Supporting Statement A For:
Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (LMICs) (NCI)
February 2, 2015
Annette Galassi
Center for Global Health
National Cancer Institute
9609 Medical Center Dr.
RM 3W250
Rockville MD, 20850
Telephone: 240-276-5810
Fax: N/A
Email: [email protected]
A.1 Circumstances Making the Collection of Information Necessary 1
A.2 Purpose and Use of the Information 3
A.3 Use of Improved Information Technology and Burden Reduction 5
A.4 Efforts to Identify Duplication and Use of Similar Information 5
A.5 Impact on Small Businesses or Other Small Entities 6
A.6 Consequences of Collecting the Information Less Frequently 6
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 7
A.9 Explanation of Any Payment or Gift to Respondents 7
A.10 Assurance of Confidentiality Provided to Respondents 7
A.11 Justification for Sensitive Questions 8
A.12 Estimates of Annualized Burden Hours and Costs 8
A.13 Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers 9
A.14 Annualized Cost to the Federal Government 9
A.15 Explanation for Program Changes or Adjustments 9
A.16 Plans for Tabulation and Publication and Project Time Schedule 10
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 10
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 11
Attachment 1: Survey
Attachment 2: Privacy Act Memo
Attachment 3: Office of Human Subjects Research Protection Exemption (OHSRP)
Attachment 4: Invitation
Attachment 5: List of Consultants
Abstract
This is a new submission for OMB to approve the “Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (LMICs)” for three years. NCI-Designated Cancer Centers have a range of international activities, some of which are funded by NCI, but many of which are not. These international activities may include oncology nursing education and training in LMICs, but the extent of these activities across cancer centers is unknown. The proposed assessment requests information about oncology nursing education and training projects including: descriptions of projects, partner organizations, types of activities, cost, and impact. The information will be collected annually. NCI’s Center for Global Health (CGH) is in the process of developing its strategic plan for oncology nursing education in LMICs. This information will help inform this strategic planning process and provide evidence to inform decisions on potential investments in grants for oncology nursing education in LMICs. Additionally, this information will be used in an online, interactive map that is being developed by CGH which will allow external organizations, such as cancer centers, to explore what projects are being done in which countries, which will facilitate collaborations and minimize duplication.
The National Cancer Institute's (NCI) Center for Global Health (CGH) has been mandated to "develop an appropriate research strategy to help incorporate cancer control into global health programs; foster relevant research activities throughout the NCI’s own extramural and intramural divisions; and work closely with the many potential collaborators who have displayed an interest in shared objectives.” 1 Incorporating cancer control is a key component of the mandate that necessitates this information collection. Cancer control has been broadly defined by the NCI as a set of activities that bring discoveries in cancer research to the population level. In global health, this gap of tailoring the evidence in cancer prevention and screening and delivering them to the populations and communities in need is stark and needs to be filled. As such, while NCI is a research agency and will not provide cancer care or orchestrate prevention campaigns directly, we will work with a wide range of partners in providing information and training about cancer control. This work will include activities “on topics that are highly relevant to the pragmatic aspects of treatment and prevention in developing countries: the geographic and cultural patterns of disease, the organization and function of health care systems, and the monitoring of the effectiveness of cancer control strategies. We also recognize that many kinds of cancers appear at different rates in different parts of the world for different reasons— and it is important to explain these differences in order to reduce the cancer burden in all countries… Finally, long-standing improvements in the control of cancer throughout the world will require the training of medical and scientific personnel who have vested interests in improving health in their own countries."1
With this in mind, CGH is developing a strategic plan for oncology nursing education in LMICs in order to build expertise and leverage resources across borders and enhance the ability to address the burden of cancer. The assessment of on-going oncology nursing education and training activities is authorized by Section 410 of the Public Health Service Act (42 USC § 285), which authorizes collection of this information, as outlined in Special Authorities of the Director – Sec. 413. [285a-2]. Section 413 authorizes the NCI Director to collect and disseminate (including through publications) to clinicians and the general public information on cancer research, diagnosis, prevention and treatment.
This assessment will allow CGH to create a strategic plan for oncology nursing education and training in LMICs by identifying gaps in education and training efforts, as well as opportunities to utilize and strengthen existing relationships, infrastructures and networks in order to advance cancer research and control. By understanding what existing efforts are on-going, CGH will be able to create new partnerships in cancer research and cancer control, leverage resources more effectively, contribute to international cancer control and research strategies, and increase the global capacity for cancer research and control. The NCI-Designated Cancer Centers have a variety of international activities that range from small research collaborations to building cancer registries to clinical trials. The funding for these activities does not exclusively come from NCI, as cancer centers use their own funds, and also apply to other funding agencies (non-profit organizations, foreign governments, etc.) to fund international activities. Many of these cancer centers have a diverse range of partners, including foreign ministries of health, U.S. and foreign academic institutions, healthcare providers, and international non-governmental organizations (NGOs), among others. CGH would like to understand what, if any activities, these cancer centers have with regard to oncology nursing education and training in LMICs.
The information collected in this assessment will be used to develop CGH’s strategic plan for oncology nursing education in LMICs. This information will provide evidence to inform decisions on potential investments in grants for oncology nursing education in LMICs. Additionally, this information will be used in an online, interactive map that is being developed by CGH which will allow external organizations, such as cancer centers, to explore what projects are being done in which countries, which will facilitate collaborations and minimize duplication.
Purpose of the Information
The current proposal is to administer a survey (Attachment 1) to assess the NCI-Designated Cancer Centers’ oncology nursing and education programs in LMICs. The Directors of Nursing for each cancer center will be invited to complete the assessment. The assessment consists of information already known to the Directors of Nursing, which has not previously been gathered and submitted to NCI. The proposed assessment requests the following information about oncology nursing and training in LMICs:
descriptions of projects/programs
partner organizations
types of activities
cost
deliverables
impact
Review and Use of Submitted Information
Completion of the proposed assessment is of great importance in building and sustaining international partnerships in cancer research and control. This assessment will help us to identify the existing efforts in these areas which will allow program staff to make strategic decisions about CGH programs and investments in oncology nursing education and training programs. Additionally, the results of the assessment will be hosted on an online, interactive tool that will allow not only CGH and NCI, but others including academic institutions, research institutions, and foreign governments to identify gaps in oncology nursing education as well as opportunities to leverage existing programs and build new collaborations. This will serve as evidence to inform decisions by CGH, other institutes across the NIH, and international governments, as to whether they should contribute to similar programs and where investments may be most needed or most effective.
An assessment of on-going programs is necessary to ensure that CGH is aware of existing efforts while developing a strategic plan and making decisions regarding investment in oncology nursing education and training programs. CGH should be utilizing the resources and skills of the NCI-Designated Cancer Centers, where appropriate, and making sure that our investments are strategic. Evidence that there are already several existing education and training programs in one country, may indicate that there is not a great need for CGH to work in that country, but could indicate that the cancer centers working in that country may have existing resources or recommendations that they may be willing to share with CGH for programs in other countries. If there are only a few programs or cancer centers working in another country, then CGH can work to identify opportunities to collaborate with these cancer centers, to ensure that we are not duplicating their efforts, and to be as efficient as possible. For those countries that do not have any oncology nursing education and training programs, CGH can investigate as to why no one is working in these areas, and whether or not there is a need for these programs, and what the surrounding circumstances are, in order to inform investment decisions. Completing the assessment annually will allow CGH to maintain the utility of the database without excessively burdening the cancer centers with requests for information.
For this proposal, all assessments will be completed electronically and a link to the assessment will be sent via email to the participants. No automated or dedicated IT system will be used for these reports. No personally identifiable information is being collected and the privacy office is currently assessing whether a PIA will be needed.
The assessment proposed here will not duplicate any existing information collection, since this information is not currently collected. There will be one survey (Attachment 1) that the Director of Nursing can fill out for each program or project that his/her cancer center works on. This assessment will elicit information on each oncology nursing education and training program and provide CGH the ability to make informed decisions regarding whether or not to invest in similar programs.
CGH has conducted a literature review and very little information about oncology nursing education and training programs is published. CGH and NCI do not currently have any assessments that would capture this information. Additionally, CGH leadership and partner organizations have been consulted and also confirmed that none of these data are currently being collected. Since NCI or NIH do not fund these programs, the OMB No. 0925-0002 Expiration Date 8/31/2015, post-award grantee progress reports does not apply to them.
No small businesses or other small entities will be involved in this information collection.
CGH will only collect information once per year. In the absence of the information provided by these assessments, the program officers will not be able to make informed decisions regarding funding future programs or develop an oncology nursing resource network to facilitate future projects and collaborations.
None of the special circumstances relating to the guidelines of 5 CFR 1320.5 apply to this information collection, and the proposed guidelines fully comply with 5 CFR 1320.5.
The 60-Day Federal Register notice soliciting comments on this study prior to initial submission to OMB was published on July 8, 2014, Vol. 79, P.38542. One public comment was received on July 9, 2014 in response to this Federal Register Notice; feedback about the comment was provided to the responder on September 15, 2014.
Members of the CGH staff have provided feedback about all relevant documents including the survey and submission package for OMB. Additionally, various members of Global Oncology Initiative, a CGH partner, assisted in drafting and reviewing these materials (Attachment 5). Finally, the Office of Science Planning and Assessment has been consulted and provided feedback on the survey.
There will be no payments or gifts to respondents.
No personally identifiable information (PII) will be collected.
The data collection is covered by NIH Privacy Act Systems of Record Notice (SORN) #09-25-0036, “Extramural Awards and Chartered Advisory Committees (IMPAC 2), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH” (Attachment 2). This SORN was published in Federal Register on 9/26/2002, Vol. 67, p. 60742.
Since this is not considered research, the Office of Human Subjects Research Protection (OHSRP) has reviewed this proposal and determined that it is exempt (Attachment 3).
There are no sensitive questions being asked in the survey.
The estimated response time will average 15 minutes, depending on the number of LMIC oncology nursing education and training programs supported. It is anticipated that a maximum of three projects will be reported. The frequency of response will be once per year.
A total of 68 Directors of Nursing will be asked to complete the assessment each year (Attachment 1) equaling a total of 204 potential participants over the course of the three-year information collection request. The estimated annual burden is 51 hours, which works out to be 153 burden hours over the course of the three-year information collection request (Table A.12-1).
Using estimated value for the Directors of Nursing from the Bureau of Labor Statistics, the total cost to the respondents is $2,484.72 over the three-year information collection request, and this works out to be an annualized cost of $828.24 (Table A.12-2). The hourly wage rate used for the Directors of Nursing is the mean hourly wage for Medical and Health Services Managers occupation code 11-9111 according to the Bureau of Labor Statistics, May 2013 http://www.bls.gov/oes/current/oes119111.htm .
Table A.12-1. Estimated Annualized Burden Hours
Type of Respondents |
Number of Respondents/ Year |
Number of Responses per Respondent |
Average Burden per Response* (in hours) |
Total Annual Burden Hours |
Director of Nursing |
68 |
3 |
15/60 |
51 |
Table A.12-2. Annualized Cost to Respondents
Type of Respondents |
Number of Respondents/ Year |
Total Annual Burden Hours |
Hourly Wage Rate |
Total Annual Respondent Cost |
Director of Nursing |
68 |
51 |
$48.72 |
$2,484.72 |
There are no direct costs to respondents other than their time to participate.
The cost of this information collection to the federal government arises entirely from the labor of federal program staff spent on the development of the assessment, the review of the responses, and the analysis of responses. There are no contractors contributing time, energy or effort to this project.
We estimate that all work on the collection of information, as well as, the analysis and storage of assessments will require the effort of approximately 200 hours during the three months that the project is active each year, which represents .1 FTE per calendar year. The program official, at a GS13 Step 1 level, will lead this effort so that this data collection will result in an estimated cost of $8,992.40/year, for each of the three years we expect to gather the information. Therefore the annual cost to the Federal government is estimated to be $8,992.40 (Table A.14-1), and the total cost over three years is estimated to be $26,977.20.
Table A.14-1. Annual Cost to the Federal Government
|
Tasks |
Title |
Grade/ Step |
Staffing (Salary x % of time) |
Annual Cost |
NIH Personnel
|
R&D, Data Collection, Report, Data Analysis
|
Program Lead |
13/1 |
$89,924 x 10%
|
$8,992.40 |
Total |
|
|
|
|
$8,992.40 |
This is a new information collection.
Basic descriptive statistics will be calculated (e.g. number of programs, number of partners, average cost, percentages of types of activities, etc.). Although the primary purpose of this information collection is to inform CGH’s strategic plan for oncology nursing education and training in LMICs, data from these assessments may be used for publications. These publications would not generalize findings to other programs. Additionally, these data will be used to inform an online, interactive map that is being developed by CGH which will be used to develop an oncology nursing resource network and facilitate future projects and collaborations.
The project time schedule (Table A.16-1) represents a 3-month time frame which begins once clearance is received. This table would be repeated annually through the three year information collection phase, so that each cancer center provides information a total of three times.
Table A.16-1. Project Time Schedule
|
Months after Workshop and Waiting Period |
||
Month 1 |
Month 2 |
Month 3 |
|
Contact Participants |
|
|
|
Obtain responses from Participants |
|
|
|
Tabulation and analysis of responses |
|
|
|
Summarize results |
|
|
|
The CGH Assessment Surveys will not require exemption from displaying the expiration date of OMB approval. Any surveys will prominently display the OMB approval number and expiration date.
The proposed project does not require any exceptions to the Certification for Paperwork Reduction Act Submissions (5 CFR 1320.9).
1 Varmus, H. and Trimble, E. Integrating Cancer Control into Global Health. Sci Transl Med. 2011;101(3):101-102. doi:10.1126/scitranslmed.300.2321.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | PLCO SCREENING TRIAL |
| Author | Linda Suit |
| File Modified | 0000-00-00 |
| File Created | 2021-01-25 |