13216 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 

rheumatology collaborative networks, 

such as the Childhood Arthritis and 

Rheumatology Research Alliance or the 

Pediatric Rheumatology Collaborative 

Study Group. 

5. Define, for phase 4 studies in JIA 

patients, the database standards and 

elements of data collection (e.g., data 

quality, monitoring) that are necessary 

and sufficient to meet FDA regulatory 

requirements. 

6. Discuss how pertinent research 

initiatives can be accomplished in the 

framework of a consolidated JIA 

registry, including: 

∑ Ethical considerations. 

∑ Data sharing considerations. 

7. Discuss the options for funding a 

consolidated JIA registry. 

B. Issues for Comment 

FDA is interested in obtaining public 

comment on the following issues 

relating to development of a 

consolidated pediatric rheumatology 

observational registry: 

1. Should we transition from productspecific registries to a consolidated 

pediatric rheumatology observational 

registry? 

2. Currently, the product-specific 

registries are conducted by the 

individual sponsors of the approved 

drugs and/or biological products with 

the safety data submitted to FDA. 

∑ How should a consolidated 

pediatric rheumatology observational 

registry be structured to collect data and 

conduct analyses to meet the standards 

for postmarketing requirements set by 

FDA and provide information about 

long-term safety? 

∑ What hurdles must be overcome to 

transition from product-specific 

registries to a consolidated pediatric 

rheumatology observational registry 

(e.g., industry concerns, pediatric 

rheumatology community concerns, 

proprietary issues of longer term data 

and informed consent, fulfilling FDA 

regulatory requirements, challenges of 

registry funding, management and 

ownership or sharing of data)? 

3. What data should be collected in a 

consolidated pediatric rheumatology 

observational registry? Consider the 

following topics: 

Database standards and terminology 

(e.g., compatibility with large 

databases). 

Necessary and sufficient data 

elements (e.g., safety, effectiveness, 

growth and development, comorbidities, 

tracking medication switches over time, 

as well as concurrent medication). 

Length of individual patients’ 

participation and overall duration of the 

consolidated pediatric rheumatology 

observational registry (e.g., managing 

pediatric data through and beyond the 

age of consent). 

4. What are the optimal methods to 

analyze data from a consolidated 

pediatric rheumatology observational 

registry to identify safety signals? For 

example, should the methods define 

risk windows for attribution to a drug or 

biological product; internal controls; 

and/or analyses of confounding by 

indication, switches in medication, and 

multiple concurrent medications? 

5. What are the opportunities for 

research initiatives within a 

consolidated observational 

rheumatology registry? 

III. Attendance and Registration to 

Speak 

There is no fee to attend the 

workshop, and attendees who do not 

wish to make an oral presentation do 

not need to register. Seating will be on 

a first-come, first-served basis. 

If you would like to make an oral 

presentation during the open public 

session on day one of the workshop, you 

must register and provide an abstract of 

your presentation by close of business 

on April 21, 2009. To speak, submit 

your name, title, business affiliation (if 

applicable), address, telephone and fax 

numbers, and e-mail address to Diane 

Ehrlich (see FOR FURTHER INFORMATION

CONTACT). FDA has included questions 

for comment in section II of this 

document. You should also identify by 

number each question you wish to 

address in your presentation, and the 

approximate time requested for your 

presentation. FDA will do its best to 

accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. Persons registered to make an 

oral presentation should check in before 

the workshop. 

Ample time will be allowed during 

the scheduled agenda for attendees to 

ask questions of panelists. In addition, 

we strongly encourage written 

comments to the docket. Written or 

electronic comments will be accepted 

until July 14, 2009. 

If you need special accommodations 

because of disability, please contact 

Diane Ehrlich (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the workshop. 

IV. Comments 

Regardless of attendance at the public 

workshop, interested persons may 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES). Submit a single copy 

of electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

with the docket number found in 

brackets in the heading of this 

document. To ensure consideration, 

submit comments by July 14, 2009 (see 

DATES). Received comments may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

V. Transcript 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: March 19, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6709 Filed 3–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be open to the 

public, with attendance limited to 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 below 

in advance of the meeting. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Gestational Diabetes 

Life-Course Study. 

Date: April 20, 2009. 

Time: 2 p.m. to 3:30 p.m. 

Agenda: To provide concept review of 

proposed concept review. 

Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 13217 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–9304, (301) 

435–6680. skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: March 20, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6786 Filed 3–25–09; 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. Appendix 2), 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. Mutiple System Atrophy. 

Date: April 7, 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. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel. Stroke Trial. 

Date: April 14, 2009. 

Time: 1 p.m. to 3 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. 

(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: March 19, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6660 Filed 3–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Council for 

Biomedical Imaging and Bioengineering. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to 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 below 

in advance of the 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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Biomedical Imaging and 

Bioengineering; NACBIB May 2009. 

Date: May 15, 2009. 

Time: 8:30 a.m. to 11:45 a.m. 

Agenda: Report from the Institute Director, 

other Institute Staff and presentations of 

working group reports. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Closed: 12:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Anthony Demsey, PhD, 

Director, National Institute of Biomedical 

Imaging and Bioengineering, 6707 

Democracy Blvd., Room 241, Bethesda, MD 

20892. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nibib1.nih.gov/about/NACBIB/ 

NACBIB.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

Dated: March 20, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6784 Filed 3–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

PubMed Central National Advisory 

Committee. 

The meeting will be open to the 

public, with attendance limited to 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 below 

in advance of the meeting. 

Name of Committee: PubMed Central 

National Advisory Committee. 

Date: June 15, 2009. 

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

Agenda: Review and Analysis of Systems. 

Place: National Library of Medicine, 

Building 38, Board Room, 2nd Floor, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: David J. Lipman, MD, 

Director, Natl Ctr for Biotechnology 

Information, National Library of Medicine, 

Building 38, Room 8N805, Bethesda, MD