Non-substantive Change Request Justification

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.