The term "inquiries" is considered to include requests from state and local government officials made via the medium of the telephone, Facsimile, hard copy mail, and electronic mail. This section will address the four main areas encountered by the Office of Partnerships (OP) depending on either their subject matter or method of processing: Freedom of Information Requests (FOIA); Requests for FDA testimony; Requests for an FDA position in an Affidavit or Declaration format; and requests for information that FDA considers as confidential and not releasable to the general public.
Freedom of Information Requests:
Correspondence from state and local officials addressed to the FDA's Freedom of Information Staff, Associate Commissioner for Public Affairs (HFI-35) are logged in, immediately logged out, and then forwarded to OP for appropriate response. This issue is addressed in Staff Manual Guide #2460.7, Section 4. General, paragraph q, which states "The following FOIA requests for records are processed outside the general procedures established: ***(2) Requests from a Federal department or agency or from a State or local government or agency who perform counterpart functions to the FDA at the State and local level are controlled and responded to by OP, ORA." Under most circumstances, the OP staff will provide a written acknowledgement to the requester advising of the receipt of the correspondence and action taken to get an FDA reply. When an appropriate response to the issues raised is obtained, OP prepares a FORMAL reply to the requester in as timely a fashion as is possible.
Affidavit/Declaration of FDA Position:
As noted under the caption "Testimony", it is the policy of the FDA to assist, upon request, state and local government agencies deliberating on issues relevant to the functions and responsibilities of the FDA by authorizing the appearance and testimony of FDA personnel at such proceedings. In an attempt to conserve the Agency's resources, on many occasions the requester will be offered a Certified Affidavit or a Declaration in lieu of "live" testimony if either of these documents serve the requesters needs. The use of these documents is especially useful when the requester simply wants to know the FDA's position on the "approval status of a drug or device", whether a drug product requires an Rx legend, etc., which they can then present in a judicial or administrative setting to support an action they are taking. These documents are prepared by the appropriate center holding the record(s) involved and are processed in a fashion similar to live testimony.
Title 21, Code of Federal Regulations, Part 20.1, Testimony by FDA employees, discusses the general procedures for obtaining FDA testimony and Staff Manual Guide #2127.2 entitled "Requests for Testimony of FDA Personnel in Non-FDA Proceedings" provides detailed processing information.
It is the policy of FDA to assist, upon request, state and local governments deliberating on issues relevant to the functions and responsibilities of FDA by authorizing the appearance and testimony of FDA personnel at such proceedings. These proceedings may be legislative, administrative or judicial in nature. The subject of the testimony may include: the FDA investigators observations during their inspection of a particular establishment; an analyst's findings on a sample analyzed in an FDA laboratory; the FDA's position on a bill introduced in a state legislature; an interpretation of the FD&C Act or regulations; a change in a state agency's rules on a particular subject; etc.
The referenced CFR provides that no FDA employee may testify before any tribunal pertaining to any function of the FDA or with respect to any information acquired in the discharge of his official duties except as authorized by the Commissioner of Food and Drugs. Requests for testimony received from state and local officials are processed through this Division.
Questions on these OP programs should be sent to firstname.lastname@example.org
Last edited on 10/21/2010