OMB control number
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
OMB 0910-0607 · 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 2029-06-30 and is listed under ICR 202504-0910-002.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0607_Supporting Statement A_2025.docx | Supporting Statement A |
 CLIA waiver applications and associated records |
Information collection |
| Request for CLIA categorization |
Other-Guidance; Administrative Procedures for CLIA Categorizatio |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202504-0910-002 | Extension without change of a currently approved collection | 2025-11-26 | ||
| 202210-0910-014 | Revision of a currently approved collection | 2022-10-26 | Approved without change | |
| 201910-0910-003 | Extension without change of a currently approved collection | 2019-10-29 | Approved without change | |
| 201608-0910-015 | Extension without change of a currently approved collection | 2016-09-09 | Approved without change | |
| 201309-0910-010 | Extension without change of a currently approved collection | 2013-09-19 | Approved without change | |
| 201008-0910-007 | Extension without change of a currently approved collection | 2010-08-23 | Approved without change | |
| 200706-0910-001 | New collection (Request for a new OMB Control Number) | 2007-06-19 | Approved with change |
OMB Details
Request for CLIA categorization
Federal Enterprise Architecture: Health - Consumer Health and Safety