Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K

OMB 0910-0776

OMB 0910-0776

This information collection helps to support implementation of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Drug Quality and Security Act (DQSA) regarding the registration of human drug compounding outsourcing facilities. The information collection also implements provisions applicable to registered outsourcing facilities and the assessment and remission of user fees under section 744K of the FD&C Act.

The latest form for Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K expires 2023-12-31 and can be found here.

OMB Details

Registration of Oursourcing Facilitites and Payment of Fees

Federal Enterprise Architecture: Health - Health Care Services

Form 3908Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction RequestFillable Fileable SignableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


© 2021 OMB.report | Privacy Policy