Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics

ICR 202101-0910-011

OMB: 0910-0850

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0850 202101-0910-011
Received in OIRA 201801-0910-011
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics
Extension without change of a currently approved collection   No
Regular 02/25/2021
  Requested Previously Approved
36 Months From Approved 03/31/2021
5 5
505 505
0 0

The ICR collects information from administrators of public human genetic variant databases who apply for recognition of their database to support clinical validity for genetic and genomic-based in vitro diagnostics. The information collected will be used by FDA to ensure the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. FDA believes that if administrators of genetic variant databases follow the recommendations, including transparency regarding evidence evaluation, and obtain FDA recognition as described, the data and assertions within would generally constitute valid scientific evidence that can be used to support clinical validity.

PL: Pub.L. 114 - 255 2011 Name of Law: 21st Century Cures Act of 2016

Not associated with rulemaking

  85 FR 59801 09/23/2020
86 FR 11300 02/24/2021

  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 5 5 0 0 0 0
Annual Time Burden (Hours) 505 505 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Ila Mizrachi 301 796-7726 [email protected]


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.

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