Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 53448-53450 [2019-21785]
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
the committee. Oral presentations from
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Notice of this meeting is given under
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U.S.C. app. 2).
Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21834 Filed 10–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
[Docket No. FDA–2019–N–3500]
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide: Version 3.1;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, August 20, 2019.
The document announced a ‘‘Fit for Use
Pilot Program Invitation for the Clinical
Data Interchange Standards Consortium
for Standard for Exchange of
Nonclinical Data Implementation Guide:
Version 3.1.’’ The document was
published with the incorrect contact
name, phone number, and email address
in the FOR FURTHER INFORMATION
CONTACT section. This document
corrects those errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jesse Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@fda.hhs.gov.
In FR Doc.
2019–17877, appearing on page 43139,
in the Federal Register of Tuesday,
August 20, 2019 (84 FR 43139), the
following correction is made:
On page 43140, in the first column, in
the FOR FURTHER INFORMATION CONTACT
section of the document, ‘‘Isaac Chang,
Office of Computational Science, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–4027501, PRAStaff@
fda.hhs.gov.’’ is corrected to read ‘‘Jesse
Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@
fda.hhs.gov.’’
SUPPLEMENTARY INFORMATION:
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Food and Drug Administration,
HHS.
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 November
6, 2019.
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 0910–0078. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
[FR Doc. 2019–21784 Filed 10–4–19; 8:45 am]
18:29 Oct 04, 2019
AGENCY:
ACTION:
Correction.
Dated: September 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
VerDate Sep<11>2014
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10a.m.–12p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Investigational Device Exemptions
Reports and Records
OMB Control Number 0910–0078—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices and
establishes rules under which new
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
115) added section 520(g)(6) to the
FD&C Act and permitted changes to be
made to either the investigational device
or to the clinical protocol without FDA
approval of an investigational device
exemption (IDE) supplement. An IDE
allows a device, which would otherwise
be subject to provisions of the FD&C
Act, such as premarket notification or
premarket approval, to be used in
investigations involving human subjects
in which the safety and effectiveness of
the device is being studied. The purpose
of part 812 (21 CFR part 812) is to
encourage, to the extent consistent with
the protection of public health and
safety and with ethical standards, the
discovery and development of useful
devices intended for human use. The
IDE regulation is designed to encourage
the development of useful medical
devices and allow investigators the
maximum freedom possible, without
jeopardizing the health and safety of the
public or violating ethical standards. To
do this, the regulation provides for
different levels of regulatory control,
depending on the level of potential risk
the investigational device presents to
human subjects.
Investigations of significant risk
devices, ones that present a potential for
serious harm to the rights, safety, or
welfare of human subjects, are subject to
the full requirements of the IDE
regulation. Nonsignificant risk device
investigations, i.e., devices that do not
present a potential for serious harm, are
subject to the reduced burden of the
abbreviated requirements. The
regulation also includes provisions for
treatment IDEs. The purpose of these
provisions is to facilitate the
availability, as early in the device
development process as possible, of
promising new devices to patients with
life-threatening or serious conditions for
which no comparable or satisfactory
alternative therapy is available. Section
812.10 permits the sponsor of the IDE to
request a waiver of any of the
requirements of part 812. Sections
812.20, 812.25, and 812.27 describe the
information necessary to file an IDE
application with FDA. The submission
of an IDE application to FDA is required
only for significant risk device
investigations. Section 812.20 lists the
data requirements for the original IDE
application, § 812.25 lists the contents
of the investigational plan, and § 812.27
lists the data relating to previous
investigations or testing. The
information in the original IDE
application is evaluated by the Center
for Devices and Radiological Health to
determine whether the proposed
investigation will reasonably protect the
public health and safety.
Upon approval of an IDE application
by FDA, a sponsor must submit certain
requests and reports. Under § 812.35, a
sponsor who wishes to make a change
in the investigation that affects the
scientific soundness of the study or the
rights, safety, or welfare of the subjects,
is required to submit a request for the
change to FDA. Section 812.150 requires
a sponsor to submit reports to FDA.
These requests and reports are
submitted to FDA as supplemental
applications. This information is needed
for FDA to assure protection of human
subjects and to allow review of the
study’s progress. Section 812.36(c)
identifies the information necessary to
file a treatment IDE application. FDA
uses this information to determine if
wider distribution of the device is in the
interest of the public health. Section
812.36(f) identifies the reports required
to allow FDA to monitor the size and
scope of the treatment IDE, to assess the
sponsor’s due diligence in obtaining
marketing clearance of the device, and
to ensure the integrity of the controlled
clinical trials.
Section 812.140 lists the
recordkeeping requirements for
investigators and sponsors. FDA
requires this information for tracking
and oversight purposes. Investigators
are required to maintain records,
including correspondence and reports
concerning the study, records of receipt,
use or disposition of devices, records of
each subject’s case history and exposure
to the device, informed consent
documentation, study protocol, and
documentation of any deviation from
the protocol. Sponsors are required to
maintain records including
correspondence and reports concerning
the study, records of shipment and
disposition, signed investigator
agreements, adverse device effects
information, and, for a nonsignificant
risk device study, an explanation of the
nonsignificant risk determination,
records of device name and intended
use, study objectives, investigator
information, investigational review
board information, and statement on the
extent that good manufacturing
practices will be followed.
For a nonsignificant risk device
investigation, the investigators’ and
sponsors’ recordkeeping and reporting
burden is reduced. Pertinent records on
the study must be maintained by both
parties, and reports are made to
sponsors and institutional review
boards (IRBs). Reports are made to FDA
only in certain circumstances, e.g.,
recall of the device, the occurrence of
unanticipated adverse effects, and as a
consequence of certain IRB actions.
In the Federal Register of June 11,
2019 (84 FR 27139), 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
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Waivers—812.10 ..................................................................
IDE Application—812.20, 812.25, and 812.27 ....................
Supplements—812.35 and 812.150 ....................................
Treatment IDE Applications—812.36(c) ..............................
Treatment IDE Reporting—812.36(f) ...................................
1
229
654
1
1
1
1
5
1
1
1
229
3,270
1
1
1
80
6
120
20
1
18,320
19,620
120
20
Total ..............................................................................
........................
........................
........................
........................
38,081
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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18:29 Oct 04, 2019
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
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
Original—812.140 ................................................................
Supplemental—812.140 .......................................................
Nonsignificant—812.140 ......................................................
229
654
356
1
5
1
229
3,270
356
10
1
6
2,290
3,270
2,136
Total ..............................................................................
........................
........................
........................
........................
7,696
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Reports for Nonsignificant Risk Studies—812.150 .............
1
1
1
6
6
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 528 hours. We
attribute this adjustment to a decrease in
the number of submissions we received
over the last few years.
Dated: September 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21785 Filed 10–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Interdisciplinary, Community Based
Linkages
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Interdisciplinary,
Community Based Linkages (ACICBL)
will hold public meetings for the 2020
calendar year (CY). Information about
ACICBL, agendas, and materials for
these meetings can be found on the
ACICBL website at https://
www.hrsa.gov/advisory-committees/
interdisciplinary-community-linkages/
index.html.
DATES: February 20–21, 2020, 8:30 a.m.–
5:00 p.m. Eastern Time (ET) and 8:30
a.m.–2:00 p.m. ET; May 1, 2020, 10:00
a.m.–4:00 p.m. ET; October 20, 2020,
10:00 a.m.–4:00 p.m. ET.
SUMMARY:
VerDate Sep<11>2014
18:29 Oct 04, 2019
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The meeting scheduled
from February 20–21, 2020, will be held
in-person at 5600 Fishers Lane, Room
5E29, Rockville, Maryland 20857 and
can be accessed via teleconference and
Adobe Connect webinar. The meetings
scheduled on May 1, 2020, and October
20, 2020, will both be held via
teleconference and Adobe Connect
webinar. Instructions for joining the
meetings either in-person or remotely
will be posted on the ACICBL website
30 business days before the date of the
meeting. For meeting information
updates, go to the ACICBL website
meeting page at https://www.hrsa.gov/
advisory-committees/interdisciplinarycommunity-linkages/meetings/
index.html.
ADDRESSES:
Joan
Weiss, Ph.D., RN, CRNP, FAAN, Senior
Advisor and Designated Federal
Official, Division of Medicine and
Dentistry, HRSA, 5600 Fishers Lane,
Rockville, Maryland 20857; 301–443–
0430; or BHWACICBL@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACICBL
provides advice and recommendations
to the Secretary of HHS on policy,
program development, and other
matters of significance concerning
activities under sections 750–760, Title
VII, Part D of the Public Health Service
Act. Agenda items are subject to change
as priorities dictate. ACICBL meetings
and agenda items for CY 2020 may
include, but are not limited to,
discussion and development of topics
for the 18th report. Refer to the ACICBL
website listed above for all current and
updated information concerning each of
the CY 2020 ACICBL meetings,
including draft agendas and meeting
materials that will be posted before each
meeting. Agendas will be posted on the
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00053
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Sfmt 9990
ACICBL website at least 14 calendar
days before each meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meetings. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to the ACICBL
should be sent to Joan Weiss using the
contact information above at least 5
business days before the scheduled
meeting date.
Individuals who need special
assistance or another reasonable
accommodation should notify Joan
Weiss using the contact information
listed above at least 10 business days
before the meeting they wish to attend.
Since the in-person meeting occurs in a
federal government building, attendees
must go through a security check to
enter the building. Non-U.S. Citizen
attendees must notify HRSA of their
planned attendance at least 20 business
days prior to the meeting in order to
facilitate their entry into the building.
All attendees are required to present
government-issued identification prior
to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–21797 Filed 10–4–19; 8:45 am]
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]]>Agencies
[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53448-53450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21785]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational
Device Exemptions Reports and Records
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
November 6, 2019.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0078.
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.m.-12p.m.,
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.
Investigational Device Exemptions Reports and Records
OMB Control Number 0910-0078--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect
information regarding investigational devices and establishes rules
under which new medical devices may be tested using human subjects in a
clinical setting. The Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-
[[Page 53449]]
115) added section 520(g)(6) to the FD&C Act and permitted changes to
be made to either the investigational device or to the clinical
protocol without FDA approval of an investigational device exemption
(IDE) supplement. An IDE allows a device, which would otherwise be
subject to provisions of the FD&C Act, such as premarket notification
or premarket approval, to be used in investigations involving human
subjects in which the safety and effectiveness of the device is being
studied. The purpose of part 812 (21 CFR part 812) is to encourage, to
the extent consistent with the protection of public health and safety
and with ethical standards, the discovery and development of useful
devices intended for human use. The IDE regulation is designed to
encourage the development of useful medical devices and allow
investigators the maximum freedom possible, without jeopardizing the
health and safety of the public or violating ethical standards. To do
this, the regulation provides for different levels of regulatory
control, depending on the level of potential risk the investigational
device presents to human subjects.
Investigations of significant risk devices, ones that present a
potential for serious harm to the rights, safety, or welfare of human
subjects, are subject to the full requirements of the IDE regulation.
Nonsignificant risk device investigations, i.e., devices that do not
present a potential for serious harm, are subject to the reduced burden
of the abbreviated requirements. The regulation also includes
provisions for treatment IDEs. The purpose of these provisions is to
facilitate the availability, as early in the device development process
as possible, of promising new devices to patients with life-threatening
or serious conditions for which no comparable or satisfactory
alternative therapy is available. Section 812.10 permits the sponsor of
the IDE to request a waiver of any of the requirements of part 812.
Sections 812.20, 812.25, and 812.27 describe the information necessary
to file an IDE application with FDA. The submission of an IDE
application to FDA is required only for significant risk device
investigations. Section 812.20 lists the data requirements for the
original IDE application, Sec. 812.25 lists the contents of the
investigational plan, and Sec. 812.27 lists the data relating to
previous investigations or testing. The information in the original IDE
application is evaluated by the Center for Devices and Radiological
Health to determine whether the proposed investigation will reasonably
protect the public health and safety.
Upon approval of an IDE application by FDA, a sponsor must submit
certain requests and reports. Under Sec. 812.35, a sponsor who wishes
to make a change in the investigation that affects the scientific
soundness of the study or the rights, safety, or welfare of the
subjects, is required to submit a request for the change to FDA.
Section 812.150 requires a sponsor to submit reports to FDA. These
requests and reports are submitted to FDA as supplemental applications.
This information is needed for FDA to assure protection of human
subjects and to allow review of the study's progress. Section 812.36(c)
identifies the information necessary to file a treatment IDE
application. FDA uses this information to determine if wider
distribution of the device is in the interest of the public health.
Section 812.36(f) identifies the reports required to allow FDA to
monitor the size and scope of the treatment IDE, to assess the
sponsor's due diligence in obtaining marketing clearance of the device,
and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for
investigators and sponsors. FDA requires this information for tracking
and oversight purposes. Investigators are required to maintain records,
including correspondence and reports concerning the study, records of
receipt, use or disposition of devices, records of each subject's case
history and exposure to the device, informed consent documentation,
study protocol, and documentation of any deviation from the protocol.
Sponsors are required to maintain records including correspondence and
reports concerning the study, records of shipment and disposition,
signed investigator agreements, adverse device effects information,
and, for a nonsignificant risk device study, an explanation of the
nonsignificant risk determination, records of device name and intended
use, study objectives, investigator information, investigational review
board information, and statement on the extent that good manufacturing
practices will be followed.
For a nonsignificant risk device investigation, the investigators'
and sponsors' recordkeeping and reporting burden is reduced. Pertinent
records on the study must be maintained by both parties, and reports
are made to sponsors and institutional review boards (IRBs). Reports
are made to FDA only in certain circumstances, e.g., recall of the
device, the occurrence of unanticipated adverse effects, and as a
consequence of certain IRB actions.
In the Federal Register of June 11, 2019 (84 FR 27139), 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
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Waivers--812.10................. 1 1 1 1 1
IDE Application--812.20, 812.25, 229 1 229 80 18,320
and 812.27.....................
Supplements--812.35 and 812.150. 654 5 3,270 6 19,620
Treatment IDE Applications-- 1 1 1 120 120
812.36(c)......................
Treatment IDE Reporting-- 1 1 1 20 20
812.36(f)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 38,081
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 53450]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140............... 229 1 229 10 2,290
Supplemental--812.140........... 654 5 3,270 1 3,270
Nonsignificant--812.140......... 356 1 356 6 2,136
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,696
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk Studies--812.150................... 1 1 1 6 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall decrease of 528 hours. We attribute this adjustment to a
decrease in the number of submissions we received over the last few
years.
Dated: September 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21785 Filed 10-4-19; 8:45 am]
BILLING CODE 4164-01-P
