall not disclose
> any information which contains or relates to a trade secret or other
> matter referred to in Section 1905 of Title 18 of the United States
> Code. Information provided under this collection is handled in a
> manner to comply with this requirement and the FDA regulations
> implementing the Freedom of Information Act, 21 CFR Part 20. All
> information provided will be protected from inappropriate disclosure.

**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}**

> The most likely respondents to this information collection will be
> electronic product and x-ray manufacturers, importers, and assemblers.
>
> The current wage rate per hour for the reporting and recordkeeping
> activities of this information collection was estimated by following
> wage guidelines posted on the Regulatory Affairs Professional Society
> (RAPS) March 2003 webpage. RAPS estimated that the average salary for
> regulatory affairs professionals ranges from \$60,000 to \$75,000
> (\$28 to \$36 per hour.) FDA has chosen to be conservative and use the
> high-end average RAPS wage rate to calculate total burden cost. FDA
> estimates, therefore that the total estimated burden cost to industry
> for reporting and recordkeeping activities relating to this
> information collection will be **\$11,698,452**, which is the total
> number of hours expended (324,957) multiplied by the RAPS high-end
> average wage rate of \$36 per hour.
>
> FDA estimates the total estimated reporting and recordkeeping burden
> for this information collection to be 324,957 hours.

#### Table 1 - Estimated Annual Reporting Burden

+---------+----------+----------+--------+--------+-------+--------+
| 21 CFR  | Form     | No. of   | Annual | Total  | Hours | Total  |
| Section |          | Res      | Fre    | Annual | per   | Hours  |
|         | Number   | pondents | quency | Res    | Res   |        |
|         |          |          | per    | ponses | ponse |        |
|         |          |          | Re     |        |       |        |
|         |          |          | sponse |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.3  |          | 10       | 1      | 10     | 12    | 120    |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.10 |          | 540      | 1.6    | 850    | 24    | 20,400 |
| and     |          |          |        |        |       |        |
| 1010.3  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.11 |          | 1,000    | 1.5    | 1,500  | 0.5   | 750    |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.12 |          | 150      | 1      | 150    | 5     | 750    |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.13 |          | 900      | 1      | 900    | 26    | 23,400 |
| Annual  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.13 |          | 250      | 2.4    | 600    | 0.5   | 300    |
| Qtrly   |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1002.20 |          | 40       | 1      | 40     | 2     | 80     |
+---------+----------+----------+--------+--------+-------+--------+
| 100     |          | 10       | 1.5    | 15     | 1     | 15     |
| 2.50(a) |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| 1002.51 |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
|         | FDA 2877 | 600      | 32     | 19,200 | 0.2   | 3,840  |
+---------+----------+----------+--------+--------+-------+--------+
| 1010.2  |          | 1        | 1      | 1      | 5     | 5      |
+---------+----------+----------+--------+--------+-------+--------+
| 1010.4  |          | 1        | 1      | 1      | 120   | 120    |
| (b)     |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1010.5  |          | 3        | 1      | 3      | 22    | 66     |
| and     |          |          |        |        |       |        |
| 1010.13 |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
|         | FDA 2767 | 145      | 11.03  | 1,600  | 0.09  | 144    |
+---------+----------+----------+--------+--------+-------+--------+
| 1020.20 |          | 1        | 1      | 1      | 1     | 1      |
| (c)(4)  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1020    | FDA 2579 | 2,345    | 8.96   | 21,000 | 0.30  | 6,300  |
| .30(d), |          |          |        |        |       |        |
| (d)(1), |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (d)(2)  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1020.30 |          | 200      | 1.33   | 265    | 35    | 9,275  |
| (g)     |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1020.30 |          | 200      | 1.33   | 265    | 35    | 9,275  |
| (h)(1)  |          |          |        |        |       |        |
| through |          |          |        |        |       |        |
| (h)(4), |          |          |        |        |       |        |
|         |          |          |        |        |       |        |
| 1020.32 |          |          |        |        |       |        |
| (a)(1)  |          |          |        |        |       |        |
| and (g) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 102     |          | 9        | 1.00   | 9      | 40    | 360    |
| 0.32(g) |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| 1       |          |          |        |        |       |        |
| 020.33( |          |          |        |        |       |        |
| c);(d); |          |          |        |        |       |        |
| (g)(4); |          |          |        |        |       |        |
| (j)(1)  |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (j)(2)  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 10      |          | 8        | 1.00   | 8      | 40    | 320    |
| 20.40(c |          |          |        |        |       |        |
| )(9)(i) |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (c)     |          |          |        |        |       |        |
| (9)(ii) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1030.1  |          | 41       | 1.61   | 66     | 20    | 1,320  |
| 0(c)(4) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 10      |          | 41       | 1.61   | 66     | 20    | 1,320  |
| 30.10(c |          |          |        |        |       |        |
| )(5)(i) |          |          |        |        |       |        |
| through |          |          |        |        |       |        |
| (c)     |          |          |        |        |       |        |
| (5)(iv) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1030    |          | 1        | 1      | 1      | 1     | 1      |
| .10(c)( |          |          |        |        |       |        |
| 6)(iii) |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (c)     |          |          |        |        |       |        |
| (6)(iv) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 10      |          | 83       | 1      | 83     | 3     | 249    |
| 40.10(a |          |          |        |        |       |        |
| )(3)(i) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 10      |          | 805      | 1.00   | 805    | 8     | 6,440  |
| 40.10(h |          |          |        |        |       |        |
| )(1)(i) |          |          |        |        |       |        |
| through |          |          |        |        |       |        |
| (h)     |          |          |        |        |       |        |
| (1)(vi) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 10      |          | 100      | 1.00   | 100    | 8     | 800    |
| 40.10(h |          |          |        |        |       |        |
| )(2)(i) |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (h)     |          |          |        |        |       |        |
| (2)(ii) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1040.1  |          | 190      | 1.00   | 190    | 10    | 1,900  |
| 1(a)(2) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 104     | FDA 3147 | 53       | 2.2    | 115    | 0.5   | 58     |
| 0.11(c) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1040.20 |          | 110      | 1.00   | 110    | 10    | 1,100  |
| (d),    |          |          |        |        |       |        |
| (e)(1), |          |          |        |        |       |        |
| and     |          |          |        |        |       |        |
| (e)(2)  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1040.3  |          | 1        | 1.00   | 1      | 1     | 1      |
| 0(c)(1) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1040.3  |          | 7        | 1.00   | 7      | 1     | 7      |
| 0(c)(2) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| 1050.1  |          | 10       | 1.00   | 10     | 56    | 560    |
| 0(f)(1) |          |          |        |        |       |        |
| through |          |          |        |        |       |        |
| (f)(    |          |          |        |        |       |        |
| 2)(iii) |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+
| TOTAL   |          |          |        |        |       | 89,278 |
| ANNUAL  |          |          |        |        |       |        |
| RE      |          |          |        |        |       |        |
| PORTING |          |          |        |        |       |        |
| BURDEN  |          |          |        |        |       |        |
+---------+----------+----------+--------+--------+-------+--------+

(Footnote) There are no capital costs or operating and maintenance costs
associated with this collection.

**Table 2.\--Estimated Annual Recordkeeping Burden**

+---------+----------+------------+----------+-----------+-----------+
| 21 CFR  | No. of   | Annual     | Total    | Hours per | Total     |
| Section | Recor    |            | Annual   | Rec       | Hours     |
|         | dkeepers | Frequency  | Records  | ordkeeper |           |
|         |          | of         |          |           |           |
|         |          | Rec        |          |           |           |
|         |          | ordkeeping |          |           |           |
+---------+----------+------------+----------+-----------+-----------+
| 1002.30 | 1,150    | 1,655.5    | 1        | 198.7     | 228,505   |
| and     |          |            | ,903,825 |           |           |
| 100     |          |            |          |           |           |
| 2.31(a) |          |            |          |           |           |
+---------+----------+------------+----------+-----------+-----------+
| 1002.40 | 2,950    | 49.2       | 145,140  | 2.4       | 7,080     |
| and     |          |            |          |           |           |
| 1002.41 |          |            |          |           |           |
+---------+----------+------------+----------+-----------+-----------+
| 102     | 22       | 1          | 22       | 0.5       | 11        |
| 0.30(g) |          |            |          |           |           |
|         |          |            |          |           |           |
| \(2\)   |          |            |          |           |           |
+---------+----------+------------+----------+-----------+-----------+
| 104     | 83       | 1          | 83       | 1.0       | 83        |
| 0.10(a) |          |            |          |           |           |
|         |          |            |          |           |           |
| (3)(ii) |          |            |          |           |           |
+---------+----------+------------+----------+-----------+-----------+
| Totals  |          |            |          |           | 235,679   |
+---------+----------+------------+----------+-----------+-----------+

(Footnote) There are no capital costs or operating and maintenance costs
associated with this collection.

> The burden estimates were derived by consultation with FDA and
> industry personnel, and are based on actual data collected from
> industry over the past 3 years. An evaluation of the type and scope of
> information requested was also used to derive some time estimates. For
> example, disclosure information primarily requires time only to update
> and maintain existing manuals.
>
> The estimated respondent reporting burden is 89,278 hours. This burden
> affects 4,100 firms, requiring an average of 21.8 hours per firm
> annually. The estimated recordkeeping burden is 235,679 hours. This
> burden affects 4,100 firms, and requires an average of 57.4 hours per
> firm annually. Since most of the burden is in generating rather than
> maintaining records, FDA reduced the number of records rather than the
> maintenance time in their estimates. The remaining records are not
> considered to be subject to the 3 year limit (5 CFR 1320.6(f)) since
> they are part of the health risk assessment records for significant
> risk products.
>
> The estimated annual cost to the industry is \$11,698,452, based on
> hourly burden presented in the burden charts. This amount is derived
> from the total burden hours (324,957 hours) multiplied by an average
> estimated industry cost of \$36 per hour (\$72,000 per staff year).
> The average hourly cost includes overhead, technical staff, support
> staff, etc., and was based on the Regulatory Affairs Professional
> Society (RAPS) March 2003 Web Page Salary Summary. Using the RAPS
> web-based Salary Summary, FDA has conservatively chosen an average
> cost for respondents to prepare, submit, and maintain records and
> reports is \$36 per hour.
>
> The following information collection requirements are not subject to
> review by OMB because they do not constitute a \"collection of
> information\" under the PRA: Sections 1002.31(c); 1003.10(a), (b), and
> (c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through
> (d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b);
> 1004.2(a) through (I); 1004.3(a) through (I); 1004.4(a) through (h);
> and 1005.21(a) through (c). These requirements apply to the collection
> of information during the conduct of general investigations or audits
> (5 CFR 1320.4(b)).
>
> The following labeling requirements are also not subject to review
> under the PRA because they are a public disclosure of information
> originally supplied by the Federal Government to the recipient for the
> purpose of disclosure to the public (5 CFR 1320.3(c)(2)): Sections
> 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and
> 1050.10(d)(1).

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

> There is no capital or operating/maintenance cost associated with this
> regulation.

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

> The estimated annual cost to the Federal government is \$2,024,100.
> During the last CDRH "Center Automated Time Reporting Survey" in
> November 2002, CDRH estimated that 20 Center employees participated in
> activities under the Radiological Control for Health and Safety Act.
> The estimated cost was determined by computing the total fully loaded
> (i.e. with benefits, etc.) full time equivalent (FTE) cost. This cost
> was determined by taking the 20 staff positions and multiplying by the
> fully loaded cost of \$103,000 per staff year of 2,080 hours. The
> total cost of \$2,060,000 was then increased by the \$230,000 contact
> for data/document management, bringing the total cost to \$2,290,000.

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

> The burden represented by this collection has not changed since OMB
> last approved the collection. However, if acceptance of full
> electronic submission becomes a standard practice at FDA, respondent
> burden is expected to decrease significantly. If acceptance of
> electronic submissions is implemented prior to OMB's next approval of
> this collection, an inventory correction worksheet will be prepared
> and submitted to OMB.

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

> There are no plans to publish the collection of information under
> these regulations for statistical use unless requested by Congress in
> accordance with Section 533 of the Act.

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

> Currently, CDRH is not requesting an exemption for display of the OMB
> expiration date.

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

> Currently, CDRH is not requesting an exemption to Certification for
> the Paperwork Reduction Act Submissions. There are no exceptions to
> the certification statement identified in Item 19 of the OMB Form
> 83-I.

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

> Information submitted which is found susceptible to tabulation for
> statistical purposes may be tabulated in accordance with program
> needs, however, there are no statistical methods being employed in
> this collection of information.
>
> **[List of Attachments to Supporting Statement]{.underline}**
>
> Attachment 1 - The Federal Food, Drug, and Cosmetic Act, Chapter V,
> Subchapter C (former title: The Radiation Control for Health and
> Safety Act of 1968 (P.L. 90-602))
>
> Attachment 2 - Electronic Product Radiation Control Regulations (21
> CFR Chapter I, Subchapter J, parts 1002-1010, 1020, 1030, 1040, and
> 1050)
>
> Attachment 3 - Delegation of Authority Regulations (21 CFR Chapter I,
> Subchapter A, part 5)
>
> Attachment 4 - 21 CFR 1002 to 1050 Information Requirements
>
> Attachment 5 - FDA Form 2579 "Report of Assembly of a Diagnostic X-Ray
> System"
>
> Attachment 6 - Form FDA 2767, \"Notice of Availability of Sample
> Electronic Product\"
>
> Attachment 7 - Form FDA 2877 and instructions
>
> Attachment 8 - Form FDA 3147 and instructions
>
> Attachment 9 - Federal Register 60 Day notice
>
> **Attachment 4**
>
> **21 CFR 1002 -- 1050 Information Requirements**
>
> FDA is requesting approval from the Office of Management and Budget
> (OMB) for the information collection requirements contained in 21 CFR
> Parts 1002, 1003, 1004, 1005, 1010 1020, 1030, 1040, and 1050 as
> follows:
>
> **21 CFR 1002.3** - Disclosure - Notification:
>
> Requires manufacturers, when directed by the FDA, to provide technical
> and safety information to users.
>
> **21 CFR 1002.10(a)-(k)** - Reporting:
>
> Requires manufacturers to report to FDA product identification,
> product design and operation, product testing, quality control
> procedures, test results, and product labeling prior to the entry of
> the product into commerce.
>
> **21 CFR 1002.11(a)-(b)** - Reporting:
>
> Requires manufacturers to provide information to FDA on changes in
> product safety or testing.
>
> **21 CFR 1002.12(a)-(e)** - Reporting:
>
> Requires manufacturers to report abbreviated information on product
> safety and testing, instead of 1002.10 reports.
>
> **21 CFR 1002.13(a)-(c)** - Reporting:
>
> Requires manufacturers to report annually to FDA a summary of
> manufacturer records maintained in accordance with 1002.30, and
> provide quarterly updates of models instead of 1002.10 or .11 reports.
>
> **21 CFR 1002.20(a)-(c)** - Reporting:
>
> Requires manufacturers to report to FDA the circumstances, amount of
> exposure, and remedial actions taken concerning any accidental
> radiation occurrence involving their electronic products. If a firm is
> also required to report the incident under 21 CFR 803, those
> regulations take precedence.
>
> **21 CFR 1002.30(a)-(b)** - Recordkeeping:
>
> Requires manufacturers to keep records on test data and procedures,
> correspondence regarding radiation safety, and distribution records.
>
> **21 CFR 1002.31(c)** - Reporting:
>
> Requires manufacturers, when requested by FDA, to provide copies of
> the distribution records required to be maintained by 1002.30(b).
> \[Excluded under 5 CFR 1320.3(c).\]
>
> **21 CFR 1002.40(a)-(c)** - Recordkeeping:
>
> Requires dealers and distributors to retain first purchaser
> information, to be used by manufacturers when a product recall is
> instituted to insure the radiation safety of a product.
>
> **21 CFR 1002.41(a)-(b)** - Recordkeeping:
>
> Specifies that the dealer/distributor records in 1002.40 may be
> retained by the dealer or forwarded to the manufacturer for retention;
> also that the manufacturer or dealer shall retain distribution records
> (1002.30(b) and 1002.40) for five years. The burden is included in
> those sections.
>
> **21 CFR 1002.50(a)** - Reporting:
>
> Specifies criteria by which manufacturers may request exemption from
> reporting and recordkeeping requirements when there is a low risk of
> injury.
>
> **21 CFR 1002.51** - Reporting:
>
> Specifies criteria by which manufacturers may request exemption from
> reporting and recordkeeping requirements if the product is intended
> for U.S. Government use. The burden is combined with the 1002.50
> exemption request, because the processes are essentially identical.
>
> **21 CFR 1003.10(a)&(c)** - Reporting:
>
> Requires manufacturers to notify FDA when their product has a defect
> or fails to comply with applicable performance standards. If 21 CFR
> 803 also applies, that regulation takes precedence. \[Excluded under 5
> CFR 1320.3(c).\]
>
> **21 CFR 1003.10(b)** - Disclosure - Notification:
>
> Requires manufacturers to notify purchasers, dealers, and distributors
> of product defects or noncompliances, including a description of
> hazard, instructions for use pending correction, and a corrective
> action plan. \[Excluded under 5 CFR 1320.3(c).\]
>
> **21 CFR 1003.11(a)(3)** - Reporting:
>
> Specifies criteria by which manufacturers may refute FDA\'s notice of
> defective or noncompliant product. \[Excluded under 5 CFR 1320.3(c).\]
>
> **21 CFR 1003.11(b)** - Reporting:
>
> Requires manufacturers, when notified by FDA, to provide information
> on the number of defective products introduced into commerce. Firms
> provide the information with the 1003.10(a) report. \[Excluded under 5
> CFR 1320.3(c).\]
>
> **21 CFR 1003.20(a)-(h)** - Reporting:
>
> Requires manufacturers to provide to FDA the same report as
> 1003.10(a), under different circumstances of discovery. \[Excluded
> under 5 CFR 1320.3(c).\]
>
> **12 CFR 1003.21(a)-(d)** - Disclosure - Notification:
>
> Specifies the content of the notification required by 1003.10(b).
> \[Excluded under 5 CFR 1320.3(c).\]
>
> **21 CFR 1003.22(a)-(b)** - Reporting:
>
> Requires manufacturers to provide to FDA copies of the 1003.10
> disclosure sent to purchasers, dealers or distributors. Firms provide
> the information with the 1003.10(a) report. \[Excluded under 5 CFR
> 1320.3(c).\]
>
> **21 CFR 1003.30(a)-(b)** - Reporting:
>
> Specifies criteria by which manufacturers may request an exemption
> from the 1003.10 disclosure and possible product recall. \[Excluded
> under 5 CFR 1320.3(c).\]
>
> **21 CFR 1003.31(a)-(b)** - Reporting:
>
> Specifies the content of the 1003.30 report. \[Excluded under 5 CFR
> 1320.3(c).\]
>
> **21 CFR 1004.2(a)-(i), 21 CFR 1004.3(a)-(i), or 21 CFR
> 1004.4(a)-(h)** - Reporting:
>
> Requires manufacturers to report to FDA a plan to remedy a product
> defect or noncompliance through repair or replacement or refund.
> \[Excluded under 5 CFR 1320.3(c).\]
>
> **21 CFR 1005.21(a)-(c)** - Reporting:
>
> Specifies criteria for manufacturers or importers to request
> correction of noncompliant products for importation into the United
> States, including specific corrections, timeframe and location for
> completion. Such requests are made on Form FDA 766, Application for
> Authorization to Relabel or to perform other action of the Federal
> Food, Drug, and Cosmetic Act and other related Acts. \[Excluded under
> 5 CFR 1320.3(c), (*Attachment 8*).\]
>
> **21 CFR 1005.25(a)-(b)** - Reporting:
>
> Requires importers to report identification information and compliance
> status of products to FDA. Initial designations are provided in the
> 1002.10, 1002.11, and 1002.12 reports, so that burden is included in
> those sections. For each shipment, identification is made on Form
> 2877.
>
> **Form FDA 2877**, Declaration for Products Subject to Radiation
> Control Standards (*Attachment 6*) is used to collect this
> information. This form will be amended in the future to clarify a
> number of concerns expressed by both importers and FDA imports
> offices. It will be sent to OMB for clearance when it is ready. We do
> not anticipate any change in burden. Approval of the current form is
> requested.
>
> **21 CFR 1010.2(d)** - Reporting:
>
> Specifies criteria for manufacturers to request alternate means of
> certification to a standard.
>
> **21 CFR 1010.3(a)-(c)** - Reporting:
>
> Requires manufacturers to provide to FDA the coding systems if
> information on labels is coded and to identify each brand name, and
> the name and address of the individual or company for whom each
> product so branded is manufactured. Firms provide such information in
> the 1002.10, 1002.11, and 1002.12 reports, therefore the burden is
> included in those sections.
>
> **21 CFR 1010.4(b)** - Reporting:
>
> Specifies criteria for manufacturers to petition FDA for a variance
> from a performance standard including alternate means of safety, or
> suitable means of safety along with reasons why the standard is
> inappropriate.
>
> **Form FDA 3147**, Application for a Variance from 1040.11(c) for a
> Laser Light Shows (*Attachment 7*) is used only by manufacturers of
> laser products to submit the required information. Since the vast
> majority of variances are submitted by this industry this form was
> developed to reduce the burden and timeframe for approvals. (No form
> is applicable to other products.) There is no change to the form.
> Approval of the form is requested.
>
> **21 CFR 1010.5(c)-(d)** - Reporting:
>
> Specifies criteria by which manufacturers or U.S. government agencies
> may request an exemption (or amendment or extension) from performance
> standards when a product is to be used exclusively by a part of the
> U.S. Government and has adequate radiation emission specifications.
>
> **21 CFR 1010.13** - Reporting:
>
> Specifies criteria for manufacturers to request alternate test
> procedures from those specified in a performance standard. The burden
> is combined with 1010.5(c)-(d) because the processes are essentially
> identical.
>
> **1020.20(c) (4) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of cold cathode tubes to provide safety
> instructions and specifications to users.
>
> **1020.30(d) (1)&(2) - Reporting:**
>
> Requires individuals or companies who install certified diagnostic
> x-ray components to submit a report of assembly to FDA as
> certification that the final product meets safety regulations (Form
> FDA 2579\*). Section 21 CFR 1020.30(d)(2) of the regulation was
> amended to omit some requirements which had resulted in a burden
> reduction. In this section, reports of assembly need not be submitted
> for replacement tube housing assemblies that are reinstalled in or
> newly assembled into existing x-ray systems; Certified accessory
> components under 21 CFR 1002.10; repaired components; or temporarily
> installed components into an x-ray system.
>
> **\* Form FDA 2579**, Report of Assembly of a Diagnostic X-ray System,
> is used to obtain the required information requested in 21 CFR
> 1020.30(d); therefore, FDA is also asking for reinstatement of
> approval of the form. There are no changes to the form since its last
> approval by OMB.
>
> **1020.30(g) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of diagnostic x-ray systems and their major
> components to provide assembly, installation, compatibility, and
> testing information to assemblers of such products, and others upon
> request.
>
> **1020.30(g) (2) (Recordkeeping):**
>
> Requires manufacturers of diagnostic x-ray systems and their major
> components to provide assemblers a statement of the maximum line
> current of the x-ray system based on the maximum input voltage and
> current characteristics of the tube housing assembly compatible with
> rated output voltage and rated output current characteristics of the
> x-ray control and associated high-voltage generator.
>
> **1020.30(h) (1)-(4) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of diagnostic x-ray systems and their major
> components to provide safety and technical information and
> instructions to the purchasers and users of such products, and others
> upon request.
>
> **1020.32 (a) (1) Disclosure - Notification (Reporting):**
>
> Requires manufacturers of fluoroscopic x-ray equipment to provide
> precautions and safety information to users. It is provided in the
> same manual as the information required in 1020.30(g).
>
> **1020.32 (g) Disclosure - Notification (Reporting):**
>
> Requires manufacturers of radiographic systems that contain Positive
> Beam Limitation (PBL) to provide precautions and safety information to
> users. It is provided in the same manual as the information required
> in 1020.30(g)*.*
>
> **1020.33(c) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of Computed Tomography (CT) x-ray systems to
> provide technical and safety information to users. It is provided in
> the same manual as the information required in 1020.30(h), or in a
> separate manual devoted entirely to this information.
>
> **1020.33(d) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of CT systems to provide quality assurance
> information to users. It is provided in a separate section in the same
> manual as the information required in 1020.30(h).
>
> **1020.33(g) (4) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of certain CT systems to provide alignment
> instructions to users. It is provided in the same manual as the
> information required in 1020.30(h).
>
> **1020.33(j) (1)&(2) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of CT x-ray systems to provide specific,
> technical instructions concerning the use of the method provided for
> calculation of the CT number mean and standard deviation to users. The
> information provided according to 21 CFR 1020.30(h) should be in the
> same manual as the information required in 1020.30(h).
>
> **1020.40(c) (9) (i)&(ii) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of cabinet x-ray systems to provide technical,
> safety, maintenance, and assembly information to purchasers.
>
> **1030.10(c) (4) Disclosure - Notification (Reporting):**
>
> Requires manufacturers of microwave ovens to provide legible radiation
> safety instructions to users. This information should be contained in
> a separate section and should be an integral part of requirements
> supplied in an enclosed cookbook or users manual.
>
> **1030.10(c) (5) (i-iv) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of microwave ovens to provide safety
> information and adequate instructions to service dealers and
> distributors and others upon request.
>
> **1030.10(c) (6) (iii) - (Reporting):**
>
> Describes warning labels on Microwave Ovens. In the history of this
> performance standard, the Director for the Center for Devices and
> Radiological Health has never determined that a specific warning is
> required for a microwave oven manufacturer. Therefore, this citation
> has been added to the burden chart with a minimal burden.
>
> **1030.10(c) (6) (iv) - (Reporting):**
>
> Specifies the information to be provided to FDA when a manufacturer of
> microwave ovens requests an exemption from required user warning
> labels.
>
> **1040.10 (a) (3) (i) (Reporting):**
>
> Requires manufacturers of laser products sold for use as a component
> or replacement to register with FDA and provide a listing by type of
> product in lieu of the reporting required by 1002.10 (0MB 0910-0025).
>
> **1040.10 (a) (3) (ii) - (Recordkeeping):**
>
> Requires manufacturers of laser products sold for use as a component
> or replacement to maintain distribution records in accordance with
> 1002.31 (0MB 0910-0025).
>
> **1040.10(h) (1) (i)-(vi) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of laser products to provide assembly,
> operation and maintenance instructions, technical information, legible
> reproductions of all label and hazard warnings, and a listing of all
> controls, adjustments, and procedures for operations and maintenance
> to users- The FDA is considering an amendment to simplify the
> information and harmonize with the international standards.
>
> **1040.10(h) (2) (i)-(ii) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of laser products to provide service
> information to dealers and distributors and to others upon request. It
> is provided in the same manual, as information required in
> 1040.10(h)(1).
>
> **1040.10(i) - (Reporting):**
>
> Requires manufacturers of laser products to recertify and reidentify
> the product in accordance with 1010.2 and 1010.3. Thus, the firm is
> required to report compliance information to FDA as required by
> 1002.10 (burden documented in 0MB 0910-0025).
>
> **1040.11 (a) (2) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of certain medical laser products to provide
> instructions and a schedule for calibration with each product. It is
> provided in the same manual, as information required in 1040.11(A)(1).
>
> **1040.20 (d) & (e) (1)&(2) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of sunlamps or ultraviolet lamps to provide
> warning labels, use instructions, and technical and safety information
> to users.
>
> **l040.30 (c) (1) - Disclosure - Notification (Reporting):**
>
> Describes the general regulations for high intensity, mercury vapor
> discharge lamps, specifically the labeling of these lamps. Burden in
> this area is considered negligible, as the imprinting of the lamps has
> become industry standard. Industry also has said that if this
> requirement were eliminated, they would continue the practice because
> of the cost implications of retooling all manufacturing of mercury
> vapor lamps.
>
> **l040.30 (c) (2) - Disclosure - Notification (Recordkeeping):**
>
> Describes labeling of mercury vapor discharge lamps in lieu of
> permanently affixing or inscribing tabs or labels on the product as
> required by §§ 1010.2(b) and 1010.3(a). The manufacturer of any high
> intensity mercury vapor discharge lamp may permanently affix or
> inscribe such required tags or labels on the lamp packaging uniquely
> associated with the applicable lamp.
>
> **1050.10(f) (1) - Disclosure - Notification (Reporting):**
>
> Requires manufacturers of ultrasonic therapy products to provide
> service information to dealers and distributors and others upon
> request. Also provides user instructions concerning safety and
> precaution, adequate description of the spatial distance of the
> ultrasonic radiation field, and adequate description of the
> uncertainties of magnitude.
>
> **1050.10(f) (2) (i)-(iii) Disclosure - Notification (Reporting):**
>
> Requires manufacturers of ultrasonic therapy products to provide
> safety and technical information to users. It is provided in the same
> manual as information required in 1050.10(f) (1).