United States Government Publishing Office
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United States
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Regulatory Information
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2010-09-23
article
Definition of Primary Mode of Action of a Combination Product
Proposed Rules
D09002ee1bde9de25
D09002ee1bde9deb2
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend its combination product regulations to define ``mode of action'' and ``primary mode of action'' (PMOA). Along with these definitions, the proposed rule sets forth an algorithm the agency would use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the proposed rule would also require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The proposed rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.
69 FR 25527
https://www.govinfo.gov/app/details/FR-2004-05-07/04-10447
04-10447
fr07my04-22
4160-01-S
https://www.govinfo.gov/app/details/FR-2004-05-07/04-10447
https://www.govinfo.gov/content/pkg/FR-2004-05-07/html/04-10447.htm
https://www.govinfo.gov/content/pkg/FR-2004-05-07/pdf/04-10447.pdf
7 p.
25527
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69 FR 25527
Code of Federal Regulations
Title 21 Part 3
21 CFR Part 3
Definition of Primary Mode of Action of a Combination Product; Federal Register Vol. 69, Issue
PRORULE
04-10447
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2004-07-06
4160-01-S
04-10447
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its combination product regulations to define ``mode of action'' and ``primary mode of action'' (PMOA). Along with these definitions, the proposed rule sets forth an algorithm the agency would use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the proposed rule would also require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The proposed rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.
Submit written comments by July 6, 2004. See section IX of this document for the proposed effective date of a final rule based on this document.
Leigh Hayes, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 301-827-9229.
Product jurisdiction:
Mode of action and primary mode of action of combination products; definitions,
fdadockets@oc.fda.gov
http://www.fda.gov/dockets/ecomments
http://www.regulations.gov
Federal Register
Vol. 69, no. 89
Office of the Federal Register, National Archives and Records Administration
2004-05-07
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daily
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348 p.
Table of Contents:
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GS 4.107:
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https://www.govinfo.gov/app/details/FR-2004-05-07
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https://www.govinfo.gov/app/details/FR-2004-05-07
https://www.govinfo.gov/content/pkg/FR-2004-05-07/pdf/FR-2004-05-07.pdf
https://www.govinfo.gov/content/pkg/FR-2004-05-07/xml/FR-2004-05-07.xml
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2010-09-23
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