Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products, 65329-65332 [2013-25962]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
65329
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Total ...........................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
...................................
6,472
are no capital costs or operating and maintenance costs associated with this collection of information.
The total respondent sample for this
data collection is 6,350, including the
two pretests. We estimate the response
burden to be 30 minutes, for a total
collection burden, including screeners,
of 6,472 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
References
mstockstill on DSK4VPTVN1PROD with NOTICES
Total hours
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Products
1. Southwell, B. G., ‘‘On the Need for a LifeSpan Approach to Health Campaign
Evaluation.’’ Health Communication, 25
(6–7), 525–528, 2010.
2. Lerner, R. M. and L. Steinberg, ‘‘The
Scientific Study of Adolescent
Development.’’ In R. M. Lerner and L.
Steinberg (Eds.), Handbook of Adolescent
Psychology (3rd ed., Vol. 1: Individual
Bases of Adolescent Development).
Hoboken, NJ: John Wiley and Sons, 2009.
3. Erikson, E. H. The Child and Society. New
York: Norton, 1963.
4. Erikson, E. H. Dimensions of a New
Identity. New York: Norton, 1974.
5. Piaget, J. The Origins of Intelligence in
Children. New York: Internal University
Press, 1952.
6. Piaget, J. The Child’s Conception of the
World. Totowa, NJ: Littlefield, Adams,
1972.
7. Kohlberg, L. ‘‘Stage and Sequence. The
Cognitive Developmental Approach to
Socialization.’’ In D. A. Goslin (Ed.),
Handbook of Socialization Theory of
Research (pp. 347–380). Chicago: Rand
McNally, 1969.
8. Rubia, K., S. Overmeyer, E. Taylor, et al.,
‘‘Functional Frontalisation with Age:
Mapping Neurodevelopmental Trajectories
with fMRI.’’ [Clinical Trial Research
Support, Non-U.S. Gov’t.]. Neuroscience
and Biobehavioral Reviews, 24(1), 13–19,
2000.
9. Goldberg, J. H., B. L. Halpern-Felsher, and
S. G. Millstein, ‘‘Beyond Invulnerability:
The Importance of Benefits in Adolescents’
Decision to Drink Alcohol.’’ Health
Psychology, 21(5), 477–484. doi: 10.1037/
0278–6133.21.5.477, 2002.
10. Albert, D. and L. Steinberg, ‘‘Judgment
and Decision Making in Adolescence.’’
Journal of Research on Adolescence, 21(1),
211–224. doi: 10.1111/j.1532–
7795.2010.00724.x, 2011.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25963 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
19:21 Oct 30, 2013
Jkt 232001
Food and Drug Administration
[Docket No. FDA–2013–N–0618]
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 December
2, 2013.
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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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.
FOR FURTHER INFORMATION CONTACT:
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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 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
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
E:\FR\FM\31OCN1.SGM
31OCN1
65330
Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
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 estimates the burden of this
collection of information as follows:
• Form FDA 2579 ‘‘Report of Assembly
of a Diagnostic X-Ray System’’
• Form FDA 2767 ‘‘Notice of
Availability of Sample Electronic
Product’’
• Form FDA 2877 ‘‘Declaration for
Imported Electronic Products Subject
to Radiation Control Standards’’
• Form FDA 3649 ‘‘Accidental
Radiation Occurrence (ARO)’’
• Form FDA 3626 ‘‘A Guide for the
Submission of Initial Reports on
Diagnostic X-Ray Systems and Their
Major Components’’
• Form FDA 3627 ‘‘Diagnostic X-Ray CT
Products Radiation Safety Report’’
• Form FDA 3628 ‘‘General Annual
Report (Includes Medical, Analytical,
and Industrial X-Ray Products Annual
Report)’’
• Form FDA 3629 ‘‘Abbreviated Report’’
• Form FDA 3630 ‘‘Guide for Preparing
Product Reports on Sunlamps and
Sunlamp Products’’
• Form FDA 3631 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Sunlamp Products’’
• Form FDA 3632 ‘‘Guide for Preparing
Product Reports on Lasers and
Products Containing Lasers’’
• Form FDA 3633’’General Variance
Request’’
• Form FDA 3634 ‘‘Television Products
Annual Report’’
• Form FDA 3635 ‘‘Laser Light Show
Notification’’
• Form FDA 3636 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Laser and Laser Light Show
Products’’
• Form FDA 3637 ‘‘Laser Original
Equipment Manufacturer (OEM)
Report’’
• Form FDA 3638 ‘‘Guide for Filing
Annual Reports for X-Ray
Components and Systems’’
• Form FDA 3639 ‘‘Guidance for the
Submission of Cabinet X-Ray System
Reports Pursuant to 21 CFR 1020.40’’
• Form FDA 3640 ‘‘Reporting Guide for
Laser Light Shows and Displays’’
• Form FDA 3147 ‘‘Application for a
Variance From 21 CFR 1040.11(c) for
a Laser Light Show, Display, or
Device’’
• Form FDA 3641 ‘‘Cabinet X-Ray
Annual Report’’
• Form FDA 3642 ‘‘General
Correspondence’’
• Form FDA 3643 ‘‘Microwave Oven
Products Annual Report’’
• Form FDA 3644 ‘‘Guide for Preparing
Product Reports for Ultrasonic
Therapy Products’’
• Form FDA 3645 ‘‘Guide for Preparing
Annual Reports for Ultrasonic
Therapy Products’’
• Form FDA 3646 ‘‘Mercury Vapor
Lamp Products Radiation Safety
Report’’
• Form FDA 3647 ‘‘Guide for Preparing
Annual Reports on Radiation Safety
Testing of Mercury Vapor Lamps’’
• Form FDA 3659 ‘‘Reporting and
Compliance Guide for Television
Products’’
• Form FDA 3660 ‘‘Guidance for
Preparing Reports on Radiation Safety
of Microwave Ovens’’
• Form FDA 3661 ‘‘A Guide for the
Submission of an Abbreviated Report
on X-Ray Tables, Cradles, Film
Changers or Cassette Holders
Intended for Diagnostic Use’’
• Form FDA 3662 ‘‘A Guide for the
Submission of an Abbreviated
Radiation Safety Report on
Cephalometric Devices Intended for
Diagnostic Use’’
• Form FDA 3663 ‘‘Abbreviated Reports
on Radiation Safety for Microwave
Products (Other than Microwave
Ovens)’’
• Form FDA 3801 ‘‘Guide for Preparing
Initial Reports and Model Change
Reports on Medical Ultraviolet Lamps
and Products Containing Such
Lamps’’
The respondents to this information
collection are electronic product and 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.
In the Federal Register of June 12,
2013 (78 FR 35279), 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
Activity/21 CFR section
mstockstill on DSK4VPTVN1PROD with NOTICES
Product reports—
1002.10(a)–(k).
Product safety or testing
changes—1002.11(a)–(b).
Abbreviated reports—
1002.12.
VerDate Mar<15>2010
Number of
respondents
FDA form
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 2
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 ......
3630—Sunlamp ..................
3646—Mercury vapor lamp
3644—Ultrasonic therapy ...
3659—TV ............................
3660—Microwave oven ......
3801—UV lamps ................
.............................................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
1,000
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
1.5
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
1,500
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
0.5
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
750
3629—General abbreviated
report.
3661—X-ray tables, etc. .....
3662—Cephalometric device.
60
2
120
5
600
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
19:21 Oct 30, 2013
Jkt 232001
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
E:\FR\FM\31OCN1.SGM
31OCN1
65331
Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
FDA form
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 2
3663—Microwave products
(non-oven).
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 ...
.............................................
........................
........................
........................
........................
........................
........................
........................
........................
3
........................
........................
........................
........................
........................
........................
........................
........................
4
........................
........................
........................
........................
........................
........................
........................
........................
12
........................
........................
........................
........................
........................
........................
........................
........................
0.5
........................
........................
........................
........................
........................
........................
........................
........................
6
3649—ARO ........................
15
6
90
2
180
3642—General correspondence.
2767—Sample product .......
10
1
10
1
10
5
1
5
0.1
1
1,000
20
20,000
0.2
4,000
.............................................
1
2
2
5
10
3633—General variance request.
3147—Laser show variance
request.
3635—Laser show notification.
.............................................
350
1
350
1.2
420
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
1
1
1
22
22
.............................................
1
1
1
10
10
2579—Assembler report .....
2,000
14
28,000
0.30
8,400
.............................................
1
1
1
1
1
50
3
150
3
450
........................
........................
........................
........................
81,460
Activity/21 CFR section
Annual reports—
1002.13(a)–(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 (d)(2).
Microwave oven exemption
from warning labels—
1030.10(c)(6)(iv).
Laser products registration—1040.10(a)(3)(i).
2877—Imports declaration
3637—Original equipment
manufacturer (OEM) report.
Total .............................
.............................................
1 There
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
mstockstill on DSK4VPTVN1PROD with NOTICES
Activity/21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
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
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
VerDate Mar<15>2010
19:21 Oct 30, 2013
Jkt 232001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\31OCN1.SGM
31OCN1
65332
Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
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) ....................................................................
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
2
1
2
5
Total ............................................................................
1
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) through (c),
1003.11(a)(3) and (b), 1003.20(a)
through (h), 1003.21(a) through (d),
1003.22(a) and (b), 1003.30(a) and (b),
1003.31(a) and (b), 1004.2(a) through (i),
1004.3(a) through (i), 1004.4(a) through
(h), 1005.21(a) through (c), and
1005.22(b). These requirements apply to
the collection of information during the
conduct of 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).
VerDate Mar<15>2010
19:21 Oct 30, 2013
Jkt 232001
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25962 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Medical Devices: The Pre-Submission
Program and Meetings With FDA Staff
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
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2013.
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—NEW and
Title: ‘‘Medical Devices: The PreSubmission Program and Meetings with
FDA Staff.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65329-65332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25962]
-----------------------------------------------------------------------
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
December 2, 2013.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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--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, subchapter 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 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
[[Page 65330]]
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 estimates the burden of this collection of information as
follows:
Form FDA 2579 ``Report of Assembly of a Diagnostic X-Ray
System''
Form FDA 2767 ``Notice of Availability of Sample Electronic
Product''
Form FDA 2877 ``Declaration for Imported Electronic Products
Subject to Radiation Control Standards''
Form FDA 3649 ``Accidental Radiation Occurrence (ARO)''
Form FDA 3626 ``A Guide for the Submission of Initial Reports
on Diagnostic X-Ray Systems and Their Major Components''
Form FDA 3627 ``Diagnostic X-Ray CT Products Radiation Safety
Report''
Form FDA 3628 ``General Annual Report (Includes Medical,
Analytical, and Industrial X-Ray Products Annual Report)''
Form FDA 3629 ``Abbreviated Report''
Form FDA 3630 ``Guide for Preparing Product Reports on
Sunlamps and Sunlamp Products''
Form FDA 3631 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Sunlamp Products''
Form FDA 3632 ``Guide for Preparing Product Reports on Lasers
and Products Containing Lasers''
Form FDA 3633''General Variance Request''
Form FDA 3634 ``Television Products Annual Report''
Form FDA 3635 ``Laser Light Show Notification''
Form FDA 3636 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Laser and Laser Light Show Products''
Form FDA 3637 ``Laser Original Equipment Manufacturer (OEM)
Report''
Form FDA 3638 ``Guide for Filing Annual Reports for X-Ray
Components and Systems''
Form FDA 3639 ``Guidance for the Submission of Cabinet X-Ray
System Reports Pursuant to 21 CFR 1020.40''
Form FDA 3640 ``Reporting Guide for Laser Light Shows and
Displays''
Form FDA 3147 ``Application for a Variance From 21 CFR
1040.11(c) for a Laser Light Show, Display, or Device''
Form FDA 3641 ``Cabinet X-Ray Annual Report''
Form FDA 3642 ``General Correspondence''
Form FDA 3643 ``Microwave Oven Products Annual Report''
Form FDA 3644 ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
Form FDA 3645 ``Guide for Preparing Annual Reports for
Ultrasonic Therapy Products''
Form FDA 3646 ``Mercury Vapor Lamp Products Radiation Safety
Report''
Form FDA 3647 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
Form FDA 3659 ``Reporting and Compliance Guide for Television
Products''
Form FDA 3660 ``Guidance for Preparing Reports on Radiation
Safety of Microwave Ovens''
Form FDA 3661 ``A Guide for the Submission of an Abbreviated
Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders
Intended for Diagnostic Use''
Form FDA 3662 ``A Guide for the Submission of an Abbreviated
Radiation Safety Report on Cephalometric Devices Intended for
Diagnostic Use''
Form FDA 3663 ``Abbreviated Reports on Radiation Safety for
Microwave Products (Other than Microwave Ovens)''
Form FDA 3801 ``Guide for Preparing Initial Reports and Model
Change Reports on Medical Ultraviolet Lamps and Products Containing
Such Lamps''
The respondents to this information collection are electronic
product and x-ray manufacturers, importers, and assemblers. The burden
estimates were derived by consultation with FDA and industry personnel,
and are based on data collected from industry, including 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 June 12, 2013 (78 FR 35279), 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 Average
Activity/21 CFR section FDA form Number of responses per Total annual burden per Total hours
respondents respondent responses 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...... .............. .............. .............. .............. ..............
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.. .............. .............. .............. .............. ..............
[[Page 65331]]
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 1002.51 3642--General correspondence 10 1 10 1 10
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.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of records per Total annual burden 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.
[[Page 65332]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety 1 1 1 12 12
information 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 15 2 30 25 750
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), 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) through (c), 1003.11(a)(3) and (b),
1003.20(a) through (h), 1003.21(a) through (d), 1003.22(a) and (b),
1003.30(a) and (b), 1003.31(a) and (b), 1004.2(a) through (i),
1004.3(a) through (i), 1004.4(a) through (h), 1005.21(a) through (c),
and 1005.22(b). These requirements apply to the collection of
information during the conduct of 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: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25962 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P
