[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64714-64718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0427]


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

DATES: Submit written or electronic comments on the collection of 
information by January 2, 2007.

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

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this

[[Page 64715]]

requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 the Code of Federal Regulations, title 21, 
chapter I, subpart J. Specifically, subpart A regulations, 21 CFR 
5.10(a)(3), 5.25(b), 5.35(a)(4), and 5.600 through 5.606, delegate 
administrative authorities to FDA.
    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.
    Parts 1002 through 1010 (21 CFR 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 
(21 CFR 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''
    FDA Form 3626 ``A Guide for the Submission of Initial Reports on 
Diagnostic X-ray Systems and Their Major Components''
    FDA Form 3627 ``Diagnostic X-ray CT Products Radiation Safety 
Report''
    FDA Form 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-ray Products Annual Report)''
    FDA Form 3629 ``Abbreviated Report''
    FDA Form 3630 ``Guide for Preparing Product Reports on Sunlamps and 
Sunlamp Products''
    FDA Form 3631 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Sunlamps and Sunlamp Products''
    FDA Form 3632 ``Guide for Preparing Product Reports on Lasers and 
Products Containing Lasers''
    FDA Form 3633 ``General Variance Request''
    FDA Form 3634 ``Television Products Annual Report''
    FDA Form 3635 ``Laser Light Show Notification''
    FDA Form 3636 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Laser and Laser Light Show Products''
    FDA Form 3637 ``Laser Original Equipment Manufacturer (OEM) 
Report''
    FDA Form 3638 ``Guide for Filing Annual Reports for X-ray 
Components and Systems''
    FDA Form 3639 ``Guidance for the Submission of Cabinet X-ray System 
Reports Pursuant to 21 CFR 1020.40''
    FDA Form 3640 ``Reporting Guide for Laser Light Shows and 
Displays''
    FDA Form 3147 ``Application for a Variance From 21 CFR 1040.11(c) 
for a Laser Light Show, Display, or Device''
    FDA Form 3641 ``Cabinet X-ray Annual Report''
    FDA Form 3642 ``General Correspondence''
    FDA Form 3643 ``Microwave Oven Products Annual Report''
    FDA Form 3644 ``Guide for Preparing Product Reports for Ultrasonic 
Therapy Products''
    FDA Form 3645 ``Guide for Preparing Annual Reports for Ultrasonic 
Therapy Products''
    FDA Form 3646 ``Mercury Vapor Lamp Products Radiation Safety 
Report''
    FDA Form 3647 ``Guide for Preparing Annual Reports on Radiation 
Safety Testing of Mercury Vapor Lamps''
    The most likely respondents to this information collection will be 
electronic product and x-ray manufacturers, importers, and assemblers.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 64716]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                         No. of       Annual Frequency   Total Annual    Hours per
21 CFR Section    FDA Form  Number     Respondents      per Response       Responses      Response   Total Hours
----------------------------------------------------------------------------------------------------------------
1002.3          ...................              10                  1              10           12          120
----------------------------------------------------------------------------------------------------------------
1002.10         ...................             540                1.6             850           24       20,400
                3626--Diagnostic X-
                 Ray
                3627--CT X-Ray
                3639--Cabinet X-Ray
                3632--Laser
                3640--Laser Light
                 Show
                3630--Sunlamp
                3646--Mercury Vapor
                 Lamp
                3644--Ultrasonic
                 Therapy
----------------------------------------------------------------------------------------------------------------
1002.11         ...................           1,000                1.5           1,500          0.5          750
----------------------------------------------------------------------------------------------------------------
1002.12         3629--Abbreviated               150                  1             150            5          750
                 Report
----------------------------------------------------------------------------------------------------------------
1002.13         ...................             900                  1             900           26       23,400
                3628--General
                3634--TV
                3638--Diagnostic X-
                 Ray
                3641--Cabinet X-Ray
                3643--Microwave
                 Oven
                3636--Laser
                3631--Sunlamp
                3647--Mercury Vapor
                 Lamp
                3645--Ultrasonic
                 Therapy
----------------------------------------------------------------------------------------------------------------
1002.13         ...................             250                2.4             600          0.5          300
----------------------------------------------------------------------------------------------------------------
1002.20         3649--ARO                        40                  1              40            2           80
----------------------------------------------------------------------------------------------------------------
1002.41(a)      ...................               1                  1               1            1            1
----------------------------------------------------------------------------------------------------------------
1002.50(a) and  3642--General                    10                1.5              15            1           15
 1002.51         Correspondence
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1005.10         2767--Sample                    145              11.03           1,600         0.09          144
                 Product
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1005.25(b)      ...................               1                  1               1            1            1
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                2877--Imports                   600                 32          19,200          0.2        3,840
                 Declaration
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1010.2 and      ...................               1                  1               1            5            5
 1010.3
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1010.4(b)       ...................               1                  1               1          120          120
                3633--General
                 Variance Request
                3147--Laser Show
                 Variance Request
                3635--Laser Show
                 Notification
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1010.5(c) and   ...................               2                  1               2           22           44
 (d)
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1010.13         ...................               1                  1               1           10           10
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1020.20(c)(4)   ...................               1                  1               1            1            1
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1020.30(d),     2579--Assembler               2,345               8.96          21,000         0.30        6,300
 (d)(1), and     Report
 (d)(2)
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1020.30(g)      ...................             200               1.33             265           35        9,275
----------------------------------------------------------------------------------------------------------------
1020.30(h)(1)   ...................             200               1.33             265           35        9,275
 through
 (h)(4),
 1020.32(a)(1)
 and (g)
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1020.30(h)(5)   ...................              20                  5             100          180       18,000
 and (h)(6)
 and
 1020.32(j)(4)
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[[Page 64717]]

 
1020.32(g) and  ...................               9               1.00               9           40          360
 1020.33(c),
 (d), (g)(4),
 (j)(3), and
 (j)(4)
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1020.40(c)(9)(  ...................               8               1.00               8           40          320
 i) and
 (c)(9)(ii)
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1030.10(c)(4)   ...................              41               1.61              66           20        1,320
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1030.10(c)(5)(  ...................              41               1.61              66           20        1,320
 i) through
 (c)(5)(iv)
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1030.10(c)(6)(  ...................               1                  1               1            1            1
 iii) and
 (c)(6)(iv)
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1040.10(a)(3)(  3637--OEM Report                 83                  1              83            3          249
 i)
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1040.10(h)(1)(  ...................             805               1.00             805            8        6,440
 i) through
 (h)(1)(vi)
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1040.10(h)(2)(  ...................             100               1.00             100            8          800
 i) and
 (h)(2)(ii)
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1040.11(a)(2)   ...................             190               1.00             190           10        1,900
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1040.20         ...................             110               1.00             110           10        1,100
 (d)(1)(ii)-
 (vi), (e)(1),
 and (e)(2)
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1040.30(c)(1)(  ...................               1               1.00               1            1            1
 ii)
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1040.30(c)(2)   ...................               7               1.00               7            1            7
----------------------------------------------------------------------------------------------------------------
1050.10(d)(1)-  ...................              10               1.00              10           56          560
 (d)(4) and
 (f)(1)-
 (f)(2)(iii)
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Total                                                                                                    107,209
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
1002.30 and                    1,150            1,655.5          1,903,825              198.7            228,505
 1002.31(a)
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1002.40 and                    2,950               49.2            145,140                2.4              7,080
 1002.41
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1020.30(g)                        22                  1                 22                0.5                 11
----------------------------------------------------------------------------------------------------------------
1040.10(a)(3)(ii)                 83                  1                 83                1.0                 83
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Totals                                                                                                   235,679
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection, OMB control number 0910-0564 (i.e. FDA 
Form 3626) has been consolidated under this information collection 
thus, requiring an adjustment of the burden estimate.
    The burden estimates were derived by consultation with FDA and 
industry personnel and 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. When information is generally provided to users, 
assemblers, or dealers in the same manual, they have been grouped 
together in the ``Estimated Annual Reporting Burden'' table.
    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

[[Page 64718]]

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 21 CFR 1020.10(c)(4), 
1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1).

    Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18559 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S