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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:
0920-0263
ICR Reference No:
201406-0920-013
Status:
Historical Active
Previous ICR Reference No:
201303-0920-003
Agency/Subagency:
HHS/CDC
Agency Tracking No:
18894
Title:
Requirements for the Importation of Nonhuman Primates into the United States
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:
09/15/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/24/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2017
36 Months From Approved
04/30/2016
Responses
5,187
0
476
Time Burden (Hours)
943
0
145
Cost Burden (Dollars)
0
0
0
Abstract:
CDC is submitting this revision to obtain authority to collect electronic information from importers/filters on nonhuman primate products over which CDC has authority, notably those found in 42 CFR part 71,. This request is consistent with requirements of the Security an Accountability for Every (SAFE) Port Act that states that all agencies that require documentation for clearing or licensing the importation and exportation of cargo participate in the International Trade Data System (ITDS) , and is also consistent with CDC authorities under Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264).
Authorizing Statute(s):
US Code:
42 USC 264
Name of Law: Regulations to Control Communicable Diseases
US Code:
19 USC 1411
Name of Law: Tariff Act of 1930 (As amended by the Safe Port Act of 2006)
EO: EO 13659 Name/Subject of EO: Streamlining the Export/Import Process for America's Businesses
Citations for New Statutory Requirements:
US Code: 42 USC 71 Name of Law: The Public Health and Welfare
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:
79 FR 15129
03/18/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 33924
06/13/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Documentation and Standard Operating Procedures (No Form)
71.53(g)(1)(iii)
Attachment E - CDC PGA Message Set Requested Data of Live Nonhuman Prima...
Documentation of Non-infectiousness
71.53
Documentation of Non - Infectionusness
Filovirus Diagnostic Specimen Submission
71.53(v) (No Form)
Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials
Importer Registration and New Importer Registration - Nonhuman Primates
7510A
Application for Registration as an Importer of Nonhuman Primates
Importer/Filer
71.53
CDC Partner Government Agency Message Set for Importing Nonhuman Primates
Nonhuman Primate Importer Application for Registration as an Importer of Nonhuman Primates (New Importer)
75.10A
Attachment C - CDC 75.10A Application for Registration as an Importer of...
Nonhuman Primate Importer Recordkeeping and reporting
75.10
Attachment E - CDC PGA Message Set Requested Data of Live Nonhuman Prima...
Quarantine Release
Recordkeeping and Reporting Requirements for importing Nonhuman Primates
71.53(n) (no form)
Recordkeeping and reporting requirements for importing Nonhuman primates
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
5,187
476
0
4,711
0
0
Annual Time Burden (Hours)
943
145
0
798
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
CDC is requesting the following changes based on the upcoming implementation of ITDS and ACE, which allows NHP importers/filers to voluntarily submit data concerning CDC-regulated imports electronically to CBP for clearance. These estimates are based on operational observation by Quarantine Staff at US ports of entry. • 150 submissions of CDC PGA Message Set importing Live Nonhuman Primates, resulting in 38 additional requested burden hours • 2280 submissions of CDC PGA Message Set data for importations of Nonhuman Primate products, resulting in an additional 570 requested burden hours • 2280 submissions of documentation indicating that Nonhuman Primate products have been rendered noninfectious, resulting in an additional 190 hours of requested burden. These submissions can be accomplished via the Document Imagining System. CDC retains the right to collect these in hard copy. The following change is a correction to clarify the public burden associated with providing the required statements and documentation that an NHP product has been rendered non-infectious. • 2280 submissions of documentation indicating that Nonhuman Primate products have been rendered noninfectious, resulting in an additional 190 hours of requested burden. These submissions can be accomplished via the Document Imagining System. CDC retains the right to collect these in hard copy. The estimates provided in this information collection request assume that every commercial importer of NHP covered by CDC's regulations will file a data entry using ITDS and ACE. However, CDC is maintaining its authority to collect hard copies of required documentation, as currently authorized by the Office of Management and Budget, because the use of ITDS/ACE will not be required for imports entering the United States until a later date. CDC will accept both hard copy and electronic filing of import-related documentation until the use of ACE is required for cargo entering the United States.
Annual Cost to Federal Government:
$433,788
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?
No
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:
Catina Conner 404 639-4775
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:
06/24/2014