[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16796-16797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7055]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0155]
Pediatric Anesthesia Safety Initiative (PASI)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Pediatric Anesthesia
Safety Initiative (PASI). The goal of PASI is to bridge the scientific
and clinical gaps in the field of pediatrics to ensure the safe use of
anesthetic and sedative agents in children. FDA seeks under PASI to
encourage and facilitate scientific collaboration among multiple
stakeholders within a public-private partnership (PPP) framework and to
support the conduct of non-clinical and clinical studies to answer
unknown questions regarding the effects of anesthetics and sedatives in
the pediatric population. The output from PASI will help to inform the
work of FDA as part of its public health mission.
DATES: Important dates are as follows:
1. The application due date is April 29, 2011.
2. The anticipated start date is July 14, 2011.
3. The opening date is March 30, 2011.
4. The expiration date is April 30, 2011.
For Further Information and Additional Requirements Contact:
ShaAvhree Buckman, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4554,
Silver Spring, MD 20993, 301-796-1653, e-mail:
[email protected]. Vieda Hubbard, Office of Acquisitions &
Grant Services, Food and Drug Administration, 5630 Fishers Lane (HFA-
500), Rockville, MD 20857, 301-827-7177, e-mail:
[email protected].
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://grants.nih.gov/grants/guide/ (select the ``Request
for Applications'' link), http://www.grants.gov/ (see ``For
Applicants'' section), and http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-11-005.
93.103.
A. Background
Non-clinical studies in juvenile animal models have shown that
exposure to some anesthestics and sedatives is associated with
neurodegenerative changes in the central nervous system, as well as
memory and learning deficits. Anesthetic agents that have been
specifically implicated are N-methyl-D-aspartate (NMDA) receptor
antagonists, such as ketamine, and gamma aminobutyric acid (GABA)
agonists, such as sevoflurane. The anesthesia community and FDA
acknowledge that there are insufficient human data to either support or
refute the clinical relevance of these findings for pediatric patients.
Therefore, numerous non-clinical and clinical studies are needed to
assess the effect of anesthetics and sedatives on the developing human
brain, including long-term studies in neonates and young children.
However, the planning and performance of the numerous studies needed to
address the aforementioned issues will involve enormous challenges in
terms of design, assurance of validity and reliability of the outcome
measures, and ethical considerations. It is unlikely that any one
entity will possess the necessary expertise and resources to accomplish
all the work needed to address the issues in an expeditious manner.
B. Objectives
PASI aims to bridge the scientific and clinical gaps in the field
of pediatrics to ensure the safe use of anesthetic and sedative agents
in children. Specific activities to be funded through this announcement
include, but are not limited to:
1. Project management of PASI PPP:
Development, implementation, and management of a
scientific and administrative infrastructure to support the creation
and execution of a series of projects aligned with PASI.
Coordination of the overall governance board, to include
luminary experts to lead the overall PPP; said governance board to
establish necessary
[[Page 16797]]
steering committees and working groups to ensure appropriate project
implementation, oversight, and management for all projects under the
PPP.
Development of a scientific review panel to evaluate the
progress of projects funded under the PPP and development of
feasibility plans for additional projects aligned with PASI.
Coordination with FDA and other partners; the development
and publication of scientific articles in support of educational and
outreach activities (with data, know-how, and other outcomes from the
aforementioned projects supported under the PPP) and to benefit
patients and other stakeholders.
Development of a strategy to identify and establish
relationships with key experts in the fields of anesthesia and
sedation, including stakeholders from industry, professional
organizations, academia, and awardees of the projects under the
``research and analysis'' section for leveraging and collaborative
efforts under PASI.
Coordination of annual scientific workshops with
collaboration by FDA and the aforementioned experts in the fields of
anesthesia and sedation, including stakeholders from industry,
professional organizations, academia, and Government Agencies.
2. Research projects (which may include, but are not limited to):
Clinical trials including prospective, randomized, and
blinded investigations assessing the immediate and delayed
neurodevelopmental effects of regional/caudal anesthesia versus general
anesthesia in neonates/infants;
Observational trials including the comparison of two
groups of children, one group exposed to general anesthesia within the
first 3 years of life and the other, unexposed. Assessments should
utilize neuropsychological tests of attention, memory, motor function,
and behavior; and
Epidemiologic investigations surveying large existing
population databases for cognitive developmental effects where exposure
to general anesthesia before the age of 3 can be compared to the
overall population.
C. Eligibility Information
Higher education institutions:
Public/state-controlled institutions of higher education
Private institutions of higher education
The following types of higher education institutions are always
encouraged to apply for National Institutes of Health support as public
or private institutions of higher education:
Hispanic serving institutions
Historically Black colleges and universities
Tribally controlled colleges and universities
Alaska Native and Native Hawaiian serving institutions
Nonprofits other than institutions of higher education
Nonprofits with 501(c)(3) Internal Revenue Service (IRS)
status (other than institutions of higher education)
Nonprofits without 501(c)(3) IRS status (other than
institutions of higher education)
For-profit organizations:
Small businesses
For-profit organizations (other than small businesses)
Other:
Regional organizations
Non-domestic (non-U.S.) entities (foreign organizations) are not
eligible to apply. Foreign (non-U.S.) components of U.S. organizations
are not allowed.
II. Award Information/Funds Available
A. Award Amount
FDA intends to fund one or more awards, corresponding to a total of
$1 million, for fiscal year 2011, to carry out the project management
and research project objectives described in Part I of this document.
Future year amounts will depend on annual appropriations. No more than
four awards are anticipated under this FOA. The number of awards is
contingent upon FDA appropriations and the submission of a sufficient
number of meritorious applications.
B. Length of Support
The anticipated length of the individual awards is 5 years.
III. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://grants.nih.gov/grants/guide/ (select the ``Request for Applications'' link), http://www.grants.gov/ (see ``For Applicants'' section) and http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm. (FDA has verified the
Web site addresses throughout this document, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.) For all electronically submitted
applications, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With Central Contractor Registration
Step 3: Obtain Username and Password
Step 4: Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration
(eRA) Commons Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov/.
Dated: March 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7055 Filed 3-24-11; 8:45 am]
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