U.S.
FOOD AND DRUG ADMINISTRATION
OFFICE OF REGULATORY AFFAIRS AND
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
Presents 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.
Guidance for Small Businesses Submission of
Comments for CFSAN Rulemaking: Guide for Small Businesses to Submit Comments, October 21,
2002, http://www.cfsan.fda.gov/~dms/sbguide.html
Press Release: FDA Proposes Labeling and
Manufacturing Standards For All Dietary Supplements, March 7, 2003, http://www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html.
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, http://www.cfsan.fda.gov/~lrd/fr030313.html
Fact sheet: FDA Proposes Labeling and
Manufacturing Standards Dietary Supplements,
http://www.fda.gov/bbs/topics/NEWS/dietarysupp/factsheet.html.
Backgrounder: FDA Proposes Manufacturing and
Labeling Standards for all Dietary Supplements, March 7, 2003, http://www.fda.gov/bbs/topics/NEWS/dietarysupp/background.html.
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.
"Current Good Manufacturing Practice in Manufacturing,
Packing or Holding Dietary Ingredients and
Dietary Supplements” PROPOSED RULE "
TECHNICAL FACT SHEET
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 22
Polarization Vertical
Channel 22
Downlink Freq. 4140 MHz
Audio 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.
"Current Good Manufacturing Practice in Manufacturing,
Packing or Holding Dietary Ingredients and
Dietary Supplements” PROPOSED RULE
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
For security reasons, the pass code and the leader's name will be required
to join your call.
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