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Regulatory Procedures Manual

Commissioning

FDA State/Local Commissioning Program

The Commissioning Program was developed to make inter-agency cooperation more effective and, hence, increase the amount of protection afforded to the American consumer. The program was designed to utilize the potential of State and local officials to perform specifically designated functions that are subject to Federal jurisdiction, e.g., to conduct examinations, inspections, and investigations; to collect and obtain samples; copy and verify records; and receive and review official FDA documents. Any officer or employee of a State, territory or a political subdivision thereof can be commissioned as an officer of the Department of Health and Human Services. Each commission is issued for a period of five years. Towards the end of this period, FDA will review each commission and determine whether it should be renewed. Depending on the scope of the commission, the receiving official might receive pocket credentials and a wall certificate or just a wall certificate.

Why are Commissions Granted?

There are many possible reasons to grant an FDA Commission including: to enable the official to conduct inspections and collect samples under a Partnership Agreement or FDA Contract, even if their own State/local laws do not provide such authority; to enable the official to operate under the Federal FD&C Act, as well as their own State/local authority whichever best serves the situation; and to enable the official to see and review certain pieces of FDA information normally considered confidential and not releasable to the general public. The ability to solicit the advice of and to tap the expertise of State and local counter parts, as well as the ability to share regulatory activities, without having to make any public disclosure of the information, is a major advantage of the program. This practice has found increasing use during the last few years.

Only State and local officials holding a credential may conduct inspections and collect samples. Those holding a certificate only may review and receive information only

What is the difference in information that can be shared under an FDA Commission and a 20.88 agreement?

Confidential, commercial and trade secret information can all be shared under a FDA Commission, while only confidential, commercial information can be shared under a 20.88 Confidentiality Agreement.

How are Commissions Granted?

The current policies and procedures were developed, and refined over the years, by FDA to grant specific authority in a specific program area in a designated State to State and local officials pursuant to the following laws: Section 702(a) of the Federal Food, Drug, and Cosmetic Act; Section 360 E(2) of the Public Health Service Act; and authority delegated to the Commissioner of Food and Drugs by the Secretary of Health and Human Services under 21 CFR 5.35.

FDA commissions are granted to State and local officials "traditional" areas such as animal feeds, foods, drugs, medical devices, etc.; and in 2009, FDA commissioning was extended to tobacco.