Development of Animal Models of Pregnancy To Address Medical Countermeasures for Influenza in the “At Risk” Population of Pregnant Women: Influenza as a Case Study; Public Workshop, 18251-18252 [2012-7290]
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18251
Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices
study goals are to: (1) Measure
consumer attitudes, beliefs, and
intended behaviors related to cigarette
smoking in response to graphic warning
labels; (2) determine whether consumer
responses to graphic warning labels
differ across various groups based on
smoking status, age, or other
demographic variables; and (3) evaluate
the relative effectiveness of various
graphic images associated with each of
the nine warning statements specified in
the Tobacco Control Act for achieving
each of the communication goals. The
information collected from the study is
necessary to inform the Agency’s efforts
to implement the mandatory graphic
warnings required by the Tobacco
Control Act.
The experimental study data will be
collected from participants of an
Internet panel of approximately 43,000
people. Participation in the
experimental study is voluntary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Portion of study
Total annual
responses
Average burden
per response
Total hours
Pretest ................................................................................
Screener .............................................................................
Experimental Survey ..........................................................
60
15,000
5,400
1
1
1
60
15,000
5,400
0.5
0.016
0.5
30
240
2,700
Total ............................................................................
........................
........................
........................
..........................
2,970
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pretest of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
15,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.016 hours), for a total
of 240 hours. Fifty-four hundred
respondents will complete the full
study, estimated to last 30 minutes, for
a total of 2,700 hours. The total
estimated burden is 2,970 hours (30
hours plus 240 hours plus 2,700 hours).
Dated: March 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–7289 Filed 3–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Development of Animal Models of
Pregnancy To Address Medical
Countermeasures for Influenza in the
‘‘At Risk’’ Population of Pregnant
Women: Influenza as a Case Study;
Public Workshop
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration’s
(FDA) Center for Drug Evaluation and
Research and FDA’s National Center for
Toxicological Research are announcing
VerDate Mar<15>2010
17:14 Mar 26, 2012
Jkt 226001
Date and Time: The public
workshop will be held on April 30,
2012, from 8:30 a.m. to 5 p.m., and on
May 1, 2012, from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Central
Shared Use (CSU) Bldg. 2, rm. 2047,
Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed, a visitor badge will be
issued, and an escort will be provided
to the meeting room. Governmentissued identification will be needed. For
additional information on parking and
DATES:
[Docket No. FDA–2012–N–0001]
AGENCY:
a 2-day public workshop entitled
‘‘Development of Animal Models of
Pregnancy To Address Medical
Countermeasures for Influenza in the
‘At Risk’ Population of Pregnant
Women: Influenza as a Case Study.’’
The purpose of this workshop is to
provide a forum to carefully consider
scientific issues related to selecting
animal models for use in evaluating
medical influenza countermeasures
(anti-influenza drugs) that may be given
during pregnancy. Specifically, this
workshop will address experimental
design issues in selecting the most
appropriate animal model that mimics
human pregnancy. The goal is to use
this model to evaluate how pregnancy
changes the pharmacokinetics of antiinfluenza drugs in animals and compare
those changes to the changes that are
known to occur in human pregnancy.
The data obtained from using this model
may enhance the knowledge base
needed to extrapolate the effects of
pregnancy on other medical
countermeasures.
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security, please refer to https://www.fda.
gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
Contact Person: For questions about
the workshop, please contact Cindy de
Sales, cindy@tepgevents.com, 240–316–
3207.
Registration: There is no fee to attend
the public workshop, but attendees
must register in advance. Space is
limited, and registration will be on a
first-come, first-served basis. Persons
interested in attending this workshop
must register online at https://
fda.contractmeetings.com before April
16, 2012. Non-U.S. citizens are subject
to additional security screening, and
they should register as soon as possible.
For those without Internet access, please
contact Cindy de Sales (see Contact
Person) to register. Onsite registration is
not available.
If you need special accommodations
due to a disability, please contact Cindy
de Sales (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: During
seasonal and pandemic influenza
outbreaks, pregnant women generally
have greater morbidity and mortality
than other adults. The data from the
2009 H1N1 influenza pandemic
suggested that pregnant women were at
increased risk for medical
complications. There is limited
information regarding the efficacy,
pharmacokinetics, optimal dosing, and
side effects of anti-influenza drugs that
may need to be used during pregnancy.
The same is true for most drugs to treat
diseases due to other infectious agents.
The anti-influenza drugs have been
selected for further study because the
influenza virus can infect pregnant
women, and oseltamivir, an anti-
E:\FR\FM\27MRN1.SGM
27MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
18252
Federal Register / Vol. 77, No. 59 / Tuesday, March 27, 2012 / Notices
influenza drug of the neurominadase
inhibitor class, was recommended for
treatment of and/or for prophylaxis in
pregnant women during the 2009 H1N1
influenza pandemic. In addition, two
clinical studies conducted in pregnant
women provide some pharmacokinetic
data for oseltamivir.
This workshop is open to all
interested parties. The target audience
includes professionals in the scientific
community interested in discussing the
challenges of evaluating medical
countermeasures for effective and safe
use during pregnancy.
The workshop will include plenary
and breakout sessions on the scientific
challenges in the development of animal
models of pregnancy that can be used to
address the safety and efficacy of
medical countermeasures. Broad topics
to be covered in the plenary sessions
include: (1) The physiology and
pharmacology of pregnancy as it relates
to model development; (2) the role of
animal models in evaluating medical
countermeasures, including influenza
therapies, that may be used during
pregnancy; and (3) experimental design
considerations. Topics of the breakout
sessions will include: (1) Animal model
selection, (2) design of the
pharmacokinetic studies, and (3)
additional issues in experimental
design.
Background information on the public
workshop, registration information, the
agenda, and other relevant information
will be posted, as it becomes available,
on the registration Web site at https://
fda.contractmeetings.com.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hard copy or
on CD–ROM, after submission of a
Freedom of Information request. Send
written requests to the Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Send faxed requests to 301–
827–9267.
Dated: March 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–7290 Filed 3–26–12; 8:45 am]
BILLING CODE 4160–01–P
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17:14 Mar 26, 2012
Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Environmental
Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: May 22–23, 2012.
Open: May 22, 2012, 8:30 a.m. to 5 p.m.
Agenda: Discussion of program policies
and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Open: May 23, 2012, 8:30 a.m. to 9:30 a.m.
Agenda: Discussion of program policies
and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Closed: May 23, 2012, 9:45 a.m. to 12:30
p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Contact Person: Gwen W. Collman, Ph.D.,
Director, Division of Extramural Research &
Training, National Institutes of Health, Nat.
Inst. of Environmental Health Sciences, 615
Davis Dr., KEY615/3112, Research Triangle
Park, NC 27709, (919) 541–4980,
collman@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
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applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
www.niehs.nih.gov/dert/c-agenda.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: March 20, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–7333 Filed 3–26–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Conference Grants.
Date: April 19–20, 2012.
Time: 11 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7179, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Ancilliary Studies in Clinical Trials.
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Notices]
[Pages 18251-18252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Development of Animal Models of Pregnancy To Address Medical
Countermeasures for Influenza in the ``At Risk'' Population of Pregnant
Women: Influenza as a Case Study; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration's (FDA) Center for Drug Evaluation
and Research and FDA's National Center for Toxicological Research are
announcing a 2-day public workshop entitled ``Development of Animal
Models of Pregnancy To Address Medical Countermeasures for Influenza in
the `At Risk' Population of Pregnant Women: Influenza as a Case
Study.'' The purpose of this workshop is to provide a forum to
carefully consider scientific issues related to selecting animal models
for use in evaluating medical influenza countermeasures (anti-influenza
drugs) that may be given during pregnancy. Specifically, this workshop
will address experimental design issues in selecting the most
appropriate animal model that mimics human pregnancy. The goal is to
use this model to evaluate how pregnancy changes the pharmacokinetics
of anti-influenza drugs in animals and compare those changes to the
changes that are known to occur in human pregnancy. The data obtained
from using this model may enhance the knowledge base needed to
extrapolate the effects of pregnancy on other medical countermeasures.
DATES: Date and Time: The public workshop will be held on April 30,
2012, from 8:30 a.m. to 5 p.m., and on May 1, 2012, from 8:30 a.m. to 5
p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Central Shared Use (CSU) Bldg. 2, rm.
2047, Silver Spring, MD 20993-0002. Entrance for the public meeting
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed, a visitor badge will be
issued, and an escort will be provided to the meeting room. Government-
issued identification will be needed. For additional information on
parking and security, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: For questions about the workshop, please contact
Cindy de Sales, cindy@tepgevents.com, 240-316-3207.
Registration: There is no fee to attend the public workshop, but
attendees must register in advance. Space is limited, and registration
will be on a first-come, first-served basis. Persons interested in
attending this workshop must register online at https://fda.contractmeetings.com before April 16, 2012. Non-U.S. citizens are
subject to additional security screening, and they should register as
soon as possible. For those without Internet access, please contact
Cindy de Sales (see Contact Person) to register. Onsite registration is
not available.
If you need special accommodations due to a disability, please
contact Cindy de Sales (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: During seasonal and pandemic influenza
outbreaks, pregnant women generally have greater morbidity and
mortality than other adults. The data from the 2009 H1N1 influenza
pandemic suggested that pregnant women were at increased risk for
medical complications. There is limited information regarding the
efficacy, pharmacokinetics, optimal dosing, and side effects of anti-
influenza drugs that may need to be used during pregnancy. The same is
true for most drugs to treat diseases due to other infectious agents.
The anti-influenza drugs have been selected for further study
because the influenza virus can infect pregnant women, and oseltamivir,
an anti-
[[Page 18252]]
influenza drug of the neurominadase inhibitor class, was recommended
for treatment of and/or for prophylaxis in pregnant women during the
2009 H1N1 influenza pandemic. In addition, two clinical studies
conducted in pregnant women provide some pharmacokinetic data for
oseltamivir.
This workshop is open to all interested parties. The target
audience includes professionals in the scientific community interested
in discussing the challenges of evaluating medical countermeasures for
effective and safe use during pregnancy.
The workshop will include plenary and breakout sessions on the
scientific challenges in the development of animal models of pregnancy
that can be used to address the safety and efficacy of medical
countermeasures. Broad topics to be covered in the plenary sessions
include: (1) The physiology and pharmacology of pregnancy as it relates
to model development; (2) the role of animal models in evaluating
medical countermeasures, including influenza therapies, that may be
used during pregnancy; and (3) experimental design considerations.
Topics of the breakout sessions will include: (1) Animal model
selection, (2) design of the pharmacokinetic studies, and (3)
additional issues in experimental design.
Background information on the public workshop, registration
information, the agenda, and other relevant information will be posted,
as it becomes available, on the registration Web site at https://fda.contractmeetings.com.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Send faxed requests to 301-827-9267.
Dated: March 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7290 Filed 3-26-12; 8:45 am]
BILLING CODE 4160-01-P
