80 FR 55855 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 180 (September 17, 2015)

Page Range		55855-55857
FR Document		2015-23332

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's meetings with tobacco manufacturers, importers, researchers, and/or investigators relating to their plans to conduct research to inform the regulation of tobacco products, or support the development or marketing of tobacco products.

Federal Register, Volume 80 Issue 180 (Thursday, September 17, 2015)

[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55855-55857]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-23332]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0429]

Agency Information Collection Activities; Proposed Collection;
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on FDA's meetings with tobacco
manufacturers, importers, researchers, and/or investigators relating to
their plans to conduct research to inform the regulation of tobacco
products, or support the development or marketing of tobacco products.

DATES: Submit either electronic or written comments on the collection
of information by November 16, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use

[[Page 55856]]

of automated collection techniques, when appropriate, and other forms
of information technology.

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 tobacco product before
it may be introduced or delivered into interstate commerce. To provide
assistance with these pathways to market particular products, FDA will
meet with tobacco product manufacturers, importers, researchers, and
investigators (or their representatives) when appropriate. 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. 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 as a level 2 guidance consistent with FDA's good guidance
practices regulations (21 CFR 10.115).
Meeting Requests: Section IV.E of 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;
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 draft list of the specific objectives/outcomes expected from
the meeting;
8. A preliminary proposed agenda, including estimated amounts of
time needed for each agenda item and designated speaker(s);
9. A draft list of specific questions, grouped by discipline (e.g.,
chemistry, clinical, nonclinical);
10. A list of all individuals (including titles and
responsibilities) who will attend the meeting on behalf of the tobacco
product manufacturer, importer, researcher, or investigator;
11. The approximate date on which supporting documentation (i.e.,
the meeting information package) will likely be received by FDA; and
12. Suggested dates and times for the meeting (note that generally
a meeting will be 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 section IV.K of the guidance,
FDA recommends that meeting information packages generally include
updated information from the meeting request (see items 1 through 8 in
section III.A of this document) and:
1. Product composition and design (as applicable);
2. Manufacturing and process control data summary (as applicable);
3. Nonclinical data summary (as applicable);
4. Clinical data summary (as applicable);
5. Behavioral and product use data summary (as applicable);
6. User and nonuser perception data summary (as applicable); 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. For the information that was previously submitted
in the meeting request, the information package should provide updated
information that reflects the most current and accurate information
available.
Description of Respondents: The respondents to this collection of
information are manufacturers, importers, researchers, and
investigators of tobacco products who seek to meet with FDA to discuss
their plans regarding the development or marketing of a tobacco
product.
FDA estimates the burden of this collection of information as
follows:

[[Page 55857]]

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 67 1 67 10 670
Request Letters for
Manufacturers, Importers, and
Researchers....................
----------------------------------------------------------------------------------------------------------------
Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and Submitting Meeting 67 1 67 18 1,206
Information Packages for
Manufacturers, Importers, and
Researchers....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,876
----------------------------------------------------------------------------------------------------------------
\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 of this document is based on the number of meeting requests to
be received over the next 3 years.
In the next three years of this collection, FDA estimates that 67
pre-application meetings will be requested. The number is not expected
to change, as the public is more experienced in submitting applications
for substantial equivalence, requests for non-substantial equivalence,
etc.
Thus, FDA estimates the number of manufacturers, importers,
researchers, and investigators who are expected to submit meeting
requests in Table 1 of this document to be 67 (50 year 1 requests + 100
year 2 requests + 50 year 3 requests divided by 3). The hours per
response, which is the estimated number of hours that a respondent
would spend preparing the information recommended by this guidance to
be submitted with a meeting request is estimated to be approximately 10
hours each, and the total burden hours are 670 hours (10 hours
preparation/mailing times 67 average respondents per year). 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's estimate of the number of respondents for compiling meeting
information packages in Table 1 of this document is based on 67
respondents each preparing copies of their information package and
submitting them to FDA, for a total of 1,206 hours annually. The hours
per response, which is the estimated number of hours that a respondent
would spend preparing the information package as recommended by the
guidance, is estimated to be approximately 18 hours per information
package. Based on FDA's experience, the Agency expects that it will
take respondents 1,206 hours of time (67 respondents times 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 1,876 hours (67 hours to prepare and submit meeting requests and
1,206 hours to prepare and submit information packages).

Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23332 Filed 9-16-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55855

certification from its national taxing official seal of the national taxing prospective applicants understand what
authority, the foreign equivalent of our authority. they need to do to meet the small
Internal Revenue Service. This Both Forms FDA 3602 and FDA business criteria for FY 2016.
certification, referred to as a ‘‘National 3602A are available in the guidance The estimated burden is based on the
Taxing Authority Certification’’, must: document, ‘‘FY 2016 Medical Device number of applications received in the
Be in English; be from the national User Fee Small Business Qualification last 3 years and includes time required
taxing authority of the country in which and Certification; Guidance for Industry, to collect the required information.
the business is headquartered; provide Food and Drug Administration Staff, Based on our experience with Form
the business’ gross receipts or sales for and Foreign Governments’’ available on FDA 3602, FDA believes it will take
the most recent year, in both the local the Internet at: http://www.fda.gov/ucm/ each respondent 1 hour to complete the
currency and in U.S. dollars, and the groups/fdagov-public/@fdagov-meddev- form. Based on our experience with
exchange rate used in converting local gen/documents/document/ Form FDA 3602A, FDA also believes
ucm456779.pdf. This guidance that it will take each respondent 1 hour
currency to U.S. dollars; provide the
describes the criteria FDA will use to to complete.
dates during which the reported receipts
decide whether an entity qualifies as a FDA estimates the burden of this
or sales were collected; and bear the MDUFMA small business and will help collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average bur-
Number of Total annual
FDA form no. responses per den per re- Total hours
respondents responses
respondent sponse

FDA 3602—FY 2016 MDUFA Small Business Qualification
and Certification For a Business Headquartered in the
United States .................................................................... 3,600 1 3,600 1 3,600
FDA 3602A—FY 2016 MDUFA Foreign Small Business
Qualification and Certification For a Business
Headquartered Outside the United States ....................... 1,400 1 1,400 1 1,400

Total .............................................................................. ........................ ........................ ........................ ........................ 5,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: September 11, 2015. public comment in response to the information they conduct or sponsor.
Leslie Kux, notice. This notice solicits comments on ‘‘Collection of information’’ is defined
Associate Commissioner for Policy. FDA’s meetings with tobacco in 44 U.S.C. 3502(3) and 5 CFR
[FR Doc. 2015–23331 Filed 9–16–15; 8:45 am] manufacturers, importers, researchers, 1320.3(c) and includes Agency requests
BILLING CODE 4164–01–P
and/or investigators relating to their or requirements that members of the
plans to conduct research to inform the public submit reports, keep records, or
regulation of tobacco products, or provide information to a third party.
DEPARTMENT OF HEALTH AND support the development or marketing Section 3506(c)(2)(A) of the PRA (44
HUMAN SERVICES of tobacco products. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or Agencies to provide a 60-day notice in
Food and Drug Administration written comments on the collection of the Federal Register concerning each
information by November 16, 2015. proposed collection of information,
[Docket No. FDA–2012–D–0429]
ADDRESSES: Submit electronic
including each proposed extension of an
Agency Information Collection comments on the collection of existing collection of information,
Activities; Proposed Collection; information to http:// before submitting the collection to OMB
Comment Request; Guidance on www.regulations.gov. Submit written for approval. To comply with this
Meetings With Industry and comments on the collection of requirement, FDA is publishing notice
Investigators on the Research and information to the Division of Dockets of the proposed collection of
Development of Tobacco Products Management (HFA–305), Food and Drug information set forth in this document.
With respect to the following
Administration, 5630 Fishers Lane, Rm.
AGENCY: Food and Drug Administration, collection of information, FDA invites
1061, Rockville, MD 20852. All
HHS. comments on these topics: (1) Whether
comments should be identified with the
ACTION: Notice. the proposed collection of information
docket number found in brackets in the
is necessary for the proper performance
heading of this document.
SUMMARY: The Food and Drug of FDA’s functions, including whether
Administration (FDA) is announcing an FOR FURTHER INFORMATION CONTACT: FDA the information will have practical
opportunity for public comment on the PRA Staff, Office of Operations, Food utility; (2) the accuracy of FDA’s
proposed collection of certain and Drug Administration, 8455 estimate of the burden of the proposed
information by the Agency. Under the Colesville Rd., COLE–14526, Silver collection of information, including the
Spring, MD 20993–0002, PRAStaff@
tkelley on DSK3SPTVN1PROD with NOTICES

Paperwork Reduction Act of 1995 (the validity of the methodology and
PRA), Federal Agencies are required to fda.hhs.gov. assumptions used; (3) ways to enhance
publish notice in the Federal Register SUPPLEMENTARY INFORMATION: Under the the quality, utility, and clarity of the
concerning each proposed collection of PRA (44 U.S.C. 3501–3520), Federal information to be collected; and (4)
information, including each proposed Agencies must obtain approval from the ways to minimize the burden of the
extension of an existing collection of Office of Management and Budget collection of information on
information, and to allow 60 days for (OMB) for each collection of respondents, including through the use

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55856 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices

of automated collection techniques, following information be included in updated information from the meeting
when appropriate, and other forms of the meeting request: request (see items 1 through 8 in section
information technology. 1. Product name and FDA-assigned III.A of this document) and:
Submission Tracking Number (if 1. Product composition and design (as
Guidance on Meetings With Industry
applicable); applicable);
and Investigators on the Research and 2. Product category (e.g., cigarettes,
Development of Tobacco Products 2. Manufacturing and process control
smokeless tobacco) (if applicable); data summary (as applicable);
(OMB Control Number 0910–0731)— 3. Product use (indicate for consumer 3. Nonclinical data summary (as
Extension use or for further manufacturing); applicable);
4. Contact information for the 4. Clinical data summary (as
The Family Smoking Prevention and authorized point of contact for the
Tobacco Control Act (Pub. L. 111–31) applicable);
company requesting the meeting; 5. Behavioral and product use data
offers tobacco product manufacturers 5. The topic of the meeting being
several pathways to obtain an order summary (as applicable);
requested; 6. User and nonuser perception data
from FDA to authorize the marketing of 6. A brief statement of the purpose of
a tobacco product before it may be summary (as applicable); and
the meeting, which could include a 7. Investigational plans for studies
introduced or delivered into interstate discussion of the types of studies or data
commerce. To provide assistance with and surveillance of the tobacco product,
to be discussed at the meeting, the including a summary of proposed study
these pathways to market particular general nature of the primary questions
products, FDA will meet with tobacco protocols containing the following
to be asked, and where the meeting fits information (as applicable):
product manufacturers, importers, in the overall product development
researchers, and investigators (or their a. Study objective(s),
plans;
representatives) when appropriate. This b. Study hypotheses,
7. A draft list of the specific
guidance is intended to assist persons c. Study design,
objectives/outcomes expected from the
who seek meetings with FDA relating to meeting; d. Study population (inclusion/
their research to inform the regulation of 8. A preliminary proposed agenda, exclusion criteria, comparison group(s)),
tobacco products, or to support the including estimated amounts of time e. Human subject protection
development or marketing of tobacco needed for each agenda item and information, including Institutional
products. In the guidance, the Agency designated speaker(s); Review Board information,
discusses, among other things: 9. A draft list of specific questions, f. Primary and secondary endpoints
• What information FDA grouped by discipline (e.g., chemistry, (definition and success criteria),
recommends persons include in a clinical, nonclinical); g. Sample size calculation,
meeting request, 10. A list of all individuals (including h. Data collection procedures,
• How and when to submit a request, titles and responsibilities) who will i. Duration of follow up and baseline
and attend the meeting on behalf of the and follow up assessments, and
• What information FDA tobacco product manufacturer, importer, j. Data analysis plan(s).
recommends persons submit prior to a researcher, or investigator; The purpose of the information
meeting. 11. The approximate date on which package is to provide Agency staff the
This guidance describes two supporting documentation (i.e., the opportunity to adequately prepare for
collections of information: (1) The meeting information package) will likely the meeting, including the review of
submission of a meeting request be received by FDA; and relevant data concerning the product. In
containing certain information and (2) 12. Suggested dates and times for the the Agency’s experience, reviewing
the submission of an information meeting (note that generally a meeting such information is critical to achieving
package in advance of the meeting. The will be scheduled for 1 hour). a productive meeting. For the
purpose of this proposed information This information will be used by the information that was previously
collection is to allow FDA to conduct Agency to: (1) Determine the utility of submitted in the meeting request, the
meetings with tobacco manufacturers, the meeting, (2) identify Agency staff information package should provide
importers, researchers, and investigators necessary to discuss proposed agenda updated information that reflects the
in an effective and efficient manner. items, and (3) schedule the meeting. most current and accurate information
FDA issued this guidance as a level 2 Meeting Information Packages: An available.
guidance consistent with FDA’s good individual submitting a meeting Description of Respondents: The
guidance practices regulations (21 CFR information package to FDA in advance respondents to this collection of
10.115). of a meeting should provide summary information are manufacturers,
Meeting Requests: Section IV.E of the information relevant to the product and importers, researchers, and investigators
guidance sets forth FDA’s supplementary information pertaining of tobacco products who seek to meet
recommendations for materials to be to any issue raised by the individual or with FDA to discuss their plans
included in a request for a meeting with FDA to be discussed at the meeting. As regarding the development or marketing
FDA to discuss the research and stated in section IV.K of the guidance, of a tobacco product.
development of tobacco products. In the FDA recommends that meeting FDA estimates the burden of this
guidance, FDA recommends that the information packages generally include collection of information as follows:
tkelley on DSK3SPTVN1PROD with NOTICES

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Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55857

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Meeting Requests

Combining and Sending Meeting Request Letters for Man-
ufacturers, Importers, and Researchers .......................... 67 1 67 10 670

Meeting Information Packages

Combining and Submitting Meeting Information Packages
for Manufacturers, Importers, and Researchers .............. 67 1 67 18 1,206

Total .............................................................................. ........................ ........................ ........................ ........................ 1,876
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA’s estimate of the number of that it will take respondents 1,206 hours existing collection of information, and
respondents for meeting requests in of time (67 respondents times 18 hours) to allow 60 days for public comment in
Table 1 of this document is based on the to gather, copy, and submit brief response to the notice. This notice
number of meeting requests to be statements about the product, a solicits comments on the information
received over the next 3 years. description of the details of the collection provisions of the Notification
In the next three years of this anticipated meeting, and data and Procedure for Substances Generally
collection, FDA estimates that 67 pre- information that generally would Recognized as Safe (GRAS).
application meetings will be requested. already have been generated for the DATES: Submit either electronic or
The number is not expected to change, planned research and/or product written comments on the collection of
as the public is more experienced in development. information by November 16, 2015.
submitting applications for substantial The total number of burden hours for
ADDRESSES: Submit electronic
equivalence, requests for non- this collection of information is 1,876
comments on the collection of
substantial equivalence, etc. hours (67 hours to prepare and submit
information to http://
Thus, FDA estimates the number of meeting requests and 1,206 hours to
www.regulations.gov. Submit written
manufacturers, importers, researchers, prepare and submit information
comments on the collection of
and investigators who are expected to packages).
information to the Division of Dockets
submit meeting requests in Table 1 of Dated: September 11, 2015. Management (HFA–305), Food and Drug
this document to be 67 (50 year 1 Leslie Kux, Administration, 5630 Fishers Lane, Rm.
requests + 100 year 2 requests + 50 year
Associate Commissioner for Policy. 1061, Rockville, MD 20852. All
3 requests divided by 3). The hours per
[FR Doc. 2015–23332 Filed 9–16–15; 8:45 am] comments should be identified with the
response, which is the estimated
BILLING CODE 4164–01–P docket number found in brackets in the
number of hours that a respondent
heading of this document.
would spend preparing the information
recommended by this guidance to be FOR FURTHER INFORMATION CONTACT: FDA
submitted with a meeting request is DEPARTMENT OF HEALTH AND PRA Staff, Office of Operations, Food
estimated to be approximately 10 hours HUMAN SERVICES and Drug Administration, 8455
each, and the total burden hours are 670 Colesville Rd., COLE–14526, Silver
Food and Drug Administration Spring, MD 20993–0002, PRAStaff@
hours (10 hours preparation/mailing
times 67 average respondents per year). [Docket No. FDA–2012–N–0021] fda.hhs.gov.
Based on FDA’s experience, the Agency SUPPLEMENTARY INFORMATION: Under the
expects it will take respondents this Agency Information Collection PRA (44 U.S.C. 3501–3520), Federal
amount of time to prepare, gather, copy, Activities; Proposed Collection; Agencies must obtain approval from the
and submit brief statements about the Comment Request; Substances Office of Management and Budget
product and a description of the Generally Recognized as Safe: (OMB) for each collection of
purpose and details of the meeting. Notification Procedure information they conduct or sponsor.
FDA’s estimate of the number of AGENCY: Food and Drug Administration, ‘‘Collection of information’’ is defined
respondents for compiling meeting HHS. in 44 U.S.C. 3502(3) and 5 CFR
information packages in Table 1 of this ACTION: Notice. 1320.3(c) and includes Agency requests
document is based on 67 respondents or requirements that members of the
each preparing copies of their SUMMARY: The Food and Drug public submit reports, keep records, or
information package and submitting Administration (FDA or we) is provide information to a third party.
them to FDA, for a total of 1,206 hours announcing an opportunity for public Section 3506(c)(2)(A) of the PRA (44
annually. The hours per response, comment on the proposed collection of U.S.C. 3506(c)(2)(A)) requires Federal
tkelley on DSK3SPTVN1PROD with NOTICES

which is the estimated number of hours certain information by the Agency. Agencies to provide a 60-day notice in
that a respondent would spend Under the Paperwork Reduction Act of the Federal Register concerning each
preparing the information package as 1995 (the PRA), Federal Agencies are proposed collection of information,
recommended by the guidance, is required to publish notice in the including each proposed extension of an
estimated to be approximately 18 hours Federal Register concerning each existing collection of information,
per information package. Based on proposed collection of information, before submitting the collection to OMB
FDA’s experience, the Agency expects including each proposed extension of an for approval. To comply with this

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Document Created: 2015-12-15 09:34:13
Document Modified: 2015-12-15 09:34:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by November 16, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 55855

80 FR 55855 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 180 (September 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration