[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28958-28961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0618]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Electronic Products

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 June 15, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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

OMB Control Number 0910-0025--Extension

    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.
    FDA uses the following forms to aid respondents in the submission 
of information for this information collection:

 Form FDA 2579 ``Report of Assembly of a Diagnostic X-Ray 
System''
 Form FDA 2767 ``Notice of Availability of Sample Electronic 
Product''
 Form FDA 2877 ``Declaration for Imported Electronic Products 
Subject to Radiation Control Standards''
 Form FDA 3649 ``Accidental Radiation Occurrence (ARO)''
 Form FDA 3626 ``A Guide for the Submission of Initial Reports 
on Diagnostic X-Ray Systems and Their Major Components''
 Form FDA 3627 ``Diagnostic X-Ray CT [Computed Tomography] 
Products Radiation Safety Report''
 Form FDA 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-Ray Products Annual Report)''
 Form FDA 3629 ``Abbreviated Report''
 Form FDA 3630 ``Guide for Preparing Product Reports on 
Sunlamps and Sunlamp Products''
 Form FDA 3631 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Sunlamp Products''
 Form FDA 3632 ``Guide for Preparing Product Reports on Lasers 
and Products Containing Lasers''
 Form FDA 3633 ``General Variance Request''
 Form FDA 3634 ``Television Products Annual Report''
 Form FDA 3635 ``Laser Light Show Notification''
 Form FDA 3636 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Laser and Laser Light Show Products''
 Form FDA 3637 ``Laser Original Equipment Manufacturer (OEM) 
Report''
 Form FDA 3638 ``Guide for Filing Annual Reports for X-Ray 
Components and Systems''
 Form FDA 3639 ``Guidance for the Submission of Cabinet X-Ray 
System Reports Pursuant to 21 CFR 1020.40''
 Form FDA 3640 ``Reporting Guide for Laser Light Shows and 
Displays''
 Form FDA 3147 ``Application for a Variance From 21 CFR 
1040.11(c) for a Laser Light Show, Display, or Device''
 Form FDA 3641 ``Cabinet X-Ray Annual Report''

[[Page 28959]]

 Form FDA 3642 ``General Correspondence''
 Form FDA 3643 ``Microwave Oven Products Annual Report''
 Form FDA 3644 ``Guide for Preparing Product Reports for 
Ultrasonic Therapy Products''
 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 3659 ``Reporting and Compliance Guide for Television 
Products''
 Form FDA 3660 ``Guidance for Preparing Reports on Radiation 
Safety of Microwave Ovens''
 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''
 Form FDA 3662 ``A Guide for the Submission of an Abbreviated 
Radiation Safety Report on Cephalometric Devices Intended for 
Diagnostic Use''
 Form FDA 3663 ``Abbreviated Reports on Radiation Safety for 
Microwave Products (Other than Microwave Ovens)''
 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, 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 January 23, 2020 (85 FR 3925), 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Number of
     Activity; 21 CFR section              FDA form           Number of     responses per   Total annual   Average  burden per  response    Total hours
                                                             respondents     respondent       responses                                         \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)         3626--Diagnostic x-             1,400             2.2           3,080  24...........................          73,920
 through (k).                        ray.
                                    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.......
Product safety or testing changes-- .....................             480             2.5           1,200  0.5 (30 minutes).............             600
 1002.11(a) and (b).
Abbreviated reports--1002.12......  3629--General                      60             1.8             108  5............................             540
                                     abbreviated report.
                                    3661--X-ray tables,
                                     etc..
                                    3662--Cephalometric
                                     device.
                                    3663--Microwave
                                     products (non-oven).
Annual reports--1002.13(a) and (b)  3628--General........           1,660             1.3           2,158  18...........................          38,844
                                    3634--TV.............
                                    3638--Diagnostic x-
                                     ray.
                                    3641--Cabinet x-ray..
                                    3643--Microwave oven.
                                    3636--Laser..........
                                    3631--Sunlamp........
                                    3647--Mercury vapor
                                     lamp.
                                    3645--Ultrasonic
                                     therapy.
Quarterly updates for new models--  .....................             120             1.4             168  0.5 (30 minutes).............              84
 1002.13(c).
Accidental radiation occurrence     3649--ARO............              30             6.7             201  2............................             402
 reports--1002.20.
Exemption requests--1002.50(a) and  3642--General                       4             1.3               5  1............................               5
 1002.51.                            correspondence.
Product and sample information--    2767--Sample product.               5               1               5  0.1 (6 minutes)..............               1
 1005.10.

[[Page 28960]]

 
Identification information and      2877--Imports                  12,620             2.5          31,550  0.2 (12 minutes).............           6,310
 compliance status--1005.25.         declaration.
Alternate means of certification--  .....................               1               2               2  5............................              10
 1010.2(d).
Variance--1010.4(b)...............  3633--General                     350             1.1             385  1.2..........................             462
                                     variance request.
                                    3147--Laser show
                                     variance request.
                                    3635--Laser show
                                     notification.
Exemption from performance          .....................               1               1               1  22...........................              22
 standards--1010.5(c) and (d).
Alternate test procedures--1010.13  .....................               1               1               1  10...........................              10
Report of assembly of diagnostic x- 2579--Assembler                 1,230              34          41,820  0.3 (18 minutes).............          12,546
 ray components--1020.30(d), and     report.
 (d)(1) and (2).
Microwave oven exemption from       .....................               1               1               1  1............................               1
 warning labels--1030.10(c)(6)(iv).
Laser products registration--       3637--OEM report.....              70             2.9             203  3............................             609
 1040.10(a)(3)(i).
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  .....................  ..............  ..............  ..............  .............................         134,366
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.


                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR section               Number of      records per    Total annual       Average  burden per  recordkeeping       Total hours
                                                recordkeepers   recordkeeper       records                                                      \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30 and 1002.31(a)           1,650           1,650       2,722,500  0.12 (7 minutes).........................         326,700
Dealer/distributor records--1002.40 and                 3,110              50         155,500  0.05 (3 minutes).........................           7,775
 1002.41.
Information on diagnostic x-ray systems--                  50               1              50  0.5 (30 minutes).........................              25
 1020.30(g).
Laser products distribution ;records--                     70               1              70  1........................................              70
 1040.10(a)(3)(ii).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         334,570
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.


                            Table 3--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
   Activity; 21 CFR section        Number of     disclosures per   Total annual     burden per      Total hours
                                  respondents      respondent       disclosures     disclosure          \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety                         1                 1               1              12              12
 information for users--1002.3
Dealer/distributor records--                30                 3              90               1              90
 1002.40 and 1002.41..........
Television receiver critical                 1                 1               1               1               1
 component warning--
 1020.10(c)(4)................
Cold cathode tubes--                         1                 1               1               1               1
 1020.20(c)(4)................
Information on diagnostic x-                 6                 1               6              55             330
 ray systems--1020.30(g)......
Statement of maximum line                    6                 1               6              10              60
 current of x-ray systems--
 1020.30(g)(2)................
Diagnostic x-ray system safety               6                 1               6             200           1,200
 and technical information--
 1020.30(h)(1) through (4)....
Fluoroscopic x-ray system                    5                 1               5              25             125
 safety and technical
 information--1020.30(h)(5)
 and (6) and 1020.32(a)(1),
 (g), and (j)(4)..............
CT equipment--1020.33(c), (d),               5                 1               5             150             750
 (g)(4), and (j)..............
Cabinet x-ray systems                        6                 1               6              40             240
 information--1020.40(c)(9)(i)
 and (ii).....................
Microwave oven radiation                     1                 1               1              20              20
 safety instructions--
 1030.10(c)(4)................

[[Page 28961]]

 
Microwave oven safety                        1                 1               1              20              20
 information and instructions--
 1030.10(c)(5)(i) through (iv)
Microwave oven warning labels--              1                 1               1               1               1
 1030.10(c)(6)(iii)...........
Laser products information--                 3                 1               3              20              60
 1040.10(h)(1)(i) through (vi)
Laser product service                        3                 1               3              20              60
 information--1040.10(h)(2)(i)
 and (ii).....................
Medical laser product                        2                 1               2              10              20
 instructions--1040.11(a)(2)..
Sunlamp products instructions--              1                 1               1              10              10
 1040.20......................
Mercury vapor lamp labeling--                1                 1               1               1               1
 1040.30(c)(1)(ii)............
Mercury vapor lamp permanently               1                 1               1               1               1
 affixed labels--1040.30(c)(2)
Ultrasonic therapy products--                1                 1               1              56              56
 1050.10(d)(1) through (d),
 (f)(1), and (f)(2)(iii)......
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............           3,058
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.

    Based on a review of the information collection, we have made no 
adjustments to our burden estimate.

    Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10373 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P


