Medical Monitoring Project

Forms and Documents

Document Name	Status
0920-0740_SupportingStatementB.doc Supporting Statement B	2009-03-18
Attachment10_Informed Consent.doc Supplementary Document	2009-03-13
Attachment8_Consultations.doc Supplementary Document	2009-03-13
Attachment9_Assurance.doc Supplementary Document	2009-03-13
attachment1_legalautho.doc Supplementary Document	2009-03-13
Attachment2_PublicComment.doc Supplementary Document	2009-03-12
Attachment12_ProviSurveyLtrs.doc Supplementary Document	2009-03-12
Attachment11_Model Scripts.doc Supplementary Document	2009-03-12
0920-0740_SupportingStatementA.doc Supporting Statement A	2009-03-18

IC Document Collections

IC ID	Document Title	Status
188680	Physician/Nurse/Practitioner Provider Survey Instruction	New
180569	Patients approached by facility staff for enrollment Instruction	Modified
180568	Facility staff providing patient lists Instruction	Modified
180566	Facility staff Providing Estimated Patient Loads Instruction	Modified
180565	Facility Staff Medical Record Abstraction Instruction	Modified
178498	Patient Short interview Instruction	Modified
178497	Patients Standard Interview Instruction	Modified

ICR Details

OMB Control No: 0920-0740	ICR Reference No: 200904-0920-003
Status: Historical Active	Previous ICR Reference No: 200701-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Medical Monitoring Project
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: 05/29/2009
	Date Received in OIRA: 04/02/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	06/30/2010
Responses	22,334	0	20,894
Time Burden (Hours)	9,603	0	9,123
Cost Burden (Dollars)	0	0	0

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Abstract: The interview and medical record abstraction instruments have been updated since the last submission to OMB based on feedback from project areas participating in the 2007 data collection cycle. Data collection instruments were changed to ensure that interview questions will be easy for respondents to understand, and that data are collected on the medical record abstraction is consistent across all 26 project areas. Interview questions and medical record abstraction fields previously collected were deleted from the instruments. None of the changes to the data collection instruments altered the burdens estimated for the respondents. The Provider Survey is a new data collection and is incorporated as one of the paradigms in the Medical Monitoring Project.

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Authorizing Statute(s): US Code: 42 USC 301 (241.)a. Name of Law: Research and investigations generally
  

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:
	73 FR 32334	06/06/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 10916	03/13/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Facility Staff Medical Record Abstraction
Facility staff Providing Estimated Patient Loads
Patients Standard Interview
Facility staff providing patient lists
Physician/Nurse/Practitioner Provider Survey
Patients approached by facility staff for enrollment
Patient Short interview

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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	22,334	20,894	0	1,440	0	0
Annual Time Burden (Hours)	9,603	9,123	0	480	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: No

Burden Reduction Due to:

Short Statement: Data collection forms were edited- some questions were removed and others were added. Some questions were changed to make them easier for respondents to understand. An additional survey was added, the provider survey

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Annual Cost to Federal Government: $13,714,425

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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)? No

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: 04/02/2009

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