0579-0472 Aphis 71

0472 2023 APHIS 71 (20230104).xlsx

Approval of Laboratories to Conduct Official Testing; Consolidation of Regulations

0579-0472 APHIS 71

OMB: 0579-0472

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OMB CONTROL NO. 0579-0472







DATE PREPARED 1/4/2023
Due to section 508 accessibility, do not merge cells. If the ICR title requires more space then allowed, key in additional words of the title in row 3. TITLE OF INFORMATION COLLECTION REQUEST (ICR) Approval of Laboratories to Conduct Official Testing









Additional line for ICR Title if title is too long.










PART I - ICR INFORMATION, POINT OF CONTACT, FEDERAL REGISTER NOTICE INFORMATION








DATA SUMMARY
Enter one: -Proposed rule -Final rule -New ICR -Renewal -Reinstatement TYPE OF REQUEST Renewal







This is the sum of Activities, Column , filtered to capture only first occurences as marked in Activitiy Description, Part II Column G. TOTAL RESPONDENTS 402
POINT OF CONTACT (POC) Suelee Robbe-Austerman







This is the sum of all entries in Part II, Column J. TOTAL ANNUAL RESPONSES 5,306
POC TELEPHONE NO. (515) 337-7301







Enter the estimated percentage of total responses that are submitted electronically. % ELECTRONIC 75%
DATE PREPARED 6/28/2022







Automatically calculates; Total Respondents X Total Annual Respondents RESPONSES PER RESPONDENT 13
Docket number assigned by RAD for 60-day public comment period Federal Register notice PUBLIC COMMENT DOCKET NO. APHIS-2022-0043







This is the sum of all entries, Section II Column L TOTAL BURDEN HOURS 37,697
Citation for 60-day public comment period Federal Register notice (e.g., 84FR38333) FEDERAL REGISTER NOTICE 87 FR 45080







Automatically calculates; Total Burden Hours ÷ Total Annual Responses HOURS PER RESPONSE 7.105
FEDERAL REGISTER DATE 7/27/2022







Enter the percentage of total business respondents that are small entities. % SMALL ENTITIES 0%
PART II - SUMMARY OF ACTIVITIES










The title must be consistent from the previous submission to the current one, and between the APHIS 71 and the Supporting Statement. If the title has changed, insert another column to the right and title it "PREVIOUS TITLE". If this activity is a discretionary change, enter (NEW) if this is a new activity, respondent type, or response time estimate; or (VIOLATION) if this is previously unreported activity. ACTIVITY DESCRIPTION AUTHORITY (U.S.C., CFR, or MANUAL) If there is a form associated with this activity, enter the form number (e.g., APHIS 123). If the activity uses a form letter or something similar, enter "letter". If the information is collected via an information system, enter the acronym for the information system (e.g., MITS). FORM NO. Enter all that apply if the collection instrument is a form: - Paper - PDF - Info System FORMAT " " - None. Leave blank if there is no change to this activity. E - Estimate. The change is to the number of respondents, responses, or burden hours only. D - Discretionary. The change is a new activity, a reported violation, or a new respondent type or response time. C - Correction. The change is to capture and report a previous error of some type. TYPE OF CHANGE Select only one group per line (e.g., FG and S1 are two lines, S1 and S2 are one line): FG - foreign government S1 - state government S2 - local government S3 - tribal government P1 - business P2 - farm P3 - non or not for profit I - individual or household TYPEOF RESPONDENT Respondents should not be counted more than once in the total number of respondents. Place an "X" in this space to indicate this activity reflects a unique group of respondents in this ICR. FIRST OCCURENCE Select only one per line: I - Reporting. Information is received from the public via voice, document, or information system. R - Recordkeeping. The respondent is required to maintain records for a prescribed period of time. TP - Third Party Disclosure. The respondent is required to post information for the benefit of a third party (e.g., labels on product packages or quarantine signs at fairs). TYPE OF RESPONSE See the comment for Column G. Do not count respondents multiple times within the same activity. Each individual or household counts as one respondent, and each business or non-U.S. Federal government activity counts as one respondent. ESTIMATED
ANNUAL NUMBER OF RESPONDENTS
OR
RECORDKEEPERS
Each instance of the activity counts as one response regardless of the respondent type. Each recordkeeper counts as one response. ESTIMATED
TOTAL ANNUAL
RESPONSES
This entry should be the same as that entered in the OMB banner at the top of the form. Times less than 1 hour should be calculated as number of minutes divided by 60 and listed to three decimal places. For recordkeepers, enter the estimated average number of hours per year the recordkeeper will spend on this activity. ESTIMATED HOURS
PER RESPONSE
OR
ANNUAL HOURS PER RECORDKEEPER
Calculation: Column J x K Formula rounds up ESTIMATED
TOTAL ANNUAL
BURDEN HOURS
Notification of Intent to Request Approval 9 CFR 71.22(a) none

P1 X I 350 350 2.50 875
Notification of Intent to Request Approval 9 CFR 71.22(a) none

S1 X I 52 52 0.50 26
Application for APHIS Approval 9 CFR 71.22(a), (g) none

P1
I 350 350 5.00 1,750
Application for APHIS Approval 9 CFR 71.22(a), (g) none

S1
I 52 52 5.00 260
Inspection 9 CFR 71.22(b) none

P1
I 350 350 4.00 1,400
Inspection 9 CFR 71.22(b) none

S1
I 52 52 4.00 208
Checklist and Agreement 9 CFR 71.22(b)-(f) none

P1
I 350 350 20.00 7,000
Checklist and Agreement 9 CFR 71.22(b)-(f) none

S1
I 52 52 20.00 1,040
Documentation of Accreditation Status 9 CFR 71.22(d) none

P1
I 350 350 1.00 350
Documentation of Accreditation Status 9 CFR 71.22(d) none

S1
I 52 52 1.00 52
Documentation of Implemented Quality System 9 CFR 71.22(c ) none

P1
I 350 350 1.00 350
Documentation of Implemented Quality System 9 CFR 71.22(c ) none

S1
I 52 52 1.00 52
Quality Documentation Verification Form 9 CFR 71.22(c ) none

P1
I 350 350 1.00 350
Quality Documentation Verification Form 9 CFR 71.22(c ) none

S1
I 52 52 1.00 52
Quality Assurance/Control Plans 9 CFR 71.22(c ) none

P1
I 350 350 10.00 3,500
Quality Assurance/Control Plans 9 CFR 71.22(c ) none

P1
R 350 350 10.00 3,500
Quality Assurance/Control Plans 9 CFR 71.22(c ) none

S1
I 52 52 10.00 520
Quality Assurance/Control Plans 9 CFR 71.22 (c ) none

S1
R 52 52 10.00 520
Notification of Proposed Changes to Assay Protocols 9 CFR 71.22(h) none

P1
I 35 35 1.00 35
Notification of Proposed Changes to Assay Protocols 9 CFR 71.22(h) none

S1
I 5 5 1.00 5
Supporting Assay Documentation 9 CFR 71.22(h) none

P1
R 350 350 10.00 3,500
Supporting Assay Documentation 9 CFR 71.22(h) none

S1
R 52 52 10.00 520
Reporting 9 CFR 71.22(f) none

P1
I 350 350 10.00 3,500
Reporting 9 CFR 71.22(f) none

S1
I 52 52 10.00 520
Test Exemption 9 CFR 71.22(i)(1) none

P1
I 10 10 0.60 6
Test Exemption 9 CFR 71.22(i)(1) none

S1
I 10 10 0.60 6
Submission of Sample Copies of Diagnostic Reports 9 CFR 71.22(f) none

P1
I 350 350 10.00 3,500
Submission of Sample Copies of Diagnostic Reports 9 CFR 71.22(f) none

S1
I 52 52 10.00 520
Sample Copies of Diagnostic Reports 9 CFR 71.22(f) none

P1
R 350 350 10.00 3,500
Sample Copies of Diagnostic Reports 9 CFR 71.22(f) none

S1
R 52 52 5.00 260
Request for Removal of Approved Status 9 CFR 71.22(i)(3) none

P1
I 5 5 1.00 5
Request for Removal of Approved Status 9 CFR 71.22(i)(3) none

S1
I 5 5 1.00 5
Appeal of Approval Denial, Suspension, or Removal 9 CFR 71.22(j) none

P1
I 5 5 1.00 5
Appeal of Approval Denial, Suspension, or Removal 9 CFR 71.22(j) none

S1
I 5 5 1.00 5
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