
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65329-65332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25962]


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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 
December 2, 2013.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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--21 CFR Parts 1002 Through 1010 (OMB Control Number 
0910-0025)--Extension

    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 the Department 
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

[[Page 65330]]

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:
    FDA estimates the burden of this collection of information as 
follows:

 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''
 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 June 12, 2013 (78 FR 35279), 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                        Average
          Activity/21 CFR section                     FDA form               Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response           \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k)...........  3626--Diagnostic x-ray......           1,500             1.1           1,650              24          39,600
                                            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--         ............................           1,000             1.5           1,500             0.5             750
 1002.11(a)-(b).
Abbreviated reports--1002.12..............  3629--General abbreviated                 60               2             120               5             600
                                             report.
                                            3661--X-ray tables, etc.....  ..............  ..............  ..............  ..............  ..............
                                            3662--Cephalometric device..  ..............  ..............  ..............  ..............  ..............

[[Page 65331]]

 
                                            3663--Microwave products      ..............  ..............  ..............  ..............  ..............
                                             (non-oven).
Annual reports--1002.13(a)-(b)............  3628--General...............           1,500               1           1,500              18          27,000
                                            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--          ............................               3               4              12             0.5               6
 1002.13(c).
Accidental radiation occurrence reports--   3649--ARO...................              15               6              90               2             180
 1002.20.
Exemption requests--1002.50(a) and 1002.51  3642--General correspondence              10               1              10               1              10
Product and sample information--1005.10...  2767--Sample product........               5               1               5             0.1               1
Identification information and compliance   2877--Imports declaration...           1,000              20          20,000             0.2           4,000
 status--1005.25.
Alternate means of certification--          ............................               1               2               2               5              10
 1010.2(d).
Variance--1010.4(b).......................  3633--General variance                   350               1             350             1.2             420
                                             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......           2,000              14          28,000            0.30           8,400
 components--1020.30(d), (d)(1), and
 (d)(2).
Microwave oven exemption from warning       ............................               1               1               1               1               1
 labels--1030.10(c)(6)(iv).
Laser products registration--               3637--Original equipment                  50               3             150               3             450
 1040.10(a)(3)(i).                           manufacturer (OEM) report.
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............          81,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping        \2\
----------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30             1,600           1,650       2,640,000            0.12         316,800
 and 1002.31(a).................
Dealer/distributor records--               3,000              50         150,000            0.05           7,500
 1002.40 and 1002.41............
Information on diagnostic x-ray               50               1              50             0.5              25
 systems--1020.30(g)............
Laser products distribution                   50               1              50               1              50
 records--1040.10(a)(3)(ii).....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         324,375
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.


[[Page 65332]]


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
    Activity/21 CFR section         Number of      disclosures     Total annual     burden  per     Total hours
                                   respondents    per respondent    disclosures     disclosure          \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety                          1              1                 1              12              12
 information for users--1002.3.
Dealer/distributor records--                 50              3               150               1             150
 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             100              2               200              55          11,000
 systems--1020.30(g)...........
Statement of maximum line                    15              1                15              10             150
 current of x-ray systems--
 1020.30(g)(2).................
Diagnostic x-ray system safety              100              2               200             200          40,000
 and technical information--
 1020.30(h)(1)-(h)(4)..........
Fluoroscopic x-ray system                    15              2                30              25             750
 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),                25              2                50             150           7,500
 (g)(4), and (j)...............
Cabinet x-ray systems                        30              2                60              40           2,400
 information--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                         1              1                 1              20              20
 information and instructions--
 1030.10(c)(5)(i)-(c)(5)(iv)...
Microwave oven warning labels--               1              1                 1               1               1
 1030.10(c)(6)(iii)............
Laser products information--              1,000              1.2           1,200              20          24,000
 1040.10(h)(1)(i)-(h)(1)(vi)...
Laser product service                     1,000              1.2           1,200              20          24,000
 information--1040.10(h)(2)(i)-
 (h)(2)(ii)....................
Medical laser product                        35              1                35              10             350
 instructions--1040.11(a)(2)...
Sunlamp products instructions--              10              5                50              10             500
 1040.20.......................
Mercury vapor lamp labeling--                 2              1                 2               1               2
 1040.30(c)(1)(ii).............
Mercury vapor lamp permanently                2              1                 2               1               2
 affixed labels--1040.30(c)(2).
Ultrasonic therapy products--                 5              1                 5              56             280
 1050.10(d)(1)-(d)(4), (f)(1),
 and (f)(2)(iii)...............
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............         111,139
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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.

    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) through (c), 1003.11(a)(3) and (b), 
1003.20(a) through (h), 1003.21(a) through (d), 1003.22(a) and (b), 
1003.30(a) and (b), 1003.31(a) and (b), 1004.2(a) through (i), 
1004.3(a) through (i), 1004.4(a) through (h), 1005.21(a) through (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 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); 1040.20(d)(1)(i), (d)(2)(i), and (d)(2)(iii); and 
1040.30(c)(1).

    Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25962 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P


