Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening

Forms and Documents

Document Name	Status
Form None assigned Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - Case Report Form Form and Instruction	New
Form None assigned Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - State Form Form and Instruction	Modified
30-Day FRN 0920-0641.pdf Supplementary Document	2006-12-14
0920-0641 Attachment 8 Study protocol.doc Supplementary Document	2006-12-12
0920-0641 Attachment 7 Parent Intro Letter and Instructions.doc Supplementary Document	2006-12-12
0920-0641 Attachment 4 Intro Letters.doc Supplementary Document	2006-12-12
0920-0641 Attachment 3 IRB approval.doc Supplementary Document	2006-12-12
0920-0641 Attachment 1 Legal Authority.doc Supplementary Document	2006-12-12
0920-0641 Attachment 2 60day FRN.pdf Supplementary Document	2006-12-12
0920-0641 Supporting Statement 12-12-2006.doc Supporting Statement A	2006-12-12

IC Document Collections

IC ID	Document Title	Status
46570	Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - Case Report Form Form and Instruction	New
37803	Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - State Form Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0641	ICR Reference No: 200612-0920-009
Status: Historical Active	Previous ICR Reference No: 200603-0920-014
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/22/2007
	Date Received in OIRA: 12/28/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2008	12 Months From Approved	03/31/2007
Responses	245	0	217
Time Burden (Hours)	29	0	36
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this data collection is to collect information regarding missed or delayed conditions detected by newborn screening. Assessment will be made of the number of cases of each disorder missed, the reasons for the miss, the health outcome (if available), and identify any possible legal outcomes. The information gleaned from this study may be used to help craft changes in the screening protocols that will make the process more organized and efficient and less likely to fail an affected child. Further, it is not clear that there is a systematic assessment of missed cases on a population basis; this project will seek to identify procedures for routine surveillance of missed cases. The method for data collection will be a questionnaire and telephone follow-up.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Research and Investigations Generally
   PL: Pub.L. 104 - 134 101(d) Name of Law: null
   PL: Pub.L. 104 - 140 1(a) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 54086	09/13/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 75255	12/14/2006
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - State Form	None assigned	0920-0641 Attachment 5 Instructions and State Form
Descriptive Epidemiology of Missed or Delayed Diagnosis for Conditions Detected by Newborn Screening - Case Report Form	None assigned	Attachment 6 Case Report Form

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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	245	217	0	28	0	0
Annual Time Burden (Hours)	29	36	0	-7	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There is a reduction in burden because the program has completed most of the study. The program needs an additional 12 months from the approval date to complete the data collection.

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Annual Cost to Federal Government: $25,675

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: 12/19/2006

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