
[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64394-64397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1009]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 28, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Information Request Regarding pH of Smokeless Tobacco 
Products.'' Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 64395]]

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, 1980, 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, original implemented 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, 
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 
Department of Health and Human Services 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 
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), 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.
    To provide context and background for each document, FDA would ask 
the respondent to include a load file containing metadata (e.g., 
manufacturer, date, author(s)) for each document. Also in the metadata 
load file, FDA would ask the respondents to 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.
    As an option, information responsive to the request that has been 
previously provided to FDA under sections 904(a)(1), 904(a)(3), 
904(c)(1), 904(c)(2), or 904(c)(3) of the FD&C Act would not have to be 
resubmitted as long as the document was fully referenced in the 
metadata load file.

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. In the Federal Register of July 23, 
2014 (79 FR 42797), FDA published a 60-day notice requesting public 
comment on the proposed collection of information. Four commenters 
submitted nine comments that were PRA related.
    (Comment 1) The Agency should request all document versions, 
including drafts, as well as comments on those versions and reasons for 
changes made in subsequent versions.
    (Response) FDA believes the request to prepare a submission that 
includes drafts including related metadata will be overly burdensome 
for the respondent. Additionally, a request to be provided the reason 
for changes made in subsequent versions is beyond the inquiries 
described in section 904(b). FDA clarified the request to note the 
original implemented protocol is to be submitted. FDA would contact 
manufacturers, if additional information is needed to facilitate the 
Agency's review of the submission.
    (Comment 2) Do not limit the request to SAS datasets as to not 
exclude other statistical software.
    (Response) It is FDA's intent that data not be excluded from the 
request based upon the statistical analysis software used. The proposed 
request asks that data be provided in a file type and structured format 
that allows for meaningful review and analysis of the data. The request 
was clarified to note that SAS.xpt is a recommended format for 
datasets.
    (Comment 3) The Agency should request the LTDL tobacco 
identification (TID) number or URL since these are unique to the 
document.
    (Response) Because the manufacturer does not assign the TID number 
or URL, FDA believes requesting this information would be overly 
burdensome for the respondent and

[[Page 64396]]

therefore would request only the Bates number(s) as proposed, given 
that this information is assigned by the manufacturer.
    (Comment 4) It would be overly burdensome for the respondent to 
locate data and provide the requested software for information dating 
back to January 1, 1970, and FDA should focus the information for more 
recent times.
    (Response) FDA believes the time period for this request should 
coincide with the commercial availability of smokeless tobacco products 
with different pH values because industry research on this topic is 
limited in the public domain. FDA has considered the scientific value 
of the data and information as well as the burden on respondents to 
provide such information to FDA. Therefore, FDA revised the request to 
ask for documents developed since January 1, 1980.
    (Comment 5) The burden for the collection was underestimated given 
that it is likely older documents may only exist in hard copy and, if 
found, would be in remote storage that would be mostly searched 
manually.
    (Response) The burden was revised given that this portion of the 
request may be performed manually.
    (Comment 6) The burden for the collection was underestimated given 
that respondents would need to perform document-by-document search of a 
third party site to provide the requested metadata from LTDL.
    (Response) The burden was revised given that this portion of the 
request may be performed manually.
    (Comment 7) It would be overly burdensome for respondents to 
provide the amount of metadata requested for documents previously 
submitted to FDA in lieu of providing the Agency with all of the 
responsive documents it locates.
    (Response) FDA clarified the purpose of the metadata load file and 
also clarified that the respondent has the option to provide metadata 
for previously submitted documents.
    (Comment 8) It would take at least 90 days to provide a response to 
the request.
    (Response) Given the Agency's experience with previous submissions 
under section 904(a)(4) and 904(b) of the FD&C Act, FDA would request a 
response within 60 days from the date of the letter and request 
respondents that anticipate difficulties with the document production 
to contact FDA within 30 days of the date of the letter. FDA will 
provide assistance in resolving any technical difficulties and 
facilitate compliance with the timeline.
    (Comment 9) The Agency previously estimated an average of 200 hours 
per response for the Agency's request for dissolvable tobacco products 
in 2011.
    (Response) FDA has since learned from experience with document 
submissions under section 904(a)(4) and 904(b) of the FD&C Act that 
some respondents have electronic document systems. Thus, estimates for 
this collection reflect automation capabilities for processing and 
managing document submissions.
    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
  Type of respondent gathering  product pH information       Number of     responses per   Total annual    burden hours     Total hours    Total capital
                                                            respondents     respondent       responses     per response                        costs
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Tobacco product manufacturers and importers with LTDL                  3               1               3             165             495             $29
 collections............................................
Additional tobacco product manufacturers and importers                 3               1               3             175             525             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...............................................  ..............  ..............  ..............  ..............           1,615             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 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 is drawing from tobacco health document submissions under 
section 904(a)(4) and 904(b) of the FD&C Act, our interaction with the 
public, and our experience to inform the burden estimates associated 
with this information collection. Additionally, based upon comments in 
response to the Federal Register notice, FDA is revising its initial 
estimates of annualized burden hours.
    FDA estimates the burden for this collection of information to be 
1,615 hours. FDA estimates it will receive 125 submissions. Based upon 
the expected number of tobacco product manufacturers and importers, 
their 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 document collections within LTDL. Manufacturers one through three 
were estimated to take 201, 206, and 85 hours respectively, for an 
approximate average of 165 hours per response, to process and prepare a 
submission (i.e., cover letter, documents and information, and metadata 
load file). Total burden hours for this portion of the collection are 
expected to be 495 hours.
     FDA anticipates documents to also be submitted by three 
additional tobacco product manufacturers and importers that provided 
health documents under section 904(a)(4). Manufacturers four through 
six were estimated to take 304, 118, and 91 hours respectively, for an 
approximate average of 175 hours per response, to process and prepare a 
submission (i.e., cover letter, documents and information, and metadata 
load file). Total burden hours for this portion of the collection are 
expected to be 525 hours.
     FDA estimates that 119 manufacturers and importers will 
not possess documents responsive to this request. These manufacturers 
do not have documents, do not manufacture smokeless tobacco products, 
or do not

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anticipate manufacturing these tobacco products and are estimated to 
take approximately 5 hours each to conduct a review of their records, 
draft and send a letter to FDA indicating that they do not have 
documents to submit. Total burden hours for this portion of the 
collection are expected to be 595 hours.

    Dated: October 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25638 Filed 10-28-14; 8:45 am]
BILLING CODE 4164-01-P


