[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38055-38057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]


Building Research Capacity in Global Tobacco Product Regulation 
Program (U18)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the Center for Tobacco 
Product's (CTP's) Building Research Capacity in Global Tobacco Product 
Regulation Program. FDA intends to accept and consider a single source 
application for award to the World Health Organization (WHO) to 
identify, support, develop, conduct, and coordinate research efforts 
relating to tobacco control laws and rules in foreign countries that 
will directly inform and support FDA's exercise of its authority to 
regulate the manufacture, distribution, marketing, and sale of tobacco 
products in the United States. The Building Research Capacity in Global 
Tobacco Product Regulation Program seeks to advance and expand research 
in support of tobacco product regulation, in order to reduce the 
morbidity and mortality associated with tobacco use both within the 
United States and internationally. The program will advance FDA's and 
CTP's mission by utilizing WHO Member States' expertise and extensive 
international contacts in global tobacco control, as well as WHO's own 
programmatic expertise, to inform and support adequate manufacture, 
distribution, and market regulations of tobacco products for the 
protection of public health in the United States.

DATES: Important dates are as follows:
    1. The application due date is July 31, 2013.
    2. The anticipated start date is September 2013.
    3. The opening date is July 1, 2013.
    4. The expiration date is August 1, 2013.

ADDRESSES: Submit electronic applications to: http://www.grants.gov. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: Caitlin Addorisio, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-796-0371; or Lisa Ko, Office of Acquisition 
and Grants Services, Food and Drug Administration, 5630 Fishers Lane, 
Rockville, MD 20857, 301-827-5095.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://www.grants.gov. Search by Funding Opportunity Number: 
RFA-FD-13-032.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

    RFA-FD-13-032.
    93.103.

A. Background

1. Authority
    The Building Research Capacity in Global Tobacco Product Regulation 
Program is authorized by 42 U.S.C. 241 of the Public Health Service Act 
and the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31).
2. Program Background
    Tobacco use is the foremost preventable cause of premature death in 
America. It causes over 443,000 deaths in the United States each year, 
and another 8.6 million smokers have at least one serious illness due 
to smoking. A compelling body of evidence illustrates that tobacco 
products are inherently dangerous and cause cancer, heart disease, and 
other serious adverse health effects.
    On June 22, 2009, President Obama signed the Tobacco Control Act, 
giving FDA regulatory authority to regulate the manufacturing, 
labeling, sale, distribution, advertising, and promotion of tobacco 
products.
    Some key FDA activities authorized or required by the Tobacco 
Control Act include:
     Mandating larger, more varied, and more prominent warning 
labels on cigarette and smokeless tobacco products (Title II of the 
Tobacco Control Act).
     Restricting tobacco product sales, advertising, and 
promotion (section 906(d) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C 387f(d)); section 102 of the Tobacco Control 
Act)).
     Establishing product standards to regulate the contents, 
design, components, emissions, and other characteristics of tobacco 
products

[[Page 38056]]

(section 907 of the FD&C Act) (21 U.S.C 387g).
     Prohibiting explicit and implicit claims of modified risk 
or modified exposure (including ``light,'' ``low,'' or ``mild'' and 
similar descriptors), without an FDA order that the modified risk 
product may be marketed (section 911 of the FD&C Act) (21 U.S.C. 387k).
     In general (with certain narrow exceptions), limiting the 
introduction of new tobacco products to those for which FDA determines 
that the marketing of the product would be ``appropriate for the 
protection of public health'' (sections 905, 910 of the FD&C Act) (21 
U.S.C. 387e, 387j).
     Collecting data on certain tobacco product constituents, 
ingredients, and additives and establishing a list of harmful and 
potentially harmful constituents in tobacco products, including smoke 
constituents, by brand and subbrand (sections 904, 915 of the FD&C Act) 
(21 U.S.C. 387d, 387o).
    Please visit http://www.fda.gov/TobaccoProducts/default.htm for 
more information on the Tobacco Control Act and related regulations, 
guidance, and other educational information.
    To implement the new law, Congress directed the creation of CTP at 
FDA. CTP oversees the implementation of the Tobacco Control Act. CTP's 
mission is to protect Americans from tobacco-related death and disease 
by regulating the manufacture, distribution, and marketing of tobacco 
products and by educating the public, especially young people, about 
tobacco products and the dangers their use poses to themselves and 
others.
    Protecting the public health requires multidimensional programs 
that address both immediate threats as well as their systemic causes. 
Using this public health approach, CTP can successfully deter youth 
from ever using tobacco products while encouraging current consumers to 
quit. CTP will communicate broadly and effectively about the Agency's 
new responsibilities for tobacco product regulation and the dangers 
tobacco use poses to young people and adults. CTP will use its unique 
authorities to develop strategies to decrease the harms associated with 
the use of tobacco products. CTP will expand its research program and, 
with it, its proven commitment to regulatory science.
    CTP's strategic public health goals include:
     Decreasing initiation of tobacco product use, especially 
among youth,
     Decreasing the harms of tobacco product use, and
     Encouraging tobacco use cessation.
3. Overarching Program Goal
    The goal of the Building Research Capacity in Global Tobacco 
Product Regulation Program is to advance and expand research in support 
of tobacco product regulation, in order to reduce the morbidity and 
mortality associated with tobacco use both within the United States and 
internationally.
    WHO, in particular WHO's Tobacco Free Initiative, will conduct and 
coordinate data collection, expert insights and analysis, and other 
research to support tobacco product regulation activities. WHO's 
activities provide a universal public health benefit by identifying and 
analyzing tobacco regulatory challenges, collating science-based tools 
to combat such challenges, and enhancing regulatory capabilities of 
governments to implement successful tobacco product regulation and 
decrease the global use of tobacco products. The activities provide a 
significant domestic benefit, as the scientific, policy, and legal 
research gathered will contribute to FDA's own tobacco product 
regulation activities aimed at decreasing domestic tobacco-related 
death and disease, and the American public will gain new information 
about tobacco products and the dangers their use poses.
    As highlighted previously, CTP continues to take steps to implement 
the Tobacco Control Act. It is beneficial for FDA to learn from the 
successes and failures of other international regulatory agencies and 
consider the vast research available globally to inform FDA's 
decisions. As CTP considers its mandate to place restrictions on the 
sale and distribution of tobacco products, implement tobacco product 
standards, review applications for new tobacco products, and consider 
applications for modified risk products, among other activities, it is 
important to consider global trends, scientific literature, and the 
support/scientific information/research or evaluation opportunities in 
other countries' relevant tobacco experience. The Building Research 
Capacity in Global Tobacco Product Regulation Program will help support 
a global network of tobacco product regulators that will enable robust 
information sharing and health research collection globally, thereby 
catalyzing the use of best practices, and complementing CTP's 
regulatory efforts.

B. Research Objectives

1. Program Purpose
    The purpose of the Building Research Capacity in Global Tobacco 
Product Regulation Program is to identify, support, develop, conduct, 
and coordinate research efforts relating to tobacco control laws and 
rules in foreign countries that will directly inform and support FDA's 
exercise of its authority to regulate the manufacture, distribution, 
marketing, and sale of tobacco products in the United States.
    The program will advance CTP's mission by utilizing the WHO's 
Member States' expertise and extensive international contacts in global 
tobacco control, as well as WHO's own programmatic expertise, to inform 
and support adequate manufacture, distribution, and market regulations 
of tobacco products for the protection of public health in the United 
States.
2. Program Priorities
    The Program's grant funds will support WHO in expanding the 
research foundation for tobacco product regulation, in an effort to 
support FDA's implementation of the Tobacco Control Act. It is expected 
that this effort may also support foreign governments' development of 
tobacco control policies and regulations. A strong application will 
seek to increase comprehensive data collection, expert insight and 
analysis, and other research related to scientific, legal, and policy 
information that can contribute to successful domestic regulation and 
policies that will protect Americans from tobacco-related death and 
disease and promote public understanding of tobacco risk.
    The application must include the following activities: (1) Propose 
a program plan, relying on WHO's long history of coordinating 
international collaborative projects in support of tobacco control 
development and its established international contacts, that supports 
FDA approaches to reducing tobacco use, harm, and addiction; (2) 
identify, support, develop, conduct, and coordinate multilateral 
research efforts in the areas of science, law, policy, and public 
health communications/education that advance FDA's regulation of the 
manufacturing, marketing, and distribution of tobacco products as found 
in the Tobacco Control Act; (3) plan, build, adapt, or expand data 
collection/information sharing mechanisms, management, and reporting 
protocols necessary to facilitate Program information exchanges, 
analysis, and other research; and (4) evaluate program activities, 
processes, and outcomes, including summation evaluation, to document 
and disseminate results and outcomes.
    The applicant must propose science-based activities that advance 
the international tobacco product regulation research foundation in 
order to reduce tobacco-related death and disease both

[[Page 38057]]

in the United States and around the world. The applicant should track 
both short-term and long-term goals, and demonstrate how the proposed 
activities are related to CTP's regulation of tobacco products under 
the Tobacco Control Act.
    By way of example, project activities could:
     In the first year, draft a long-term strategy for 
increasing WHO's capacity to facilitate global tobacco-related 
research;
     Create global data information systems to support the 
program research goals and allow for efficient and timely information 
sharing with FDA and other partners;
     Continue to coordinate and mobilize an international 
tobacco regulators' network, via conferences, workshops, 
teleconferences, and other regular engagements, for the purpose of 
sharing global tobacco regulation experience and expertise; and
     Analyze tobacco-related research and produce technical 
papers on various issues of relevance to tobacco product regulation, 
e.g., illicit trade in tobacco products, tobacco control and 
intellectual property rights, tobacco control and international trade, 
nicotine addiction, and other topics.
    The applicant must be familiar with the specific provisions of the 
Tobacco Control Act and the regulatory activities of FDA. In addition 
to demonstrating how the proposed project is related to CTP's 
regulation of tobacco products under the Tobacco Control Act, the 
applicant must demonstrate how it will advance the public health goals 
that underlie these FDA activities. Please visit http://www.fda.gov/TobaccoProducts/default.htm for more information on the Tobacco Control 
Act and related regulations, guidance, and other educational 
information.

C. Eligibility Information

    The following organization is eligible to apply: WHO.
    As FDA seeks to proactively work with other countries and identify 
research and evaluation opportunities that will impact FDA's ability to 
successfully implement the Tobacco Control Act, further collaboration 
with WHO is anticipated. With the financial support from FDA, WHO is 
uniquely qualified to undertake these activities, given its mandate, 
wide access to data, participation of member states, and access to 
worldwide regulatory expertise.
Specific Evidence To Justify Single Eligibility
     Example databases already in place:
    [cir] WHO Framework Convention on Tobacco Control Health Warnings 
Database (http://www.who.int/tobacco/healthwarningsdatabase/en/index.html).
    [cir] Tobacco Industry Monitoring Database.
     Examples of Global Tobacco Research Reports/White Papers:
    [cir] WHO report on the global tobacco epidemic, 2001, 2009, 2008.
    [cir] Developing Legislation for Tobacco Control.
    [cir] WHO Study Group on Tobacco Product Regulation Report on the 
Scientific Basis of Tobacco Product Regulation.
    [cir] Confronting the tobacco epidemic in a new era of trade and 
investment liberalization.
    [cir] See more examples at: http://www.who.int/tobacco/publications/prod_regulation/en/index.html.
     Examples of Global Tobacco Regulator Workshops and 
Meetings/Network of Scientists:
    [cir] Tobacco Product Regulation (TobReg): http://www.who.int/tobacco/industry/product_regulation/tobreg/en/index.html.
    [cir] Tobacco Laboratory Network (TobLabNet): http://www.who.int/tobacco/industry/product_regulation/toblabnet/en/index.html.
    [cir] Experience coordinating and conducting regular scientific 
meetings: http://www.who.int/tobacco/industry/product_regulation/toblabnet/meetings/en/index.html.
    [cir] 2011 International Tobacco Regulators Conference that was 
cosponsored by WHO and FDA: http://www.who.int/tobacco/industry/product_regulation/forum/conference2012.pdf.

II. Award Information/Funds Available

A. Award Amount

    FDA/CTP anticipates providing in fiscal year (FY) 2013 up to $1 
million (total costs including indirect costs for one award subject to 
availability of funds) in support of this project. FDA/CTP anticipates 
the possibility of four additional years of support up to $4 million of 
funding contingent upon successful performance and the availability of 
funding. Program funds may not be used for any purpose other than those 
directly tied to the regulation of tobacco products under the Tobacco 
Control Act.
     FY Funds: 2013.
     Estimated Current FY Funding: $1 million.
     Maximum Size Award in Current Fiscal Year: $1 million.
     Estimated Number of Awards: 1.
     Estimated Future Year Funding: FY 2014 ($1 million), FY 
2015 ($1 million), FY 2016 ($1 million), and FY 2017 ($1 million).
     Maximum Size Award in Future Years: FY 2014 ($1 million), 
FY 2015 ($1 million), FY 2016 ($1 million), and FY 2017 ($1 million).
     Maximum Project Period: 5 Years.

B. Length of Support

    The length of support will depend on the nature of the project. The 
budget period in current and future funding years will be as follows: 
FY 2013 (12 months), FY 2014 (12 months), FY 2015 (12 months), FY 2016 
(12 months), and FY 2017 (12 months).

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at http://www.grants.gov. Search 
by Funding Opportunity Number: RFA-FD-13-032. (FDA has verified the Web 
site addresses throughout this document, but FDA is not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.) For all electronically submitted 
applications, the following steps are required.
    Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
    Step 2: Register With System for Award Management (SAM).
    Step 3: Obtain Username & Password.
    Step 4: Authorized Organization Representative (AOR) Authorization.
    Step 5: Track AOR Status.
    Step 6: Register With Electronic Research Administration (eRA) 
Commons.
    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15097 Filed 6-24-13; 8:45 am]
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