Evaluation of Genomic Applications in Practice and Prevention (EGAPP)

Forms and Documents

Document Name	Status
(EGAPP) - General Survey - att D5 Form and Instruction	New
(EGAPP) - Policy Survey - att D4 Form and Instruction	New
(EGAPP) - Purchaser Survey - att D3 Form and Instruction	New
(EGAPP) - Policy Payer survey - att D2 Form and Instruction	New
(EGAPP) - Health Care Providers (att D1) Form and Instruction	New
EGAPP Summary.doc Supporting Statement B	2007-08-13
ATTACHMENT C Intro Letter.doc Supplementary Document	0000-00-00
ATTACHMENT 1 Index of Survey's D 1 thru D5.doc Supplementary Document	0000-00-00
60 Day FINAL.pdf Supplementary Document	0000-00-00
30 Day FINAL.pdf Supplementary Document	0000-00-00
ATTACHMENT B Public Law.doc Supplementary Document	0000-00-00
Summmary State EGAPP. 06BI.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
179077	(EGAPP) - General Survey - att D5 Form and Instruction	New
179076	(EGAPP) - Policy Survey - att D4 Form and Instruction	New
179075	(EGAPP) - Purchaser Survey - att D3 Form and Instruction	New
179074	(EGAPP) - Policy Payer survey - att D2 Form and Instruction	New
179073	(EGAPP) - Health Care Providers (att D1) Form and Instruction	New

ICR Details

OMB Control No: 0920-0751	ICR Reference No: 200703-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Evaluation of Genomic Applications in Practice and Prevention (EGAPP)
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 with change	Conclusion Date: 08/16/2007
	Date Received in OIRA: 03/16/2007
Terms of Clearance: Approved consistent with revisions outlined in CDC memos submitted to OMB and included in the public docket.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved
Responses	2,691	0	0
Time Burden (Hours)	443	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this evaluation research study is to collect information on the value and impact of the EGAPP products developed and disseminated (e.g., evidence reports, EGAPP Working Group recommendations) by surveying members of key stakeholder groups considered by project advisors to have the most immediate need and interest in EGAPP products. The four key stakeholder groups are healthcare providers (e.g., physicians, mid-level practitioners, nurses), healthcare payers and purchasers, policy makers (e.g., medical professional organizations, healthcare policy organizations), as well as targeted consumer groups and website visitors. Four survey distributions will be conducted at intervals of six months. Healthcare providers and payers have expressed interest in evidence-based information on emerging genetic tests, and will receive the first surveys about six months after the release of the first evidence reports and EGAPP Working Group recommendations; healthcare providers and payers will be surveyed again one year later. Policy makers, consumers and healthcare purchasers are likely to identify and be impacted by information developed by EGAPP over a somewhat longer timeline. Therefore, these groups will be the subjects of the second survey distribution, beginning six months after first surveys of healthcare providers and payers; these groups will also be surveyed again one year later. During two specified periods of time one year apart, individuals accessing the EGAPP website will be asked to participate in an EGAPP survey. Keywords: genetic diseases, health care, evidence-based medicine, genetic testing

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health and Welfare-Part A Reseach and Investigations
  

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 36343	06/26/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 5972	02/08/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
(EGAPP) - Health Care Providers (att D1)	None	Health Care Provider Survey
(EGAPP) - Policy Payer survey - att D2	None	D. 2 Policy/Payer Survey
(EGAPP) - Purchaser Survey - att D3	None	Attachment D3 HealthCare Purchaser Survey
(EGAPP) - Policy Survey - att D4	None	D4. Policy Survey
(EGAPP) - General Survey - att D5	None	D5. General Survey

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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	2,691	0	0	2,691	0	0
Annual Time Burden (Hours)	443	0	0	443	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: Recommendations on the development and clinical implementation of safe and effective genetic tests have been produced by advisory panels, professional organizations, and clinical experts since 1995. However, a coordinated process for effectively integrating genetic tests into clinical practice and health policy is still needed.

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Annual Cost to Federal Government: $64,750

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: 03/16/2007

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