Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs

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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0746 Program Evaluation SSA 2022 Rev.docx Supporting Statement A
Interviews Other-Agency Performance Goals
Surveys Other-Agency Performance Goals

All Historical Document Collections

202208-0910-017 Approved without change	Revision of a currently approved collection	2022-08-31
201908-0910-016 Approved without change	Extension without change of a currently approved collection	2019-09-03
201710-0910-016 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-10-27
201607-0910-013 Approved without change	Extension without change of a currently approved collection	2016-07-28
201305-0910-002 Approved with change	New collection (Request for a new OMB Control Number)	2013-05-14

OMB Details

Pretest

Federal Enterprise Architecture: Health - Consumer Health and Safety