[Federal Register Volume 68, Number 194 (Tuesday, October 7, 2003)]
[Notices]
[Pages 57909-57911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0213]


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 the 
proposed collection of information listed below 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 
November 6, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 from 
radiation from electronic products. The regulations issued under these 
authorities are listed in 21 CFR 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 sections 
535(e) and (f) of the act direct 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

[[Page 57910]]

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: (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.
    In the Federal Register of June 12, 2003 (68 FR 35231), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received two comments on the FDA radiation 
program paperwork burden (under OMB control number 0910-0025). One 
comment pertained to the information collection. It stated that the 
Occupational Safety and Health Administration and the Department of 
Health and Human Services (DHHS) already have radiation standards and 
that government paperwork on radiation emissions is of dubious value 
until more research is conducted, particularly on nonthermal effects of 
microwave/radiofrequency radiation. FDA is the agency of DHHS that is 
responsible for radiation safety standards for electronic products. 
Industry paperwork on radiation safety provides the agency with 
critical information on radiation controls, such as safety interlocks, 
timers, warning labels, etc., and on radiation emissions that are 
compared to known bioeffects hazards, whether specified in mandatory 
FDA standards or more recent consensus standards. Specifically, 
information provided to FDA on microwave radiation is compared to 
levels known to cause thermal injuries.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                     Annual Frequency   Total Annual    Hours per
  21 CFR Section     Form No.   No. of Respondents     per Response       Responses     Response     Total Hours
----------------------------------------------------------------------------------------------------------------
1002.3              ..........           10                   1              10           12             120
----------------------------------------------------------------------------------------------------------------
1002.10 and 1010.3  ..........          540                   1.6           850           24          20,400
----------------------------------------------------------------------------------------------------------------
1002.11             ..........        1,000                   1.5         1,500            0.5           750
----------------------------------------------------------------------------------------------------------------
1002.12             ..........          150                   1             150            5             750
----------------------------------------------------------------------------------------------------------------
1002.13 annual      ..........          900                   1             900           26          23,400
----------------------------------------------------------------------------------------------------------------
1002.13 quarterly   ..........          250                   2.4           600            0.5           300
----------------------------------------------------------------------------------------------------------------
1002.20             ..........           40                   1              40            2              80
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1010.4(b)           ..........            1                   1               1          120             120
----------------------------------------------------------------------------------------------------------------
1010.5 and 1010.13  ..........            3                   1               3           22              66
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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)
----------------------------------------------------------------------------------------------------------------
1020.40(c)(9)(i)    ..........            8                   1               8           40             320
 and (c)(9)(ii)
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[[Page 57911]]

 
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)(iii)  ..........            1                   1               1            1               1
 and (c)(6)(iv)
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1040.10(a)(3)(i)    ..........           83                   1              83            3             249
----------------------------------------------------------------------------------------------------------------
1040.10(h)(1)(i)    ..........          805                   1             805            8           6,440
 through
 (h)(1)(vi)
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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
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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 Reporting Burden                                                                         89,278
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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\
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    21 CFR                            Annual Frequency      Total Annual
   Section     No. of Recordkeepers   of Recordkeeping        Records       Hours per 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)(2)                    22            1                     22               0.5                 11
----------------------------------------------------------------------------------------------------------------
1040.10(a)(3)                    83            1                     83               1.0                 83
 (ii)
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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 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 table 1 of this document.
    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)). According to 5 CFR 1320.3(c)(2), 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: Sections 1020.10(c)(4), 1030.10(c)(6), 
1040.10(g), 1040.30(c)(1), and 1050.10(d)(1).

    Dated: September 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25304 Filed 10-6-03; 8:45 am]
BILLING CODE 4160-01-S