Attachments F,G,R,S

Attachment F
QFT Intro and Informed Consent

INTRODUCTION AND INFORMED CONSENT FOR
INTERVIEW RESPONDENTS AGE 18+

IF INTERVIEW RESPONDENT IS NOT SCREENING RESPONDENT,
INTRODUCE YOURSELF AND STUDY AS NECESSARY: Hello, I’m ________,
and I’m working on a nationwide study sponsored by the U.S. Department of
Health and Human Services. You should have received a letter about this study.
(SHOW LEAD LETTER, IF NECESSARY.)
READ THE BOXED INFORMATION BELOW
BEFORE STARTING EVERY INTERVIEW

This year, we are interviewing about 70,000 people across the nation. You have
been randomly chosen to take part. You may choose not to take part in this study,
but no one else can take your place. We will give you $30 when you finish the
interview.
GIVE GRAY STUDY DESCRIPTION TO R IF YOU HAVE NOT ALREADY DONE
SO.
This study asks about tobacco, alcohol, and drug use or non-use, knowledge and
attitudes about drugs, mental health, and other health issues. It takes about an
hour. You will answer most of the questions on the computer, so I will not see your
answers. We are only interested in the combined responses from all 70,000 people,
not just one person’s answers. This is why we do not ask for your name and we
keep your answers separate from your address. RTI may contact you by phone or
mail to ask a few questions about the quality of my work. This is why we ask for
your phone number and mailing address at the end of the interview.
While the interview has some personal questions, federal law keeps your answers
private. We hope that protecting your privacy will help you to give accurate
answers. You can quit the interview at any time and you can refuse to answer any
questions.
If it is all right with you, let’s get started.
(Can we find a private place to complete the interview?)

INTRODUCTION AND INFORMED CONSENT FOR
INTERVIEW RESPONDENTS AGE 12-17
FIRST, OBTAIN PERMISSION FROM THE PARENT
AND READ THE BOXED INFORMATION BELOW

Your (AGE) year-old child has been selected to be in this study. Your child’s participation is
voluntary. This interview asks about tobacco, alcohol, and drug use or non-use, knowledge
and attitudes about drugs, mental health, and other health related issues. All of your child’s
answers will be confidential and used only for statistical purposes. Since your child will answer
most of the questions on the computer, I will never see the answers, and you are not allowed
to see them either. If it is all right with you, we’ll get started.
(Can we find a private place to complete the interview?)

THEN, READ THE BOXED INFORMATION BELOW BEFORE STARTING EVERY INTERVIEW
WITH A 12-17 YEAR OLD

This year, we are interviewing about 70,000 people across the nation. You have been
randomly chosen to take part. You may choose not to take part in this study, but no one else
can take your place. We will give you $30 when you finish the interview.
GIVE GRAY STUDY DESCRIPTION TO R IF YOU HAVE NOT ALREADY DONE SO.
This study asks about tobacco, alcohol, and drug use or non-use, knowledge and attitudes
about drugs, mental health, and other health issues. It takes about an hour. You will answer
most of the questions on the computer, so I will not see your answers. Your answers will
never be seen by either your parents or your school. We are only interested in the combined
responses from all 70,000 people, not just one person’s answers. This is why we do not ask
for your name and we keep your answers separate from your address. RTI may contact you
by phone or mail to ask a few questions about the quality of my work. This is why we ask for
your phone number and mailing address at the end of the interview.
While the interview has some personal questions, federal law keeps your answers private. We
hope that protecting your privacy will help you to give accurate answers. You can quit the
interview at any time and you can refuse to answer any questions.
If it is all right with you, let’s get started.

Attachment G
QFT Study Description

Study
Description

Your address is one of several in this area randomly chosen for the 2012 National
Survey on Drug Use and Health. This study, sponsored by the U.S. Department of
Health and Human Services, collects information for research and program planning by
asking about:
 tobacco, alcohol, and drug use or non-use,
 knowledge and attitudes about drugs, 
 mental health, and
 other health issues. 
You cannot be identified through any information you give us. Your name and address
will never be connected to your answers. Also, federal law requires us to keep all of
your answers confidential. Any data that you provide will only be used by authorized
personnel for statistical purposes according to the Confidential Information Protection
and Statistical Efficiency Act of 2002.
The screening questions take just a few minutes. If anyone is chosen, the interview will
take about an hour. You can refuse to answer any questions, and you can quit at any
time. Each person who is chosen and completes the interview will receive $30
in cash.
If you have questions about the study, call the Project Representative at 1-800-8484079. If you have questions about your rights as a study participant, call RTI’s Office of
Research Protection at 1-866-214-2043 (a toll-free number). You can also visit our
project website: http://nsduhweb.rti.org/ for more information.
Thank you for your cooperation and time.

Michael Jones, Project Officer
Center for Behavioral Health Statistics and Quality
Substance Abuse and Mental Health Services Administration (SAMHSA)
U.S. Department of Health and Human Services
Your confidentiality is protected by the Confidential Information Protection and Statistical Efficiency Act of 2002
(CIPSEA, PL 107-347). Any project staff or authorized data user who violates CIPSEA may be subject to a jail
term of up to 5 years, a fine of up to $250,000, or both.
v. QFT 9.12

Attachment R
Confidentiality Agreement

CIPSEA Confidentiality Agreement, SAMHSA/CBHSQ 
Administered by RTI International   
This agreement is intended for review and signature by employees of RTI International and all its subcontractors who have 

access to information designated as confidential on a research study sponsored by SAMHSA/CBHSQ covered under CIPSEA. 
This agreement must be renewed each year as part of mandated CIPSEA training to maintain access to confidential project 

information. 
Assurances of Confidentiality under CIPSEA 
For any research study sponsored by the Substance Abuse and Mental Health Services Administration’s (SAMHSA) 
Center for Behavioral Health Statistics and Quality (CBHSQ) that is covered under the Confidential Information 
Protection and Statistical Efficiency Act (CIPSEA) of 2002* and Section 501(n) of the Public Health Service Act, all 
data and associated materials collected and/or utilized on that study are subject to protection by CIPSEA. CIPSEA 
ensures the confidentiality of all information provided is protected by Federal Law and stipulates that all 
information collected shall be used exclusively for statistical purposes. All research subjects contacted on 
SAMHSA/CBHSQ’s behalf by RTI International are notified of these protections prior to study participation.  
You have been identified as a person who has access to confidential information on a SAMHSA/CBHSQ‐sponsored 
study covered under CIPSEA (NSDUH and/or DAWN**) and therefore have been designated as an Agent under 
CIPSEA. This confidential information includes (but is not limited to) all electronic and hard copy documents 
containing respondent information and data, as well as non‐data related records containing information that could 
identify a location or respondent associated with a particular study.  
Protection Agreement under CIPSEA 
Per CIPSEA regulations, you agree that any materials that would permit the identification of research subjects are 
to be treated as confidential, and that you will never share or use that confidential information with anyone else or 
in a manner other than those authorized by CBHSQ. This includes never disclosing confidential information with 
law enforcement officials, officers of the court or your supervisor (if not also authorized as an Agent). 
To ensure the protection of all confidential information in both physical and electronic form, as an Agent, you also 
agree to: 
1) keep all confidential information in a space where access is limited only to authorized personnel, 
whether on a computer or in hard copy form; 
2) keep all confidential information within computer memory controlled by password protection; 
3) maintain a secure location (such as file cabinet or locked drawer) for printed materials, diskettes, and 
data on hard disks of personal computers when not in use; 
4) never remove confidential information from your approved worksite without prior approval from 
CBHSQ and/or RTI International; 
5) never permit any unauthorized removal of any confidential project information from the limited access 
space protected under the provisions of this agreement without first notifying and obtaining written 
approval from RTI;  
6) notify RTI when you no longer have access to electronic or hard copy files or printed materials 
containing confidential project information;  
*   Public Law 107‐347, Title V; for more info: http://www.whitehouse.gov/omb/fedreg/2007/061507_cipsea_guidance.pdf 
**National Survey on Drug Use and Health (NSDUH); Drug Abuse Warning Network (DAWN) 

v. 2012 

CIPSEA Confidentiality Agreement, SAMHSA/CBHSQ 
Administered by RTI International   

7) when appropriate, return all confidential project information to RTI; 
8) complete annual training on restrictions associated with the use of confidential information;   
9)  agree that representatives of CBHSQ have the right to make unannounced and unscheduled 
inspections of the facilities where you work to evaluate compliance with this agreement; 
10) notify RTI International immediately upon receipt of any legal, investigatory, or other demand for 
disclosure of confidential project information;  
11) notify RTI International immediately upon discovering any breach or suspected breach of security or 
any disclosure of confidential project information to unauthorized parties or agencies. 
12) and agree that obligations under this agreement will survive the termination of any assignment with 
SAMHSA/CBHSQ and/or RTI International.  
Penalties under CIPSEA 
Any violation of the terms and conditions of this agreement may subject you, the Agent, to immediate termination 
of access to confidential information by RTI International or CBHSQ, and will require the immediate return of all 
electronic and hard copy files and materials in your possession.  
Any violation of this agreement may also be a violation of Federal criminal law under Title V, subtitle A of the E‐
Government Act of 2002 (P.L. 107‐347); and/or Section 501(n) of the Public Health Services Act. Alleged violations 
under the Title V, subtitle A of the E‐Government Act of 2002 are subject to prosecution by the United States 
Attorney. The penalty for violation of subtitle A of the E‐Government Act of 2002 is a fine of not more than 
$250,000 and imprisonment for a period of not more than 5 years. In addition to the above, all relevant statutory 
and regulatory penalties apply. 
Your signature (whether in electronic or written form) below affirms your understanding and acknowledgement of 
all the regulations, requirements and penalties associated with CIPSEA as part of your work on this 
SAMHSA/CBHSQ project for RTI International.  

Name   

ID Number (if applicable, RTI employees only) 

Company Name 

Job Title 

Signature 

Date 

v. 2012 

Attachment S
Response to FR Comment

1724 Massachusetts Avenue, NW
Washington, DC 20036
202-454-5555
www.LegacyForHealth.org

Lawrence G. Wasden, Chair
Attorney General of Idaho
Boise, ID

April 30, 2012

Susan Curry, Ph.D., Vice-Chair
Dean, College of Public Health
Distinguished Professor, Health Management and Policy
University of Iowa
Iowa City, IA

VIA ELECTRONIC MAIL

Jonathan E. Fielding, Treasurer
Director Health Officer,
Los Angeles County Department of Public Health
Professor of Health Services and Pediatrics
Schools of Public Health and Medicine
University of California, Los Angeles
Los Angeles, CA

Summer King
SAMHSA Reports Clearance Officer
Room 8-1099
One Choke Cherry Road
Rockville, MD 20857

Benjamin K. Chu, M.D., M.P.H., M.A.C.P.
Immediate Past Chair
President, Southern California Region
Kaiser Foundation Health Plan and Hospitals
Pasadena, CA
Donald K. Boswell
President and CEO
Western New York Public Broadcasting Association
Buffalo, NY
Gary R. Herbert
Governor
State of Utah
Salt Lake City, UT
Tom Miller
Attorney General of Iowa
Des Moines, IA
Jeremiah W. (Jay) Nixon
Governor
State of Missouri
Jefferson City, MO
Charles K. Scott
Wyoming State Senator
Casper, WY
Leticia Van de Putte
Texas State Senator
San Antonio, TX
Cass Wheeler
Chief Executive Officer Emeritus
American Heart Association
Dallas, TX
Ritney Castine, Youth Board Liaison
Southern University
Baton Rouge, LA
Lee Storrow, Youth Board Liaison
University of North Carolina at Chapel Hill Alum
Chapel Hill, NC
Cheryl G. Healton, Dr. P.H. Ex-Officio
President and CEO
Legacy

RE: 2012 National Survey on Drug Use and Health
Questionnaire Field Test -- NEW
Dear. Ms. King:
Legacy appreciates the opportunity to comment on the 2012
National Survey on Drug Use and Health (NSDUH) Field Test
for the NSDUH 2015 survey year. We respectfully submit the
following comments that focus on emerging tobacco products,
cigar products and smokeless tobacco products.
The tobacco product landscape is changing and many novel
tobacco products have found their way to the market. In
addition, products that have been around for decades are
undergoing changes in order to take advantage of the new world
where cigarettes and smokeless tobacco are regulated for the first
time, but for now, other tobacco products are not. In order for
federal, state and local policy makers to develop policies to
protect the public health from the devastating toll tobacco exacts,
particularly on youth, national surveys must monitor these new
tobacco products and the trends in their use. NSDUH is an
important example of a national study that garners critical
information from a wide audience of both youth and adults. The
Field Test study for the redesigned 2015 NSDUH presents a
perfect opportunity to introduce and test new questions regarding
various tobacco products. While we have and will continue to
suggest similar questions for NSDUH surveys prior to 2015, at
the least, the 2015 survey should contain questions that are on the
cutting edge of tobacco control.
First, as the Food and Drug Administration (FDA) implements
the Family Smoking Prevention and Tobacco Control Act

(Tobacco Control Act), it is critical that all studies, whether funded or conducted by FDA or other
agencies, be harmonized, so that information can be compared across studies. For example, FDA is
currently funding the Population Assessment of Tobacco and Health (PATH) study that will monitor
tens of thousands of tobacco users and non-users over time. It will be important to be able to
compare the information gathered from that study with surveys such as NSDUH. We strongly urge
the Substance Abuse and Mental Health Services Administration (SAMHSA) to coordinate closely
with FDA in developing NSDUH questions.
Secondly, Legacy suggests the following regarding questions concerning specific tobacco products.
Cigarettes: The NSDUH Field Test contains several questions regarding the time respondents first
smoked a cigarette, including age and date of respondents’ first cigarette. Legacy respectfully
suggests that a question be added regarding whether or not a respondent’s first cigarette was
mentholated, a regular flavor cigarette, or if it contained some other flavor. Research suggests that
menthol cigarettes are a starter product among youth. For example, studies, including previous
NSDUH data, show that among smokers, a disproportionate number of youth and other vulnerable
populations smoke menthol cigarettes.1,2 In addition, a CDC analysis of the 2004 and 2006 National
Youth Tobacco Survey concluded that among established, middle and high school smokers,
Newport, a solely menthol brand at that time, was the second most preferred brand.3 A study of
earlier NYTS data suggests that menthol cigarettes are a starter product that may be associated with
smoking uptake by youth.4 However, there are few national studies that ask specifically if the first
cigarette used was a mentholated cigarette. Because FDA is currently reviewing the TPSAC report
regarding menthol cigarettes, knowing whether respondents started smoking with menthol or other
flavored cigarettes is of critical importance, and may be useful to FDA, as well as state and local
authorities, in making its policy determinations regarding menthol and other flavored tobacco
products. Similarly, in the section asking questions about becoming an everyday smoker, it would
be helpful to know if respondents were using mentholated, regular or other flavored cigarettes when
they started smoking every day. We suggest asking such questions for each category of tobacco
product.
Smokeless tobacco: Smokeless products in particular are on the forefront of the changing landscape
of tobacco products. For example, snus is a relatively new smokeless tobacco product in the United
States. In addition, products known as dissolvable tobacco products may be considered smokeless
tobacco by FDA.5 As newcomers to the U.S. tobacco market, there is a paucity of information on
these products. Therefore, it is critical that national surveys include questions regarding these
products in order to get a better picture of what respondents are actually using. This will also aid
FDA as well as state and local policy makers in making prudent public health policy decisions
regarding these products.
With regard to smokeless products, Legacy suggests that the current iteration of the Field Test does
not adequately capture information about the various smokeless tobacco types. While the Field Test
has added snus to the “smokeless category”, at the same time it has combined snus, snuff and
chewing tobacco products into one question. We suggest that questions be asked separately for each
of the different smokeless products to get the most accurate information. Indeed, in the 2013

NSDUH, as revised, questions are asked separately about snuff and chewing tobacco.6 We do not
recommend lumping together all the smokeless products but rather suggest that it would be
beneficial to separate out snuff and chewing tobacco and add questions about additional types of
smokeless tobacco, such as dissolvable tobacco or snus. Whether questions about the different
smokeless products are asked at the same time or asked separately, it may be helpful to add brand
name prompts into the initial questions regarding smokeless tobacco products. This can help ensure
that respondents understand which products they are being asked about, and may be particularly
helpful with newer products, such as snus.
At the same time, Legacy suggests that questions regarding brand names of smokeless tobacco be
added. There are brand name questions associated with cigarette and cigar products in the NSDUH
Field Test, the same should hold for smokeless products. The 2013 NSDUH, as revised, contains
brand name questions about snuff and chewing tobacco.7 We recommend keeping the questions
regarding brand names in the Field Test, and the subsequent 2015 NSDUH, and adding questions
about brand names of other smokeless products, such as snus or dissolvable tobacco.
Finally, Legacy recommends that questions regarding flavors of smokeless products be added. As
we suggested in the cigarette section, it would be valuable to add a question about the first time
respondents used a smokeless tobacco product and whether or not that product was flavored. In
addition, we suggest that a question or questions be added regarding whether or not the products
respondents are currently using are flavored. It may be helpful to include a list of potential flavors
and allow respondents to choose which they use currently or have used in the past.
Cigars: Legacy has submitted suggestions for changes to NSDUH questions in previous comments
submitted to SAMHSA. We reiterate those here. First, because the users and the usage patterns
appear to vary across the different types of cigars, Legacy encourages NSDUH to ask questions
about typical large cigars, sometimes referred to as “stogies,” separately from the questions about
little cigars or cigarillos. Research suggests large cigar users and little cigar and cigarillo users have
different demographic profiles and may have different patterns of multiple product use, with little
cigars and cigarillos being more popular among young adults, males, African-Americans, individuals
with lower education and those reporting current cigarette, marijuana and blunt use.8,9,10
Furthermore, since the 2009 federal excise tax that increased the tax on little cigars to equal that of
cigarettes, some little cigar manufacturers have slightly increased the weight of their little cigars
(though not so much as to look very different to the average consumer) and they now qualify as large
cigars and get a more preferable tax treatment.11,12,13 This conflation of cigar products creates a need
to be more specific in survey questions regarding cigar products.
In addition, we recommend that NSDUH amend and re-structure questions about brand use for little
cigars and cigarillos. Research indicates that little cigar and cigarillo users may not recognize these
products as cigars or even as tobacco products.14,15 Studies demonstrate that little cigar and cigarillo


Snus, moist snuff in tea bag-like packets, may also be addressed in the snuff category. While the 2013 NSDUH does
ask about snuff separately as we advocate, it does not ask about snus products, and no snus brand names are included in
the questions on snuff brand names. SAMHSA should either add snus and snus brand names to the snuff questions or
ask about snus separately from snuff products.

users do not self-report as cigar users despite reporting that they smoke a little cigar or cigarillo
when asked specifically about brands like Swisher Sweets or Black & Mild.16,17 Little cigar and
cigarillo brands may be more reliably reported than cigar type (i.e., little cigar or cigarillo),
particularly among at-risk groups such as younger and African-American users.18,19,20 Asking only
about little cigar or cigarillo use without specific brand item prompts may lead to underestimates of
prevalence.21
Currently in the NSDUH, only respondents who report past 30 day cigar use are asked brandspecific questions. Those who do not report smoking cigars at least once in their lifetime and those
who report smoking cigars at least once in their lifetime but not in the past 30 days are not
subsequently asked about brand use. To improve the precision of prevalence estimates, we
recommend that the NSDUH include brand-specific prompts, particularly of little cigar and cigarillo
brands, for questions regarding cigar ever and current use for all respondents.
The lack of significant data regarding the different types of cigar products is illustrated in a recent
analysis using 2002-2008 NSDUH data. That analysis showed that the top 5 cigar brands smoked by
respondents (Black & Mild, Swisher Sweets, Phillies, White Owl, and Garcia y Vega) include large
cigars, cigarillos and little cigar products. Yet, the authors were unable to determine whether
respondents were smoking large cigars as opposed to little cigars or cigarillos due to the grouping
together of cigar products in the questions.22
As we have suggested for other tobacco products, SAMSHA should include questions regarding the
use of flavored and non-flavored cigars for little cigars and cigarillos in the NSDUH. This is
especially important for cigar products given the fact that flavored cigarettes, except for menthol,
were banned by the Family Smoking Prevention and Tobacco Control Act. Furthermore, there is
evidence that some brands of flavored cigarettes simply changed their products to flavored cigars.23
Finally, we suggest adding a question regarding the number of cigar products smoked per day for
those who report usage in the past 30 days, as well as questions that ascertain concurrent use of
cigars with other tobacco products. These types of questions regarding usage patterns are critical in
understanding how and when respondents are using cigar products.
Electronic Cigarettes: Electronic cigarettes are also new products that have been deemed by the
courts to be a tobacco product.24 While not yet subject to FDA regulation, FDA has given
indications that they intend to regulate these products.25,26 There are currently no questions in the
Field Test regarding electronic cigarettes. Questions in national surveys about these products would
be very helpful to FDA, as well as state and local entities, in making public policy decisions
regarding electronic cigarettes. We suggest adding questions regarding ever use and past 30 day use
of electronic cigarettes to the NSDUH Field Test.
Legacy appreciates SAMHSA taking these comments into account as it develops this Field Test. As
we have stated above, we hope that these comments can be applied to earlier versions of NSDUH, as
well as to the 2012 Field Test for the 2015 NSDUH. It is critical that we have the appropriate
information about tobacco products in order to best determine how to protect the public health from

the deadly effects of tobacco, especially as the breadth and variety of tobacco products continues to
change. If you have questions or need further information, please contact Diane Canova, Vice
President of Government Affairs at dcanova@legacyforhealth.org or 202-454-5559.
Sincerely,

David Dobbins, JD
Chief Operating Officer

1

Caraballo R. Menthol and Demographics. Presentation to Food and Drug Administration Tobacco
Products Scientific Advisory Committee. March 30, 2010.
2
Substance Abuse and Mental Health Services Administration (SAMHSA). The NSDUH Report: The Use
of Menthol Cigarettes. Rockville, MD: Substance Abuse and Mental Health Services Administration,
Office of Applied Studies. November 19, 2009
3
Centers for Disease Control Cigarette Brand Preference Among Middle and High School Students Who Are
Established Smokers – United States, 2004 and 2006. February 13, 2009 MMWR 58(05);112-115
4
Hersey et al, Are menthol cigarettes a starter product for youth? Nicotine and Tobacco Research. 2006; 8(3): 40313.
5
FDA statement Clarification About Dissolvable Products
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm248801.htm . Accessed 04-24-12.
6
Substance Abuse and Mental Health Services Administration 2013 National Survey on Drug Use and Health:
Draft CAI Specifications for Programming English Version Prepared by Research Triangle Institute March 2012
7
Substance Abuse and Mental Health Services Administration 2013 National Survey on Drug Use and Health:
Draft CAI Specifications for Programming English Version Prepared by Research Triangle Institute March 2012
8
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among Young Adults
aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health. 2011
9
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny, KA., Shaw, N., Danosky, L. Adult use of cigars,
little cigars, and cigarillos in Cuyahoga County, Ohio: A cross-sectional study. Nicotine and Tobacco Research.
2010;12(6):669-673.
10
Richardson A et al. “Primary and Dual Users of Cigars and Cigarettes: Profiles, Tobacco Use Patterns and
Relevance to Policy.” Nicotine and Tobacco Research, January 17, 2012
11
Kesmodal, D. Close and It Is a Cigar: Tobacco Manufacturers Are Accused of Exploiting a Tax Loophole to
Boost Sales. The Wall Street Journal. September 23, 2010.
http://online.wsj.com/article/SB10001424052748703399404575505670223138144.html. Accessed 4-25-12.
12
Government Accountability Office. Illicit Tobacco: Various Schemes Are Used to Evade Taxes and Fees. GAO11-313. March 2011. http://www.gao.gov/new.items/d11313.pdf. Accessed 4-25-12.
13
Government Accountability Office. Large Disparities in Rates for Smoking Products Trigger Significant Market
Shifts to Avoid Higher Taxes. GAO-12-475. April 2012. http://www.gao.gov/assets/600/590192.pdf Accessed 425-12.
14
Page JB, Evans, S. Cigars, Cigarillos, and Youth: Emergent Patterns in Subcultural Complexes.
Journal of Ethnicity in Substance Abuse. 2003;2(4):63-76.
15
Yerger VP, C., Malone, M.E. When is a cigar not a cigar? African American youths' understanding of
cigar use. American Journal of Public Health. 2001;91(2):316-317.
16
Terchek J, Larkin, EMG., Male, ML., Frank, SH. Measuring cigar use in adolescents: Inclusion of a
brand-specific item. Nicotine and Tobacco Research. 2009;11(7):842-846.
17
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny, KA., Shaw, N., Danosky, L. Adult use of cigars,
little cigars, and cigarillos in Cuyahoga County, Ohio: A cross-sectional study. Nicotine and Tobacco Research.
2010;12(6):669-673.
18
Terchek J, Larkin, EMG., Male, ML., Frank, SH. Measuring cigar use in adolescents: Inclusion of a brandspecific item. Nicotine and Tobacco Research. 2009;11(7):842-846.
19
Borawski E, Brooks, A., Colabianchi, N., Trapl, ES, Przepyszny, KA., Shaw, N., Danosky, L. Adult use of cigars,
little cigars, and cigarillos in Cuyahoga County, Ohio: A cross-sectional study. Nicotine and Tobacco Research.
2010;12(6):669-673.
20
Trapl ES, Terchek JJ, Danosky L, Cofie L, Brooks-Russell A, Frank SH. Complexity of measuring "cigar
use" in adolescents: results from a split sample experiment. Nicotine and Tobacco Research. Apr
2011;13(4):291-295.
21
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among Young Adults
aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health. 2011.
22
Cullen J, Mowery P, Delnevo C, et al. Seven Year Patterns in U.S Cigar Use Epidemiology among Young Adults
aged 18-25: A Focus on Race/Ethnicity and Brand American Journal of Public Health. 2011.

23

Letter from Rep. Henry Waxman to FDA Commissioner Margaret Hamburg. March 28, 2011. Available at :
http://democrats.energycommerce.house.gov/index.php?q=news/rep-waxman-urges-fda-to-ban-clove-flavoredcigars Accessed 4-23-12.
24
Sottera, Inc. v. Food and Drug Administration, 627 F.3d 891 (D.C. Cir. 2010)
25
Food and Drug Administration letter to industry stakeholders April 2011. Available at:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm . Accessed 4-25-12.
26
Health and Human Services Semiannual Regulatory Agenda “Tobacco Products Subject to the Federal Food,
Drug and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act.” RIN 0910AG38. Published in the Federal Register July 7, 2011,at 40061-40062; and February 13, 2012, at 7952. Available
respectively at:
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM263819.pdf
(accessed 4-25-12) and http://www.gpo.gov/fdsys/pkg/FR-2012-02-13/pdf/2012-1647.pdf (accessed 4-25-12).

May 10, 2012

Mr. David Dobbins, JD
Chief Operating Officer
Legacy for Health
1724 Massachusetts Ave, NW
Washington, DC 20036
Re: Comments on the 2012 National Survey on Drug Use and Health Questionnaire Field Test
Dear Mr. Dobbins:
Thank you very much for your interest in the 2012 National Survey on Drug Use and Health
Questionnaire Field Test and for your valuable suggestions. You have provided us with very
useful information on the changing nature of the tobacco landscape. These issues are important
and we agree that they should be studied.
In the early stages of the redesign, several new items were developed for the tobacco module to
capture additional detail as you have suggested. Given that NSDUH has been conducted since
1971, however, maintaining trends is an essential part of the study. After review by senior
SAMHSA management and ONDCP, it was decided to give preservation of trends the highest
priority. With that in mind, there was a decision not to alter the core drug modules, with the
exception of prescription drugs, in the redesigned questionnaire. Therefore, changes to the core
tobacco module have been limited. Nevertheless, SAMHSA maintains communications with the
FDA and the Office on Smoking and Health to keep abreast of emerging tobacco products that
may be considered for future non-core modules.
The one exception that was permitted was to combine the smokeless substances. As you know,
the NSDUH provides current data on the use of illicit drugs, alcohol, and tobacco in the U.S.
population – aged 12 or older – as well as each state. In an effort to preserve response rates and
control respondent burden, we strive to maintain average interview length of 60 minutes.
Therefore, we are required to consider the data obtained from each topic and whether valid and
reliable national estimates can eventually be produced from the questions. In analyzing our data
on chewing tobacco and snuff, we found that a large proportion of respondents could not
differentiate between these two classes of smokeless tobacco. This was evident from the brand
names reported in response to subsequent questions. Given the uncertainty of these responses,
particularly when multiple brand names or no brand names are reported, the most practical thing
to do is to combine these data in analysis. Since most respondents seem to be able to report
using a smokeless product, but many are unable to differentiate between chewing tobacco and
snuff, it was prudent to combine the questions and save time in the instrument. Although we see

the analytic value, we do not feel that producing separate estimates of chewing tobacco and snuff
from NSDUH data would be appropriate.
As always, we appreciate and welcome your comments and input. If you have any questions,
please let us know.
Sincerely,

Michael Jones
NSDUH Project Officer
Substance Abuse and Mental Health Services Administration
1 Choke Cherry Road
Rockville, MD 20857