Notice2026-03097
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products Requirements
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Published
February 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7504-7507]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03097]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1560]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Products
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 20, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0025.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#fbaba9baa88f9a9d9dbb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="69393b283a1d080f0f290f0d084701011a470e061f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Electronic Products Requirements
OMB Control Number 0910-0025--Revision
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360ii through 360ss), FDA has the
responsibility to protect the public from unnecessary exposure of
radiation from electronic products. The regulations issued under these
authorities are listed in Title 21 of the Code of Federal Regulations,
chapter I, subchapter J, parts 1000 through 1050 (21 CFR parts 1000
through 1050).
Section 532 of the FD&C Act directs the Secretary of Health and
Human Services (the Secretary), to establish and carry out an
electronic product radiation control program, including the
development, issuance, and administration of performance standards to
control the emission of electronic product radiation from electronic
products. The program is designed to protect the public health and
safety from electronic radiation, and the FD&C Act 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) of the FD&C Act directs the Secretary to
review and evaluate industry testing programs on a continuing basis;
and section 535(e) and (f) of the FD&C Act directs the Secretary to
immediately notify manufacturers of, and ensure correction of,
radiation defects or noncompliance with performance standards. Section
537(b) of the FD&C Act contains the authority to require manufacturers
of electronic products to establish and maintain records (including
testing records), make reports, and provide information to determine
whether the manufacturer has acted in compliance.
The regulations under parts 1002 through 1010 specify reports to be
provided by manufacturers and distributors to FDA and records to be
maintained in the event of an investigation of a safety concern or a
product recall. FDA conducts laboratory compliance testing of products
covered by regulations for product standards in parts 1020, 1030, 1040,
and 1050.
FDA details product-specific performance standards that specify
information to be supplied with the product or require specific
reports. The information collections are either specifically called for
in the FD&C Act or were developed to aid the Agency in performing its
obligations under the FD&C Act. The data reported to FDA and the
records maintained are used by 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 of, location of, operational characteristics of, 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.
[[Page 7505]]
FDA uses the following forms to aid respondents in the submission
of information for this information collection:
<bullet> Form FDA 2579 ``Report of Assembly of a Diagnostic X-Ray
System''
<bullet> Form FDA 2767 ``Notice of Availability of Sample Electronic
Product''
<bullet> Form FDA 2877 ``Declaration for Imported Electronic Products
Subject to Radiation Control Standards''
<bullet> Form FDA 3626 ``A Guide for the Submission of Initial Reports
on Diagnostic X-Ray Systems and Their Major Components''
<bullet> Form FDA 3627 ``Diagnostic X-Ray CT Products Radiation Safety
Report''
<bullet> Form FDA 3628 ``General Annual Report (Includes Medical,
Analytical, and Industrial X-Ray Products Annual Report)''
<bullet> Form FDA 3629 ``Abbreviated Report''
<bullet> Form FDA 3630 ``Guide for Preparing Product Reports on
Sunlamps and Sunlamp Products''
<bullet> Form FDA 3631 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Sunlamp Products''
<bullet> Form FDA 3632 ``Guide for Preparing Product Reports on Lasers
and Products Containing Lasers''
<bullet> Form FDA 3633 ``General Variance Request''
<bullet> Form FDA 3634 ``Television Products Annual Report''
<bullet> Form FDA 3635 ``Laser Light Show Notification''
<bullet> Form FDA 3636 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Laser and Laser Light Show Products''
<bullet> Form FDA 3637 ``Laser Original Equipment Manufacturer (OEM)
Report''
<bullet> Form FDA 3638 ``Guide for Filing Annual Reports for X-Ray
Components and Systems''
<bullet> Form FDA 3639 ``Guidance for the Submission of Cabinet X-Ray
System Reports Pursuant to21 CFR 1020.40''
<bullet> Form FDA 3640 ``Reporting Guide for Laser Light Shows and
Displays''
<bullet> Form FDA 3147 ``Application for a Variance From21 CFR
1040.11(c) for a Laser Light Show, Display, or Device''
<bullet> Form FDA 3641 ``Cabinet X-Ray Annual Report''
<bullet> Form FDA 3642 ``General Correspondence''
<bullet> Form FDA 3643 ``Microwave Oven Products Annual Report''
<bullet> Form FDA 3644 ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
<bullet> Form FDA 3645 ``Guide for Preparing Annual Reports for
Ultrasonic Therapy Products''
<bullet> Form FDA 3646 ``Mercury Vapor Lamp Products Radiation Safety
Report''
<bullet> Form FDA 3647 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
<bullet> Form FDA 3649 ``Accidental Radiation Occurrence (ARO)''
<bullet> Form FDA 3649C ``Consumer Accidental Radiation Occurrence
Report''
<bullet> Form FDA 3659 ``Reporting and Compliance Guide for Television
Products''
<bullet> Form FDA 3660 ``Guidance for Preparing Reports on Radiation
Safety of Microwave Ovens''
<bullet> 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''
<bullet> Form FDA 3662 ``A Guide for the Submission of an Abbreviated
Radiation Safety Report on Cephalometric Devices Intended for
Diagnostic Use''
<bullet> Form FDA 3663 ``Abbreviated Reports on Radiation Safety for
Microwave Products (Other than Microwave Ovens)''
<bullet> Form FDA 3801 ``Guide for Preparing Initial Reports and Model
Change Reports on Medical Ultraviolet Lamps and Products Containing
Such Lamps''
The respondents to this information collection are electronic
product and x-ray manufacturers, importers, consumers, and assemblers.
The burden estimates were derived by consultation with FDA and industry
personnel, and are based on data collected from industry, including
product report submissions. An evaluation of the type and scope of
information requested was also used to derive some time estimates.
In the Federal Register of July, 14, 2025 (90 FR 31211), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Activity/21 CFR section FDA form Number of responses per annual Average burden per response Total
respondents respondent responses hours
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Product reports--1002.10(a)-(k)........ 3639--Cabinet x-ray, 3632-- 1,686 2.2 3,709 24............................. 89,016
Laser, 3640--Laser light
show, 3630--Sunlamp,
3659--TV, 3660--Microwave
oven, 3801--UV lamps.
Supplemental reports--1002.11(a)-(b)... .......................... 484 2.5 1,210 0.5 (30 minutes)............... 605
Abbreviated reports--1002.12........... 3629--General abbreviated 80 1.8 144 5.............................. 720
report, 3646--Mercury
vapor lamp products
radiation safety report,
3663--Microwave products
(non-oven).
Annual reports--1002.13(a)-(b)......... 3628--General, 3634--TV, 2,344 1.3 3,047 18............................. 54,846
3641--Cabinet x-ray,
3643--Microwave oven,
3636--Laser, 3631--
Sunlamp.
Accidental radiation occurrence 3649--ARO................. 96 4 384 2.............................. 768
reports--1002.20.
Accidental radiation occurrence 3649S--ARO Summary........ 4 4 16 10............................. 160
reports--1002.20.
Accidental radiation occurrence 3649C--Consumer ARO....... 10 1 10 0.25........................... 3
reports--1002.20.
Exemption requests--1002.50(a) and 3642--General 5 1.3 7 1.............................. 7
1002.51. correspondence.
Product and sample information--1005.10 2767--Sample product...... 10 1 10 0.1 (6 minutes)................ 1
Identification information and 2877--Imports declaration. 14,506 67 971,902 0.2 (12 minutes)............... 194,380
compliance status--1005.25.
[[Page 7506]]
Alternate means of certification-- .......................... 1 1 1 5.............................. 5
1010.2(d).
Variance--1010.4(b).................... 3633--General variance 580 1.1 638 1.2............................ 766
request, 3147--Laser show
variance request, 3635--
Laser show notification.
Exemption from performance standards-- .......................... 1 1 1 22............................. 22
1010.5(c) and (d).
Alternate test procedures--1010.13..... .......................... 1 1 1 10............................. 10
Microwave oven exemption from warning .......................... 1 1 1 1.............................. 1
labels--1030.10(c)(6)(iv).
Laser products registration-- 3637--Original equipment 42 2.9 122 3.............................. 366
1040.10(a)(3)(i). manufacturer (OEM) report.
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Total.............................. .......................... 19,851 .............. 981,203 ............................... 341,676
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\1\ Numbers have been rounded.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total
Activity/21 CFR section Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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Manufacturer test and 2,129 1,650 3,512,850 0.12 (7 minutes)........ 421,542
distribution records--1002.30
and 1002.31(a).
Dealer/distributor records-- 3,000 50 150,000 0.05 (3 minutes)........ 7,500
1002.40 and 1002.41.
Information on diagnostic x-ray 50 1 50 0.5 (30 minutes)........ 25
systems--1020.30(g).
Laser products distribution 121 1 121 1....................... 121
records--1040.10(a)(3)(ii).
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Total...................... 5,300 .............. 3,663,021 ........................ 429,188
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\1\ Numbers have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden
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Number of
Number of disclosures Total Total
Activity/21 CFR section FDA form respondents per annual Average burden per disclosure hours
respondent disclosures \1\
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Technical and safety information for ........................... 1 1 1 12.............................. 12
users--1002.3.
Dealer/distributor records--1002.40 and ........................... 30 3 90 1............................... 90
1002.41.
Television receiver critical component ........................... 1 1 1 1............................... 1
warning--1020.10(c)(4).
Cold cathode tubes--1020.20(c)(4)....... ........................... 1 1 1 1............................... 1
Report of assembly of diagnostic x-ray FDA 2579--Assembler report. 1,235 34 41,990 0.30 (18 minutes)............... 12,597
components--1020.30(d), (d)(1), and
(d)(2).
Information on diagnostic x-ray systems-- ........................... 6 1 6 55.............................. 330
1020.30(g).
Statement of maximum line current of x- ........................... 6 1 6 10.............................. 60
ray systems--1020.30(g)(2).
Diagnostic x-ray system safety and ........................... 6 1 6 200............................. 1,200
technical information--1020.30(h)(1)-
(h)(4).
Fluoroscopic x-ray system safety and ........................... 5 1 5 25.............................. 125
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), ........................... 5 1 5 150............................. 750
and (j).
Cabinet x-ray systems information-- ........................... 6 1 6 40.............................. 240
1020.40(c)(9)(i)-(c)(9)(ii).
Microwave oven radiation safety ........................... 1 1 1 20.............................. 20
instructions--1030.10(c)(4).
Microwave oven safety information and ........................... 1 1 1 20.............................. 20
instructions--1030.10(c)(5)(i)-(c)(5)(i
v).
Microwave oven warning labels-- ........................... 1 1 1 1............................... 1
1030.10(c)(6)(iii).
Laser products information-- ........................... 2 1 2 20.............................. 40
1040.10(h)(1)(i)-(h)(1)(vi).
Laser product service information-- ........................... 2 1 2 20.............................. 40
1040.10(h)(2)(i)-(h)(2)(ii).
Medical laser product instructions-- ........................... 2 1 2 10.............................. 20
1040.11(a)(2).
Sunlamp products instructions--1040.20.. ........................... 1 1 1 10.............................. 10
Mercury vapor lamp labeling-- ........................... 1 1 1 1............................... 1
1040.30(c)(1)(ii).
Mercury vapor lamp permanently affixed ........................... 1 1 1 1............................... 1
labels--1040.30(c)(2).
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Total............................... ........................... 1,314 ........... 42,129 ................................ 15,559
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\1\ Total hours have been rounded.
Our estimated burden for the information collection reflects an
overall increase of 381,821 hours and a corresponding increase of
2,135,962 responses/records.
We attribute this adjustment to the addition of the new FDA Form
3649C to this collection and the adjustment to an
[[Page 7507]]
increase in respondents in the number of submissions we received over
the last few years.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03097 Filed 2-17-26; 8:45 am]
BILLING CODE 4164-01-P
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