OMB control number
GFI: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
OMB 0910-0777 · HHS/FDA.
OMB 0910-0777
This information collection supports agency guidance. The guidance implements provisions added to the Federal Food, Drug, and Cosmetic Act by the Drug Quality and Security Act in which Congress created a new category of "outsourcing facilities" that compound human drugs. Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) allows persons or entities to register with FDA as outsourcing facilities, and the guidance discusses the process for doing so. Respondents to the collection are those engaged in these activities.
The latest form for GFI: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act expires 2020-12-31 and is listed under ICR 201710-0910-007.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Waiver Request From Electronic Submission of Registration Information |
Information collection |
| Electronic Submission of Registration Information Using SPL Format |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201710-0910-007 | Extension without change of a currently approved collection | 2017-10-17 | Approved without change | |
| 201409-0910-001 | New collection (Request for a new OMB Control Number) | 2014-09-08 | Approved without change |
OMB Details
Electronic Submission of Registration Information Using SPL Format
Federal Enterprise Architecture: Health - Consumer Health and Safety