Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products, 35279-35282 [2013-13855]
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35279
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Content and format when seeking written recommendations; results of studies; amendments (§§ 316.10,
316.12, 316.14) ................................................................
Content and format of a request for orphan-drug designation; request for verification of orphan-drug status;
amendments (§§ 316.20, 316.21, 316.26) Form FDA
3671 ..................................................................................
Notifications of changes in agents (§ 316.22) .....................
Submissions to change ownership of orphan-drug designation (§ 316.27) ............................................................
Annual reports (§ 316.30) ....................................................
Assurance of the availability of sufficient quantities of the
orphan drug; holder’s consent for the approval of other
marketing applications for the same drug (§ 316.36) ......
Total ..............................................................................
1 There
BILLING CODE 4160–01–P
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
Food and Drug Administration,
HHS.
Notice.
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 either electronic or
written comments on the collection of
information by August 12, 2013.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Total hours
2
1
2
100
200
214
55
2
1
428
55
150
2
64,200
110
43
1,652
1
1
43
1,652
5
3
215
4,956
1
3
3
15
45
........................
........................
........................
........................
69,726
VerDate Mar<15>2010
18:14 Jun 11, 2013
Jkt 229001
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
ADDRESSES:
[FR Doc. 2013–13858 Filed 6–11–13; 8:45 am]
ACTION:
Average
burden per
response
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR Section and Form FDA
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 1002
Through 1010 (OMB Control Number
0910–0025)—Extension
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, subpart J, parts 1000 through 1050 (21
CFR parts 1000 through 1050).
Section 532 of the FD&C 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 FD&C Act authorizes the Secretary
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35280
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
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
noncompliances 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:
• 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 Report on Cephalometric Devices
Intended for Diagnostic Use’’
• FDA Form 3663 ‘‘Abbreviated
Reports on Radiation Safety for
Microwave Products (Other Than
Microwave Ovens)’’
• FDA Form 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
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.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 CFR section
Product reports—
1002.10(a)–(k).
Number of
respondents
FDA form
3626—Diagnostic x-ray ....
Number of
responses per
respondent
1,500
Total annual
responses
1.1
Average burden
per response
1,650
3627—CT x-ray.
3639—Cabinet x-ray.
3632—Laser.
3640—Laser light show.
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24
Total hours 2
39,600
35281
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity/21 CFR section
Product safety or testing
changes—1002.11(a)–
(b).
Abbreviated reports—
1002.12.
Annual reports—
1002.13(a)–(b).
mstockstill on DSK4VPTVN1PROD with NOTICES
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 (d)(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
3630—Sunlamp.
3646—Mercury vapor
lamp.
3644—Ultrasonic therapy.
3659—TV.
3660—Microwave oven.
3801—UV lamps.
...........................................
1,000
Total annual
responses
1.5
Average burden
per response
1,500
0.5
60
2
120
5
600
1,500
1
1,500
18
27,000
3634—TV.
3638—Diagnostic x-ray.
3641—Cabinet x-ray.
3643—Microwave oven.
3636—Laser.
3631—Sunlamp.
3647—Mercury vapor
lamp.
3645—Ultrasonic therapy.
...........................................
3
4
12
0.5
3649—ARO ......................
15
6
90
2
180
3642—General correspondence.
2767—Sample product .....
10
1
10
1
10
5
1
5
0.1
1
2877—Imports declaration
1,000
20
20,000
0.2
4,000
...........................................
1
2
2
3633—General variance
request.
3147—Laser show variance request.
3635—Laser show notification.
...........................................
350
1
350
1
1
1
22
22
...........................................
1
1
1
10
10
2579—Assembler report ...
2,000
14
28,000
...........................................
1
1
1
1
1
3637—Original equipment
manufacturer (OEM) report.
50
3
150
3
450
...........................................
........................
..........................
........................
5
1.2
0.30
..........................
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
VerDate Mar<15>2010
750
3629—General abbreviated report.
3661—X-ray tables, etc.
3662—Cephalometric device.
3663—Microwave products (non-oven).
3628—General .................
1 There
2 Total
Total hours 2
16:32 Jun 11, 2013
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Fmt 4703
Sfmt 4703
E:\FR\FM\12JNN1.SGM
12JNN1
6
10
420
8,400
81,460
35282
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
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) ......
1,600
3,000
50
50
1,650
50
1
1
2,640,000
150,000
50
50
0.12
0.05
0.5
1
316,800
7,500
25
50
Total ............................................................................
........................
........................
........................
..........................
324,375
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
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
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)–(h)(4) .........................................................
Fluoroscopic x-ray system safety and technical information—1020.30(h)(5)–(h)(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)–
(c)(9)(ii) .............................................................................
Microwave
oven
radiation
safety
instructions—
1030.10(c)(4) ....................................................................
Microwave oven safety information and instructions—
1030.10(c)(5)(i)–(c)(5)(iv) .................................................
Microwave oven warning labels—1030.10(c)(6)(iii) .............
Laser products information—1040.10(h)(1)(i)–(h)(1)(vi) ......
Laser product service information—1040.10(h)(2)(i)–
(h)(2)(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)–(d)(4), (f)(1),
and (f)(2)(iii) ......................................................................
Total ..............................................................................
Average
burden per
disclosure
Total annual
disclosures
Total Hours 2
1
50
1
3
1
150
12
1
12
150
1
1
100
1
1
2
1
1
200
1
1
55
1
1
11,000
15
1
15
10
150
100
2
200
200
40,000
15
25
2
2
30
50
25
150
750
7,500
30
2
60
40
2,400
1
1
1
20
20
1
1
1,000
1
1
1.2
1
1
1,200
20
1
20
20
1
24,000
1,000
35
10
2
1.2
1
5
1
1,200
35
50
2
20
10
10
1
24,000
350
500
2
2
1
2
1
2
5
1
5
56
280
........................
........................
........................
........................
111,139
1 There
mstockstill on DSK4VPTVN1PROD with NOTICES
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
The following 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)–(c), 1003.11(a)(3)
and (b), 1003.20(a)–(h), 1003.21(a)–(d),
1003.22(a) and (b), 1003.30(a) and (b),
1003.31(a) and (b), 1004.2(a)–(i),
1004.3(a)–(i), 1004.4(a)–(h), 1005.21(a)–
(c), and 1005.22(b). These requirements
apply to the collection of information
during the conduct of investigations or
audits (5 CFR 1320.4).
VerDate Mar<15>2010
16:32 Jun 11, 2013
Jkt 229001
The following labeling requirements
are 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
1030.10(c)(6); 1040.10(g);
1040.20(d)(1)(i), (d)(2)(i), and (d)(2)(iii);
and 1040.30(c)(1).
PO 00000
Frm 00044
Fmt 4703
Sfmt 9990
Dated: June 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13855 Filed 6–11–13; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\12JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35279-35282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13855]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 either electronic or written comments on the collection
of information by August 12, 2013.
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.
Electronic Products--21 CFR Parts 1002 Through 1010 (OMB Control Number
0910-0025)--Extension
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, subpart J, parts 1000 through 1050 (21 CFR parts 1000
through 1050).
Section 532 of the FD&C 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 FD&C Act authorizes the
Secretary
[[Page 35280]]
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 noncompliances 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:
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 Report on Cephalometric Devices Intended for
Diagnostic Use''
FDA Form 3663 ``Abbreviated Reports on Radiation Safety
for Microwave Products (Other Than Microwave Ovens)''
FDA Form 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.
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 Total hours
respondents respondent responses per response \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k).......... 3626--Diagnostic x-ray...... 1,500 1.1 1,650 24 39,600
3627--CT x-ray.
3639--Cabinet x-ray.
3632--Laser.
3640--Laser light show.
[[Page 35281]]
3630--Sunlamp.
3646--Mercury vapor lamp.
3644--Ultrasonic therapy.
3659--TV.
3660--Microwave oven.
3801--UV lamps.
Product safety or testing changes-- ............................ 1,000 1.5 1,500 0.5 750
1002.11(a)-(b).
Abbreviated reports--1002.12............. 3629--General abbreviated 60 2 120 5 600
report.
3661--X-ray tables, etc.
3662--Cephalometric device.
3663--Microwave products
(non-oven).
Annual reports--1002.13(a)-(b)........... 3628--General............... 1,500 1 1,500 18 27,000
3634--TV.
3638--Diagnostic x-ray.
3641--Cabinet x-ray.
3643--Microwave oven.
3636--Laser.
3631--Sunlamp.
3647--Mercury vapor lamp.
3645--Ultrasonic therapy.
Quarterly updates for new models-- ............................ 3 4 12 0.5 6
1002.13(c).
Accidental radiation occurrence reports-- 3649--ARO................... 15 6 90 2 180
1002.20.
Exemption requests--1002.50(a) and 3642--General correspondence 10 1 10 1 10
1002.51.
Product and sample information--1005.10.. 2767--Sample product........ 5 1 5 0.1 1
Identification information and compliance 2877--Imports declaration... 1,000 20 20,000 0.2 4,000
status--1005.25.
Alternate means of certification-- ............................ 1 2 2 5 10
1010.2(d).
Variance--1010.4(b)...................... 3633--General variance 350 1 350 1.2 420
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...... 2,000 14 28,000 0.30 8,400
components--1020.30(d), (d)(1), and
(d)(2).
Microwave oven exemption from warning ............................ 1 1 1 1 1
labels--1030.10(c)(6)(iv).
Laser products registration-- 3637--Original equipment 50 3 150 3 450
1040.10(a)(3)(i). manufacturer (OEM) report.
--------------------------------------------------------------------------------
Total................................ ............................ .............. ............... .............. .............. 81,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.
[[Page 35282]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping \2\
----------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30 1,600 1,650 2,640,000 0.12 316,800
and 1002.31(a).................
Dealer/distributor records-- 3,000 50 150,000 0.05 7,500
1002.40 and 1002.41............
Information on diagnostic x-ray 50 1 50 0.5 25
systems--1020.30(g)............
Laser products distribution 50 1 50 1 50
records--1040.10(a)(3)(ii).....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 324,375
----------------------------------------------------------------------------------------------------------------
\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
Activity/21 CFR section Number of disclosures Total annual Average burden Total Hours
respondents per respondent disclosures per disclosure \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety information 1 1 1 12 12
for users--1002.3..............
Dealer/distributor records-- 50 3 150 1 150
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 100 2 200 55 11,000
systems--1020.30(g)............
Statement of maximum line 15 1 15 10 150
current of x-ray systems--
1020.30(g)(2)..................
Diagnostic x-ray system safety 100 2 200 200 40,000
and technical information--
1020.30(h)(1)-(h)(4)...........
Fluoroscopic x-ray system safety 15 2 30 25 750
and technical information--
1020.30(h)(5)-(h)(6) and
1020.32(a)(1), (g), and (j)(4).
CT equipment--1020.33(c)-(d), 25 2 50 150 7,500
(g)(4), and (j)................
Cabinet x-ray systems 30 2 60 40 2,400
information--1020.40(c)(9)(i)-(
c)(9)(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)-(c)(5)(iv)....
Microwave oven warning labels-- 1 1 1 1 1
1030.10(c)(6)(iii).............
Laser products information-- 1,000 1.2 1,200 20 24,000
1040.10(h)(1)(i)-(h)(1)(vi)....
Laser product service 1,000 1.2 1,200 20 24,000
information--1040.10(h)(2)(i)-(
h)(2)(ii)......................
Medical laser product 35 1 35 10 350
instructions--1040.11(a)(2)....
Sunlamp products instructions-- 10 5 50 10 500
1040.20........................
Mercury vapor lamp labeling-- 2 1 2 1 2
1040.30(c)(1)(ii)..............
Mercury vapor lamp permanently 2 1 2 1 2
affixed labels--1040.30(c)(2)..
Ultrasonic therapy products-- 5 1 5 56 280
1050.10(d)(1)-(d)(4), (f)(1),
and (f)(2)(iii)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 111,139
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours have been rounded.
The following 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)-(c), 1003.11(a)(3) and (b), 1003.20(a)-
(h), 1003.21(a)-(d), 1003.22(a) and (b), 1003.30(a) and (b), 1003.31(a)
and (b), 1004.2(a)-(i), 1004.3(a)-(i), 1004.4(a)-(h), 1005.21(a)-(c),
and 1005.22(b). These requirements apply to the collection of
information during the conduct of investigations or audits (5 CFR
1320.4).
The following labeling requirements are 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 1030.10(c)(6);
1040.10(g); 1040.20(d)(1)(i), (d)(2)(i), and (d)(2)(iii); and
1040.30(c)(1).
Dated: June 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13855 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P
