[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35279-35282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for reporting and recordkeeping, general and specific 
requirements, and the availability of sample electronic products for 
manufacturers and distributors of electronic products.

DATES: Submit either electronic or written comments on the collection 
of information by August 12, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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, subpart 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

[[Page 35280]]

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 noncompliances 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:
     FDA Form 2579 ``Report of Assembly of a Diagnostic X-Ray 
System''
     FDA Form 2767 ``Notice of Availability of Sample 
Electronic Product''
     FDA Form 2877 ``Declaration for Imported Electronic 
Products Subject to Radiation Control Standards''
     FDA Form 3649 ``Accidental Radiation Occurrence (ARO)''
     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 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-Ray Products Annual Report)''
     FDA Form 3629 ``Abbreviated Report''
     FDA Form 3630 ``Guide for Preparing Product Reports on 
Sunlamps and Sunlamp Products''
     FDA Form 3631 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Sunlamps and Sunlamp Products''
     FDA Form 3632 ``Guide for Preparing Product Reports on 
Lasers and Products Containing Lasers''
     FDA Form 3633 ``General Variance Request''
     FDA Form 3634 ``Television Products Annual Report''
     FDA Form 3635 ``Laser Light Show Notification''
     FDA Form 3636 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Laser and Laser Light Show Products''
     FDA Form 3637 ``Laser Original Equipment Manufacturer 
(OEM) Report''
     FDA Form 3638 ``Guide for Filing Annual Reports for X-Ray 
Components and Systems''
     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 3147 ``Application for a Variance From 21 CFR 
1040.11(c) for a Laser Light Show, Display, or Device''
     FDA Form 3641 ``Cabinet X-Ray Annual Report''
     FDA Form 3642 ``General Correspondence''
     FDA Form 3643 ``Microwave Oven Products Annual Report''
     FDA Form 3644 ``Guide for Preparing Product Reports for 
Ultrasonic Therapy Products''
     FDA Form 3645 ``Guide for Preparing Annual Reports for 
Ultrasonic Therapy Products''
     FDA Form 3646 ``Mercury Vapor Lamp Products Radiation 
Safety Report''
     FDA Form 3647 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Mercury Vapor Lamps''
     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 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 Report on Cephalometric Devices Intended for 
Diagnostic Use''
     FDA Form 3663 ``Abbreviated Reports on Radiation Safety 
for Microwave Products (Other Than Microwave Ovens)''
     FDA Form 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                            Number of
         Activity/21 CFR section                     FDA form               Number of     responses per    Total annual   Average burden    Total hours
                                                                           respondents      respondent       responses     per 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.

[[Page 35281]]

 
                                           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.
                                           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         3642--General correspondence              10              1                10            1                 10
 1002.51.
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
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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.


[[Page 35282]]


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         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
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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
     Activity/21 CFR section         Number of      disclosures    Total annual   Average burden    Total Hours
                                    respondents   per respondent    disclosures   per disclosure        \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety information               1               1               1              12              12
 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 safety              15               2              30              25             750
 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)-(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 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: June 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13855 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P