Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products, 26937-26939 [2017-12104]
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Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
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: Fax written comments on the
collection of information by July 12,
2017.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 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 10A63, 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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
Electronic Products OMB Control
Number 0910–0025—Reinstatement
Under sections 532 through 542 of the
Federal Food, Drug, and Cosmetic Act
(the 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
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
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’’
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
26937
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 XRay Tables, Cradles, Film Changers or
Cassette Holders Intended for Diagnostic
Use’’
E:\FR\FM\12JNN1.SGM
12JNN1
26938
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
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 xray manufacturers, importers, and
assemblers. The burden estimates were
which the FDA distributes and collects
Form FDA 2579, ‘‘Report of Assembly of
a Diagnostic X-Ray System.’’ While
these comments were not responsive to
the four information collection-related
topics on which we requested comment,
FDA would like to provide assurance
that these comments have been noted
and are being considered as part of
FDA’s efforts to review the process by
which Form FDA 2579 is distributed
and collected.
FDA estimates the burden of this
collection of information as follows:
derived by consultation with FDA and
industry personnel, and are based on
data collected from industry, including
recent 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 November
10, 2016 (81 FR 79030), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information.
FDA received five comments relating
to potential changes to the process by
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Activity/21 CFR section
Number of
respondents
FDA form No.
Product reports—1002.10(a) through (k)
Product safety or testing changes—
1002.11(a) and (b).
Abbreviated reports—1002.12 .................
Annual reports—1002.13(a) and (b) ........
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.
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), (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
Total annual
responses
Average
burden per
response
Total hours
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; 3659—TV;
3660—Microwave oven; 3801—UV
lamps.
..................................................................
1,400
2.2
3,080
24 .........................
73,920
480
2.5
1,200
.5 (30 minutes) .....
600
3629—General
abbreviated
report;
3661—X-ray tables, etc.; 3662—
Cephalometric device; 3663—Microwave products (non-oven).
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.
..................................................................
60
1.8
108
5 ...........................
540
1,660
1.3
2,158
18 .........................
38,844
120
1.4
168
.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
.1 (6 minutes) .......
1
2877—Imports declaration ......................
12,620
2.5
31,550
.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
..................................................................
2579—Assembler report ..........................
1
1,230
1
34
1
41,820
10 .........................
.30 (18 minutes) ...
10
12,546
..................................................................
1
1
1
1 ...........................
1
3637—OEM report ..................................
70
2.9
203
3 ...........................
609
..................................................................
....................
....................
....................
...............................
134,366
1 There
asabaliauskas on DSKBBXCHB2PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 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) .....
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR section
PO 00000
Frm 00036
1,650
3,110
50
Fmt 4703
Sfmt 4703
1,650
50
1
Average
burden per
recordkeeping
Total annual
records
2,722,500
155,500
50
E:\FR\FM\12JNN1.SGM
.12 (7 minutes)
.05 (3 minutes)
.5 (30 minutes)
12JNN1
Total hours
326,700
7,775
25
26939
Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR section
Average
burden per
recordkeeping
Total annual
records
Total hours
Laser products distribution records—1040.10(a)(3)(ii) .....
70
1
70
1 .......................
70
Total ...........................................................................
........................
........................
........................
...........................
334,570
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Average
burden per
disclosure
Total annual
disclosures
Total hours
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) ....................................................................
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 (4),
(f)(1), and (f)(2)(iii) ............................................................
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
1
1
3
3
2
1
1
1
1
1
1
1
1
1
1
1
3
3
2
1
1
20
1
20
20
10
10
1
20
1
60
60
20
10
1
1
1
1
1
1
1
1
1
56
56
Total ..............................................................................
........................
........................
........................
........................
3,058
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Dated: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12104 Filed 6–9–17; 8:45 am]
[Docket No. FDA–2017–N–0001]
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
BILLING CODE 4164–01–P
Science Board to the Food and Drug
Administration Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Science Board to the
SUMMARY:
VerDate Sep<11>2014
17:28 Jun 09, 2017
Jkt 241001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Food and Drug Administration. The
general function of the committee is to
provide advice to the Commissioner of
Food and Drugs and other appropriate
officials on specific, complex scientific
and technical issues important to FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
E:\FR\FM\12JNN1.SGM
12JNN1
Agencies
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26937-26939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12104]
[[Page 26937]]
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by July
12, 2017.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 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
10A63, 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--Reinstatement
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (the 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 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''
[[Page 26938]]
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 recent 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 November 10, 2016 (81 FR 79030), FDA
published a 60-day notice requesting public comment on the proposed
collection of information.
FDA received five comments relating to potential changes to the
process by which the FDA distributes and collects Form FDA 2579,
``Report of Assembly of a Diagnostic X-Ray System.'' While these
comments were not responsive to the four information collection-related
topics on which we requested comment, FDA would like to provide
assurance that these comments have been noted and are being considered
as part of FDA's efforts to review the process by which Form FDA 2579
is distributed and collected.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total
Activity/21 CFR section FDA form No. respondents per annual Average burden per response Total hours
respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 .5 (30 minutes)................ 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 .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--1005.10 2767--Sample product...... 5 1 5 .1 (6 minutes)................. 1
Identification information and 2877--Imports declaration. 12,620 2.5 31,550 .2 (12 minutes)................ 6,310
compliance 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 .30 (18 minutes)............... 12,546
components--1020.30(d), (d)(1), and
(2).
Microwave oven exemption from warning .......................... 1 1 1 1.............................. 1
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\ Numbers have been rounded.
Table 2--Estimated Annual Recordkeeping Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30 and 1002.31(a).. 1,650 1,650 2,722,500 .12 (7 minutes)........................ 326,700
Dealer/distributor records--1002.40 and 1002.41 3,110 50 155,500 .05 (3 minutes)........................ 7,775
Information on diagnostic x-ray systems-- 50 1 50 .5 (30 minutes)........................ 25
1020.30(g).
[[Page 26939]]
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\ Numbers have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
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............
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 (4),
(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\ Numbers have been rounded.
Dated: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12104 Filed 6-9-17; 8:45 am]
BILLING CODE 4164-01-P