Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices 18229 

over the last year in refining the 

prioritization process. These include the 

need for more preliminary information 

on candidate drugs (for example, 

information on frequency of use and 

frequency of condition) as well as expert 

input, a better approach for mass 

outreach, enhancement of NIH 

interagency collaborations, and 

improvement in the overall 

prioritization process. 

The revised process includes: 

• A Well-defined process, using a 

systematic approach with clear 

objectives and outcomes; 

• Well-defined objective criteria that 

are mutually exclusive and of a 

manageable number; 

• A dynamic process, including 

transparency, stakeholder input, and 

leadership; and 

• Expert involvement to inform and 

contribute to the process. 

For 2010, NIH solicited nominations 

for the BPCA Priority List of Needs in 

Pediatric Therapeutics through a 

‘‘Request for Information’’ (RFI) 

announcement as part of NIH’s 

authority and responsibility to establish 

the program for pediatric drug testing 

and development outlined in the BPCA 

legislation. The BPCA Priority List 

consists of key therapeutic needs in the 

medical treatment of children and 

adolescents. The list is organized by 

Therapeutic Area, which can be a group 

of conditions, a subgroup of the 

population, or a setting of care. Each 

calendar year, a few Therapeutic Areas 

are selected for discussion and further 

prioritization. Below is a summary of 

the revised BPCA prioritization process: 

• In early 2010, the RFI was issued to 

solicit nominations for future studies of 

pediatric therapeutics under the BPCA. 

• The Obstetric and Pediatric 

Pharmacology Branch of the NICHD 

received 107 nominations, 67 of which 

met the criteria for review. 

• All nominations were reviewed and 

evaluated on six key criteria, as follows: 

• Relevance to BPCA Mission and 

Goals 

• No disqualifying ethical concerns 

• Evidence: consideration of the level 

of evidence available and current gaps 

• Impact: potential effect on children, 

society, and delivery of care 

• Population: consideration of the 

different populations that may benefit 

from the research 

• Feasibility: consideration of the 

resources available to conduct the study 

• Twenty-two volunteer health 

professional evaluators scored the 67 

nominations according to evidence, 

impact, and the pediatric population 

affected. Each nomination was reviewed 

by a panel of three evaluators. 

• Therapeutic Area working groups 

(several Therapeutic Areas are 

determined annually) were developed 

and met through the 2010 year to 

discuss the gaps in knowledge in the 

therapeutic approaches to diseases in 

gastroenterology, endocrinology, and 

neurology. 

• Minutes of all working group 

meetings conducted under the BPCA 

can be found on the BPCA Web site, 

http://bpca.nichd.nih.gov. 

• As a final step in the process, the 

NICHD, with input from the FDA, 

ranked the nominations based on the 

evaluators’ scores, quality and quantity 

of existing studies, and feasibility of the 

proposed study. The result was a tiered 

list of nominations considered for 

listing. Tier One represents the highest 

percentage of scores: nominations of 

interest to the NICHD for prioritization. 

Tier Two represents the average 

percentage of scores: nominations of 

possible interest to the NICHD at a later 

time. Tier Three represents the lowest 

percentage of scores: Nominations of 

least interest to the NICHD at this time 

for prioritization. 

The NICHD sponsored the annual 

BPCA prioritization meeting, held 

November 9–10, 2010, with 

stakeholders from the NIH, the FDA, the 

American Academy of Pediatrics, other 

pediatric organizations and societies, 

and patient advocates. The meeting 

allowed the NICHD to review the 

present progress from ongoing research 

and to discuss the proposed Therapeutic 

Areas from the 2010 nominations to be 

prioritized for future study under the 

BPCA and added to the existing BPCA 

priority list. 

Below is an updated list of 

Therapeutic Areas and drugs that have 

been prioritized for study since the 

inception of the BPCA. It includes new 

areas of prioritization from Tier One 

nominations of the 2010 outreach and a 

summary of the NICHD’s plans and 

progress in all these areas. 

Priority List of Needs in Pediatric 

Therapeutics 2011 

In accordance with the BPCA 

legislation, the list outlines priority 

needs in pediatric therapeutics for 

multiple Therapeutic Areas listed 

below. The priority list can be found on 

the BPCA Web site at the following 

address: http://bpca.nichd.nih.gov 

• Table 1: Infectious Disease 

Priorities 

• Table 2: Cardiovascular Disease 

Priorities 

• Table 3: Respiratory Disease 

Priorities 

• Table 4: Intensive Care Priorities 

• Table 5: Bio-defense Research 

Priorities 

• Table 6: Pediatric Cancer Priorities 

• Table 7: Psychiatric Disorder 

Priorities 

• Table 8: Neurological Disease 

Priorities 

• Table 9: Neonatal Research 

Priorities 

• Table 10: Adolescent Research 

Priorities 

• Table 11: Hematologic Disease 

Priorities 

• Table 12: Endocrine Disease 

Priorities and Diseases with Limited 

Alternative Therapies 

• Table 13: Dermatologic Disease 

Priorities 

• Table 14: Gastrointestinal Disease 

Priorities 

• Table 15: Renal Disease Priorities 

• Table 16: Rheumatologic Disease 

Priorities 

• Table 17: Special Considerations 

FOR FURTHER INFORMATION CONTACT: Dr. 

Perdita Taylor-Zapata via e-mail at 

taylorpe@mail.nih.gov or by telephone 

at 301–496–9584 (not a toll-free 

number). 

Dated: March 24, 2011. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. 2011–7673 Filed 3–31–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Cell 

Signaling and Guidance. 

Date: April 7–11, 2011. 

Time: 10 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSKH9S0YB1PROD with NOTICES

18230 Federal Register / Vol. 76, No. 63 / Friday, April 1, 2011 / Notices 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Joanne T Fujii, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4184, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1178, fujiij@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 28, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7818 Filed 3–31–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Loan Repayment Program. 

Date: April 25–29, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Nancy Lewis Ernst, PhD, 

Scientific Review Official, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–7383, 

nancy.ernst@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Targeted Clinical Research 

to Address Select Viral Infections. 

Date: April 25–26, 2011. 

Time: 8 p.m. to 6 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Crowne Plaza Hotel—Silver Spring, 

8777 Georgia Avenue, Silver Spring, MD 

20910. 

Contact Person: Eleazar Cohen, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health, NIAID, 6700 B 

Rockledge Drive, Room 3129, Bethesda, MD 

20892, 301–435–3564, ec17w@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immune Response to 

Infection Meeting I. 

Date: April 25–26, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Quirijn Vos, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIH/NIAID/DHHS, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892, 301–451– 

2666, qvos@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immune Response to 

Infection Meeting II. 

Date: April 26, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Quirijn Vos, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIH/NIAID/DHHS, 6700B Rockledge Drive, 

MSC 7616, Bethesda, MD 20892, 301–451– 

2666, qvos@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 28, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7817 Filed 3–31–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; ‘‘HIV Vaccine Design’’. 

Date: April 27, 2011. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Raymond R. Schleef, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, (301) 451–3679, 

schleefrr@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 28, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–7816 Filed 3–31–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

mstockstill on DSKH9S0YB1PROD with NOTICES