**SUPPORTING STATEMENT FOR REQUEST FOR OMB APPROVAL**

**UNDER THE PAPERWORK REDUCTION ACT AND 5 USC PART 1320**

**FOR FOCUS GROUPS AS USED BY THE FOOD AND DRUG ADMINISTRATION**

A.  [JUSTIFICATION]{.underline}

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1.  [Circumstances Necessitating Information Collection]{.underline}

The Food and Drug Administration (FDA) is requesting approval for the
information collection requirements through the use of focus groups.
This information will be used to develop programmatic proposals, and as
such compliments other important research findings to develop these
proposals. Focus groups do provide an important role in gathering
information because they allow for a more in-depth understanding of
consumers' attitudes, beliefs, motivations, and feelings than do
quantitative studies. Also, information from these focus groups will be
used to develop policy and redirect resources, when necessary, to our
constituents

This information will be used to develop programmatic proposals that are
aligned with the respondents' input. A focus group supplements other
forms of public involvement. It serves the narrowly defined need for
direct and informal opinion on a specific topic.

2.  [How, By Whom, Purpose of Collection]{.underline}

Information from these focus groups will be used also to develop policy
and redirect resources, when necessary, to our constituents. If this
information is not collected, a vital link in gathering information by
FDA to develop policy and programmatic proposals will be missed causing
further delays in the development of such.

> Focus groups used as a qualitative research tool have three major
> purposes:

-   To obtain consumer information useful for developing variables and
    measures for quantitative studies;

-   To better understand consumers' attitudes and emotions in response
    to topics and concepts; and

-   To further explore findings obtained from quantitative studies.

> Focus groups do not yield meaningful quantitative findings. They can
> provide public input, but they do not yield data about public opinion
> that can be generalized. As such, they cannot be used [to
> drive]{.underline} the development of policies, programs, and
> services. Policy makers and educators can use focus groups findings to
> test and refine their ideas, but should then conduct further research
> before making important decisions such as adopting new policies and
> allocating or redirecting significant resources to support these
> policies.
>
> Focus groups can be used to develop programmatic proposals, and as
> such complements other important research findings used to develop
> these proposals. Focus groups do provide an important role in
> gathering information because they allow for a more in-depth
> understanding of consumers' attitudes, beliefs, motivations, and
> feelings than do quantitative studies.
>
> Every center in FDA will likely make use of focus groups for gauging
> public opinion and use public input to drive the development of
> policies, programs and services and the allocation of resources.
>
> According to OMB guidelines for generic clearances for focus groups,
> FDA will establish an independent review process to assure the
> development and implementation of high quality focus groups by FDA.
> FDA will provide OMB a copy of the survey instrument for inclusion in
> the public docket.

3.  [Consideration Given to Information Technology]{.underline}

Focus group studies are directed group discussions that do not produce
quantitative data, but which enable skilled observers to infer the
underlying views and assumptions of the group that are expressed in the
discussion. To facilitate interpretation, discussion are recorded and
videotaped so that both a visual record and written transcript of the
discussion are available for review.

4.  [Duplication or Similar Information]{.underline}

> It is not expected that any of the information to be submitted to the
> FDA during these focus group studies is duplicative or is already in
> the possession of the Federal Government. The proposed focus groups
> will address the needs of the Agency and significantly improve our
> ability to test and redefine ideas that will allow FDA to conduct
> further research before making important decisions such as adopting
> new policies and allocating or redirecting significant resources to
> support these pollicies.

5.  [Minimize Burden to Small Entities]{.underline}

> Not Applicable

6.  [Consequences of Not Conducting Collection]{.underline}

Usually FDA will collect data only once to provide information to gauge
public opinion and use public input to drive the development of
policies, programs and services and the allocation of resources. This is
not a periodic data collection. Without these data collections, existing
disagreements within the stakeholder community about how to proceed in
this matter will be much harder to resolve. Without additional
information of the kind that would be provided by the study, large
segments of the stakeholder community will likely be unsatisfied with
whatever option is adopted. Only by feeding information about the likely
consumer impacts of different options back into the policy, program, or
service allocation dialogue, will it be possible to bridge the gaps
between stakeholders and arrive at a mutually acceptable policy,
program, or service allocation decisions. Ultimately, the speed and
level of marketplace adoption of policies, program, or service
allocations depend on this information.

7.  [Information Collection Circumstances]{.underline}

There are no special circumstances for the collection of information.

8.  [Consultations with Persons Outside FDA]{.underline}

> FDA will use routine contacts with customers, review of subject
> materials and other qualitative information collection activities to
> identify areas of interest and concern to customers. FDA will use
> in-house statistical staff and outside contractors in developing focus
> group plans. According to OMB guidelines for generic clearances for
> focus groups, FDA will establish an independent review process to
> assure the development and implementation of high quality focus groups
> by FDA. FDA will provide OMB a copy of the survey instrument for
> inclusion in the public docket.

In accordance with 5 CFR 1320.8(d) on May 24, 2002, FDA published a
60-day Federal Register notice (67 FR 36613) titled "Agency Information
Collection Activities; Proposed Collection; Comment Request: Focus
Groups as Used by the Food and Drug Administration". FDA received four
comments, but they did not pertain to the information collection though
one heartily supported the use of focus groups as an instrument to help
FDA better understand how well respondents comprehend health issues.

> The first comment was not at all germane to this information
> collection and pertained that a company made up data it submitted to
> FDA and violated FDA regulations.
>
> The second comment was from someone who is opposed to FDA "infringing
> on her rights to buy and use health care supplements by making laws
> (sic) prohibiting their sale and use".
>
> The third comment is from a person who thinks this information
> collection is useful and worth the cost and time and thinks that FDA
> should try Internet surveys.
>
> The final comment was from the American Red Cross and it is in favor
> tot he use of focus groups and supports the "clearance" since focus
> groups, if well defined, can be an useful mechanism for aiding donor
> recruitment programs and the development o donor screening.

Again none of the comments pertain the paperwork considerations of this
information collection.

9.  [Payment or Gift]{.underline}

It is standard practice to reimburse focus group respondents for their
time. Incentives will be decided on a case by case basis

10. [Assurance of Confidentiality]{.underline}

The confidentiality of respondents will be assured by using an
independent contractor to collect the information, by enacting
procedures to prevent unauthorized access to respondent data, and by
preventing the public disclosure of the responses of individual
participants.

11. [Privacy]{.underline}

No questions will be asked that are of a personal or sensitive nature.

12. [Burden of Information Collection]{.underline}

The total annual estimated burden imposed by this collection of
information is approximately 2,884 hours annually.

TABLE 1. -- ESTIMATED ANNUAL REPORTING BURDEN

  -------------- -------------------- --------- ----------- -------------- ------------ --------
  Center         Subject              No. of    No. of      No. of         Hours of     Total
                                      Focus     Focus       Participants   Duration for Hours
                                      Groups    Groups      per Group      Each Group   
                                      per Study Sessions                   (includes    
                                                Conducted                  screening)   
                                                Annually                                

  Center for     May use focus groups 1         5           9              1.58         71
  Biologics      when appropriate                                                       
  Evaluation and                                                                        
  Research                                                                              

  Center for     Varies (e.g.,        10        100         9              1.58         1,422
  Drug           direct-to-consumer                                                     
  Evaluation and Rx drug promotion,                                                     
  Research       physician labeling                                                     
                 of Rx drugs,                                                           
                 medication guides,                                                     
                 over-the-counter                                                       
                 drug labeling, risk                                                    
                 communication)                                                         

  Center for     Varies (e.g., FDA    5         25          9              2.08         468
  Devices and    Seal of Approval,                                                      
  Radiological   patient labeling,                                                      
  Health         tampons, on-line                                                       
                 sales of medical                                                       
                 products, latex                                                        
                 gloves)                                                                

  Center for     Varies (e.g., food   8         32          9              1.58         455
  Food Safety    safety, nutrition,                                                     
  and Applied    dietary supplements,                                                   
  Nutrition      and consumer                                                           
                 education)                                                             

  Center for     Varies (e.g., animal 5         25          9              2.08         468
  Veterinary     nutrition,                                                             
  Medicine       supplements,                                                           
                 labeling of animal                                                     
                 Rx)                                                                    

  Total                               29        187                        1.99         3,352
  -------------- -------------------- --------- ----------- -------------- ------------ --------

1

There are no capital costs of operating and maintenance costs associated
with this collection of

information.

The estimates for question 12 come from projected focus group usage for
the next year. Each center and office was asked for the number and size
(studies) of the focus groups that they will conduct next year.

13. [Cost to Respondents]{.underline}

Not applicable. Respondents will have no additional burden beyond the
hours burden shown in item 12. Respondents will not need capital
equipment, on going recordkeeping operations, or services to complete
the information collection.

14. [Costs to Federal Government]{.underline}

The Agency incurs costs to set up the focus groups including hiring the
contractor (facilitator or moderator), renting meeting space, travel and
subsistence and the payment of a de minimis cost in the form of a token
stipend. For these expenses, FDA spends approximately \$160,000
annually.

15. [Reason for Change]{.underline}

> This is the first time that the Agency has asked for approval for the
> use of focus groups to help FDA fulfill the Agency's mission of
> protecting public health. It can used to drive the development of
> policies, programs and services and the allocation of resources.

16. [Statistical Reporting]{.underline}

There are no tabulated results for this information collection.

In light of the recently issued information quality guidelines, it seems
appropriate to include in this package a restriction on the
dissemination of the results of focus groups. Please add that to the
package. The following will be added to item #16.

Information gathered from focus groups is qualitative in nature. They
allow for a more in-depth understanding of consumers' attitudes,
beliefs, motivations, and feelings than do quantitative studies. This
information will be used to develop programmatic proposals that are
aligned with the respondents' input. It serves the narrowly defined need
for direct and informal opinion on a specific topic.

Focus groups do not yield meaningful quantitative findings. They can
provide public input, but they do not yield data about public opinion
that can be generalized. Policy makers can use focus groups findings to
test and refine their ideas, but should then conduct further research
before making important decisions such as adopting new policies and
allocating or redirecting significant resources to support these
policies.

> The confidentiality of respondents will be assured by using an
> independent contractor to collect the information, by enacting
> procedures to prevent unauthorized access to respondent data, and by
> preventing the public disclosure of the responses of individual
> participants. With such information FDA does not plan to disseminate
> the results of focus groups.
>
> The confidentiality of respondents will be assured by using an
> independent contractor to collect the information, by enacting
> procedures to prevent unauthorized access to respondent data, and by
> preventing the public disclosure of the responses of individual
> participants.

For the above reasons, there is no reason for FDA to disseminate to the
public information procured through Focus Groups and will not do so.

17. [Display of OMB Approval Date]{.underline}

FDA is requesting no exemption.

18. [Exceptions to "Certification for Paperwork Reduction Act
    Submissions"]{.underline}

These activities will comply with the requirements in 5 CFR 1320.9.

**B. STATISTICAL METHODS**

> There are no plans to publish this information for statistical use.