THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY

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
110784	THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY	Migrated

ICR Details

OMB Control No: 0920-0145	ICR Reference No: 198401-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/31/1984
	Date Received in OIRA: 01/06/1984
Terms of Clearance: 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
Expiration Date	06/30/1984	06/30/1984
Responses	1,800	0	0
Time Burden (Hours)	2,308	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
THE POSSIBLE ASSOCIATION BETWEEN REYE SYNDROME AND MEDICATION - PILOT STUDY

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/06/1984

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