[Federal Register: March 3, 2004 (Volume 69, Number 42)]
[Notices]
[Page 10050-10051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr04-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0508]
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 April
2, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: 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
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 provide an important role in
gathering information because they allow for a more in depth
understanding of consumers' attitudes, beliefs, motivations, and
feelings than 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.
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.
In the Federal Register of November 24, 2003 (68 FR 65938), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
[[Page 10051]]
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 Group (includes
Annually screening
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Center for May use focus 1 5 9 1.58 71
Biologics groups when
Evaluation appropriate
and Research
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Center for Varies (e.g., 10 100 9 1.58 1,422
Drug direct-to-
Evaluation consumer Rx
and Research 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., 4 16 9 2.08 300
Devices and FDA Seal of
Radiological Approval,
patient
labeling,
tampons, on-
line sales of
medical
products,
latex gloves
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Center for Varies (e.g., 8 40 9 1.58 569
Food Safety food safety,
and Applied nutrition,
Nutrition dietary
supplements,
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 ............... 28 186 .................. 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.
Dated: February 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4655 Filed 3-2-04; 8:45 am]
BILLING CODE 4160-01-S