0013 2022 Aphis 79

0013 2022 APHIS 79.xlsx

Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124

0013 2022 APHIS 79

OMB: 0579-0013

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TITLE OF INFORMATION COLLECTION REQUEST OMB CONTROL NO.
Virus-Serum-Toxin Act and Regulations 0579-0013
DATE PREPARED
February 3, 2022








OPM PAY TABLE 09/2019 Benefits account for 38% of employee costs and wages account for the remaining 62%. W = .62 x TC TC = 1.6129 x W FB = .38 x TC TC = 2.6316 x FB 2.6316 x FB = TC = 1.6129 x W FB = (1.6129 / 2.6316) x W FB = .613 x W Fringe Benefits = Wages x .613 FRINGE BENEFITS FACTOR OVERHEAD COST FACTOR TOTAL FEDERAL GOVERNMENT COSTS

(A) (B) (C)

2022-DM 0.613 0.139 $2,606,101






ACTIVITY DESCRIPTION (incl form number) TOTAL ANNUAL RESPONSES AVG TIME PER RESPONSES TOTAL HOURS PER YEAR SALARY TOTAL COSTS
GRADE WAGE (Step 4)

(D) (E) (F) (G) (H) (1+B+C) X F X H
Application for U.S. Veterinary Biologics Establishment License (APHIS 2001) 22 1.000 22 14 58.94 $2,272
CVB Inspection and Compliance Facility Document Submission Worksheet (APHIS 2009) 46 0.500 23 13 49.88 $2,010
Application for U.S. Veterinary Biologics License (APHIS 2003) 88 1 88 14 58.94 $9,087
Certificate of Licensing and Inspection (APHIS 2046/S and 2047/S) 1,240 1 620 13 49.88 $54,182
Qualifications of Veterinary Biologics Personnel (APHIS 2007) 1,170 0 293 13 49.88 $25,605
Request for Restriction on Distribution and Use of a Veterinary Biological Product 1 1 1 13 49.88 $87
Petition for Reissue of Conditional License 24 1 24 14 58.94 $2,478
Application to Produce Experimental Products 112 1 56 14 58.94 $5,783
Application for Authorization to Ship Experimental Veterinary Biological Products (APHIS 2071) 315 0 79 14 58.94 $8,158
Application for U.S. Veterinary Biologics Product Permit (APHIS 2005) 540 1 540 14 58.94 $55,762
Show Intent to Resume Production 9 1 9 14 58.94 $929
Transmittal of Labels and Circulars or Outlines, Reporting (APHIS 2015) 156 0 16 14 58.94 $1,652
Written Authorization Statement, Reporting 2,475 0 248 14 58.94 $25,609
List of Approved Labels Currently Being Used 83 1 42 13 49.88 $3,670
Official Export Certificate for Animal Biological Products (APHIS 2017) 1,860 1 1,860 13 49.88 $162,545
Request for Reference, Reagent, or Reagent Seed Material (APHIS 2018) 352 0 88 13 49.88 $7,690
Shipment and Receipt of Biologics Samples (APHIS 2020) 13,500 0 4,455 13 49.88 $389,321
Application for Authorization to Ship Biological Product Samples for APHIS Confirmatory Testing (APHIS 2072) 32 0 8 13 49.88 $699
Veterinary Biologics Production and Test Report (APHIS 2008 and 2008A) 16,300 1 16,300 13 49.88 $1,424,453
Request for Reprocessing and Rebottling for a Serial or Subserial (APHIS 2008 and 2008A) 12 1 12 13 49.88 $1,049
Application for Authorization to Ship Master Seed or Cell Samples for APHIS Confirmatory Testing (APHIS 2070) 14 0 4 14 58.94 $413
Request to Use an Isolate Beyond the Time Prescribed 20 1 10 13 49.88 $874
Protocol and Additional Testing Requirements for Autogenous Biologics 1 1 1 13 49.88 $87
Request for Extension of Expiration Date for a Serial or Subserial 33 1 33 13 49.88 $2,884
Wholesaler Notification (Licensees and Permittees) 1 10 10 14 58.94 $1,033
Accounting of Inventory (Licensees and Permittees) 1 10 10 14 58.94 $1,033
Accounting of Inventory (Wholesalers, Jobbers, etc,.) 1 10 10 14 58.94 $1,033
Reports on Activities (CVB Inspection and Compliance E-Submission Form, APHIS 2048) 900 1 450 13 49.88 $39,325
Reports on Activities (CVB Regulations/Policy, Evaulation, and Licensing E-Submission Form, APHIS 2049) 6,930 1 3,465 14 58.94 $357,806
Patent Term Restoration; Letter of Application for Extending the Term of a Veterinary Biologic Patent 1 1 1 13 49.88 $87
Request for Revision of the Regulatory Review Period 1 1 1 14 58.94 $103
Due Diligence Petition and Certification Statement 2 1 2 14 58.94 $207
Applicant's Response to Petition 1 1 1 14 58.94 $103
Request for Due Diligence Hearing 2 1 2 14 58.94 $207
Adverse Event Report 345 1 173 14 58.94 $17,864
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