0025 ss 6-30-2020

Electronic Products
0910-0025
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Sections 532 through 542 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360ii through 360ss) 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 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) through (c) of the FD&C Act. The program includes the
development, issuance, and administration of performance standards to control the
emission of electronic product radiation from electronic products.
FDA’s regulations regarding Radiological Health (Electronic Products) are codified at 21
CFR, Chapter I, Subpart J (parts 1000 through 1050).
FDA is requesting extension of approval from the Office of Management and Budget
(OMB), for the information collections associated with the Electronic Products.
The following 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)(c), 1003.11(a)(3) and (b), 1003.20(a)-(h), 1003.21(a)-(d), 1003.22(a) and (b), 1003.30(a)
and (b), 1003.31(a) and (b), 1004.2(a)-(i), 1004.3(a)-(i), 1004.4(a)-(h), 1005.21(a)-(c),
and 1005.22(b). These requirements apply to the collection of information during the
conduct of investigations or audits (5 CFR 1320.4).
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 1030.10(c)(6), 1040.10(g), and 1040.30(c)(1).
The following are descriptions of each information collection (IC) in this ICR:

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Technical and safety information for users (21 CFR 1002.3)—Third-party disclosure
Requires manufacturers, when directed by the FDA, to provide technical and safety
information to users.
Product reports (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. The following report forms are used to
obtain the required information requested in 21 CFR 1002.10 for each specific product,
following the applicable performance standard in parts 1020 through 1050:
• FDA Form 3626 “A Guide for the Submission of Initial Reports on Diagnostic
X-Ray Systems and Their Major Components”
• FDA Form 3627 “Diagnostic X-Ray CT Products Radiation Safety Report”
• FDA Form 3630 “Guide for Preparing Product Reports on Sunlamps and
Sunlamp Products”
• FDA Form 3632 “Guide for Preparing Product Reports on Lasers and Products
Containing Lasers”
• FDA Form 3639 “Guidance for the Submission of Cabinet X-Ray System
Reports Pursuant to 21-CFR 1020.40”
• FDA Form 3640 “Reporting Guide for Laser Light Shows and Displays”
• FDA Form 3644 “Guide for Preparing Product Reports for Ultrasonic Therapy
Products”
• FDA Form 3646 “Mercury Vapor Lamp Products Radiation Safety Report”
• FDA Form 3659 “Reporting and Compliance Guide for Television Products”
• FDA Form 3660 “Guidance for Preparing Reports on Radiation Safety of
Microwave Ovens”
• FDA Form 3801 “Guide for Preparing Initial Reports and Model Change Reports
on Medical Ultraviolet Lamps and Products Containing Such Lamps”
Product safety or testing changes (21 CFR 1002.11(a)-(b))—Reporting
Requires manufacturers to provide information to FDA on changes in product safety or
testing.
Abbreviated reports (21 CFR 1002.12)—Reporting
Requires manufacturers to report abbreviated information on product safety and testing,
instead of 1002.10 reports. The following forms are used to obtain the required
information:
• Form FDA 3629 “Abbreviated Report”
• FDA Form 3661 “Guide for the Submission of an Abbreviated Report on X-ray
Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use”
• FDA Form 3662 “Guide for Submission of an Abbreviated Radiation Safety
Reports on Cephalometric Devices Intended for Diagnostic Use”
• FDA Form 3663 “Abbreviated Reports on Radiation Safety for Microwave
Products (Other than Microwave Ovens)”

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Annual 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 1002.11 reports. The following report forms are used
to obtain the required information:
• FDA Form 3628 “General Annual Report (includes Medical, Analytical, and
Industrial X-Ray Products Annual Report)”
• FDA Form 3631 “Guide for Preparing Annual Reports on Radiation Safety
Testing of Sunlamps and Sunlamp Products”
• FDA Form 3634 “Television Products Annual Report”
• FDA Form 3636 “Guide for Preparing Annual Reports on Radiation Safety
Testing of Laser and Laser Light Show Products”
• FDA Form 3638 “Guide for Filing Annual Reports for X-Ray Components
and Systems”
• FDA Form 3641 “Cabinet X-Ray Annual Report”
• FDA Form 3643 “Microwave Oven Products Annual Report”
• FDA Form 3645 “Guide for Preparing Annual Reports for Ultrasonic
Therapy Products”
• FDA Form 3647 “Guide for preparing Annual Reports on Radiation Safety
Testing of Mercury Vapor Lamps”
Accidental radiation occurrence reports (21 CFR 1002.20)—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 part
803, those regulations take precedence.
• Form FDA 3649 “Accidental Radiation Occurrence (ARO)” report is used to
obtain the required information requested in 21 CFR 1002.20.
Manufacturers records (21 CFR 1002.30 and 1002.31(a))—Recordkeeping
Requires manufacturers to keep records on test data and procedures, correspondence
regarding radiation safety, and distribution records.
Distribution records (21 CFR 1002.31(c))—Excluded under 5 CFR 1320.4
Requires manufacturers, when requested by FDA, to provide copies of the distribution
records required to be maintained by 1002.30(b).
Dealer/distributor records (21 CFR 1002.40 and 1002.41)—Recordkeeping and
Third-party disclosure
Section 1002.40 requires dealers and distributors to retain first purchaser
information, to be used by manufacturers when a product recall is instituted to
ensure the radiation safety of a product. Section 1002.41 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 for five years.

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Exemption requests (21 CFR 1002.50(a) and 1002.51)—Reporting
Section 1002.50(a) specifies criteria by which manufacturers may request exemption
from reporting and recordkeeping requirements when there is a low risk of injury.
Section 1002.51 specifies criteria by which manufacturers may request exemption
from reporting and recordkeeping requirements if the product is intended for U.S.
Government use. The burdens are combined because the processes are essentially
identical.
• FDA Form 3642 “General Correspondence”
Discovery of defect or failure to comply, notification, and exemption from notification
(21 CFR 1003.10, 1003.11(a)(3) and (b), 1003.20(a)-(h), 1003.21(a)-(d), 1003.22(a) and
(b), 1003.30(a) and (b), 1003.31(a) and (b), 1004.2(a)-(i), 1004.3(a)-(i), 1004.4(a)-(h),
1005.21(a)-(c), and 1005.22(b))—Excluded under 5 CFR 1320.4
Section 1003.10(a) and (c) 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. Section 1003.10(b) requires manufacturers to
notify purchasers, dealers, and distributors of product defects or noncompliance,
including a description of hazard, instructions for use pending correction, and a
corrective action plan. Section 1003.11(a)(3) specifies criteria by which manufacturers
may refute FDA's notice of defective or noncompliant product. Section 1003.11(b)
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. Section 1003.20(a)-(h) requires manufacturers to provide to FDA the
same report as 1003.10(a), under different circumstances of discovery. Section
1003.21(a)-(d) specifies the content of the notification required by 1003.10(b). Section
1003.22(a) and (b) 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. Section 1003.30(a) and (b) specifies criteria by which
manufacturers may request an exemption from the 1003.10 disclosure and possible
product recall. Section 1003.31(a) and (b) specifies the content of the 1003.30 report.
Section 1005.21(a)-(c) 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. Section 1005.22(b)
specifies criteria for manufacturers or importers to request extension of time to bring
product into compliance.
Product and sample information (21 CFR 1005.10)—Reporting
Requires manufacturers or their agents, when notified by FDA, to
provide certain information on the product being introduced into
commerce and sample being shipped to FDA for testing.
• Form FDA 2767 "Notice of Availability of Sample Electronic
Product," is used to collect the required information requested in
21 CFR 1005.10.

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Identification information and compliance status (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,” is used to collect the required information requested in 21 CFR
1005.25.
Alternate means of certification (21 CFR 1010.2(d))—Reporting
Specifies criteria for manufacturers to request alternate means of certification to a
standard.
Coding system information (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.
Variance (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 3633 “General Variance Request” is applicable to products other
than Laser Light Shows and related products and is used to obtain the required
information requested in 21 CFR 1010.4.
• Form FDA 3147 “Application for a Variance from 21 CFR 1040.11(c) for a
Laser Light Show, Display, or Device” is used only by manufacturers of laser
light show products to submit the required information in order to justify a
variance approval.
• Form FDA 3635 “Laser Light Show Notification” is used to obtain certain
required information specified in Form FDA 3147.
Exemption from performance standards (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.
Alternate test procedures (21 CFR 1010.13)—Reporting
Specifies criteria for manufacturers to request alternate test procedures from those
specified in a performance standard.

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Television receiver critical component warning (1020.10(c)(4))—Third-party disclosure
Requires manufacturers of television receivers to permanently affix or inscribe a warning
label that includes the specification of operating high voltage and an instruction for
adjusting the high voltage to the specified value.
Cold cathode tubes (1020.20(c)(4))—Third-party disclosure
Requires manufacturers of cold cathode tubes to provide safety instructions and
specifications to users.
Report of assembly of diagnostic x-ray components (1020.30(d)(1)-(d)(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). 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).
Information on diagnostic x-ray systems (1020.30(g))—Recordkeeping and Third-party
disclosure
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. Section 1020.30(g)(2) 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 highvoltage generator.
Diagnostic x-ray system safety and technical information (1020.30(h)(1)-(h)(4))—
Third-party disclosure
Section 1020.30(h)(1)-(h)(4) 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.
Fluoroscopic x-ray system safety and technical information (1020.30(h)(5)-(h)(6) and
1020.32(a)(1), (g), and (j)(4))—Third-party disclosure
Section 1020.30(h)(5) and (h)(6) requires manufacturers of fluoroscopic x-ray systems to
provide safety information and instructions to the purchasers and users of such products,
and others upon request. Section 1020.32(a)(1) requires manufacturers to provide to users
precautions concerning the importance of remote control operation. Section 1020.32(g)
requires manufacturers of radiographic systems that contain Positive Beam Limitation to
provide precautions and safety information to users. Section 1020.32(j)(4) requires the
manufacturers of fluoroscopic x-ray equipment to provide technical information to users.

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Computed tomography (CT) equipment (1020.33(c)-(d), (g)(4), and (j))—Third-party
disclosure
Section 1020.33(c) requires manufacturers of 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.
Section 1020.33(d) requires manufacturers of CT systems to provide quality assurance
information to users. Section 1020.33(g)(4) requires manufacturers of certain CT
systems to provide alignment instructions to users. Section 1020.33(j) 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.
Cabinet x-ray systems information (1020.40(c)(9)(i)-(c)(9)(ii))—Third-party
disclosure
Requires manufacturers of cabinet x-ray systems to provide technical, safety,
maintenance, and assembly information to purchasers.
Microwave oven radiation safety instructions (1030.10(c)(4))—Third-party disclosure
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 user
manual.
Microwave oven safety information and instructions (1030.10(c)(5)(i)-(c)(5)(iv))—Thirdparty disclosure
Requires manufacturers of microwave ovens to provide safety information and adequate
instructions to service dealers and distributors and others upon request.
Microwave oven warning labels (1030.10(c)(6)(iii))—Third-party disclosure
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.
Microwave oven exemption from warning labels (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.
Laser products registration (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.
• Form FDA 3637 “Laser Original Equipment Manufacturer (OEM) Report” is
used to obtain the required information requested in 21 CFR 1040.10(a)(3)(i).
Laser products distribution records (1040.10(a)(3)(ii))—Recordkeeping

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Requires manufacturers of laser products sold for use as a component or replacement to
maintain distribution records in accordance with 1002.31.
Laser products information (1040.10(h)(1)(i)-(h)(1)(vi))—Third-party disclosure
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.
Laser product service information (1040.10(h)(2)(i)-(h)(2)(ii))—Third-party disclosure
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).
Laser products recertification (1040.10(i))—Reporting
The reporting burden for laser products recertification is included in the burden
estimate for Product Reports—1002.10. Section 1040.10(i) requires manufacturers
who modify certified 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. Manufacturers report this information on
Form FDA 3632.
Medical laser product instructions (1040.11(a)(2))—Third-party disclosure
Requires manufacturers of certain medical laser products to provide instructions and a
schedule for calibration with each product. It may be provided in the same manual as
information to purchasers required in 1040.10(h)(1).
Sunlamp products (1040.20)—Third-party disclosure
Describes the labeling requirements for sunlamp products and ultraviolet lamps intended
for use in sunlamp products. As described above, the labeling requirements in
1040.20(d)(1)(i), (d)(2)(i), and (d)(2)(iii) are 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)).
Mercury vapor lamp labeling (l040.30(c)(1)(ii))—Third-party disclosure
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.
Mercury vapor lamp permanently affixed labels (l040.30(c)(2))—Third-party disclosure
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

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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.
Ultrasonic therapy products (1050.10(d) and (f))—Third-party disclosure
Section 1050.10(d) requires manufacturers of ultrasonic therapy products to provide
informational labels on the components. Section 1050.10(f)(1) 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. Section 1050.10(f)(2) 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).
This information collection is not related to the American Recovery and Reinvestment
Act of 2009.
2. Purpose and Use of the Information Collection
The respondents to this information collection are from the private sector; businesses for
profit. The information collections are either specifically called for in the FD&C Act or
were developed to aid FDA in performing its obligations under the FD&C 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 that 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, conformance with
performance standards, and adequacy of quality control testing. Potential and actual
problems are resolved with the individual firm. The information supplied can be used by
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 FDA’s
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

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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
FD&C Act.
3. Use of Improved Information Technology and Burden Reduction
FDA has implemented several improved information technologies and methods to reduce
the burden placed on manufacturers and assemblers, such as electronic transfer and
optical storage of documents. This collection’s forms have been designed to provide the
minimum needed information in order to evaluate the product.
Well-designed forms can eventually lead to automated reviews of the submissions by
software, identifying potential compliance problems and potential radiation hazards
within days of receipt, reducing current time-consuming FDA processing and review
times by an order of magnitude, and utilizing modern communication techniques to pass
the information back to the manufacturer almost immediately.
The forms included here are portable document format (pdf) files, all except form FDA
2579 is printed from the electronic submission system FDA has developed and provided
for respondent use. The FDA encourages electronic filing via the FDA Electronic
Submissions Gateway (FDA ESG) allowing manufacturers to create files using the
CDRH eSubmitter software application, then send them via Internet through the FDA
Gateway, significantly reducing the time burden of time delay and marketing restrictions
placed on manufacturers and importers from 1 month to 5 minutes.
The FDA’s voluntary electronic submission (eSubmitter) program utilizes information
technology tools to automatically edit-check for errors in online submissions, ensure data
integrity, and allow FDA staff to perform reviews, trending, and sampling analyses with
greater ease. The eSubmitter software reduces the number of supplements needed, and
provides data often missing from paper submissions. Additionally, as each form has been
developed, the subject matter experts have streamlined the data collection and
information requirements to a critical minimum, thereby reducing further the reporting
burden on manufacturers.
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 document retrieval system, IMAGE, has been
modified to accommodate the eSubmitter applications for the radiological health area.

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We have been consistently receiving approximately 50 percent of submissions using
eSubmitter. FDA staff continues to encourage usage and provide individual assistance to
industry.
4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only authorized Agency to regulate the radiation from electronic products.
Therefore, these activities are not duplicated anywhere else. Those electronic products
that are also medical devices may be subject to additional (and different) FDA
regulations under a separate section of the FD&C Act. In rare cases there has been minor
duplication of information and where there has been, exemptions have been granted and
the requirements changed 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. There is no
similar information collected that can be used to carry out the enforcement of these
regulations.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately 22 percent of respondents are small businesses
(manufacturers, importers and assemblers of electronic products).
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 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 to purchasers 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 Winchester Engineering and Analytical Center (WEAC) in Winchester,
Massachusetts. The government often purchases the product, and/or pays all shipping and
insurance charges.
FDA also maintains a CDRH website which provides firms with information pertaining
to medical devices and radiological health. The Radiological Health homepage
(http://www.fda.gov/Radiation-EmittingProducts/default.htm ) provides all the paperbased report forms as well as the opportunity to download and install the new eSubmitter
application and User Guide for electronic submission of required information.
Furthermore, there is a subscription service which allows subscribers to be automatically
notified by email whenever there are updates and new postings to the homepage. This
helps provide answers to questions and problems with radiological health and electronic
products to all firms, regardless of size.

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FDA’s Center for Devices and Radiological Health (CDRH), Division of International
and Consumer Education (DICE), provides technical and other non-financial assistance
to small firms, expressly to aid them in complying with the requirements of the Act.
DICE participates in and presents conferences, workshops, and seminars on the
application and interpretation of relevant regulations. They also consult with individual
firms, 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 DICE may be obtained by any firm with
internet access by logging onto the FDA’s web site (http:\\www.fda.gov) and clicking on
the Radiological Health Program link.
6. Consequences of Collecting the Information Less Frequently
The frequency of the collection requirements depends on the type of information. There
are one-time product reports and annual reports. A firm introducing a new electronic
product is required to prepare a one-time product report, for which the burden has been
estimated to be 24 hours. Subsequent modifications to that product may require a
supplemental report, which take a half hour and are only required when the new model
has changes that affect the radiation hazard from the product. Again, this would be a
one-time submission. Generally, all manufacturers of electronic products subject to the
reporting requirements under this clearance must file an annual report, which is a
production summary report. This burden has been estimated to be 18 hours, an annual
burden.
If this information were obtained less frequently, fewer report reviews and evaluations of
compliance could be conducted by FDA, 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 informed decisions and
take actions relating to safety.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A few of the information collection requirements are inconsistent with those 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.
Over the past several years, recordkeeping requirements have been significantly reduced,
but the timeframe for maintaining these records (5 years) remains the same. These

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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(d)(2)(iv)).
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 the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment
in the Federal Register of 01/23/2020 (85 FR 3925). No comments were received.
FDA/CDRH’s Office of Communication, Education, and Radiation Programs (OCER)
staff 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 FD&C 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.
9. Explanation of Any Payment or Gift to Respondents
There is no payment or gift provided to respondents of this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected.
This ICR collects personally identifiable information (PII). The PII collected is for
business contact purposes only. The PII submitted via each FDA form is: Form FDA
3636 (Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and
Laser Light Show Products); Form FDA 3639 (Cabinet X-ray System Reporting Form);
Form FDA 3640 (Reporting Guide for Laser Light Shows and Displays); Form FDA
3643 (Microwave Oven Products Annual Report); Form FDA 3645 (Guide for Preparing
Annual Reports for Ultrasonic Therapy Products); Form FDA 3646 (Mercury Vapor
Lamp Products Radiation Safety Report); Form FDA 3647 (Guide for Preparing Annual
Reports on Radiation Safety Testing of Mercury Vapor Lamps); Form FDA 3663
(Abbreviated Reports on Radiation Safety for Microwave Products (Other than
Microwave Ovens)); Form FDA 3759 (Abbreviated Reports on Radiation Safety of NonMedical Ultrasonic Products); Form FDA 3801 (Guide for Preparing Initial Reports and

13

Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such
Lamps); Form FDA 4004 (Guidance for the Preparing Abbreviated Reports of
Microwave and RF Emitting Electronic Products Intended for Medical Use); Form FDA
3147 (Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show,
Display, or Device); Form FDA 3628 (Guide for Preparing Annual Reports on Radiation
Safety Testing of Electronic Products (General); Form FDA 3630 (Guide for Preparing
Product Reports on Sunlamps and Sunlamp Products); Form FDA (Guide for Preparing
Annual Reports on Radiation Safety Testing of Sunlamp Products); and Form FDA 3632
(Guide for Preparing Product Reports for Lasers and Products Containing Lasers) collect
name, title, work address, work telephone number, and work email address. Form FDA
3661 (A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles,
Film Changers or Cassette Holders Intended for Diagnostic Use); and Form FDA 3662
(A Guide for the Submission of an Abbreviated Radiation Safety Report on
Cephalometric Devices Intended for Diagnostic Use) collect name, work address, work
telephone number, and work email address. Form FDA 3637 (Laser Original Equipment
Manufacture Report); Form FDA 3642 (General Correspondence Report for CDRH
Electronic Submissions); Form FDA 3649 (Accidental Radiation Occurrence Report);
Form FDA 3659 (TV Product Report); Form FDA 3760 (Guide for Preparing Product
Reports for Medical Ultrasound Products); Form FDA 3629 (Abbreviated Report); Form
FDA 3633 (General Variance Request); Form FDA 3634 (TV Annual Report); Form
FDA 3635 (Laser Light Show Notification); Form FDA 3638 (Guide for Filing Annual
Reports for X-Ray Components and Systems); and Form FDA 3641 (Cabinet X-Ray
Annual Report) collect name, title, work address, work telephone number, work fax
number, and work email address. Form FDA 3644 (Guide for Preparing Product Reports
for Ultrasonic Therapy Products) collects name, title, work address, and work email
address. Form FDA 3660 (Guidance for Preparing Reports on Radiation Safety of
Microwave Ovens); and Form FDA 2767 (Notice of Availability of Sample Electronic
Product) collect name, title, work address and work telephone number. Form FDA 2877
(Declaration for Imported Electronic Products Subject to Radiation Control Standards
collects name, title, and work address. Form FDA 2579 (Report of Assembly of a
Diagnostic X-Ray System); Form FDA 3626 (A Guide for the Submission of Initial
Reports on Diagnostic X-Ray Systems and Their Major Components); and Form FDA
3627 (A Guide for the Submission of Initial Reports on Computed Tomography X-Ray
Systems) collect name.
FDA further determined that although PII is collected the collection is not subject to the
Privacy Act of 1974 and the particular notice and other requirements of the Act do not
apply. Specifically, FDA does not use name or any other personal identifier to retrieve
records from the information collected. FDA also minimized the PII to be collected to
protect the privacy of the individuals.
Section 537 of the FD&C 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

14

Freedom of Information Act, 21 CFR part 20. All information provided will be protected
from inappropriate disclosure.
11. Justification for Sensitive Questions
The information collection does not include questions about sexual behavior and
attitudes, religious beliefs, or other matters that are commonly considered private or
sensitive in nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Respondents to this collection of information are electronic product manufacturers,
importers, and assemblers. The burden estimates were derived by consultation with FDA
and industry personnel, and are based on actual data collected from industry, including
recent product report submissions. An evaluation of the type and scope of information
requested was also used to derive some time estimates.
Activity/ 21 CFR
Section

Product reports—
1002.10(a)-(k)

Product safety or
testing changes—
1002.11(a)-(b)
Abbreviated
reports—1002.12

Annual reports—
1002.13(a)-(b)

Table 1.--Estimated Annual Reporting Burden
FDA Form
No. of
No. of
Respondents
Responses
per
Respondent
3626—Diagnostic x-ray
1,400
2.2
3627—CT x-ray
3639—Cabinet x-ray
3632—Laser
3640—Laser light show
3630—Sunlamp
3646—Mercury vapor lamp
3644—Ultrasonic therapy
3659—TV
3660—Microwave oven
3801—UV lamps
480
2.5

3629—General abbreviated
report
3661—X-ray tables, etc.
3662—Cephalometric device
3663—Microwave products
(non-oven)
3628—General
3634—TV
3638—Diagnostic x-ray
3641—Cabinet x-ray
3643—Microwave oven
3636—Laser
3631—Sunlamp
3647—Mercury vapor lamp
3645—Ultrasonic therapy

15

Total
Annual
Responses
3,080

Average
Burden
per
Response
24

Total
Hours1

1,200

0.5

600

73,920

60

1.8

108

5

540

1,660

1.3

2,158

18

38,844

Activity/ 21 CFR
Section

Quarterly updates
for new models—
1002.13(c)
Accidental radiation
occurrence
reports—1002.20
Exemption
requests—
1002.50(a) and
1002.51
Product and sample
information—
1005.10
Identification
information and
compliance status—
1005.25
Alternate means of
certification—
1010.2(d)
Variance—
1010.4(b)

Table 1.--Estimated Annual Reporting Burden
FDA Form
No. of
No. of
Respondents
Responses
per
Respondent
120
1.4

3649—ARO

Total
Annual
Responses
168

Average
Burden
per
Response
0.5

Total
Hours1

84

30

6.7

201

2

402

3642—General correspondence

4

1.3

5

1

5

2767—Sample product

5

1

5

0.1

1

12,620

2.5

31,550

0.2

6,310

1

2

2

5

10

350

1.1

385

1.2

462

1

1

1

22

22

1

1

1

10

10

1,230

34

41,820

0.30

12,546

1

1

1

1

1

70

2.9

203

3

609

2877—Imports declaration

3633—General variance
request
3147—Laser show variance
request
3635—Laser show notification

Exemption from
performance
standards—
1010.5(c) and (d)
Alternate test
procedures—
1010.13
Report of assembly
2579—Assembler report
of diagnostic x-ray
components—
1020.30(d), (d)(1),
and (d)(2)
Microwave oven
exemption from
warning labels—
1030.10(c)(6)(iv)
Laser products
3637—Original equipment
registration—
manufacturer (OEM) report
1040.10(a)(3)(i)
Total
1 Total hours have been rounded.

134,366

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Table 2.--Estimated Annual Recordkeeping Burden
No. of
No. of Records
Total
Recordkeepers
per
Annual
Recordkeeper
Records

Activity/ 21 CFR Section

Average Burden
per
Recordkeeping

Total
Hours1

Manufacturers records—1002.30 and
1002.31(a)

1,650

1,650

2,722,500

0.12

326,700

Dealer/distributor records—1002.40
and 1002.41

3,110

50

155,500

0.05

7,775

50

1

50

0.5

25

70

1

70

1

70

Information on diagnostic x-ray
systems—1020.30(g)
Laser products distribution records—
1040.10(a)(3)(ii)
Total
1 Total hours have been rounded.

Activity/ 21 CFR Section

Technical and safety
information for users—
1002.3
Dealer/distributor records—
1002.40 and 1002.41
Television receiver critical
component warning—
1020.10(c)(4)
Cold cathode tubes—
1020.20(c)(4)
Information on diagnostic xray systems—1020.30(g)
Statement of maximum line
current of x-ray systems—
1020.30(g)(2)
Diagnostic x-ray system
safety and technical
information—1020.30(h)(1)(h)(4)
Fluoroscopic x-ray system
safety and technical
information—1020.30(h)(5)(h)(6) and 1020.32(a)(1), (g),
and (j)(4)
CT equipment—1020.33(c)(d), (g)(4), and (j)
Cabinet x-ray systems
information—
1020.40(c)(9)(i)-(c)(9)(ii)
Microwave oven radiation
safety instructions—
1030.10(c)(4)

334,570

Table 3.--Estimated Annual Third-Party Disclosure Burden
No. of
No. of
Total Annual
Average Burden
Respondents
Disclosures
Disclosures
per Disclosure
per
Respondent
1
1
1
12

Total Hours1

12

30

3

90

1

1

1

1

1

1

1

1

1

1

6

1

6

55

330

6

1

6

10

60

6

1

6

200

1,200

5

1

5

25

125

5

1

5

150

750

6

1

6

40

240

1

1

1

20

20

17

1

90

Activity/ 21 CFR Section

Microwave oven safety
information and
instructions—
1030.10(c)(5)(i)-(c)(5)(iv)
Microwave oven warning
labels—1030.10(c)(6)(iii)
Laser products
information—
1040.10(h)(1)(i)-(h)(1)(vi)
Laser product service
information—
1040.10(h)(2)(i)-(h)(2)(ii)
Medical laser product
instructions—1040.11(a)(2)
Sunlamp products
instructions—1040.20
Mercury vapor lamp
labeling—1040.30(c)(1)(ii)
Mercury vapor lamp
permanently affixed labels—
1040.30(c)(2)
Ultrasonic therapy
products—1050.10(d)(1)(d)(4), (f)(1), and (f)(2)(iii)
Total
1 Total hours have been rounded.

Table 3.--Estimated Annual Third-Party Disclosure Burden
No. of
No. of
Total Annual
Average Burden
Respondents
Disclosures
Disclosures
per Disclosure
per
Respondent
1
1
1
20

Total Hours1

20

1

1

1

1

1

3

1

3

20

60

3

1

3

20

60

2

1

2

10

20

1

1

1

10

10

1

1

1

1

1

1

1

1

1

1

1

1

1

56

56

3,058

12b. Annualized Cost Burden Estimate
We expect that the information collection will be satisfied by regulatory affairs
professionals. We have updated the hourly wage rate estimate.
Type of Respondent
Regulatory Affairs
Professional*

Total Burden
Hours
471,994

Hourly Wage Rate
$30.50

Total Respondent
Costs
$14,395,817

*The estimated wage rate for a Regulatory Affairs Professional was calculated from the median annual
salary ($63,444) listed on Payscale.com
(http://www.payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary, accessed 01-31-17).
The hourly wage rate assumes a 40-hour work week and is rounded to the nearest dollar.

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There is no capital or operating/maintenance cost associated with this collection.

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14. Annualized Cost to the Federal Government
FDA estimates that 15 full time equivalent (FTE) positions participate in activities under
the Radiation Control for Health and Safety Act. An average full time equivalent (FTE)
employee is projected to cost FDA’s Center for Devices and Radiological Health
(CDRH) $213,944 (rounded),* which consists of the employee’s salary and any overhead
which accompanies that employee. Therefore, the estimated annualized burden to
government for this information collection is $3,209,160 per year ($213,944 x 15 FTEs).
* Based on the FY 2017 FDA Budget Request – Executive Summary – All Purpose Table.

15. Explanation for Program Changes or Adjustments
There are no program changes or adjustments associated with this request for extension.
Note that in the Federal Register of April 1, 2019 (84 FR 12147), FDA proposed to
amend and repeal parts of the radiological health regulations covering recommendations
for radiation protection during medical procedures, certain records and reporting for
electronic products, and performance standards for diagnostic x-ray systems
and their major components, laser products, and ultrasonic therapy products. As required
in 5 CFR part 1320, we requested public comment on proposed revisions to this ICR. At
the time of this extension request, the rulemaking has not been finalized.
16. Plans for Tabulation and Publication and Project Time Schedule
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 FD&C
Act.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

19