[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26964-26967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0088]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting and 
Recordkeeping Requirements and Availability of Sample Electronic 
Products for Manufacturers and Distributors of Electronic Products

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by June 
14, 2010.

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 e-mailed 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:  Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, email: 
[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.

Reporting and Recordkeeping Requirements and Availability of Sample 
Electronic Products for Manufacturers and Distributors of Electronic 
Products (OMB Control Number 0910-0025)--Extension

    Under sections 532 through 542 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA has the 
responsibility to protect the public from unnecessary exposure of 
radiation from electronic products. The regulations issued under these 
authorities are listed in title 21 of the Code of Federal Regulations, 
chapter I, subpart J, parts 1000 through 1050 (parts 1002 through 
1050).
    Section 532 of the 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 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 act directs the Secretary to review and 
evaluate industry testing programs on a continuing basis; and section 
535(e) and (f) of the act directs the Secretary to immediately notify 
manufacturers of, and ensure correction of, radiation defects or 
noncompliances with performance standards. Section 537(b) of the 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 act or were developed to aid the Agency in performing its 
obligations under the act. The data reported to FDA and the records 
maintained are used by FDA and the industry to make decisions and take 
actions that protect the public from radiation hazards presented by 
electronic products. This information refers to the identification of, 
location of, operational characteristics of, quality assurance programs 
for, and problem identification and correction of electronic products. 
The data provided to users and others are intended to encourage actions 
to reduce or eliminate radiation exposures.
    FDA uses the following forms to aid respondents in the submission 
of information for this information collection:
     FDA Form 2579 ``Report of Assembly of a Diagnostic X-Ray 
System''
     FDA Form 2767 ``Notice of Availability of Sample 
Electronic Product''
     FDA Form 2877 ``Declaration for Imported Electronic 
Products Subject to Radiation Control Standards''
     FDA Form 3649 ``Accidental Radiation Occurrence (ARO)''
     FDA Form 3626 ``A Guide for the Submission of Initial 
Reports on Diagnostic X-Ray Systems and Their Major Components''
     FDA Form 3627 ``Diagnostic X-Ray CT Products Radiation 
Safety Report''
     FDA Form 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-Ray Products Annual Report)''
     FDA Form 3629 ``Abbreviated Report''
     FDA Form 3630 ``Guide for Preparing Product Reports on 
Sunlamps and Sunlamp Products''
     FDA Form 3631 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Sunlamps and Sunlamp Products''
     FDA Form 3632 ``Guide for Preparing Product Reports on 
Lasers and Products Containing Lasers''
     FDA Form 3633 ``General Variance Request''
     FDA Form 3634 ``Television Products Annual Report''
     FDA Form 3635 ``Laser Light Show Notification''
     FDA Form 3636 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Laser and Laser Light Show Products''
     FDA Form 3637 ``Laser Original Equipment Manufacturer 
(OEM) Report''
     FDA Form 3638 ``Guide for Filing Annual Reports for X-Ray 
Components and Systems''

[[Page 26965]]

     FDA Form 3639 ``Guidance for the Submission of Cabinet X-
Ray System Reports Pursuant to 21 CFR 1020.40''
     FDA Form 3640 ``Reporting Guide for Laser Light Shows and 
Displays''
     FDA Form 3147 ``Application for a Variance From 21 CFR 
1040.11(c) for a Laser Light Show, Display, or Device''
     FDA Form 3641 ``Cabinet X-Ray Annual Report''
     FDA Form 3642 ``General Correspondence''
     FDA Form 3643 ``Microwave Oven Products Annual Report''
     FDA Form 3644 ``Guide for Preparing Product Reports for 
Ultrasonic Therapy Products''
     FDA Form 3645 ``Guide for Preparing Annual Reports for 
Ultrasonic Therapy Products''
     FDA Form 3646 ``Mercury Vapor Lamp Products Radiation 
Safety Report''
     FDA Form 3647 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Mercury Vapor Lamps''
     FDA Form 3659 ``Reporting and Compliance Guide for 
Television Products''
     FDA Form 3660 ``Guidance for Preparing Reports on 
Radiation Safety of Microwave Ovens''
     FDA Form 3661 ``Guide for the Submission of an Abbreviated 
Report on X-Ray Tables, Cradles, Film Changers, or Cassette Holders 
Intended for Diagnostic Use''
     FDA Form 3662 ``Guide for Submission of an Abbreviated 
Radiation Safety Report on Cephalometric Devices Intended for 
Diagnostic Use''
     FDA Form 3663 ``Abbreviated Reports on Radiation Safety 
for Microwave Products (Other than Microwave Ovens)''
     FDA Form 3801 ``Guide for Preparing Initial Reports and 
Model Change Reports on Medical Ultraviolet Lamps and Products 
Containing Such Lamps''
    The most likely respondents to this information collection will be 
electronic product and x-ray manufacturers, importers, and assemblers.
    In the Federal Register of February 26, 2010 (75 FR 8963), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1 -Estimated Annual Reporting Burden\1\
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                                                                                 No. of       Annual Frequency   Total Annual    Hours per
      21 CFR Section/Part                       FDA Form  No.                  Respondents      per Response       Responses      Response   Total Hours
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1002.3                           N/A                                                     10                  1              10           12          120
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1002.10                          3626--Diagnostic X-Ray                               1,000                1.2           1,200           24       28,800
                                 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
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1002.11                          N/A                                                    400                0.6             240          0.5          120
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1002.12                          3629--General Abbreviated Report                        50                  1              50            5          250
                                 3661--X-Ray Tables, etc.
                                 3662--Cephalometric Device
                                 3663--non-Oven Microwave Product
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1002.13                          3628--General                                        1,000                  1           1,000           18       18,000
                                 3634--TV
                                 3638--Diagnostic X-Ray
                                 3641--Cabinet X-Ray
                                 3643--Microwave Oven
                                 3636--Laser
                                 3631--Sunlamp
                                 3647--Mercury Vapor Lamp
                                 3645--Ultrasonic Therapy
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1002.13(c)                       N/A                                                    100                2.4             240          0.5          120
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1002.20                          3649--ARO                                               25                  1              25            2           50
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1002.41(a)                       N/A                                                      1                  1               1            1            1
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1002.50(a) and 1002.51           3642--General Correspondence                            10                0.5               5            1            5
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1005.10                          2767--Sample Product                                    50                  1              50          0.1            5
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1005.25(b)                       N/A                                                      1                  1               1            1            1
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1005                             2877--Imports Declaration                              600                 32          19,200          0.2        3,840
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[[Page 26966]]

 
1010.2                           N/A                                                      1                  1               1            5            5
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1010.4(b)                        3633--General Variance Request                         160                0.3              48          1.2           58
                                 3147--Laser Show Variance Request
                                 3635--Laser Show Notification
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1010.5(c) and (d)                N/A                                                      4                  1               4           22           88
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1010.13                          N/A                                                      1                  1               1           10           10
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1020.20(c)(4)                    N/A                                                      1                  1               1            1            1
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1020.30(d), (d)(1), and (d)(2)   2579--Assembler Report                               1,150               10.7          12,305         0.30        3,692
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1020.30(g)                       N/A                                                    200               1.33             266           35        9,310
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1020.30(h)(1) through (h)(4),    N/A                                                    200               1.33             266           35        9,310
 1020.32(a)(1) and (g)
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1020.30(h)(5) and (h)(6) and     N/A                                                     20                  5             100           18        1,800
 1020.32(j)(4)
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1020.32(g), 1020.33(c), (d),     N/A                                                      9                  1               9           40          360
 (g)(4), (j)(3), and (j)(4)
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1020.40(c)(9)(i) and (c)(9)(ii)  N/A                                                      8                  1               8           40          320
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1030.10(c)(4)                    N/A                                                     41                1.6              66           20        1,320
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1030.10(c)(5)(i) through         N/A                                                     41                1.6              66           20        1,320
 (c)(5)(iv)
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1030.10(c)(6)(iii) and           N/A                                                      1                  1               1            1            1
 (c)(6)(iv)
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1040.10(a)(3)(i)                 3637--OEM Report                                        40                  1              40            3          120
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1040.10(h)(1)(i) through         N/A                                                    805                  1             805            8        6,440
 (h)(1)(vi)
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1040.10(h)(2)(i) and (h)(2)(ii)  N/A                                                    100                  1             100            8          800
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1040.11(a)(2)                    N/A                                                     50                  1              50           10          500
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1040.20(d)(1)(ii) through        N/A                                                    110                  1             110           10        1,100
 (d)(1)(vi), (e)(1), and (e)(2)
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1040.30(c)(1)(ii)                N/A                                                      1                  1               1            1            1
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1040.30(c)(2)                    N/A                                                      7                  1               7            1            7
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1050.10(d)(1) through (d)(4)     N/A                                                     10                  1              10           56          560
 and (f)(1) through (f)(2)(iii)
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Total Annual Reporting Burden                                                                                                                     88,435
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information


[[Page 26967]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                            No. of         Annual Frequency      Total Annual
                   21 CFR Section                        Recordkeepers     of Recordkeeping         Records        Hours per  Record      Total Hours
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1002.30 and 1002.31(a)                                             1,150             1,655.5           1,903,825                0.12             228,459
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1002.40 and 1002.41                                                2,950                49.2             145,140                0.05               7,257
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1020.30(g)                                                            22                   1                  22                 0.5                  11
--------------------------------------------------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(ii)                                                     40                   1                  40                 1.0                  40
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Totals                                                                                                                                           235,767
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates were derived by consultation with FDA and 
industry personnel, and are based on actual data collected from 
industry. An evaluation of the type and scope of information requested 
was also used to derive some time estimates. For example, disclosure 
information primarily requires time only to update and maintain 
existing manuals. Initial development of manuals has been performed 
except for new firms entering the industry.
    The following information collection requirements are not subject 
to review by OMB because they do not constitute a ``collection of 
information'' under the PRA: Sections 1002.31(c); 1003.10(a), (b), and 
(c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through 
(d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b); 
1004.2(a) through (i); 1004.3(a) through (i); 1004.4(a) through (h); 
1005.21(a) through (c); and 1005.22(b). These requirements apply to the 
collection of information during the conduct of general investigations 
or audits (5 CFR 1320.4(b)).
    The following labeling requirements are also not subject to review 
under the PRA because they are a public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public (5 CFR 1320.3(c)(2)): Sections 
1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 
1050.10(d)(1).

    Dated: May 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11396 Filed 5-12-10; 8:45 am]
BILLING CODE 4160-01-S