10 Public Comments from 60-day FRN

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 10
Public Comments from 60-day FRN
June 18, 2013

June 7, 2012
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
RE: FR Doc No: 2012-12017
Dear Dr. Collins:
The American Lung Association wishes to express its support for the efforts of
the National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) in the launching of the Population Assessment of Tobacco and Health
study (PATH) to monitor and evaluate the effects of FDA regulation of tobacco
products. The American Lung Association is proud of our role in fighting for the
passage of the Family Smoking Prevention and Tobacco Control Act, and this
effort to evaluate its impacts on public health and behavior is crucial to its
success. With this study and other activities, NIH will play an invaluable role
with the FDA in implementing this legislation and saving lives.
Establishing the PATH study will allow the tobacco control community and
public to see the positive effects of regulating tobacco product advertising,
labeling, marketing, constituents, ingredients and additives. This system will
be invaluable in informing the public of the positive effects of tobacco
regulation and measuring the long term health and behavior of tobacco
consumers.
A careful evaluation of FDA’s policies such as this will help understand the
impact FDA’s policies have on tobacco use and ultimately drive down the rate
of tobacco use in the United States. Reducing tobacco use will prevent disease,
save lives and reduce tobacco-related health care costs. As you know, the 45
million Americans who currently smoke are at heightened risk for a variety of
cancers, heart disease, chronic obstructive pulmonary disease, and other
serious medical conditions.

The American Lung Association strongly supports the FDA and NIH’s mission to improve the health of
the American people. We are encouraged by NIH and FDA’s efforts to measure the impact of current
and future smoking regulations and communications. Thank you for you continued leadership.
Sincerely,

Paul Billings, Vice President of National Policy and Advocacy
American Lung Association

Cc: Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
Dr. Laurence Deyton, Director, Center for Tobacco Products

June 20, 2012

Mr. Paul Billings
Vice President
National Policy and Advocacy
American Lung Association
1301 Pennsylvania Avenue, N.W.
Suite 800
Washington, D.C. 2004-1725
Dear Mr. Billings:
Thank you for your letter to Dr. Francis S. Collins, Director of the National Institutes of Health
(NIH), in support of the efforts of the NIH and the Food and Drug Administration (FDA) in
launching the Population Assessment of Tobacco and Health (PATH) study. Your letter has
been forwarded to the National Institute on Drug Abuse for reply.
We agree that this research will provide important new data on tobacco use behaviors in the U.S.
population and on the near- and long-term effects of tobacco use on the health of individuals and
of the Nation. The NIH and FDA together have long recognized that tobacco use is the leading
preventable cause of disease and death in the U.S., including cancers, heart disease, chronic
obstructive pulmonary diseases, and other serious medical conditions. This new collaboration
will measure the population-based impact of tobacco product use on public health. Its data will
inform new efforts to promote public understanding of the contents and consequences of tobacco
use on health; to reduce tobacco use initiation among our Nation’s youth; to help those who use
tobacco to quit; and to advance the scientific knowledge base for FDA’s development,
implementation, and evaluation of effective tobacco product regulations to reduce the toll of
tobacco-related disease, disability, and death.
Thank you again for the expression of support by the American Lung Association for the PATH
study.
Sincerely,

Nora D. Volkow, M.D.
Director

cc: Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
Dr. Lawrence Deyton, Director, Center for Tobacco Products