[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3925-3929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0618]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the
[[Page 3926]]
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 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 either electronic or written comments on the collection
of information by March 23, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0618 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Products.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Electronic Products--21 CFR Parts 1000 Through 1050
OMB Control Number 0910-0025--Extension
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (FD&C 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
[[Page 3927]]
I, subchapter J, parts 1000 through 1050 (21 CFR parts 1000 through
1050).
Section 532 of the FD&C Act directs the Secretary 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 FD&C 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 FD&C Act directs the Secretary to
review and evaluate industry testing programs on a continuing basis;
and section 535(e) and (f) of the FD&C Act directs the Secretary to
immediately notify manufacturers of, and ensure correction of,
radiation defects or noncompliance with performance standards. Section
537(b) of the FD&C 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.
The regulations under 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 FD&C Act or were developed to aid the Agency in performing its
obligations under the FD&C 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:
Form FDA 2579 ``Report of Assembly of a Diagnostic X-Ray
System''
Form FDA 2767 ``Notice of Availability of Sample Electronic
Product''
Form FDA 2877 ``Declaration for Imported Electronic Products
Subject to Radiation Control Standards''
Form FDA 3649 ``Accidental Radiation Occurrence (ARO)''
Form FDA 3626 ``A Guide for the Submission of Initial Reports
on Diagnostic X-Ray Systems and Their Major Components''
Form FDA 3627 ``Diagnostic X-Ray CT Products Radiation Safety
Report''
Form FDA 3628 ``General Annual Report (Includes Medical,
Analytical, and Industrial X-Ray Products Annual Report)''
Form FDA 3629 ``Abbreviated Report''
Form FDA 3630 ``Guide for Preparing Product Reports on
Sunlamps and Sunlamp Products''
Form FDA 3631 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Sunlamp Products''
Form FDA 3632 ``Guide for Preparing Product Reports on Lasers
and Products Containing Lasers''
Form FDA 3633 ``General Variance Request''
Form FDA 3634 ``Television Products Annual Report''
Form FDA 3635 ``Laser Light Show Notification''
Form FDA 3636 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Laser and Laser Light Show Products''
Form FDA 3637 ``Laser Original Equipment Manufacturer (OEM)
Report''
Form FDA 3638 ``Guide for Filing Annual Reports for X-Ray
Components and Systems''
Form FDA 3639 ``Guidance for the Submission of Cabinet X-Ray
System Reports Pursuant to 21 CFR 1020.40''
Form FDA 3640 ``Reporting Guide for Laser Light Shows and
Displays''
Form FDA 3147 ``Application for a Variance From 21 CFR
1040.11(c) for a Laser Light Show, Display, or Device''
Form FDA 3641 ``Cabinet X-Ray Annual Report''
Form FDA 3642 ``General Correspondence''
Form FDA 3643 ``Microwave Oven Products Annual Report''
Form FDA 3644 ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
Form FDA 3645 ``Guide for Preparing Annual Reports for
Ultrasonic Therapy Products''
Form FDA 3646 ``Mercury Vapor Lamp Products Radiation Safety
Report''
Form FDA 3647 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
Form FDA 3659 ``Reporting and Compliance Guide for Television
Products''
Form FDA 3660 ``Guidance for Preparing Reports on Radiation
Safety of Microwave Ovens''
Form FDA 3661 ``A Guide for the Submission of an Abbreviated
Report on X-Ray Tables, Cradles, Film Changers, or Cassette Holders
Intended for Diagnostic Use''
Form FDA 3662 ``A Guide for the Submission of an Abbreviated
Radiation Safety Report on Cephalometric Devices Intended for
Diagnostic Use''
Form FDA 3663 ``Abbreviated Reports on Radiation Safety for
Microwave Products (Other than Microwave Ovens)''
Form FDA 3801 ``Guide for Preparing Initial Reports and Model
Change Reports on Medical Ultraviolet Lamps and Products Containing
Such Lamps''
The respondents to this information collection are electronic
product and x-ray manufacturers, importers, and assemblers. The burden
estimates were derived by consultation with FDA and industry personnel,
and are based on data collected from industry, including product report
submissions. An evaluation of the type and scope of information
requested was also used to derive some time estimates.
FDA estimates the burden of this collection of information as
follows:
[[Page 3928]]
Table 1--Estimated Annual Reporting Burden 1
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Number of Average
Activity/21 CFR section FDA form Number of responses per Total annual burden per Total hours 2
respondents respondent responses response
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Product reports--1002.10(a) through (k)... 3626--Diagnostic x-ray, 1,400 2.2 3,080 24 73,920
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,
3801--UV lamps.
Product safety or testing changes-- ............................ 480 2.5 1,200 0.5 600
1002.11(a) and (b).
Abbreviated reports--1002.12.............. 3629--General abbreviated 60 1.8 108 5 540
report, 3661--X-ray tables,
etc., 3662--Cephalometric
device, 3663--Microwave
products (non-oven).
Annual reports--1002.13(a) and (b)........ 3628--General, 3634--TV, 1,660 1.3 2,158 18 38,844
3638--Diagnostic x-ray,
3641--Cabinet x-ray, 3643--
Microwave oven, 3636--
Laser, 3631--Sunlamp, 3647--
Mercury vapor lamp, 3645--
Ultrasonic therapy.
Quarterly updates for new models-- ............................ 120 1.4 168 0.5 84
1002.13(c).
Accidental radiation occurrence reports-- 3649--ARO................... 30 6.7 201 2 402
1002.20.
Exemption requests--1002.50(a) and 1002.51 3642--General correspondence 4 1.3 5 1 5
Product and sample information--1005.10... 2767--Sample product........ 5 1 5 0.1 1
Identification information and compliance 2877--Imports declaration... 12,620 2.5 31,550 0.2 6,310
status--1005.25.
Alternate means of certification-- ............................ 1 2 2 5 10
1010.2(d).
Variance--1010.4(b)....................... 3633--General variance 350 1.1 385 1.2 462
request, 3147--Laser show
variance request, 3635--
Laser show notification.
Exemption from performance standards-- ............................ 1 1 1 22 22
1010.5(c) and (d).
Alternate test procedures--1010.13........ ............................ 1 1 1 10 10
Report of assembly of diagnostic x-ray 2579--Assembler report...... 1,230 34 41,820 0.30 12,546
components--1020.30(d), and (d)(1) and
(2).
Microwave oven exemption from warning ............................ 1 1 1 1 1
labels--1030.10(c)(6)(iv).
Laser products registration-- 3637--Original equipment 70 2.9 203 3 609
1040.10(a)(3)(i). manufacturer (OEM) report.
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Total................................. ............................ .............. .............. .............. .............. 134,366
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Table 2--Estimated Annual Recordkeeping Burden 1
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Number of Average
Activity/21 CFR section Number of records per Total annual burden per Total hours 2
recordkeepers recordkeeper records recordkeeping
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Manufacturers records--1002.30 1,650 1,650 2,722,500 0.12 326,700
and 1002.31(a).................
Dealer/distributor records-- 3,110 50 155,500 0.05 7,775
1002.40 and 1002.41............
Information on diagnostic x-ray 50 1 50 0.5 25
systems--1020.30(g)............
Laser products distribution 70 1 70 1 70
records--1040.10(a)(3)(ii).....
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Total....................... .............. .............. .............. .............. 334,570
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden 1
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Number of Average
Activity/21 CFR section Number of disclosures Total annual burden per Total hours 2
respondents per respondent disclosures disclosure
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Technical and safety information 1 1 1 12 12
for users--1002.3..............
Dealer/distributor records-- 30 3 90 1 90
1002.40 and 1002.41............
[[Page 3929]]
Television receiver critical 1 1 1 1 1
component warning--
1020.10(c)(4)..................
Cold cathode tubes-- 1 1 1 1 1
1020.20(c)(4)..................
Information on diagnostic x-ray 6 1 6 55 330
systems--1020.30(g)............
Statement of maximum line 6 1 6 10 60
current of x-ray systems--
1020.30(g)(2)..................
Diagnostic x-ray system safety 6 1 6 200 1,200
and technical information--
1020.30(h)(1) through (4)......
Fluoroscopic x-ray system safety 5 1 5 25 125
and technical information--
1020.30(h)(5) and (6) and
1020.32(a)(1), (g), and (j)(4).
CT equipment--1020.33(c), (d), 5 1 5 150 750
(g)(4), and (j)................
Cabinet x-ray systems 6 1 6 40 240
information--1020.40(c)(9)(i)
and (ii).......................
Microwave oven radiation safety 1 1 1 20 20
instructions--1030.10(c)(4)....
Microwave oven safety 1 1 1 20 20
information and instructions--
1030.10(c)(5)(i) through (iv)..
Microwave oven warning labels-- 1 1 1 1 1
1030.10(c)(6)(iii).............
Laser products information-- 3 1 3 20 60
1040.10(h)(1)(i) through (vi)..
Laser product service 3 1 3 20 60
information--1040.10(h)(2)(i)
and (ii).......................
Medical laser product 2 1 2 10 20
instructions--1040.11(a)(2)....
Sunlamp products instructions-- 1 1 1 10 10
1040.20........................
Mercury vapor lamp labeling-- 1 1 1 1 1
1040.30(c)(1)(ii)..............
Mercury vapor lamp permanently 1 1 1 1 1
affixed labels--1040.30(c)(2)..
Ultrasonic therapy products-- 1 1 1 56 56
1050.10(d)(1) through (d),
(f)(1), and (f)(2)(iii)........
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Total....................... .............. .............. .............. .............. 3,058
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Based on a review of the information collection, we have made no
adjustments to our burden estimate.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01073 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P