OMB control number
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE
OMB 0910-0906 · HHS/FDA.
OMB 0910-0906
The Food and Drug Administration (FDA, the Agency, or we) is establishing new regulations that amend current good manufacturing practice (CGMP) requirements, postmarketing safety reporting, and product labeling, that apply to certain medical gases. Conforming changes are also being made in associated regulations that apply to medical gases. The regulations are intended to promote greater efficiency in the regulation of medical gases while helping to ensure that they adhere to all applicable safety and quality standards.
The latest form for Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE expires 2028-02-29 and is listed under ICR 202406-0910-006.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form FDA 3864 Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE) | Form |
 RIN AH96 Designated Medical Gases SSA June 2024.docx | Supporting Statement A |
| FRIAMedGases-CLEAN (002).docx | Supplementary Document |
 Certification & postmarket reporting for medical gases (Tables 5 and 6 FINAL RULE) |
Form |
| Current Good Manufacturing Practice for Medical Gases (Tables 3 and 4 from FINAL RULE) |
Information collection |
| Labeling of medical gas containers (Table 2 from FINAL RULE) |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202406-0910-006 | New collection (Request for a new OMB Control Number) | 2024-07-03 | ||
| 202205-0910-004 | New collection (Request for a new OMB Control Number) | 2022-05-23 | Comment filed on proposed rule |
OMB Details
Labeling of medical gas containers (Table 2 from FINAL RULE)
Federal Enterprise Architecture: Health - Consumer Health and Safety