0677 SS Part B for 2017 Extension

Food and Drug Administration (FDA):
Focus Groups About Drug Products
OMB Control Number 0910-0677
Supporting Statement
Part B

1. Respondent Universe and Sampling Methods
Focus group studies are directed group discussions that enable skilled observers to infer the
underlying views and assumptions of the group members that are expressed in the discussion.
Focus group research relies on qualitative methods and is not intended to yield results that can be
generalized to the overall population. Results of this research will not be used to make
statements representative of the universe of study, to produce statistical descriptions (careful,
repeatable measurements), or to generalize the information beyond the scope of the sample.
For these focus group studies, we may use quota sampling to select a convenience sample of
individuals who meet certain qualifications that reflect characteristics typical of the target
audience. Response rate is not applicable to quota sampling because this type of sampling
results in a nonprobability sample which is not representative of the population. In these studies,
we will usually initially contact respondents by telephone or through the mail; over-recruiting is
done to compensate for not following up with non-respondents. In certain cases, cluster
sampling may be used to form focus groups for specific purposes in which a population grouped
by household or by residence may be desired.
2. Procedures for the Collection of Information
Focus groups, or group interviews, are used to obtain insights into target audience perceptions,
beliefs, and attitudes in the early stages of the communication process (i.e., in concept, strategy,
and materials development.) Focus groups are usually composed of 8 - 10 people who have
characteristics similar to the target audience or to subgroups of the target audience. The groups
are conducted by a professional moderator who keeps the session on track while allowing
respondents to talk openly and spontaneously. The moderator uses a loosely structured
discussion outline, which allows him/her to change direction as the discussion unfolds and new
topics emerge.
Focus groups will generally be held in locations that participants travel to by car or short-range
public transportation. When a specialized population of participants is necessary, such as
physicians with expertise in a particular specialty, focus groups may be held at scientific or
academic meetings. Some geographic diversity may be built in where such diversity is deemed
appropriate by conducting focus groups in different regions across the 48 contiguous United
States. Sometimes, however, when there is a particular need for rapidly gathering information
from people who are located across the United States, focus groups may be held by telephone
and may use Web technology to decrease burden and increase efficiency.
All data collection and analysis will be performed in compliance with OMB standards and
guidance, Privacy Act, and Protection of Human Subjects requirements.

3. Methods to Maximize Response Rates and Deal with Non-response
To reduce the number of no-shows, scheduled focus group participants will be sent a reminder
letter and/or telephone call giving the time of the interview and directions to the location. As
described in Part A of the supporting statement, participants will receive a stipend. As
previously noted, the information collected under this generic clearance will be qualitative; these
methods to deal with non-response are adequate for this purpose.
4. Test of Procedures or Methods to be Undertaken
Before each information collection is implemented, we will pilot test the moderator guide and
study protocol. Lessons from the pilot test will be identified, and changes as necessary will be
incorporated into the moderator guide and study protocol. All pilot tests will involve internal
staff or no more than nine members of the public. If we require more than nine pretest
respondents from the public, we will submit the pretest protocol for review and approval under
this generic clearance.
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing
Data
Focus group studies are qualitative in nature and do not require statistical consultation.
In general, FDA plans to use a contractor to for recruiting and conducting focus group
discussions. They will also provide an analysis of the information and provide a summary report.