0523 generic 2015Supporting Statement_Rev 091616

Supporting Statement for

“GenERIC CLEARANCE

FOR THE DEVELOPMENT OF Nutrition education messages

and Resources for the general public”

Colette Rihane, Director, Office of Nutrition Guidance and Analysis

Center for Nutrition Policy and Promotion

Food, Nutrition and Consumer Services

United States Department of Agriculture

3101 Park Center Drive, Room 1034

Alexandria, VA 22302

703-305-7600 (office)

703-305-3300 (fax)

E:Mail: [email protected]

TABLE of CONTENTS

Chapter Page

1. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary 4

2. Purpose and Use of the Information 8

3. Use of Information Technology and Burden Reduction 10

4. Efforts to Identify Duplication and Use of Similar Information 10

5. Impacts on Small Businesses or Other Small Entities 11

6. Consequences of Collecting the Information Less Frequently 11

7. Special Circumstances Relating to the Guideline of 5 CFR 1320.5 12

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

Outside Agency 12

9. Explanation of Any Payment or Gift to Respondents 15

10. Assurance of Confidentiality Provided to Respondents 15

11. Justification for Sensitive Questions 16

12. Estimates of Hour Burden Including Annualized Hourly Costs 16

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 17

14. Annualized Cost to the Federal Government 17

15. Explanation for Program Changes or Adjustments 18

16. Plans for Tabulation and Publication and Project Time Schedule 18

17. Reason(s) that Display of OMB Expiration Date is Inappropriate 18

18. Exceptions to the Certification Statement for Paperwork Reduction Act Submissions 19

2. Collections of Information Employing Statistical Methods N/A

3. appendices

APPENDIX 1 Public Comments

APPENDIX 2 OMB Burden Statement/Sample Participant Screener

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

Delegated Authority and Mission of the Center for Nutrition Policy and Promotion

This is an extension of a currently approved data collection. The title of this information collection package has changed from: Generic Clearance for the Development of Nutrition Education Messages and Products for the General Public to Generic Clearance for the Development of Nutrition Education Messages and Resources for the General Public.

The Center for Nutrition Policy and Promotion (CNPP) of the U.S. Department of Agriculture (USDA) conducts consumer research to identify key issues of concern related to the understanding and use of the Dietary Guidelines for Americans (Dietary Guidelines or Guidelines), as well as the tools and resources used to implement the Dietary Guidelines (SuperTracker Information Collection for Registration, Login, & Food Intake and Physical Activity Assessment, OMB 0584-0535 exp. October 31, 2018). The Dietary Guidelines, a primary source of dietary health information, are issued jointly by the USDA and Health and Human Services (HHS) and serve as the cornerstone of Federal nutrition policy and form the basis for nutrition education efforts (nutrition messaging and development of consumer materials) of these agencies. After the release of the 2010 Dietary Guidelines a communication initiative built around USDA’s new MyPlate icon, including the resources at ChooseMyPlate.gov, was launched. MyPlate is a visual cue supported by Dietary Guidelines messages to help consumers make better food choices. It illustrates the five food groups, but uses a familiar mealtime visual, a place setting, to prompt Americans to eat more healthfully. Information collected from consumer research will be used in further development of Dietary Guidelines and messages supporting MyPlate and related resources. USDA jointly works with HHS in developing Dietary Guidelines each revision cycle for producing updated and/or new Guidance every five years. New messages and resources (on-line and print) are developed to support the Dietary Guidelines for Americans.

These may include:

1. Messages and resources related to the latest Dietary Guidelines that help consumers make healthier food and physical activity choices;

2. Additions and enhancements to the ChooseMyPlate.gov website nutrition and physical activity messaging and related materials;

3. Materials relaying the latest Dietary Guidelines and messages supporting MyPlate for special population groups; and

4. New policy, messages, resources, and tools that might be developed as a result of the most current Dietary Guidelines revisions.

CNPP works to improve the health and well-being of Americans by developing and promoting dietary guidance that links scientific research to the nutrition needs of consumers.

CNPP has among its major functions the development and coordination of nutrition policy within USDA and is involved in the investigation of techniques for effective nutrition communication. Under Subtitle D of the National Agriculture Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3171-3175), the Secretary of Agriculture is required to develop and implement a national food and human nutrition research and extension program, including the development of techniques to assist consumers in selecting food that supplies a nutritionally adequate diet. Pursuant to 7 CFR 2.19(a)(3), the Secretary of Agriculture has delegated authority to CNPP for, among other things, developing materials to aid the public in selecting food for good nutrition; coordinating nutrition education promotion and professional education projects within the Department; and consulting with the Federal and State agencies, the Congress, universities, and other public and private organizations and the general public regarding food consumption and dietary adequacy.

The National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341), requires the Secretaries of Agriculture and Health and Human Services to publish jointly every 5 years a report entitled, the Dietary Guidelines for Americans. The intent is to provide advice for healthy Americans ages two years and over about food choices that help promote health and prevent disease. USDA’s MyPlate icon is supported by a robust education program to assist Americans in selecting foods for a dietary pattern that meets Dietary Guidelines recommendations. Ensuring that MyPlate resources and related tools are useful to intended audiences and that the food pattern recommendations continue to be scientifically sound, appropriate, and useful to the public is critical to CNPP’s mission and is a major activity included in its 5-year strategic plan in fulfillment of the Government Performance and Results Act of 1993 (31 U.S.C. 9701).

Justification for data collection

The approval of information collection is necessary to obtain input into the development of educational messages and materials in support of the Dietary Guidelines and the messages and resources supporting the MyPlate icon, which will target the general public.

This clearance request describes data collection activities related to obtaining consumer feedback via various avenues which could include a limited set of focus groups, qualitative interviews, ethnographic studies, Web-based surveys, or other forms of gathering information based on availability of emerging technologies. Consumer feedback on clarity, understandability, and acceptability of messages and materials related to MyPlate and other healthy eating content during the product development stage will be gathered. Other types of activities could be related to Market Research (segmentation, trends, etc.) performed through environmental scans, customer analysis, competitor analysis, and reach or impact analysis. According to OMB guidance regarding generic clearance, individual memos explaining the exact method for information collection will be submitted as well as copies of the tools or instruments to be used in gathering the data.

Every five years the Dietary Guidelines are revised based on the evaluation of any new scientific information that might be available related to nutrition, health, diet and food consumption patterns. A simultaneous evaluation of resources and tools to implement and communicate the Guidelines takes place in order to ensure that nutritional goals remain accurate and that consumers are being provided with useful advice.

An essential part of the reassessment process is to conduct formative research with consumers to examine their understanding of Dietary Guidelines concepts and concepts supporting MyPlate, as well as barriers to using them. Some of the information collected will attempt to answer questions about how Americans use health information to help them make food and activity choices—for example, how individuals perceive and understand dietary guidance and physical activity messages, and whether and how they use these messages to make decisions about food and physical activity choices in the food environment. Information is also needed for different audiences, based on various income levels, marital status, education level, race/ethnicity, gender, age, activity levels and desires for weight loss to determine if particular messages are more readily understood and useful, and the context for such, so that guidance can be tailored to meet various population’s needs.

CNPP believes that obtaining information that is formative from consumers is fundamentally necessary for reassessing and revising the Dietary Guidelines and updating Guidelines implementation and communications approaches. Formative research is particularly useful for gaining insights and a better understanding of the target audience. Without this data from consumers, CNPP would not be able to incorporate useful messages and materials for the intended audience in any proposed revision of these guidance pieces. Formative research consists of qualitative techniques, such as open-ended structured discussions or interviews with individuals or small groups of individuals, and most often includes ethnographic studies, depth interviews, Wed-based collections, as well as focus groups., or .

As part of its commitment to advancing dietary and physical activity guidance in a way that motivates behavior change, CNPP plans to continue its implementation of nutrition and physical activity recommendations based on the Dietary Guidelines while developing resources and tools to continue to support various audiences through www.choosemyplate.gov . The key is for all messages to be simple, clear and actionable, in order to help improve the health of all Americans.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

This revised formative input and feedback information collected will assist CNPP in its efforts to develop practical and meaningful nutrition and physical activity guidance and communication efforts for Americans to help improve their health. The primary users of the research results will be CNPP and FNS programs, State agencies, and other Federal agencies tasked with developing and using practical and meaningful nutrition and physical activity guidance resources for empowering American consumers.

The primary goal of information collection (through consumer focus groups, qualitative interviews, ethnographic studies, Web-based surveys, etc.) will be to expand the knowledge base about how theGuidelines recommendations and messages supporting MyPlate are understood and how they can be used by consumers to improve the balance of their food intake with physical energy expenditure for good health. Focus groups have been used in the Dietary Guidelines revision process since 1995. Focus groups and usability testing were used in the development of Dietary Guidelines implementation tools including the original 1992 Food Guide Pyramid, and the 2005 MyPyramid educational messages and materials. More recently, focus groups and surveys were conducted in designing and developing the MyPlate icon and related resources at www.choosemyplate.gov.

To gather deeper insights into daily eating decisions and behaviors, CNPP hopes to utilize an anthropological approach called journaling, which asks participants to record certain aspects of their daily experiences over the course of days or weeks. During the allotted timeframe, participants will be probed or questioned by the researcher to gather real time feedback about their decision-making and its relation to the participant’s knowledge and attitudes. Afterwards, CNPP would like to hold small in depth follow-up discussions with a subset of participants completing the journaling exercise to better understand their responses.

More information is needed about changing behavior related to nutrition and physical activity, including a better understanding of target audience perceptions and potential motivators and barriers for changing dietary and physical activity habits. More information is also needed about responses to message concepts and reactions to nutrition and physical activity education materials. All of this will be helpful in presenting messages that are targeted to various audiences.

The approval of this information collection is necessary for USDA to develop a communications and audience outreach strategy that consumers not only find relevant, but are also designed to accurately reflect the everyday decisions today’s consumers face when making choices about nutrition and health.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also, describe any consideration of using information technology to reduce burden.

CNPP is committed to complying with the E-Government Act of 2002, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

CNPP is aware and will submit any websites and/or screenshots associated with generic clearance 0584-0523 during ancillary information collection requests. Collecting information during website development or various materials development may be accomplished via computers. Focus group discussions and interviews may be video or audio taped and transcribed to maximize access to detail.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose described in item 2 above.

There may be similar data collections; however, those do not meet our needs. This information collection also builds on prior research efforts. CNPP may modify previous research efforts to ensure that previous results remain relevant to specific audiences. Focus groups were used in the Dietary Guidelines revision process for the years 1995, 2000, 2005, 2010, and were or will also be used for 2015-2020. Focus groups and usability testing were used in the development of Dietary Guidelines implementation tools including the original 1992 Food Guide Pyramid, and the 2005 MyPyramid educational messages and materials. In 2010, focus groups and surveys were conducted in designing and developing the MyPlate icon and related resources at www.choosemyplate.gov. Information that continues to be collected may include previous messages and products that help general consumers make healthier food and physical activity choices, provide additions and enhancements to www.choosemyplate.gov, and help develop resources for special population groups that might be identified. The possibility for developing new messages, materials, and tools also exists with revised or new recommendations in future Dietary Guidelines.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

There will be no impact on small businesses or other small entities. No small businesses will be involved in this information collection request.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

This is an ongoing data collection. If this information is not collected, USDA’s ability to incorporate messages and materials that are practical, meaningful, and relevant for the intended audience in any proposed update of the Guidelines or related resources at Choosemyplate.gov will be impaired. The National Nutrition Monitoring and Related Research Act of 1990 requires the publication of a report entitled Dietary Guidelines for Americans that shall contain dietary information and guidance for the general public and that shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health programs. The MyPlate icon is supported by nutrition education efforts designed to empower Americans in making healthy food choices that are consistent with the Dietary Guidelines. Collection of data is a critical element of assessing effective methods of translating the Dietary Guidelines to ensure that its recommendations and messages continue to be scientifically sound, understood, and actionable by the public. CNPP would not be able to carry out this critical element of its mission if these data were not collected.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

• requiring respondents to report information to the agency more often than quarterly;

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any document;

• requiring respondents to retain records, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

• in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances. The collection of information is conducted in a manner consistent with the guidelines in 5 CFR 1320.5.

8. a. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments.

The Department of Agriculture - Center for Nutrition Policy and Promotion; Agency Information Collection Activities; Proposed Collection; Comment Request--Generic Clearance for the Development of Nutrition Education Messages and Products for the General Public 60-day Federal Register Notice was published on August 25, 2015 on pages 51531-51532 of the Federal Register, Vol. 80, No. 164. Ten comments were received and are included in Appendix 1. Most of the comments supported data collection activities to advance nutrition education efforts related to the Guidelines. These comments offered advice or opinions about the following:

• Three of the comments offered favorable support for the information collection and a request for more resources that reflect the most relevant version of the Dietary Guidelines for Americans. The comment submissions also encouraged CNPP to expand its catalog to provide additional materials that reflect a healthful, overall dietary pattern.

• Three of the comments offered evidence, suggested messages, or market data to support the addition of water to the current MyPlate icon. Comments included a suggested design to show water as part of the overall visual.

• One of the comments was interested in partnering with CNPP to conduct any planned research and offered a description of the work it has done to reach relevant audiences.

• One of the comments requested that CNPP use the words enriched rather than refined in promoting grains among consumers.

• One comment requested that CNPP observe methods that enhance message effectiveness and consider the diverse audiences that utilize the Dietary Guidelines for Americans.

• One of the ten comments was negative and only offered discontent with farming and agriculture. No substantive information was included in this comment.

b. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported.

The following is a list of Federal staff that serve as Agency representatives to the Dietary Guidance Review Committee, which is led and supported by representatives in USDA and HHS.  These individuals serve as consultants when reviewing messages and materials that are being developed for the American public to ensure that they are consistent with the current Dietary Guidelines for Americans. Individuals also provide technical expertise as it relates to Agency specific work they are involved in, i.e., nutrient content of foods, food safety issues, labeling regulations, plain language, to name a few. For some reviews, all individuals may be involved and at other times the review of materials is tailored to the specific focus of the material. Involvement of consumer message testing is handled in the same manner.

HHS Members

Holly McPeak, MS (Co-Chair)

Nutrition Advisor

HHS/OPHS/ODPHP

Vincent DeJesus

Nutritionist

HHS/FDA

Holly Greuling, RD, LDN

National Nutritionist

HHS/ACL

Rachel Fisher, MS, MPH, RD

Program Analyst

NIH, DNRC

Leah Maynard, PhD

Epidemiologist

HHS/CDC/DNPAO

Lisa Martin, MA, RD, CDE

Nutritionist/Diabetes Coordinator

HHS/IHS

Ursuline Singleton, MPH, RD

Public Health Advisor

HHS/OWH/OASH

Denise Sofka, MPH, RD

Senior Program Analyst

HHS/HRSA

USDA Members

Colette Rihane, MS, RD (Co-Chair)

Director, Office of Nutrition Guidance and Analysis

USDA/FNCS/CNPP

Elizabeth Rahavi, RD (Agency Representative)

Nutritionist

USDA/FNCS/CNPP

Deirdra Chester, PhD, RD

National Program Leader, Division of Nutrition

USDA/NIFA

Wendy Davis

Nutrition and Food Safety Program Leader

USDA/ARS/NAL

Joanne Guthrie, PhD, MPH, RD

Food Economics Division

USDA/ERS

Tina Hanes

Technical Information Specialist

USDA/FSIS-Office of Public Affairs & Consumer Education

David Klurfeld, PhD

National Program Leader, Human Nutrition

USDA/ARS /NPS

Cheryl Lewis, MPA, RD, LDN

Director, Nutrition Promotion & Technical Assistance Division

USDA/FNS/CND

Laura Walter, MPH, RD

Nutritionist

USDA/AMS

8. Explain any decision to provide any payment or gift to respondents, other than reenumeration of contractors or grantees.

Focus group and selected in-person interview participants may receive a gift card incentive intended to reimburse for expenses such as transportation and childcare costs. Amounts and justifications will be determined on an individual project basis associated with this generic clearance request. This information will be included in the information collection request (ICR) memo provided to OMB for each supplemental information collection request submitted under this generic clearance.

8. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

CNPP and contractors will follow procedures for maintaining safeguards consistent with the Privacy Act during all stages of data collection. A system of record notice (SORN) titled FNS-8 USDA/FNS Studies and Reports in the Federal Register on March 31, 2000, Volume 65, Number 63, and is located on pages 17251-17252 discusses the terms of protections that will be provided to respondents. Exact procedures will be explained in each supplemental information collection request. This information will be included in the memo provided to OMB for each formative input session to be conducted. Respondents will receive information about privacy and safeguards in an advance letter or during the telephone screening process and again before the information collection sessions begin. Respondents will be informed that all information will be kept private and will not be disclosed to anyone but the researchers conducting this investigation, except as otherwise required by law. The release form for the focus groups will cite the Privacy Act.

Respondents in focus group sessions will not know each other and will be asked to introduce themselves by first name only. The focus group sessions will be in a room with a closed door so passers-by cannot eavesdrop on the discussion. Focus group sessions will be timed to allow more than enough time between sessions to avoid respondents in different groups seeing each other. Individual interviews will be conducted in a private setting.

At the beginning of focus group sessions, individual interview sessions and prototype testing sessions, the facilitator will explain that the respondents’ names and addresses will never be associated with the formative input session results.

8. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

Information collection will not involve questions of a sensitive nature.

8. Provide estimates of the hour burden of the collection of information. The statement should:

Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

Testing Instrument	Estimated Number of Individual Respondents	Number of Responses per Respondent	Estimated Time per Response in Hours	Estimated Total Annual Responses per respondent	Estimated Total Annual Burden in Hours
Focus Group Screeners	7,500	1	.25	7,500	1,875
Interview Screeners	7,500	1	.25	7,500	1,875
Focus Groups	500	1	2	500	1,000
Journaling	500	14	.25	7000	1,750
Interviews	500	1	1	500	500
Web-based Collections	20,000	1	.25	20,000	5,000
Consent Form	21,000	1	.08	21,000	1,753.50
Total	57,500		32	57,500	13,753.50

The total estimated annual burden is 13,753.50 hours. Current estimates are based on both historical numbers of respondents from past projects as well as projections for projects to be conducted in the next three years.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

Testing Instrument	Total Burden Hrs	Hourly Rate ($)	Total Cost ($)
Focus Group Screeners	1875.00	$25.09*	47,043.75
Interview Screeners	1,875	$25.09	47,043.75
Focus Groups	1,000	$25.09	25,090.00
Journaling	1,750	$25.09	43,907.50
Interviews	500	$25.09	12,545.00
Web-based Collections	5,000	$25.09	125,450.00
Consent Form	1,753.50	$25.09	43,995.32
Total	13,753.50	$25.09	345,075.32

*$25.09 hourly rate is derived from the U.S. Department of Labor, Bureau of Labor Statistics, September 2015. See http://www.bls.gov/news.release/pdf/empsit.pdf

8. Provide estimates of the total annual cost burden to respondents or record keepers resulting from the collection of information, (do not include the cost of any hour burden shown in items 12 and 14). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

There are no capital/start-up or ongoing operation/maintenance costs associated with this information collection.

8. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

The Agency incurs costs in setting up testing environments to include such things as hiring contractors, facilitators or moderators, renting meeting space, in providing cash incentives, etc. Costs will be determined on an individual project basis and will be included in the memo provided to OMB for each formative input session to be conducted.

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

This is an extension of a currently approved information collection request. The current burden inventory remains unchanged at 12,003.50 although newly developed instruments will be used for nutrition education efforts.

15. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

No complex 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 submitted to CNPP. The reports will describe the focus group and interview testing methods, findings, conclusions, implications, and recommendations for use in the assessment and potential revision of the resources that translate and implement the Dietary Guidelines and that support MyPlate. Analysis will be qualitative in nature, although information about results may include documentation of methodology and response rates. There will be no specific quantitative analysis of data. After data collection has been completed, it is anticipated that the findings may be published in appropriate journals and shared at nutrition meetings and conferences to disseminate information to those who share similar goals of gathering insights about how consumers understand and use nutrition information and how it may impact their behavior. The information collected will not be nationally representative or statistically valid.

15. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

The agency plans to display the expiration date for OMB approval of the information collection on all instruments.

15. Explain each exception to the certification statement identified in Item 19 "Certification for Paperwork Reduction Act."

There are no exceptions to the certification statement.

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