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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.
Guidance for Small Businesses Submission of Comments for CFSAN Rulemaking: Guide for Small Businesses to Submit Comments, October 21, 2002
Press Release: FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements, March 7, 2003.
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
Fact sheet: FDA Proposes Labeling and Manufacturing Standards Dietary Supplements.
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:
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.
DATE: | May 9, 2003 |
TEST TIME: | 12:00 pm - 12:30 p.m. EDT 11:00 am - 11:30 a.m. CDT 10:00 am - 10:30 a.m. MDT 9:00 am - 9:30 a.m. PDT |
PROGRAM TIME: | 12:30 pm - 3:30 p.m. EDT 11:30 am - 2:30 p.m. CDT 10:30 am - 1:30 p.m. MDT 9:30 am - 12:30p.m. PDT |
SATELLITE TROUBLE NUMBER: | 1-888-626-8730 |
Q&A NUMBER: | 1-800-527-1401 |
FAX Q & A NUMBER: | 1-888-361-4011 |
C-Band: Galaxy 4R (G4 or G6) 99 degrees West | ||||
---|---|---|---|---|
Transponder | Polarization | Channel | Downlink Freq. | Audio |
22 | Vertical | 22 | 4140 MHz | 6.2/6.8 |
IMPORTANT SATELLITE INFORMATION TO HELP YOU TUNE IN
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)
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.
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.
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.