Genetic Testing Registry (OD)

Forms and Documents

Document Name	Status
Form 1 Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	New
Form 1 Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	New
Form 1 Laboratory Personnel Using Bulk Submission Optional Fields Form and Instruction	New
Form 1 Laboratory Personnel Using Bulk Submission Minimal Fields Form and Instruction	New
Form 4 Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	Removed
Form 3 Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	Removed
Form 2 Laboratory Personnel Using Bulk Submission Optional Fields Form and Instruction	Removed
Form 1 Laboratory Personnel Using Bulk Submission Minimal Fields Form and Instruction	Removed
30 day FRN 2018-14435.pdf Supplementary Document	2018-07-09
CLEAN PRA Supporting Statement GTR_06_20_2018.docx Supporting Statement A	2018-06-28
SOP_Resolving GTR Complaints_11-13-12.docx Supplementary Document	2015-07-07

IC Document Collections

IC ID	Document Title	Status
232002	Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	New
232001	Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	New
232000	Laboratory Personnel Using Bulk Submission Optional Fields Form and Instruction	New
231999	Laboratory Personnel Using Bulk Submission Minimal Fields Form and Instruction	New
215625	Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	Removed
215624	Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	Removed
215623	Laboratory Personnel Using Bulk Submission Optional Fields Form and Instruction	Removed
215622	Laboratory Personnel Using Bulk Submission Minimal Fields Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0651	ICR Reference No: 201806-0925-003
Status: Active	Previous ICR Reference No: 201503-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Genetic Testing Registry (OD)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/07/2018
	Date Received in OIRA: 07/10/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	08/31/2018
Responses	18,850	0	16,298
Time Burden (Hours)	4,198	0	5,536
Cost Burden (Dollars)	0	0	0

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Abstract: The National Institutes of Health (NIH) created the 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 genetic tests, including newer types of tests such as pharmacogenomic tests. NCBI is considered a suitable developer of the GTR because of its experience in building databases of genetic and medical information and its ability to integrate the information with other data, greatly enhancing the GTR's utility for medical professionals and researchers. The GTR is also integrated with other relevant NIH databases to assist these user groups. NIH is, therefore, a natural home for the GTR because of its role in advancing public health through science and its strong expertise in developing databases.

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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:
	83 FR 14018	04/02/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 31410	07/05/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Laboratory Personnel Not Using Bulk Submission Optional Fields	4	Not using Bulk Submission Optional Fields
Laboratory Personnel Using Bulk Submission Minimal Fields	1	GTR Information Collection
Laboratory Personnel Using Bulk Submission Optional Fields	1	GTR Information collection screenshots
Laboratory Personnel Using Bulk Submission Optional Fields	2	Bulk Submission Optional Fields
Laboratory Personnel Not Using Bulk Submission Minimal Fields	1	GTR Information Collection screenshots
Laboratory Personnel Using Bulk Submission Minimal Fields	1	Bulk Submission Minimal Fields
Laboratory Personnel Not Using Bulk Submission Minimal Fields	3	Not using Bulk Submission Minimal Fields
Laboratory Personnel Not Using Bulk Submission Optional Fields	1	GTR Information Collection screenshots

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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	18,850	16,298	0	0	2,552	0
Annual Time Burden (Hours)	4,198	5,536	0	0	-1,338	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There are no program changes; burden estimates were adjusted based on actual GTR registration data over 5.8 years. Total annual burden hours have decreased to 4,198 from 5,536 in 2015. This is largely due to the increase in proportion of test submitted using time-saving bulk submission (from 62% of submissions to 83% of submissions).

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Annual Cost to Federal Government: $2,565,000

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? Uncollected

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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: 07/10/2018

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