Request for Change

Non-substantive change request_2016-12-01.docx

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

Request for Change

OMB: 0920-0576

Document [docx]
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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 12/31/2018



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]

November 28, 2016, 2016


















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 12/31/2018


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, Section 1A – Entity Information, State Blocks


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 3 – Select Agents and Toxins (HHS Agents and Toxins)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Conotowxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephaltis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 3 – Select Agents and Toxins (Overlap Agents and Toxins)


Dropdown list that includes: Bacillus anthracis Pasteur strain, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Genomic material - Venezuelan equine encephalitis virus, Hendra virus, Nipah virus, Rift Valley fever virus, Venezuelan equine encephalitis virus

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 3 – Select Agents and Toxins (USDA Agents and Toxins)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Classical swine fever virus, Foot-and-mouth disease virus, Genomic material - Classical swine fever virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Swine vesicular disease virus, Goat pox virus, Lumpy skin disease virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus,

Rinderpest virus, Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Xanthomonas oryzae

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7A – Principal Investigator (PI) Information and Select Agent and Toxin Locations (Select Agent/Toxin/Regulated Nucleic Acid)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis complex virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7A – Principal Investigator (PI) Information and Select Agent and Toxin Locations (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7B – Strain or Serotype Designation Information & Section 7C - Description of Work (Select Agents & Toxins)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis Pasteur strain, Bacillus anthracis, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Foot-and-mouth disease virus, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, SARS-associated coronavirus (SARS-CoV), Sabia, Saxitoxin, Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7C - Description of Work (Biosafety Level(s))


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7C - Description of Work (Agent)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus anthracis, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Foot-and-mouth disease virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis, All select agents on PI’s Section 7A

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Section 7C - Description of Work (Toxin)


Dropdown list that includes: Abrin, Botulinum neurotoxins, Contoxins (Short, paralytic alpha conotoxins), Diacetoxyscirpenol, Ricin, Saxitoxin,

Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, All select toxins on PI’s Section 7A

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment A - Work with Toxins (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins,

Recombinant/Synthetic Nucleic Acids, or Recombinant/Synthetic Organisms (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins,

Recombinant/Synthetic Nucleic Acids, or Recombinant/Synthetic Organisms (Select Agent tables)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis complex virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins,

Recombinant/Synthetic Nucleic Acids, or Recombinant/Synthetic Organisms (List Toxin(s) tables)


Dropdown list that includes: Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment C - Work with Animals (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment C - Work with Animals (Select Agent/Toxin)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis complex virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment D – Work with Plants (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment D – Work with Plants (Select Agent/Toxin)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis complex virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment E – Work with Arthropods (Laboratory Safety Level)


Dropdown list that includes: BSL2, BSL3, BSL4, ABSL2, ABSL3, ABSL4, NIHBL2, NIHBL3, NIHBL4, NIH BL2N, NIH BL3N, NIH BL4N, NIH BL2-LS, NIH BL3-LS, NIH BL4-LS, BSL3 Ag, ACL3, ACL4

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 1, Attachment E – Work with Arthropods (Select Agent/Toxin)


Dropdown list that includes: African horse sickness virus, African swine fever virus, Avian influenza virus, Bacillus anthracis, Bacillus anthracis Pasteur strain, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Brucella abortus, Brucella melitensis, Brucella suis, Burkholderia mallei, Burkholderia pseudomallei, Chapare, Classical swine fever virus, Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Classic swine fever virus, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Foot-and-mouth disease virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus, Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Swine vesicular disease virus, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Tick-borne encephaltis virus, Siberian subtype, Genomic material - Venezuelan Equine Encephalitis virus, Goat pox virus, Guanarito, Hendra virus, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Lumpy skin disease virus, Machupo, Marburg virus, Monkeypox virus, Mycoplasma capricolum, Mycoplasma mycoides, Newcastle disease virus, Nipah virus, Omsk hemorrhagic fever virus, Peronosclerospora philippinensis (Peronosclerospora sacchari), Peste des petits ruminants virus, Phoma glycinicola (formerly Pyrenochaeta glycines), Ralstonia solanacearum, Rathayibacter toxicus, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Rift Valley fever virus, Rinderpest virus, Sabia, SARS-associated coronavirus (SARS-CoV), Sclerophthora rayssiae, Sheep pox virus, Swine vesicular disease virus, Synchytrium endobioticum, Tick-borne encephalitis complex virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype), Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Venezuelan equine encephalitis virus, Xanthomonas oryzae, Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 2 (Blocks #5 and 17)


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 2 (Blocks #26 and 27)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Classical swine fever virus, Conotoxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephalitis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 2 (Block #30)


Dropdown list that includes: Liquid, Powder, Agar Slant, Agar Plate

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 2 (Block #31)


Dropdown list that includes: uL, L, mL, mg, g, ng, ug

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 3 (Block #8)


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 3 (Block #22)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Classical swine fever virus, Conotoxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephalitis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4A (Section A and C, Block #12)


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4A (Section B and D, Block #1)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Classical swine fever virus, Conotoxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephalitis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4A (Section B and D, Block #5)


Clinical/diagnostic-Animal, Clinical/diagnostic-Human, Clinical/diagnostic-Plant, Environmental sample, Food sample, Isolate-Animal, Isolate-Human, Isolate-Plant

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4B (Section A, Block #12)


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4B (Section B, Block #1)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Classical swine fever virus, Conotoxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephalitis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 4C (Section B, Block #2)


Dropdown list that includes: Abrin, Bacillus cereus Biovar anthracis, Botulinum neurotoxin producing species of Clostridium, Botulinum neurotoxins, Chapare, Classical swine fever virus, Conotoxins (Short paralytic alpha conotoxins), Coxiella burnetii, Crimean-Congo haemorrhagic fever virus, Diacetoxyscirpenol, Eastern Equine Encephalitis virus, Ebola virus, Francisella tularensis, Genomic material - Eastern Equine Encephalitis virus, Genomic material - Kyasanur Forest disease virus, Genomic material - Omsk hemorrhagic fever virus

Genomic material - SARS-associated coronavirus (SARS-CoV), Genomic material - Tick-borne encephaltis virus, Siberian subtype

Genomic material - Tick-borne encephalitis virus, Siberian subtype, Guanarito, Junin, Kyasanur Forest disease virus, Lassa fever virus, Lujo virus, Machupo, Marburg virus, Monkeypox virus, Omsk hemorrhagic fever virus, Recombinant/synthetic nucleic acids encoding Abrin, Recombinant/synthetic nucleic acids encoding Botulinum neurotoxin, Recombinant/synthetic nucleic acids encoding Short, paralytic alpha conotoxins, Recombinant/synthetic nucleic acids encoding Ricin, Recombinant/synthetic nucleic acids encoding Staphylococcal enterotoxins, Reconstructed 1918 Influenza virus, Ricin, Rickettsia prowazekii, Sabia, SARS-associated coronavirus (SARS-CoV), Saxitoxin, Staphylococcal enterotoxins, T-2 toxin, Tetrodotoxin, Tick-borne encephalitis virus, Far Eastern subtype, Tick-borne encephalitis virus, Siberian subtype, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), Yersinia pestis

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.

APHIS/CDC Form 5 (Block #5)


Dropdown list that includes: AL, AK, AZ, AR, AS, CA, CO, CT, DC, DE, FL, FM, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MH, MI, MN, MP, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, PW, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, WY

Dropdown lists added to the pdf-fillable format. The additions will ease respondent completion and further automate the forms.


Mini Supporting Statement


Justification for Change


This is a request for nonmaterial/non-substantive changes is for dropdown lists to be added to the pdf-fillable format. The drop down lists have been updated to include Bacillus cereus Biovar anthracis, which was added to the list of HHS select agents and toxins on September 14, 2016 by an interim final rule (81 FR 63138). The additions will also ease respondent completion and further automate the forms. The nonmaterial/non-substantive changes will not affect the burden in completing the forms.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSteinberg, Shari (CDC/OD/OADS)
File Modified0000-00-00
File Created2021-01-23

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