Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding pH of Smokeless Tobacco Products, 42797-42800 [2014-17294]
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Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices
0920–0212) and the National Hospital
Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920–0278) may
investigate the addition of facility and
patient information especially as it
relates to insurance and electronic
medical records.
Discussion is underway with the
DHHS Office of Minority Health on the
possibility of conducting a study to
collect data on the awareness, adoption
and implementation of the Enhanced
National Standards on Culturally and
Linguistically Appropriate Services
(CLAS) in physician offices. The study
may be preceded by a feasibility study.
The National Health Care Surveys
collect critical, accurate data that are
used to produce reliable national
estimates—and in recent years, statelevel estimates—of clinical services and
of the providers who delivered those
services in inpatient, outpatient,
ambulatory, and long-term care settings.
The data from these surveys are used by
providers, policy makers and
researchers to address important topics
of interest, including the quality and
disparities of care among populations,
epidemiology of medical conditions,
diffusion of technologies, effects of
policies and practice guidelines, and
changes in health care over time.
Research studies need to be conducted
to improve existing and proposed
survey design and procedures of the
National Health Care Surveys, as well as
to evaluate alternative data collection
approaches particularly due to the
expansion of electronic health record
use, and to develop new sample frames
of currently out-of-scope providers and
settings of care. There is no cost to
respondents other than their time to
participate. Average burdens are
designed to cover 15–40 min interviews
as well as 90 minute focus groups,
longer on-site visits, and situations
where organizations may be preparing
electronic data files. The total estimated
annualized burden is 7,085 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Health Care Providers and Business entities
Health Care Providers,State/local government
agencies, and business entities.
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–17328 Filed 7–22–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1009]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information
Request Regarding pH of Smokeless
Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 and to allow 60 days for
public comment in response to the
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SUMMARY:
VerDate Mar<15>2010
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Jkt 232001
Number of
respondents
Form name
Interviews, surveys,
ments (in person,
electronic mail).
Interviews, surveys,
ments (in person,
electronic mail).
6,667
1
1
focus groups, experiphone, internet, postal/
167
1
2.5
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
SUPPLEMENTARY INFORMATION:
Frm 00043
Average
burden per
response
(in hours)
focus groups, experiphone, internet, postal/
notice. This notice solicits comments on
the collection of information regarding
pH of smokeless tobacco products.
DATES: Submit either electronic or
written comments on the collection of
information by September 22, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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.
PO 00000
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
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
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
of automated collection techniques,
when appropriate, and other forms of
information technology.
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mstockstill on DSK4VPTVN1PROD with NOTICES
Information Request Regarding pH of
Smokeless Tobacco Products (OMB
Control Number 0910–NEW)
On June 22, 2009, President Obama
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by granting FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect the public health
generally and to reduce tobacco use by
minors.
Section 904(b) of the FD&C Act (21
U.S.C. 387d(b)) states that at the request
of the Secretary, each tobacco product
manufacturer or importer, or agents
thereof, must submit:
• Any or all documents (including
underlying scientific information)
relating to research activities, and
research findings, conducted,
supported, or possessed by the
manufacturer (or agents thereof) on the
health, toxicological, behavioral, or
physiological effects of tobacco products
and their constituents (including smoke
constituents), ingredients, components,
and additives.
• Any or all documents (including
underlying scientific or financial
information) relating to research
activities, and research findings,
conducted, supported, or possessed by
the manufacturer (or agents thereof) that
relate to the issue of whether a
reduction in risk to health from tobacco
products can occur upon the
employment of technology available or
known to the manufacturer.
• Any or all documents (including
underlying scientific or financial
information) relating to marketing
research involving the use of tobacco
products or marketing practices and the
effectiveness of such practices used by
tobacco manufacturers and distributors.
If the Secretary requests information
from the manufacturer of a tobacco
product not manufactured in the United
States, the importer of the tobacco
product is required to supply the
information.
FDA is requesting OMB approval of
an information collection under section
904(b) of the FD&C Act. To become
better informed about the impact of the
use of tobacco products on the public
health, FDA would request information
about the effects of product pH in
smokeless tobacco products from all
tobacco product manufacturers. FDA
would send letters to tobacco product
manufacturers and importers who FDA
has identified as having an obligation to
respond based on information before the
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17:33 Jul 22, 2014
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Agency. The requested information
would include information about
research requested under section 904(b)
of the FD&C Act as well as information
to be provided voluntarily beyond the
inquiries described in section 904(b).
I. Information Requested
The proposed request would include
the following information:
All documents (including underlying
scientific information and financial
information) relating to research
activities, and research findings,
conducted, supported, or possessed by
the respondent or the respondent’s
agents relating to a specified set of
topics listed in this document. The
request includes but is not limited to
documents relating to research findings
and activities, if any, that the
respondent possesses as the result of
acquiring or merging with another
company. For purposes of the request,
‘‘research’’ would include, but would
not be limited to, focus groups, surveys,
experimental clinical studies,
toxicological and biochemical assays, in
vivo and in vitro assays including
animal testing, laboratory formulation
and processing testing, taste panels, and
assessments of the effectiveness of
product marketing practices. The
request would apply to research relating
to any and all smokeless tobacco
products, including but not limited to
those products for research,
investigational use, developmental
studies, test marketing, and/or
commercial marketing, and also to the
components, parts, or accessories of
such products. For products not
manufactured in the United States, the
request would apply to the extent the
respondent has imported such products
into the United States.
II. Topics
Under section 904(b) of the FD&C Act,
FDA would request all documents and
underlying scientific and financial
information relating to research
activities, research findings, and
marketing research for smokeless
tobacco products developed since
January 1, 1970, on the following topics:
• The effect of product pH on ratio of
free/bound (unprotonated/protonated)
nicotine;
• the effect of product pH on user
behavior;
• the effect of product pH on user
subjective effects and experiences
including, but not limited to, sensory
effects in the mouth and throat, liking,
craving and withdrawal symptoms,
stimulation, concentration, and anxiety;
• the effect of product pH on user
physiological responses including, but
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
not limited to, heart rate, blood
pressure, temperature, and nicotine
pharmacokinetics; and
• for smokeless tobacco products that
have a pH of 7.2 or less, marketing
research that includes attractiveness or
appeal to new users, inexperienced
users, and/or to persons under the age
of 25.
Research and development of
methodology for adjusting the pH of
smokeless tobacco products would be
specifically excluded from this 904(b)
request.
III. Limitations on Types of Documents
and Information
With respect to the topics listed, FDA
would request only the following
documents and information:
• Study proposals, protocols
(including all amendments), analysis
plans, agreements, notebooks, data
collection tools, including but not
limited to, forms and assessment scales
for planned, ongoing, or completed
studies, surveys, and other research,
whether for external release or internal
use;
• final data analyses and reports
regarding studies, surveys, data
compilations, or other research, whether
for external or internal use (if there were
no final analyses, interim data analyses
would be included in the request);
• posters and/or presentations
exhibited or to be exhibited at external
meetings or conferences if the
underlying data has not been presented
in other documents and information
within the request;
• manuscripts, articles, editorials,
and letters that have been submitted for
publication but not yet published (e.g.,
in review, accepted, rejected); and
• underlying data (e.g., in the form of
spreadsheets, SAS datasets, charts,
tables, and diagrams) analyzed to
produce any of the data analyses,
reports, posters, manuscripts, or articles
requested previously in this notice.
FDA would request only the final
versions of documents, or in the absence
of a final version, the most recent draft
of each document. Published (i.e.,
publically available) press releases,
abstracts, editorials, letters,
manuscripts, material safety data sheets,
and HHS correspondences, would not
be requested, although FDA would
appreciate a list of such publications
provided as a separate appendix.
Data supporting summary reports
would be included in the request, and
FDA would ask that spreadsheets or
SAS datasets be submitted both in PDF
and in a file type and structured format
that allows for meaningful review and
analysis of the data (e.g., Excel (.xls),
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Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices
comma separated values (.csv), or SAS
transport (.xpt) file formats). Also, FDA
would request relevant data
submissions be accompanied by the
name and version of the software used
to create the file, and names and
definitions of variables and copies of
programs and macros needed to
generate the analyses. FDA would also
ask that respondents include any data
analyses that stratify scientific results by
gender, race, ethnicity, age, or other
similar factors.
Information responsive to the request
that has been previously provided to
FDA under the FD&C Act would not
have to be resubmitted as long as the
document was fully referenced in the
metadata load file. For documents
previously provided to FDA under
section 904(a)(1), 904(a)(3), 904(c)(1),
904(c)(2), or 904(c)(3) of the FD&C Act,
FDA would ask that the respondent
provide the following additional
information in the metadata load file:
The file name and file extension, Bates
number (begin Bates number to end
Bates number) and relevant page
numbers, date of submission, section
under which the document was
submitted, tobacco product brand/
subbrand name, and product
identification number. FDA would also
ask that respondents identify the
presence of each document in the
University of California San Francisco
Legacy Tobacco Documents Library
(LTDL) as one of the following: Present
with the Bates number (begin Bates
number to end Bates number), not
present, or unknown.
IV. Additional Information
FDA would ask the respondent to
submit voluntarily the following
additional information, as applicable, to
provide context and background for
FDA:
• A summary (one to five pages in
length) for each of the topics previously
mentioned in this notice, that includes
the number and type of documents
included, and a high-level overview of
the content and
• an explanation of the scientific and
business reasons, rationale, or
justification for developing and
marketing smokeless tobacco products
with different pH values, including
expected and observed perception and
behavior of current and potential
consumers.
This is a new collection of
information. FDA would use the
information to assess the effects of pH
of smokeless tobacco products on
consumers and the public health.
V. Burden Estimate
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of respondent gathering product pH
information
Tobacco product manufacturers and importers with LTDL collections ...............
Additional tobacco product manufacturers and importers with previous submissions to FDA ...................................
Other manufacturers who have no documents, do not manufacture smokeless
tobacco products, or do not anticipate
manufacturing these products ..............
Total ..................................................
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1 There
Number of
responses per
respondent
Number of
respondents
Average
burden hours
per response
Total annual
responses
Total hours
Total capital
costs
3
1
3
120
360
$29
3
1
3
125
375
186
119
1
119
5
595
59
........................
........................
........................
........................
1,330
274
are no operating and maintenance costs associated with this collection of information.
We estimate the capital costs
associated with this document
submission to be $274. This estimate is
based upon: (1) 3 submissions being
submitted by mailing an average of 10
CDs per envelope ($29); (2) 3
submissions being submitted by mailing
a package of paper documents weighing
an average of 50 pounds total ($186);
and (3) 119 submissions of 1 business
class letter describing that no
documents are available (119 × $0.49
(the price of a first class business
stamp), or $59).
FDA developed its reporting burden
estimates from the expected volume of
documents to be received based upon
broad searches of LTDL, the Agency’s
experience with previous information
collection requests under section 904(b)
of the FD&C Act, and submissions
received as health documents under
section 904(a)(4).
FDA estimates the burden for this
one-time collection of information to be
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1,330 hours. FDA estimates it will
receive 125 submissions. Based upon
the expected number of tobacco product
manufacturers and importers, the
burden has been broken into three tiers:
• FDA anticipates documents for this
request will be submitted by three
tobacco product manufacturers and
importers that have related document
collections within LTDL. Manufacturers
1 through 3 were estimated to take 140,
142, and 80 hours respectively, for an
approximate average of 120 hours per
response, to process and prepare a
submission (i.e., cover letter, documents
and information, and metadata load
file). Total estimated burden hours for
this portion of the collection are
expected to be 360 hours.
• FDA anticipates documents will
also be submitted by three additional
tobacco product manufacturers and
importers that provided health
documents under section 904(a)(4) of
the FD&C Act. Manufacturers 4 through
PO 00000
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Sfmt 4703
6 were estimated to take 194, 96, and 83
hours respectively, for an approximate
average of 125 hours per response, to
process and prepare a submission (i.e.,
cover letter, documents and
information, and metadata load file).
Total estimated burden hours for this
portion of the collection are expected to
be 375 hours.
• FDA estimates that 119
manufacturers and importers will not
have documents responsive to this
request and are estimated to take
approximately 5 hours each to conduct
a review of their records and to draft
and send a letter to FDA indicating that
they do not have documents to submit.
These manufacturers do not have
documents, do not manufacture
smokeless tobacco products, or do not
anticipate manufacturing these tobacco
products. Total estimated burden hours
for this portion of the collection are
expected to be 595 hours.
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Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices
Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2014–17294 Filed 7–22–14; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2007–D–0369]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft and Revised Draft Guidances for
Industry Describing Product-Specific
Bioequivalence Recommendations;
Availability
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[Docket No. FDA–2013–N–1496]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Generic Food and Drug Administration
Rapid Response Surveys
The Food and Drug
Administration (FDA) is announcing the
availability of additional draft and
revised draft product-specific
bioequivalence (BE) recommendations.
The recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site. The BE
recommendations identified in this
notice were developed using the process
described in that guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on these draft
and revised draft guidances before it
begins work on the final versions of the
guidances, submit either electronic or
written comments on the draft and
revised draft product-specific BE
recommendations listed in this notice
by September 22, 2014.
ADDRESSES: Submit written requests for
single copies of the individual BE
guidances to the Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 2201, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance recommendations.
Submit electronic comments on the
draft product-specific BE
recommendations to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
´
Andre, Center for Drug Evaluation and
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Generic FDA Rapid Response Surveys’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On April
23, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Generic FDA Rapid Response
Surveys’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0500. The
approval expires on July 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17292 Filed 7–22–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
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SUMMARY:
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Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, rm. 1615, Silver Spring,
MD 20993–0002, 240–402–7959.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. Under that
process, draft recommendations are
posted on FDA’s Web site and
announced periodically in the Federal
Register. The public is encouraged to
submit comments on those
recommendations within 60 days of
their announcement in the Federal
Register. FDA considers any comments
received, and either publishes final
recommendations or publishes revised
draft recommendations for comment.
Recommendations were last announced
in the Federal Register on April 2, 2014
(79 FR 18561). This notice announces
draft product-specific
recommendations, either new or
revised, that are posted on FDA’s Web
site.
II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing the availability of
a new draft guidance for industry on
product-specific BE recommendations
for drug products containing the
following active ingredients:
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR
DRUG PRODUCTS
A ........
C ........
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Alogliptin benzoate.
Alogliptin benzoate; Metformin hydrochloride (HCl).
Alogliptin benzoate; Pioglitazone
HCl.
Amoxicillin (multiple reference listed
drugs).
Atenolol; Chlorthalidone.
Canagliflozin.
Carbidopa.
Carbinoxamine maleate.
23JYN1
]]>Agencies
[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42797-42800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1009]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Request Regarding pH of Smokeless 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information regarding pH
of smokeless tobacco products.
DATES: Submit either electronic or written comments on the collection
of information by September 22, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://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 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 of automated collection techniques, when
appropriate, and other forms of information technology.
[[Page 42798]]
Information Request Regarding pH of Smokeless Tobacco Products (OMB
Control Number 0910-NEW)
On June 22, 2009, President Obama signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by granting FDA authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
Section 904(b) of the FD&C Act (21 U.S.C. 387d(b)) states that at
the request of the Secretary, each tobacco product manufacturer or
importer, or agents thereof, must submit:
Any or all documents (including underlying scientific
information) relating to research activities, and research findings,
conducted, supported, or possessed by the manufacturer (or agents
thereof) on the health, toxicological, behavioral, or physiological
effects of tobacco products and their constituents (including smoke
constituents), ingredients, components, and additives.
Any or all documents (including underlying scientific or
financial information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer (or
agents thereof) that relate to the issue of whether a reduction in risk
to health from tobacco products can occur upon the employment of
technology available or known to the manufacturer.
Any or all documents (including underlying scientific or
financial information) relating to marketing research involving the use
of tobacco products or marketing practices and the effectiveness of
such practices used by tobacco manufacturers and distributors.
If the Secretary requests information from the manufacturer of a
tobacco product not manufactured in the United States, the importer of
the tobacco product is required to supply the information.
FDA is requesting OMB approval of an information collection under
section 904(b) of the FD&C Act. To become better informed about the
impact of the use of tobacco products on the public health, FDA would
request information about the effects of product pH in smokeless
tobacco products from all tobacco product manufacturers. FDA would send
letters to tobacco product manufacturers and importers who FDA has
identified as having an obligation to respond based on information
before the Agency. The requested information would include information
about research requested under section 904(b) of the FD&C Act as well
as information to be provided voluntarily beyond the inquiries
described in section 904(b).
I. Information Requested
The proposed request would include the following information:
All documents (including underlying scientific information and
financial information) relating to research activities, and research
findings, conducted, supported, or possessed by the respondent or the
respondent's agents relating to a specified set of topics listed in
this document. The request includes but is not limited to documents
relating to research findings and activities, if any, that the
respondent possesses as the result of acquiring or merging with another
company. For purposes of the request, ``research'' would include, but
would not be limited to, focus groups, surveys, experimental clinical
studies, toxicological and biochemical assays, in vivo and in vitro
assays including animal testing, laboratory formulation and processing
testing, taste panels, and assessments of the effectiveness of product
marketing practices. The request would apply to research relating to
any and all smokeless tobacco products, including but not limited to
those products for research, investigational use, developmental
studies, test marketing, and/or commercial marketing, and also to the
components, parts, or accessories of such products. For products not
manufactured in the United States, the request would apply to the
extent the respondent has imported such products into the United
States.
II. Topics
Under section 904(b) of the FD&C Act, FDA would request all
documents and underlying scientific and financial information relating
to research activities, research findings, and marketing research for
smokeless tobacco products developed since January 1, 1970, on the
following topics:
The effect of product pH on ratio of free/bound
(unprotonated/protonated) nicotine;
the effect of product pH on user behavior;
the effect of product pH on user subjective effects and
experiences including, but not limited to, sensory effects in the mouth
and throat, liking, craving and withdrawal symptoms, stimulation,
concentration, and anxiety;
the effect of product pH on user physiological responses
including, but not limited to, heart rate, blood pressure, temperature,
and nicotine pharmacokinetics; and
for smokeless tobacco products that have a pH of 7.2 or
less, marketing research that includes attractiveness or appeal to new
users, inexperienced users, and/or to persons under the age of 25.
Research and development of methodology for adjusting the pH of
smokeless tobacco products would be specifically excluded from this
904(b) request.
III. Limitations on Types of Documents and Information
With respect to the topics listed, FDA would request only the
following documents and information:
Study proposals, protocols (including all amendments),
analysis plans, agreements, notebooks, data collection tools, including
but not limited to, forms and assessment scales for planned, ongoing,
or completed studies, surveys, and other research, whether for external
release or internal use;
final data analyses and reports regarding studies,
surveys, data compilations, or other research, whether for external or
internal use (if there were no final analyses, interim data analyses
would be included in the request);
posters and/or presentations exhibited or to be exhibited
at external meetings or conferences if the underlying data has not been
presented in other documents and information within the request;
manuscripts, articles, editorials, and letters that have
been submitted for publication but not yet published (e.g., in review,
accepted, rejected); and
underlying data (e.g., in the form of spreadsheets, SAS
datasets, charts, tables, and diagrams) analyzed to produce any of the
data analyses, reports, posters, manuscripts, or articles requested
previously in this notice.
FDA would request only the final versions of documents, or in the
absence of a final version, the most recent draft of each document.
Published (i.e., publically available) press releases, abstracts,
editorials, letters, manuscripts, material safety data sheets, and HHS
correspondences, would not be requested, although FDA would appreciate
a list of such publications provided as a separate appendix.
Data supporting summary reports would be included in the request,
and FDA would ask that spreadsheets or SAS datasets be submitted both
in PDF and in a file type and structured format that allows for
meaningful review and analysis of the data (e.g., Excel (.xls),
[[Page 42799]]
comma separated values (.csv), or SAS transport (.xpt) file formats).
Also, FDA would request relevant data submissions be accompanied by the
name and version of the software used to create the file, and names and
definitions of variables and copies of programs and macros needed to
generate the analyses. FDA would also ask that respondents include any
data analyses that stratify scientific results by gender, race,
ethnicity, age, or other similar factors.
Information responsive to the request that has been previously
provided to FDA under the FD&C Act would not have to be resubmitted as
long as the document was fully referenced in the metadata load file.
For documents previously provided to FDA under section 904(a)(1),
904(a)(3), 904(c)(1), 904(c)(2), or 904(c)(3) of the FD&C Act, FDA
would ask that the respondent provide the following additional
information in the metadata load file: The file name and file
extension, Bates number (begin Bates number to end Bates number) and
relevant page numbers, date of submission, section under which the
document was submitted, tobacco product brand/subbrand name, and
product identification number. FDA would also ask that respondents
identify the presence of each document in the University of California
San Francisco Legacy Tobacco Documents Library (LTDL) as one of the
following: Present with the Bates number (begin Bates number to end
Bates number), not present, or unknown.
IV. Additional Information
FDA would ask the respondent to submit voluntarily the following
additional information, as applicable, to provide context and
background for FDA:
A summary (one to five pages in length) for each of the
topics previously mentioned in this notice, that includes the number
and type of documents included, and a high-level overview of the
content and
an explanation of the scientific and business reasons,
rationale, or justification for developing and marketing smokeless
tobacco products with different pH values, including expected and
observed perception and behavior of current and potential consumers.
This is a new collection of information. FDA would use the
information to assess the effects of pH of smokeless tobacco products
on consumers and the public health.
V. Burden Estimate
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent gathering product pH information Number of responses per Total annual hours per Total hours Total capital
respondents respondent responses response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco product manufacturers and importers with LTDL 3 1 3 120 360 $29
collections............................................
Additional tobacco product manufacturers and importers 3 1 3 125 375 186
with previous submissions to FDA.......................
Other manufacturers who have no documents, do not 119 1 119 5 595 59
manufacture smokeless tobacco products, or do not
anticipate manufacturing these products................
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 1,330 274
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
We estimate the capital costs associated with this document
submission to be $274. This estimate is based upon: (1) 3 submissions
being submitted by mailing an average of 10 CDs per envelope ($29); (2)
3 submissions being submitted by mailing a package of paper documents
weighing an average of 50 pounds total ($186); and (3) 119 submissions
of 1 business class letter describing that no documents are available
(119 x $0.49 (the price of a first class business stamp), or $59).
FDA developed its reporting burden estimates from the expected
volume of documents to be received based upon broad searches of LTDL,
the Agency's experience with previous information collection requests
under section 904(b) of the FD&C Act, and submissions received as
health documents under section 904(a)(4).
FDA estimates the burden for this one-time collection of
information to be 1,330 hours. FDA estimates it will receive 125
submissions. Based upon the expected number of tobacco product
manufacturers and importers, the burden has been broken into three
tiers:
FDA anticipates documents for this request will be
submitted by three tobacco product manufacturers and importers that
have related document collections within LTDL. Manufacturers 1 through
3 were estimated to take 140, 142, and 80 hours respectively, for an
approximate average of 120 hours per response, to process and prepare a
submission (i.e., cover letter, documents and information, and metadata
load file). Total estimated burden hours for this portion of the
collection are expected to be 360 hours.
FDA anticipates documents will also be submitted by three
additional tobacco product manufacturers and importers that provided
health documents under section 904(a)(4) of the FD&C Act. Manufacturers
4 through 6 were estimated to take 194, 96, and 83 hours respectively,
for an approximate average of 125 hours per response, to process and
prepare a submission (i.e., cover letter, documents and information,
and metadata load file). Total estimated burden hours for this portion
of the collection are expected to be 375 hours.
FDA estimates that 119 manufacturers and importers will
not have documents responsive to this request and are estimated to take
approximately 5 hours each to conduct a review of their records and to
draft and send a letter to FDA indicating that they do not have
documents to submit. These manufacturers do not have documents, do not
manufacture smokeless tobacco products, or do not anticipate
manufacturing these tobacco products. Total estimated burden hours for
this portion of the collection are expected to be 595 hours.
[[Page 42800]]
Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17294 Filed 7-22-14; 8:45 am]
BILLING CODE 4164-01-P
