POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION

ICR 198409-0920-003

OMB: 0920-0163

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
110807
Migrated
ICR Details
0920-0163 198409-0920-003
Historical Active
HHS/CDC
POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/07/1984
Retrieve Notice of Action (NOA) 09/10/1984
THIS REQUEST FOR CLEARANCE IS APPROVED PROVIDING THE STUDY DESIGN AND ANALYTICAL PLAN ARE MODIFIED AS FOLLOWS: 1. PRIOR TO ANALYZING THE DATA, CDC SHALL DEVELOP A SEVERITY INDEX OF THE ANTECEDENT ILLNESSES, AND WELL DEFINED CRITERIA FOR DETER MINING THE ONSET OF REYES SYNDROME. BOTH THE INDEX AND CRITERIA SHALL BE REVIEWED BY THE INSTITUTE OF MEDICINE PRIOR TO APPLICATION OF THE STUDY. 2. THE STATISTICAL TESTS AND ESTIMATES WILL BE CALCULATED AT THE CONCLUSION OF THE TWO YEAR STUDY PERIOD ON ALL THE DATA IN ORDER TO INSURE THAT THE FINAL RESULTS WILL HAVE THE 90 PERCENT POWER OF DETECTING A RELATIVE RISK OF 4.0 AS PROPOSED BY CDC. CDC HAS NOT DEMONSTRATED THAT THE MIDPOINT ANALYSIS WILL HAVE THE DESIRED POWER, ANND THEREFORE, SUCH AN INTERIM ANALYSIS COULD SERIOUSLY LOWER THE LIKLIHOOD OF DETECTING A POSITIVE ASSOCIATION BETWEEN USE OF MEDICATION AND REYES SYNDROME AT THE FINAL DATA ANALYSIS STAGE THEREBY DIMINISHING THE PRACTICAL UTILITY OF THE STUDY. AN INTERIM ANALYSIS MAY BE CONDUCTED AFTER CDC HAS DEMONSTRATED THAT THE FINAL EXPECTED POWER REMAINS AT OR ABOVE 90 PERCENT. 3. WHERE THERE IS ANY RISK AT ALL OF DETERIORATION OF THE CASES CONDITION, THE INTERVIEW OF THE CARE PROVIDER MUST NOT BE DELAYED. 4. BY SEPTEMBER 1985, HHS/CDC SHALL SUBMIT A DETAILED DATA ANALYSIS PLAN TO THE INSTITUTE OF MEDICINE FOR REVIEW BY IOM.
  Inventory as of this Action Requested Previously Approved
05/31/1986 05/31/1986
1,350 0 0
1,581 0 0
0 0 0

THIS PROPOSED STUDY WILL EXAMINE THE POSSIBLE RELATIONSHIP BETWEEN REY SYNDROME AND SALICYLATES. THE INFORMATION DERVIED WILL BE USED FOR DECISIONS RELATED TO RECOMMENDATIONS AND WARNINGS REGARDING THE USE OF MEDICATIONS FOR SAFELY TREATING CHILDHOOD ILLNESSES. PAREN OR GUARDIANS OF CASES AND CONTROLS WILL BE INTERVIEWED CONCERNING MEDICATIONS TAKEN, SYMPTOMS AND CONDITIONS DURING ILLNESS.

None
None


No

1
IC Title Form No. Form Name
POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION

  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 1,350 0 0 1,350 0 0
Annual Time Burden (Hours) 1,581 0 0 1,581 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
09/10/1984


© 2024 OMB.report | Privacy Policy