OMB control number
Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K
OMB 0910-0776 ยท HHS/FDA.
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 2027-01-31 and is listed under ICR 202311-0910-015.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 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All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202311-0910-015 | Extension without change of a currently approved collection | 2023-12-01 | Approved without change | |
| 202011-0910-001 | Revision of a currently approved collection | 2020-11-27 | Approved without change | |
| 201710-0910-008 | Extension without change of a currently approved collection | 2017-10-19 | Approved without change | |
| 201409-0910-002 | New collection (Request for a new OMB Control Number) | 2014-09-08 | Approved without change |
OMB Details
Registration of Oursourcing Facilitites and Payment of Fees
Federal Enterprise Architecture: Health - Health Care Services
| Form | Name | Electronic access | Type |
|---|---|---|---|
| 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.