[Federal Register: November 3, 2006 (Volume 71, Number 213)]
[Notices]
[Page 64714-64718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no06-76]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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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
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1002.11 ................... 1,000 1.5 1,500 0.5 750
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1002.12 3629--Abbreviated 150 1 150 5 750
Report
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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
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1002.13 ................... 250 2.4 600 0.5 300
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1002.20 3649--ARO 40 1 40 2 80
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1002.41(a) ................... 1 1 1 1 1
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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
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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
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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\
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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
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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