Information Collection

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

IC 281721 under ICR 202508-0910-002 · OMB 0910-0120.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Guidance_Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagn www.fda.gov/regulatory-information/search-fda-guidance-documents/use-public-human-genetic-variant-databases-support-clin	Other-Guidance; Use of Public Human

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance; Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics				https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-public-human-genetic-variant-databases-support-clinical-validity-genetic-and-genomic-based-vitro	Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	505	505
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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