Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations; Public Workshop, 25281-25282 [2019-11411]
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Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices
Estimated Total Annual Burden
Hours: 3,149,174.
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. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 9836A.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–11370 Filed 5–30–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
Improving the Implementation of RiskBased Monitoring Approaches of
Clinical Investigations; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, we) is
announcing the following pubic
workshop entitled ‘‘Improving the
Implementation of Risk-Based
Monitoring Approaches of Clinical
Investigations.’’ This public workshop is
convened by Duke University’s Robert J.
Margolis, MD, Center for Health Policy
and supported by a cooperative
agreement with FDA. The purpose of
the public workshop is to capture
stakeholder experiences with risk-based
approaches to monitoring of clinical
investigations and gather stakeholder
input on opportunities to further the
implementation of risk-based
approaches to monitoring.
DATES: The public workshop will be
held on July 17, 2019, from 8:30 a.m. to
5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Marriott Marquis
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:42 May 30, 2019
Jkt 247001
Washington, DC at 901 Massachusetts
Ave. NW, in Washington DC. For
additional travel and hotel information,
please refer to the following website:
https://healthpolicy.duke.edu/events/
improving-implementation-risk-basedmonitoring-approaches-clinical-trials.
There will also be a live webcast for
those unable to attend the meeting in
person (see Streaming Webcast of the
Public Workshop).
FOR FURTHER INFORMATION CONTACT:
Raymond Chiang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2232,
Silver Spring, MD 20993, 301–796–
1940, Raymond.Chiang@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
To support greater implementation of
risk-based approaches to monitoring
(RBM) of clinical investigations, FDA
issued draft guidance for industry in
March 15, 2019 (84 FR 9531) entitled ‘‘A
Risk-Based Approach to Monitoring of
Clinical Investigations: Questions and
Answers, ‘‘ which is available at https://
www.fda.gov/media/121479/download.
This draft guidance expands on the
guidance for industry entitled,
‘‘Oversight of Clinical Investigations—A
Risk-Based Approach to Monitoring’’
(August 2013) by providing additional
guidance to facilitate sponsors’
implementation of risk-based
monitoring.
Traditionally, sponsors and research
organizations have depended upon onsite monitoring and 100 percent source
data verification for each clinical site,
an approach that is resource intensive
and may contribute to increased clinical
trial costs. Adoption of RBM could lead
to improvements to human subject
protections, data integrity, and the
efficiency of clinical investigations.
Data suggest that RBM has not yet
been widely implemented. Therefore,
FDA is seeking additional feedback from
stakeholders on the challenges, barriers,
and enablers that might be impacting
the adoption of RBM. The public
workshop addressed in this document is
being held to capture stakeholder
experiences with risk-based approaches
to monitoring of clinical investigations
and to gather stakeholder input on ways
to improve the implementation of riskbased approaches to monitoring.
II. Topics for Discussion at the Public
Workshop
During the public workshop, speakers
and participants will cover a range of
issues related to implementation of riskbased approaches to monitoring. Topics
PO 00000
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Fmt 4703
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25281
for discussion will include, and are not
limited to, challenges to implementation
of RBM, enablers to support
implementation of RBM, and lessons
learned from strategies employed to
implement RBM.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, complete the registration
form at https://healthpolicy.duke.edu/
events/improving-implementation-riskbased-monitoring-approaches-clinicaltrials. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register online by July 16, 2019, by 5
p.m. Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
registered. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact the
Duke-Margolis Center for Health Policy
(phone: 202–791–9561, email:
margolisevents@duke.edu) no later than
July 10, 2019.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast and archived video
footage will be available at the event
website. Persons interested in viewing
the live webcast are encouraged to
register in advance (see Registration).
The live webcast will also be available
at the website above on the day of the
event without preregistration.
Registered webcast participants will be
sent technical system requirements in
advance of the event. It is recommended
that you review these technical system
requirements prior to joining the
streaming webcast of the public
workshop.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and will
be publicly available at the DukeMargolis Center for Health Policy
website: https://healthpolicy.duke.edu/
E:\FR\FM\31MYN1.SGM
31MYN1
25282
Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices
events/improving-implementation-riskbased-monitoring-approaches-clinicaltrials.
Transcripts: Please be advised that
transcripts of the public workshop will
not be available.
Dated: May 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11411 Filed 5–30–19; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–0032]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
Food and Drug Administration,
HHS.
ACTION:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food Labeling; Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Notice.
The Food and Drug
Administration (FDA or we) 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 July 1,
2019.
SUMMARY:
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 0910–0331. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
OMB Control Number 0910–0331—
Extension
Section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 343(r)(6)) and § 101.93 (21 CFR
101.93) of our regulations require that,
no later than 30 days after the first
marketing, we be notified by the
manufacturer, packer, or distributor of a
dietary supplement that it is marketing
a dietary supplement product that bears
on its label or in its labeling a statement
provided for in section 403(r)(6) of the
FD&C Act. In accordance with these
requirements, submissions must
include: (1) The name and address of
the manufacturer, packer, or distributor
of the dietary supplement product; (2)
the text of the statement that is being
made; (3) the name of the dietary
ingredient or supplement that is the
subject of the statement; (4) the name of
the dietary supplement (including the
brand name); and (5) the signature of a
responsible individual or the person
who can certify the accuracy of the
information presented, and who must
certify that the information contained in
the notice is complete and accurate, and
that the notifying firm has
substantiation that the statement is
truthful and not misleading.
Our electronic form (Form FDA 3955)
allows respondents to the information
collection to electronically submit
notifications to FDA via an electronic
system. We are upgrading our current
system (the FDA Unified Registration
Listing System known as FURLS) to
deploy the Food Applications
Regulatory Management (FARM)
system. FARM is modeled after FURLS
and collects the same information, but
improves our operational efficiency. A
web link of the FARM system can be
found here: https://www.fda.gov/Food/
DietarySupplements/IndustryInfo/
ucm485532.htm. Firms that prefer to
submit a paper notification in a format
of their own choosing still have the
option to do so; however, Form FDA
3955 prompts respondents to include
certain elements in their structure/
function claim notification (SFCN)
described in § 101.93 in a standard
electronic format and helps respondents
organize their SFCN to include only the
information needed for our review of
the claim. Note that the SFCN, whether
electronic or paper, is used for all
claims made pursuant to section
403(r)(6) of the FD&C Act, including
nutrient deficiency claims and general
well-being claims in addition to
structure/function claims. The
electronic form, and any optional
elements prepared as attachments to the
form (e.g., label), can be submitted in
electronic format. Submissions of
SFCNs will continue to be allowed in
paper format. We use this information to
evaluate whether statements made for
dietary ingredients or dietary
supplements are permissible under
section 403(r)(6) of the FD&C Act.
In the Federal Register of February 7,
2019 (84 FR 2528), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKBBV9HB2PROD with NOTICES
101.93 ...............................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR Section
3,690
Total annual
responses
1
3,690
Average burden per response
0.75 (45 minutes) .............................
Total hours
2,767.5
are no capital costs or operating and maintenance costs associated with this collection of information.
Our burden estimate reflects an
overall increase of 1,117.5 hours (from
1,650 hours) and a corresponding
increase of 1,490 responses (from 2,200
VerDate Sep<11>2014
16:42 May 30, 2019
Jkt 247001
responses). We attribute this adjustment
to an increase in the average number of
notification submissions we received
over the preceding 12 months, which
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
we expect will continue over the next 3
years. We believe gathering information
to satisfy the notification requirements
of section 403(r)(6) of the FD&C Act by
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25281-25282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0001]
Improving the Implementation of Risk-Based Monitoring Approaches
of Clinical Investigations; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we) is announcing the
following pubic workshop entitled ``Improving the Implementation of
Risk-Based Monitoring Approaches of Clinical Investigations.'' This
public workshop is convened by Duke University's Robert J. Margolis,
MD, Center for Health Policy and supported by a cooperative agreement
with FDA. The purpose of the public workshop is to capture stakeholder
experiences with risk-based approaches to monitoring of clinical
investigations and gather stakeholder input on opportunities to further
the implementation of risk-based approaches to monitoring.
DATES: The public workshop will be held on July 17, 2019, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at the Marriott Marquis
Washington, DC at 901 Massachusetts Ave. NW, in Washington DC. For
additional travel and hotel information, please refer to the following
website: https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. There will also be a
live webcast for those unable to attend the meeting in person (see
Streaming Webcast of the Public Workshop).
FOR FURTHER INFORMATION CONTACT: Raymond Chiang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2232, Silver Spring, MD 20993, 301-796-
1940, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
To support greater implementation of risk-based approaches to
monitoring (RBM) of clinical investigations, FDA issued draft guidance
for industry in March 15, 2019 (84 FR 9531) entitled ``A Risk-Based
Approach to Monitoring of Clinical Investigations: Questions and
Answers, `` which is available at https://www.fda.gov/media/121479/download. This draft guidance expands on the guidance for industry
entitled, ``Oversight of Clinical Investigations--A Risk-Based Approach
to Monitoring'' (August 2013) by providing additional guidance to
facilitate sponsors' implementation of risk-based monitoring.
Traditionally, sponsors and research organizations have depended
upon on-site monitoring and 100 percent source data verification for
each clinical site, an approach that is resource intensive and may
contribute to increased clinical trial costs. Adoption of RBM could
lead to improvements to human subject protections, data integrity, and
the efficiency of clinical investigations.
Data suggest that RBM has not yet been widely implemented.
Therefore, FDA is seeking additional feedback from stakeholders on the
challenges, barriers, and enablers that might be impacting the adoption
of RBM. The public workshop addressed in this document is being held to
capture stakeholder experiences with risk-based approaches to
monitoring of clinical investigations and to gather stakeholder input
on ways to improve the implementation of risk-based approaches to
monitoring.
II. Topics for Discussion at the Public Workshop
During the public workshop, speakers and participants will cover a
range of issues related to implementation of risk-based approaches to
monitoring. Topics for discussion will include, and are not limited to,
challenges to implementation of RBM, enablers to support implementation
of RBM, and lessons learned from strategies employed to implement RBM.
III. Participating in the Public Workshop
Registration: To register for the public workshop, complete the
registration form at https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register online by July 16, 2019, by 5 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
registered. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact the Duke-Margolis Center for Health Policy (phone: 202-791-
9561, email: [email protected]) no later than July 10, 2019.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast and archived video footage will be available at the
event website. Persons interested in viewing the live webcast are
encouraged to register in advance (see Registration). The live webcast
will also be available at the website above on the day of the event
without preregistration. Registered webcast participants will be sent
technical system requirements in advance of the event. It is
recommended that you review these technical system requirements prior
to joining the streaming webcast of the public workshop.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
Meeting Materials: All event materials will be provided to
registered attendees via email prior to the workshop and will be
publicly available at the Duke-Margolis Center for Health Policy
website: https://healthpolicy.duke.edu/
[[Page 25282]]
events/improving-implementation-risk-based-monitoring-approaches-
clinical-trials.
Transcripts: Please be advised that transcripts of the public
workshop will not be available.
Dated: May 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11411 Filed 5-30-19; 8:45 am]
BILLING CODE 4164-01-P
