FDA Solicits Comments on the Collection of Information Related to Adverse Reporting for Outsourcing Facilities – APhA submits compounding comments to FDA. – (866) 348-2889.
FDA has announced an opportunity for public comment on the proposed collection of certain information by the agency. A recently published Federal Register notice solicits comments on adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This information collection supports agency implementation of the Drug Quality and Security Act, which amended the FD&C Act by adding section 503B.
With respect to the collection of information, FDA invites comments on the following topics:
- Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
- The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;