[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Notices]
[Page 58309-58310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc07-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0098]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Focus Groups as Used
by the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 14, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0497. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Focus Groups as Used by the Food and Drug Administration--(OMB Control
Number 0910-0497)--Extension
Focus groups 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. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and as a qualitative research
toolhave three major purposes:
To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
[[Page 58310]]
To better understand consumers' attitudes and emotions in
response to topics and concepts, and
To further explore findings obtained from quantitative
studies.
FDA will use focus group findings to test and refine their ideas,
but will generally conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
In the Federal Register of March 27, 2007 (72 FR 14279), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for completing the forms for this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Hours of
No. of No. of Focus No. of Duration for
FDA Center Subject Focus Groups Sessions Participants Each Group Total
Groups per Conducted per Group (Includes Hours
Study Annually Screening)
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Center for May use focus 1 5 9 1.58 71
Biologics groups when
Evaluation and appropriate
Research
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Center for Drug Varies (e.g., 10 200 9 1.58 2,844
Evaluation and direct-to-consumer
Research Rx drug promotion,
physician labeling
of Rx drugs,
medication guides,
over-the-counter
drug labeling,
risk
communication)
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Center for Devices Varies (e.g., FDA 4 16 9 2.08 300
and Radiological Seal of Approval,
Health patient labeling,
tampons, online
sales of medical
products, latex
gloves)
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Center for Food Varies (e.g., food 8 40 9 1.58 569
Safety and safety, nutrition,
Applied Nutrition dietary
supplements, and
consumer
education)
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Center for Varies (e.g., 5 25 9 2.08 468
Veterinary animal nutrition,
Medicine supplements,
labeling of animal
Rx)
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Total ................... 28 286 9 1.78 4,252
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Annually, FDA projects about 28 focus group studies using 186 focus
groups lasting an average of 1.78 hours each. FDA has allowed burden
for unplanned focus groups to be completed so as not to restrict the
agency's ability to gather information on public sentiment for its
proposals in its regulatory as well as other programs.
Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20291 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S