Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration, 58309-58310 [E7-20291]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
GSA has published rules in the
Federal Register that fall under
information collection 3090–0250. The
rule that prescribed clause 552.238–70
‘‘Identification of Electronic Office
Equipment Providing Accessibility for
the Handicapped’’ was published at 56
FR 29442, June 27, 1991, titled
‘‘Implementation of Public Law 99–
506’’, with an effective date of July 8,
1991; and Clause 552.238–74
‘‘Industrial Funding Fee and Sales
Reporting’’ published at 68 FR 41286,
July 11, 2003.
B. Annual Reporting Burden
None.
OBTAINING COPIES OF
PROPOSALS: Requesters may obtain a
copy of the information collection
documents from the General Services
Administration, Regulatory Secretariat
(VIR), 1800 F Street, NW., Room 4035,
Washington, DC 20405, telephone (202)
501–4755. Please cite OMB Control No.
3090–0250, Zero Burden Information
Collection Reports, in all
correspondence.
Dated: October 5, 2007.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E7–20255 Filed 10–12–07; 8:45 am]
BILLING CODE 6820–61–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting of the National Advisory
Council for Healthcare Research and
Quality
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: In accordance with section
10(a) of the Federal Advisory Committee
Act, this notice announces a meeting of
the National Advisory Council for
Healthcare Research and Quality.
DATES: The meeting will be held on
Friday, November 9, 2007, from 9 a.m.
to 3 p.m.
ADDRESSES: The meeting will be held at
the Eisenberg Conference Center,
Agency for Healthcare Research and
Quality, 540 Gaither Road, Rockville,
Maryland 20850.
FOR FURTHER INFORMATION CONTACT:
Deborah Queenan, Coordinator of the
Advisory Council, at the Agency for
Healthcare Research and Quality, 540
Gaither Road, Rockville, Maryland
20850, (301) 427–1330. For press-related
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
information, please contact Karen
Migdail at (301) 427–1855.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact Mr.
Donald L. Inniss, Director, Office of
Equal Employment Opportunity
Program, Program Support Center, on
(301) 443–1144, no later than November
2, 2007. The agenda, roster, and minutes
are available from Ms. Bonnie Campbell,
Committee Management Officer, Agency
for Healthcare Research and Quality,
540 Gaither Road, Rockville, Maryland
20850. Her phone number is (301) 427–
1554.
SUPPLEMENTARY INFORMATION:
I. Purpose
The National Advisory Council for
Healthcare Research and Quality was
established in accordance with Section
921 (now Section 931) of the Public
Health Service Act (42 U.S.C. 299c). In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to actions of
the Agency to enhance the quality,
improve the outcomes, reduce the costs
of health care services, improve access
to such services through scientific
research, and to promote improvements
in clinical practice and in the
organization, financing, and delivery of
health care services. The Council is
composed of members of the public,
appointed by the Secretary, and Federal
ex-officio members.
II. Agenda
On Friday, November 9, the Council
meeting will convene at 9 a.m., with the
call to order by the Council Chair and
approval of previous Council minutes.
The Director, AHRQ, will present her
update on AHRQ’s current research,
programs, and initiatives. The agenda
will include a discussion of the National
Healthcare Quality and Disparities
Reports, needed research on Health Care
Value and Capacity Building. The
official agenda will be available on
AHRQ’s Web site at https://
www.ahrq.gov no later than November
2, 2007.
Dated: October 5, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–5057 Filed 10–12–07; 8:45 am]
BILLING CODE 4160–90–M
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
58309
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0098]
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.
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 November
14, 2007.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0497. Also
include the FDA 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: 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
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 toolhave three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
E:\FR\FM\15OCN1.SGM
15OCN1
58310
Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
• 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
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden for
completing the forms for this collection
of information as follows:
generally conduct further research
before making important decisions such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
In the Federal Register of March 27,
2007 (72 FR 14279), FDA published a
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
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)
1
5
9
1.58
71
10
200
9
1.58
2,844
Total
Hours
Center for Biologics Evaluation and Research
May use focus groups when
appropriate
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)
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: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20291 Filed 10–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on PROD1PC70 with NOTICES
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Aug<31>2005
21:55 Oct 12, 2007
Jkt 214001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues. The committee
also advises and makes
recommendations to the Secretary of
Health and Human Services under 45
CFR 46.407 on research involving
children as subjects that is conducted or
supported by the Department of Health
and Human Services, when that
research is also regulated by FDA.
Date and Time: The meeting will be
held on Tuesday, November 27, 2007,
from 8 a.m. to 5:30 p.m. and
Wednesday, November 28, 2007, from 8
a.m. to 6 p.m.
Location: Hilton, Washington DC
North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
˜
Contact Person: Carlos Pena, Office of
Science and Health Coordination, Office
of the Commissioner (HF–33), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery, rm. 14B–08),
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Rockville, MD 20857, 301–827–3340, e˜
mail:Carlos.Pena@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
8732310001. Please call the Information
Line for up to date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On November 27, 2007, in
response to the Pediatric Advisory
Committee’s 2005 request for specific
updates after 2 additional years of
influenza seasons, the committee will
receive information on adverse event
reports, focusing on neuropsychiatric
and behavioral events, for Tamiflu
(OSELTAMIVIR). On November 28,
2007, the Pediatric Advisory Committee
will hear and discuss reports by the
agency, as mandated in Section 17 of
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58309-58310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20291]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0098]
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.
-----------------------------------------------------------------------
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
November 14, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0497. Also
include the FDA 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: 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
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
toolhave three major purposes:
To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
[[Page 58310]]
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.
In the Federal Register of March 27, 2007 (72 FR 14279), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for completing the forms for this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Hours of
No. of No. of Focus No. of Duration for
FDA Center Subject Focus Groups Sessions Participants Each Group Total
Groups per Conducted per Group (Includes Hours
Study Annually Screening)
----------------------------------------------------------------------------------------------------------------
Center for May use focus 1 5 9 1.58 71
Biologics groups when
Evaluation and appropriate
Research
----------------------------------------------------------------------------------------------------------------
Center for Drug Varies (e.g., 10 200 9 1.58 2,844
Evaluation and direct-to-consumer
Research Rx drug promotion,
physician labeling
of Rx drugs,
medication guides,
over-the-counter
drug labeling,
risk
communication)
----------------------------------------------------------------------------------------------------------------
Center for Devices Varies (e.g., FDA 4 16 9 2.08 300
and Radiological Seal of Approval,
Health patient labeling,
tampons, online
sales of medical
products, latex
gloves)
----------------------------------------------------------------------------------------------------------------
Center for Food Varies (e.g., food 8 40 9 1.58 569
Safety and safety, nutrition,
Applied Nutrition dietary
supplements, and
consumer
education)
----------------------------------------------------------------------------------------------------------------
Center for Varies (e.g., 5 25 9 2.08 468
Veterinary animal nutrition,
Medicine 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: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20291 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S
