[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26937-26939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12104]



[[Page 26937]]

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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: Fax written comments on the collection of information by July 
12, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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--Reinstatement

    Under sections 532 through 542 of the Federal Food, Drug, and 
Cosmetic Act (the 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 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''
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''

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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 recent 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 November 10, 2016 (81 FR 79030), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information.
    FDA received five comments relating to potential changes to the 
process by which the FDA distributes and collects Form FDA 2579, 
``Report of Assembly of a Diagnostic X-Ray System.'' While these 
comments were not responsive to the four information collection-related 
topics on which we requested comment, FDA would like to provide 
assurance that these comments have been noted and are being considered 
as part of FDA's efforts to review the process by which Form FDA 2579 
is distributed and collected.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden 1 2
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                                                                                   Number of
                                                                      Number of    responses      Total
        Activity/21 CFR section                 FDA form No.         respondents      per         annual      Average burden per response    Total hours
                                                                                   respondent   responses
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Product reports--1002.10(a) through (k)  3626--Diagnostic x-ray;           1,400          2.2        3,080  24.............................       73,920
                                          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  .5 (30 minutes)................          600
 1002.11(a) and (b).
Abbreviated reports--1002.12...........  3629--General abbreviated            60          1.8          108  5..............................          540
                                          report; 3661--X-ray
                                          tables, etc.; 3662--
                                          Cephalometric device;
                                          3663--Microwave products
                                          (non-oven).
Annual reports--1002.13(a) and (b).....  3628--General; 3634--TV;          1,660          1.3        2,158  18.............................       38,844
                                          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  .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--1005.10  2767--Sample product......            5            1            5  .1 (6 minutes).................            1
Identification information and           2877--Imports declaration.       12,620          2.5       31,550  .2 (12 minutes)................        6,310
 compliance status--1005.25.
Alternate means of certification--       ..........................            1            2            2  5..............................           10
 1010.2(d).
Variance--1010.4(b)....................  3633--General variance              350          1.1          385  1.2............................          462
                                          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
Report of assembly of diagnostic x-ray   2579--Assembler report....        1,230           34       41,820  .30 (18 minutes)...............       12,546
 components--1020.30(d), (d)(1), and
 (2).
Microwave oven exemption from warning    ..........................            1            1            1  1..............................            1
 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\ Numbers have been rounded.


                                                   Table 2--Estimated Annual Recordkeeping Burden 1 2
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                                                                    Number of
            Activity/21 CFR section                 Number of      records per    Total annual       Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records
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Manufacturers records--1002.30 and 1002.31(a)..           1,650           1,650       2,722,500  .12 (7 minutes)........................         326,700
Dealer/distributor records--1002.40 and 1002.41           3,110              50         155,500  .05 (3 minutes)........................           7,775
Information on diagnostic x-ray systems--                    50               1              50  .5 (30 minutes)........................              25
 1020.30(g).

[[Page 26939]]

 
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\ Numbers have been rounded.


                           Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Technical and safety information               1               1               1              12              12
 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-ray                6               1               6              55             330
 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 safety               5               1               5              25             125
 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 safety                1               1               1              20              20
 instructions--1030.10(c)(4)....
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 (4),
 (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\ Numbers have been rounded.


    Dated: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12104 Filed 6-9-17; 8:45 am]
 BILLING CODE 4164-01-P