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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Document and maintain health care worker exposure records
New
1
0
0
Other-PHS Guideline
Document complete necropsy results
New
8
2
0
Other-PHS Guideline
Document justification of quarantine period
New
1
1
0
Other-PHS Guideline
Document location and nature of archived specimens in health care records
New
12
1
0
Other-PHS Guideline
Document monitoring program results
New
32
8
0
Other-PHS Guideline
Document necropsy investigations
New
8
2
0
Other-PHS Guideline
Document presence/absence of infectious agent
New
1
0
0
Other-PHS Guideline
Document xenotransplant procedures
New
2
1
0
Other-PHS Guideline
Establish records regarding xenotransplantation product recipient
New
1
16
0
Other-PHS Guideline
Maintain archives of Source Animal Medical Records
New
8
1
0
Other-PHS Guideline
Maintain health care worker monitoring records
New
1
0
0
Other-Guidance
Maintain health care worker monitoring records
New
50
9
0
Other-PHS Guideline
Maintain medical and research records
New
2
2
0
Other-PHS Guideline
Maintain summary of source animal records
New
2
0
0
Other-PHS Guideline
Notify FDA regarding new archive site
Modified
1
1
0
Other-PHS Guideline
Notify sponsor regarding infectious agent in source animal/herd
New
1
0
0
Other-PHS Guideline
Notify sponsor regarding new archive site
New
1
1
0
Other-PHS Guideline
Provide SOPs of source animal facility to appropriate review bodies
New
2
0
0
Other-PHS Guideline
Provide informed consent document regarding potentially increased infectious risk
New
1
0
0
Other-PHS Guideline
Provide xenotransplant product recipient records to appropriate review bodies
New
4
2
0
Other-PHS Guideline
Total burden requested under this ICR:
139
47
0
To view an IC, click on IC Title
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