Genetic Testing Registry (OD)

Forms and Documents

Document Name	Status
Form 1 Laboratory Personnel Form and Instruction	New
30 day comments and responses.pdf Supplementary Document	2012-02-29
Revised IC screenshots.pdf Supplementary Document	2012-02-29
Attachment3_GTR Clinical Advisors[1].doc Supplementary Document	2011-11-18
Attachment1_GTR Data Fields[1].docx Supplementary Document	2011-11-18
Revised Supporting Statement.docx Supporting Statement A	2012-02-29

IC Document Collections

IC ID	Document Title	Status
200267	Laboratory Personnel Form and Instruction	New

ICR Details

OMB Control No: 0925-0651	ICR Reference No: 201111-0925-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Genetic Testing Registry (OD)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/29/2012
	Date Received in OIRA: 11/28/2011
Terms of Clearance: This collection is approved contingent on a commitment by NIH to develop and test a more active community policing mechanism or NIH moderator role within the next 18 months. The plan and pilot test design should be submitted to OMB as a non-substantive change to the current approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved
Responses	9,240	0	0
Time Burden (Hours)	27,720	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In 2010, NIH announced its plan to develop the Genetic Testing Registry (GTR), a centralized, online resource that will provide information about the availability and scientific basis of genetic tests. With an increasing number of genetic tests available, NIH recognized the importance of making information about these tests easily accessible to health care providers, researchers, patients, consumers, payers, and others. The overarching goal of the GTR is to advance the public health and research in the genetic basis of health and disease. As such, the Registry will have several key functions, including (1) encouraging providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; (2) providing an information resource for the public, including health care providers, patients, and researchers, to locate laboratories that offer particular tests; and (3) facilitating genetic and genomic data-sharing for research and new scientific discoveries. The GTR will be created, designed, and maintained by the NIH National Center for Biotechnology Information (NCBI) with input from the stakeholder community and oversight by an NIH steering group. Respondents to the GTR are expected to include clinical laboratories, test manufacturers, researchers, and entities that report and interpret tests performed elsewhere. The GTR is not limited to U.S. respondents; it will also include submissions from outside the United States. Information will be collected and managed using an online submission system.

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Authorizing Statute(s): US Code: 42 USC 46 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:
	76 FR 44937	07/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 72424	11/23/2011
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Laboratory Personnel	1	Registry

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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	9,240	0	0	9,240	0	0
Annual Time Burden (Hours)	27,720	0	0	27,720	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 ICR.

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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: 11/28/2011

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