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

Forms and Documents

Document Name	Status
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician Form	New
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse Form	New
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk Form	New
IRB Determination 28OCT2014.pdf Supplementary Document	2014-10-29
60day FRN.pdf Supplementary Document	2014-10-20
Att 1 Authorizing Legislation.docx Supplementary Document	2014-10-20
SupportingStatementB 10 14 2014.doc Supporting Statement B	2014-10-20
SupportingStatementA 10 14 2014.doc Supporting Statement A	2014-10-20
Attachment 8 ConsentForm - NSSAE.doc Supplementary Document	2011-10-12
Attachment 3 Guidelines - NSSAE 9 19 2011.doc Supplementary Document	2011-10-12

IC Document Collections

IC ID	Document Title	Status
213552	Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician Form	New
213551	Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse Form	New
213550	Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk Form	New
183195	Adverse Events to LTBI Treatment (AELT) NSSAE - Clerk Instruction	Removed
183194	Adverse Events to LTBI Treatment (AELT) NSSAE - Nurses Instruction	Removed
183193	Adverse Events LBTI NSSAE - Physicians Instruction	Removed

ICR Details

OMB Control No: 0920-0773	ICR Reference No: 201410-0920-024
Status: Historical Active	Previous ICR Reference No: 201110-0920-006
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/12/2015
	Date Received in OIRA: 11/10/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2018	36 Months From Approved	01/31/2015
Responses	30	0	30
Time Burden (Hours)	60	0	60
Cost Burden (Dollars)	0	0	0

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Abstract: Severe adverse events (SAEs) to Tuberculosis (TB) treatment are rare but continue to be a public health problem. In order to continue to determine risk factors and to monitor trends of SAEs related to the treatment of Latent TB Infection (LTBI), CDC requests approval to continue collecting SAE reports through NSSAE. 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)OMB No.0920-0026, Exp. Date 3/17/2017. Data will be collected on each occurrence of SAEs reported by healthcare providers through the local and state health departments. Data collection is initiated when a health department is notified of a person hospitalized with severe adverse reactions to the medications prescribed to treat LTBI. Since OMB approval of the NSSAE collection form 3 years ago, the project officers have received 28 reports of SAEs.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Services Act
  

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:
	79 FR 36066	06/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 63404	10/23/2014
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
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse	None	Reporting Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse
Adverse Events LBTI NSSAE - Physicians
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk	None	Reporting Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk
Adverse Events to LTBI Treatment (AELT) NSSAE - Nurses
Adverse Events to LTBI Treatment (AELT) NSSAE - Clerk
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician	None	Reporting Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician

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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	30	0	20	-20	0
Annual Time Burden (Hours)	60	60	0	50	-50	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes in Burden are the result of NSSAE data collection form previous 3 years and estimation of severe adverse effects (SAEs) during the extension approval period.

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Annual Cost to Federal Government: $40,548

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: 11/10/2014

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