NIH Usage of the Interagency Domestic Manufacturing Waiver Form, Common Form

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
277691	Common Form: Interagency Domestic Manufacturing Waiver Form	Other-Form with no form number	New

ICR Details

OMB Control No: 0693-0103	ICR Reference No: 202509-0925-001CF
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: NIH Usage of the Interagency Domestic Manufacturing Waiver Form, Common Form
Type of Information Collection: RCF New	Common Form ICR:
Type of Review Request:
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/17/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/02/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2028
Responses	10	0	0
Time Burden (Hours)	130	0	0
Cost Burden (Dollars)	0	0	0

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Abstract:

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR?

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Common Form: Interagency Domestic Manufacturing Waiver Form

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ICR Summary of Burden

table that charts list 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: The National Institutes of Health (NIH) will adopt the Common Form for Interagency Domestic Manufacturing Waivers, under 35 U.S.C. §204.

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Annual Cost to Federal Government: $18,480

Does this IC contain surveys, censuses, or employ statistical methods?

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.    

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.    

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR: 

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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:

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