Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration, 14279-14280 [E7-5505]
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14279
Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 20, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1481 Filed 3–26–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2007N–0098]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration
Food and Drug Administration,
HHS.
ACTION:
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
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
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: https://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.
Notice.
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
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 BURDEN1
No. of
Focus
Groups per
Study
Subject
Center for Biologics Evaluation and Research
sroberts on PROD1PC70 with NOTICES
FDA Center
No. of Focus
Groups Sessions
Conducted
Annually
No. of
Participants
per Group
Hours of Duration for
Each Group (Includes
Screening)
1
5
9
1.58
May use focus groups when
appropriate
VerDate Aug<31>2005
16:38 Mar 26, 2007
Jkt 211001
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
E:\FR\FM\27MRN1.SGM
27MRN1
Total
Hours
71
14280
Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
FDA Center
No. of
Focus
Groups per
Study
Subject
No. of Focus
Groups Sessions
Conducted
Annually
No. of
Participants
per Group
Hours of Duration for
Each Group (Includes
Screening)
Total
Hours
Center for Drug Evaluation and Research
Varies (e.g., direct-to-consumer Rx drug promotion,
physician labeling of Rx
drugs, medication guides,
over-the-counter drug labeling, risk communication)
10
200
9
1.58
2,844
Center for Devices and
Radiological Health
Varies (e.g., FDA Seal of Approval, patient labeling, tampons, online sales of medical
products, latex gloves)
4
16
9
2.08
300
Center for Food Safety
and Applied Nutrition
Varies (e.g., food safety, nutrition, dietary supplements,
and consumer education)
8
40
9
1.58
569
Center for Veterinary
Medicine
Varies (e.g., animal nutrition,
supplements, labeling of animal Rx)
5
25
9
2.08
468
28
286
9
1.78
4,252
Total
1There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E–0252]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; A180
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for A180
and is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
VerDate Aug<31>2005
16:38 Mar 26, 2007
Jkt 211001
extension of a patent which claims that
animal drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
360b(j)) became effective and runs until
the approval phase begins. The approval
phase starts with the initial submission
of an application to market the animal
drug product and continues until FDA
grants permission to market the drug
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (for example,
half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a animal drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA approved for marketing the
animal drug product A180
(danofloxacin mesylate). A180 is
indicated for treatment of bovine
respiratory disease associated with
Mannheimia (Pasteurella) haemolytica
and Pasteurella multocida in beef cattle.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for A180
(U.S. Patent No. 4,861,779) from Pfizer,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 16, 2003, FDA advised the Patent
and Trademark Office that this animal
drug product had undergone a
regulatory review period and that the
approval of A180 represented the first
permitted commercial marketing or use
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 72, Number 58 (Tuesday, March 27, 2007)]
[Notices]
[Pages 14279-14280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5505]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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\
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Center for May use focus 1 5 9 1.58 71
Biologics groups when
Evaluation and appropriate
Research
----------------------------------------------------------------------------------------------------------------
[[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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Center for Food Varies (e.g., 8 40 9 1.58 569
Safety and food safety,
Applied nutrition,
Nutrition dietary
supplements, and
consumer
education)
----------------------------------------------------------------------------------------------------------------
Center for Varies (e.g., 5 25 9 2.08 468
Veterinary animal
Medicine nutrition,
supplements,
labeling of
animal Rx)
----------------------------------------------------------------------------------------------------------------
Total ................. 28 286 9 1.78 4,252
----------------------------------------------------------------------------------------------------------------
\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
