OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201410-0920-024 · OMB 0920-0773 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Physician Form New Available
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Nurse Form New Available
Reporting Severe Adverse Events (Hospitalization or Death) Associated with Treatment of Latent Tuberculosis Infection (LTBI) - Med Clerk Form New Repair queued
IRB Determination 28OCT2014.pdf Supplementary Document Uploaded 2014-10-29 Available
60day FRN.pdf Supplementary Document Uploaded 2014-10-20 Available
Att 1 Authorizing Legislation.docx Supplementary Document Uploaded 2014-10-20 Repair queued
SupportingStatementB 10 14 2014.doc Supporting Statement B Uploaded 2014-10-20 Available
SupportingStatementA 10 14 2014.doc Supporting Statement A Uploaded 2014-10-20 Repair queued
Attachment 8 ConsentForm - NSSAE.doc Supplementary Document Uploaded 2011-10-12 Repair queued
Attachment 3 Guidelines - NSSAE 9 19 2011.doc Supplementary Document Uploaded 2011-10-12 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0773 201410-0920-024
Historical Active 201110-0920-006
HHS/CDC
National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection
Extension without change of a currently approved collection   No
Regular
Approved without change 01/12/2015
Retrieve Notice of Action (NOA) 11/10/2014
  Inventory as of this Action Requested Previously Approved
01/31/2018 36 Months From Approved 01/31/2015
30 0 30
60 0 60
0 0 0
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.
US Code: 42 USC 241 Name of Law: Public Health Services Act
  
None
Not associated with rulemaking
  79 FR 36066 06/25/2014
79 FR 63404 10/23/2014
No
  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.
$40,548
Yes Part B of Supporting Statement
Yes
No
No
No
Uncollected
Jeffrey Zirger 404 639-7118 [email protected]
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/10/2014