OMB control number
Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs
OMB 0910-0746 · HHS/FDA.
OMB 0910-0746
This information collection supports Food and Drug Administration (FDA) performance goals and procedures as set forth under the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA). These goals are the result of agency, industry, and public input, as Congressionally mandated under the applicable statutes and represent the renewed performance goals agreed to by FDA in support of these respective programs.
The latest form for Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs expires 2022-09-30 and is listed under ICR 201908-0910-016.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0746 Program Evaluation SSA 2022 Rev.docx | Supporting Statement A |
 Interviews |
Other-Agency Performance Goals |
| Surveys |
Other-Agency Performance Goals |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202208-0910-017 | Revision of a currently approved collection | 2022-08-31 | Approved without change | |
| 201908-0910-016 | Extension without change of a currently approved collection | 2019-09-03 | Approved without change | |
| 201710-0910-016 | No material or nonsubstantive change to a currently approved collection | 2017-10-27 | Approved without change | |
| 201607-0910-013 | Extension without change of a currently approved collection | 2016-07-28 | Approved without change | |
| 201305-0910-002 | New collection (Request for a new OMB Control Number) | 2013-05-14 | Approved with change |
OMB Details
Pretest
Federal Enterprise Architecture: Health - Consumer Health and Safety