Document ID: FDA-2010-N-0088-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products
Posted Date: 2010-02-26T05:00Z

[Federal Register: February 26, 2010 (Volume 75, Number 38)]
[Notices]               
[Page 8963-8966]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe10-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for reporting and recordkeeping, general and specific 
requirements, and the availability of sample electronic products for 
manufacturers and distributors of electronic products.

DATES:  Submit written or electronic comments on the collection of 
information by April 27, 2010.

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

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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

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.
    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.
    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)''

[[Page 8964]]

     FDA Form 3626 ``A Guide for the Submission of Initial 
Reports on Diagnostic X-Ray Systems and Their Major Components''
     FDA Form 3627 ``Diagnostic X-Ray CT Products Radiation 
Safety Report''
     FDA Form 3628 ``General Annual Report (Includes Medical, 
Analytical, and Industrial X-Ray Products Annual Report)''
     FDA Form 3629 ``Abbreviated Report''
     FDA Form 3630 ``Guide for Preparing Product Reports on 
Sunlamps and Sunlamp Products''
     FDA Form 3631 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Sunlamps and Sunlamp Products''
     FDA Form 3632 ``Guide for Preparing Product Reports on 
Lasers and Products Containing Lasers''
     FDA Form 3633 ``General Variance Request''
     FDA Form 3634 ``Television Products Annual Report''
     FDA Form 3635 ``Laser Light Show Notification''
     FDA Form 3636 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Laser and Laser Light Show Products''
     FDA Form 3637 ``Laser Original Equipment Manufacturer 
(OEM) Report''
     FDA Form 3638 ``Guide for Filing Annual Reports for X-Ray 
Components and Systems''
     FDA Form 3639 ``Guidance for the Submission of Cabinet X-
Ray System Reports Pursuant to 21 CFR 1020.40''
     FDA Form 3640 ``Reporting Guide for Laser Light Shows and 
Displays''
     FDA Form 3147 ``Application for a Variance From 21 CFR 
1040.11(c) for a Laser Light Show, Display, or Device''
     FDA Form 3641 ``Cabinet X-Ray Annual Report''
     FDA Form 3642 ``General Correspondence''
     FDA Form 3643 ``Microwave Oven Products Annual Report''
     FDA Form 3644 ``Guide for Preparing Product Reports for 
Ultrasonic Therapy Products''
     FDA Form 3645 ``Guide for Preparing Annual Reports for 
Ultrasonic Therapy Products''
     FDA Form 3646 ``Mercury Vapor Lamp Products Radiation 
Safety Report''
     FDA Form 3647 ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Mercury Vapor Lamps''
     FDA Form 3659 ``Reporting and Compliance Guide for 
Television Products''
     FDA Form 3660 ``Guidance for Preparing Reports on 
Radiation Safety of Microwave Ovens''
     FDA Form 3661 ``Guide for the Submission of an Abbreviated 
Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders 
Intended for Diagnostic Use''
     FDA Form 3662 ``Guide for Submission of an Abbreviated 
Radiation Safety Reports on Cephalometric Devices Intended for 
Diagnostic Use''
     FDA Form 3663 ``Abbreviated Reports on Radiation Safety 
for Microwave Products (Other than Microwave Ovens)''
    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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                              No. of        Annual Frequency    Total Annual     Hours per       Total
          21 CFR Section                     FDA Form Number               Respondents        per Response        Responses       Response       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
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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
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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
                                   3663--Non-Oven Microwave Product
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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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[[Page 8965]]

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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1005.3                             2877--Imports Declaration                          600               32             19,200           0.2        3,840
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1010.2 and 1010.3                  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) and   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) and 1020.33(c), (d),    N/A                                                  9                1                  9          40            360
 (g)(4), (j)(1), and (j)(2)
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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 (c)(6)(iv)  N/A                                                  1                1                  1           1              1
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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) and (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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[[Page 8966]]

1040.30(c)(2)                      N/A                                                  7                1                  7           1              7
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1050.10(d)(1) through (d)(4) and   N/A                                                 10                1                 10          56            560
 (f)(1) through (f)(2)(iii)
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Total Annual Reporting Burden                                                                                                                     88,435
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\1\ There are no operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                No. of           Annual Frequency        Total Annual
             21 CFR Section                  Recordkeepers       per 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
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1040.10(a)(3)(ii)                                          40                     1                    40                     1.0                     40
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Total                                                                                                                                            235,767
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\1\ There are no 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: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4002 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S