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:
0920-1448
ICR Reference No:
202409-0920-015
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-24HP
Title:
Compliance Attestation Statement for the Framework for Nucleic Acid Synthesis Screening
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
Yes
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/04/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/26/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2027
36 Months From Approved
Responses
60
0
0
Time Burden (Hours)
20
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Project is designed to assist providers and manufacturers of synthetic nucleic acids and benchtop nucleic acid synthesis equipment in making an attestation that they have instituted a process to screen nucleic acid sequences of concern and verify customer legitimacy, in accordance with the requirements outlaid in the OSTP Framework for Nucleic Acid Synthesis Screening.
Authorizing Statute(s):
EO: EO 14110 Name/Subject of EO: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence
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:
89 FR 59916
07/24/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 78874
09/26/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Synthetic Nucleic Acids Providers/Manufacturers - Attestation Form
0920-XXXX
Attestation Form
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
60
0
0
60
0
0
Annual Time Burden (Hours)
20
0
0
20
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:
Submission of 0920-24HP is a New ICR (on behalf of NSC/OSTP).
Annual Cost to Federal Government:
$4,881
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:
CDC seeks approval of a data collection titled Workplan Template for Self-Attestation Statement for the Framework for Nucleic Acid Synthesis Screening. The associated form will be used by NSC/OSTP to assist providers and manufacturers of synthetic nucleic acids and benchtop nucleic acid synthesis equipment in making an attestation that they have instituted a process to screen nucleic acid sequences of concern.
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:
09/26/2024
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