0990-0281 Father Genric Supporting Statement 9.17.21

Supporting Statement for Request for Clearance:

Prevention Communication Formative Research

­

OMB No. 0990-0281

Contact Information:

Jennifer A. Bishop, ScD, MPH

Public Health Educator

Office of Disease Prevention and Health Promotion

Office of the Assistant Secretary for Health

Office of the Secretary/HHS

1101 Wootton Parkway, Suite 420

Rockville, MD 20852

240-453-8626

240-453-8281 (fax)

[email protected]

September 2021

SUPPORTING STATEMENT

PREVENTION COMMUNICATION FORMATIVE RESEARCH

This is a revision of an approved collection of information (OMB No. 0990-0281). According to OMB guidance regarding generic clearance, individual memos explaining the exact methods for information collection will be submitted for each study under this clearance.

Changes in this request include updating the national hourly wage and data collection activities and related burden hours. This request builds on previous formative research approaches to place more emphasis on web-based data collection to allow greater geographical diversity among respondents, to decrease respondent burden, and to save government costs.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Office of Disease Prevention and Health Promotion (ODPHP) is located in the Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS). ODPHP was established by Congress to provide a central focus for stimulating and coordinating federal activities in prevention (Public Law 94-317, National Consumer Health Information and Health Promotion Act of 1976, Section 207, Section 7). Our office focuses on developing and disseminating prevention information to the public. Recent advances in information and communication technologies provide new opportunities for ODPHP to more effectively reach its intended professional and consumer audiences with key information, interactive tools and recommendations about disease prevention, and health promotion, including the benefits of healthy eating, increased physical activity, and patient safety.

In addition to the ODPHP, on occasion this clearance request will provide support for the HHS Office on Women’s Health (OWH). OWH was established in 1991 as part of the Office of the Assistant Secretary for Health within the U.S. Department of Health and Human Services (HHS). OWH was reauthorized in 2010 under Public Law 111–148 section 3509 of the 111th Congress. OWH coordinates women's health efforts across HHS and addresses critical women's health issues by informing and advancing policies, educating health care professionals and consumers, and supporting innovative programs. OWH is mandated to support and maintain the National Women’s Health Information Center— which consists of the Office’s two websites-- Womenshealth.gov and Girlshealth.gov.

New communication opportunities for ODPHP (and OWH) occur against a backdrop of increasingly urgent interest in finding effective ways to communicate health information to America’s diverse population. ODPHP strives to be responsive to the needs of America’s diverse audiences while simultaneously serving all Americans across a range of channels, from print to new communication technologies. To carry out this mandate, ODPHP is committed to conducting formative and usability research to provide guidance on the development and implementation of communication and education efforts. This generic clearance request describes data collection activities involving methods such as: individual interviews, focus groups, web-based surveys and forms, card sorting and various types of usability testing to establish a deeper understanding of the interests and needs of consumers and health professionals for disease prevention and health promotion information and tools.

2. Purpose and Use of Information Collection

This generic clearance request is for a revision to the use of the approved information collection assigned OMB control number 0990-0281. The request describes data collection activities involving a limited set of research activities with consumers and health professionals to better understand their needs and preferences related to disease prevention, health promotion, and women’s health products and initiatives. Specific to ODPHP, the office will use the information collected to improve its communication, products, and services that support key office activities including: Healthy People, Dietary Guidelines for Americans, Physical Activity Guidelines for Americans, MyHealthfinder, the Move Your Way® Campaign, the President’s Council on Sports, Fitness & Nutrition, health literacy and healthy aging. ODPHP communicates through its websites (www.health.gov) and through other channels including social media, print materials, interactive training modules, and reports.

Data collection methods will be qualitative and quantitative and may include in-depth interviews, focus groups, web-based surveys and forms, omnibus surveys, card sorting, and various types of usability testing of materials and interactive tools to assess the public’s understanding of health information, interest in engaging in health promotion activities, responses to prototype materials, and barriers to effective use.

The research methods outlined in this supporting statement have five major purposes:

1. To obtain useful intended audience information for the formation of messages and

materials

2. To further explore messages and materials in contexts that would be most beneficial for intended audiences

3. To identify and verify audience segmentation strategies for providing health information

4. To inform the development and refinement of user-friendly websites and other interactive tools

5. To identify user challenges and obstacles to accessing health information to guide website, material, and interactive tool development and refinement

6. To assess interest from the public in engaging in various health promotional activities

3. Use of Improved Information Technology and Burden Reduction

Remote, web-based testing is a cost-efficient method to obtain quantitative and qualitative input from a greater number of participants who are more representative of the U.S. population. Below is a description of how ODPHP will use technology, when possible, to reduce response burden.

Interviews and focus groups are recorded so that written transcripts of the interviews are available for review. Remote interviews and focus groups may be conducted by telephone or through web conferencing software.

Web-based surveys may be conducted among visitors to health.gov, or through an already existing survey tool (e.g., Qualtrics, Alchemer).

Online and omnibus surveys may be conducted remotely and online through a survey tool such as Qualtrics or Alchemer.

Card sorting is a common method for gaining insights from participants on how to effectively organize a website or online application. In-person card sorting is typically conducted in a one-on-one interview setting with a moderator and note taker. Web-based card sorting allows participants to use a “drag-and-drop” online interface to perform an un-moderated card sort on their own time.

Usability testing can be conducted either in person or remotely using Web conferencing software. The participant’s screen and voice are typically recorded during both in-person and remote sessions so they can be reviewed later for reporting purposes. Usability testing also includes online methods such as tree testing and click testing.

4. Efforts to Identify Duplication and Use of Similar Information

It is not expected that any of the information to be submitted to ODPHP during these formative research studies is duplicative or is already in the possession of the federal government. The proposed generic research will allow ODPHP to significantly improve their ability to develop and refine messages, materials, websites, and interactive tools that will be used by multiple agencies within HHS.

5. Impact on Small Businesses or Other Small Entities

Not applicable.

6. Consequences of Collecting the Information Less Frequently

If this information is not collected, the ability of ODPHP to effectively communicate health information to the American public will be compromised. For example, relatively little is currently known about how to present messages in ways that can maximize how individuals with low health literacy can easily access and comprehend vitally important information about how to protect and promote their health. In addition, the emergence of new technologies requires that agencies conduct prototype testing in order to ensure that technology-based information and tools are easy for the public to use. There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

Various data collection activities may be conducted under the auspices of this request.

Each activity is anticipated to be a one-time collection. This request fully complies with regulations.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A 60-day Federal Register Notice was published in the Federal Register on June 28, 2021, Volume 86, Number 121, pp. 34025-34026. A comments was received from the Academy of Nutrition and Dietetics. Please see the comment and ODPHP’s responses as follows. Correspondence from the Academy of Nutrition and Dietetics was submitted directly to Sherrette Funn on June 28, 2021.

Academy of Nutrition and Dietetics:

Asked for the ICR package, but there were no comments received.

ODPHP Responded:

“Thank you for your interest in the HHS Office of Health Promotion and Disease Prevention’s (ODPHP) data collection activities that were noted in the Federal Register under our Agency Information Collection Request ID: 0990-0281-60D. The published Notice is a request for a blanket clearance which would enable ODPHP to conduct formative research to support its health promotion and communication activities beginning in Fiscal Year 2021. Accordingly, no surveys have been designed to date.”  

This revision was also reviewed by: Frances Bevington, MA, Director, Division of Health Promotion and Communications, Office of Disease Prevention and Health Promotion, HHS.

9. Explanation of Any Payment or Gift to Respondent

Participants will be offered a cash incentive for the time they spent engaged in formative research activities. Amounts and justifications will be determined on an individual project basis. This information will be included in the memo provided to OMB for each formative input session to be conducted.

10. Information Regarding Confidentiality Provided to Respondents

ODPHP and its contractors will follow procedures for assuring and maintaining privacy to the extent allowed by law during all stages of data collection. Respondents will receive information about privacy in an advance letter and again before the information collection sessions begin. Respondents will be informed that all information will be kept private by the research team and that comments will not be associated with their names. There will be no promise of total and absolute confidentiality for individually identifiable information unless there is a firm legal basis for withholding information in the face of a subpoena or court order or other Federal, State, or Local legislation.

Respondents in focus-group sessions will not know each other and will be asked to introduce themselves by first name only. In-person focus-group sessions will be in a room with a closed door so passersby cannot overhear the discussion. In-person research sessions will be scheduled to allow more than enough time between sessions to avoid respondents in different groups seeing each other. All in-person testing will be conducted in a private setting.

At the beginning of each testing session, the facilitator will explain that the respondents’ names and addresses will not be associated with the formative input session results.

11. Justification for Sensitive Questions

No questions will be asked that are of a personal or sensitive nature.

12. Estimates of Annualized Burden Hours and Cost

1. Burden Hours

The total annual estimated burden imposed by this collection of information is 9,975 hours over a 3-year period.

Type of Respondent	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Consumers (screening & omnibus survey)	7725	1	10/60	1287.5
Consumers (qualitative testing)	1250	1	1	1250
Consumers (focus groups)	575	1	1.5	862.5
Consumers (screening & intercepts)	35250	1	5/60	2937.5
Consumers (survey)	10000	1	15/60	2500
Consumers (gatekeeper reviews)	325	1	30/60	162.5
Consumers (cognitive tests)	50	1	2	100
Health care professionals (screening)	1350	1	10/60	225
Health care professionals (interview)	50	1	1	50
Health care professionals (focus group)	400	1	1.5	600
Total				9,975

2. Burden Cost (average hourly rate)

Type of Respondent	Total Burden Hours	Hourly Wage Rate Respondent	Respondent Cost
Consumers (screening)	1287.5	$27.07	$34,852.63
Consumers (qualitative testing)	1250	$27.07	$33,837.50
Consumers (focus groups)	862.5	$27.07	$23,347.88
Consumers (screening & intercepts)	2937.5	$27.07	$79,518.13
Consumers (survey)	2500	$27.07	$67,675.00
Consumers (gatekeeper reviews)	162.5	$27.07	$4,398.88
Consumers (cognitive tests)	100	$27.07	$2,707.00
Health care professionals (screening)	225	$41.30	$9,292.50
Health care professionals (interview)	50	$41.30	$2,065.00
Health care professionals (focus group)	600	$41.30	$24,780.00
Total			$282,474.50

The $27.07 hourly wage rate for consumers/general public is derived from the U.S. Department of Labor, Bureau of Labor Statistics May 2020 report “National Occupational Employment and Wage Estimates United States”¹. The $41.30 hourly wage rate for health care professionals is based on the U.S. Department of Labor, Bureau of Labor Statistics May 2020 report “National Occupational Employment and Wage Estimates United States” for Healthcare Practitioners and Technical Occupations. The total estimated cost for this information collection for 9,975 hours of reporting time is $282,474.50.

The number of respondents and length of response was determined on the basis of other HHS agency’s prior experience with communications testing and an estimate of the market research needs. The actual numbers will vary depending upon the topic of interest.

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There will be no new annual capital or maintenance costs to the respondent as a result of this data collection.

14. Annualized Cost to the Government

ODPHP may incur the following estimated costs annually in setting up testing environments and collecting and summarizing data:

• Developing study protocols: $50,000

• Developing study stimulus materials: $30,000

• Moderators and usability experts to conduct research: $15,000

• Study participant recruitment: $20,000

• Meeting space for data collection: $15,000

• Study participant stipends: $15,000

• Data summary and reports: $70,000

Estimated Annualized Cost to Government: $215,000

15. Explanation for Program Changes or Adjustments

ODPHP is proposing the following program changes:

1. Revise purpose and justification to reflect office initiatives and priorities for the next 3 years.

2. Increase estimated hourly rate of respondents due to cost of living increases.

3. Some data collection efforts are no longer needed.

16. Plans for Tabulation and Publication and Project Time Schedule

There are no tabulated results for this information collection.

No complex or analytical techniques will be used for the results of the collection of information. Findings from all data collection will be included in individual summary reports. The reports will describe the testing methods, findings, conclusions, implications, and recommendations for use in development and refinement of disease prevention and health promotion messages, materials, and tools. There will be no specific quantitative analysis of data. No attempt will be made to generalize the findings to be nationally representative.

17. Reason(s) Display of OMB Expiration Date Is Inappropriate

Expiration date display exemption is not requested.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

The data encompassed by the projects discussed in this supporting statement will fully comply with all guidelines of 5 CFR 1320.9. No exception is requested to certification for Paperwork Reduction Act Submission.

B. Collection of Information Employing Statistical Methods

Information will not be collected requiring statistical analysis employing statistical methods.

APPENDICES

1. OMB Burden Hours Statement

2. 60 Day Federal Register Notice

3. Collection of Information Employing Statistical Methods

Appendix A

APPENDIX A: 0990-0281

Burden Hours

The total annual estimated burden imposed by this collection of information is 9,975 over a 3-year period.

Data Collection Task	Instrument/	# of Respondents	# Responses/ respondent	Average Burden/ Response (in hours)	Total Response Burden (in hours)
	Form Name
In-depth interviews	Screener	1500	1	10/60	250
	Interview	500	1	1.00	500
Focus groups	Screener	2925	1	10/60	487.5
	Focus Group	975	1	1.50	1462.5
Intercept interviews	Interview	5250	1	5/60	437.50
Cognitive testing of instruments	Screener	150	1	10/60	25
	Cognitive Test	50	1	2.00	100
Web-based surveys	Screener	30000	1	5/60	2500
	Survey	10000	1	15/60	2500
Omnibus surveys	Survey	2100	1	10/60	350
Gatekeeper reviews	Review	325	1	30/60	162.5
Card sorting	Screener	600	1	10/60	100
	Card Sort	200	1	1.00	200
Usability and prototype testing of materials (print and web)	Screener	1800	1	10/60	300
	Usability Test	600	1	1.00	600
TOTAL					9,975.00

APPENDIX B:

APPENDIX B: 0990-0281

Billing code: 4150-32

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0281]

Agency Information Collection Request. 60-Day Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

DATES: Comments on the ICR must be received on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].

ADDRESSES: Submit your comments to [email protected] or by calling (202) 795-7714.

FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference, to Sherrette A. Funn, email: [email protected], or call (202) 795-7714 the Reports Clearance Officer.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collection: Prevention Communication Formative Research

Type of Collection: Revision

OMB No.: 0990-0281

Abstract: The Office of Disease Prevention and Health Promotion (ODPHP) is focused on developing and disseminating health information to the public. ODPHP faces an increasingly urgent interest in finding effective ways to communicate health information to America’s diverse population. ODPHP strives to be responsive to the needs of America’s diverse audiences while simultaneously serving all Americans across a range of channels, from print to new communication technologies. To carry out prevention information efforts, ODPHP is committed to conducting formative and usability research to provide guidance on the development and implementation of their communication and education efforts. The information collected will be used to improve communication, products, and services that support key office activities including: Healthy People, Dietary Guidelines for Americans, Physical Activity Guidelines for Americans, the Move Your Way Campaign and the President’s Council on Sports, Fitness & Nutrition. ODPHP communicates through its website (www.health.gov) and through other channels including social media, print materials, interactive training modules, and reports. Data collection will be qualitative and quantitative and may include in-depth interviews, focus groups, web-based surveys, omnibus surveys, card sorting, and various forms of usability testing of materials and interactive tools to assess the public’s understanding of disease prevention and health promotion content, responses to prototype materials, and barriers to effective use.

The program is requesting a 3-year extension of the clearance.

Annualized Burden Hour Table

Forms (If necessary)	Number of Respondents	Number of Responses per Respondents	Average Burden per Response	Total Burden Hours
In-depth interviews-Screener	1,500	1	10/60	250
In-depth interviews-Instrument	500	1	1.00	500
Focus groups—Screener	2,925	1	10/60	487.5
Focus groups-- Instrument	975	1	1.50	1,462.5
Intercept interviews	5,250	1	5/60	437.50
Cognitive testing of instruments--Screener	150	1	10/60	25
Cognitive testing of instruments—Cognitive test	50	1	2.00	100
Web-based surveys--Screener	30,000	1	5/60	2,500
Web-based surveys-- Survey	10,000	1	15/60	2,500
Omnibus surveys	2,100	1	10/60	350
Gatekeeper reviews	325	1	30/60	162.5
Card sorting—Screener	600	1	10/60	100
Card sorting—Card sort	200	1	1.00	200
Usability and prototype testing of materials (print and web)—Screener	1,800	1	10/60	300
Usability and prototype testing of materials (print and web)— usability tests	600	1	1.00	600
Total				9,975.00

Sherrette A. Funn,

Paperwork Reduction Act Reports Clearance Officer,

Office of the Secretary.

APPENDIX C

APPENDIX C: 0990-0281

Collection of Information Employing Statistical Methods

Due to the nature of the research proposed, information will not be collected requiring statistical analysis employing statistical methods.

1. Respondent Universe and Sampling Methods

A large majority of research proposed in this clearance request will utilize a convenience sample. ODPHP will partner with community organizations and other health care organizations to recruit a sample that meets the demographic characteristics of target audiences. When needed, ODPHP will use a recruitment firm to recruit participants from their databases who meet specific screening criteria.

2. Procedures for the Collection of Information

Information will not be collected requiring statistical analysis employing statistical methods.

3. Methods to Maximize Response Rates and Deal with Nonresponse

ODPHP will not conduct mail or phone-based surveys, which cuts down on nonresponse issues. As mentioned above, a majority of the research will be done with a convenience sample, and ODPHP will recruit participants interested in the subject matter. ODPHP will offer a small token of appreciation to participants. In the past, ODPHP has had a very low ‘no show’ rate of 10% on average.

4. Tests of Procedures of Methods to Be Undertaken

ODPHP often pre-tests focus group, interview, and survey questions with fewer than 10 participants to make sure the questions and concepts are understandable. These pre-tests are done before submitting the memo to OMB for each formative input session.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

ODPHP uses a number of contracting firms to conduct formative research. Contractors are chosen for research projects on a competitive basis. Specific names and contact information of contractors who will design, collect, and analyze data will be included in the memo provided to OMB for each formative input session to be conducted.

1 See https://www.bls.gov/oes/current/oes_nat.htm.

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