[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Notices]
[Pages 71165-71167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0443]
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 24, 2006.
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
[[Page 71166]]
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 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 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. 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 as follows:
The total annual estimated burden imposed by this collection of
information is 4,252 hours annually.
Table 1.\1\
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No. of Focus Hours of
No. of Focus Groups No. of Duration for
Center Subject Groups per Sessions Participants Each Group Total Hours
Study Conducted per Group (Includes
Annually Screening)
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Center May Use Focus Groups 1 5 9 1.58 71
for When Appropriate
Biologi
cs
Evaluat
ion and
Researc
h
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Center Varies (e.g., Direct-to- 10 200 9 1.58 2,844
for Consumer Rx Drug
Drug Promotion, Physician
Evaluat Labeling of Rx Drugs,
ion and Medication Guides, Over-
Researc the-Counter Drug
h Labeling, Risk
Communication
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Center Varies (e.g., FDA Seal 4 16 9 2.08 300
for of Approval, Patient
Devices Labeling, Tampons, On-
and line Sales of Medical
Radiolo Products, Latex Gloves
gical
Health
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Center Varies (e.g., Food 8 40 9 1.58 569
for Safety, Nutrition,
Food Dietary Supplements,
Safety Consumer Education)
and
Applied
Nutriti
on
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Center Varies (e.g., Animal 5 25 9 2.08 468
for Nutrition, Supplements,
Veterin Labeling of Animal Rx)
ary
Medicin
e
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Total ........................ 28 286 .............. 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.
[[Page 71167]]
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, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23248 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S