View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-0576
ICR Reference No:
201810-0920-006
Status:
Historical Inactive
Previous ICR Reference No:
201804-0920-015
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0576 18AXH
Title:
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Withdrawn and continue
Conclusion Date:
10/24/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/23/2018
Terms of Clearance:
CDC may resubmit the change request after the relevant SORN(s) have been updated.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2020
10/31/2020
01/31/2021
Responses
7,869
0
7,869
Time Burden (Hours)
8,347
0
8,347
Cost Burden (Dollars)
0
0
0
Abstract:
The Centers for Disease Control and Prevention collects information under 42CFR Part 73, with the purpose of ensuring select agents or toxins are managed appropriately to prevent any threats to human health or safety. This Non-Substantive Change Request is to modify APHIS/CDC Form 4A to clarify the meaning/intent of the question for the select agent or toxin identified as Botulinum neurotoxins. The revised Form 4A will result in a decrease in 60 Burden Hours for regulated entities.
Authorizing Statute(s):
PL:
Pub.L. 107 - 188 Subtitle A
Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 96456
12/30/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 36144
08/03/2017
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
33
IC Title
Form No.
Form Name
Administrative Review
none
Administrative Review
Amendment to a Certificate of Registration
none
Amendment to Registration
Application for Registration (APHIS/CDC Form 1)
APHIS/CDC FORM 1, none
Application for Registration
,
Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Application for Registration (APHIS/CDC Form 1) - Guidance
NA
Guidance Document for the completion of APHIS/CDC Form 1
Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C
NA, APHIS/CDC FORM 4C
Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report (APHIS/CDC Form 4C)
,
Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
BioSafety Plan Template
NA
BioSafety Plan Template
BioiSafety Plan Guidance
NA
Guidance Documnet for the completion of BioSafety Plan
Biosafety Plan
none
Biosafety Plan
Documentation of Self-Inspection
none
Documentation of self-inspection
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure
NA, APHIS/CDC FORM 3
Incident Notification and Reporting APHIS/CDC Form 3 (Theft/Loss/Release)
,
INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE
Incident Response Plan
none
Incident Response Plan
Incident Response Plan Guidance
NA
Guidance Document for the completion of Incident Response Plan
Incident Response Plan Template
NA
Incident Response Plan Template
Inventory of Select Agents Guidance
NA
Guidance document for the completion of Inventory Records of Select Agents
Records
none
Records
Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance
0920-0576
Guidance Document for the Completion of APHIS/CDC Form 4
Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen
0920-0576
APHIS/CDC FORM 4A - REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN
Report of Identification of a Select Agent or Toxin from a Proficiency Test
NA, APHIS/CDC FORM 4B
REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B)
,
REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN: PROFICIENCY TESTING REPORT
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance
NA
Guidance Document for the completion of APHIS/CDC Form 3
Request Regarding a Restricted Experiment
none
Request Regarding Restricted Experiment
Request Regarding a Restricted Experiment Guidance
NA
Guidance Document for the completion of Restricted Experiment Request
Request for Exclusion - Guidance
NA
Guidance Document for Exclusion of Select Agents and Toxins
Request for Exclusions
none
Request for Exclusions
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5)
none
Request for Exemption
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance
NA
Guidance Document for the completion of APHIS/CDC Form 5
Request for Expedited Review
none
Request for Expedited Review
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2)
APHIS/CDC FORM 2, none
Request to Transfer Select Agents and Toxins
,
REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance
NA
Guidance Document for the completion of APHIS/CDC Form 2
Security Plan
none
Secuity Plan
Security Plan - Guidance
NA
Guidance Document for the completion of Security Plan
Security Plan Template
NA
Security Plan Template
Training
none
Training
Training Guidance
NA
Guidance Document for the completion of Training
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This Non-Substantive Change Request includes a revised Form 4A that will reduce 120 forms for approximately 8 entities, resulting in a reduction of 60 Burden Hours.
Annual Cost to Federal Government:
$20,210,121
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Thelma Sims 4046394771
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
10/23/2018
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