16796 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 24, 

2011 (76 FR 4120), FDA published a 

notice with a 60-day comment period to 

request comments from stakeholders on 

strategies to address a document for the 

NARMS program entitled ‘‘NARMS 

Strategic Plan 2011–2015.’’ The notice 

expressed FDA’s interest in receiving 

comments on the goals and objectives in 

the Strategic Plan and whether the goals 

and objectives meet the 

recommendations of the subcommittee. 

The Agency has received requests for 

a 60-day extension of the comment 

period along with request for 

background material on the 

development of the ‘‘NARMS Strategic 

Plan 2011–2015.’’ The requests 

conveyed concern that the current 60- 

day comment period does not allow 

respondents sufficient time to address 

fully the many important issues FDA 

raised in the notice. 

FDA has considered the requests and 

is extending the comment period for the 

notice for 60 days, until May 24, 2011. 

The Agency believes that a 60-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying the 

Agency’s consideration of these 

important issues. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain documents at either http:// 

www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/ 

NationalAntimicrobialResistance

MonitoringSystem/default.htm, http:// 

www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/ 

NationalAntimicrobialResistance

MonitoringSystem/ucm062630.htm, 

http://www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/

NationalAntimicrobial

ResistanceMonitoringSystem/ 

ucm059135.htm, http://www.fda.gov/

ohrms/dockets/ac/07/briefing/2007- 

4329b_02_06_

NARMS%20Review%20Update.pdf, or 

http://www.regulations.gov. 

Dated: March 21, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7068 Filed 3–24–11; 8:45 am] 

BILLING CODE 4160–01–P 

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-Daspartate (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 nonclinical 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 


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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meeting 

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 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 Center for 

Research Resources Special Emphasis Panel; 

LOAN REPAYMENT. 

Date: April 7, 2011. 

Time: 8 a.m. to 5 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: Carol Lambert, PhD, 

Scientific Review Officer, Office of Review, 

NCRR, National Institutes of Health, 6701 

Democracy Blvd., One Democracy Plaza, 

Room 1076, MSC 4874, Bethesda, MD 20892– 

4874, 301–435–0814, lambert@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 


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