[Federal Register: June 12, 2003 (Volume 68, Number 113)]
[Notices]               
[Page 35231-35233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn03-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0213]

 
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 August 11, 2003.

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: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

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: (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 No. 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 from 
radiation from electronic products. The regulations issued under these 
authorities are listed in the Code of Federal Regulations, title 21, 
chapter I, subchapter J. Specifically, subchapter 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 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

[[Page 35232]]

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: (1) Form FDA 2767, 
``Notice of Availability of Sample Electronic Product,'' (2) Form FDA 
2877, ``Declaration for Imported Electronic Products Subject to 
Radiation Control Standards,'' and (3) Form FDA 3147, ``Application for 
a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or 
Device.''
    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\
----------------------------------------------------------------------------------------------------------------
                     Form          No. of       Annual Frequency   Total Annual      Hours per
 21 CFR Section     Number      Respondents       per Response       Responses       Response       Total Hours
----------------------------------------------------------------------------------------------------------------
1002.3            ..........  10               1                  10              12              120
----------------------------------------------------------------------------------------------------------------
1002.10 and       ..........  540              1.6                850             24              20,400
1010.3
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1002.11           ..........  1,000            1.5                1,500           0.5             750
----------------------------------------------------------------------------------------------------------------
1002.12           ..........  150              1                  150             5               750
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1002.13 Annual    ..........  900              1                  900             26              23,400
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1002.13 Qtrly     ..........  250              2.4                600             0.5             300
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1002.20           ..........  40               1                  40              2               80
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1002.50(a) and    ..........  10               1.5                15              1               15
1002.51
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                  FDA 2877    600              32                 19,200          0.2             3,840
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1010.2            ..........  1                1                  1               5               5
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1010.4 (b)        ..........  1                1                  1               120             120
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1010.5 and        ..........  3                1                  3               22              66
1010.13
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                  FDA 2767    145              11.03              1,600           0.09            144
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1020.20 (c)(4)    ..........  1                1                  1               1               1
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1020.30(d),       FDA 2579    2,345            8.96               21,000          0.30            6,300
(d)(1), and
(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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1020.32(g) and    ..........  9                1                  9               40              360
1020.33(c), (d),
(g)(4), (j)(1),
 and
(j)(2)
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1020.40(c)(9)(i)  ..........  8                1                  8               40              320
and (c)(9)(ii)
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1030.10(c)(4)     ..........  41               1.61               66              20              1,320
----------------------------------------------------------------------------------------------------------------
1030.10(c)(5)(i)  ..........  41               1.61               66              20              1,320
through
 (c)(5)(iv)
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1030.10(c)(6)(ii  ..........  1                1                  1               1               1
 i)
and (c)(6)(iv)
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1040.10(a)(3)(i)  ..........  83               1                  83              3               249
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1040.10(h)(1)(i)  ..........  805              1                  805             8               6,440
through
(h)(1)(vi)
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[[Page 35233]]


1040.10(h)(2)(i)  ..........  100              1                  100             8               800
 and
(h)(2)(ii)
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1040.11(a)(2)     ..........  190              1                  190             10              1,900
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1040.11(c)        FDA 3147    53               2.2                115             0.5             58
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1040.20(d),       ..........  110              1                  110             10              1,100
(e)(1), and
 (e)(2)
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1040.30(c)(1)     ..........  1                1                  1               1               1
----------------------------------------------------------------------------------------------------------------
1040.30(c)(2)     ..........  7                1                  7               1               7
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1050.10(f)(1)     ..........  10               1                  10              56              560
through
(f)(2)(iii)
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Total Annual      ..........  ...............  .................  ..............  ..............  89,278
 Reporting
 Burden
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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\
------------------------------------------------------------------------
                                Annual      Total
   21 CFR        No. of     Frequency per   Annual    Hours per    Total
  Section    Recordkeepers  Recordkeeping  Records  Recordkeeper   Hours
------------------------------------------------------------------------
1002.30 and  1,150          1,655.5        1,903,8  198.7         228,50
1002.31(a)                                  25                     5
------------------------------------------------------------------------
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
 2)
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1040.10(a)(  83             1              83       1.0           83
 3)(ii)
------------------------------------------------------------------------
Totals       .............  .............  .......  ............  235,67
                                                                   9
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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 actual data collected from industry over the 
past 3 years. 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); 
and 1005.21(a) through (c). 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: June 5, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14821 Filed 6-11-03; 8:45 am]

BILLING CODE 4160-01-S