51374 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

government to petition for an exemption 

from preemption under the provisions 

of section 403A of the FD&C Act. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21041 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Direct Discovery of HLA Associated 

Influenza Epitopes Isolated From 

Human Cells for Vaccine and 

Therapeutic Evaluation and 

Development (U01) 

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 a sole source cooperative 

agreement with the University of 

Oklahoma Health Sciences Center. The 

goal of the FDA, Center for Drug 

Evaluation and Research, Office of Chief 

Scientist, is to develop technology to 

molecularly characterize peptide 

epitopes that are processed and 

presented on soluble HLA (human 

leucocyte antigen) expressed by human 

cells. Initial studies will examine and 

characterize influenza peptides isolated 

from several different soluble Class I 

HLAs produced from influenza infected 

human lung cell lines. There is a 

growing interest in developing universal 

vaccines for influenza by targeting 

conserved internal proteins to stimulate 

cross-protective CTLs (cytolytic T 

lymphocyte) to provide long-lasting 

immunity. It is therefore critically 

important to identify which viral 

epitopes are generated by antigen 

processing in influenza infected lung 

cells, the target cells of cell mediated 

immune response to respiratory viruses. 

FDA seeks a collaboration to develop 

this technology for this purpose which 

can then be applied to identifying and 

characterizing other HLA-presented 

epitopes in viral infections, cancer, and 

immune toxicities. 

DATES: Important dates are as follows: 

1. The application due date is 

September 1, 2011. 

2. The anticipated start date is 

November 1, 2011. 

3. The opening date is August 18, 

2011. 

4. The expiration date is November 2, 

2011. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

For Programmatic questions and 

concerns contact: Michael Norcross, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 9000 Rockville Pike, 

N29B, Rm. 4NN (HFD 122), Bethesda, 

MD 20892, Telephone: 301–827–0793; 

E-mail: Michael.norcross@fda.hhs.gov. 

For Financial and Administrative 

questions and concerns contact: Gladys 

M. Bohler, Food and Drug 

Administration, Office of Acquisitions 

and Grant Services, 5630 Fisher’s Lane, 

Rm. 1078 (HFA 500), Rockville, MD 

20857, Telephone: 301–827–7175, 

E-mail: gladys.bohler@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:// 

www.fda.gov/AboutFDA/CentersOffices/ 

CDER/ucm088761.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Funding Opportunity Number: RFA–FD–12– 

001. 

Catalog of Federal Domestic Assistance 

Number: 93.103. 

A. Background 

Knowledge on how viral and self 

proteins are processed and presented in 

HLA molecules is important to 

understand how the body defends itself 

from infection and how immune 

responses can lead to tissue toxicities. 

Developing technology to allow direct 

identification of epitopes bound by HLA 

molecules is critical to vaccine and 

therapeutic immune strategies. FDA is 

interested in collaborative research to 

develop and implement this technology 

which will be valuable in evaluation 

and review of vaccines and 

therapeutics. Initial studies will address 

identifying epitopes from influenza that 

are presented by different HLA alleles in 

infected lung cells. 

Influenza virus infection affects a 

significant proportion of the population 

and is associated with serious morbidity 

and mortality. Although many epitopes 

can be predicted by computer programs 

and by screening peripheral blood cells 

with panels of viral peptides from 

influenza, the peptides that are 

presented on the infected target cells in 

the tissues and the infiltrating T cells 

that recognize the HLA-peptide 

complexes are the critical elements to 

control and recover from infection. The 

technology of directly identifying viral 

epitopes in HLA can elucidate viral 

targets for T cells and provide the 

foundation for new approaches for rapid 

development of effective vaccines. More 

effective vaccines to prevent and control 

influenza infections will have broad 

public health benefits by reducing 

morbidity and mortality of this 

infectious disease. 

B. Research Objectives 

For this purpose, a direct epitope 

elution approach is needed to allow 

milligram quantities of HLA-peptide 

complexes to be purified from influenza 

infected lung cells lines that express 

soluble HLA. Human lung cell lines 

engineered to secrete soluble HLA from 

three supertypes (A*01, A*03, and 

B*27) should be infected with at least 

two current influenza strains and HLA 

collected during infection. HLA will be 

purified and bound peptides eluted. 

Influenza peptides should be 

systematically identified by mass 

spectrometry analysis and sequencing. 

Synthetic viral peptides can then be 

tested for binding to recombinant HLA 

to verify binding specificity and affinity. 

Influenza epitopes identified in this 

initial phase of the project can be 

evaluated for immunogenicity and 

antigenicity in follow up studies. 

This project will provide the 

regulatory science to facilitate 

development and evaluation of direct 

discovery of HLA presented epitopes. 

The direct epitope methodology will be 

applied to current influenza strains 

initially, but has the flexibility to 

address novel pandemic strains and 

other pathological agents. 

Goal 1: Identify virus-encoded class I 

HLA peptides presented during 

influenza infection of human lung cells. 

Goal 2: In vitro validation of class I 

HLA-presented influenza peptides. 

Goal 3: Develop HLA-epitope directdiscovery technology for use in FDA 

laboratories. 

C. Eligibility Information 

The technology requires extensive 

infrastructure for growing cells, 

purifying HLA from culture 

supernatants, and for mass spectrometry 

analysis. Staff at the University of 

Oklahoma Health Sciences Center are 

leaders in this technology and have 

published the first reports on applying 

this method to influenza. Support of 

this project will allow the extension of 

the methodology to examine other HLA 

types. FDA believes this is a novel and 

valuable methodology that should be 

implemented at FDA. Funding this 

collaborative initiative will allow FDA 

to acquire the proteomic expertise, 

training, and tissue culture support to 

establish a laboratory in the field of 

immunoproteomics. The direct 

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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51375 

identification of viral epitopes is 

critically important to understanding 

immune responses to infection and 

vaccination, and there are currently no 

comparable methods besides the classic 

screening of vast arrays of overlapping 

viral peptides on blood lymphocytes. 

Peptide screening methods only identify 

possible target epitopes, but do not 

define which epitopes are expressed in 

lung tissue. The technology will be 

valuable for vaccine development and 

evaluation, and has the flexibility to 

allow rapid analysis of novel pandemic 

strains for immunogenic epitopes. The 

technology can be applied to other 

infectious diseases, cancer, and 

immunotoxicities. 

II. Award Information/Funds Available 

A. Award Amount 

Only one grant award will be made in 

fiscal year (FY) 2012. The application 

budget is not limited, but it needs to 

reflect the actual needs of the proposed 

project. However, presently for FY 2012, 

the funds are available in the amount of 

$400,000 (total cost), and are subject to 

change based on the availability of 

funds. 

B. Length of Support 

The maximum period is 1 year with 

the option of 4 more years of budget 

support depending on the availability of 

funds. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

located at http://www.fda.gov/ 

AboutFDA/CentersOffices/CDER/ 

ucm088761.htm. Persons interested in 

applying for a grant may obtain an 

application at http://grants2.nih.gov/ 

grants/funding/phs398/phs398.html. 

For all paper application submissions, 

the following steps are required: 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number. 

• Step 2: Register With Central 

Contractor Registration. 

• Step 3: Register With Electronic 

Research Administration (eRA) 

Commons. 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. Step 3, in 

detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit paper applications to: Gladys 

Bohler, Grants Management Specialist 

(see FOR FURTHER INFORMATION CONTACT

section of this document). 

Dated: August 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21043 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Dialogues in Diversifying Clinical 

Trials: Successful Strategies for 

Engaging Women and Minorities in 

Clinical Trials 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

Office of Women’s Health and Society 

for Women’s Health Research jointly 

sponsored meeting: Dialogues in 

Diversifying Clinical Trials: Successful 

Strategies for Engaging Women and 

Minorities in Clinical Trials. The 

purpose of this symposium is to 

facilitate the broader discussion and 

dissemination of innovative strategies 

for increasing the recruitment and 

retention of women and minority 

subpopulations into clinical trials. The 

overarching goal of this symposium is to 

use a best practices learning exchange to 

share information and encourage 

successful methods and/or model 

implementation within a broad research 

community—industry, academia, and 

government. 

Date and Time: The meeting will be 

held on September 22, 2011, from 8 a.m. 

to 9 a.m. (registration); 9 a.m. to 5:30 

p.m. (program); 5:30 p.m. to 6:30 p.m. 

(reception); and September 23, from 8 

a.m. to 1:30 p.m. 

Location: The meeting will be held at 

L’Enfant Plaza Hotel, 480 L’Enfant 

Plaza, SW., Washington, DC 20024. 

Contact: Deborah Kallgren, FDA 

Office of Women’s Health, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 2314, 

Silver Spring, MD 20993–0002, 301– 

796–9442, Fax: 301–847–8604, e-mail: 

deborah.kallgren@fda.hhs.gov. 

Registration: Registration is free, but 

seating is limited to 200. Registration 

will be accepted online and is available 

at http://www.swhr.org through 

September 16, 2011. For information 

regarding registration contact: Rachel 

Griffith, Society for Women’s Health 

Research (SWHR), 1025 Connecticut 

Ave., NW., Suite 701, Washington, DC 

20036, 202–496–5001, Fax: 202–833– 

3472, e-mail: rachel@swhr.org. 

If you need special accommodations 

due to a disability, please contact 

Rachel Griffith at least 7 days in 

advance. 

Dated: August 12, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21042 Filed 8–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463, codified at 5 U.S.C. 

App. 2), notice is hereby given of the 

following meeting: 

Name: Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children. 

Dates and Times: September 22, 2011, 

8:30 a.m. to 5 p.m.; September 23, 2011, 

8:30 a.m. to 3:30 p.m. 

Place: Renaissance Washington, DC 

DuPont Circle Hotel, 1143 New 

Hampshire Avenue, NW., Washington, 

DC 20037. 

Status: The meeting will be open to 

the public with attendance limited due 

to space availability. Participants are 

asked to register for the meeting by 

going to the registration Web site at 

http://altarum.cvent.com/event/ 

SACHDNC092011. The registration 

deadline is Tuesday, September 20, 

2011. Individuals who need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate their 

needs on the registration website. The 

deadline for special accommodation 

requests is Friday, September 19, 2011. 

If there are technical problems gaining 

access to the Web site, please contact 

Maureen Ball, Meetings Coordinator, at 

conferences@altarum.org. 

Purpose: The Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children (Advisory 

Committee) was established by Congress 

to advise and guide the Secretary 

regarding the most appropriate 

application of universal newborn 

screening tests, technologies, policies, 

guidelines and programs for effectively 

reducing morbidity and mortality in 

newborns and children having (or at 

risk) for heritable disorders. The 

Advisory Committee, as authorized by 

Public Law 106–310, which added 

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