This ICR includes information collection from accreditation bodies (ABs) who wish to obtain recognition from the Agency so that they can accredit testing laboratories (TLs) for the voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The ICR also includes information collection from TLs who wish to obtain ASCA Accreditation from the Agency so that they can conduct testing under the ASCA Pilot. The ASCA Pilot Program, under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(d)), supports the Agency’s continued efforts to effectively use its scientific resources to protect and promote public health by simplifying certain aspects of premarket review, thereby reducing burdens on the Agency for individual submissions.
The latest form for Accreditation Scheme for Conformity Assessment Pilot Program expires 2023-06-30 and can be found here.
Justification for No Material/Nonsubstantive Change
Supporting Statement A
Approved without change
|No material or nonsubstantive change to a currently approved collection||2021-09-10|
Approved with change
|New collection (Request for a new OMB Control Number)||2020-05-01|