0579-0013 (mergers) 2018 APHIS 71

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

August 27, 2018
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS
SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

RECORDS

TOTAL ANNUAL
RESPONSES

HOURS PER
RESPONSE

(Col. D x E)

TOTAL HOURS

(G)

APHIS
2001

20

1

20

1.000

20

102.1, 108.2

CVB Inspection and Compliance Facility
Document Submission Worksheet
(Business) (New)

APHIS
2009

1

1

1

0.150

1

102.1

Application for U.S. Veterinary Biologics License
(Business)

APHIS
2003

25

3

75

1.000

75

102.4

Certificate of Licensing and Inspection (Business)

100

35

3,500

0.333

1,166

102.4, 114.7

Qualifications of Veterinary Biologics Personnel
(Business)

APHIS
2007

90

8

720

0.200

144

102.5

Request for Restriction on Distribution and Use of
a Veterinary Biological Product (Business)

none

1

1

1

1.000

1

102.6

Petition for Reissue of Conditional License
(Business)

none

10

1

10

1.000

10

103.1

Application to Produce Experimental Products
(Business)

none

50

1

50

0.500

25

103.3

Application for Authorization to Ship Experimental
Veterinary Biological Products (Business)

APHIS
2071

45

8

360

1.000

360

TOTAL OF ALL PAGES

10,183

COLUMNS H + K = OMB 831, 13c

(J)

(K)

4,737

1,802

0

0

298,820,111

64,071

690

58,927

298,820,801

122,998

TOTAL
COLUMNS F + I = OMB 831, 13b

(I)

RECORD- KEEPING
HOURS
(Col. I x J)

(H)

9 CFR
102.1, 108.2

SUBTOTAL

ANNUAL HOURS
PER RECORDKEEPER

(Col. F x G)

(F)

Application for U.S. Veterinary Biologics
Establishment License (includes plot plants and
blueprints) (Business)

APHIS 2046,
2046S, 2047,
2047S

NO. OF
RECORDKEEPERS

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

August 27, 2018
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS

RECORDS

SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

104.5

Applications for U.S. Veterinary Biologics Product
Permit (Business)

APHIS
2005

220

1

220

1.000

220

105.4

Show Intent to Resume Production (Business)

none

50

1

50

1.000

50

107.2, 114.2

State notifies APHIS of each Establishment and
Product License Issued or Terminated (State)

none

1

1

1

1.000

1

112.1, 112.2

Package Labeling (Business)
(Third Party Disclosure) (New)

none

100

2,987,637

298,763,700

0.000028

8,365

112.2, 112.5,
112.9, 113.3,
113.47, 114.9

Transmittal of Labels and Circulars or Outlines,
Reporting (Business) (Merger)

112.2, 113.3

112.5

TOTAL ANNUAL
RESPONSES

HOURS PER
RESPONSE

(Col. D x E)

TOTAL HOURS

ANNUAL HOURS
PER RECORDKEEPER

(I)

(J)

(Col. F x G)

(F)

(G)

100

48

4,800

0.050

240

Written Authorization Statement, Reporting
(Foreign Government) (Merger)

none

100

8

800

0.050

40

List of Approved Labels Currently Being Used
(Business)

none

48

1

48

0.250

12

112.47, 112.69, Official Export Certificate for Animal Biological
112.71
Products (Business)

APHIS
2017

100

10

1,000

1.000

1,000

113, 114.4,
114.8, 114.9

Request for Reference, Reagent, or Reagent
Seed Material (Business)

APHIS
2018

200

2

400

0.100

40

113.3

Shipment and Receipt of Biologics Samples
(Business)

APHIS
2020

100

115

11,500

0.300

3,450

113.3, 113.6

Application for Authorization to Ship Biological
Product Samples for Confirmatory Testing
(Business)

APHIS
2072

48

1

48

1.000

48

298,782,567

RECORD- KEEPING
HOURS
(Col. I x J)

(H)

APHIS
2015

SUBTOTAL

NO. OF
RECORDKEEPERS

13,466

0

(K)

0

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

August 27, 2018
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS
SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

RECORDS

TOTAL ANNUAL
RESPONSES

HOURS PER
RESPONSE

(Col. D x E)

113.5,.68,.69,
Veterinary Biologics Production and Test Report
.70,.71, 114.17,
(Business)
116.7
114.18

Request for Reprocessing and Rebottling for a
Serial or Subserial (Business)
Application for Authorization to Ship Master Seed

113.52, 113.100,
or Cell Samples for Confirmatory Testing by
113.200, 113.300

APHIS (Business)

TOTAL HOURS

ANNUAL HOURS
PER RECORDKEEPER

(I)

(J)

(Col. F x G)

(F)

(G)

APHIS
2008 &
2008A

100

160

16,000

1.000

16,000

APHIS
2008 &
2008A

30

1

30

1.000

30

APHIS
2070

60

2

120

1.000

120

Request for Authorization to Prepare an
Autogenous Biologic for Use in Herds
Adjacent...to the Herd of Origin (Business)

none

20

1

20

0.250

5

113.113

Request to Use an Isolate Beyond the Time Limit
Prescribed (Business)

none

20

1

20

0.500

10

113.113

Protocol and Additional Testing Requirements for
Autogenous Biologics (Business)

none

1

1

1

1.000

1

114.14

Request for Extension of Expiration Date for a
Serial or Subserial (Business)

none

50

10

500

1.000

500

115.2

Notify Wholesalers (Licensee and Permittees)
(Business)

none

5

1

5

0.167

1

115.2(b)(3)

Accounting of Inventory (Licensees and
Permittees) (Business)

none

5

1

5

1.000

5

115.2(b)(4)

Accounting of Inventory (Wholesalers, Jobbers,
etc.) (Business)

none

50

1

50

2.000

100

116.5

Reports on Activities [Center for Vet Biologics,
Inspection and Compliance E-Submission form]
(Business)

APHIS
2048

25

1

25

0.500

13

16,776

RECORD- KEEPING
HOURS
(Col. I x J)

(H)

113.113

SUBTOTAL

NO. OF
RECORDKEEPERS

16,785

0

(K)

0

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

August 27, 2018
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS

RECORDS

SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

Reports on Activities [Veterinary Biologics
Regulation E-Submission form Policy, Evaluation,
and Licensing] (Business)

APHIS
2049

25

1

25

0.500

13

none

1

1

1

1.000

1

1

1

1

1.000

1

TOTAL ANNUAL
RESPONSES

HOURS PER
RESPONSE

(Col. D x E)

116.5

Patent Term Restoration Letter of Application for
124.10, 124.20 Extending the Term of a Veterinary Biologic
Patent (Business)

TOTAL HOURS

NO. OF
RECORDKEEPERS

ANNUAL HOURS
PER RECORDKEEPER

(I)

(J)

(Col. F x G)

(F)

(G)

RECORD- KEEPING
HOURS
(Col. I x J)

(H)

(K)

124.22

Request for Revision of the Regulatory Review
Period (Business)

none

124.30

Due Dilligence Petition and Certification
Statement of True and Complete Copy
(Business)

none

1

1

1

1.000

1

0

124.30

Due Dilligence Petition and Certification
Statement of True and Complete Copy
(Individual)

none

1

1

1

1.000

1

0

124.31

Applicants Response to Petition (Business)

none

1

1

1

1.000

1

0

124.40

Request for Due Dilligence Hearing (Business)

none

1

1

1

1.000

1

0

124.40

Request for Due Dilligence Hearing (Individual)

none

1

1

1

1.000

1

0

103.2

Records of Disposition of Test Animals
(Business)

0

0

44

0.333

15

107.1

Records of Exempt Biologics (Business)

0

0

1

1.000

1

109.2

Sterilization and Pasteurization Records
(Business)

0

0

32

20

SUBTOTAL

100
145

9.500

950
966

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

0579-0013
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS
SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

RECORDS

TOTAL ANNUAL
RESPONSES

HOURS PER
RESPONSE

TOTAL HOURS

(Col. D x E)

NO. OF
RECORDKEEPERS

ANNUAL HOURS
PER RECORDKEEPER

(I)

(J)

(Col. F x G)

(F)

(G)

RECORD- KEEPING
HOURS
(Col. I x J)

(H)

(K)

113.5, 113.6

Records of All Tests (Business)

0

0

100

172.000

17,200

113.45

Records of Antiserum or Serum Pasteurized
(Business)

0

0

20

46.000

920

114.5

Identity of the Microorganism (Business)

0

0

25

0.500

13

114.5

Records of Microorganisms Used (Business)

0

0

100

143.000

14,300

114.6, 115.1,
116.1,.2,.5,.8

Records of Production of Product, Inventory and
Disposition (Business)

0

0

100

5.250

525

112.2, 112.5, 112.9,
113.3, 113.47, 114.9,
116.3

Label Records (Business)

0

0

100

250.000

25,000

116.6, 117

Animal Records (Business)

0

0

100

0.033

3

116.9

Adverse Event Report (Business) (merger)

APHIS
2080

3,333

1

3,333

2

6,666

0

0.000

0

116.9

Adverse Event Report (State) (merger)

APHIS
2080

3,333

1

3,333

2

6,666

0

0.000

0

116.9

Adverse Event Report (Individual) (merger)

APHIS
2080

3,333

1

3,333

2

6,666

0

0.000

0

116.9

Adverse Event Report Followup (Business)
(merger)

APHIS
2081

2,000

1

2,000

2.000

4,000

0

0.000

0

23,998

545

SUBTOTAL

11,999

57,961

INSTRUCTIONS:

OMB NO.

TITLE OF INFORMATION COLLECTION DOCUMENT

0579-0013

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

DATE PREPARED

0579-0013
ANNUAL BURDEN
IDENTIFICATION OF REPORTING OR RECORDKEEPING REQUIREMENT
REPORTS
SECTION OF REGS

DESCRIPTION

FORM NO's
(if none, so
state)

NO. OF
RESPONDENTS

NO. OF
RESPONSES PER
RESPONDENT

(A)

(B)

(C)

(D)

(E)

TOTAL ANNUAL
RESPONSES

RECORDS
HOURS PER
RESPONSE

(Col. D x E)
(F)

TOTAL HOURS

NO. OF
RECORDKEEPERS

ANNUAL HOURS
PER RECORDKEEPER

(I)

(J)

(Col. F x G)
(G)

(H)

RECORD- KEEPING
HOURS
(Col. I x J)
(K)

116.9

Adverse Event Report Followup (State) (merger)

APHIS
2081

2,000

1

2,000

2.000

4,000

0

0.000

0

116.9

Adverse Event Report Followup (Individual)
(merger)

APHIS
2081

2,000

1

2,000

2.000

4,000

0

0.000

0

8,000

0

SUBTOTAL

4,000

0