55114 Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 

text or that certain text fields be 

modified to ask supplemental questions 

of the reporter. 

FDA has carefully considered each of 

these changes but does not concur with 

making these elective changes, which 

are not based on any changes in law, 

rule, or regulation. Because FDA 

encourages electronic submission of 

postmarketing adverse event reports by 

mandatory reporters, and the majority of 

mandatory reporters use the paperbased Form FDA 3500A only for backup 

purposes, the agency believes that it 

would be an unfair burden to 

manufacturers who submit 

electronically to expend resources to 

change their electronic versions of the 

paper document which would be used 

only in times of rare network or server 

outages. FDA believes that each of these 

suggested elective text changes and 

additions can be addressed satisfactorily 

with specific clarifying information 

provided in the instructions section that 

supplements Form FDA 3500A. 

One comment suggests that FDA 

modify the forms to include wording as 

a ‘‘disclaimer by consumer authorizing 

the treating physician to speak with a 

manufacturer’s representative.’’ FDA 

disagrees with the inclusion of this type 

of information within the standard 

reporting form and believes that this 

type of information is best treated as 

part of other documentation maintained 

by the mandatory reporter. 

One comment suggests that provisions 

be made to allow for the inclusion of 

attachments with the serious adverse 

event report. FDA agrees and 

attachments are currently permitted 

both as supplements to mailed and 

faxed submissions. One comment 

acknowledged and supported the 

recently announced development of a 

unified federal approach to adverse 

event reporting, and suggested that this 

approach will ease the reporting burden 

for both industry and FDA and 

indirectly benefit consumers. 

The newly revised Forms FDA 3500 

and 3500A with updated instructions, 

which will address several comments’ 

concerns about clarity, will be made 

available, upon OMB approval, on the 

FDA’s MedWatch Web site at http:// 

www.fda.gov/medwatch/getforms.htm. 

Dated: September 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22440 Filed 9–23–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Endocrinologic and Metabolic 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Endocrinologic 

and Metabolic 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 October 21, 2008, from 8 a.m. 

to 5 p.m. 

Location: Crowne Plaza Hotel/ 

Washington DC–Silver Spring, The 

Ballrooms, 8777 Georgia Ave., Silver 

Spring, MD, 301–589–0800. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. 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 October 21, 2008, the 

committee will begin with a closed 

session from 8 a.m. to 11 a.m. Following 

the closed session, from 11 a.m. to 5 

p.m., the meeting will be open to the 

public. The committee will discuss the 

safety and efficacy of biologic license 

application (BLA) 125291, MYOZYME 

(alglucosidase alfa), Genzyme Corp., for 

the treatment of late onset Pompe 

disease. 

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 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: On October 21, 2008, from 

11 a.m. to 5 p.m., the meeting is open 

to the public. 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 October 7, 2008. 

Oral presentationsfrom the public will 

be scheduled between approximately 12 

noon and 1 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

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 September 29, 2008. 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 

September 30, 2008. 

Closed Committee Deliberations: On 

October 21, 2008, from 8 a.m. to 11 a.m., 

the meeting will be closed to permit 

discussion and review of trade secret 

and/or confidential information (5 

U.S.C. 552b(c)(4)). During this session, 

the committee will discuss the 

manufacturing as well as relevant 

biochemical and physiochemical 

attributes of alglucosidase alfa and how 

they impact clinical efficacy. 

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 Paul Tran at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 186 / Wednesday, September 24, 2008 / Notices 55115 

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: September 16, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–22437 Filed 9–23–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0513] 

Product Tracing Systems for Fresh 

Produce; Public Meetings 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

two public meetings regarding product 

tracing systems for fresh produce. The 

purpose of the meetings is to stimulate 

and focus a discussion about 

mechanisms to enhance product tracing 

systems for fresh produce and to 

improve FDA’s ability to use the 

information in such systems to identify 

the source of contamination associated 

with fresh produce-related outbreaks of 

foodborne illness. This discussion will 

help FDA determine what short and 

long term steps we should take to 

enhance the current tracing system. 

DATES: See ‘‘How to Participate in the 

Meetings’’ in the SUPPLEMENTARY

INFORMATION section of this document. 

ADDRESSES: See ‘‘How to Participate in 

the Meetings’’ in the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: For 

registration, requests to make an oral 

presentation, and submission of written 

material for the presentation: Deborah 

Harris, EDJ Associates, Inc., 11300 

Rockville Pike, suite 1001, Rockville, 

MD 20852, 240–221–4326, FAX: 301– 

945–4295, e-mail: 

dharris@edjassociates.com. 

For general questions about the 

meeting, to request onsite parking for 

the October 16 meeting, or for special 

accommodations due to a disability: 

Juanita Yates, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration (HFS–009), 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. How to Participate in the Meetings 

Stakeholders will have an opportunity 

to provide oral comments. Due to 

limited space and time, we encourage 

all persons who wish to attend one or 

both of the meetings, including those 

requesting an opportunity to make an 

oral presentation at one or both of the 

meetings, to register in advance. 

Depending on the number of oral 

presentations, we may need to limit the 

time of each oral presentation (e.g., 5 

minutes each). If time permits FDA may 

grant requests for an opportunity to 

make a presentation from individuals or 

organizations that did not register in 

advance. 

Table 1 of this document provides 

information on participation in the 

meetings and on submitting comments. 

TABLE 1. 

Date Address Electronic Address Other Information 

First Public Meeting October 16, 

2008, from 9 

a.m. to 5 p.m. 

Harvey W. Wiley Federal 

Building, Food and Drug 

Administration, Center for 

Food Safety and Applied 

Nutrition, 5100 Paint 

Branch Pkwy., College 

Park, MD 20740-3835 

(Metro stop: College Park 

on the Green Line) 

Advance registration October 8, 2008 We encourage you to use 

electronic registration if 

possible.1

http://www.cfsan. 

fda.gov/register.html 

Registration information, information on 

requests to make an oral presentation, 

and written material associated with 

an oral presentation may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Make a request for 

oral presentation 

October 1, 2008 

Provide a brief description of the oral 

presentation and 

any written material 

for the presentation 

October 8, 2008 

Request special accommodations due 

to a disability 

October 8, 2008 See FOR FURTHER INFORMATION CONTACT 

Request onsite parking October 10, 2008 See FOR FURTHER INFORMATION CONTACT 


jlentini on PROD1PC65 with NOTICES