Genetic Testing Registry (OD)

ICR 202111-0925-004

OMB: 0925-0651

Federal Form Document

ICR Details
0925-0651 202111-0925-004
Received in OIRA 201806-0925-003
HHS/NIH
Genetic Testing Registry (OD)
Extension without change of a currently approved collection   No
Regular 11/29/2021
  Requested Previously Approved
36 Months From Approved 11/30/2021
6,432 18,850
2,299 4,198
0 0

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.

US Code: 42 USC 286 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  86 FR 50140 11/07/2021
86 FR 67068 11/24/2021
No

  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 6,432 18,850 0 -12,418 0 0
Annual Time Burden (Hours) 2,299 4,198 0 -1,899 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
There are no program changes; burden estimates were adjusted based on actual GTR registration data over 9 years. Total annual burden hours have decreased to 2,299 from 4,178 in 2018 and from 5,536 in 2015. This is largely due to a decrease in new test submissions and increased use of the time-saving bulk submission (from 62% of submissions in 2015, and 83% of submissions in 2018 and 78% of submissions in 2021).

$570,150
No
    Yes
    Yes
No
No
No
No
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/29/2021


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