SSA DCEG Application Final

Supporting Statement A For:

Division of Cancer Epidemiology and Genetics

OMB# 0925-0716 Expiration Date

National Cancer Institute

National Institutes of Health

Fellowship Program and Summer Student Applications

March 3, 2018

Jackie Lavigne, Ph.D., M.P.H.

Chief, Office of Education

Division of Cancer Epidemiology and Genetics (DCEG)

National Cancer Institute

9609 Medical Center Drive
MSC 9776
Bethesda, Maryland 20892-9776

Telephone: 240-376-7237

E-mail: [email protected]

Table of Contents

A. Justification 1

A.1 Circumstances Making the Collection of Information Necessary 2

A.2. Purpose and Use of the Information Collection 3

A.3 Use of Improved Information Technology and Burden Reduction 4

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 6

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 10

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

List of Attachments

Attachment 1: Fellowship Program Application

Attachment 2: Student Program Application

Attachment 3: Privacy Act Memo

Section A. JUSTIFICATION

This is a request for approval of an “Extension” for three years. The National Cancer Institute, Division of Cancer Epidemiology and Genetics (DCEG) Office of Education administers a variety of programs and initiatives to recruit pre-college through post-doctoral educational level individuals into the Intramural Research Program to facilitate their development into future biomedical scientists. DCEG trains post-doctoral, doctoral candidates, graduate and baccalaureate students, through full time fellowships, summer fellowships, and internships in preparation for research careers in cancer epidemiology and genetics. The proposed information collection involves brief online applications completed by applicants to the full time and the summer fellowship programs. Full-time fellowships include: Full-time Equivalents (FTE) and non-FTE fellowships for US citizens, permanent residents and international fellows. These applications are essential to the administration of these training programs as they enable OE to determine the eligibility and quality of potential awardees; to assess their potential as future scientists; to determine where mutual research interests exist; and to make decisions regarding which applicants will be proposed and approved for traineeship awards. In each case, completing the application is voluntary, but in order to receive due consideration, the prospective trainee is encouraged to complete all relevant fields. The information is for internal use to make decisions about prospective fellows and students that could benefit from the DCEG program.

A1. Circumstances Making the Collection of Information Necessary

The fellowship programs fulfill the requirements of the National Cancer Institute (NCI) training authority as established under: Section 413 (b) (3) of the Public Health Service Act, 42 USC 285a-2 (b) (3), as amended pertaining to the NCI, which states that the Director, NCI, in carrying out the National Cancer Program . . . shall . . . "support appropriate programs of education and training (including continuing education and laboratory and clinical research training)”. Training early career scientists is a critical part of the NCI mission. DCEG’s research enterprise is dependent upon the research efforts of these fellows. It follows then, that a full one third of the DCEG research program is comprised of fellows, who are young scientists in training for cancer epidemiology and genetics research careers. DCEG scientists conduct population-, family-, and laboratory-based studies that seek to explain the environmental and genetic causes of cancer. Fellows gain comprehensive experience in designing and executing research studies, analyzing data, and publishing in peer-reviewed journals.

The principal appointment authorities for Division of Cancer Epidemiology and Genetics (DCEG) training programs are the: Cancer Research Training Award (CRTA); NIH Visiting Fellow program; and the Research and Clinical Fellowship appointments. These mechanisms were established in response to studies showing declining numbers of U.S. college graduates pursuing careers in biomedical research. These programs were designed to facilitate and enhance the systematic development of future U.S. biomedical scientists by making available unique research training opportunities in NCI intramural research programs during the formative stages of their academic training or research careers.

The DCEG Office of Education (OE) administers a variety of programs and initiatives to recruit pre-college through post-doctoral educational level individuals into the Intramural Research Program to facilitate their development into future biomedical scientists.

The proposed information collection involves two brief online forms completed by applicants to the DCEG training programs: 1) Fellowship Program Application which is completed by research, clinical, and visiting fellows (Attachment 1), and 2) Summer Fellowship Application (Attachment 2). These applications are essential to the administration of these training programs as they enable OE to determine the eligibility and quality of potential awardees for traineeships in these programs.

A2. Purpose and Use of the Information Collection

The purpose of the proposed information collection activity is to assure that prospective trainees to the two DCEG fellowship programs meet basic eligibility requirements; to assess their potential as future scientists; to determine where mutual research interests exist; and to make decisions regarding which applicants will be proposed and approved for traineeship awards. In each case, completing the application is voluntary, but in order to receive due consideration, the prospective trainee is encouraged to complete all relevant fields. The information is for internal use to make decisions about prospective fellows and students that could benefit from the DCEG program.

Participation in the DCEG Fellowship Program includes U.S. citizens, non-citizen nationals of the U.S., individuals lawfully admitted for permanent residence in the U.S., and foreign nationals who are eligible for the appropriate training visas. The full-time fellowship program may include: post-baccalaureates who have completed either college or master level degrees; doctoral students; and postdoctoral level fellows who have completed a doctoral degree, including a medical or dental or other doctoral-level degree. The DCEG Summer Fellowship is open to current students, who are U.S. citizens, starting at the high school level through doctoral level, including medical and dental students.

In the last three years we have received a total 436 full-time fellowship applications and 1290 summer student applications. These applications came directly to DCEG and allowed us the ability to circulate all the collected summary applications to all our division researchers. Also having the application system within DCEG, allows us to contact each interested applicant with information about the division and guidance about identifying researchers and programs of interest to them. This is especially important for applicants in public health fields, specifically cancer epidemiology, biostatistics and population genetics/genomics, since these are very specialized fields at NIH, unique to DCEG.

A3. Use of Information Technology and Burden Reduction

Prospective trainees for admission must apply directly to DCEG. The applications are web based and accessible through the DCEG web site: www.dceg.cancer.gov, under the tab labeled “Fellowships.”

The NCI Privacy Act Coordinator was consulted and it was determined that a Privacy Impact Assessment (PIA) is needed. A PIA is pending approval.

A4. Efforts to Identify Duplication and Use of Similar Information

It is estimated that there are less than 30 epidemiology trainees across the other 27 NIH institutes and centers, therefore DCEG must make targeted fellowship recruitment efforts in order to attract epidemiology trainees. Though the NIH Office of Intramural Training and Education, which is part of the NIH Office of the Director, Office of Intramural Research, (NIH/OD/OIR/OITE) (OMB No. 0925-0299 Expiration Date 06/30/2019) has a fellowship application and review process, it is difficult for OITE to target epidemiology trainees. The OITE application is used by all NIH fellowship programs, but does not include questions designed to describe the applicant’s interests in the areas of cancer epidemiology and genetics that would help to determine their proper placement within DCEG. Also, OITE applications are directed at a slightly different trainee population, primarily lab-based trainees, which is not what DCEG is offering. The OITE application system does not have a straight-forward way to filter potential epidemiology fellows. In addition, OITE does not have a system for postdoctoral level applications, where as 80% of fellows recruited by DCEG are at the postdoctoral level.

The DCEG specific fellowship applications described in this submission will create a short information summary for applicants interested in cancer epidemiology that will allow us to communicate with these potential fellows expeditiously and provide information specific to their interests.

A5. Impact on Small Businesses or Other Small Entities

No small businesses or other small entities will be affected by the implementation of the DCEG application system.

A6. Consequences of Collecting the Information Less Frequently

Without approval to collect applications specific to the program’s needs, the DCEG Fellowship (full-time) and DCEG Summer Fellowship Programs would be compromised in their ability to identifying highly qualified trainees of various educational levels for the NCI intramural research programs.

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

There are no special circumstances.

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

The 60-day Federal Register Notice was published on December 20, 2017 (Vol. 82, P. 60407) and allowed 60 days for public comment. No public comments were received.

DCEG consulted with NIH Office of Intramural Training and Education (OITE) and it was determined that the existing NIH OITE training program application forms would need to undergo significant revisions to meet the needs of DCEG. It was decided that DCEG would request OMB approval for their own application form using this submission route, however it was agreed that for future applications collaboration between NIH OITE and NCI DCEG OE would be beneficial to both offices.

A9. Explanation of Any Payment or Gift to Respondents

Neither payments nor gifts will be provided to respondents who complete the applications.

A10. Assurance of Confidentiality Provided to Respondents

Applicants submit their information to the DCEG website via HTML form data transmitted with SSL encryption over the secure HTTPS protocol. Information collected is made available only to DCEG scientific and program officials who recommend or approve fellowship awards and to administrative, human resources, and financial officials who prepare the necessary documentation to arrange for stipend payments and to activate, approved awards. These authorized individuals are assigned login credentials, including “strong” passwords to conform to standards used by the NIH Center for Information Technology. The online tools these individuals use to access applicant data are also secured with SSL and HRRPS. The online tools these individuals use to access applicant data are restricted to DCEG-approved users.

Personally identifiable information (PII) is collected and the Privacy Act applies to this information collection. The System of Records Notice (SORN) is #09–25–0014, “Clinical Research; Student Records, HHS/PHS/NIH/OD/OIR/OE.”

The DCEG website, the applicant data, and the online access tools are stored and hosted in the Information Management Services, Inc. data center. The IMS data center and network are protected at all entry points by firewalls and intrusion detection devices. Physical controls such as user/group authorization, encryption of data at rest, and weekly security/virus scans are employed in the data center to ensure continued data security while at IMS. All IMS employees are required to sign a confidentiality agreement at the time of employment. They must also complete yearly security trainings. Information will be kept private, to the extent provided by law.

Since this is not considered research nor will there be publications, thus Federal regulations for the protection of human subjects do not apply to this activity. The Privacy Act will apply as stated in the Privacy Act memorandum from the Privacy Act Coordinator. (Attachment 3).

A11. Justification for Sensitive Questions

The DCEG fellowship applications do not contain sensitive questions. These applications do collect personally identifiable information (PII), including: name, contact information, education, research interests, and publication history, if applicable. This information will be used solely to contact the applicant and to determine their suitability for the program.

A12. Estimates of Annualized Burden Hours and Costs

The annual estimate of burden is expected to be 175 hours for a total of 450 applicants (Table A.12-1) averaging to about 525 hours for 1350 applicants over a three-year information collection period.

Form Name	Type of Respondent	Number of Respondents	Number of Responses Per Respondent	Average Burden Per Response (in hours)	Total Annual Burden Hours
Fellowship Program Application (Attach 1)	Full-time Fellows	150	1	30/60	75
Summer Program Application (Attach 2)	Summer Students	300	1	20/60	100
	Totals	450	450		175

Table A12-1. Estimates of Annual Burden Hours

Hourly wage rates for trainees are based on the NCI Cancer Research Training (CRTA) stipend charts (https://www.cancer.gov/grants-training/training/at-nci/crta.pdf ) to establish costs of burden. The annual respondent costs are estimated to be $3,737 (Table A.12-2), or approximately $11,211 over a three-year information collection period.

Table A12-2. Annualized Cost to Respondents

Type of Respondent	Number of Respondents	Total Annual Burden Hours	Wage Rate (per hour)	Total Respondent Cost
Full-time Fellows	150	75	$30.66	$2,300
Summer Students	300	100	$14.57	$1,457
Totals	450	175		$3,737

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

There are no capital costs, operating costs, or maintenance costs to report.

A14. Annualized Cost to the Federal Government

The annualized cost to the government is $17,373. DCEG works with the IMS contractor on setting up and managing the application system for the full-time and summer fellowship programs. The IMS contractor is responsible for setting up and managing the web-based system. The DCEG staff person manages the review and distribution of the applications. The annual contractor cost to the Federal government is estimated at $4,000 (Table A.14-1).

Table A14-1. Annualized Cost to the Federal Government

Cost Descriptions	Grade/Step	Salary	Percent Effort	Fringe (if applicable)3	Total Cost to Gov’t
Federal Oversight					$12,873
Program Analyst	13/10	$126,062	10		$12,873
Contractor Cost					$4,500
Computer Analyst					$4,500
Travel					0
Other Cost					0
Total					$17,373

A15. Explanation for Program Changes or Adjustments

This is an extension.

A16. Plans for Tabulation and Publication and Project Time Schedule

There are no plans for tabulation since this is an application. Additionally, the application information will not be published. The applications will be used for annual program assessments and reviews, as well as to assess the appropriateness of an applicant for the DCEG fellowship program.

Table A16-1. Project Time Schedule: Application Opening and Closing Dates

Training Program	Application Opening Date	Application Closing Date
DCEG Summer Fellowship Program	November	March
DCEG Fellowship Program (full-time)	Open all year	Not applicable

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

There is no request for exemption from displaying the expiration date for OMB approval.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the Certification for Paperwork Reduction Act Submissions.