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

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.

Latest Forms, Documents, and Supporting Material

Document Name
0776 Registration and Fees Outsourcing Facilities 2023 SSA EXT.docx Supporting Statement A
Retention of small business designation notification Other-Guidance
Registration of Oursourcing Facilitites and Payment of Fees Other-Guidance

All Historical Document Collections

202311-0910-015 Approved without change	Extension without change of a currently approved collection	2023-12-01
202011-0910-001 Approved without change	Revision of a currently approved collection	2020-11-27
201710-0910-008 Approved without change	Extension without change of a currently approved collection	2017-10-19
201409-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	2014-09-08

OMB Details

Registration of Oursourcing Facilitites and Payment of Fees

Federal Enterprise Architecture: Health - Health Care Services

Form 3908

Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request

Fillable Fileable Signable

Form and instruction

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