Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products, 3925-3929 [2020-01073]
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Product-Specific
Guidance for Levonorgestrel;
Intrauterine Device.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ will be
publicly viewable at https://
www.regulations.gov or at the Dockets
Management Staff office between 9 a.m.
and 4 p.m., Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
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docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Wendy Good, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
4730, Silver Spring, MD 20993–0002,
301–796–5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific guidances
and to provide a meaningful
opportunity for the public to consider
and comment on the guidances. This
notice announces the availability of a
revised draft guidance on a generic
levonorgestrel intrauterine device.
FDA initially approved new drug
application 21225 for MIRENA
(levonorgestrel intrauterine device) in
December 2000. In April 2014, FDA
issued a draft product-specific guidance
for industry on a generic levonorgestrel
intrauterine device. FDA subsequently
withdrew that draft guidance in October
2014 because the recommended in vitro
studies lacked adequate specificity. We
are now issuing a revised draft guidance
for industry on a generic levonorgestrel
intrauterine device (‘‘Draft Guidance on
Levonorgestrel’’) with recommendations
for a combination of two studies, in
vitro testing and an in vivo/ex vivo
study, to demonstrate BE.
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3925
In December 2015, Bayer HealthCare
LLC, manufacturer of the reference
listed drug MIRENA, submitted a citizen
petition requesting that FDA withhold
approval of any ANDA for a generic
version of MIRENA unless certain
conditions were satisfied, including
conditions related to demonstrating BE
((Docket No. FDA–2015–P–4600),
available at https://
www.regulations.gov). FDA is reviewing
the issues raised in that petition.
However, FDA will consider any
comments received on the guidance
entitled, ‘‘Draft Guidance on
Levonorgestrel,’’ before responding to
the citizen petition.
The revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on the design
of BE studies to support ANDAs for a
levonorgestrel intrauterine device. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01072 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0618]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
SUMMARY:
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on requirements for
reporting and recordkeeping, general
and specific requirements, and the
availability of sample electronic
products for manufacturers and
distributors of electronic products.
DATES: Submit either electronic or
written comments on the collection of
information by March 23, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 23, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0618 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Electronic Products.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
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and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Electronic Products—21 CFR Parts 1000
Through 1050
OMB Control Number 0910–0025—
Extension
Under sections 532 through 542 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360ii through
360ss), FDA has the responsibility to
protect the public from unnecessary
exposure of radiation from electronic
products. The regulations issued under
these authorities are listed in Title 21 of
the Code of Federal Regulations, chapter
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
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
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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’’
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3927
• 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
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:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours 2
Activity/21 CFR section
FDA form
Product reports—1002.10(a) through
(k).
3626—Diagnostic x-ray, 3627—CT xray, 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
0.5
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 xray,
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
0.5
84
3649—ARO .........................................
30
6.7
201
2
402
3642—General correspondence .........
4
1.3
5
1
5
2767—Sample product .......................
5
1
5
0.1
1
2877—Imports declaration ..................
12,620
2.5
31,550
0.2
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
0.30
10
12,546
.............................................................
1
1
1
1
1
3637—Original equipment manufacturer (OEM) report.
70
2.9
203
3
609
.............................................................
........................
........................
........................
........................
134,366
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), and (d)(1)
and (2).
Microwave oven exemption from
warning labels—1030.10(c)(6)(iv).
Laser
products
registration—
1040.10(a)(3)(i).
Total .............................................
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
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours 2
Manufacturers records—1002.30 and 1002.31(a) ...............
Dealer/distributor records—1002.40 and 1002.41 ...............
Information on diagnostic x-ray systems—1020.30(g) ........
Laser products distribution records—1040.10(a)(3)(ii) ........
1,650
3,110
50
70
1,650
50
1
1
2,722,500
155,500
50
70
0.12
0.05
0.5
1
326,700
7,775
25
70
Total ..............................................................................
........................
........................
........................
........................
334,570
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/21 CFR section
Technical and safety information for users—1002.3 ...........
Dealer/distributor records—1002.40 and 1002.41 ...............
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Number of
disclosures
per respondent
1
30
Fmt 4703
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Total annual
disclosures
1
3
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1
90
23JAN1
Average
burden per
disclosure
12
1
Total hours 2
12
90
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
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 (d),
(f)(1), and (f)(2)(iii) ............................................................
Total ..............................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
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
........................
........................
........................
........................
3,058
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01073 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0145]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting
Associated With Animal Drug and
Animal Generic Drug User Fees
AGENCY:
Food and Drug Administration,
jbell on DSKJLSW7X2PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
Under the Paperwork Reduction Act of
1995 (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 the information
collection provisions of FDA’s animal
drug and animal generic drug user fee
programs.
DATES: Submit either electronic or
written comments on the collection of
information by March 23, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 23, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3925-3929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01073]
-----------------------------------------------------------------------
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the
[[Page 3926]]
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements for reporting and
recordkeeping, general and specific requirements, and the availability
of sample electronic products for manufacturers and distributors of
electronic products.
DATES: Submit either electronic or written comments on the collection
of information by March 23, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0618 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Products.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Electronic Products--21 CFR Parts 1000 Through 1050
OMB Control Number 0910-0025--Extension
Under sections 532 through 542 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360ii through 360ss), FDA has the
responsibility to protect the public from unnecessary exposure of
radiation from electronic products. The regulations issued under these
authorities are listed in Title 21 of the Code of Federal Regulations,
chapter
[[Page 3927]]
I, subchapter J, parts 1000 through 1050 (21 CFR parts 1000 through
1050).
Section 532 of the FD&C Act directs the Secretary of Health and
Human Services (the Secretary), to establish and carry out an
electronic product radiation control program, including the
development, issuance, and administration of performance standards to
control the emission of electronic product radiation from electronic
products. The program is designed to protect the public health and
safety from electronic radiation, and the FD&C Act authorizes the
Secretary to procure (by negotiation or otherwise) electronic products
for research and testing purposes and to sell or otherwise dispose of
such products. Section 534(g) of the FD&C Act directs the Secretary to
review and evaluate industry testing programs on a continuing basis;
and section 535(e) and (f) of the FD&C Act directs the Secretary to
immediately notify manufacturers of, and ensure correction of,
radiation defects or noncompliance with performance standards. Section
537(b) of the FD&C Act contains the authority to require manufacturers
of electronic products to establish and maintain records (including
testing records), make reports, and provide information to determine
whether the manufacturer has acted in compliance.
The regulations under parts 1002 through 1010 specify reports to be
provided by manufacturers and distributors to FDA and records to be
maintained in the event of an investigation of a safety concern or a
product recall. FDA conducts laboratory compliance testing of products
covered by regulations for product standards in parts 1020, 1030, 1040,
and 1050.
FDA details product-specific performance standards that specify
information to be supplied with the product or require specific
reports. The information collections are either specifically called for
in the FD&C Act or were developed to aid the Agency in performing its
obligations under the FD&C Act. The data reported to FDA and the
records maintained are used by FDA and the industry to make decisions
and take actions that protect the public from radiation hazards
presented by electronic products. This information refers to the
identification of, location of, operational characteristics of, quality
assurance programs for, and problem identification and correction of
electronic products. The data provided to users and others are intended
to encourage actions to reduce or eliminate radiation exposures.
FDA uses the following forms to aid respondents in the submission
of information for this information collection:
Form FDA 2579 ``Report of Assembly of a Diagnostic X-Ray
System''
Form FDA 2767 ``Notice of Availability of Sample Electronic
Product''
Form FDA 2877 ``Declaration for Imported Electronic Products
Subject to Radiation Control Standards''
Form FDA 3649 ``Accidental Radiation Occurrence (ARO)''
Form FDA 3626 ``A Guide for the Submission of Initial Reports
on Diagnostic X-Ray Systems and Their Major Components''
Form FDA 3627 ``Diagnostic X-Ray CT Products Radiation Safety
Report''
Form FDA 3628 ``General Annual Report (Includes Medical,
Analytical, and Industrial X-Ray Products Annual Report)''
Form FDA 3629 ``Abbreviated Report''
Form FDA 3630 ``Guide for Preparing Product Reports on
Sunlamps and Sunlamp Products''
Form FDA 3631 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Sunlamp Products''
Form FDA 3632 ``Guide for Preparing Product Reports on Lasers
and Products Containing Lasers''
Form FDA 3633 ``General Variance Request''
Form FDA 3634 ``Television Products Annual Report''
Form FDA 3635 ``Laser Light Show Notification''
Form FDA 3636 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Laser and Laser Light Show Products''
Form FDA 3637 ``Laser Original Equipment Manufacturer (OEM)
Report''
Form FDA 3638 ``Guide for Filing Annual Reports for X-Ray
Components and Systems''
Form FDA 3639 ``Guidance for the Submission of Cabinet X-Ray
System Reports Pursuant to 21 CFR 1020.40''
Form FDA 3640 ``Reporting Guide for Laser Light Shows and
Displays''
Form FDA 3147 ``Application for a Variance From 21 CFR
1040.11(c) for a Laser Light Show, Display, or Device''
Form FDA 3641 ``Cabinet X-Ray Annual Report''
Form FDA 3642 ``General Correspondence''
Form FDA 3643 ``Microwave Oven Products Annual Report''
Form FDA 3644 ``Guide for Preparing Product Reports for
Ultrasonic Therapy Products''
Form FDA 3645 ``Guide for Preparing Annual Reports for
Ultrasonic Therapy Products''
Form FDA 3646 ``Mercury Vapor Lamp Products Radiation Safety
Report''
Form FDA 3647 ``Guide for Preparing Annual Reports on
Radiation Safety Testing of Mercury Vapor Lamps''
Form FDA 3659 ``Reporting and Compliance Guide for Television
Products''
Form FDA 3660 ``Guidance for Preparing Reports on Radiation
Safety of Microwave Ovens''
Form FDA 3661 ``A Guide for the Submission of an Abbreviated
Report on X-Ray Tables, Cradles, Film Changers, or Cassette Holders
Intended for Diagnostic Use''
Form FDA 3662 ``A Guide for the Submission of an Abbreviated
Radiation Safety Report on Cephalometric Devices Intended for
Diagnostic Use''
Form FDA 3663 ``Abbreviated Reports on Radiation Safety for
Microwave Products (Other than Microwave Ovens)''
Form FDA 3801 ``Guide for Preparing Initial Reports and Model
Change Reports on Medical Ultraviolet Lamps and Products Containing
Such Lamps''
The respondents to this information collection are electronic
product and x-ray manufacturers, importers, and assemblers. The burden
estimates were derived by consultation with FDA and industry personnel,
and are based on data collected from industry, including product report
submissions. An evaluation of the type and scope of information
requested was also used to derive some time estimates.
FDA estimates the burden of this collection of information as
follows:
[[Page 3928]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section FDA form Number of responses per Total annual burden per Total hours 2
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a) through (k)... 3626--Diagnostic x-ray, 1,400 2.2 3,080 24 73,920
3627--CT x-ray, 3639--
Cabinet x-ray, 3632--Laser,
3640--Laser light show,
3630--Sunlamp, 3646--
Mercury vapor lamp, 3644--
Ultrasonic therapy, 3659--
TV, 3660--Microwave oven,
3801--UV lamps.
Product safety or testing changes-- ............................ 480 2.5 1,200 0.5 600
1002.11(a) and (b).
Abbreviated reports--1002.12.............. 3629--General abbreviated 60 1.8 108 5 540
report, 3661--X-ray tables,
etc., 3662--Cephalometric
device, 3663--Microwave
products (non-oven).
Annual reports--1002.13(a) and (b)........ 3628--General, 3634--TV, 1,660 1.3 2,158 18 38,844
3638--Diagnostic x-ray,
3641--Cabinet x-ray, 3643--
Microwave oven, 3636--
Laser, 3631--Sunlamp, 3647--
Mercury vapor lamp, 3645--
Ultrasonic therapy.
Quarterly updates for new models-- ............................ 120 1.4 168 0.5 84
1002.13(c).
Accidental radiation occurrence reports-- 3649--ARO................... 30 6.7 201 2 402
1002.20.
Exemption requests--1002.50(a) and 1002.51 3642--General correspondence 4 1.3 5 1 5
Product and sample information--1005.10... 2767--Sample product........ 5 1 5 0.1 1
Identification information and compliance 2877--Imports declaration... 12,620 2.5 31,550 0.2 6,310
status--1005.25.
Alternate means of certification-- ............................ 1 2 2 5 10
1010.2(d).
Variance--1010.4(b)....................... 3633--General variance 350 1.1 385 1.2 462
request, 3147--Laser show
variance request, 3635--
Laser show notification.
Exemption from performance standards-- ............................ 1 1 1 22 22
1010.5(c) and (d).
Alternate test procedures--1010.13........ ............................ 1 1 1 10 10
Report of assembly of diagnostic x-ray 2579--Assembler report...... 1,230 34 41,820 0.30 12,546
components--1020.30(d), and (d)(1) and
(2).
Microwave oven exemption from warning ............................ 1 1 1 1 1
labels--1030.10(c)(6)(iv).
Laser products registration-- 3637--Original equipment 70 2.9 203 3 609
1040.10(a)(3)(i). manufacturer (OEM) report.
-------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 134,366
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of records per Total annual burden per Total hours 2
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30 1,650 1,650 2,722,500 0.12 326,700
and 1002.31(a).................
Dealer/distributor records-- 3,110 50 155,500 0.05 7,775
1002.40 and 1002.41............
Information on diagnostic x-ray 50 1 50 0.5 25
systems--1020.30(g)............
Laser products distribution 70 1 70 1 70
records--1040.10(a)(3)(ii).....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 334,570
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of disclosures Total annual burden per Total hours 2
respondents per respondent disclosures 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............
[[Page 3929]]
Television receiver critical 1 1 1 1 1
component warning--
1020.10(c)(4)..................
Cold cathode tubes-- 1 1 1 1 1
1020.20(c)(4)..................
Information on diagnostic x-ray 6 1 6 55 330
systems--1020.30(g)............
Statement of maximum line 6 1 6 10 60
current of x-ray systems--
1020.30(g)(2)..................
Diagnostic x-ray system safety 6 1 6 200 1,200
and technical information--
1020.30(h)(1) through (4)......
Fluoroscopic x-ray system safety 5 1 5 25 125
and technical information--
1020.30(h)(5) and (6) and
1020.32(a)(1), (g), and (j)(4).
CT equipment--1020.33(c), (d), 5 1 5 150 750
(g)(4), and (j)................
Cabinet x-ray systems 6 1 6 40 240
information--1020.40(c)(9)(i)
and (ii).......................
Microwave oven radiation safety 1 1 1 20 20
instructions--1030.10(c)(4)....
Microwave oven safety 1 1 1 20 20
information and instructions--
1030.10(c)(5)(i) through (iv)..
Microwave oven warning labels-- 1 1 1 1 1
1030.10(c)(6)(iii).............
Laser products information-- 3 1 3 20 60
1040.10(h)(1)(i) through (vi)..
Laser product service 3 1 3 20 60
information--1040.10(h)(2)(i)
and (ii).......................
Medical laser product 2 1 2 10 20
instructions--1040.11(a)(2)....
Sunlamp products instructions-- 1 1 1 10 10
1040.20........................
Mercury vapor lamp labeling-- 1 1 1 1 1
1040.30(c)(1)(ii)..............
Mercury vapor lamp permanently 1 1 1 1 1
affixed labels--1040.30(c)(2)..
Ultrasonic therapy products-- 1 1 1 56 56
1050.10(d)(1) through (d),
(f)(1), and (f)(2)(iii)........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,058
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Total hours have been rounded.
Based on a review of the information collection, we have made no
adjustments to our burden estimate.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01073 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P
