Comprehensive Communication Campaign for HITECH ACT

Forms and Documents

Document Name	Status
Generic Statement B Communication Campaign REV 6 22.DOCX Supporting Statement B	2011-06-27
Generic Statement A Communication Campaign REV 6 22.DOCX Supporting Statement A	2011-06-27

IC Document Collections

IC ID	Document Title	Status
202204	mHealth Privacy and Security Consumer Research Focus Group Other-survey	New
201817	eConsent Administer Focus Group Sessions Across Patient Population Other-Focus Group Script	New
200924	Survey Respondents Other-survey	New
200902	eConsent surveys Other-survey	New
200676	mHealth focus groups Other-survey	New
200298	Conduct Cognitive Testing of Test Survey Questions Other-testing	New
198466	Conduct Focus Groups to Test Messages and Materials Other-study	New

ICR Details

OMB Control No: 0990-0376	ICR Reference No: 201106-0990-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Comprehensive Communication Campaign for HITECH ACT
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: 07/01/2011
	Date Received in OIRA: 06/27/2011
Terms of Clearance: This generic clearance for ONC developmental research associated with the development of communication strategies is approved for 3-years under the following conditions: (1) For individual projects, ONC shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, number of focus groups, justification for any proposed incentive, and estimated burden); (b) all instruments (including participant screeners and moderator guides), and c) any other information that will go to the public (e.g., recruitment flyers). (2) OMB endeavors to respond with clearance or questions within 10 working days.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved
Responses	34,366	0	0
Time Burden (Hours)	6,928	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: ONC requests OMB approval for a generic clearance for collecting information through a variety of research methods for developing and testing communications involving health information technology and health information privacy. This information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages. ONC intends to utilize best practices for effective health communication research set forth by other DHHS agencies such as the National Cancer Institute.

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Authorizing Statute(s): EO: EO 13335 Name/Subject of EO: Office of the National Coordinator for Health Information Technology
   EO: EO 13335 Name/Subject of EO: Health Information Technology for Economic and Clinical Health Act
   US Code: 42 USC 3011a Name of Law: Public Health Service Act
   US Code: 42 USC 13301 Name of Law: HITECH Act
  

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:
	75 FR 19974	04/16/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 28986	05/19/2011
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
mHealth focus groups
Conduct Cognitive Testing of Test Survey Questions
Conduct Focus Groups to Test Messages and Materials
Survey Respondents
eConsent surveys
eConsent Administer Focus Group Sessions Across Patient Population
mHealth Privacy and Security Consumer Research Focus Group

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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	34,366	0	0	34,366	0	0
Annual Time Burden (Hours)	6,928	0	0	6,928	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: New collections

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Annual Cost to Federal Government: $629,708

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? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 06/27/2011

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