CONSUMER USE OF HOME TESTING DEVICES

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Forms and supporting documents for this ICR

Document	Type	Status	Availability

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Information collection document groups

IC ID	Collection	Type	Status	Form
116761	CONSUMER USE OF HOME TESTING DEVICES		Migrated

ICR Details

OMB Control No:	ICR Reference No: 199101-0990-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: CONSUMER USE OF HOME TESTING DEVICES
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: Disapproved	Conclusion Date: 04/28/1991
	Date Received in OIRA: 01/28/1991
Terms of Clearance: This collection is disapproved pursuant to 5 CFR 1320.4 (b)(3) and 5 CFR 1320 (c). In particular, it is unclear that this collection is necessary for the proper performance of the HHS Office of the Inspector General's functions. OMB believes the survey would more appropriately be conducted by the Food and Drug Administration. In addition, OMB questions the practical utility of focusing the collection of information on consumer behavior with home testing devices, apart from the larger universe of devices used by hospital-based, independent, or physician office labs. Regardless of the test accuracy, how would the consumer act if the findings came from a clinic versus a home test? Do the same consumers use home test kits as those that use health care settings? In other words, would the outcome be different and better if no home test kits were available? Without this kind of information HHS cannot understand the implications of the information it proposes to collect. OMB believes that the effectiveness of all laboratory devices is significantly influenced by consumer behavior, as well as physician practices. Finally, the survey instrument has many question that solicit biased and subjective information. OMB believes that future survey efforts should be coordinated with the CLIA '88 Section Sec. 4 studies. OMB will assist in the studies' design and coordinatio

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: THIS REQUEST FOR INFORMATION ON CONSUMER USE OF HOME TESTING DEVICES I NEEDED TO DETERMINE THE EXTENT OF THE PUBLIC'S USE AND THE NATURE OF THEIR EXPERIENCES WITH SUCH DEVICES. IT WILL BE USED TO ASSESS FDA'S CLEARANCE AND APPROVAL PROCESS OF HOME TESTING DEVICES.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
CONSUMER USE OF HOME TESTING DEVICES

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Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 01/28/1991

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