Document ID: FDA-2011-N-0155-0001
Agency: fda
Document Type: Notice
Title: Pediatric Anesthesia Safety Initiative - Notice
Posted Date: 2011-03-25T04:00Z

[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16796-16797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7055]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
ShaAvhreeBuckman@fda.hhs.gov. Vieda Hubbard, Office of Acquisitions & 
Grant Services, Food and Drug Administration, 5630 Fishers Lane (HFA-
500), Rockville, MD 20857, 301-827-7177, e-mail: 
vieda.hubbard@fda.hhs.gov.
    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]
BILLING CODE 4160-01-P