View Information Collection Request (ICR) Package
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View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0920-0199
ICR Reference No:
201312-0920-005
Status:
Historical Active
Previous ICR Reference No:
201012-0920-001
Agency/Subagency:
HHS/CDC
Agency Tracking No:
21107
Title:
Import Permit Applications (42 CFR 71.54)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/23/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/19/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2017
36 Months From Approved
01/31/2014
Responses
1,635
0
2,010
Time Burden (Hours)
545
0
670
Cost Burden (Dollars)
0
0
0
Abstract:
The Application for Permit to Import Biological Agents and Vectors of Human Disease into the US form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. The form requests applicant and sender contact information; description of material for importation; facility isolation and containment information; and personnel qualifications.
Authorizing Statute(s):
US Code:
42 USC CFR Part 71.54
Name of Law: FOREIGN QUARANTINE - Subpart F--Importations
US Code:
42 USC 264
Name of Law: PHSA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0920-AA37
Final or interim final rulemaking
78 FR 7674
02/04/2013
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 55259
09/10/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 75921
12/13/2013
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Application for Permit to Import or Transport Live Bats (71.54)
none
Application for Permit to Import or Transfer Live Bats
Importation of Infectious Biological Agents, Infectious Substances, and Vectors into the US
none
Application for Permit to Import Biological Agents or Vectors of Human Disease into the US
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
1,635
2,010
0
-375
0
0
Annual Time Burden (Hours)
545
670
0
-125
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The reduction in burden is due to revised estimates of respondents based on past experience. CDC requests form revisions to include information on where the imported material will be stored at the recipient facility and who is responsible for the location; verification that the permittee has implemented biosafety measures commensurate with the hazard posed by the infectious biological agent, infectious substance, and/or vector to be imported, and the level of risk given its intended use; and a secondary contact information for the permittee. The additional data elements do not affect the burden. We also request a title change to Import Permit Applications (42 CFR 71.54).
Annual Cost to Federal Government:
$1,335,495
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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:
Shari Steinberg 404 639-4942 sxw2@cdc.gov
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:
12/19/2013
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