| OMB CONTROL NO. |
TITLE OF INFORMATION COLLECTION REQUEST |
DATE PREPARED |
| 0579-0013 |
|
February 3, 2022 |
|
Enter one:
Proposed rule
Final rule
New ICR
Renewal
Reinstatement
TYPE OF REQUEST |
|
Virus-Serum-Toxin Act and Regulations |
Docket number assigned by RAD for for 60-day public comment period Federal Register notice
PUBLIC COMMENT DOCKET NO. |
| Renewal |
APHIS 2021-0035 |
| POINT OF CONTACT |
Citation for 60-day public comment period Federal Register notice (e.g., 84FR38333)
FEDERAL REGISTER NOTICE |
| Bonnie Coyle |
86 FR 40446 |
| TELEPHONE NO. |
FEDERAL REGISTER DATE |
| (515) 337-6561 |
July 28, 2021 |
| PART I - SUMMARY |
|
This is the sum of Part II, Column I, filtered to capture only first occurences as marked in Part II, Column C.
TOTAL RESPONDENTS |
This is the sum of all entries in Part II, Column J.
TOTAL ANNUAL RESPONSES |
Enter the estimated percentage of total responses that are submitted electronically
% ELECTRONIC |
RESPONSES PER RESPONDENT |
This is the sum of all entries in Part II, Column L.
TOTAL BURDEN HOURS |
HOURS PER RESPONSE |
Enter the percentage of total business respondents that are small entities
% SMALL ENTITIES |
| 478 |
435,797,533 |
80% |
911,710 |
43,072 |
0.00010 |
95% |
| PART II - LIST OF ACTIVITIES |
|
" " - 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
TYPE OF 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 |
AUTHORITY (U.S.C., CFR, or Manual) |
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 (title, respondent type, and type of change if discretionary) |
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 |
See the comment for Column C. 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 |
ESTIMATED TOTAL ANNUAL BURDEN HOURS |
| (A) |
(B) |
(C) |
(D) |
(E) |
(F) |
(G) |
(H) |
(I) |
(J) |
(K) |
(L) |
| E |
P1 |
|
I |
9 CFR 102.1, 108.2 |
Application for U.S. Veterinary Biologics Establishment License |
APHIS 2001 |
Info system |
22 |
22 |
1.000 |
22 |
| E |
P1 |
|
I |
9 CFR 102.1, 108.2 |
CVB Inspection and Compliance Facility Document Submission Worksheet (includes plot plans and blueprints) |
APHIS 2009 |
Info system |
23 |
46 |
0.150 |
7 |
| E |
P1 |
|
I |
9 CFR 102.1 |
Application for U.S. Veterinary Biologics License |
APHIS 2003 |
Info system |
22 |
88 |
1.000 |
88 |
| E |
P1 |
|
I |
9 CFR 102.4 |
Certificate of Licensing and Inspection |
APHIS 2046, 2046S, 2047, and 2047S |
Info system |
20 |
1,240 |
0.333 |
413 |
| E |
P1 |
|
I |
9 CFR 102.4, 114.7 |
Qualifications of Veterinary Biologics Personnel |
APHIS 2007 |
Info system |
90 |
1,170 |
0.200 |
234 |
| E |
P1 |
|
I |
9 CFR 102.5 |
Request for Restriction on Distribution and Use of a Veterinary Biological Product |
None |
Info system |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 102.6 |
Petition for Reissue of Conditional License |
None |
Info system |
12 |
24 |
1.000 |
24 |
| E |
P1 |
|
I |
9 CFR 103.1 |
Application to Produce Experimental Products |
None |
Info system |
14 |
112 |
0.500 |
56 |
| E |
P1 |
|
I |
9 CFR 103.3 |
Application for Authorization to Ship Experimental Veterinary Biological Products |
APHIS 2071 |
Info system |
35 |
315 |
1.000 |
315 |
| E |
P1 |
|
I |
9 CFR 104.5 |
Application for U.S. Veterinary Biologics Product Permit |
APHIS 2005 |
Info system |
60 |
540 |
1.000 |
540 |
| E |
P1 |
|
I |
9 CFR 105.4 |
Show Intent to Resume Production |
None |
Info system |
3 |
9 |
1.000 |
9 |
| E |
P1 |
|
TP |
9 CFR 112.1, 112.2 |
Package Labeling |
None |
Info system |
27 |
435,749,193 |
0.000 |
12,201 |
| E |
P1 |
|
I |
9 CFR 112.2, 112.5, 112.9, 113.3, 113.47, 114.9 |
Transmittal of Labels and Circulars or Outlines, Reporting |
APHIS 2015 |
Paper |
6 |
156 |
0.050 |
8 |
| E |
FG |
X |
I |
9 CFR 112.2, 113.3 |
Written Authorization Statement, Reporting |
None |
Info system |
45 |
2,475 |
0.050 |
124 |
| E |
P1 |
|
I |
9 CFR 112.5 |
List of Approved Labels Currently Being Used |
None |
Info system |
83 |
83 |
0.250 |
21 |
| E |
P1 |
|
I |
9 CFR 112.2(e) (2) |
Official Export Certificate for Animal Biological Products |
APHIS 2017 |
Info system |
20 |
1,860 |
1.000 |
1,860 |
| E |
P1 |
|
I |
9 CFR part 113 9 CFR 114.4, 114.8, 114.9 |
Request for Reference, Reagent, or Reagent Seed Material |
APHIS 2018 |
Info system |
88 |
352 |
0.100 |
36 |
| E |
P1 |
X |
I |
9 CFR 113.3 |
Shipment and Receipt of Biologics Samples |
APHIS 2020 |
Info system |
100 |
13,500 |
0.330 |
4,455 |
| E |
P1 |
|
I |
9 CFR 113.3, 113.6 |
Application for Authorization to Ship Biological Product Samples for APHIS Confirmatory Testing |
APHIS 2072 |
Info system |
8 |
32 |
1.000 |
32 |
| E |
P1 |
|
I |
9 CFR 113.5, 113.68, 113.69, 113.70, 113.71, 114.17,116.7 |
Veterinary Biologics Production and Test Report |
APHIS 2008 and 2008A |
Info system |
100 |
16,300 |
1.000 |
16,300 |
| E |
P1 |
|
I |
9 CFR 114.18 |
Request for Reprocessing or Rebottling for a Serial or Subserial |
APHIS 2008 and 2008A |
Info system |
6 |
12 |
1.000 |
12 |
| E |
P1 |
|
I |
9 CFR 113.52, 113.100, 113.200, 113.300 |
Application for Authorization to Ship Master Seed or Cell Samples for APHIS Confirmatory Testing |
APHIS 2070 |
Info system |
7 |
14 |
1.000 |
14 |
| E |
P1 |
|
I |
9 CFR 113.113 |
Request to Use an Isolate Beyond the Time Prescribed |
None |
Info system |
20 |
20 |
0.500 |
10 |
| E |
P1 |
|
I |
9 CFR 113.113 |
Protocol and Additional Testing Requirements for Autogenous Biologics |
None |
Info system |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 114.14 |
Request for Extension of Expiration Date for a Serial or Subserial |
None |
Info system |
11 |
33 |
1.000 |
33 |
| E |
P1 |
|
TP |
9 CFR 115.2 |
Wholesaler Notifications (Licensees and Permittees) |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 115.2(b) |
Accounting of Inventory (Licensees and Permittees) |
None |
Paper |
1 |
1 |
2.000 |
2 |
| E |
P1 |
|
I |
9 CFR 115.2(b) |
Accounting of Inventory (Wholesalers, Jobbers, etc.) |
None |
Paper |
1 |
1 |
2.000 |
2 |
| E |
P1 |
|
I |
9 CFR 116.5 |
Reports on Activities (Center for Veterinary Biologics, Inspection and Compliance E-Submission Form) |
APHIS 2048 |
Info system |
90 |
900 |
0.500 |
450 |
| E |
P1 |
|
I |
9 CFR 116.5 |
Reports on Activities (Center for Veterinary Biologics, Regulation and Policy, Evaluation, and Licensing E-Submission Form) |
APHIS 2049 |
Info system |
90 |
6,930 |
0.500 |
3,465 |
| E |
P1 |
|
I |
9 CFR 124.10, 124.20 |
Patent Term Restoration - Letter of Application for Extending the Term of a Veterinary Biologic Patent |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 124.22 |
Request for Revision of the Regulatory Review Period |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 124.30 |
Due Diligence Petition and Certification Statement of True and Complete Copy |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
I |
|
I |
9 CFR 124.30 |
Due Diligence Petition and Certification Statement of True and Complete Copy |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 124.31 |
Applicant's Response to Petition |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 124.40 |
Request for Due Diligence Hearing |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
I |
|
I |
9 CFR 124.40 |
Request for Due Diligence Hearing |
None |
Paper |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
I |
9 CFR 116.9 |
Adverse Event Report |
APHIS 2080 |
Info system |
11 |
11 |
0.330 |
4 |
| E |
I |
X |
I |
9 CFR 116.9 |
Adverse Event Report |
APHIS 2080 |
Info system |
332 |
332 |
0.330 |
110 |
| E |
S1 |
X |
I |
9 CFR 116.9 |
Adverse Event Report |
APHIS 2080 |
Info system |
1 |
1 |
0.330 |
1 |
| E |
P1 |
|
R |
9 CFR 103.2 |
Records of Disposition of Test Animals |
None |
Info system |
44 |
44 |
0.330 |
15 |
| E |
P1 |
|
R |
9 CFR 107.1 |
Records of Exempt Biologics |
None |
Info system |
1 |
1 |
1.000 |
1 |
| E |
P1 |
|
R |
9 CFR 109.2 |
Sterilization and Pasteurization Records |
None |
Info system |
61 |
61 |
4.000 |
244 |
| E |
P1 |
|
R |
9 CFR 113.5, 9 CFR 113.6 |
Records of All Tests |
None |
Info system |
88 |
88 |
2.000 |
176 |
| E |
P1 |
|
R |
9 CFR 113.450 |
Records of Antiserum or Serum Pasteurized |
None |
Info system |
1,172 |
1,172 |
0.500 |
586 |
| E |
P1 |
|
R |
9 CFR 114.5 |
Identity of the Microorganism |
None |
Info system |
26 |
26 |
0.500 |
13 |
| E |
P1 |
|
R |
9 CFR 114.5 |
Records of Microorganisms Used |
None |
Info system |
95 |
95 |
5.000 |
475 |
| E |
P1 |
|
R |
9 CFR 114.6, 115.1, 116.1, 116.2, 116.5, 116.8 |
Records of Production of Product, Inventory, and Disposition |
None |
Info system |
88 |
88 |
3.000 |
264 |
| E |
P1 |
|
R |
9 CFR 112.1, 112.5(e), 116.3 |
Label Records |
None |
Info system |
88 |
88 |
3.000 |
264 |
| E |
P1 |
|
R |
9 CFR 116.6, 9 CFR part 117 |
Animal Records |
None |
Info system |
88 |
88 |
2.000 |
176 |