OMB Supporting Statement A CareerTrac REVISED 2.15.2013

Supporting Statement
for

CareerTrac

Paperwork Reduction Act Submission

Section A

Introduction

This request seeks clearance for collecting career-related data for trainees funded or co-funded by the Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Science (NIGMS), National Library of Medicine (NLM) and National Cancer Institute (NCI). The data collection system provides a streamlined, web-based application permitting principal investigators and their administrators to record career achievement progress by trainee on a voluntary basis. FIC, NIEHS, NIGMS, NLM and NCI Program Officers will use this data to monitor, evaluate and adjust grants to ensure desired outcomes are achieved, respond to congressional inquiries, and inform future strategic and management decisions regarding the grants program.

A.1.Circumstances Requiring the Collection of Data

CareerTrac was the first system at NIH to provide a system for tracking international trainees, and is more comprehensive in its approach to tracking outcomes than IMPACII. The primary purpose of designing a global trainee tracking system is to track and report short and long-term outputs, outcomes, and impacts of FIC, NIEHS, NIGMS, NLM and NCI, thereby making informed management decisions about health research training programs. Trainee tracking and evaluation are specific and critical components of the FIC, NIEHS and NIGMS strategic plans.¹ FIC, NIEHS NIGMS, NLM and NCI train many different types of individuals but have similar tracking needs.

The Fogarty International Center and the National Cancer Institute
FIC and NCI have a specific need to track international trainees funded in their extramural program. International trainees differ greatly from U.S.-trainees. International trainees conduct their research in institutions abroad but can be trained in the United States and/or abroad. The degree, certificate, or training they are granted can be from an overseas or domestic institution and the degree or certificate earned may or may not differ from those granted in the United States. International trainees may participate with several different mentors, both domestic and international. Frequently, international trainees publish their results in important national, regional, or international journals that may or may not be familiar to U.S scientists or be listed in U.S. databases such as PubMed. International trainees may lack social security numbers, which are often used to track U.S. trainees.

International research training programs are structured to build research capacity by training individual researchers. This structure requires a database that tracks complex metrics that indicate progress towards these program goals. Currently, several of FIC's international training programs focus on both traditional (chronic and infectious diseases) and non-traditional areas (bioethics and bioinformatics) of research important to developing countries. The focus of these NCI and FIC programs necessitates tracking traditional and non-traditional metrics such as publications, awarded degree, Institutional Review Boards (IRBs) formed, new databases developed, new curriculum initiated, new departments started, new career paths forged and new networks created. The Fogarty International Center's mission is “to advance the mission of the National Institutes of Health by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs.” Operationally FIC accomplishes its mission through both research and research-training programs. In order to make informed management decisions about its training programs and to demonstrate the outputs, outcomes and impacts of its training programs FIC must be able to track its trainees using an accurate and up-to-date system. CareerTrac was initially developed by FIC after concluding that the NIH’s primary administrative and reporting database, IMPAC II, would not fit its needs.

The National Institute of Environmental Health Sciences (NIEHS)

NIEHS needs to track outputs, activities and outcomes of trainees funded through its individual and institutional trainee grant and contract programs. NIEHS trainees are a range of intramural and extramural programs, such as the Intramural Research and Training Award (IRTA) and Superfund Research Program (SRP). CareerTrac will provide NIEHS with an integrated database of all trainees supported by both intramural and extramural programs. Our Director will be able to understand the “big picture” of training, which is a critical component of the Institute’s Strategic Plan (2012).

For extramural trainees, NIH captures pertinent data about trainees during their training process using trainee appointment forms (form PHS 2271). This information is now captured electronically through the X-Train interface). However, limited output, outcomes, and long term job information are captured by NIH data systems. At the same time, however, institutional training grant programs are required to track trainees for 10 years after their appointment to a training grant. Currently outcomes information provided by principal investigators in progress reports is submitted as a PDF, and thus cannot be used for evaluation purposes because it is not captured as structured data. CareerTrac allows principal investigators to use the system to track trainee information as required in their grants, and print Tables 5, 6 and 12A and B in the appropriate format to submit for progress reports and program analysis.

The NIEHS Intramural program is interested in tracking its trainees so that they can understand broad programmatic accomplishments, along side extramural trainee accomplishments. CareerTrac provides a robust interface for Intramural PIs to record trainee achievements both during and after training. Having this information readily available will be particularly helpful for PIs to demonstrate their mentorship of trainees during Board of Scientific Counselor Reviews. Intramural PI’s and program staff are interested in in using the data both to evaluate training programs, and to expand the trainee network.

The NIEHS Superfund Research Program has supported nearly 1400 trainees throughout its 25 year history. Appointment forms are not used in this program, so there was no systematic way to track SRP trainees prior to CareerTrac. Training outcome data in CareerTrac will help SRP improve their training programs and demonstrate an important component of their training mandate (as authorized in the Superfund Amendments and Reauthorization Act of 1986).

The National Institute of General Medical Sciences (NIGMS)

NIGMS, the NIH Institute responsible for the most trainees, is an emerging partner for CareerTrac. Discussions are currently ongoing to develop a pilot project around the Bridges to Baccalaureate and Bridges to Doctorate programs. These trainees are currently appointed in X-Train, but program officers are not able to track the full range of trainee outcomes using existing NIH systems. The pilot project will be undertaken as a proof of principal concept. Once complete, we will discuss other opportunities to bring in NIGMS trainees (and revise this application accordingly).

The National Library of Medicine (NLM)

NLM is also participating in a pilot project with CareerTrac. They will be tracking biomedial informatics trainees funded on the T15 mechanism (who are tracked in X-Train), and are also interested in tracking students who participate in the Summers of Discovery training programs (these trainees are not tracked in X-Train).

In the long term, FIC, NIEHS, NIGMS, NLM and NCI would also like to track trainees funded through other mechanisms (e.g. Superfund Program Trainees) that are not necessarily included in the IMPAC II database. Additionally, other NIH Institutes and Centers have trainees that follow both “models” (i.e. those tracked in IMPAC II and those that are not.) Therefore, a single system that allows FIC, NIEHS, NIGMS, NLM, NCI, and eventually other NIH Institutes and Centers, to track multiple types of trainees is desirable.

The request for information is authorized by 42 U.S.C 287b, 42 U.S.C 286b-3, 42. U.S.C 285k, and by 42 U.S.C 2851. The full authorizing text is included as Attachment 1.

A.2.Purposes and Uses of the Data

NIH needs to understand the long term outcomes of its substantial investment in trainee development. The system will collect and facilitate analysis of the career achievements of trainees funded by FIC, NIEHS, NIGMS, NLM, and NCI grants, including career accomplishments achieved during or post training. Program officers will use the data to report on, analyze, and modify training programs; FIC, NIEHS, NIGMS, NLM, and NCI will use this data to inform management decisions about its health research training programs and to report on the outputs, outcomes and impacts of its programs; Evaluation and Policy officers will use the data to report to NIH and HHS administration. Additionally, the evaluation officers and staff will use the collected data to help analyze and evaluate programs. Trainee data may be used for bench marking and comparisons across programs or ICs. Submission of this data is voluntary.

In addition, it is envisioned that by developing a database of international trainees accessible to NIH program officers, the system may also facilitate implementation of global scientific projects by allowing Program Officers to identify international partnership opportunities, particularly for U.S. PIs or program alumni who desires collaboration with an individual who has expertise in a specific scientific area, international site or institution. CareerTrac users are also interested in facilitating partnerships, further training opportunities, and other networking.

Major changes to the system since last OMB submission:

Phase 3: (Oct 2010 – Sept 2011)

• Merged separate systems from FIC and NIEHS to one consolidated system

• Moved the location of the production system and database to the NIEHS data warehouse

• Enhanced user interface for the query/reporting functionality

• Converted the CareerTrac database from SQL to Oracle

• Added canned reports to assist PIs with submission of Progress Reports and Competitive Grant renewals

Major changes planned for Phase 4 (Oct 2011 – March 2013) include:

• Incorporating new CareerTrac “tenants”

  • NIGMS (Pilot project)

  • NLM (Pilot project)

  • Several other institutes have expressed interest in developing pilot projects, but no explicit plans have been made – as other Institutes and Centers come on board, this clearance will be modified accordingly

• Creating a report to assess “completion” of the trainee profile

• Expanding data fields transferred from IMPAC II to eliminate duplicate data entry

A.3.Use of Information Technology to Reduce Burden

A web-based application with a minimum number of required fields is currently in production and being used by FIC and NIEHS. The system supports the collection and reporting of this data, significantly reducing the burden of maintaining paper-based files and manually collating data for reporting. All PIs with access to the Internet are able to access the system from anywhere at any time. Drop-down selection list and radio button selections are leveraged to streamline and standardize the data collection.

In addition, a PIA was completed for the joint CareerTrac application (NIEHS and FIC). The SORN is 09-25-0014 NIH Senior Official for Privacy approval of PIA - 4/9/2011. An update has been provided (August 30, 2012) and we are awaiting approval of the revised PIA (see Attachment 2 in the Appendix).

A.4.Efforts to Identify Duplication

The initial OMB and renewal applications for CareerTrac (2006 and 2009) did not identify any duplicate efforts. The initial system was developed for FIC’s international programs. International trainees are still not tracked in any other system at the NIH. Further, the diverse range of long-term trainee outcomes , both domestic and international, are not tracked in any other system at the NIH.

Before developing CareerTrac, FIC searched for similar systems to track international trainees throughout the government. It found such a system at the US Agency for International Development (USAID). USAID tracks its international trainees to monitor training costs and results for all USAID funded training activities occurring in the U.S. and abroad. The USAID collection was reviewed extensively by NIH-FIC for applicability. Several discussions were held with USAID and NIH in 2003 and 2004 prior to NIH embarking on a new data collection. It was determined that the NIH collection would not duplicate USAID Efforts and that the USAID automated system could be adopted as a baseline tool for the NIH-FIC collection.

Some NIH trainees are tracked during their training experiences in IMPAC II. However, very little information about the trainee is maintained in IMPAC II during their training. In 2008, a training reporting module was created in IMPAC II to provide reports of trainees during their training (counts, degree type, grant, tuition costs and stipend information is tracked.) Additionally, links to any subsequent grant applications and awards are provided, allowing analysis of two measures of trainee success. Since the 1970s the IMPAC II system has captured previous education; race, ethnicity; gender; disability; Ph.D. completion. More recently NIH has begun tracking non-PI roles on NIH and other PHS grants.

PI’s of institutional training grants (T32s) are required to track trainees for the previous 10 years. The tracking data are not submitted in a structured format (i.e. it is submitted as a PDF table), and thus it is impossible to analyze in any systematic way. CareerTrac provides PI’s with a system that tracks their trainees in a way that NIH can analyze the data much more efficiently. CareerTrac allows NIH to track alternative metrics of long term success, such as working in a non PI capacity in academia, in a government science, health or regulatory agency, or in a related industry. Other outcome metrics related to non-NIH fellowships, patents, policies and publications can be captured easily in CareerTrac – these are not represented in IMPAC II.

CareerTrac is designed to integrate with existing IMPAC II data as much as possible, and provide an opportunity to collect new, relevant trainee outcome data. CareerTrac staff are making every effort to ensure that any existing data stored in IMPAC II are automatically populated into CareerTrac. The goal is to reduce duplication of effort as much as possible, without sharing data inappropriately across platforms. CareerTrac substantially reduces effort on the part of NRSA PIs, who currently have to maintain data that can be readily extracted from IMPAC II in external spreadsheets that require cumbersome manual updates.

The National Institute of Neurological Disorders and Stroke (NINDS) has recently developed a data collection tool that assists Institutional Training Grant Directors (the “T32 program”) in collecting and storing the data needed to complete Tables required for applications, progress reports and competitive renewals. Key differences between the NINDS Trainee Tracking System (TTS) and CareerTrac include:

Difference	TTS	CareerTrac
Data source	Users enter all data directly into TTS.	Pulls data from IMPAC II whenever possible; users add long term outcome information
Outcome/Achievements	Captures data needed for the grant application and progress report tables	Provides robust, structured framework for grantees to track trainee outcomes and achievements
Data Analysis	No data analysis capability in system	Provides ability to query and filter data, as well as export all data into excel files for easy data analysis by all users
Reporting	Provides canned reports for all 12 NRSA tables	Provides versatile and robust query/reporting/exporting functionality for all data elements in the system; Provides canned reports for NRSA Tables 5, 6 and 12

Given the differences between TTS and CareerTrac, CareerTrac is still not a duplicate system. Nevertheless, conversations about leveraging and combining the best components of these two systems are underway between NINDS and within the NIH Training Activities Committee. In the meantime, it is essential that the production CareerTrac system continue to function without a service interruption so that programs can be evaluated and continually improved.

Recently, a database has been developed by the NIH Office of Intramural Training and Education to track NIH trainees from multiple Institutes and Centers. This Trainee Alumni Database (OMB No. 0925-0299, Expiration Date 03/31/2014) encourages trainees to voluntarily provide contact information, NIH training history, education and employment information.

Difference	NIH Alumni Database	CareerTrac
Data source	Former/Current Trainees enter data into database (voluntary)	Pulls data from existing personnel records. Intramural PIs enter information on behalf of trainees.
Outcome/Achievements	Captures employment, subsequent education and networking contact information	Additionally captures other outcomes such as publications, fellowships, and narrative accounts of training impacts. CareerTrac is also hoping to link trainees to subsequent applications and awards sought by linking them to data in IMPAC II.
Scope	Is designed for intramural fellows, no extramural training alumni captured.	Allows NIEHS to analyze and report achievements across all its trainee programs in a single integrated database, giving us unprecedented information to evaluate our training programs as a whole.

In summary, some data that CareerTrac collects are collected in other systems, but we are making every effort to leverage these data as appropriate. It may be possible in the future to create additional data linkages and imports from other sources. For example it has been suggested that the Commons ID can be used as a way to create a primary identifier that links information across several IMPAC II models and CareerTrac. We intend to explore opportunities for leveraging this data field as much as possible to avoid duplication of effort.

A.5.Small Business

No small businesses will be involved in this collection.

A.6.Consequences of Not Collecting the Information

Without regular, periodic updates to trainee data, NIH will not be able to document the impacts and outcomes of awarded grants. Meeting regulatory compliance requirements and responding to Congress in an accurate and timely manner will be difficult. Ultimately, FIC, NIEHS, NIGMS, NLM and NCI will be unable to make informed management decisions about its grants programs without this data.

A.7.Special Circumstances Justifying Inconsistencies with Guidelines in 5 CFR 1320.6

This project fully complies with all guidelines of 5 CFR 1320.5 (Controlling Paperwork Burdens on the Public General Information Collection Guidelines). There are no circumstances that require deviation from these guidelines.

A.8.Consultation Outside the Agency

Included as an attachment is the Federal Register Notice 60 Day Notice, Vol. 77, No. 106, on June 1, 2012, page 32648-32649.

One comment was received from this notification regarding the cost and hour burden estimates. Please see attached comments and response in Attachment 3 of the Appendix.

The system has been in full production with FIC PIs since December 2008. The PIs have been asked to comment on the system several times. Their comments regarding the ease of use of the system and the type of data being collected have been incorporated into enhancements of the application. NIEHS has also worked with nine grantees to test the system in 2011 and 2012. Feedback from these grantees have been incorporated into the system as well.

A.9.Payments or Gifts to Respondents

Respondents will not be paid for participating in this collection and will not receive any gifts in return for participation. Participation is completely voluntary. Rather than a monitory award we intend to give an "achievement award" each year, based on data on former trainees in the CareerTrac system. One option is to recognize up to 5 of the best trainees (at various Career stages) and their PIs each year for their outstanding track record and accomplishments. This should act as an incentive for the PIs to keep updating the data in the database.

A.10.Assurances of Privacy

The NIH Privacy Officer has reviewed CareerTrac and determined that the system is subject to the Privacy Act. The Privacy Impact Assessment for CareerTrac is provided as Attachment 2.

CareerTrac falls under the NIH System of Records Notice (SORN) 09-25-0014, Federal Register Notice Vol. 67, No. 187, September 26, 2002. The trainees are informed about the nature and usage of the data collected. Trainees provide the data voluntarily and can opt to decline to provide the requested information. The CareerTrac system automatically generates a privacy act disclosure statement that can be verified online by the trainees. Once the privacy act disclosure statement is reviewed and submitted by the trainee, verification is noted in the system.

CareerTrac data is available to PIs, Principal Investigator Administrators (PIA), Project Officers (PO), and other NIH staff, such as Evaluation Officers. The following information may be disclosed individually or in aggregate for "routine uses": current training status, returned to home country, area of training, country of origin, work e-mail, degrees earned through NIH funded programs, accomplishments that are public products, and trainee career highlights. Datasets stripped of personal identifiers may be created for NIH evaluation purposes (similar to the concept of “public use datasets” for hospitalization data). Gender and minority status will not be disclosed on an individual basis. Trainees who are not appointed using the X-Train data interface may elect to “not agree” to be tracked in the database. In that case, their information will be filed as “anonymous” and they will not be tracked as an individual. The following CareerTrac information will not be made publicly available: employment status, phone, fax, year of birth, or biographical data.

Routine uses of records maintained in the system include, but are not restricted to the following categories of users and purposes:

1. FIC, NIEHS, NIGMS, NLM and NCI, HHS and Congress for reporting and evaluation purposes;

2. The PI and Collaborators for the purpose of monitoring the program, submitting progress reports and grant applications, and writing journal articles describing the programs;

3. FIC and NIEHS co-funding partners and co-sponsors of FIC and NIEHS programs for the purpose of reporting progress and conducting evaluations of the programs; and

4. Interested public, for example, for the purpose of convening a scientific meeting in a particular country to which former trainees will be invited.

The application is hosted in NIEHS's data center, which is certified and accredited for moderate risk applications and includes several processes for securing and protecting the individually identifiable data. Due to the long-term, on-going nature of this program, records may be maintained indefinitely. All existing NIH guidelines for retention and destruction of Individually Identifiable Data will be adhered to. All confidentiality controls for Moderate Risk systems from the NIST 800-53 are followed. The system has a current and active accreditation. Information on specific IT security controls may be obtained from the IT Security Plan for the NIEHS General Support System. Listed below are some of the key security controls employed:

• Card reader access is required for access to the NIEHS Data Center.

• All doors are alarmed for breakage or tampering.

• The data center is monitored 24x7.

• Visitors are logged and escorted at all times by an authorized person while in the data center.

• Procedures are in place to renew all data center access on a quarterly basis.

• Procedures are in place for deactivating card reader access for terminated employees/contractors.

• Procedures are in place to remove terminated employee/contractor IDs on all systems.

• Virus scanning software is installed on all servers and is continuously executed.

• File system access control lists are restrictive to prevent unauthorized access.

• Firewalls restrict access to servers.

• Strong password controls are enforced.

• Procedures are in place to apply patches when vulnerabilities and fixes are published.

• Routers and firewalls on the data center network detect and defend against Denial of Service (DoS)

• A combination of incremental backups and snapshots of data foremost systems with an identified need are made daily.

• Server configuration standards, general operating procedures, maintenance procedures, software/hardware change control procedures are documented online.

A.11.Questions of a Sensitive Nature

CareerTrac collects the name, race/ethnicity and gender of the trainee, which can be classified as Personally Identifiable Information (PII). While answering the race/ethnicity and gender questions, the trainees can “choose not to specify.”

A.12 Estimates of Response Burden

Hour burden estimates are based upon beta testing conducted using test versions of the data collection system. Principal Investigators are expected to enter data for 30 trainees, annually. We expect that approximately 20 of those 30 trainees will provide data to PIs using the form. PIs will gather data directly from the remaining 10 of 30 trainees. Typical users can complete a record entry in 30 minutes or less, including time to gather the required data. A few records are more complex and require additional time.

A.12.1.Number of Respondents, Frequency of Response, and Annual Hour Burden

	A.12-1 Estimate of Hours Burden
Type of Respondents	Number of Respondents	Response Frequency	Average Time per Response (in Hrs)	Annual Hour Burden
Principal Investigators /Administrators (Using form)	300	30	10/60	1,500
Principal Investigators /Administrators (Not using form)	150	30	30/60	2,250
Total PIs	450			3750
Trainees	9000	1	20/60	3000
Total PI + Trainee	9450			6750

Estimates of the number of training grants per center are:

• 140 NIEHS (without Superfund Research Program)

• 35 Superfund Research Program

• 65 NIGMS

• 20 NLM

• 10 NCI

• 180 FIC
  
  

A.12.2.Estimates of Annualized Cost to Respondents for the Hour Burdens

The CareerTrac team has determined that administrators, not PIs, are responsible for entering the majority of data into the system. Therefore, the $40 hourly wage rate reflects the wage estimate for administrative staff rather than scientific staff. We estimate that an average wage for trainee would range from $10-50/hour, depending on how long they were beyond their training period, the nature of their work and their location in the world. The hourly wages are based on past experience.

A.12-2 Annualized Cost to Respondents
Type of Respondents	Number of Respondents	Response Frequency	Average Time per respondent	Hourly Wage Rate	Respondent Cost
Principal Investigators/ Administrators (Using Form)	300	30	10/60	$40	$60,000
Principal Investigators /Administrators (Not using form)	150	30	30/60	$40	$90,000
Trainees	9000	1	20/60	$25	$75,000
Total					$225,000

A.13.Estimate of Total Capital and Startup Costs/Operation and Maintenance Costs to Respondents or Record Keepers

There are no Capital Costs or Operating and Maintenance Costs to report. The data collection system is a web-based application available to respondents at no cost using their existing desktop hardware and software.

A.14.Estimates of Costs to the Federal Government

The costs below are the additional costs required supporting this data collection. Existing computer facilities and equipment are being utilized at no additional cost to NIH. The estimated cost to develop, test and implement the data collection system assumes a minimum ten-year life expectancy for the application, with technology refreshes accounted for in the annual cost to maintain the data collection system.

A.14 Annualized Cost to the Federal Government
Cost to develop, test and implement the data collection system (Annualized over an estimated 10-year life)	$75,000
Annual cost to maintain the data collection system.	$60,000
Total Annualized Cost	$135,000

A.15.Changes in Burden

FIC and NIEHS are partnering with NIGMS, NLM and NCI to develop a unified CareerTrac system. Since the system will now serve four ICs, the number of respondents has increased.

A.16.Plans for Publication, Analysis, and Schedule

NIH Program managers will use the data collected in this system for program analysis and to produce annual management reports, with the objective of verifying and demonstrating that program objectives are being achieved. The results of this analysis and supporting reports will be published annually in Program Reports. Examples of reports for each program include:

• Awarded degrees (by Grant, Program, Country, Region, Discipline)

• Type of training (by Grant, Program, Country, Region, Discipline)

• Trainee Return Rate by Grant , Program, Country, Discipline

• Trainee Accomplishments: Publications, Posters, Policy, Products, Employment, Career Highlights, teaching, new funding, further education

This information collection will not employ statistical methods.

	A.16 Project Time Schedule
Activity		Time Schedule
Record Trainee Data in CareerTrac		Immediately after OMB approval; at least annually thereafter.
Validate record entries		3 months after OMB approval; at least annually thereafter.
Review program results		6 months after OMB approval; at least annually thereafter.
Prepare management reports		9 months after OMB approval; at least annually thereafter.
Publish reports		10 months after OMB approval; at least annually thereafter.

A.17.Approval to Not Display Expiration Date

OMB Expiration Date will be displayed on the survey instruments.

A.18Exceptions to Item 19 of OMB Form 83-I

No exceptions are sought from the Paperwork Reduction Act or from form 83-I.

1 FIC Strategic Plan: http://www.fic.nih.gov/about/pages/strategic-plan.aspx ;
NIEHS Strategic Plan: http://www.niehs.nih.gov/about/strategicplan/

NIEHS

NIGMS Strategic Plan: http://publications.nigms.nih.gov/strategicplan/

Revised 9/24/2012 12