[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 https://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)”
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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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
——————————————————————————————————————————————————–
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
——————————————————————————————————————————————————–
1040.10(a)(3)(i) 3637–OEM Report 40 1 40 3 120
——————————————————————————————————————————————————–
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
——————————————————————————————————————————————————–
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