
[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]


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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.

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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 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 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\
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                                                                             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
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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................
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    Total...............................................  ..............  ..............  ..............  ..............           1,330             274
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\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


