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Federal forms, ICRs, and supporting documents

Information Collection Request

THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY

ICR 198401-0920-001 · OMB 0920-0145 · Historical Active

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DocumentTypeStatusAvailability
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IC Document Collections
IC IDCollectionTypeStatusForm
110784 THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY Migrated
ICR Details
0920-0145 198401-0920-001
Historical Active
HHS/CDC
THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/31/1984
Retrieve Notice of Action (NOA) 01/06/1984
THIS COLLECTION IS APPROVED PROVIDING THE FOLLOWING CONDITIONS ARE MET 1.THE FOLLOWING CHANGES ARE MADE IN THE QUESTIONNAIRES: A.RELOCATE ALL QUESTIONS DEALING WITH KNOWLEDGE OF REYE SYNDROME TO THE END OF EACH QUESTIONNAIRE, E.G. QUESTIONS 23-27 IN QUESTION NAIRE 3 AND CORRESPONDING CHANGES IN OTHER QUESTIONNAIRES B.REPHRASE QUESTION 20 IN QUESTIONNAIRE 3 AND CORRESPONDING QUESTIONS IN THE OTHER QUESTIONNAIRES TO SOLICIT INFORMATION ON THE REASONS FOR SELECTING A PARTICULAR MEDICATION C.EXPAND CONTROL QUESTIONNAIRES TO SOLICIT DATA ON RACE AND SEX 2.A SERIOUS EFFORT SHOULD BE MADE TO OBTAIN HOSPITAL AND EMERGENCY ROOM CONTROLS FOR THE CASES IDENTIFIED BY STATE HEALTH DEPARTMENTS. THIS WILL ENABLE HHS TO MAKE THE SAME STATISTICAL COMPARISONS FOR ALL CASES REGARDLESS OF SOURCE OF IDENTIFICATION. 3.HHS SHALL SUBMIT A CLEARANCE REQUEST FOR THE FULL STUDY FOR OMB REVIEW UNDER THE PAPERWORK REDUCTION ACT NO LATER THAN SEPTEMBER 1, 1984. OMB EXPECTS THE FULL STUDY TO BEGIN BY DECEMBER 1, 1984. IOM REVIEW OF THE RESULTS OF THE PILOT STUDY AND RECOMMENDATIONS ON THE FULL STUDY WILL BE CONSIDERED CAREFULLY DURING THE OMB REVIEW. 4.HHS SHALL SHARE EARLIER RESEARCH ON BIAS, RECALL, AND REPORTING METH ODOLOGY SUPPORTIVE OF THAT PROPOSED FOR THE FULL STUDY WITH IOM. 5.HHS SHALL SUBMIT A LIST AND DESCRIPTION OF EACH PHS COLLECTION EX EMPTED FROM OMB REVIEW UNDER THE CLINICAL EXEMPTION SINCE 5/1/83.
  Inventory as of this Action Requested Previously Approved
06/30/1984 06/30/1984
1,800 0 0
2,308 0 0
0 0 0
IN EPIDEMIOLOGIC STUDIES DURING THE PAST 4 YEARS, STATISTICALLY SIGNIFICANT ASSOCIATIONS HAVE BEEN OBSERVED BETWEEN DEVELOPING REYE SYNDROME AND INGESTION OF SALICYLATES DURING THE ANTECEDENT ILLNESS. CONCLUSIONS AND RECOMMENDATIONS FROM THESE STUDIES HAVE BEEN QUESTIONE AND AN HHS TASK FORCE HAS DEVELOPED A STUDY OF REYE SYNDROME CASES AND CONTROLS TO TEST THE NULL HYPOTHESIS THAT THERE IS NO ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATIONS USED DURING THE ANTECEDENT
None
None
No
1
IC Title Form No. Form Name
THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY
  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 1,800 0 0 1,800 0 0
Annual Time Burden (Hours) 2,308 0 0 2,308 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.
01/06/1984