05-2098. Food and Drug Administration Drug Educational Forum; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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: [e-mail], 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: [phone], e-mail: [e-mail].

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: [e-mail],
• FAX: [phone], or
• Mail to: Food and Drug Administration, Southwest Regional Office, Small Business Representative, 4040 N. Central Expressway, suite 900, Dallas, TX 75204-3128.

Name: XXXXXXXXXXXXXXXX

Company Name: XXXXXXXXXXXXXXXX

Mailing Address: XXXXXXXXXXXXXXXX

City: XXXXXX State:XXXX

Zip Code: XXXXXXXXXXXXXXXX

Phone: (  ) XXXXXXX

Fax: (  ) XXXXXXXXXXXXXXXX

E-mail: (  ) XXXXXXXXXXXXXXXX

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.