Zdrowie i gospodarka · 30/11/1999

Citizen Petitions; Actions That Can be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action

The Food and Drug Administration (FDA) is proposing to amend its regulations pertaining to citizen petitions. The proposal would cover citizen petition requests to issue, amend, or revoke a regulation; requests to amend or revoke an order that FDA has issued or published; or any other action specifically authorized by another FDA regulation. The document further clarifies that persons who wish to contact the agency on matters outside these three types of actions would still be able to do so through informal means, such as letters and telephone calls. In addition the proposal would also revise certain content requirements for citizen petitions and would permit FDA to refer petitions for other administrative action, seek clarification of a petitioner's requests, withdraw certain petitions, and combine petitions. These changes are intended to improve the citizen petition mechanism.