Attach4B_ miniSSA_Sub-study#2_DCEG_9_26_13

Attachment 4B: Mini Supporting Statement A For

“Generic Clearance to Support Programs and Administrative Operations

At the National Cancer Institute (NCI)”

0925-XXXX, Expiration Date xx/xx/20xx

Title of Sub-Project: Division of Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer Student Applications

Contact Person: Kristen Kiser

Section A.

A1. Circumstances Making the Collection of Information Necessary

The fellowship programs fulfill the requirements of the National Cancer Institute regarding training as established under: Section 413 (b) (3) of the Public Health Service Act, 42 USC 285a-2 (b) (3), as amended pertaining to the National Cancer Institute, 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"). 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.

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. The program was 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. DCEG trains post-doctoral, doctoral candidates, graduate and baccalaureate students, through full time fellowships, summer fellowships, and internships.

The proposed information collection involves the online applications completed by applicants to the 1) DCEG Fellowship Program (full-time), which includes research, clinical, and visiting fellows, and the 2) DCEG Summer Fellowship Program. 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 must complete all required 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 is restricted to U.S. citizens, non-citizen nationals of the U.S., individuals lawfully admitted for permanent residence in the United States, 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 starting at the high school level through doctoral level students, including medical and dental students.

A3. Use of Information Technology and Burden Reduction

Prospective trainees for admission must apply directly to DCEG and the applications are web based and accessible through the DCEG web site: www.dceg.cancer.gov.

A4. Efforts to Identify Duplication and Use of Similar Information

It is estimated that there are less than 30 epidemiology trainees in other NIH institutes, therefore DCEG must make targeted fellowship recruitment efforts in order to attract epidemiology trainees. Though the NIH Office of Intramural Training and Education (NIH/OD/OIR/OITE) (OMB No. 0925-0299) has an application and process for review, it is difficult for them to target epidemiology trainees. The OITE application is used by all NIH fellowship programs and 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.

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 business 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

DCEG consulted with NIH 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

Information collected is available only to DCEG scientific and program officials who recommend or approve awards and to administrative, human resources, and financial officials who prepare the necessary documentation to arrange for stipend payments and to activate, renew, and terminate approved awards. These individuals are assigned login credentials, including "strong" passwords that conform to standards used by the NIH Center for Information Technology, and the online tools these individuals use to access applicant data are restricted to DCEG-approved users. Applicants receive login credentials, including randomly generated or user-defined passwords, when they first apply. Also, references submit their letters of recommendation via a password-protected Web site.

The Information Management Services (IMS) Inc. network is protected at all entry points by firewalls and intrusion detection devices. Transmission of data outside of the data center is secured using standard SSL or HTTPS based protocols. 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.

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.

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, and employment history. This information will be used solely to contact the applicant and to determine their suitability for the program.

A12. Estimates of Hour Burden Including Annualized Hourly Costs

Table A12-1. Estimates of Hour Burden over three years:

Type of Respondent	Number of Respondents	Number of Responses Per Respondent	Average Burden Per Response (in hours)	Total Burden Hours
Summer Students	900	1	20/60	300
Full-time Fellows	450	1	30/60	225
Totals	1,350			525

Table A12-2. Annualized Cost to Respondents. Hourly wage rates for trainees are based on the NCI 2013 Cancer Research Training (CRTA) stipend charts to establish costs of burden.

Type of Respondent	Number of Respondents	Total Burden Hours	Wage Rate (per hour)	Total Respondent Cost
Summer Students	900	300	$12.98	$3,894
Full-time Fellows	450	225	$29.04	$6,534
Totals	1,350	525		$10,428

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

DCEG works with IMS on setting up the application system for the full-time and summer fellowship programs.

Table A14-1. Cost to the Federal Government

Contract	Duration of Contract	Cost of Contract	Average Cost per Year
IMS	5 years	$10,000 to 20,000	$2,000 to $4,000

A15. Explanation for Program Changes or Adjustments

This is a new generic sub-project.

A16. Plans for Tabulation and Publication and Project Time Schedule

There are no plans for tabulation since this is an application.

The application information will not be published but 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

The OMB Clearance Number, Expiration Date, and Burden Disclosure Statements will be displayed on the applications.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

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

Attachments:

• Attachment 4A: Generic IC Form

• Attachment 4C: Fellowship Program Application

• Attachment 4D: Student Program Application

4