Genetic Testing Registry (OD)

Forms and Documents

Document Name	Status
Form 4 Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	New
Form 3 Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	New
Form 2 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 1 Laboratory Personnel Form and Instruction	Removed
SOP_Resolving GTR Complaints_11-13-12.docx Supplementary Document	2015-07-07
PRA Supporting Statement GTR 3-4-2015.docx Supporting Statement A	2015-03-09

IC Document Collections

IC ID	Document Title	Status
215625	Laboratory Personnel Not Using Bulk Submission Optional Fields Form and Instruction	New
215624	Laboratory Personnel Not Using Bulk Submission Minimal Fields Form and Instruction	New
215623	Laboratory Personnel Using Bulk Submission Optional Fields Form and Instruction	New
215622	Laboratory Personnel Using Bulk Submission Minimal Fields Form and Instruction	New
200267	Laboratory Personnel Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0651	ICR Reference No: 201503-0925-002
Status: Historical Active	Previous ICR Reference No: 201111-0925-007
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/07/2015
	Date Received in OIRA: 03/24/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2018	36 Months From Approved	02/28/2015
Responses	16,298	0	9,240
Time Burden (Hours)	5,536	0	27,720
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:
	79 FR 227	11/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 15013	03/20/2015
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 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	4	Not using Bulk Submission Optional Fields
Laboratory Personnel	1	Registry ,   Registry
Laboratory Personnel Using Bulk Submission Optional Fields	2	Bulk Submission Optional Fields

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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	16,298	9,240	0	0	7,058	0
Annual Time Burden (Hours)	5,536	27,720	0	0	-22,184	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: reinstatement without change

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Annual Cost to Federal Government: $2,900,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? 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: 03/24/2015

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