[Federal Register: February 3, 2005 (Volume 70, Number 22)]
[Notices]
[Page 5686-5687]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe05-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration Drug Educational Forum; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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[[Page 5687]]
SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER), in collaboration with FDA's Office of
Regulatory Affairs (ORA), Southwest Regional Office (SWRO), is
announcing a public workshop entitled ``FDA Drug Educational Forum.''
This public workshop is intended to provide information about FDA's
premarket requirements to the drug industry, particularly small
businesses, startups, and entrepreneurs.
Date and Time: The public workshop will be held on May 11, 2005,
from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Kansas City
Health Department Auditorium, 2400 Troost Ave., Kansas City, MO 64108-
2666. For directions to the facility, please call 816-513-6008, e-mail:
health@kcmo.org, or visit http://www.kcmo.org/health.nsf/web/healthmap?opendocument.
(FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the Web site after
this document publishes in the Federal Register.)
Contact: David Arvelo or Cassandra Davis, Food and Drug
Administration, 4040 N. Central Expressway, suite 900, Dallas, TX
75204-3128, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail:
oraswrsbr@ora.fda.gov.
Registration: Registration begins on April 6, 2005, and ends May 6,
2005. Registration is free. Seats are limited, please register as soon
as possible. Space will be filled in order of receipt of registration.
Those registered will receive confirmation. Registration will close
after available space fills. Registration at the site will be based on
space availability on the day of the event starting at 8 a.m.
If you need special accommodations due to disability, please
contact David Arvelo or Cassandra Davis (see CONTACT) at least 7 days
in advance.
Registration Form Instructions: To register, complete the following
registration form and submit via:
E-mail: oraswrsbr@ora. fda.gov,
FAX: 214-253-4970, or
Mail to: Food and Drug Administration, Southwest Regional
Office, Small Business Representative, 4040 N. Central Expressway,
suite 900, Dallas, TX 75204-3128.
Name: ________________
Company Name: ________________
Mailing Address: ________________
City: ______ State:____
Zip Code: ________________
Phone: ( ) _______
Fax: ( ) ________________
E-mail: ( ) ________________
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts may be
requested in writing from the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville,
MD 20857, approximately 15 working days after the public workshop at
cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The public workshop is being held in
response to the interest in the topics discussed from small drug
manufacturers, startups, and entrepreneurs in the FDA Southwest Region
area. FDA, CDER, and ORA present this public workshop to help achieve
objectives set forth in section 406 of the Food and Drug Administration
Modernization Act of 1997 (21 U.S.C. 393), which include working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. This is also consistent
with the purposes of FDA's Regional Small Business Program, which are
in part to respond to industry inquiries, develop educational
materials, sponsor workshops and conferences to provide firms,
particularly small businesses, with firsthand working knowledge of
FDA's requirements and compliance policies. This public workshop is
also consistent with the Small Business Regulatory Enforcement Fairness
Act of 1996 (Public Law 104-121), as outreach activities by Government
agencies to small businesses.
The goal of the public workshop is to present information that will
enable manufacturers and regulated industry to better comply with the
new drug approval process (21 CFR part 314). Information presented will
be based on agency position as articulated through regulation,
compliance policy guides, and information previously made available to
the public. Topics to be discussed at the public workshop include the
following: (1) Planning for successful, efficient, pharmaceutical
product approval; (2) current challenges and concerns for generic
abbreviated new animal drug applications (ANDAs); (3) regulatory
aspects and challenges in the development of over-the-counter (OTC)
Drugs; (4) the basics of chemistry, manufacturing and control; (5) FDA
483 issues; (6) mastering regulatory compliance; and (7) incentives for
small businesses.
Dated: January 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2098 Filed 2-2-05; 8:45 am]
BILLING CODE 4160-01-S