17202 Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 

Dated: April 7, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8479 Filed 4–13–09; 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 

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 

Neurological Disorders and Stroke Special 

Emphasis Panel; Aneurysm Trial. 

Date: April 23, 2009. 

Time: 3:15 p.m. to 5:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Richard D. Crosland, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301– 

594–0635, rc218u@nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Review of NINDS PPG on 

CA∧2+ Signaling in Spines. 

Date: April 24, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Ernest W Lyons, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20892– 

9529, 301–496–4056, lyonse@ninds.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: April 7, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8481 Filed 4–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of a Public Consultation 

Meeting on Proposed Revisions to the 

NIH Guidelines for Research Involving 

Recombinant DNA Molecule (NIH 

Guidelines) 

There will be a public consultation 

meeting to solicit stakeholder input 

regarding the proposed revisions to the 

NIH Guidelines. The meeting will be 

held on Tuesday, June 23, 2009 at the 

Hyatt Regency Crystal City, 2799 

Jefferson Davis Highway, Arlington, 

Virginia, 22202, from approximately 8 

a.m. to 5 p.m. 

Discussions will focus on the 

proposed revisions to the NIH 

Guidelines which include: (1) 

Broadening the scope of the NIH 

Guidelines, which currently cover 

laboratory and clinical research 

involving DNA molecules created via 

recombinant techniques (i.e., joining of 

DNA molecules), to apply to nucleic 

acids that are synthesized chemically or 

by other means without the use of 

recombinant technology; (2) Revising 

the criteria for determining when the 

introduction of a drug resistance trait 

into a microorganism must be reviewed 

by the Recombinant DNA Advisory 

Committee and approved by the NIH 

Director; and (3) Changing the level of 

review required for recombinant or 

synthetic experiments involving more 

than one-half but less than two-thirds of 

the genome of certain viruses in tissue 

culture as described in Section III–E–1 

of the NIH Guidelines. 

The Notice of Consideration of a 

Proposed Action under the NIH 

Guidelines was published in the 

Federal Register on March 4, 2009 (74 

FR 9411) and may be located at the 

following link: http://oba.od.nih.gov/ 

rdna/rdna.html. 

For further information concerning 

this meeting contact Ms. Laurie 

Lewallen, Advisory Committee 

Coordinator, Office of Biotechnology 

Activities, Office of the Director, 

National Institutes of Health, 6705 

Rockledge Drive, Room 750, Bethesda, 

MD 20892–7985, 301–496–9838, 

lewallenl@od.nih.gov. 

The meeting will be open to the 

public, with attendance limited to the 

space available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed above in 

advance of the meeting. 

A draft agenda and additional 

information for the meeting will be 

posted on the OBA Web site: http:// 

oba.od.nih.gov/rdna/rdna.html. 

Background and supplemental 

information may also be obtained by 

contacting NIH OBA by e-mail 

oba@od.nih.gov. 

Dated: April 8, 2009. 

Jacqueline Corrigan-Curay, 

Acting Director, Office of Biotechnology 

Activities, National Institutes of Health. 

[FR Doc. E9–8478 Filed 4–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Request for Research Sites To 

Measure Composition of Sealed Area 

Atmosphere in Coal Mines 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), is 

seeking research sites to measure 

composition of sealed area atmosphere 

in coal mines. 

NIOSH seeks to conduct scientific 

studies of the composition of sealed area 

atmospheres and the mechanisms of 

methane accumulation within sealed 

areas. Research questions to be 

addressed are: (1) Whether potentially 

explosive gas mixtures exist within 

sealed areas, (2) how extensive such 

mixtures might be, (3) how the gas 

composition changes over time, (4) 

whether methane layering exists, (5) the 

homogeneity of the atmosphere, and (6) 

how barometric pressure changes 

impact the sealed atmosphere. NIOSH 

will document measurements of the 

composition of the sealed area 

atmosphere over time, analyze the 

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