13214 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section 741(d) of the Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

741(d)—Minor Use or Minor Species 

Fee Waiver & Reduction Requests 9 1 9 2 18 

Request for Reconsideration; CVM 

AGDUFA Waiver Officer2 1 1 1 1 1 

Request for Review; CVM AGDUFA 

Appeals Officer 1 1 1 1 1 

Request for Review; FDA User Fee 

Appeals Officer 1 1 1 1 1 

Total 21 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 CVM means Center for Veterinary Medicine. 

Appeals for reconsideration or review 

of AGDUFA user fee waiver decisions 

will be very rare. Waivers are granted 

only for user fees involving minor use 

or minor species as defined by the 

Minor Use and Minor Species Act of 

2008 (MUMS). Decisions on waivers of 

user fees based on minor species do not 

allow for agency discretion as ‘‘minor 

species’’ is defined specifically in the 

MUMS statute. As to minor use in a 

major species, FDA, under MUMS, 

determines that a new animal drug is for 

minor use in a major species at the time 

that the pioneer new animal drug 

application is submitted. This 

determination carries over to the 

abbreviated (generic) new animal drug 

application. Therefore, we do not 

anticipate that there will be more than 

one request for review or 

reconsideration for either the ‘‘minor 

use’’ or ‘‘minor species’’ waivers or 

reductions under AGDUFA per year. 

Fee Waiver or Reduction Requests: 

For those who, after reading the 

guidance, decide to apply for a waiver 

or reduction of one or more of the fees 

they were assessed, the time to complete 

the information required for their 

waiver application, based on the 

guidance provided, is estimated to be 2 

hours or less. 

Based on FDA’s database system, 

there are an estimated 50 sponsors of 

products subject to AGDUFA. However, 

not all sponsors will have submissions 

in a given year. CVM estimates nine 

waiver requests that include minor use 

or minor species. The estimated hours 

per response are based on past FDA 

experience with the various waiver 

requests in CVM. The hours per 

response listed in table 1 of this 

document are based on the average of 

these estimates. 

Dated: March 19, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6724 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–0664] 

Joint Meeting of the Pediatric Advisory 

Committee and the Oncologic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee and Oncologic 

Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Monday, April 27, 2009, from 

8 a.m. to 6 p.m. 

Addresses: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Carlos Pen ̃ a, Office of 

the Commissioner (HF–33), Food and 

Drug Administration, 5600 Fishers Lane 

(for express delivery, rm. 14B–08), 

Rockville, MD 20857, 301–827–3340, or 

by e-mail: carlos.pen ̃ a@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

8732310001. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On Monday, April 27, 2009, 

the Pediatric Advisory Committee and 

the Oncologic Drugs Advisory 

Committee will meet to discuss the 

scientific and ethical issues involved in 

obtaining and using brain biopsy 

specimens to evaluate gene expression 

patterns in children with diffuse 

pontine gliomas. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 13, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

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