[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Pages 19713-19714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07576]



Food and Drug Administration

[Docket No. FDA-2013-N-0305]

Possible Role of Independent Third Parties in Industry-Sponsored 
Tobacco Product Research; Establishment of a Public Docket; Request for 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for data, information, 
and comments.


SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket for interested parties to submit to FDA comments on the 
Institute of Medicine's (IOM) recommendation regarding third-party 
governance of industry-sponsored tobacco product research.

DATES: Submit electronic or written comments by September 30, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0305, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Electronic Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-0305. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read comments received, go to 
http://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts and/or go to the Division of Dockets Management, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laila Noory, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1-877-287-1373 (choose Option 4), FAX: 240-276-
3761, email: CTP.3PGovernance@fda.hhs.gov.


I. Background

    On June 22, 2009, President Obama signed into law the Family 
Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco 
Control Act). The Tobacco Control Act amends the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) by adding chapter IX (21 U.S.C. 387 et 
seq.) and grants FDA authority to regulate the manufacture, marketing, 
and distribution of tobacco products to protect public health generally 
and to reduce tobacco use by minors.
    FDA expects that tobacco product manufacturers will undertake 
tobacco product research as part of activities regulated under the 
Tobacco Control Act, including submission of applications for marketing 
orders under sections 910 and 911 of the FD&C Act. Section 911 of the 
FD&C Act requires FDA to issue regulations or guidance (or any 
combination thereof) on the scientific evidence required for assessment 
and ongoing review of modified risk tobacco products (MRTPs). Section 
911(l)(2) requires that such regulations or guidance be developed in 
consultation with the Institute of Medicine (IOM), among others, on the 
design and conduct of such studies and surveillance. Pursuant to this 
requirement, the IOM convened a multidisciplinary committee and 
published a report in December 2011. In the report, entitled 
``Scientific Standards for Studies on Modified Risk Tobacco Products'' 
(http://www.iom.edu/Reports/2011/Scientific-Standards-for-Studies-on-Modified-Risk-Tobacco-Products.aspx), the IOM notes that ``governance 
of research is critical to the production of credible and reliable 
    Specifically, the IOM report states ``[t]here is profound distrust 
of the tobacco industry and of research supported by the tobacco 
industry. This distrust is the direct result of the tobacco industry's 
history of improperly influencing or manipulating scientific findings 
and messaging about the health

[[Page 19714]]

effects of tobacco. This history and the lack of trust may prevent 
independent experts from participating in research on tobacco products 
and therefore may impede the production of data on MRTPs necessary to 
assess public health impact.'' The IOM also notes that ``the tobacco 
industry currently lacks the infrastructure and expertise to 
independently produce the necessary evidence to support an application 
to market an MRTP.''
    As a result of these findings, the IOM recommends in its report 
that ``MRTP sponsors should consider use of independent third parties 
to undertake one or more key functions, including the design and 
conduct of research, the oversight of specific studies, and the 
distribution of sponsor funds for research. Such independent third 
parties should be approved by the FDA in advance of the research.''
    The IOM report focuses on research to support MRTP applications, 
but FDA is also interested in information on third-party governance as 
it relates more generally to industry-sponsored tobacco research. FDA 
is interested in receiving information on whether some form of third-
party governance should be considered for other types of industry-
sponsored tobacco product research, including research to support 
premarket tobacco product applications and other submissions to FDA, as 
well as research designed to contribute to general knowledge regarding 
tobacco products.

II. Request for Comments and Information

    As FDA considers how and whether to implement third-party 
governance of industry-sponsored tobacco product research, we are 
requesting comments on the IOM's recommendation. We encourage you to 
submit any available research or evidence to support your comments. FDA 
specifically requests comments on:
    1. What are some potential models of third-party governance of 
industry-sponsored tobacco product research? What are the strengths and 
weaknesses of these models?
    2. What criteria could FDA use to evaluate any potential model of 
third-party governance of industry-sponsored tobacco product research?
    3. What role would various interested parties (e.g., individual 
researchers, academic institutions, for-profit and not-for-profit 
research organizations) play in a third-party governance model of 
tobacco product research?
    4. Who would participate in a third-party governance model? How 
could a governance model be structured to reduce conflict of interest 
and bias in industry-sponsored tobacco product research?
    5. What barriers, if any, would have to be overcome to encourage 
the broader scientific community to participate in a third-party 
governance model?
    6. Are there unique research challenges faced by small 
manufacturers and how should they be addressed in a third-party 
governance model?
    7. What kinds of tobacco product research could be subject to 
third-party governance? For example, could it be applied to:
     Product testing?
     Nonclinical studies?
     Studies in human subjects? (e.g., health effects research, 
behavioral research, abuse liability studies, consumer perception 
     Computational modeling?
     Postmarket surveillance?
    8. What aspects of tobacco product research could be subject to 
third-party governance? For example, should both the design and conduct 
of research studies be subject to third-party governance?
    9. Are there governance models or other steps FDA can take that are 
more effective for overseeing research to produce generalizable 
knowledge, such as establishing better testing/research methods and 
standards, compared to specific product research?

III. Submission of Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07576 Filed 4-1-13; 8:45 am]