National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection

Forms and Documents

Document Name	Status
SupportingStatement B .doc Supporting Statement B	2011-10-12
Attachment 8 ConsentForm - NSSAE.doc Supplementary Document	2011-10-12
Attachment 7 ResearchDetermination- NSSAE.docx Supplementary Document	2011-10-12
Attachment 1 Legislation - NSSAE.pdf Supplementary Document	2011-10-12
Attachment 3 Guidelines - NSSAE 9 19 2011.doc Supplementary Document	2011-10-12
SupportingStatement_Part_A.doc Supporting Statement A	2011-11-03

IC Document Collections

IC ID	Document Title	Status
183195	Adverse Events to LTBI Treatment (AELT) NSSAE - Clerk Instruction	Modified
183194	Adverse Events to LTBI Treatment (AELT) NSSAE - Nurses Instruction	Modified
183193	Adverse Events LBTI NSSAE - Physicians Instruction	Modified

ICR Details

OMB Control No: 0920-0773	ICR Reference No: 201110-0920-006
Status: Historical Active	Previous ICR Reference No: 200712-0920-013
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/17/2011
	Date Received in OIRA: 10/17/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2014	36 Months From Approved
Responses	30	0	0
Time Burden (Hours)	60	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Since approval of the NSSAE collection form 3 years ago, the project officers published the article Severe Isoniazid-associated Liver Injuries Among persons Being Treated for Latent Tuberculosis Infection--- United States, 2004--2008, Morbidity and Mortality Report , 2010. In this article, the project officers described 17 reports of severe adverse events (SAEs) in 15 adults and two children; all patients had received isoniazid (INH) and had experienced severe liver injury. This article emphasized that healthcare providers should prescribe only 1-month supply of INH with careful monitoring. Providers should report possible INH-associated SAEs to their respective health department staff who will in turn report to CDC. The project officers also have presented these SAEs to national and international audiences at scientific conferences. There has been an increase in the number of SAE reports. Since 2008, project officers received an additional 25 SAE reports and investigated 5 of these on site. A better understanding of the data needed to accurately capture important elements describing factors that led to these events and as a result, the NSSAE data collection form has been shortened into four pages instead of the original 6 pages.

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

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 22399	04/21/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 63924	10/14/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Adverse Events to LTBI Treatment (AELT) NSSAE - Clerk
Adverse Events LBTI NSSAE - Physicians
Adverse Events to LTBI Treatment (AELT) NSSAE - Nurses

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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	30	0	0	30	0	0
Annual Time Burden (Hours)	60	0	0	60	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: The project officers have conducted onsite investigation of SAEs for the past 3 years and now have a better understanding of the data needed to accurately capture important elements describing factors that led to these events. As a result, the NSSAE data collection form has been shortened into four pages instead of the original 6 pages. Variables such as results of liver biopsy and hepatitis serology were removed because these were usually unreliable because of incomplete reporting or misreporting of information The project officers also have received increased number of SAE reports from 3 to 10 reports per year. The annual reporting burden increased from 24 hours to 60 hours.

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Annual Cost to Federal Government: $39,478

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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

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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: 10/17/2011

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