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:
0920-1313
ICR Reference No:
202304-0920-004
Status:
Historical Active
Previous ICR Reference No:
202212-0920-010
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1313
Title:
[NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
Yes
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
04/21/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/19/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2026
03/31/2026
03/31/2026
Responses
900
0
900
Time Burden (Hours)
80
0
80
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of this information collection (IC) is for the CDC to assure that the Traceable Opioid Material* Kits (TOM Kits*) are being distributed to different types of laboratories in public, private, and non-profit sectors. The intended use is: 1) To gather information on the types of laboratories requesting the kits. 2) To determine the types of instrumentation, matrices, and sample size for those requesting kits. Data will be collected by online survey. This Non-Substantive Change Request is submitted to split Question #1 on both the Domestic (Attachment 5a) and International (Attachment 5b) surveys into two questions for clarity. There is no change to the approved burden hours.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: Public Health Service Act
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:
87 FR 56957
09/16/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 79890
12/28/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Federal Laboratories
0920-1313, 0920-1313
Test Kit Application and Questions for US Laboratories (online)
,
Test Kit Application and Questions for U.S. Laboratories (online)
International Laboratories
0920-1313, 0920-1313
Att5b Test Kit Qs Int Labs (Word) 20221202
,
Test Kit Application and Questions for International Laboratories (online)
Private or Not-for-Profit Institutions
0920-1313, 0920-1313
Att5a Test Kit Applctn Qs US Labs (Word) 20221202
,
Test Kit Application and Questions for U.S. Laboratories (online)
State, Local, and Tribal Government Laboratories
0920-1313, 0920-1313
Att5a Test Kit Applctn Qs US Labs (Word) 20221202
,
Test Kit Application and Questions for U.S. Laboratories (online)
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
900
900
0
0
0
0
Annual Time Burden (Hours)
80
80
0
0
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:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$4,737,737
Does this IC contain surveys, censuses, or employ statistical methods?
No
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.
No
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.
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?
No
Agency Contact:
Jeffrey Zirger 404 639-7118 wtj5@cdc.gov
Common Form ICR:
Yes
Description/Changes for Common Form Usage:
No changes to Common Forms.
Approved RCFs using this ICR
Agency/Sub Agency
RCF ID
RCF Title
RCF Status
IC Title
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:
04/19/2023
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