[Federal Register: November 24, 2003 (Volume 68, Number 226)]
[Notices]
[Page 65938-65939]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no03-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0508]
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. Policymakers can use focus group results to test
and refine their ideas so they can conduct further research, as well
as, adopt new policies and to allocate or redirect significant
resources to support these policies.
DATES: Submit written or electronic comments on the collection of
information by January 23, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: JonnaLynn P. Capezzuto, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers
[[Page 65939]]
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 the Food and Drug Administration--(OMB Control
Number 0910-0497)
FDA will collect and use information gathered through the focus
group vehicle. 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 indepth
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. If
this information is not collected, a vital link in information
gathering by FDA to develop policy and programmatic proposals will be
missed causing further delays in policy and program development.
FDA estimates the burden for completing the forms for this
collection of information in table 1 of this document .
The total annual estimated burden imposed by this collection of
information is 2,830 hours annually.
Table 1.--Estimated Annual Reporting Burden\1\
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Hours of
No. of Focus No. of Focus No. of Duration for
Center Subject Groups per Groups Sessions Participants per Each Group Total Hours
Study Conducted Annually Group (includes
screening)
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Center for May use 1 5 9 1.58 71
Biologics focus
Evaluation groups
and when
Research appropriat
e
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Center for Varies 10 100 9 1.58 1,422
Drug (e.g.,
Evaluation direct-to-
and consumer
Research Rx drug
promotion,
physician
labeling
of Rx
drugs,
medication
guides,
over-the-
counter
drug
labeling,
risk
communicat
ion
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Center for Varies 4 16 9 2.08 300
Devices (e.g., FDA
and Seal of
Radiologic Approval,
al Health patient
labeling,
tampons,
on-line
sales of
medical
products,
latex
gloves
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Center for Varies 8 40 9 1.58 569
Food (e.g.,
Safety and food
Applied safety,
Nutrition nutrition,
dietary
supplement
s,
consumer
education)
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Center for Varies 5 25 9 2.08 468
Veterinary (e.g.,
Medicine animal
nutrition,
supplement
s,
labeling
of animal
Rx)
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Total ........... 28 186 .................. 1.78 2,830
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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: November 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29197 Filed 11-21-03; 8:45 am]
BILLING CODE 4160-01-S