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.
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.