[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79030-79033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27199]


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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 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 January 9, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0618 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Electronic Products.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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,

[[Page 79031]]

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, 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 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''
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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 79032]]



                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                                                    Number of
        Activity/21 CFR section                  FDA form            Number of    responses per  Total annual       Average  burden per      Total hours
                                                                    respondents    respondent      responses             response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a) through     3626--Diagnostic x-ray...         1,400             2.2         3,080  24..........................       73,920
 (k).
                                        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.........................          600
 1002.11(a) and (b).                                                                                           (30 minutes)................
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............         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.........................           84
 1002.13(c).                                                                                                   (30 minutes)................
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.........................            1
 1005.10.                                                                                                      (6 minutes).................
Identification information and          2877--Imports declaration        12,620             2.5        31,550  0.2.........................        6,310
 compliance status--1005.25.                                                                                   (12 minutes)................
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.                                                              (1 hour and 12 minutes).....
                                        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  0.30........................       12,546
 components--1020.30(d), (d)(1), and                                                                           (18 minutes)................
 (2).
Microwave oven exemption from warning   .........................             1               1             1  1...........................            1
 labels--1030.10(c)(6)(iv).
Laser products registration--           3637--Original equipment             70             2.9           203  3...........................          609
 1040.10(a)(3)(i).                       manufacturer (OEM)
                                         report.
                                                                  --------------------------------------------------------------------------------------
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.


[[Page 79033]]


                               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    Total  hours
                               recordkeepers   recordkeeper       records     per  recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers records--                1,650           1,650       2,722,500  0.12..............         326,700
 1002.30 and 1002.31(a).                                                      (7 minutes).......
Dealer/distributor records--           3,110              50         155,500  0.05..............           7,775
 1002.40 and 1002.41.                                                         (30 minutes)......
Information on diagnostic x-              50               1              50  0.5...............              25
 ray systems--1020.30(g).                                                     (30 minutes)......
Laser products distribution               70               1              70  1.................              70
 records--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
                                     Number of      disclosures    Total annual       Average
     Activity/21 CFR section        respondents         per         disclosures     burden per      Total hours
                                                    respondent                      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: November 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27199 Filed 11-9-16; 8:45 am]
 BILLING CODE 4164-01-P