CD4+ T-LYMPHOCYTE TESTING IMPACT EVALUATION

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
111082	CD4+ T-LYMPHOCYTE TESTING IMPACT EVALUATION	Migrated

ICR Details

OMB Control No: 0920-0345	ICR Reference No: 199312-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: CD4+ T-LYMPHOCYTE TESTING IMPACT EVALUATION
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: 03/22/1994
	Date Received in OIRA: 12/23/1993
Terms of Clearance: Approved for use through March 1996, with the following changes which were raised by OMB and accepted by PHS: 1) instruction pages of questionnaires will indicate that participation is voluntary; 2) infor mation indicating that no laboratory is being identified in the report to CDC will be highlighted; 3) in Attachment 1, item 10 on page 3 will be re-worded to sharpen the difference between it and item 3 on page 1 and 4) the reference date of January 1, 1990 will be replaced with "in the last four years" to remove any possible negative impressions to respondents that their laboratories were expected/required by law to make some changes in CD4+ T-Lymphocyte testing procedures after the guideline was published.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/1996	03/31/1996
Responses	734	0	0
Time Burden (Hours)	734	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: THE PURPOSE OF THE PROPOSED SURVEY IS TO EVALUATE THE RELATIVE EFFECTIVENESS OF EACH OF DLS' INITIATIVES, WHILE CONTROLLING FOR INFLUENCE OF NON-CDC FACTORS IN IMPROVING THE QUALITY OF CD4+ T-CELL TESTING IN CLINICAL FLOW CYTOMETRY LABORATORIES. THIS STUDY WILL COLLECT NEW INFORMATION FROM CD4+ T-CELL TESTING STAFF TO CHARACTERIZE CHANGES IN LABORATORY PRACTICE IN BOTH MPEP AND NON-MPEP LABORATORIES.

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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

IC Title	Form No.	Form Name
CD4+ T-LYMPHOCYTE TESTING IMPACT EVALUATION

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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	734	0	0	734	0	0
Annual Time Burden (Hours)	734	0	0	734	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:

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: 12/23/1993

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