Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 17203 

findings, and report the findings 

generically to all interested parties. 

DATES: Letter of interest must be 

received within 90 calendar days of 

publication in the Federal Register. 

ADDRESSES: Mining companies able to 

provide NIOSH with mine sites for this 

research should submit a letter of 

interest to the NIOSH Pittsburgh 

Research Laboratory (PRL) Director. The 

letter should provide the name of the 

mine and a brief description of the 

anticipated sealing plans. Any questions 

should be addressed by phone or e-mail. 

Please send letter of interest to: R. Gu ̈ner 

Gu ̈rtunca, PhD, NIOSH Pittsburgh 

Research Laboratory (PRL), 626 

Cochrans Mill Road, Post Office Box 

18070, Pittsburgh, PA 15236, telephone 

(412) 386–6601, E-mail 

GGurtunca@cdc.gov. 

Background: Recent research reports 

published by NIOSH and the U.S. Army 

Corps of Engineers describe the 

potential for explosive methane 

mixtures to develop within sealed areas 

of underground coal mines. The 

composition and behavior of the 

atmosphere within sealed areas are not 

scientifically well-understood. Areas of 

interest include the extent and nature of 

explosive mixtures of gases, how the 

composition of these mixtures change 

over time, whether methane layering 

exists, the homogeneity of the 

atmosphere, and how barometric 

pressure changes impact the atmosphere 

behind seals. 

Description: To conduct these 

measurements, NIOSH will deploy a 

tube bundle system (TBS) at the mine 

site for a period of 2 to 5 months 

(usually not more than 3 months). A 

TBS is a mechanical system for 

collecting and analyzing atmospheric 

samples continuously from anywhere in 

a mine. The TBS that NIOSH plans to 

use is a system that is currently being 

successfully deployed in many 

Australian underground coal mines. 

NIOSH seeks three to four underground 

coal mines throughout the U.S. to 

cooperate in this study. Underground 

coal mines covering at least one square 

mile and producing a medium to high 

volume of methane are needed. 

Sampling will be conducted one mine at 

a time. Either longwall or room-andpillar mines are acceptable. NIOSH 

wants to deploy the system in a variety 

of geological conditions. A soon-to-beabandoned coal mine is another option 

for deployment of the TBS. 

Prior to sealing, NIOSH will install 

plastic sample tubing throughout the 

mine and the future sealed area. This 

should require a few days to accomplish 

and will require minimal effort from the 

cooperating mine. NIOSH will need to 

be present during the sealing process to 

insure that the tubing is properly 

installed through the seals. After 

sealing, NIOSH will monitor the 

composition of the atmosphere 

throughout the sealed area during the 

initial methane-accumulation phase and 

for several months thereafter until 

stability of the sealed atmosphere 

develops. Collected data will not be 

analyzed on a real time basis other than 

to insure that the system is properly 

working. 

NIOSH will require the following 

assistance from mining company 

personnel: 

• Site-specific guidance concerning 

the area to be sealed and how to most 

efficiently run the sampling tube out of 

the mine to the sampling analysis 

location. 

• Transportation to and from the 

sealed area during the installation phase 

of the TBS and to occasionally check the 

status of the TBS underground. 

• A surface location to locate the 

sampling trailer. 

• For a mine site to be acceptable to 

NIOSH for this testing, the cooperating 

mine must be installing 120 psi seals 

that meet the current design standard. 

• After installation, NIOSH will 

require little assistance from mining 

company personnel until NIOSH is 

ready to remove the system from the 

mine when some transportation 

assistance will be needed. 

After the data is analyzed, the 

cooperating mine will be provided the 

data pertaining to its mine. NIOSH will 

present and/or publish data in a manner 

that does not identify the cooperating 

mines. Cooperating mines will have the 

opportunity to review publications and 

presentations by NIOSH prior to their 

release. While NIOSH will not identify 

the mines in its publications, the 

identity of cooperating mines may be 

subject to release in response to a 

request for documents made under the 

Freedom of Information Act. This 

announcement does not obligate NIOSH 

to enter into an agreement with any 

respondent. 

FOR FURTHER INFORMATION CONTACT: R. 

Gu ̈ner Gu ̈rtunca, PhD, NIOSH 

Pittsburgh Research Laboratory (PRL), 

626 Cochrans Mill Road, Post Office Box 

18070, Pittsburgh PA, 15236, telephone 

(412) 386–6601, e-mail 

GGurtunca@cdc.gov. 

Dated: April 6, 2009. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8462 Filed 4–13–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

The Best Pharmaceuticals for Children 

Act (BPCA) Priority List of Needs in 

Pediatric Therapeutics 

ACTION: Notice. 

SUMMARY: For many decades, the 

pediatric medical community, the 

public health community, and 

government agencies have recognized a 

range of questions regarding the use of 

therapeutics in children, including the 

shortage of clinical studies of drugs in 

children resulting in inadequate 

labeling for pediatric use. The lack of 

appropriate labeling results in off-label 

use of prescription drugs in many 

children and for many conditions. 

Contributing factors to this frequent offlabel use of drugs in pediatrics include 

the rarity of some conditions in children 

with limited patient availability, the 

ethical concerns regarding the conduct 

of clinical trials in children, the lack of 

accurate information about which drugs 

are used by children, and the lack of 

long-term data on the medications that 

are frequently used. 

Several steps have been taken in 

response to the growing awareness of 

the knowledge gaps that exist in 

pediatric therapeutics. The BPCA was 

originally enacted in January 2002 and 

reauthorized in September 2007, with 

the overall purpose of improving the 

level of information about 

pharmaceuticals used to treat children 

(http://www.fda.gov/opacom/laws/ 

pharmkids/contents.html). The BPCA 

outlines a number of goals, including 

the identification and prioritization of 

therapeutic needs in pediatrics, 

especially drugs, biologics, or 

indications that require study. The 

legislation also calls for the conduct of 

pediatric research to learn more about 

the efficacy and safety of drugs in 

children as well as the training of 

experts needed to address the 

knowledge gaps in pediatric 

pharmacology. To identify drugs in 

need of further study, the BPCA 

mandates that the National Institutes of 

Health (NIH), in consultation with the 

U.S. Food and Drug Administration 

(FDA) and experts in pediatrics, develop 

17204 Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 

a process for prioritizing needs in 

pediatric therapeutics and publish a 

priority list at least every 3 years, 

starting in September 2008. In this 

notice, we will summarize past efforts to 

prioritize off-patent drugs that need 

further study as mandated by the BPCA 

2002 and describe the plans for 

identifying needs in pediatric 

therapeutics as authorized by the BPCA 

2007. 

DATES: The list is effective upon 

publication. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Perdita Taylor-Zapata, Eunice Kennedy 

Shriver National Institute of Child 

Health and Human Development 

(NICHD), 6100 Executive Boulevard, 

Suite 4A–01, Bethesda, MD 20892– 

7510, e-mail taylorpe@mail.nih.gov or 

BestPharmaceuticals@mail.nih.gov, 

telephone 301–496–9584 (not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: In the 

Federal Register Notice of January 21, 

2003 (Vol. 68, No. 13), the NICHD 

announced the first list of off-patent 

drugs to be considered for study and 

described the process used in 

developing this list. Prioritization of 

drugs on the list was based in general 

on three major factors: (1) Frequency of 

use in the pediatric population, (2) 

severity of the condition being treated, 

and (3) potential for providing a health 

benefit in the pediatric population. 

These factors follow from the original 

BPCA legislation, which required NIH 

to consider (among other criteria) for 

each drug ‘‘whether new pediatric 

studies concerning the drug may 

produce health benefits in the pediatric 

population.’’ 

During the initial years of the BPCA 

prioritization process (2003–2005), the 

NICHD identified many individual 

drugs and indications that required 

further dosing, efficacy, and safety 

information. In 2005, based on the input 

of pediatric experts, an alternative 

approach was proposed that included 

identifying and prioritizing pediatric 

conditions and therapeutic approaches 

for those conditions. This proposed 

condition-based approach would allow 

us to identify gaps in scientific 

knowledge, determine key research 

agendas in pediatric medicine, evaluate 

the treatments of these conditions, and 

compare the use of drugs within a 

therapeutic class (both on- and offpatent). This approach would also allow 

us to obtain focused expertise in 

specific therapeutic areas that would 

help elucidate the scientific gaps within 

the prioritized area. 

Update on BPCA Conditions/ 

Therapeutic Areas 

In 2006, the NICHD and the FDA, in 

collaboration with pediatric experts, 

considered an alternative approach for 

prioritization—from a drug/indication 

approach to a condition-based 

approach. Please refer to the Federal 

Register Notice of April 25, 2006 

(Volume 71, No. 79), and the Federal 

Register Notice of March 28, 2007 

(Volume 72, No. 59), for a complete 

review of the previous prioritization 

process and therapeutic categories 

considered under the 2002 BPCA 

legislation. In addition, an update on 

the status of all drugs previously listed 

under BPCA 2002 is provided at 

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

following conditions have been listed to 

date, with brief updates on progress 

and/or current NICHD commitments. 

• 2006 

—Oncology: Four clinical trials are 

under way in collaboration with the 

National Cancer Institute (NCI) and 

the Children’s Oncology Group (COG) 

to evaluate the pharmacokinetics 

(PK)/pharmacodynamics (PD), safety, 

and efficacy of chemotherapeutic 

agents used in children with cancer. 

The drugs under study are 

methotrexate, vincristine, 

daunomycin, and actinomycin-D. 

—Sickle Cell Disease (SCD): A clinical 

trial of PK, efficacy, and safety of 

hydroxyurea to treat infants and 

young children with SCD is under 

way, with a planned safety follow-up. 

—Attention Deficit Hyperactivity 

Disorder: The NICHD is funding basic 

and clinical research to evaluate the 

potential toxicity of methylphenidate. 

—Organophosphate poisonings: 

Existing data on the use of 

pralidoxime for this indication is 

under review. 

• 2007 

—Oncology: The NICHD consulted with 

experts in pediatric oncology to 

discuss the use of 13-cis-retinoic acid 

for the indication of neuroblastoma 

and to develop a pediatric 

formulation for this indication. 

—Methicillin-resistant Staphylococcus 

aureus (MRSA) infections: The 

NICHD consulted with experts in 

infectious disease to discuss the need 

for PK, safety, and efficacy studies of 

clindamycin, doxycycline, 

tetracycline, and trimethoprimsulfamethoxazole for the treatment of 

MRSA infections. 

—Asthma: The NICHD has pursued 

potential collaborations with research 

networks within the NIH that are 

conducting clinical trials and other 

research in pediatric asthma, 

specifically networks supported by 

the National Heart, Lung, and Blood 

Institute and the National Institute of 

Allergy and Infectious Diseases. 

—Hypertension: A written request for 

the study of hydrochlorothiazide in 

hypertension has been received by the 

NICHD. The NICHD has conducted a 

third working group meeting with 

experts in the field of pediatric 

hypertension to discuss studies 

needed in this area. Future clinical 

trials are being considered. 

• Other areas of continued or future 

consideration for study under the BPCA 

discussed in previous Federal Register 

Notices and/or BPCA scientific meetings 

include: 

—Obesity: The NICHD is consulting 

with experts in the field on the 

treatment of the metabolic syndrome 

and obesity-related Type-2 diabetes 

and hypertension. 

—Counterterrorism research: The 

NICHD has developed a working 

group to discuss the needs in 

pediatric therapeutics for the 

treatment of chemical, biologic, 

radiologic, nuclear, and explosive 

(CBRNE) exposure. The NICHD is 

collaborating with the National 

Institute of Neurological Disorders 

and Stroke on its Counter-Act 

initiative to develop new and 

improved medical counter-measures 

against chemical threats in children 

and adults. 

—Influenza and parasitic diseases: The 

NICHD held preliminary discussions 

with international experts on global 

pediatric pharmacology issues. 

Influenza and parasitic diseases are 

potential prototypes for future 

collaborations. 

—Fragile X syndrome: The NICHD 

continues to consult with experts in 

the field, including the National 

Institute of Mental Health, to consider 

selected drugs and clinical outcome 

measures for evaluation and/or study. 

—Depression: The NICHD has consulted 

with experts in the field to consider 

the approaches and design of safety 

studies of psychotropic medications 

in children, including antidepressants 

and other psychotropic medications. 

Throughout 2007 and 2008, the 

NICHD continued its outreach to 

pediatric organizations and other NIH 

Institutes and Centers. The goal of these 

discussions was specifically to identify 

current gaps in scientific knowledge 

regarding research and treatment of 

pediatric conditions with the ultimate 

goal of determining approved drugs for 

which future pediatric studies are 

needed. Minutes of all working group 

Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 17205 

meetings conducted under the BPCA 

can be found on the BPCA Web site 

listed above. 

The ‘‘New’’ BPCA 

Title V of Public Law 110–85, the Best 

Pharmaceuticals for Children Act of 

2007, was enacted on September 27, 

2007, as part of the Food and Drug 

Administration Amendments Act of 

2007. 

This legislation, which reauthorizes 

the BPCA (Section 409I of the Public 

Health Service Act), extends the 

provision of additional patent 

exclusivity for currently on-patent drugs 

that are being tested for pediatric use. 

This legislation also extends and 

expands the research program at the 

NIH established in the earlier law. The 

NICHD administers the research 

program through its Obstetric and 

Pediatric Pharmacology Branch, 

working in cooperation with the other 

NIH Institutes and Centers with 

significant pediatric research portfolios. 

Important changes to the 2002 BPCA 

legislation for the NIH include the 

following: 

• Focus on condition-based approach. 

• More flexible funding mechanisms. 

• Development of Proposed Pediatric 

Study Requests (PPSR). 

• Feasibility study for the 

development of a pediatric formulary. 

The NICHD will prioritize all 

therapeutic areas over the upcoming 

years based on the following 

considerations: 

• Building upon the current 

foundation established by the 2002 

BPCA implementation; 

• Evaluating all currently listed drugs 

and therapeutic areas for feasibility and 

identification of additional or new 

scientific and therapeutic gaps; 

• Changing the listing process from 

an individual drug/indication approach 

to listing needs in pediatric therapeutic 

areas; 

• Determining new areas of need 

based on consultation with other NIH 

Institutes and Centers, as well as experts 

in pediatric therapeutics and the 

pediatric medical community. 

The overall goal of the NIH for 

implementing the provisions of the 

BPCA is to improve pediatric 

therapeutics through scientific 

advancements and labeling changes that 

will have an impact on the safe and 

effective use of drugs in children. This 

can be accomplished through the 

following: 

• Data gathering 

—Using the principles of 

pharmacoepidemiology research to 

quantify adverse drug reactions, drug 

efficacy, and patterns of drug use in 

large populations to elucidate health 

services utilization. 

—Bringing together multidisciplinary 

teams to provide input on needs in 

pediatric therapeutics through 

outreach to experts in pediatric 

research in academic institutions; 

other NIH Institutes and Centers; and 

pediatric organizations, societies, 

advocacy groups, and industry. 

• Clinical trials 

—Phase 1, 2, and 3 clinical trials to 

increase the knowledge of PK, safety, 

and efficacy of medicines used in 

children. 

• Basic and translational research 

—To inform such areas as 

developmental pharmacology, 

pharmacogenomics, and pediatric 

clinical trial design. 

There will be an open scientific 

meeting annually, starting in 2008, to 

review and discuss the proposed 

therapeutic areas, to present progress 

from ongoing research, and to provide 

an opportunity for the medical 

community to provide input into the 

future therapeutic areas to be studied 

under the BPCA. Stakeholders will 

include the NIH, the FDA, and members 

of the American Academy of Pediatrics, 

and other pediatric organizations and 

societies. There will be a report to 

Congress at least every 3 years starting 

in 2008. Throughout the year, there will 

also be smaller group meetings with 

expert panels within prioritized 

therapeutic areas under the BPCA. The 

goals of the working group meetings 

will be to evaluate and discuss the gaps 

in scientific knowledge (whether 

necessary data are available or 

unavailable) as well as to determine 

gaps in the treatments of these 

conditions; for example, to determine 

what may be needed to enhance the 

treatment of these conditions in 

children. These consultations will assist 

the NICHD in the development of future 

proposed areas of study encompassing 

multiple therapeutic categories and/or 

addressing multiple questions within a 

therapeutic category. 

A scientific prioritization meeting was 

held in Rockville, Maryland, from June 

30 to July 1, 2008, to determine needs 

in pediatric therapeutics as mandated 

by the BPCA 2007 legislation. The final 

BPCA List of Needs in Pediatric 

Therapeutics, and information on the 

prioritization process, will be posted on 

the BPCA Web site http:// 

bpca.nichd.nih.gov. 

Dated: April 7, 2009. 

Raynard S. Kington, 

Acting Director, National Institutes of Health. 

[FR Doc. E9–8477 Filed 4–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2009–0008] 

The National Infrastructure Advisory 

Council 

AGENCY: Directorate for National 

Protection and Programs, Department of 

Homeland Security. 

ACTION: Committee Management; Notice 

of cancellation for Federal Advisory 

Committee Meeting. 

SUMMARY: The meeting of the National 

Infrastructure Advisory Council (NIAC) 

scheduled for Tuesday April 14, 2009 at 

the J.W. Marriott, 1331 Pennsylvania 

Avenue, Washington, DC announced in 

the Federal Register on February 17, 

2009 (73 FR 7456), will not be held. 

FOR FURTHER INFORMATION CONTACT: 

Contact Matthew Sickbert by phone at 

703–235–2888 or by e-mail at 

Matthew.Sickbert@associates.dhs.gov. 

Dated: April 9, 2009. 

Nancy J. Wong, 

Designated Federal Officer for the NIAC. 

[FR Doc. E9–8541 Filed 4–10–09; 11:15 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

United States Immigration and 

Customs Enforcement 

60-Day Notice of New Information 

Collection; Form 70–005, ICE Secure 

Communities Stakeholder ID 

Assessment Questionnaire; Agency 

Information Collection Activities: New 

Information Collection; Comment 

Request 

ACTION: 60-Day Notice of New 

Information Collection; Form 70–005, 

ICE Secure Communities Stakeholder ID 

Assessment Questionnaire. 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (USICE), has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until June 15, 2009.