Supporting Statement Part A

Supporting Statement: Part A

Evaluation of the Action Plan for the

National Public Health Initiative on Diabetes and Women’s Health

Supported by:

Division of Diabetes Translation

National Center for Chronic Disease Prevention

and Health Promotion

Centers for Disease Control and Prevention

U.S. Public Health Service

Department of Health and Human Services

November 5, 2009

Government Project Officer:

Michelle D. Owens-Gary, Ph.D.

Centers for Disease Control and Prevention

4770 Buford Highway, NE

MS K-10

Atlanta, GA 30341

Telephone: 770-488-5014

Fax: 770-488-5195

Email: MOwens1@cdc.gov

Table of Contents

Part A: Justification

A1. Circumstances Making the Collection of Information Necessary

A2. Purpose and Use of Information Collection

A3. Use of Improved Information Technology and Burden Reduction

A4. Efforts to Identify Duplication and Use of Similar Information

A5. Impact on Small Businesses or Other Entities

A6. Consequences of Collecting the Information Less Frequently

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A9. Explanation of Any Payment or Gift to Respondents

A10. Assurance of Confidentiality Provided to Respondents

A11. Justification for Sensitive Questions

A12. Estimates of Annualized Burden Hours and Costs

A12-1.Estimated Annualized Burden Hours

A12-2.Cost to Respondents

A13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

A14. Annualized Cost to the Federal Government

A15. Explanation for Program Changes or Adjustments

A16. Plans for Tabulation and Publication and Project Time Schedule

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

A18. Exceptions to Certification for Paperwork Reduction Act

Attachments

Attachment A. Authorizing Legislation

Attachment B. Federal Register Notice

Attachment C. Description of the National Public Health Initiative on Diabetes and Women’s Health

Attachment D. Partner Survey

Attachment D1. Partner Invitation

Attachment D2. Partner Reminder

Attachment E. Co-sponsor Survey

Attachment E1. Co-sponsor Invitation

Attachment E2. Co-sponsor Reminder

Evaluation of the Action Plan for the

National Public Health Initiative on Diabetes and Women’s Health

1. Justification

A1. Circumstances Making the Collection of Information Necessary

Approximately 24 million Americans have diabetes, and more than 9 million of these individuals are women. It is projected that from 2000 to 2025, women will represent more than half of all cases of diabetes in the United States.

Diabetes can have unique and profound effects on women’s lives and health. For instance, diabetes is a more common cause of coronary heart disease among women than men. In addition, among people with diabetes, the prognosis of heart disease is worse for women than men, with women having poorer quality of life and lower survival rates. The burden of diabetes for women is also unique because the disease can affect mothers and their unborn children. After pregnancy, as many as 10—50% of women with gestational diabetes mellitus (GDM) are diagnosed with type 2 diabetes within five years of delivery. The offspring of women with a history of gestational diabetes are also at risk for becoming obese during childhood or adolescence, which may increase their risk of developing type 2 diabetes later in life.

To address the burden of diabetes on women’s health, the National Public Health Initiative on Diabetes and Women’s Health (“The Initiative”) was established to provide support and resources for the creation and implementation of a national public health Action Plan. The Initiative is co-sponsored by the American Diabetes Association (ADA), the American Association of Diabetes Educators (AADE), the American Public Health Association (APHA), the Association of State and Territorial Health Officials (ASTHO), and the Centers for Disease Control and Prevention (CDC). CDC’s Division of Diabetes Translation is dedicated to the prevention and control of diabetes, and to reducing or eliminating health disparities through targeted research, programs, and partnerships. Additional information about the Initiative and its objectives is provided in Attachment C.

The Initiative’s Action Plan is structured to examine the impact of diabetes through the life stages of women who have diabetes or are at high risk of developing diabetes. The Action Plan identifies gaps in diabetes-related research and programmatic activities, and strategic objectives, within the areas of: 1) community health; 2) diabetes state programs; 3) education and community outreach; 4) quality of care; 5) research; and 6) surveillance. It also establishes measurable indicators of those objectives. Co-sponsors of the Initiative and other partner organizations have been encouraged to act on the deficiencies and priorities identified in the Action Plan.

CDC proposes to conduct a survey to assess collective progress toward achieving the objectives outlined in the Action Plan. Participation is voluntary. Respondents will be approximately 124 collaborating organizations that are doing work in areas targeting women with or at risk for diabetes. These organizations include approximately 20 state-based diabetes prevention and control programs (DPCPs) that receive CDC funding; approximately 100 private-sector public health partners, such as professional associations and volunteer organizations; and the four organizations co-sponsoring the Initiative with CDC (ADA, AADE, APHA and ASTHO). The survey will ask respondents about specific strategies, resources, and partnerships that have been employed to complete the women’s health objectives that have been established by the Initiative. Survey responses will be compiled into a report and disseminated to respondents, allowing them to learn about each other’s activities and the steps needed to replicate successful diabetes prevention and control efforts.

This data collection fits into CDC’s Health Promotion goals as the proposed project focuses on reducing health and gender disparities by partnering with national and local organizations to achieve health impact. CDC emphasizes the importance and necessity of developing and nurturing partnerships to expand the scope and depth of public health services provided. In alignment with CDC’s focus on partnerships, this proposed project (through the support of the Initiative) has identified diverse partnerships that can help shape strategies for achieving CDC’s health protection goals and the needs of Americans with or at risk for diabetes. This data collection will contribute to the promotion of research, investigations, and studies related to the treatment, control, and prevention of physical diseases as defined in section 301 of the Public Health Service Act [42 U.S.C. section 241] (see Attachment A).

Privacy Impact Assessment

Overview of the Data Collection System

The survey will be conducted electronically using Survey Monkey, a web-based data collection system. Co-sponsors and partner organizations will be asked to complete slightly different versions of the survey (see Attachments D and E). Personal information in identifiable form (IIF) will not be collected because the survey questions pertain to organizational attributes and activities. Potential respondent organizations will receive a letter in the mail informing them of the availability of the online survey (see Attachments D1 and E1). As a means of limiting non-response, a reminder will be sent to all potential respondents (see Attachments D2 and E2). We estimate that the study will be in data collection for approximately 3 to 4 months.

Data collection, management and analysis will be conducted by staff at Centers for Disease Control and Prevention. CDC staff will be responsible for sending out the project letters, reminders, and aggregating the data collected.

Information will be collected on a yearly basis for three years, as the objectives established by the Initiative indicate that they should be completed according to this timeframe.

Items of Information to be Collected

The survey includes questions regarding specific strategies co-sponsors and partners have implemented to address topics related to diabetes and women’s health, demographic information about the respondent organization, the target audience that the activity or research was directed toward, resources used to implement a strategy, and the results of any activity related to the strategy area. Additional information asked in the survey includes questions about cost, types of partners, and resources used to implement the specific strategy.

To minimize burden to respondents, the survey will be programmed with skip patterns to route the respondent only to the most relevant questions.

No individually identifiable information is being collected.

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

An online survey, which will be housed on Survey Monkey, will be employed for this project. The Survey Monkey Web site does not have any content directed at children under 13 years of age. Only partners and co-sponsors of the Initiative will be provided with information to access this particular survey. The Survey Monkey system has the capability of collecting computer “cookies,” however, this function will be de-selected for this data collection. The Survey Monkey privacy policy is posted on the website.

A2. Purpose and Use of Information Collection

The survey will collect information about activities in the priority areas of communication and education, quality of care, research, and surveillance. This data collection will allow CDC and other participants in the Initiative to systematically identify and document the efforts of the partners and the cosponsors, and changes over time. The data collected will be analyzed and compiled into a report to be published by CDC. One of the primary purposes of program monitoring and evaluation activities is to improve programs by sharing and using lessons learned. Therefore, CDC will disseminate the summary report to the partners and cosponsoring organizations so that all organizations associated with the Initiative can learn about partner activities and the steps needed to replicate successful efforts.

Without this data, CDC will not be able to identify or aggregate information related to the efforts of partners in addressing the burden of diabetes for women with or at risk for diabetes, and participants will have limited information about strategies that others have used to implement the Initiative’s objectives.

CDC plans to conduct a follow-up information collection five years after completing the initial three years of information collection. The five-year information collection will support long-term evaluation of success in implementing the objectives defined in the Initiative’s Action Plan.

Privacy Impact Assessment Information

The information being collected will aid the Initiative in determining and documenting the specific strategies that co-sponsors and partners have taken to address priority areas for women with diabetes. The information will be compiled into a report and shared with the Initiative’s co-sponsors and partners to aid them in identifying future activities that they can replicate based on information provided in the report that will be developed.

The proposed data collection will have little or no effect on the respondent’s privacy. Respondents are organizations and no IIF is being collected. The Survey Monkey system has the technical capability of collecting cookies, however, cookies will be turned off for this data collection.

A3. Use of Improved Information Technology and Burden Reduction

All data collected (100%) for this project will be gathered using an electronic survey available on the internet. By using an electronic format for the evaluation instrument, this will reduce the burden of respondents having to use a paper format and then mail their responses back to CDC.

A4. Efforts to Identify Duplication and Use of Similar Information

The information proposed to be collected is unique in that it relates solely to the objectives created specifically for The Initiative. This is the first time that these specific objectives will be evaluated. There are no existing projects to our knowledge that will collect data from national organizations in regards to strategies that they have completed to address the diabetes burden for women. The proposed information collection does not duplicate the information currently collected from states through the Automated Management Information System for Diabetes Control Programs (OMB 0920-0479, exp. date 5/31/2010). Some of the information to be collected for this evaluation may be incorporated into a future version of the Management Information System (MIS) for the Division of Diabetes Translation at CDC. If that occurs, we will restrict this evaluation survey to partner organizations who do not submit information through the MIS.

A5. Impact on Small Businesses or Other Entities

Some small businesses such as national organizations will serve as respondents to the Partner Survey. The questions on the evaluation instrument have been held to the minimum required for the purposes of obtaining information about the implementation efforts of the partners and cosponsors of The Initiative.

A6. Consequences of Collecting the Information Less Frequently

Respondents will be asked to complete the evaluation instrument annually, for three consecutive years. Having respondents complete the instrument on an annual basis would enable the cosponsors of the Initiative to determine whether objectives were completed during the proposed timeframe. Collecting the data on an annual basis will also allow CDC to determine the status of each objective, which ones have been completed and which objectives are in progress or are planned for future years. There are no legal obstacles to reducing the burden.

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances relating to the guidelines of 5 CFR 1320.5 and the project fully complies.

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A.8a. A 60-Day Federal Register Notice was published on December 29, 2008, Vol. 73, pages 79490-79491 (see Attachment B). There were no public comments.

A.8b. The electronic survey that has been designed was developed and reviewed by members of the steering committee for The Initiative. Members of the steering committee include representatives from AADE, ADA, APHA, and ASTHO.

Marcia Draheim, RN, CDE

President

American Association of Diabetes Educators

319-455-3156

Marciedraheim@gmail.com

Allison Brooks

Associate Manager, Strategic Alliances

American Diabetes Association

703-549-1500 x1391

Abrooks@diabetes.org

Mighty Fine, MPH

Public Health Analyst

American Public Health Association

202-777-2493

Mighty.fine@apha.org

Beth Topf, MPPA

Senior Analyst

Association of State and Territorial Health Officials

btopf@astho.org

A9. Explanation of Any Payment or Gift to Respondents

Respondents will not receive any payment or gifts as a result of their completing the aforementioned survey.

A10. Assurance of Confidentiality Provided to Respondents

Respondents will be diabetes state programs and national organizations. The only identifiable information collected is the name of the organization that the respondent represents. This information will be collected so that the data collected can be compiled and reported on by state or organizational affiliation. The information collected relates to organizational activities and performance measures. It is not a survey about individuals.

A. Privacy Act Determination

This information collection request has been reviewed by staff in CDC’s Information Collection Review Office, who determined that the Privacy Act is not applicable. CDC will not receive identifiable response data from individuals. The respondents are speaking from their roles as representatives of their organizations. The survey will not ask for the names of any respondents and the respondents will not be providing any personal information about themselves.

2. Safeguards

The CDC project officer will safeguard the responses and will not release any information. All data collected will be compiled into a report that does not contain any personal identifiers. To protect anonymity, the reminder letter about the availability of the survey will be sent to all potential responders. This follow-up method eliminates the need to track and obtain personal identifiers. Although the Survey Monkey online data collection system provides the option of obtaining respondents’ e-mail addresses, this option will not be selected. The Survey Monkey system collects and uses IP addresses for system administration and record-keeping purposes, but IP addresses will not be provided to CDC. Survey responses cannot be linked or traced to any unique respondent identifiers. Additional information about Survey Monkey is available at http://www.surveymonkey.com.

This project has been identified as public health practice by CDC and does not constitute research involving human subjects. IRB approval is not required.

3. Consent

Consent is implied by participation.

4. Voluntary

All respondents are informed through the survey instructions that their responses are voluntary.

A11. Justification for Sensitive Questions

This proposed project does not contain sensitive questions. Participants who complete the survey will be asked to identify activities that they have completed to address diabetes and women’s health issues. Respondents are organizational entities.

A12. Estimate of Annualized Burden Hours and Costs

Respondents will be recruited from a master list of partners maintained by the National Public Health Initiative on Diabetes and Women’s Health. Respondents will be the 4 co-sponsors of the Initiative, 20 CDC-funded, state-based diabetes prevention and control programs, and approximately 100 private-sector public health organizations with a focus on diabetes and/or women’s health. The principal information collection instrument is the Partner Survey (Attachment C). Partner organizations will receive a letter of invitation (Attachment C1) and a follow-up reminder (Attachment C2). Co-sponsors will receive slightly modified versions of the survey (Attachment D), the letter of invitation (Attachment D1), and the follow-up reminder (Attachment D2). Due to the size and complexity of the activities managed by co-sponsors, co-sponsors will have the option of submitting multiple survey responses, in order to capture the full range of activities conducted by different units of the co-sponsoring organization. It is estimated that each co-sponsor will submit an average of three responses. The estimated burden per response is 30 minutes for each survey, and the total estimated annualized burden hours are 66.

Table A.12-1. Estimated Annualized Burden Hours

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden per Response (in hrs)	Total Burden (in hrs)
Co-Sponsors	Co-Sponsor Survey	4	3	.5	6
State-based DPCPs	Partner Survey	20	1	.5	10
Private Sector Partners	Partner Survey	100	1	.5	50
	Total				66

The only cost to respondents is their time. We anticipate that health educator staff will complete the survey on behalf of co-sponsors, and that a mix of health educator staff and health services staff will complete the Partner Survey. The mean hourly wage is $22.76 for health educators and $40.86 for health service managers; see http://www.bls.gov/oes/2007/may/oes_nat.htm#b21-0000 [Last accessed March 12, 2009]. For partner organizations we have used the mean of the average hourly wage rates of both job classifications to estimate cost to respondents (($22.76 + $40.86) / 2 = $31.81)). The total estimated annualized cost to respondents is $2,046.

Table A.12-2. Estimated Annualized Cost to Respondents

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden per Response (in hrs)	Average Hourly Wage	Total Cost
Co-Sponsors (health educators)	Co-Sponsor Survey	4	3	.5	$22.76	$137
State-based DPCPs (health educators and health service managers)	Partner Survey	20	1	.5	$31.81	$318
Private Sector Partners (health educators and health service managers)	Partner Survey	100	1	.5	$31.81	$1,591
	Total					$2,046

A13. Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no other costs to respondents.

A14. Annualized Cost to the Federal Government

Governmental costs for this project include personnel costs for federal staff involved in the planning and designing the survey and OMB materials, collecting and analyzing the data, and reporting, which includes approximately 5 percent of a GS-13 scientist’s time and 3% of an intern’s time. The total estimated annualized cost to the Federal Government is $6,020.00.

Table A.14-1. Estimated Annualized Cost to the Federal Government
Labor:
5% Behavioral Scientist’s time for project, planning, management, OMB review, analysis of findings, and report writing	$5,150
5% ORISE fellow’s time for data preparation, collection	$870
Total estimated cost	$6,020

A15. Explanation for Program Changes or Adjustments

This is a new data collection.

A16. Plans for Tabulation and Publication and Project Time Schedule

A.16-1 Survey Time Schedule
Activity	Time Schedule
Distribute Invitation	1 month after OMB approval
Initiate electronic survey	1 month OMB approval
Collect Data via electronic survey	3-4 months after OMB approval
Complete data analyses	5-8 months after OMB approval
Report on survey results	9-11 months after OMB approval

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

No exemption is requested. The OMB expiration date will be displayed in the upper right hand corner of all data collection instruments.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions requested.

References

Beckles GLA, Thompson-Reid PE, editors. Diabetes and Women’s Health Across the Life Stages: A Public Health Perspective. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Diabetes Translation, 2001.

Boyle JP, Honeycutt AA, Narayan KM, Hoerger TJ, Geiss LS, Chen H, Thompson TJ. Projection of diabetes burden through 2050: Impact of changing demography and disease prevalence in the U.S. Diabetes Care 2001; 24: 1936—1940.

Buchanan TA, Xiang A, Kjos SL, et al. Gestational diabetes: Antepartum characteristics that predict postpartum glucose intolerance and type 2 diabetes in Latino women. Diabetes 1998; 47:1302-1310.

Kim C, Newton K, Knopp R. Gestational diabetes and incidence of type 2 diabetes mellitus: a systematic review. Diabetes Care 2002; 25: 1862—1868.

Kjos S, Peters R, Xiang A, Henry O, Montoro M, Buchanan T. Predicting future diabetes in Latino women with gestational diabetes. Diabetes 1995; 44: 586—591.

Metzger BE, Nelson L, Niznik C, Dooley SL. Update on gestational diabetes. Womens Health 2006; 2: 211-216.

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