Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products, 28958-28961 [2020-10373]
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28958
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10359 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0618]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0025. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
jbell on DSKJLSW7X2PROD with NOTICES
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Electronic Products
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
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
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, 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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 [Computed Tomography] 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’’
E:\FR\FM\14MYN1.SGM
14MYN1
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
• 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
28959
Ultraviolet Lamps and Products
Containing Such Lamps’’
The respondents to this information
collection are electronic product and xray 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.
In the Federal Register of January 23,
2020 (85 FR 3925), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours 2
FDA form
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.
.........................................
480
2.5
1,200
0.5 (30 minutes) .....
600
Product safety or testing
changes—1002.11(a)
and (b).
Abbreviated reports—
1002.12.
Annual reports—
1002.13(a) and (b).
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR section
Quarterly updates for
new models—
1002.13(c).
Accidental radiation occurrence reports—
1002.20.
Exemption requests—
1002.50(a) and
1002.51.
Product and sample information—1005.10.
VerDate Sep<11>2014
3629—General abbreviated report.
3661—X-ray tables, etc..
3662—Cephalometric
device.
3663—Microwave products (non-oven).
3628—General ...............
60
1.8
108
5 .............................
540
1,660
1.3
2,158
18 ...........................
38,844
3634—TV.
3638—Diagnostic x-ray.
3641—Cabinet x-ray.
3643—Microwave oven.
3636—Laser.
3631—Sunlamp.
3647—Mercury vapor
lamp.
3645—Ultrasonic therapy.
.........................................
120
1.4
168
0.5 (30 minutes) .....
84
3649—ARO ....................
30
6.7
201
2 .............................
402
3642—General correspondence.
4
1.3
5
1 .............................
5
2767—Sample product ..
5
1
5
0.1 (6 minutes) ......
1
18:29 May 13, 2020
Jkt 250001
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Fmt 4703
Sfmt 4703
E:\FR\FM\14MYN1.SGM
14MYN1
28960
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity; 21 CFR section
Identification information
and compliance status—1005.25.
Alternate means of certification—1010.2(d).
Variance—1010.4(b) .......
Exemption from performance standards—
1010.5(c) and (d).
Alternate test procedures—1010.13.
Report of assembly of diagnostic x-ray components—1020.30(d), and
(d)(1) and (2).
Microwave oven exemption from warning labels—1030.10(c)(6)(iv).
Laser products registration—1040.10(a)(3)(i).
Total .........................
Number of
responses per
respondent
Number of
respondents
FDA form
2877—Imports declaration.
Average
burden per
response
Total annual
responses
Total hours 2
12,620
2.5
31,550
0.2 (12 minutes) .....
6,310
.........................................
1
2
2
5 .............................
10
3633—General variance
request.
3147—Laser show variance request.
3635—Laser show notification.
.........................................
350
1.1
385
1.2 ..........................
462
1
1
1
22 ...........................
22
.........................................
1
1
1
10 ...........................
10
1,230
34
41,820
0.3 (18 minutes) .....
12,546
.........................................
1
1
1
1 .............................
1
3637—OEM report .........
70
2.9
203
3 .............................
609
.........................................
........................
........................
........................
................................
134,366
2579—Assembler report
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
Number of
records per
recordkeeper
Number of
recordkeepers
Activity; 21 CFR section
Average
burden per
recordkeeping
Total annual
records
Total hours 2
Manufacturers records—1002.30 and 1002.31(a) ......
Dealer/distributor records—1002.40 and 1002.41 ......
Information on diagnostic x-ray systems—1020.30(g)
Laser products distribution ;records—1040.10(a)(3)(ii)
1,650
3,110
50
70
1,650
50
1
1
2,722,500
155,500
50
70
0.12 (7 minutes) .....
0.05 (3 minutes) .....
0.5 (30 minutes) .....
1 .............................
326,700
7,775
25
70
Total ......................................................................
........................
........................
........................
................................
334,570
1 There
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
jbell on DSKJLSW7X2PROD with NOTICES
Technical and safety information for users—1002.3 .......
Dealer/distributor records—1002.40 and 1002.41 ...........
Television receiver critical component warning—
1020.10(c)(4) ................................................................
Cold cathode tubes—1020.20(c)(4) .................................
Information on diagnostic x-ray systems—1020.30(g) ....
Statement of maximum line current of x-ray systems—
1020.30(g)(2) ................................................................
Diagnostic x-ray system safety and technical information—1020.30(h)(1) through (4) ...................................
Fluoroscopic x-ray system safety and technical information—1020.30(h)(5) and (6) and 1020.32(a)(1), (g),
and (j)(4) .......................................................................
CT equipment—1020.33(c), (d), (g)(4), and (j) ...............
Cabinet x-ray systems information—1020.40(c)(9)(i) and
(ii) ..................................................................................
Microwave oven radiation safety instructions—
1030.10(c)(4) ................................................................
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
Number of
disclosures per
respondent
Number of
respondents
Activity; 21 CFR section
PO 00000
Frm 00034
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
1
30
1
3
1
90
12
1
12
90
1
1
6
1
1
1
1
1
6
1
1
55
1
1
330
6
1
6
10
60
6
1
6
200
1,200
5
5
1
1
5
5
25
150
125
750
6
1
6
40
240
1
1
1
20
20
Fmt 4703
Sfmt 4703
E:\FR\FM\14MYN1.SGM
14MYN1
28961
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures per
respondent
Number of
respondents
Activity; 21 CFR section
Microwave oven safety information and instructions—
1030.10(c)(5)(i) through (iv) .........................................
Microwave oven warning labels—1030.10(c)(6)(iii) .........
Laser products information—1040.10(h)(1)(i) through
(vi) .................................................................................
Laser product service information—1040.10(h)(2)(i) and
(ii) ..................................................................................
Medical laser product instructions—1040.11(a)(2) ..........
Sunlamp products instructions—1040.20 ........................
Mercury vapor lamp labeling—1040.30(c)(1)(ii) ..............
Mercury vapor lamp permanently affixed labels—
1040.30(c)(2) ................................................................
Ultrasonic therapy products—1050.10(d)(1) through (d),
(f)(1), and (f)(2)(iii) ........................................................
Total ..........................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
1
1
1
1
1
1
20
1
20
1
3
1
3
20
60
3
2
1
1
1
1
1
1
3
2
1
1
20
10
10
1
60
20
10
1
1
1
1
1
1
1
1
1
56
56
........................
............................
........................
........................
3,058
1 There
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10373 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0800. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3065]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Drug
Compounding Under Sections 503A
and 503B of the Federal Food, Drug,
and Cosmetic Act
AGENCY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
ACTION:
OMB Control Number 0910–0800—
Revision
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
ADDRESSES:
VerDate Sep<11>2014
18:29 May 13, 2020
Human Drug Compounding Under
Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act
Jkt 250001
This information collection supports
Agency implementation of sections
503A and 503B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). For
efficiency of Agency operations, we are
revising the information collection
currently approved under OMB control
number 0910–0800 pertaining to human
drug compounding and section 503B of
the FD&C Act (21 U.S.C. 355b) to
include reference to Agency guidance
regarding section 503A of the FD&C Act
(21 U.S.C. 355a), and to also include
information collection that we attribute
to a final standard memorandum of
understanding (MOU) provided for by
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
section 503A (‘‘final standard MOU’’).
Finally, we are revising the title of the
information collection from ‘‘Adverse
Event Reporting for Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act’’
to ‘‘Human Drug Compounding Under
Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act.’’ As
information collection activity is
planned and undertaken by FDA, we
find consolidating related collection
elements better utilizes our resources.
Agency Guidance Regarding Section
503A
We are revising the information
collection to include reference to the
guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance is available from our website
at: https://www.fda.gov/media/94393/
download. The guidance was issued
consistent with our Good Guidance
Practice regulations (21 CFR 10.115),
which provide for comment at any time.
The guidance communicates FDA’s
intention with regard to enforcement of
section 503A of the FD&C Act to
regulate entities that compound drugs
and notes that parts of section 503A
require rulemaking and consultation
with a Pharmacy Compounding
Advisory Committee to implement and
explains how the provisions will be
applied pending those consultations
and rulemaking. Although the guidance
does not include recommended
information collection, we are including
the guidance as a supplemental
reference for respondents.
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28958-28961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0618]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 15, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0025. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
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.
Electronic Products
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 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 [Computed Tomography]
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''
[[Page 28959]]
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.
In the Federal Register of January 23, 2020 (85 FR 3925), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section FDA form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a) 3626--Diagnostic x- 1,400 2.2 3,080 24........................... 73,920
through (k). ray.
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 (30 minutes)............. 600
1002.11(a) and (b).
Abbreviated reports--1002.12...... 3629--General 60 1.8 108 5............................ 540
abbreviated report.
3661--X-ray tables,
etc..
3662--Cephalometric
device.
3663--Microwave
products (non-oven).
Annual reports--1002.13(a) and (b) 3628--General........ 1,660 1.3 2,158 18........................... 38,844
3634--TV.............
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 (30 minutes)............. 84
1002.13(c).
Accidental radiation occurrence 3649--ARO............ 30 6.7 201 2............................ 402
reports--1002.20.
Exemption requests--1002.50(a) and 3642--General 4 1.3 5 1............................ 5
1002.51. correspondence.
Product and sample information-- 2767--Sample product. 5 1 5 0.1 (6 minutes).............. 1
1005.10.
[[Page 28960]]
Identification information and 2877--Imports 12,620 2.5 31,550 0.2 (12 minutes)............. 6,310
compliance status--1005.25. declaration.
Alternate means of certification-- ..................... 1 2 2 5............................ 10
1010.2(d).
Variance--1010.4(b)............... 3633--General 350 1.1 385 1.2.......................... 462
variance request.
3147--Laser show
variance request.
3635--Laser show
notification.
Exemption from performance ..................... 1 1 1 22........................... 22
standards--1010.5(c) and (d).
Alternate test procedures--1010.13 ..................... 1 1 1 10........................... 10
Report of assembly of diagnostic x- 2579--Assembler 1,230 34 41,820 0.3 (18 minutes)............. 12,546
ray components--1020.30(d), and report.
(d)(1) and (2).
Microwave oven exemption from ..................... 1 1 1 1............................ 1
warning labels--1030.10(c)(6)(iv).
Laser products registration-- 3637--OEM report..... 70 2.9 203 3............................ 609
1040.10(a)(3)(i).
---------------------------------------------------------------------------------------------------------------------
Total......................... ..................... .............. .............. .............. ............................. 134,366
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30 and 1002.31(a) 1,650 1,650 2,722,500 0.12 (7 minutes)......................... 326,700
Dealer/distributor records--1002.40 and 3,110 50 155,500 0.05 (3 minutes)......................... 7,775
1002.41.
Information on diagnostic x-ray systems-- 50 1 50 0.5 (30 minutes)......................... 25
1020.30(g).
Laser products distribution ;records-- 70 1 70 1........................................ 70
1040.10(a)(3)(ii).
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 334,570
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity; 21 CFR section Number of disclosures per Total annual burden per Total hours
respondents respondent disclosures disclosure \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety 1 1 1 12 12
information for users--1002.3
Dealer/distributor records-- 30 3 90 1 90
1002.40 and 1002.41..........
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- 6 1 6 55 330
ray 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 5 1 5 25 125
safety 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 1 1 1 20 20
safety instructions--
1030.10(c)(4)................
[[Page 28961]]
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)......
---------------------------------------------------------------------------------
Total..................... .............. ................ .............. .............. 3,058
----------------------------------------------------------------------------------------------------------------
\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: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10373 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
