Att2 Public Comments from 60-day FRN

PATH Study Generic Clearance for Methodological Studies (NIDA)

Attachment 2
Public Comments from 60-day FRN
January 29, 2013

January 11, 2013
Department of Health and Human Services
National Institutes of Health
Attn: PATH Project Officer
RE: FR Doc. 2012-28575 – Proposed Collection; Comment Request; Methodological Studies for the Population
Assessment of Tobacco and Health (PATH) Study
To Whom It May Concern:
The Campaign for Tobacco-Free Kids supports the request to the Office of Management and Budget (OMB)
from the National Institute on Drug Abuse (NIDA) for generic approval for methodological studies to improve
the Population Assessment of Tobacco and Health (PATH) study instrumentation and data collection
procedures. With the passage in 2009 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA),
the Food and Drug Administration (FDA) finally has the authority to regulate the product that is the leading
preventable cause of death in the United States and around the world. The PATH study is critical to successful
implementation of many provisions of the FSPTCA, and generic approval is critical to successful execution of
the PATH study.
For the first time ever, the FDA has the authority to regulate the manufacture, sale, and marketing of tobacco
products. This authority includes, among other things, the following:
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Authority to set conditions on the sale of tobacco products
Authority to place restrictions on the time, place, and manner of tobacco marketing
Requirement that all new tobacco products be reviewed by the FDA to ensure that their introduction
to the market is appropriate for the protection of public health
Requirement that any modified risk claims for tobacco products are reviewed by FDA to ensure that
they benefit the population as a whole
Authority to set product standards for tobacco products
Authority to require large graphic warning labels on tobacco products

The PATH study is critical to the FDA because it will provide information on how youth and adult smokers and
non-smokers respond to tobacco marketing (including modified risk claims), use different tobacco products
over time, use different approaches to smoking cessation, etc. By providing this information on the same
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respondents over time, it will allow FDA to both develop and evaluate actions taken under its new authority to
reduce the toll that tobacco takes on health.
To maximize the benefit of the PATH study, NIDA and FDA will need to act regularly and quickly to refine and
improve the study in response to new developments, including actions taken by the tobacco companies. For
example, in recent years, a plethora of new and novel tobacco products (e.g., dissolvable tobacco products, ecigarettes, and numerous cigar and smokeless tobacco products) have been introduced to the market. It is
critical understand how these products and their marketing affect tobacco use initiation, cessation, frequency
of use, etc. so the FDA can take appropriate action to improve public health.
With such a dynamic market and an ever-innovative industry, it is critical that NIDA be able to refine the PATH
study in a timely fashion to capture changes in the market and their impact on tobacco use over time.
Generic approval will allow NIDA to conduct the kind of methodological studies to refine the PATH study in a
timely fashion so FDA can act appropriately under its authority to protect public health. This cannot be done
effectively or efficiently if NIDA has to seek OMB approval each time it wants to conduct research to refine the
PATH study.
We urge OMB to grant the request from NIDA for generic approval and are happy to provide further
information regarding this request.
Sincerely,

Daniel E. McGoldrick
Vice President, Research
Campaign for Tobacco-Free Kids

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