Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 13215 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before April 3, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 6, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Dr. Carlos 

Pen ̃ a at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 19, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–6796 Filed 3–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0145] 

Developing a Consolidated Pediatric 

Rheumatology Observational Registry; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Developing a 

Consolidated Pediatric Rheumatology 

Observational Registry.’’ This 2-day 

public workshop is intended to seek 

constructive input from key 

stakeholders in the pediatric 

rheumatology community, the 

pharmaceutical industry and the public 

to explore the value and feasibility of 

developing a consolidated pediatric 

rheumatology observational registry. 

DATES: The public workshop will be 

held on May 12, 2009, from 8:30 a.m. to 

5 p.m. and on May 13, 2009, from 8:30 

a.m. to noon. Register by April 21, 2009, 

to make a presentation at the workshop. 

See section III of this document for 

information on how to attend or present 

at the workshop. We are opening a 

docket to receive your written or 

electronic comments. Written or 

electronic comments must be submitted 

to the docket by July 14, 2009. 

ADDRESSES: The public workshop will 

be held at the Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD 20910 

(Metro: Silver Spring Station on the Red 

Line). Submit written or electronic 

requests to make a presentation to Diane 

Ehrlich (see FOR FURTHER INFORMATION

CONTACT). 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061. Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the 

workshop. 

FOR FURTHER INFORMATION CONTACT: 

Diane Ehrlich, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6190, 

Silver Spring, MD 20993–0002, 301– 

796–3452, FAX: 301–847–8753, e-mail: 

Diane.Ehrlich@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Currently, approved drug and 

therapeutic biological products for 

patients with juvenile idiopathic 

arthritis (JIA) (or juvenile rheumatoid 

arthritis (JRA)) are monitored for longterm safety beyond the information 

available at the time of approval on a 

product-by-product basis using 

registries mandated by FDA’s 

postmarketing requirements. FDA is 

addressing concerns raised by 

individuals in the pediatric 

rheumatology community about the 

current approach of using productspecific pediatric rheumatology 

observational safety registries. Some of 

the concerns expressed include the 

following: 

1. It is difficult to capture important 

information from children and 

adolescents whose medication is 

switched over time because long-term 

data on these patients will not be 

available under the product specific 

registries. Patients on ‘‘real-life’’ 

combinations of medications and/or 

nonstandard doses are often not 

included in product-specific registries. 

2. Current registries do not always 

provide an adequate control group to 

assess background rates of important 

adverse events. 

3. The limited number of patients 

with JIA will make adequate enrollment 

in product-specific observational 

registries more difficult as the number 

of approved drug and biological 

products increases. 

4. A nonproprietary registry rather 

than a proprietary registry would allow 

wider access to the safety data that is 

collected. 

5. A consolidated pediatric 

rheumatology observational registry 

may allow more efficient identification 

of longer term safety issues in this 

population. 

II. Scope of Public Workshop 

At the public workshop, FDA will 

present its current thinking on the use 

of product-specific postmarketing 

registries to capture long-term safety 

data of drug and biological products 

administered to patients with JIA. 

Product-specific registries will be 

compared with a consolidated pediatric 

rheumatology observational registry that 

could meet the regulatory postmarketing 

requirements of FDA and also collect 

other safety information and support 

potential research initiatives. 

A. Objectives of the Workshop 

The workshop objectives are as 

follows: 

1. Discuss potential registry models, 

taking into account existing registries 

for other diseases and in other 

countries. 

2. Discuss the advantages and 

disadvantages of a common 

consolidated registry for JIA, taking into 

account: 

∑ The pediatric rheumatology 

perspective. 

∑ The pharmaceutical company 

perspective. 

3. Discuss methods to capture 

information regarding safety signals in 

rare diseases. 

4. Discuss the value of working 

through existing large pediatric 

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.