National Institute of Arthritis and Musculoskeletal and Skin Diseases; Amended Notice of Meeting, 25063 [2019-11206]
Download as PDF
<![CDATA[
25063
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices
6. User and nonuser perception data
summary; and
7. Investigational plans for studies
and surveillance of the tobacco product,
including a summary of proposed study
protocols containing the following
information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/
exclusion criteria, comparison group(s));
e. Human subject protection
information, including Institutional
Review Board information;
f. Primary and secondary endpoints
(definition and success criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline
and follow up assessments, and
j. Data analysis plan(s).
The purpose of the information
package is to provide Agency staff the
opportunity to adequately prepare for
the meeting, including the review of
relevant data concerning the product. In
the Agency’s experience, reviewing
such information is critical to achieving
a productive meeting. If the information
package was previously submitted in
the meeting request, it should be
revised, as applicable, so that the
information reflects the most current
and accurate information available.
In the Federal Register of September
12, 2018 (83 FR 46174), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Three comments were
received; however, none were PRA
related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Meeting Requests
Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers ..........................
83
1
83
10
830
Meeting Information Packages
Combining and Submitting Meeting Information Packages
for Manufacturers, Importers, and Researchers ..............
83
1
83
18
1,494
Total ..............................................................................
........................
........................
........................
........................
2,324
jbell on DSK3GLQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents for meeting requests in
table 1 is based on the number of
meeting requests received and projected
over the next 3 years. FDA estimates
that 83 preapplication meetings will be
requested.
The hours per response for combining
and sending meeting request letters are
estimated at 10 hours each, and the total
burden hours for meeting requests are
expected to be 830 hours. Based on
FDA’s experience, the Agency expects it
will take respondents this amount of
time to prepare, gather, copy, and
submit brief statements about the
product and a description of the
purpose and details of the meeting.
FDA estimates that 83 respondents
will compile meeting information
packages and submit to FDA at 18 hours
per response. Based on FDA’s
experience, the Agency expects that it
will take respondents, collectively,
1,494 hours (83 respondents × 18 hours)
to gather, copy, and submit brief
statements about the product, a
description of the details of the
anticipated meeting, and data and
information that generally would
already have been generated for the
planned research and/or product
development.
VerDate Sep<11>2014
18:08 May 29, 2019
Jkt 247001
The total number of burden hours for
this collection of information is
estimated to be 2,324 hours (830 hours
to prepare and submit meeting requests
and 1,494 hours to prepare and submit
information packages).
Our estimated burden for the
information collection reflects an
overall increase of 16 respondents and
448 hours. We attribute this adjustment
to an increase in the number of industry
meetings as the premarket tobacco
application compliance deadlines will
come due in the next 3 years.
Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11225 Filed 5–29–19; 8:45 am]
BILLING CODE 4164–01–P
published in the Federal Register on
May 20, 2019, 84 FR 22866.
This notice is being amended to
update location information to Hyatt
Regency Bethesda, One Bethesda Metro
Center, Bethesda, MD 20814. The date
and time will remain the same. This
meeting is closed to the public.
Dated: May 23, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–11206 Filed 5–29–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Amended Notice of Meeting
National Institutes of Health
Notice is hereby given of a change in
the meeting of the National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel, which
was published in the Federal Register
on May 20, 2019, 84 FR 22870.
The meeting date, time and place
remain the same. This notice is
amended to update contact
information—Dr. Kathy Salaita, Chief,
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Arthritis and
Musculoskeletal and Skin Diseases
Special Grants Review Committee, June
18, 2019 to June 19, 2019, which was
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Page 25063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin
Diseases; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the Arthritis
and Musculoskeletal and Skin Diseases Special Grants Review Committee,
June 18, 2019 to June 19, 2019, which was published in the Federal
Register on May 20, 2019, 84 FR 22866.
This notice is being amended to update location information to
Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814.
The date and time will remain the same. This meeting is closed to the
public.
Dated: May 23, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-11206 Filed 5-29-19; 8:45 am]
BILLING CODE 4140-01-P
