Non-substantive Change Request Justification

Non-substantive change request_2021-08-13.docx

Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

Non-substantive Change Request Justification

OMB: 0920-0576

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Justification for Change


Possession, Use, and Transfer of Select Agents and Toxins (42 CFR Part 73)

(OMB Control No. 0920-0576) Expiration 1/31/2024


Non-Substantive Change Request



Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response

Division of Select Agents and Toxins



Lori Bane

(404) 718-2006

(404) 718-2097 FAX

[email protected]

September 3, 2021


















Nonmaterial/non-substantive change to an OMB approved information collection for Possession, Use, and Transfer of Select Agents and Toxins (42 CFR Part 73) (OMB Control No. 0920-0576) Expiration 1/31/2024

Justification for the Change - A nonmaterial/non-substantive can be explained in table format as shown below:

Form

Current Item

Requested Change

Justification

APHIS/CDC Form 2:

Request to Transfer Selects and Toxins

Section 1A, Question 2:

Entity Registration Number

Section 1A, Question 2:

Remove question

This question is not needed for form.

APHIS/CDC Form 2:

Request to Transfer Selects and Toxins

Section 2D, Question 23:

Transfer is canceled

Section 2D, Question 23:

Remove question

This question is not needed for form.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Title:

Report of a Release/Loss/Theft

Title:

Report of a Release/Loss/Theft of a Select Agent or Toxin

This change clarifies the form title.

APHIS/CDC Form 3: Report of a Release/Loss/Theft

Section B, Question 2:

Date of Immediate Notification

Section B, Question 2: Change to “Date of Immediate Notification to CDC or APHIS”

This change clarifies the question.

APHIS/CDC Form 3: Report of a Release/Loss/Theft

Section B, Question 3:

Type of notification

Section B, Question 3:

Change to “Type of notification to CDC or APHIS”

This change clarifies the question.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section B, Question 6: Strain designation of Select Agent or Toxin:

Recombinant Agent

PPQ Agent

Remove “PPQ Agent” selection

This change clarifies the question.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section B, Question 10: BSL3Ag

Section B, Question 10: Change to “ABSL3Ag”

Updated to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section C, Question 1: Package damaged in transit/ complete B-11

Release

Unintended Animal/Plant Pathogen

Section C, Question 1: Edit Change to “Package damaged in transit (complete B-11)”and “Unintended exposure of animals or plants” and remove release.

This change fixes grammatical issue.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section C, Question 3:

Body Protection (e.g., lab coat)

Respiratory Protection

Section C, Question 3:

Add examples to these bullets:

Body Protection (e.g., lab coat, BSL4 suit)

Respiratory Protection (e.g., PAPR, N95)

This change clarifies the meaning/intent of the question.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section C, Question 6:

No treatment

Section C, Question 6:

Change to “None”

This change clarifies the meaning/intent of the question.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section C, Question 7b:

Remodel lab/facility

Section C, Question 7b:

Change to “Review/revise risk assessment”

This change clarifies the meaning/intent of the question.

APHIS/CDC Form 3:

Report of a Release/Loss/Theft

Section D, Question 1: Sample lost in transit/ complete B-11

Section D, Question 1: Change to “Sample lost in transit (complete B-11)”

This change fixes grammatical issue.

APHIS/CDC Form 4:

Reporting the Identification of a Select Agent or Toxin

Section D, Question 5:

Case/Patient/sample origin (zip code)

Section D, Question 5: Change to “Zip code for case/patient/sample origin”

This change clarifies the intent of the question





Mini Supporting Statement


Justification for Change


This is a request for nonmaterial/non-substantive changes clarifies the meaning/intent of the questions. The nonmaterial/non-substantive changes will not affect the burden in completing the form.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSteinberg, Shari (CDC/OD/OADS)
File Modified0000-00-00
File Created2022-04-05

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