Center for Food Safety and Applied Nutrition   |   Office of Regulatory Affairs CGMPs for Dietary Supplements April 15, 2003

via Satellite Broadcast

"Current Good Manufacturing Practice
in Manufacturing, Packing or Holding Dietary Ingredients
and Dietary Supplements"
PROPOSED RULE

CLOSED CAPTIONED

May 9, 2003

12:30 - 3:30 PM ET
(Test Signal: 12:00 PM ET)

PROGRAM OBJECTIVES: This program will:

• Describe proposed CGMP provisions for the manufacturing, packaging, labeling, testing, quality control, releasing for distribution, and holding of dietary ingredients and dietary supplements

• Indicate how to make general comments and what types of comments FDA would find helpful in developing a final rule

• Describe how the Small Business Administration (SBA) offers help to small firms

• Offer an opportunity to ask questions about the proposed rule

WHO SHOULD PARTICIPATE: Stakeholders including:

• Dietary ingredient and supplement manufacturers, packagers, distributors, and holders

• Small businesses, their representatives and consultants

• State and local representatives

• FDA Small Business Representatives

• Other interested parties

READING MATERIALS: IMPORTANT:

Specific material for this program is posted on the CFSAN Dietary Supplement home page as indicated below. We suggest that participants read these references prior to the downlink.

1. Guidance for Small Businesses Submission of Comments for CFSAN Rulemaking: Guide for Small Businesses to Submit Comments, October 21, 2002

2. Press Release: FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements, March 7, 2003.

3. Proposed Rule: Federal Register: March 13, 2003, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements, pages 12164 and 12165-Proposal Highlights and Requests for Comments

4. Fact sheet: FDA Proposes Labeling and Manufacturing Standards Dietary Supplements.

5. Backgrounder: FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements, March 7, 2003.

General information about dietary ingredients and supplements is posted on http://www.cfsan.fda.gov/~dms/supplmnt.html.

PROGRAM VIEWING:
This program will be delivered via satellite to any location that has access to a steerable C-band satellite dish. The Technical Information Sheet is attached. For up-to-date technical information (coordinates, updates; potential "Open" downlink sites) visit the following web page prior to the broadcast:

http://www.fda.gov/cdrh/ohip/dcm/html/program_calendar.html

BUSINESS VIEWERS:
Small businesses may wish to contact their local FDA Regional Small Business Representative concerning availability of the program. Small Business Representatives are listed at ORA's web site: http://www.fda.gov/ora/fed_state/Small_Business/sbrtext.htm

STATE AND LOCAL OFFICIALS:
State and local counterparts who wish to participate may wish to consider any local viewing location that has the appropriate steerable C Band dish.

VIDEOCONFERENCING: (FDA ONLY)
Dial-in numbers will be provided for FDA sites that do not have access for satellite or fiber reception. Dial-in number will be provided by DHRD to ORA Videoconference Coordinators via separate e-mail.

AUDIO-CONFERENCING:
A "meet-me" conference call is scheduled for up to 50 participants. "Meet Me Conference Call" information is attached. These numbers should be used by participants that do not have viewing capabilities.

OTHER (FDA ONLY):
Participants time spent viewing this program should be reported into the appropriate Operation code and PAC number 03R8000.

VIDEOTAPING:
All sites are urged to videotape this program locally. A copy of this tape will be available in the ORA-U lending library. For loan information, e-mail ORADLT@ora.fda.gov

FDA HEADQUARTERS:
ORA Parklawn viewers will need to reserve a room with Channel 40 (fiber) viewing capability. FDA Center/Office viewers should contact your Center/Office training office for local viewing information.

ORA FIELD:
Contact your local downlink site coordinator for local viewing information.

IMPORTANT SATELLITE INFORMATION TO HELP YOU TUNE IN

1. Galaxy 4R is located at 99 degrees West. You can probably find it by choosing G4 or G6 or G2 on your receiver. (This popular location has been the "home" for the first Galaxy 4, Galaxy 6, and Galaxy 2, in the past.) If you would like to set up and/or test your receiver early, the following programming exists on Galaxy 4R (as of this writing):

   Channel 15  World Harvest (religious)
   Channel 16  Shepherd's Chapel (religious)

2. If you see this programming, it is highly likely you will be able to receive our programming, however, if after several tries you don't see this programming, you may need to have your equipment checked out by a professional. After successfully finding programming on these channels, don't forget to change to Channel 22 for our program.

3. It is very important for you to test your equipment as soon as possible to ensure that it is functioning properly and to see if you can get programming from the satellite we'll be on. Storms can cause damage and/or move your antenna out of alignment or you may not have your satellite of choice programmed in. Do not wait until test time to discover problems. If you think your dish and/or receiver are malfunctioning or not programmed correctly, have them checked out by a professional well before the program.

4. Although a Troubleshooter will be provided, we cannot guarantee the performance of your equipment.

May 9, 2003

12:30 - 3:30 PM ET
(Test Signal: 12:00 PM ET)

AUDIO CONFERENCE PARTICIPANT ACCESS INFORMATION

IMPORTANT!
Listening sites MUST keep your phones on MUTE.

Please join me on MAY-09-2003 (Friday) at 12:00 PM EASTERN TIME. Access information is below.

AUDIO PARTICIPANT ACCESS

CALL DATE: MAY-09-2003 (Friday)
CALL TIME: 12:00 PM EASTERN TIME
DURATION: 3 hr 30 min
LEADER: MS BARBARA GIGANTI

USA Toll Free Number: 877-546-1567

PASSCODE: 10827

The pass code and the leader's name will be required to join your call.