[Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14279-14280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr07-46]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0098]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on focus groups as used by FDA to
gauge public opinion.
DATES: Submit written or electronic comments on the collection of
information by May 29, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Focus Groups as Used by FDA (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 tool
have three major purposes:
To obtain consumer information that is 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.
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.
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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No. of No. of Focus Hours of Duration
Focus Groups Sessions No. of for Each Group Total
FDA Center Subject Groups per Conducted Participants (Includes Hours
Study Annually per Group 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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[[Page 14280]]
Center for Drug Varies (e.g., 10 200 9 1.58 2,844
Evaluation and direct-to-
Research consumer Rx drug
promotion,
physician
labeling of Rx
drugs,
medication
guides, over-the-
counter drug
labeling, risk
communication)
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Center for Varies (e.g., FDA 4 16 9 2.08 300
Devices and Seal of
Radiological Approval,
Health patient
labeling,
tampons, online
sales of medical
products, latex
gloves)
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Center for Food Varies (e.g., 8 40 9 1.58 569
Safety and food safety,
Applied nutrition,
Nutrition dietary
supplements, and
consumer
education)
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Center for Varies (e.g., 5 25 9 2.08 468
Veterinary animal
Medicine nutrition,
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: March 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5505 Filed 3-26-07; 8:45 am]
BILLING CODE 4160-01-S