OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

OMB 0910-0607 ยท HHS/FDA.

OMB 0910-0607

This information collection helps support implementation of statutory provisions applicable to laboratories that conduct testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These requirements are codified in 42 U.S.C. 263a and implementing regulations are found in 42 CFR 493.

The latest form for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization expires 2026-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
All Historical Document Collections
 Extension without change of a currently approved collection 2025-11-26
Approved without change
 Revision of a currently approved collection 2022-10-26
Approved without change
 Extension without change of a currently approved collection 2019-10-29
Approved without change
 Extension without change of a currently approved collection 2016-09-09
Approved without change
 Extension without change of a currently approved collection 2013-09-19
Approved without change
 Extension without change of a currently approved collection 2010-08-23
Approved with change
 New collection (Request for a new OMB Control Number) 2007-06-19
OMB Details

Request for CLIA categorization

Federal Enterprise Architecture: Health - Consumer Health and Safety