Marketed Unapproved Drugs; Public Workshop, 64284-64285 [E6-17959]

Download as PDF 64284 Federal Register / Vol. 71, No. 211 / Wednesday, November 1, 2006 / Notices that have interests in health systems change and personalized health care. Some examples of these organizations include: • Community health delivery systems. • Health maintenance organizations. • University-based health systems. • State and local public health departments. • Other Federal agencies. • Advocacy groups and public interest organizations. • Consumer and patient interests groups. • Health care professional societies. • Trade industry organizations. • Purchasers of health care. • Health information technology industry vendors. Dated: October 26, 2006. John O. Agwunobi, Assistant Secretary for Health, Office of Public Health and Science. [FR Doc. E6–18371 Filed 10–31–06; 8:45 am] BILLING CODE 4150–26–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0478] Marketed Unapproved Drugs; Public Workshop AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs. DATES: The public workshop will be held on January 9, 2007, from 9 a.m. to 4 p.m. Registration is open until November 15, 2006. Submit requests for specific discussion topics by November 15, 2006. ADDRESSES: The public workshop will be held in the Center for Drug Evaluation and Research Advisory Committee conference room, 5630 VerDate Aug<31>2005 17:36 Oct 31, 2006 Jkt 211001 Fishers Lane, rm. 1066, Rockville, MD. The agenda for the meeting will be posted at https://www.fda.gov/cder/drug/ unapproved_drugs. Submit topics by mail to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit topics electronically to https://www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed topics, except that individuals may submit one paper copy. All requests for discussion topics should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen Kirchberg, Center for Drug Evaluation and Research (HFD–330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–8916, e-mail: karen.kirchberg@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 9, 2006 (71 FR 33466), FDA announced the availability of a guidance entitled ‘‘Marketed Unapproved Drugs— Compliance Policy Guide’’ (the Marketed Unapproved Drugs CPG). The guidance describes how FDA intends to exercise its enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. The guidance explains that FDA intends to continue to give priority to enforcement actions involving unapproved drugs that have potential safety risks, lack evidence of effectiveness, and constitute health fraud, among other categories. The Marketed Unapproved Drugs CPG also explains how the agency intends to address those situations in which a company obtains approval to sell a drug that other companies have sold without FDA approval for some time. In the Marketed Unapproved Drugs CPG, FDA encourages companies to comply with the drug approval requirements of the Federal Food, Drug, and Cosmetic Act. Following the publication of the Marketed Unapproved Drugs CPG, a number of drug companies have contacted FDA seeking clarification about how to obtain approval to legally market their unapproved drug products and whether applications for marketing are subject to user fees, among other issues. The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 II. Scope of the Public Workshop As part of FDA’s goal to ensure that all marketed drugs comply with appropriate FDA requirements to ensure their safety and efficacy, FDA is holding a public workshop to educate businesses on the drug application and OTC monograph processes and to discuss issues of interest to participants. Topics for discussion include the following: (1) The various routes for legal marketing—NDAs, ANDAs, and OTC monographs; (2) application processes; (3) user fee applicability and waivers; and (4) market exclusivity for newly-approved drugs. The information provided during registration will help us determine additional topics for discussion and how to further focus the workshop. III. Participation in the Public Workshop A. Registration Register via e-mail to CDER_330CATS@cder.fda.gov by providing complete contact information for each attendee (including name, title, affiliation, e-mail address, and phone number(s)) by November 15, 2006. Please indicate ‘‘Workshop— Unapproved Products’’ in the ‘‘subject’’ line of the e-mail. FDA intends to respond to registration requests by email after November 15, 2006. There is no registration fee to attend. Space is limited; therefore, interested parties are encouraged to register early and FDA may need to limit the number of attendees from each firm or organization. If you need special accommodations due to a disability, please e-mail your request at least 7 days before the meeting. B. Suggested Topics If you would like to request discussion of a specific topic for the workshop, submit it to the Division of Dockets Management (see ADDRESSES) using the docket number, found in brackets in the heading of this document, by November 15, 2006. We may not be able to include all submitted topics in the workshop agenda. C. Parking, Transportation, and Security Limited visitor parking is available for a fee, and the Twinbrook Metro station is within walking distance. Early arrival is encouraged, as there will be security screening. Workshop participants will be asked for government-issued picture identification by the security officers. IV. Transcripts Following the workshop, transcripts will be available for review at the E:\FR\FM\01NON1.SGM 01NON1 Federal Register / Vol. 71, No. 211 / Wednesday, November 1, 2006 / Notices Division of Dockets Management (see ADDRESSES), Monday through Friday between 9 a.m. and 4 p.m. You may also request a copy of the transcript from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. Dated: October 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–17959 Filed 10–31–06; 8:45 am] BILLING CODE 4160–01–S Dated: October 25, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8984 Filed 10–31–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–M National Institute on Drug Abuse; Notice of Closed Meeting sroberts on PROD1PC70 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, NIDA– K conflicts SEP A. Date: November 14, 2006. Time: 4 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Mark Swieter, PhD, Chief, Training and Special Projects Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6101 Executive Boulevard, Suite 220, Bethesda, MD 20892–8401, (301) 435–1389, ms80x@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, NIDA– K conflicts SEP B. Date: November 14, 2006. Time: 5 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. VerDate Aug<31>2005 17:36 Oct 31, 2006 Jkt 211001 Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Mark Swieter, PhD, Chief, Training and Special Projects Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6101 Executive Boulevard, Suite 220, Bethesda, MD 20892–8401, (301) 435–1389, ms80x@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Neuro AIDS Imaging II. Date: November 3, 2006. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Phillip F. Wiethorn, Scientific Review Administrator, DHHS/NIH/ NINDS/DER/SRB, 6001 Executive Boulevard; MSC 9529, Neuroscience Center; Room 3203, Bethesda, MD 20892–9529, (301) 496–5388, wiethorp@ninds.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 64285 (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: October 25, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–8985 Filed 10–31–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special Emphasis Panel, Mental Health Services in Non-Specialty Settings. Date: November 7, 2006. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Aileen Schulte, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd, Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–1225, aschulte@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) E:\FR\FM\01NON1.SGM 01NON1

Agencies

[Federal Register Volume 71, Number 211 (Wednesday, November 1, 2006)]
[Notices]
[Pages 64284-64285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0478]


Marketed Unapproved Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop on issues related to the application process for seeking 
approval for marketed unapproved drugs. This will be a 1-day workshop 
involving FDA staff and representatives from businesses currently 
marketing unapproved drugs. The purpose of the workshop is to provide 
clarification and direction to businesses on how to seek approval to 
legally market drugs through the new drug application (NDA) and 
abbreviated new drug application (ANDA) processes and how to legally 
market drugs through compliance with the over-the-counter (OTC) 
monographs.

DATES: The public workshop will be held on January 9, 2007, from 9 a.m. 
to 4 p.m. Registration is open until November 15, 2006. Submit requests 
for specific discussion topics by November 15, 2006.

ADDRESSES: The public workshop will be held in the Center for Drug 
Evaluation and Research Advisory Committee conference room, 5630 
Fishers Lane, rm. 1066, Rockville, MD. The agenda for the meeting will 
be posted at https://www.fda.gov/cder/drug/unapproved_drugs.
    Submit topics by mail to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit topics electronically to https://
www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed 
topics, except that individuals may submit one paper copy. All requests 
for discussion topics should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen Kirchberg, Center for Drug 
Evaluation and Research (HFD-330), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8916, e-mail: 
karen.kirchberg@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 9, 2006 (71 FR 33466), FDA 
announced the availability of a guidance entitled ``Marketed Unapproved 
Drugs--Compliance Policy Guide'' (the Marketed Unapproved Drugs CPG). 
The guidance describes how FDA intends to exercise its enforcement 
discretion with regard to drugs marketed in the United States that do 
not have required FDA approval for marketing. The guidance explains 
that FDA intends to continue to give priority to enforcement actions 
involving unapproved drugs that have potential safety risks, lack 
evidence of effectiveness, and constitute health fraud, among other 
categories. The Marketed Unapproved Drugs CPG also explains how the 
agency intends to address those situations in which a company obtains 
approval to sell a drug that other companies have sold without FDA 
approval for some time. In the Marketed Unapproved Drugs CPG, FDA 
encourages companies to comply with the drug approval requirements of 
the Federal Food, Drug, and Cosmetic Act.
    Following the publication of the Marketed Unapproved Drugs CPG, a 
number of drug companies have contacted FDA seeking clarification about 
how to obtain approval to legally market their unapproved drug products 
and whether applications for marketing are subject to user fees, among 
other issues. The agency is committed to working with companies to 
facilitate the process of ensuring that products are safe and effective 
and meet appropriate standards for manufacturing and labeling.

II. Scope of the Public Workshop

    As part of FDA's goal to ensure that all marketed drugs comply with 
appropriate FDA requirements to ensure their safety and efficacy, FDA 
is holding a public workshop to educate businesses on the drug 
application and OTC monograph processes and to discuss issues of 
interest to participants.
    Topics for discussion include the following: (1) The various routes 
for legal marketing--NDAs, ANDAs, and OTC monographs; (2) application 
processes; (3) user fee applicability and waivers; and (4) market 
exclusivity for newly-approved drugs. The information provided during 
registration will help us determine additional topics for discussion 
and how to further focus the workshop.

III. Participation in the Public Workshop

A. Registration

    Register via e-mail to CDER--330CATS@cder.fda.gov by providing 
complete contact information for each attendee (including name, title, 
affiliation, e-mail address, and phone number(s)) by November 15, 2006. 
Please indicate ``Workshop--Unapproved Products'' in the ``subject'' 
line of the e-mail. FDA intends to respond to registration requests by 
e-mail after November 15, 2006. There is no registration fee to attend. 
Space is limited; therefore, interested parties are encouraged to 
register early and FDA may need to limit the number of attendees from 
each firm or organization. If you need special accommodations due to a 
disability, please e-mail your request at least 7 days before the 
meeting.

B. Suggested Topics

    If you would like to request discussion of a specific topic for the 
workshop, submit it to the Division of Dockets Management (see 
ADDRESSES) using the docket number, found in brackets in the heading of 
this document, by November 15, 2006. We may not be able to include all 
submitted topics in the workshop agenda.

C. Parking, Transportation, and Security

    Limited visitor parking is available for a fee, and the Twinbrook 
Metro station is within walking distance. Early arrival is encouraged, 
as there will be security screening. Workshop participants will be 
asked for government-issued picture identification by the security 
officers.

IV. Transcripts

    Following the workshop, transcripts will be available for review at 
the

[[Page 64285]]

Division of Dockets Management (see ADDRESSES), Monday through Friday 
between 9 a.m. and 4 p.m. You may also request a copy of the transcript 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page.

    Dated: October 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-17959 Filed 10-31-06; 8:45 am]
BILLING CODE 4160-01-S

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