82_FR_27048 82 FR 26937 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products

82 FR 26937 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 111 (June 12, 2017)

Page Range26937-26939
FR Document2017-12104

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.

Federal Register, Volume 82 Issue 111 (Monday, June 12, 2017)
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26937-26939]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12104]



[[Page 26937]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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''

[[Page 26938]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Number of
                                                                      Number of    responses      Total
        Activity/21 CFR section                 FDA form No.         respondents      per         annual      Average burden per response    Total hours
                                                                                   respondent   responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            Activity/21 CFR section                 Number of      records per    Total annual       Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
\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



                                                                                   Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices                                               26937

                                                    DEPARTMENT OF HEALTH AND                                carry out an electronic product radiation              Form FDA 2767 ‘‘Notice of Availability of
                                                    HUMAN SERVICES                                          control program, including the                           Sample Electronic Product’’
                                                                                                            development, issuance, and                             Form FDA 2877 ‘‘Declaration for Imported
                                                    Food and Drug Administration                                                                                     Electronic Products Subject to Radiation
                                                                                                            administration of performance
                                                                                                                                                                     Control Standards’’
                                                    [Docket No. FDA–2013–N–0618]                            standards to control the emission of                   Form FDA 3649 ‘‘Accidental Radiation
                                                                                                            electronic product radiation from                        Occurrence (ARO)’’
                                                    Agency Information Collection                           electronic products. The program is                    Form FDA 3626 ‘‘A Guide for the
                                                    Activities; Submission for Office of                    designed to protect the public health                    Submission of Initial Reports on Diagnostic
                                                    Management and Budget Review;                           and safety from electronic radiation, and                X-Ray Systems and Their Major
                                                    Comment Request; Electronic                             the FD&C Act authorizes the Secretary                    Components’’
                                                                                                            to procure (by negotiation or otherwise)               Form FDA 3627 ‘‘Diagnostic X-Ray CT
                                                    Products                                                                                                         Products Radiation Safety Report’’
                                                                                                            electronic products for research and
                                                    AGENCY:    Food and Drug Administration,                                                                       Form FDA 3628 ‘‘General Annual Report
                                                                                                            testing purposes and to sell or otherwise                (Includes Medical, Analytical, and
                                                    HHS.                                                    dispose of such products. Section 534(g)                 Industrial X-Ray Products Annual Report)’’
                                                    ACTION:   Notice.                                       of the FD&C Act directs the Secretary to               Form FDA 3629 ‘‘Abbreviated Report’’
                                                                                                            review and evaluate industry testing                   Form FDA 3630 ‘‘Guide for Preparing
                                                    SUMMARY:   The Food and Drug
                                                                                                            programs on a continuing basis; and                      Product Reports on Sunlamps and
                                                    Administration (FDA) is announcing                                                                               Sunlamp Products’’
                                                                                                            section 535(e) and (f) of the FD&C Act
                                                    that a proposed collection of                                                                                  Form FDA 3631 ‘‘Guide for Preparing
                                                                                                            directs the Secretary to immediately
                                                    information has been submitted to the                                                                            Annual Reports on Radiation Safety
                                                                                                            notify manufacturers of, and ensure
                                                    Office of Management and Budget                                                                                  Testing of Sunlamp Products’’
                                                                                                            correction of, radiation defects or
                                                    (OMB) for review and clearance under                                                                           Form FDA 3632 ‘‘Guide for Preparing
                                                                                                            noncompliance with performance                           Product Reports on Lasers and Products
                                                    the Paperwork Reduction Act of 1995.
                                                                                                            standards. Section 537(b) of the FD&C                    Containing Lasers’’
                                                    DATES: Fax written comments on the
                                                                                                            Act contains the authority to require                  Form FDA 3633 ‘‘General Variance
                                                    collection of information by July 12,                   manufacturers of electronic products to                  Request’’
                                                    2017.                                                   establish and maintain records                         Form FDA 3634 ‘‘Television Products
                                                    ADDRESSES: To ensure that comments on                   (including testing records), make                        Annual Report’’
                                                    the information collection are received,                reports, and provide information to                    Form FDA 3635 ‘‘Laser Light Show
                                                    OMB recommends that written                                                                                      Notification’’
                                                                                                            determine whether the manufacturer
                                                                                                                                                                   Form FDA 3636 ‘‘Guide for Preparing
                                                    comments be faxed to the Office of                      has acted in compliance.                                 Annual Reports on Radiation Safety
                                                    Information and Regulatory Affairs,                        The regulations under parts 1002                      Testing of Laser and Laser Light Show
                                                    OMB, Attn: FDA Desk Officer, FAX:                       through 1010 specify reports to be                       Products’’
                                                    202–395–7285, or emailed to oira_                       provided by manufacturers and                          Form FDA 3637 ‘‘Laser Original Equipment
                                                    submission@omb.eop.gov. All                             distributors to FDA and records to be                    Manufacturer (OEM) Report’’
                                                    comments should be identified with the                  maintained in the event of an                          Form FDA 3638 ‘‘Guide for Filing Annual
                                                    OMB control number 0910–0025. Also                      investigation of a safety concern or a                   Reports for X-Ray Components and
                                                    include the FDA docket number found                     product recall. FDA conducts laboratory                  Systems’’
                                                    in brackets in the heading of this                                                                             Form FDA 3639 ‘‘Guidance for the
                                                                                                            compliance testing of products covered
                                                                                                                                                                     Submission of Cabinet X-Ray System
                                                    document.                                               by regulations for product standards in                  Reports Pursuant to 21 CFR 1020.40’’
                                                    FOR FURTHER INFORMATION CONTACT:                        parts 1020, 1030, 1040, and 1050.                      Form FDA 3640 ‘‘Reporting Guide for Laser
                                                    JonnaLynn Capezzuto, Office of                             FDA details product-specific                          Light Shows and Displays’’
                                                    Operations, Food and Drug                               performance standards that specify                     Form FDA 3147 ‘‘Application for a
                                                    Administration, Three White Flint                       information to be supplied with the                      Variance From 21 CFR 1040.11(c) for a
                                                    North 10A63, 11601 Landsdown St.,                       product or require specific reports. The                 Laser Light Show, Display, or Device’’
                                                                                                            information collections are either                     Form FDA 3641 ‘‘Cabinet X-Ray Annual
                                                    North Bethesda, MD 20852, 301–796–                                                                               Report’’
                                                    3794, PRAStaff@fda.hhs.gov.                             specifically called for in the FD&C Act
                                                                                                                                                                   Form FDA 3642 ‘‘General Correspondence’’
                                                    SUPPLEMENTARY INFORMATION: In
                                                                                                            or were developed to aid the Agency in
                                                                                                                                                                   Form FDA 3643 ‘‘Microwave Oven
                                                    compliance with 44 U.S.C. 3507, FDA                     performing its obligations under the                     Products Annual Report’’
                                                    has submitted the following proposed                    FD&C Act. The data reported to FDA                     Form FDA 3644 ‘‘Guide for Preparing
                                                    collection of information to OMB for                    and the records maintained are used by                   Product Reports for Ultrasonic Therapy
                                                    review and clearance.                                   FDA and the industry to make decisions                   Products’’
                                                                                                            and take actions that protect the public               Form FDA 3645 ‘‘Guide for Preparing
                                                    Electronic Products OMB Control                         from radiation hazards presented by                      Annual Reports for Ultrasonic Therapy
                                                    Number 0910–0025—Reinstatement                          electronic products. This information                    Products’’
                                                                                                            refers to the identification of, location              Form FDA 3646 ‘‘Mercury Vapor Lamp
                                                       Under sections 532 through 542 of the                                                                         Products Radiation Safety Report’’
                                                    Federal Food, Drug, and Cosmetic Act                    of, operational characteristics of, quality
                                                                                                                                                                   Form FDA 3647 ‘‘Guide for Preparing
                                                    (the FD&C Act) (21 U.S.C. 360ii through                 assurance programs for, and problem                      Annual Reports on Radiation Safety
                                                    360ss), FDA has the responsibility to                   identification and correction of                         Testing of Mercury Vapor Lamps’’
                                                    protect the public from unnecessary                     electronic products. The data provided                 Form FDA 3659 ‘‘Reporting and
                                                                                                            to users and others are intended to                      Compliance Guide for Television
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    exposure of radiation from electronic
                                                    products. The regulations issued under                  encourage actions to reduce or eliminate                 Products’’
                                                    these authorities are listed in Title 21 of             radiation exposures.                                   Form FDA 3660 ‘‘Guidance for Preparing
                                                                                                               FDA uses the following forms to aid                   Reports on Radiation Safety of Microwave
                                                    the Code of Federal Regulations, chapter                                                                         Ovens’’
                                                    I, subchapter J, parts 1000 through 1050                respondents in the submission of
                                                                                                            information for this information                       Form FDA 3661 ‘‘A Guide for the
                                                    (21 CFR parts 1000 through 1050).                                                                                Submission of an Abbreviated Report on X-
                                                       Section 532 of the FD&C Act directs                  collection:                                              Ray Tables, Cradles, Film Changers or
                                                    the Secretary of Health and Human                       Form FDA 2579 ‘‘Report of Assembly of a                  Cassette Holders Intended for Diagnostic
                                                    Services (the Secretary), to establish and                Diagnostic X-Ray System’’                              Use’’



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                                                    26938                                         Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices

                                                    Form FDA 3662 ‘‘A Guide for the                                                     derived by consultation with FDA and                                                     which the FDA distributes and collects
                                                      Submission of an Abbreviated Radiation                                            industry personnel, and are based on                                                     Form FDA 2579, ‘‘Report of Assembly of
                                                      Safety Report on Cephalometric Devices                                            data collected from industry, including                                                  a Diagnostic X-Ray System.’’ While
                                                      Intended for Diagnostic Use’’
                                                                                                                                        recent product report submissions. An                                                    these comments were not responsive to
                                                    Form FDA 3663 ‘‘Abbreviated Reports on
                                                      Radiation Safety for Microwave Products                                           evaluation of the type and scope of                                                      the four information collection-related
                                                      (Other than Microwave Ovens)’’                                                    information requested was also used to                                                   topics on which we requested comment,
                                                    Form FDA 3801 ‘‘Guide for Preparing Initial                                         derive some time estimates.                                                              FDA would like to provide assurance
                                                      Reports and Model Change Reports on                                                 In the Federal Register of November                                                    that these comments have been noted
                                                      Medical Ultraviolet Lamps and Products                                            10, 2016 (81 FR 79030), FDA published                                                    and are being considered as part of
                                                      Containing Such Lamps’’                                                           a 60-day notice requesting public                                                        FDA’s efforts to review the process by
                                                      The respondents to this information                                               comment on the proposed collection of                                                    which Form FDA 2579 is distributed
                                                    collection are electronic product and x-                                            information.                                                                             and collected.
                                                    ray manufacturers, importers, and                                                     FDA received five comments relating                                                      FDA estimates the burden of this
                                                    assemblers. The burden estimates were                                               to potential changes to the process by                                                   collection of information as follows:
                                                                                                                        TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
                                                                                                                                                                                                                 Number of                                             Average
                                                                                                                                                                                           Number of              responses             Total annual
                                                               Activity/21 CFR section                                                    FDA form No.                                                                                                               burden per                  Total hours
                                                                                                                                                                                          respondents                per                 responses                    response
                                                                                                                                                                                                                 respondent

                                                    Product reports—1002.10(a) through (k)                          3626—Diagnostic x-ray; 3627—CT x-ray;                                            1,400                     2.2                3,080        24 .........................          73,920
                                                                                                                       3639—Cabinet x-ray; 3632—Laser;
                                                                                                                       3640—Laser light show; 3630—Sun-
                                                                                                                       lamp; 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               report;                       60                   1.8                    108      5 ...........................            540
                                                                                                                       3661—X-ray tables, etc.; 3662—
                                                                                                                       Cephalometric device; 3663—Micro-
                                                                                                                       wave products (non-oven).
                                                    Annual reports—1002.13(a) and (b) ........                      3628—General; 3634—TV; 3638—Diag-                                                1,660                     1.3                2,158        18 .........................          38,844
                                                                                                                       nostic 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 reports—                        3649—ARO .............................................                               30                    6.7                   201       2 ...........................            402
                                                      1002.20.
                                                    Exemption requests—1002.50(a) and                               3642—General correspondence .............                                              4                    1.3                      5     1 ...........................               5
                                                      1002.51.
                                                    Product and sample information—                                 2767—Sample product ............................                                        5                     1                      5     .1 (6 minutes) .......                      1
                                                      1005.10.
                                                    Identification information and compliance                       2877—Imports declaration ......................                                12,620                       2.5             31,550         .2 (12 minutes) .....                   6,310
                                                      status—1005.25.
                                                    Alternate     means     of   certification—                      ..................................................................                    1                      2                       2    5 ...........................              10
                                                      1010.2(d).
                                                    Variance—1010.4(b) ................................             3633—General variance request; 3147—                                               350                     1.1                    385      1.2 ........................             462
                                                                                                                       Laser show variance request; 3635—
                                                                                                                       Laser show notification.
                                                    Exemption from performance stand-                               ..................................................................                     1                       1                     1     22 .........................               22
                                                      ards—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
                                                      1 There
                                                            are no capital costs or operating and maintenance costs associated with this collection of information.
                                                      2 Numbers have been rounded.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                                    TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
                                                                                                                                                                                             Number of                                                       Average
                                                                                                                                                             Number of                                                     Total annual
                                                                               Activity/21 CFR section                                                                                      records per                                                     burden per                       Total hours
                                                                                                                                                           recordkeepers                                                     records
                                                                                                                                                                                           recordkeeper                                                   recordkeeping

                                                    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—1020.30(g) .....                                                                   50                              1                         50            .5 (30 minutes)                                  25



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                                                                                                Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices                                                                                                               26939

                                                                                                  TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
                                                                                                                                                                                       Number of                                                       Average
                                                                                                                                                       Number of                                                    Total annual
                                                                              Activity/21 CFR section                                                                                 records per                                                     burden per                Total hours
                                                                                                                                                     recordkeepers                                                    records
                                                                                                                                                                                     recordkeeper                                                   recordkeeping

                                                    Laser products distribution records—1040.10(a)(3)(ii) .....                                                          70                              1                             70         1 .......................               70

                                                           Total ...........................................................................         ........................       ........................       ........................       ...........................       334,570
                                                       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                                                       Average
                                                                                                                                                          Number of                      disclosures                   Total annual
                                                                                Activity/21 CFR section                                                                                                                                                 burden per              Total hours
                                                                                                                                                         respondents                         per                       disclosures                      disclosure
                                                                                                                                                                                         respondent

                                                    Technical and safety information for users—1002.3 ...........                                                           1                                  1                          1                              12               12
                                                    Dealer/distributor records—1002.40 and 1002.41 ...............                                                         30                                  3                         90                               1               90
                                                    Television           receiver          critical        component              warning—
                                                       1020.10(c)(4) ....................................................................                                       1                              1                              1                           1                1
                                                    Cold-cathode tubes—1020.20(c)(4) .....................................                                                      1                              1                              1                           1                1
                                                    Information on diagnostic x-ray systems—1020.30(g) ........                                                                 6                              1                              6                          55              330
                                                    Statement of maximum line current of x-ray systems—
                                                       1020.30(g)(2) ....................................................................                                       6                              1                              6                          10               60
                                                    Diagnostic x-ray system safety and technical information—
                                                       1020.30(h)(1) through (4) .................................................                                              6                              1                              6                        200             1,200
                                                    Fluoroscopic x-ray system safety and technical informa-
                                                       tion—1020.30(h)(5) and (6) and 1020.32(a)(1), (g), and
                                                       (j)(4) ..................................................................................                                5                              1                              5                         25               125
                                                    CT equipment—1020.33(c), (d), (g)(4), and (j) ...................                                                           5                              1                              5                        150               750
                                                    Cabinet x-ray systems information—1020.40(c)(9)(i) and
                                                       (ii) ......................................................................................                              6                              1                              6                          40              240
                                                    Microwave              oven         radiation           safety          instructions—
                                                       1030.10(c)(4) ....................................................................                                       1                              1                              1                          20               20
                                                    Microwave oven safety information and instructions—
                                                       1030.10(c)(5)(i) through (iv) .............................................                                              1                              1                              1                          20               20
                                                    Microwave oven warning labels—1030.10(c)(6)(iii) .............                                                              1                              1                              1                           1                1
                                                    Laser products information—1040.10(h)(1)(i) through (vi) ..                                                                 3                              1                              3                          20               60
                                                    Laser product service information—1040.10(h)(2)(i) and (ii)                                                                 3                              1                              3                          20               60
                                                    Medical laser product instructions—1040.11(a)(2) ..............                                                             2                              1                              2                          10               20
                                                    Sunlamp products instructions—1040.20 ............................                                                          1                              1                              1                          10               10
                                                    Mercury vapor lamp labeling—1040.30(c)(1)(ii) ..................                                                            1                              1                              1                           1                1
                                                    Mercury vapor lamp permanently affixed labels—
                                                       1040.30(c)(2) ....................................................................                                       1                              1                              1                            1                  1
                                                    Ultrasonic therapy products—1050.10(d)(1) through (4),
                                                       (f)(1), and (f)(2)(iii) ............................................................                                     1                              1                              1                          56               56

                                                           Total ..............................................................................        ........................       ........................       ........................        ........................          3,058
                                                       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.                                                        DEPARTMENT OF HEALTH AND                                                                Food and Drug Administration. The
                                                    Anna K. Abram,                                                                HUMAN SERVICES                                                                          general function of the committee is to
                                                    Deputy Commissioner for Policy, Planning,                                                                                                                             provide advice to the Commissioner of
                                                    Legislation, and Analysis.                                                    Food and Drug Administration                                                            Food and Drugs and other appropriate
                                                    [FR Doc. 2017–12104 Filed 6–9–17; 8:45 am]                                                                                                                            officials on specific, complex scientific
                                                                                                                                  [Docket No. FDA–2017–N–0001]                                                            and technical issues important to FDA
                                                    BILLING CODE 4164–01–P
                                                                                                                                                                                                                          and its mission, including emerging
                                                                                                                                  Science Board to the Food and Drug
                                                                                                                                                                                                                          issues within the scientific community.
                                                                                                                                  Administration Advisory Committee;
                                                                                                                                                                                                                          Additionally, the Science Board
                                                                                                                                  Notice of Meeting
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                                                                                                                                                                                                                          provides advice to the Agency on
                                                                                                                                  AGENCY:            Food and Drug Administration,                                        keeping pace with technical and
                                                                                                                                  HHS.                                                                                    scientific developments including in
                                                                                                                                  ACTION:        Notice.                                                                  regulatory science, input into the
                                                                                                                                                                                                                          Agency’s research agenda, and on
                                                                                                                                  SUMMARY:  The Food and Drug                                                             upgrading its scientific and research
                                                                                                                                  Administration (FDA) announces a                                                        facilities and training opportunities. It
                                                                                                                                  forthcoming public advisory committee                                                   will also provide, where requested,
                                                                                                                                  meeting of the Science Board to the                                                     expert review of Agency sponsored


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Document Created: 2017-06-10 01:40:48
Document Modified: 2017-06-10 01:40:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by July 12, 2017.
ContactJonnaLynn 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]
FR Citation82 FR 26937 

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