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

Forms and Documents

Document Name	Status
NEW_Supporting Statement.docx Supporting Statement A	2018-01-31

IC Document Collections

IC ID	Document Title	Status
229929	Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics Other-Guidance	New

ICR Details

OMB Control No: 0910-0850	ICR Reference No: 201801-0910-011
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics
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: 03/26/2018
	Date Received in OIRA: 01/31/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved
Responses	5	0	0
Time Burden (Hours)	505	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): PL: Pub.L. 114 - 255 2011 Name of Law: 21st Century Cures Act of 2016
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 44611	07/08/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 2451	01/17/2018
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics

---

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	5	0	0	5	0	0
Annual Time Burden (Hours)	505	0	0	505	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: New collection

---

Annual Cost to Federal Government: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

---

Common Form ICR:  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:

(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: 01/31/2018

---