Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products, 25062-25063 [2019-11225]
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25062
Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: May 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11295 Filed 5–29–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 1,
2019.
DATES:
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 0910–0731. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
jbell on DSK3GLQ082PROD with NOTICES
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.
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:
VerDate Sep<11>2014
18:08 May 29, 2019
Jkt 247001
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products
OMB Control Number 0910–0731—
Extension
The Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31)
offers tobacco product manufacturers
several pathways to obtain an order
from FDA to authorize the marketing of
a new tobacco product before it may be
introduced or delivered into interstate
commerce. To provide assistance with
these pathways to market products, FDA
will meet with tobacco product
manufacturers, importers, researchers,
and investigators (or their
representatives) when appropriate as
described in Guidance on Meetings with
Industry and Investigators on the
Research and Development of Tobacco
Products. This guidance is intended to
assist persons who seek meetings with
FDA relating to their research to inform
the regulation of tobacco products, or to
support the development or marketing
of tobacco products. The original
guidance issued in 2012 was revised for
updating and clarity in July 2016.
In the guidance, the Agency
discusses, among other things:
• What information FDA
recommends persons include in a
meeting request;
• How and when to submit a request;
and
• What information FDA
recommends persons submit prior to a
meeting.
This guidance describes two
collections of information: (1) The
submission of a meeting request
containing certain information and (2)
the submission of an information
package in advance of the meeting. The
purpose of this proposed information
collection is to allow FDA to conduct
meetings with tobacco manufacturers,
importers, researchers, and investigators
in an effective and efficient manner.
FDA issued this guidance and the
revisions consistent with FDA’s good
guidance practices regulations (21 CFR
10.115).
Meeting Requests: The guidance sets
forth FDA’s recommendations for
materials to be included in a request for
a meeting with FDA to discuss the
research and development of tobacco
products. In the guidance, FDA
recommends that the following
information be included in the meeting
request:
1. Product name and FDA-assigned
Submission Tracking Number (if
applicable);
2. Product category (e.g., cigarettes,
smokeless tobacco) (if applicable);
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
3. Product use (indicate for consumer
use or for further manufacturing);
4. Contact information for the
authorized point of contact for the
company requesting the meeting;
5. The topic of the meeting being
requested (e.g., a new tobacco product
application, an application for
permission to market a modified risk
tobacco product, or investigational use
of a new tobacco product);
6. A brief statement of the purpose of
the meeting, which could include a
discussion of the types of studies or data
to be discussed at the meeting, the
general nature of the primary questions
to be asked, and where the meeting fits
in the overall product development
plans;
7. A preliminary list of the specific
objectives/outcomes expected from the
meeting;
8. A preliminary proposed agenda,
including an estimate of the time
needed and a designated speaker for
each agenda item;
9. A preliminary list of specific
questions, grouped by discipline (e.g.,
chemistry, clinical, nonclinical);
10. A list of all individuals who will
attend the meeting on behalf of the
tobacco product manufacturer, importer,
researcher, or investigator, including
titles and responsibilities;
11. The date on which the meeting
information package will be received by
FDA; and
12. Suggested format of the meeting
(e.g., conference call, in-person meeting
at FDA offices, video conference, or
written response) and suggested dates
and times for the meeting. Meetings are
usually scheduled for 1 hour.
This information will be used by the
Agency to: (1) Determine the utility of
the meeting, (2) identify Agency staff
necessary to discuss proposed agenda
items, and (3) schedule the meeting.
Meeting Information Packages: An
individual submitting a meeting
information package to FDA in advance
of a meeting should provide summary
information relevant to the product and
supplementary information pertaining
to any issue raised by the individual or
FDA to be discussed at the meeting. As
stated in the guidance, FDA
recommends that meeting information
packages generally include updates of
information that was submitted with the
meeting request and, as applicable:
1. Product composition and design
data summary;
2. Manufacturing and process control
data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data
summary;
E:\FR\FM\30MYN1.SGM
30MYN1
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
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E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Pages 25062-25063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11225]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Meetings
With Industry and Investigators on the Research and Development of
Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 (PRA).
DATES: Fax written comments on the collection of information by July 1,
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 0910-0731.
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.
Guidance on Meetings With Industry and Investigators on the Research
and Development of Tobacco Products
OMB Control Number 0910-0731--Extension
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) offers tobacco product manufacturers several pathways to obtain an
order from FDA to authorize the marketing of a new tobacco product
before it may be introduced or delivered into interstate commerce. To
provide assistance with these pathways to market products, FDA will
meet with tobacco product manufacturers, importers, researchers, and
investigators (or their representatives) when appropriate as described
in Guidance on Meetings with Industry and Investigators on the Research
and Development of Tobacco Products. This guidance is intended to
assist persons who seek meetings with FDA relating to their research to
inform the regulation of tobacco products, or to support the
development or marketing of tobacco products. The original guidance
issued in 2012 was revised for updating and clarity in July 2016.
In the guidance, the Agency discusses, among other things:
What information FDA recommends persons include in a
meeting request;
How and when to submit a request; and
What information FDA recommends persons submit prior to a
meeting.
This guidance describes two collections of information: (1) The
submission of a meeting request containing certain information and (2)
the submission of an information package in advance of the meeting. The
purpose of this proposed information collection is to allow FDA to
conduct meetings with tobacco manufacturers, importers, researchers,
and investigators in an effective and efficient manner. FDA issued this
guidance and the revisions consistent with FDA's good guidance
practices regulations (21 CFR 10.115).
Meeting Requests: The guidance sets forth FDA's recommendations for
materials to be included in a request for a meeting with FDA to discuss
the research and development of tobacco products. In the guidance, FDA
recommends that the following information be included in the meeting
request:
1. Product name and FDA-assigned Submission Tracking Number (if
applicable);
2. Product category (e.g., cigarettes, smokeless tobacco) (if
applicable);
3. Product use (indicate for consumer use or for further
manufacturing);
4. Contact information for the authorized point of contact for the
company requesting the meeting;
5. The topic of the meeting being requested (e.g., a new tobacco
product application, an application for permission to market a modified
risk tobacco product, or investigational use of a new tobacco product);
6. A brief statement of the purpose of the meeting, which could
include a discussion of the types of studies or data to be discussed at
the meeting, the general nature of the primary questions to be asked,
and where the meeting fits in the overall product development plans;
7. A preliminary list of the specific objectives/outcomes expected
from the meeting;
8. A preliminary proposed agenda, including an estimate of the time
needed and a designated speaker for each agenda item;
9. A preliminary list of specific questions, grouped by discipline
(e.g., chemistry, clinical, nonclinical);
10. A list of all individuals who will attend the meeting on behalf
of the tobacco product manufacturer, importer, researcher, or
investigator, including titles and responsibilities;
11. The date on which the meeting information package will be
received by FDA; and
12. Suggested format of the meeting (e.g., conference call, in-
person meeting at FDA offices, video conference, or written response)
and suggested dates and times for the meeting. Meetings are usually
scheduled for 1 hour.
This information will be used by the Agency to: (1) Determine the
utility of the meeting, (2) identify Agency staff necessary to discuss
proposed agenda items, and (3) schedule the meeting.
Meeting Information Packages: An individual submitting a meeting
information package to FDA in advance of a meeting should provide
summary information relevant to the product and supplementary
information pertaining to any issue raised by the individual or FDA to
be discussed at the meeting. As stated in the guidance, FDA recommends
that meeting information packages generally include updates of
information that was submitted with the meeting request and, as
applicable:
1. Product composition and design data summary;
2. Manufacturing and process control data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data summary;
[[Page 25063]]
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
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests
----------------------------------------------------------------------------------------------------------------
Combining and Sending Meeting 83 1 83 10 830
Request Letters for
Manufacturers, Importers, and
Researchers....................
----------------------------------------------------------------------------------------------------------------
Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and Submitting Meeting 83 1 83 18 1,494
Information Packages for
Manufacturers, Importers, and
Researchers....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,324
----------------------------------------------------------------------------------------------------------------
\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 x 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.
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
