Change Request Information

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]

July 1, 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 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins	BSL3Ag	ABSL3Ag	Updated to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL).
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Section 6B, Question 6	Access to the laboratory is through two self-closing doors.	Access to the laboratory is through two consecutive, self-closing doors.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment C, Question 10	Describe animal housing for each species, including whether cages provide primary containment and a brief description (e.g. cage or cage rack is HEPA filtered, active or passive ventilation of the cages, non-containment caging housed within inward flow ventilated enclosure).	Describe animal housing for each species, including whether cages provide primary containment and a brief description (e.g. cage or cage rack is HEPA filtered, active or passive ventilation of the cages, non-containment caging housed within inward flow ventilated enclosure).  For active ventilation caging, indicate whether or not the system is equipped to indicate operational malfunctions.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 1 (part 2)	For materials which are temperature sensitive, a gas sterilizer, pass-through liquid dunk tank, or a cold gas decontamination chamber are provided.	For materials and equipment that cannot be decontaminated in the autoclave, a pass-through dunk tank, fumigation chamber, or equivalent decontamination method is available.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 6	There is HEPA filtration of all supply and exhaust air to and from the containment space.	There are two HEPA filters installed in series prior to air being exhausted from the containment space. Supply air passes through ductwork with a HEPA filter and/or fast acting bioseal (i.e., bubble tight) damper that fails in the closed position.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 7a	Personnel ingress and egress only through a series of rooms which includes a ventilated vestibule.	Entrance into the facility is through an interlocking double door vestibule that separates containment areas from non-containment areas.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 7c	Doors that define a containment boundary have compressible or inflatable gaskets, with airtight hinges and latch/knob areas.	Doors that define a containment boundary are sealed and verified airtight through pressure decay testing.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 8	A second shower is required at the facility access control point before donning street clothing.	A second shower is required at the facility access control point before donning street clothing. If no, describe the alternate strategies used to satisfy the BMBL 6th edition.	Updated to reflect the changes in the recently published 6th edition of BMBL.
APHIS/CDC Form 1: Registration for Possession, Use, and Transfer of Select Agents and Toxins Attachment F, BSL3 Ag, Question 9	Humane restraining devices are provided in large animal rooms.	Remove question	Updated to reflect the changes in the recently published 6th edition of BMBL.

Mini Supporting Statement

Justification for Change

This is a request for nonmaterial/non-substantive change made to Form 1 is to reflect the changes in the recently published 6th edition of Biosafety in Microbiological and Biomedical Laboratories.