View Information Collection Request (ICR) Package

OMB Control No: 0920-0773	ICR Reference No: 200712-0920-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection
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: 04/25/2008
	Date Received in OIRA: 12/20/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	36 Months From Approved
Responses	12	0	0
Time Burden (Hours)	32	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Between October 2000 and October 2007, 79 patients receiving treatment for Latent TB Infection (LTBI) were reported to the Division of Tuberculosis Elimination (DTBE), Centers for Disease Control and Prevention (CDC) with severe adverse events to their medications (s). A severe adverse event is defined as a drug-related reaction resulting in hospitalization or death of a person receiving treatment for LTBI. Deaths reported among persons with LTBI included, 2 of 50 persons who were on the recommended two-month regimen of rifampin and pyrazinamide (RZ); 9 of 22 treated with isoniazid alone, and 2 of 3 patients on other regimens (e.g., pyrazinamide and ethambutol). Severe adverse events such as hospitalizations, liver transplants, and death related to treatment of LTBI continue to be reported to DTBE. In order to determine risk factors and to monitor trends of severe adverse events related to the treatment of LTBI, CDC requests approval for information collection through the National Surveillance for Severe Adverse Events Associated with Treatment of LTBI. These reports are from healthcare providers and health departments (local/state/territorial) from any of the 60 reporting areas for the National TB Surveillance System (NTSS). CDC currently conducts and maintains NTSS pursuant to the provisions of Section 301 (a) of the Public Service Act [42 U.S.C. 241] and Section 306 of the Public Service Act [42 U.S.C. 241 (a)] which also authorizes this proposed information collection (Attachment 1). In compliance with the recommendations of the Institute of Medicine (IOM), Ending Neglect: The Elimination of Tuberculosis in the United States towards reaching the Healthy People (HP) 2010 objective, CDC is detecting and treating latent TB infection (LTBI) through targeted testing and administration of LTBI treatment to prevent transmission. Persons with LTBI are at highest risk for progression from latent infection to TB disease. However, with the increased number of persons with LTBI who will be treated with the recommended regimen of antibiotics, we anticipate that severe adverse events will occur more frequently. The purpose of this information collection request is to determine the annual number and trends of severe adverse events associated with treatment of LTBI and identify common characteristics of patients with severe adverse events during treatment of LTBI. The data will also guide the revision of the TB treatment protocols in order to prevent severe adverse events associated with treatment of LTBI. CDC will use the information to monitor trends in LTBI detection and compile the nature of severe adverse events to treatment regimens associating patient characteristics, clinical events and the treatment regimens that the patient has been required to take. Most importantly, the presence of HIV infections or HIV-related treatment regimens will be evaluated closely. The data will be used to generate trends and analyze associations of the severe reactions with patient characteristics or concurrent medications. CDC will use the cumulated data on LTBI treatment and severe adverse events to convene stakeholders and recommend revisions of current LTBI treatment regimens based on patient's medical history and the perceived risk of severe adverse events.

Authorizing Statute(s): PL: Pub.L. 42 - 301 241 Name of Law: Research and Investigation

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:
	71 FR 75956	12/14/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 64228	11/15/2007
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	12	12
Annual Time Burden (Hours)	32	32
Annual Cost Burden (Dollars)	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: This is a new data collection

Annual Cost to Federal Government: $38,582

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

Agency Contact: Maryam Daneshvar 4046394604

View ICR - OIRA Conclusion