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	Modified
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse Form	Modified
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk Form	Modified
SSA_02072018.doc Supporting Statement A	2018-02-07
Att8_Consent.docx Supplementary Document	2018-02-06
Att7_Project Determination.pdf Supplementary Document	2018-02-06
Att3_Guidelines_02062018.docx Supplementary Document	2018-02-06
Att2 60 Day FRN.pdf Supplementary Document	2018-02-06
Att1_Legislation.docx Supplementary Document	2018-02-06
SSB_02062018.doc Supporting Statement B	2018-02-06

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	Modified
213551	Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse Form	Modified
213550	Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk Form	Modified

ICR Details

OMB Control No: 0920-0773	ICR Reference No: 201802-0920-002
Status: Active	Previous ICR Reference No: 201410-0920-024
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 without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/12/2018
	Date Received in OIRA: 02/07/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved
Responses	30	0	0
Time Burden (Hours)	60	0	0
Cost Burden (Dollars)	2,702	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 12/31/2019. 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 66 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:
	82 FR 39787	08/22/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 5103	02/05/2018
Did the Agency receive public comments on this ICR? Yes

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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	n/a	Reporting Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk	n/a	Reporting Severe Adverse Events Associated with Treatment of Latent Tuberculosis Investion (LTBI) - Med Clerk
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician	n/a	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	0	0	30	0	0
Annual Time Burden (Hours)	60	0	0	60	0	0
Annual Cost Burden (Dollars)	2,702	0	0	2,702	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: There are no changes in the burden hour estimates. However the burden cost has been added to this Reinstatement.

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Annual Cost to Federal Government: $32,851

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

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: 02/07/2018

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