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 201110-0920-006 · OMB 0920-0773 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
SupportingStatement B .doc Supporting Statement B Uploaded 2011-10-12 Available
Attachment 8 ConsentForm - NSSAE.doc Supplementary Document Uploaded 2011-10-12 Available
Attachment 7 ResearchDetermination- NSSAE.docx Supplementary Document Uploaded 2011-10-12 Available
Attachment 1 Legislation - NSSAE.pdf Supplementary Document Uploaded 2011-10-12 Available
Attachment 3 Guidelines - NSSAE 9 19 2011.doc Supplementary Document Uploaded 2011-10-12 Available
SupportingStatement_Part_A.doc Supporting Statement A Uploaded 2011-11-03 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0773 201110-0920-006
Historical Active 200712-0920-013
HHS/CDC
National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection
Reinstatement with change of a previously approved collection   No
Regular
Approved with change 11/17/2011
Retrieve Notice of Action (NOA) 10/17/2011
  Inventory as of this Action Requested Previously Approved
11/30/2014 36 Months From Approved
30 0 0
60 0 0
0 0 0
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.
PL: Pub.L. 42 - 301 241 Name of Law: Research and Investigation
  
None
Not associated with rulemaking
  76 FR 22399 04/21/2011
76 FR 63924 10/14/2011
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 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
Yes
Miscellaneous Actions
No
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.
$39,478
Yes Part B of Supporting Statement
Yes
No
No
No
Uncollected
Catina Conner 4046394775
  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.
10/17/2011