Genetic Testing Registry (OD)

Forms and Documents

Document	Type	Status	Availability
Form 1 Form	Form	New	Available
Form 1 GTR Information Collection screenshots	Form and Instruction	Modified	Available
Form 1 GTR Information Collection screenshots	Form and Instruction	Modified	Available
Form 1 GTR Information collection screenshots	Form and Instruction	Modified	Available
Form 1 GTR Information Collection	Form and Instruction	Modified	Available
30day GTR.pdf	Supplementary Document	Uploaded 2026-07-01	Available
Attachment 2 GTR PA Memo 25.05.14 signed.pdf	Supplementary Document	Uploaded 2026-06-29	Available
Attachment 1 GTR PIA HHS 5-6-2025.pdf	Supplementary Document	Uploaded 2026-06-29	Available
SSA for GTR_5.13.26.docx	Supporting Statement A	Uploaded 2026-06-29	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
280407	Laboratory Personnel (updated test)	Form	New	Form
232002	Laboratory Personnel Not Using Bulk Submission Optional Fields	Form and Instruction	Modified	GTR Information Collection screenshots
232001	Laboratory Personnel Not Using Bulk Submission Minimal Fields	Form and Instruction	Modified	GTR Information Collection screenshots
232000	Laboratory Personnel Using Bulk Submission Optional Fields	Form and Instruction	Modified	GTR Information collection screenshots
231999	Laboratory Personnel Using Bulk Submission Minimal Fields	Form and Instruction	Modified	GTR Information Collection

ICR Details

OMB Control No: 0925-0651	ICR Reference No: 202605-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202111-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Genetic Testing Registry (OD)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/01/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	16,870	0
Time Burden (Hours)	5,217	0
Cost Burden (Dollars)	0	0

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Abstract: This application is to reinstate, without change, an Office of Management and Budget (OMB) approved collection of information, 0925-0651. The purpose of the reinstatement is to continue the National Institutes of Health (NIH) Genetic Testing Registry (GTR), a public database that health care providers, researchers, and others can search for information submitted voluntarily by genetic test providers. The GTR aims to enhance access to information about the availability and scientific basis of molecular, cytogenetic and biochemical clinical and research genetic tests. In 2020, to support efforts to mitigate the impact of the COVID-19 pandemic, GTR expanded its scope to include molecular and serologic tests for SARS-CoV-2 that causes COVID-19.

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Authorizing Statute(s): US Code: 42 USC 286 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 2788	01/22/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 39628	06/30/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Laboratory Personnel (updated test)	1	Form
Laboratory Personnel Not Using Bulk Submission Minimal Fields	1	GTR Information Collection screenshots
Laboratory Personnel Not Using Bulk Submission Optional Fields	1	GTR Information Collection screenshots
Laboratory Personnel Using Bulk Submission Minimal Fields	1	GTR Information Collection
Laboratory Personnel Using Bulk Submission Optional Fields	1	GTR Information collection screenshots

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ICR Summary of Burden

	Total Request	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	16,870	0	0	16,870	0	0
Annual Time Burden (Hours)	5,217	0	0	5,217	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: NIH is requesting a reinstatement without change of the information collection approval. There are no program changes; burden estimates were adjusted based on actual GTR registration data over 12 years. Total annual burden hours have increased to 5,217 from 2,299 in 2021.

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Annual Cost to Federal Government: $2,138,647

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.     Yes

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

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Common Form ICR:  No

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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: 07/01/2026

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