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:
0693-0103
ICR Reference No:
202406-0693-001
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
DOC/NIST
Agency Tracking No:
ER
Title:
Common Form: Interagency Domestic Manufacturing Waiver Form
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 with change
Conclusion Date:
07/10/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/27/2024
Terms of Clearance:
This collection is approved based on the revised materials provided by the agency. NIST shall ensure that any data assets resulting from this collection are entered into the agency’s comprehensive data inventory as required by the Open Government Data Act of 2018 and in conformity with OMB’s implementation guidance in M-25-05.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
36 Months From Approved
Responses
10
0
0
Time Burden (Hours)
130
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Bayh-Dole Act (35 USC 18) and its implementing regulations (37 CFR 401) allow for recipients of federal research funding (Contractors) to retain ownership of inventions developed under federal funding agreements. In exchange, the government retains certain rights to the invention, including a world-wide right to use by or on behalf of the U.S. government. The law also requires the Contractor to obtain permission for certain actions and fulfill reporting requirements. One such requirement under the Bayh-Dole Act is that Contractors (as defined in the statute and regulations) shall not grant “the exclusive right to use or sell any subject invention in the United States unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States.” However, the law allows an agency to waive this requirement if a Contractor has shown that “reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacturing is not commercially feasible.” Pursuant to Executive Order 14104, NIST was directed to consult with the Interagency Working Group for Bayh-Dole to create a set of common questions to be used by all agencies as an application to apply for waivers of the domestic manufacturing requirement under the Bayh-Dole Act.
Authorizing Statute(s):
EO: EO 14104 Name/Subject of EO: Federal Research and Development in Support of Domestic Manufacturing and United States Jobs
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:
88 FR 85243
12/07/2023
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 45847
05/24/2024
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
Common Form: Interagency Domestic Manufacturing Waiver 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
10
0
0
10
0
0
Annual Time Burden (Hours)
130
0
0
130
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:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection
Annual Cost to Federal Government:
$2,498
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.
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.
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:
Elizabeth Reinhart 301 975-8707 elizabeth.reinhart@nist.gov
Common Form ICR:
Yes
Description/Changes for Common Form Usage:
This is a new Information Collection submitted for interagency use of a common form, Pursuant to Executive Order 14104. Individual agencies must independently request usage to report agency burden. Additionally, if an agency decides to retain the information in a Privacy Act System of Records in which they are retrieving by contact names, they must provide an agency specific Privacy Act Statement.
Approved RCFs using this ICR
Agency/Sub Agency
RCF ID
RCF Title
RCF Status
IC Title
HHS/NIH
202509-0925-001CF
NIH Usage of the Interagency Domestic Manufacturing Waiver Form, Common Form
Active
Common Form: Interagency Domestic Manufacturing Waiver Form
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:
06/27/2024
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