Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Information on Pediatric Uses of Medical Devices, 21241-21242 [2020-08010]
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21241
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total
number of
respondents
Instrument
Emergency Significant Incident Report Addendum (Form A–10B) .................
Significant Incident Report (Form A–10C) .......................................................
Significant Incident Report Addendum (Form A–10D) ....................................
Sexual Abuse Significant Incident Report (Form A–10E) ...............................
Sexual Abuse Significant Incident Report Addendum (Form A–10F) .............
UAC Satisfaction Survey (Form A–11 & A–11s) .............................................
UAC Satisfaction Survey Aggregate Data .......................................................
Hotline Alert (Form A–12) ................................................................................
Estimated Annual Burden Total:
3,982,800.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Fax written comments on the
collection of information by May 18,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0748. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–07995 Filed 4–15–20; 8:45 am]
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.
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission of Information on Pediatric
Uses of Medical Devices; Requirement
for Submission of Information on
Pediatric Subpopulations That Suffer
From a Disease or Condition That a
Device Is Intended To Treat, Diagnose,
or Cure Under Section 515A of the
Federal Food, Drug, and Cosmetic
Act—21 CFR 814
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Information on Pediatric Uses of
Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
1,360
80,340
25,630
5,980
4,190
72,840
235
80
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.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232;
Flores v. Reno Settlement Agreement, No.
CV85–4544–RJK (C.D. Cal. 1996).
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.
SUMMARY:
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
OMB Control Number 0910–0748—
Extension
Section 515A(a) of the Food, Drug,
and Cosmetic Act (21 U.S.C. 360e-1)
(FD&C Act) requires applicants who
submit certain medical device
applications to include readily available
information providing a description of
any pediatric subpopulations that suffer
from the disease or condition that the
device is intended to treat, diagnose, or
cure, and the number of affected
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
Annual
number of
responses per
respondent
1
1
1
1
1
1
4
1
Average
burden
minutes
per response
15
20
15
20
15
20
240
15
Annual
burden
minutes
20,400
1,606,800
384,450
119,600
62,850
1,456,800
225,600
1,200
pediatric patients. The information
submitted will allow FDA to track the
number of approved devices for which
there is a pediatric subpopulation that
suffers from the disease or condition
that the device is intended to treat,
diagnose, or cure and the review time
for each such device application.
These requirements apply to
applicants who submit humanitarian
device exemption requests (HDEs),
premarket approval applications (PMAs)
or PMA amendments or supplements, or
a product development protocol (PDP).
FDA expects to receive approximately
47 original PMA/PDP/HDE applications
each year, 1 of which FDA expects to be
HDEs. This estimate is based on the
average of FDA’s receipt of new PMA
applications. The Agency estimates that
11 of the estimated 47 original PMA
submissions will fail to provide the
required pediatric use information and
their sponsors will therefore be required
to submit PMA amendments. The
Agency also expects to receive
approximately 928 supplements that
will include the pediatric use
information required by section 515A(a)
of the FD&C Act and part 814 (21 CFR
part 814).
All that is required is to gather,
organize, and submit information that is
readily available, using any approach
that meets the requirements of section
515A(a) of the FD&C Act and part 814.
We believe that because the applicant is
required to organize and submit only
readily available information, no more
than 8 hours will be required to comply.
Furthermore, because supplements may
include readily available information on
pediatric populations by referencing a
previous submission, FDA estimates the
average time to obtain and submit the
required information is a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 2,392 hours.
Additionally, the document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff’’ describes how to
E:\FR\FM\16APN1.SGM
16APN1
21242
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
compile and submit the readily
available pediatric use information
required under section 515A(a) of the
FD&C Act. Respondents are permitted to
submit information relating to uses of
the device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A(a)
of the FD&C Act will choose to submit
this information and that it will take 30
minutes for them to do so.
In the Federal Register of December 2,
2019 (84 FR 65986), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Pediatric information in an original PMA or PDP—
814.20(b)(13).
Pediatric information in a PMA amendment—
814.37(b)(2).
Pediatric information in a PMA supplement—
814.39(c)(2)(i).
Pediatric information in an HDE—814.104(b)(6) .......
Pediatric information for uses outside approved indication.
Total ....................................................................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR part
Average
burden per
response
Total annual
responses
Total hours
11
1
11
8 ..............................
88
5
1
5
8 ..............................
40
928
1
928
2 ..............................
1,856
1
800
1
1
1
800
8 ..............................
.5 (30 minutes) ........
8
400
........................
........................
........................
.................................
2,392
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden and
corresponding responses reflect the
requirements under section 515A(a) of
the FD&C Act, in addition to the
submission of data related to pediatric
uses outside an approved indication, as
described in the document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff.’’ OMB previously
approved the information collection
related to uses outside an approved
indication under OMB control number
0910–0762. As the information
collection uses the same data and relies
upon the same legal authority as OMB
control number 0910–0748, we intend
to discontinue OMB control number
0910–0762 and consolidate the
information collection accordingly. Our
estimated burden for the information
collection reflects an overall increase of
632 hours. Additionally, we have
altered the title of the collection to
reflect all collections of pediatric uses.
Our estimated burden for the
information collection reflects an
overall increase of 632 hours and a
corresponding increase of supplements
and of uses outside of approved
indications. We attribute this
adjustment to an increase in the number
of supplements we received over the
last 5 years and merging data from
discontinued OMB control number
0910–0762.
VerDate Sep<11>2014
18:20 Apr 15, 2020
Jkt 250001
Dated: April 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08010 Filed 4–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1207]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining a List of U.S.
Manufacturers/Processors of Feed
Additives, Premixes, Compound Feed,
Distillers’ Dried Grains, and Distillers’
Dried Grains With Solubles for Use
With Animals With Interest in
Exporting to The People’s Republic of
China
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
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
SUMMARY:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
solicits comments on the information
collection associated with establishing
and maintaining a list of U.S.
manufacturers and processors interested
in exporting to the People’s Republic of
China.
DATES: Submit either electronic or
written comments on the collection of
information by June 15, 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 June 15, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 15, 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,
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]]>Agencies
[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21241-21242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-3995]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Information on Pediatric Uses of Medical Devices
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 May 18,
2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0748. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Submission of Information on Pediatric Uses of Medical Devices;
Requirement for Submission of Information on Pediatric Subpopulations
That Suffer From a Disease or Condition That a Device Is Intended To
Treat, Diagnose, or Cure Under Section 515A of the Federal Food, Drug,
and Cosmetic Act--21 CFR 814
OMB Control Number 0910-0748--Extension
Section 515A(a) of the Food, Drug, and Cosmetic Act (21 U.S.C.
360e-1) (FD&C Act) requires applicants who submit certain medical
device applications to include readily available information providing
a description of any pediatric subpopulations that suffer from the
disease or condition that the device is intended to treat, diagnose, or
cure, and the number of affected pediatric patients. The information
submitted will allow FDA to track the number of approved devices for
which there is a pediatric subpopulation that suffers from the disease
or condition that the device is intended to treat, diagnose, or cure
and the review time for each such device application.
These requirements apply to applicants who submit humanitarian
device exemption requests (HDEs), premarket approval applications
(PMAs) or PMA amendments or supplements, or a product development
protocol (PDP).
FDA expects to receive approximately 47 original PMA/PDP/HDE
applications each year, 1 of which FDA expects to be HDEs. This
estimate is based on the average of FDA's receipt of new PMA
applications. The Agency estimates that 11 of the estimated 47 original
PMA submissions will fail to provide the required pediatric use
information and their sponsors will therefore be required to submit PMA
amendments. The Agency also expects to receive approximately 928
supplements that will include the pediatric use information required by
section 515A(a) of the FD&C Act and part 814 (21 CFR part 814).
All that is required is to gather, organize, and submit information
that is readily available, using any approach that meets the
requirements of section 515A(a) of the FD&C Act and part 814. We
believe that because the applicant is required to organize and submit
only readily available information, no more than 8 hours will be
required to comply. Furthermore, because supplements may include
readily available information on pediatric populations by referencing a
previous submission, FDA estimates the average time to obtain and
submit the required information is a supplement to be 2 hours. FDA
estimates that the total estimated burden is 2,392 hours.
Additionally, the document entitled ``Providing Information About
Pediatric Uses of Medical Devices--Guidance for Industry and Food and
Drug Administration Staff'' describes how to
[[Page 21242]]
compile and submit the readily available pediatric use information
required under section 515A(a) of the FD&C Act. Respondents are
permitted to submit information relating to uses of the device outside
the approved or proposed indication if such uses are described or
acknowledged in acceptable sources of readily available information. We
estimate that 20 percent of respondents submitting information required
by section 515A(a) of the FD&C Act will choose to submit this
information and that it will take 30 minutes for them to do so.
In the Federal Register of December 2, 2019 (84 FR 65986), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR part Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric information in an original PMA or 11 1 11 8........................................ 88
PDP--814.20(b)(13).
Pediatric information in a PMA amendment-- 5 1 5 8........................................ 40
814.37(b)(2).
Pediatric information in a PMA supplement-- 928 1 928 2........................................ 1,856
814.39(c)(2)(i).
Pediatric information in an HDE-- 1 1 1 8........................................ 8
814.104(b)(6).
Pediatric information for uses outside 800 1 800 .5 (30 minutes).......................... 400
approved indication.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 2,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden and corresponding responses reflect the
requirements under section 515A(a) of the FD&C Act, in addition to the
submission of data related to pediatric uses outside an approved
indication, as described in the document entitled ``Providing
Information About Pediatric Uses of Medical Devices--Guidance for
Industry and Food and Drug Administration Staff.'' OMB previously
approved the information collection related to uses outside an approved
indication under OMB control number 0910-0762. As the information
collection uses the same data and relies upon the same legal authority
as OMB control number 0910-0748, we intend to discontinue OMB control
number 0910-0762 and consolidate the information collection
accordingly. Our estimated burden for the information collection
reflects an overall increase of 632 hours. Additionally, we have
altered the title of the collection to reflect all collections of
pediatric uses.
Our estimated burden for the information collection reflects an
overall increase of 632 hours and a corresponding increase of
supplements and of uses outside of approved indications. We attribute
this adjustment to an increase in the number of supplements we received
over the last 5 years and merging data from discontinued OMB control
number 0910-0762.
Dated: April 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08010 Filed 4-15-20; 8:45 am]
BILLING CODE 4164-01-P
