Generic Clearance_SS_ A_qualitative 6 18 OMB

Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

0901-NEW

Supporting Statement

1. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

FDA’s Center for Tobacco Products oversees implementation of the Family Smoking Prevention and Tobacco Control Act, also known as the Tobacco Control Act (Attachment 1), signed into law on June 22, 2009. Also, section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355) provides that FDA may take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&C Act. Further, the FD&C Act also authorizes FDA to conduct educational and public information programs (21 U.S.C. 393(d)(2)(D)). In addition to regulating the manufacture, distribution, and promotion of tobacco products, the Center for Tobacco Products also conducts studies to inform regulatory actions and communicates with the public on the health risks of tobacco use.

To ensure that regulatory actions and communications activities have the highest potential to be received, understood, and accepted by those for whom they are intended, FDA’s Center for Tobacco Products will conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act (42 U.S.C 241(a)) (Attachment 3). FDA is requesting approval of this new generic for collecting information through the use of qualitative methods (i.e., individual in-depth interviews (IDIs), small group discussions, and focus groups) for studies about tobacco products. Qualitative studies play an important role in exploring areas of research and gathering information because the studies allow for an in-depth understanding of individuals’ attitudes, beliefs, motivations, and feelings. This information will be used to inform the regulatory science knowledge base, as well as to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communication messages and educational campaigns related to public health.

FDA will submit individual collections under this generic clearance to the Office of Management and Budget (OMB). Before submission to OMB, individual collections will undergo review by FDA’s Research Involving Human Subjects Committee (RIHSC), senior leadership in the Center for Tobacco Products, and Paperwork Reduction Act (PRA) specialists. FDA will prepare a report during the OMB collection renewal summarizing the number of hours used, as well as the nature and results of the activities completed under this clearance.

2. Purpose and Use of the Information Collection

In conducting studies relating to the control and prevention of tobacco-related disease, FDA will need to employ qualitative research, including individual in-depth interviews (IDIs), small group discussions, and focus groups to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve two major purposes. First, it will provide critical knowledge about target audiences. FDA must first understand people’s knowledge and perceptions about tobacco-related topics prior to developing survey/research questions, stimuli for experimental studies, and draft communication messages directed at consumers. Second, initial testing will allow FDA to assess consumer understanding of survey/research questions and draft messages. These qualitative data collection methods will allow FDA to generate exploratory data on a given research topic or area of research, and to inform survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, analyze, and interpret information gathered through this generic clearance in order to (1) better understand characteristics of the target audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, and materials directed to consumers; (2) more efficiently and effectively design survey/research questions and study stimuli; (3) more efficiently and effectively design experimental studies; and (4) gain an in-depth understanding of a pertinent research area and topic.

FDA will only submit a collection for approval under this generic clearance if it meets the following conditions:

• The collections are voluntary;

• The collections are low burden for respondents (based on considerations of total burden hours, total number of respondents, or burden hours per respondent) and are low cost for both the respondents and the Federal Government;

• The collections are noncontroversial;

• Personally identifiable information (PII) is collected only to the extent necessary¹ and is not retained;

• Information gathered will not be used for the purpose of substantially informing influential policy decisions;² and

• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. 

If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process.

To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation (e.g., a copy of the interview or moderator guide, screening questionnaire). Before submission to OMB, individual collections will undergo review by FDA’s RIHSC, senior leadership in the Center for Tobacco Products, and PRA specialists.

The types of collections that this generic clearance covers include, but are not limited to:

• Focus groups or small group discussions, which may include 2 to 12 participants

• Individual in-depth interviews (IDIs)

3. Use of Improved Information Technology and Burden Reduction

Consideration will be given to collecting information electronically or using online collaboration tools to reduce burden. However, the applicability of such tools to in-person interviews and/or discussions is at present relatively unlikely, since the quality and level of detail in qualitative data collection would be difficult to obtain via virtual data collection methods. Therefore, due to the nature of qualitative research, approximately 5 percent of these information collections will be completed electronically.

4. Efforts to Identify Duplication and Use of Similar Information

As each new research study is developed, FDA will review existing literature and databases, including pretesting reports on existing messages and materials. FDA will also consult with outside experts to evaluate available information on similar messages with comparable audiences. FDA will work with other HHS agencies responsible for communicating about tobacco use with the general public.

However, because communications to consumers, surveys, and studies on the use of tobacco will be diverse and vary by target audience, new data collection instruments generally will be prepared for each qualitative study.

Therefore, data collected by FDA is unique. Coordination with other agencies ensures that duplicative data is not being gathered. Further, no similar data are gathered or maintained by FDA or are available from other sources known to FDA.

5. Impact on Small Businesses or Other Small Entities

Small businesses, or other small entities, may be involved in efforts related to collections of information approved under this clearance. However FDA will minimize the effect and burden on them by sampling appropriately

6. Consequences of Collecting the Information Less Frequently

Often, this qualitative information is used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, the collection of timely data will be important to the development and conduct of ongoing and future research efforts at the Agency. Without these types of feedback about consumer knowledge and perceptions, FDA will not have timely information to adjust its survey/research questions, study stimuli and draft communication messages

This information may also be used to help develop materials directed at consumers. FDA is using a variety of messages and materials to inform and educate the public about the risks of tobacco use. Communicating effectively about the risks of using tobacco products involves conveying complex concepts, and without detailed data from qualitative testing, FDA cannot fully ensure that tobacco messages and materials directed at consumers are serving their intended purpose. As a result, FDA could spend a large amount of money on communications, surveys, or other studies that are ineffective in achieving the intended purpose of reducing tobacco-associated costs to people’s lives and to the government.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances for this collection of information. The information collected will be voluntary and will not be used for statistical purposes.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment on the proposed collection of information in the FEDERAL REGISTER of August 1, 2014 (79 FR 44779). FDA received two comments. However, only one comment was considered to be PRA-related.

(Comment) One comment was supportive of the information collection stating that such “collections are, in fact, essential.” That submission also made suggestions about what the specific goals of messages tested in information collections included under this generic collection should focus on and suggested that those collections be made available for further public comments

(Response) FDA agrees that the request in this collection of information is essential to the mission of the FDA as a science-based agency in its implementation of the Tobacco Control Act. Although we appreciate suggestions for the content of future submissions submitted under this generic clearance, ultimately such decisions will be driven by needs determined by the Agency in consultation with other HHS agencies, FDA advisory committees, and/or the public when appropriate.

9. Explanation of Any Payment or Gift to Respondents

It is standard practice in commercial market research to offer recruited respondents some form of remuneration for the time they spend engaged in a personal interview activity. Instances for offering a small incentive will be determined on a case-by-case basis (depending on the particular information collection design). Small amounts of money may be offered as an incentive for participation in in-person interviews. Incentives for in-person cognitive interviews should not be more than $40 or more than $75 for in person focus groups of 90 -120 min. FDA will provide empirical evidence will be presented to justify proposed incentives beyond these standards. Significantly lower incentives for Web-based or telephone focus groups will be offered. In certain instances of difficult-to-recruit populations, FDA may propose incentives at a higher rate if evidence is provided.

10. Assurance of Confidentiality Provided to Respondents

While anonymity of respondents generally cannot be assured unless there is a statutory requirement associated with the information collection, information provided by respondents will be kept private and anonymous, to the extent allowable by law. This will be communicated to respondents by means of introductory letters, explanatory texts on the cover pages of questionnaires, scripts read prior to focus groups, telephone interviews, and consent forms. Respondents also will be advised of the following: the nature of the activity; the purpose and use of the data collected; FDA sponsorship (when appropriate);³ and the fact that participation is voluntary at all times. Because responses are voluntary, respondents will be assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any particular questions.

Only personnel from a contractor conducting the information collection will have access to focus group or interview data. All project staff from a contractor conducting the information collection must take required measures to ensure the privacy and anonymity of data. Personally identifiable data will be limited to information that may be required in the process of respondent enrollment. Personally identifiable information will be accessible to contractors on an as needed basis, and will not be linked to interview data. All personally identifiable data will be destroyed following data collection at the completion of the study. Neither FDA employees nor any Federal employee of any other agency will have access to this information.

All electronic and hard copy data will be maintained securely throughout the information collection and data processing phases. While under review, electronic data will be stored in locked files on secured computers and hard copy data will be maintained in secure building facilities in locked filing cabinets. As a further guarantee of privacy and anonymity, all presentation of data in reports will be in aggregate form, with no links to individuals. Reports will be used only for research purposes and for the development of communication messages.

Interviews are typically considered exempt from the “Regulations for the Protection of Human Subjects” in accordance with 45 CFR 46.101(b)(3). Before data are collected, FDA researchers will obtain either an exemption or a full approval for all research from FDA’s Investigational Review Board (IRB), the Research Involving Human Subjects Committee.

Minors (or children) are persons who have not attained the legal age for consent to treatments or procedures described in the study are covered under the applicable law of the jurisdiction in which the research will be conducted. Where FDA’s IRB determines that minors are capable of giving an assent, the IRB will determine whether adequate provisions are made for soliciting assent. Generally, assent to the research requires securing the signature of a minor in a separate assent form, in addition to the consent form the parent or legal guardian signs. An assent document should contain an explanation of the study, a description of what is required of the subject (e.g., what the child will experience (in what setting the interview or focus group will take place, whether the child's parents will be with him or her, etc.)), an explanation of any risks or mental anguish associated with the study topic, and an explanation of the benefits to the child or others.

11. Justification for Sensitive Questions

Some studies require the inclusion of people who match selected characteristics of the target audience that FDA is trying to reach. Efforts to match characteristics may require asking a question about race/ethnicity, income, education and/or health status on the initial screening questionnaire used for recruiting. Potential participants are informed that this is being done to make sure that FDA speaks with the kinds of people for whom its messages are intended. Again, respondents are assured that the information is voluntary and will be treated as private and anonymous. All information on race/ethnicity will comply fully with the standards of OMB Statistical Policy Directive No. 15, October 1997 (http://www.whitehouse.gov/omb/fedreg/1997standards.html).

Because FDA research activities may be concerned with the prevention of premature mortality from heart disease and oral and respiratory cancers, some projects may involve asking questions about (or discussing) how one perceives his/her own personal risk for serious illness. This information is needed to gain a better understanding of the target audience so that the messages, strategies, and materials designed will be appropriate and sensitive. Questions of this nature, while not as personal as those about sexual behavior or religious beliefs, still require some sensitivity in how they are worded and approached. In face-to-face data collections, questions of this kind are generally asked later in the interview or group discussion, when respondents are more comfortable with the interview situation and are more at ease with the interviewer/moderator. Participants are informed prior to actual participation about the nature of the activity and the voluntary nature of their participation. The interviewer/moderator makes it clear that they do not have to respond to any question that makes them uncomfortable.

FDA tobacco research and communications may also be concerned with discouraging tobacco use by adolescents before they start. FDA acknowledges the sensitivity of questions about the purchase and use of tobacco, which is illegal for minors in some states. Because questions are being asked of teenagers, interviews will be conducted by moderators specifically trained for interaction with adolescents.

Raw data from data collections that may include sensitive information (for example, screening questionnaires and audio tapes) are not retained once the data have been extracted and aggregated. The information never becomes part of a system of records containing permanent identifiers that can be used for retrieval.

12. Estimates of Annualized Burden Hours and Costs

A variety of instruments and platforms will be used to collect information from respondents. The annual respondent burden hours requested (6184) are based on the number of collections we expect to conduct over the requested time frame for this clearance.

12a. Annualized Hour Burden Estimate

Table 1.--Estimated Annual Reporting Burden, by Anticipated Data Collection Methods

Type of Interview	Number of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden Per Response	Total Hours
In-Person Individual In-Depth Interviews	350	1	350	1.0	350
Focus Group Screening Interviews	7200	1	7200	.25	1800
General Public Focus Group Interviews	2400	1	2400	1.5	3600
Telephone Screening Interviews	4,800	1	4,800	.08	384
Telephone Individual In-Depth Interviews	50	1	50	1.0	50
TOTAL	14800				6184

12b. Annualized Cost Burden Estimate

The general public will complete the majority of data collections. The average hourly compensation for this group is $22.33.⁴ The estimated annualized annual cost for the general public in this information collection for 6184 hours of reporting time is $138.088.72. The number of respondents and length of response was determined on the basis of FDA prior experience with communications testing and an estimate of the communication needs of the Center for Tobacco Products. The actual numbers will vary depending upon the topic of interest

Type of Interview	Total Burden Hours	Average Rate	Total Respondent Cost
In Person Individual In-Depth Interviews	350	$22.33	$7,815.50
Focus Group Screening Interviews	1800	$22.33	$40,194
General Public Focus Group Interviews	3600	$22.33	$80,388
Telephone Screening Interviews	384	$22.33	$8,574.72
Telephone Individual In-Depth Interviews	50	$22.33	$1,116.50
TOTAL			$138,088.72

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs

There are no capital, start-up, operating, or maintenance costs associated with this information collection.

14. Annualized Cost to Federal Government

FDA incurs costs to set up IDIs and focus groups, including potentially hiring a contractor to provide a facilitator/moderator, rent meeting space, travel to conduct the groups, and provide respondents with minimum payment cost in the form of a token stipend.

Costs will include contractor expenses for designing and conducting information collection activities, specifically, drawing samples, training interviewers, collecting and analyzing information, and reporting findings. Contractor expenses may vary from $20,000-$250,000 depending on the size of the study. Therefore, in a given year, it is anticipated that approximately $1 million in contractor expenses will be expended to fund at least two large scale study and eight smaller scale studies.

In addition, government staff costs may be incurred for monitoring by the government Project Officer and Senior Analyst, projected to be about 25 percent of an FTE’s time per year (522 hours). Given an FDA personnel cost of $48.35 per hour, $25,238.70 would be spent annually on government staff salaries.

The total estimated annual cost to the government for this collection of information is $1,025,238.70 (which is equal to the total of contractor expenses ($1 million) plus FDA government staff salary cost ($25,238.70)).

15. Explanation for Program Changes or Adjustments

This is a new collection of information

16. Plans for Tabulation and Publication and Project Time Schedule

Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. Findings will be used to inform experimental research, public education, or communication activities.

FDA will disseminate the findings when appropriate, strictly following FDA's "Guidelines for Ensuring the Quality of Information Disseminated to the Public," and will include specific discussion of the limitation of the qualitative results discussed above.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

We are not requesting an exemption to this requirement. The OMB expiration date will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

These information collection activities comply with the requirements in 5 CFR 1320.9 and involve no exception to the Certification for Paperwork Reduction Act Submissions.

1 For example, collections that collect PII in order to provide remuneration for participants of focus groups and cognitive laboratory studies will be submitted under this request. All privacy act requirements will be met.

2 As defined in OMB and agency Information Quality Guidelines, “influential” means that “an agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions.”

3 In some cases, FDA sponsorship will not be made known to respondents prior to data collection out of concern for the potential introduction of bias to study results. In such cases, FDA sponsorship will be made known after the data are collected.

5