Supporting Statement[1]

Supporting Statement A for

NIH INTRAMURAL RESEARCH

TRAINING PROGRAM APPLICATIONS

NIH/OD/OIR/OITE

August 17, 2009

Sharon Milgram, Ph.D.

Director, Office of Intramural Training & Education

Graduate Partnerships Program

National Institutes of Health

2 Center Drive: Building 2 / 2E06

Bethesda, Maryland 20892-0234

Phone: (301) 594-9605

Fax: (301) 594-9606

E-mail: [email protected]

Web: http://www.training.nih.gov

Michael Gottesman, M.D.

Deputy Director for Intramural Research

National Institutes of Health

1 Center Drive

Building 1 / Room 103

Bethesda, MD 20892

Phone Number: (301) 496-1921

Fax Number: (301) 402-4273

E-mail Address: [email protected]

Table of Contents

A1. Circumstances Making the Collection of Information Necessary 4

A2. Purpose and Use of the Information Collection 8

A3. Use of Information Technology and Burden Reduction 9

A4. Efforts to Identify Duplication and Use of Similar Information 9

A5. Impact on Small Businesses or Other Small Entities 10

A6. Consequences of Collecting the Information Less Frequently 10

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 11

A8. Comments in Response to Federal Register Notice and Efforts to Consult Outside Agency 11

A9. Explanation of Any Payment or Gift to Respondents 12

A10. Assurance of Confidentiality Provided to Respondents 12

A11. Justification for Sensitive Questions 13

A12. Estimates of Hour Burden Including Annualized Hourly Costs 14

A13. Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers 16

A14. Annualized Cost to the Federal Government 16

A15. Explanation for Program Changes or Adjustments 18

A16. Plans for Tabulation and Publication and Project Time Schedule 18

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate 18

A18. Exceptions to Certification for Paperwork Reduction Act Submissions 18

LIST OF ATTACHMENTS

ATTACHMENT 1 – Data Collection Instruments

A1. Circumstances Making the Collection of Information Necessary

The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit and develop individuals who participate in research training activities on the NIH's main campus in Bethesda, Maryland, as well as other facilities around the country. These activities range from internships at the pre-college level through postdoctoral and clinical fellowships. To facilitate its recruitment function, the OITE maintains the NIH Research and Training Opportunities Web site, http://www.training.nih.gov, which includes applications and related forms for the following intramural research training programs:

1. Postdoctoral Fellowship Program

2. Summer Internship Program in Biomedical Research (SIP)

3. Biomedical Engineering Summer Internship Program (BESIP)

4. Postbaccalaureate Intramural Research Training Award (IRTA)

5. NIH Academy

6. Clinical Research Training Program (CRTP)

7. Technical Intramural Research Training Award (IRTA)

8. Year-Off Training Program for Graduate or Medical Students

9. Clinical Electives Program (CEP)

10. National Graduate Student Research Festival (NGSRF)

The proposed information collection activity is necessary in order to determine the eligibility and quality of potential awardees for traineeships in these programs.

Title 42 Section 282(b)(13) of the U.S. Code authorizes the Director, NIH, to conduct and support research training for which fellowship support is not provided under Part 487 of the PHS Act (i.e., National Research Service Awards), and that is not residency training of physicians or other health professionals. Section 405(b)(1)(C) of the Public Health Service (PHS) Act [42 U.S.C. 284(b)(1)(C)] grants this same authority to the Director of each national research institute.

In addition, Title 42 Part 63 of the Code of Federal Regulations specifies NIH rules regarding the procedure for applying for traineeships, the minimum qualifications for awards, and the criteria for awarding traineeships. Fellowships are awarded based on merit to promising students and young scientists who will gain the most benefit from the training opportunity—not on the basis of geographic, formula, per capita, or other extrinsic factors. To be considered, an individual must apply directly to the NIH for support, providing information on her academic background and previous research experience, along with a statement of her research goals and reasons for seeking a training experience. This information in available only from the individual wishing to participate in the program, not from other sources, and is used by program officials to assure that applicant meets basic eligibility requirements and to determine whether the individual should be granted an award.

The principal appointment authority for programs (2) through (8) above is the Intramural Research Training Award (IRTA). The IRTA program was 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 laboratories of the NIH during the formative stages of their academic training or research careers.

Participation in the IRTA fellowship program is restricted to U.S. citizens, non-citizen nationals of the U.S., and individuals lawfully admitted for permanent residence in the United States. Eligibility for three of the programs above, however, extends as well to foreign citizens. These are the Postdoctoral Fellowship Program, the Clinical Electives Program (CEP), and the National Graduate Student Research Festival (NGSRF).

Applicants with foreign citizen status who are chosen for postdoctoral fellowships may be appointed as part of the Visiting Fellowship (VF) program. The VF is an award to a foreign scientist, with 5 years or less of relevant postdoctoral research experience, offering advanced research experience and training and not requiring the performance of services for the NIH. VFs are authorized by section 307 of the Public Health Service Act [42 U.S.C. 242l] and PHS Regulations at 42 CFR, Part 61, Subpart A.

Applicants chosen to participate in the Clinical Electives Program—regardless of their country of citizenship—serve as part of the Special Volunteer (SV) Program. SVs are individuals who provide research services, direct patient care, clerical support, technical assistance, or any other necessary services for NIH. The legal authority for this program is from Sections 402 and 405 of the PHS Act (42 U.S.C. 282 and 42 U.S.C. 284), according to which the Director, NIH, and the Directors of the national research institutes and centers may accept and use the services of volunteers in carrying out the functions of NIH pursuant to section 301 of the PHS Act (42 U.S.C. 241).

Finally, applicants chosen to participate in the NGSRF—a two-day recruitment event held on the main NIH campus in Bethesda, MD—come to the NIH as guests.

Upon submitting an application to any one of the above programs, the applicant is invited to complete an optional Race/Gender/Ethnicity survey. Data collected via this form are made available to NIH staff in aggregate form only; NIH personnel do not and cannot link individual survey responses to specific applications.

In addition to the statutes referenced above, legal authority also exists for specific NIH Institutes and Centers to conduct and support research training, as follows: The National Cancer Institute (NCI) [per 42 U.S.C. 241 and 42 U.S.C. 285]; the National Center for Complementary and Alternative Medicine (NCCAM) [per 42 U.S.C. 287c-21(a)]; the National Human Genome Research Institute (NHGRI) [per 42 U.S.C. 287c(b)]; the National Institute of Nursing Research (NINR) [per 42 U.S.C. 285q-1]; the National Library of Medicine (NLM) [per 42 U.S.C. 286b-3]; the National Center on Minority Health and Health Disparities (NCMHD) [per 42 U.S.C. 287c-31]; and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) [per 42 U.S.C. 285r]. See Attachment 1 for copies of these and all other statutes referenced in this section.

A2. Purpose and Use of the Information Collection

The purpose of the proposed information collection activity is to assure that applicants to traineeships in the NIH Intramural Research Program 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.

To apply for a traineeship, an individual must provide his contact information; citizenship status and, if applicable, visa status or Alien Registration Number; a cover letter describing his research goals and interests; a resume or curriculum vitae; and names and contact information for individuals who can write letters of reference for the applicant and/or verify his student status and approve his participation in the training program (one letter for the NGSRF; two for SIP, BESIP, Technical IRTA, and CEP; three for all other programs). In addition, there are several application-specific required items, such as publications, academic background, including institutions attended, degrees earned, coursework completed, and grades received. For details, see Attachment 1.

The purpose of the collection from the applicant's references is to obtain others' perspectives on the applicant's academic strengths, interest in biomedical research, and career potential, thus providing NIH staff involved in the award process better data on which to base their decisions.

The purpose of the collection involving the Race/Gender/Ethnicity survey is to assess the extent to which the various NIH Institutes and Centers are making progress toward the common goal of building a diverse community in NIH's research training programs. The NIH scientists and administrators who have access to this data receive it in aggregate form only.

In the past three years, the collection has operated smoothly. While the number of applications submitted via OITE's online system has increased by 30% since 2006, the system has handled the increased traffic without a problem.

A3. Use of Information Technology and Burden Reduction

The applications for the ten research training programs listed above reside on the NIH Research and Training Opportunities Web site, http://www.training.nih.gov. Prospective trainees submit their applications, and references submit their letters of recommendation, via this site. In addition, each online application has an associated online tool that enables the user to update and modify her application, check to see whether her letters of recommendation have been submitted, and, if not, resend an e-mail request for the letter to the reference. (The Modify Application tools enable the applicant to view each letter's status only—i.e., not the letters, themselves.)

While applicants who are selected to participate in a training program must then submit hard copies of certain documents (e.g., official transcripts, proof of citizenship, etc.), the OITE's online system reduces the burden on every applicant by streamlining the application process, improves agency efficiency and responsiveness to the public, and reduces the financial cost to applicants.

A Privacy Impact Assessment has been completed for this system.

A4. Efforts to Identify Duplication and Use of Similar Information

In general, this is not applicable. No duplicate or similar information exists. All required information is known by the applicants alone, is unique to the individuals concerned, and is not available from other sources. The only exceptions are the Postdoctoral Fellowship Program and the NGSRF. The postdoctoral program is unique in that it allows users to submit applications for multiple fellowships, whereas the other programs disallow multiple applications from the same individual. To minimize the amount of duplicate information that a returning user must enter, the postdoctoral system pre-populates all fields on the application form (except the cover letter field) with data the user provided on her most recently submitted application.

Similarly, the NGSRF application is designed to facilitate the user's subsequent application to the Postdoctoral Fellowship Program by importing most of the common data from the NGSRF application into the postdoctoral fellowship application and vice versa.

A5. Impact on Small Businesses or Other Small Entities

Not applicable. Only individuals are eligible for the intramural training programs, not small businesses.

A6. Consequences of Collecting the Information Less Frequently

Summer traineeships are not renewable, so applicants must submit the required information each time they apply for program consideration, at most once a year. For those traineeships that are renewable, participants submit the required information only once, at the time they initially apply. Applications remain in the program database for one year (two years for CEP), after which time they are archived. An individual whose application has been archived, but who is still eligible for the program, may submit a new application. Here, and in this case of summer traineeships, collecting the information less frequently would have an untoward affect on the award process, as it would require NIH investigators and administrators who make these decisions to do so on the basis of information that is potentially out of date.

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

This information collection is consistent with these guidelines.

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

The Federal Register Notice was originally published on June 16, 2009 (Vol. 74, No. 114) on pages 28501-28502 of the Federal Register. No public comments were received.

Informal consultations were held with a number of university officials at the time the program was established. The burden to potential applicants was viewed as minimal and appropriate. Current participants and applicants have readily agreed to provide this information, without objection regarding any of the specific requirements. In addition, OITE and the Offices of Human Resources and Intramural Research are in continual contact with the NIH Institutes and Centers, and continuing dialogue indicates the programs are operating well.

A9. Explanation of Any Payment or Gift to Respondents

No payment or gifts were given to respondents.

A10. Assurance of Confidentiality Provided to Respondents

Information collected is available only to NIH 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 Center for Information Technology, and the online tools these individuals use to access applicant data are restricted to NIH users only. 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 collected is subject to the Privacy Act, and is collected and maintained in accordance with records system number 09-25-0158, "Administration Records of Applicants and Awardees of the Intramural Research Training Awards Program, HHS/NIH/OD/OE," records system number 09-25-0014, "Clinical Research: Student Records, HHS/NIH/OD/OIR/OE," and records system number 09-25-0108, "Personnel: Guest Researchers, Special Volunteers, and Scientists Emeriti, HHS/NIH/OHRM."

The Privacy Act Notification Statement that appears on each application states, "Collection of this information is authorized under 42 U.S.C. 282(b)(13), 284(b)(1)(C), 241, 242l, 282(b)(10), 284(b)(1)(K), 42 CFR Part 63, and 42 CFR Part 61, Subpart A. The primary use of this information is to evaluate your qualifications for research training at the National Institutes of Health. Additional disclosures may be made to law enforcement agencies concerning violations of law or regulation. Application for this program is voluntary; however, in order for us to process your application, you must complete the required fields."

OITE's Web site contractor is required to adhere to the security guidelines contained in the DHHS Automated Information Systems Security Program (AISSP) Handbook. Software development is performed on a shared NIH server residing inside the NIH firewall. Development occurs on contractor-owned servers, with staging on servers maintained by the NIH Office of Information Technology. All contract employees are subject to a National Agency Check and Inquiry Investigation plus a Credit Check (NACIC).

Data collected via the Race/Gender/Ethnicity form are made available to NIH staff in aggregate form only; NIH personnel cannot link individual survey responses to specific applications.

A11. Justification for Sensitive Questions

Not applicable. The applications do not contain sensitive questions. The system does collect Personally Identifiable Information (PII)—including the applicant's name, contact information, and education and employment history. See section A2 above. The purpose of collecting this information is to assure that applicants meet basic eligibility requirements and to assess their potential as future scientists.

In addition, the system includes an optional Race/Gender/Ethnicity survey. The purpose of collecting this data is to assess the extent to which the various NIH Institutes and Centers are making progress toward the common goal of building a diverse community in NIH's research training programs. NIH personnel who have access to this data receive it in aggregate form only.

A12. Estimates of Hour Burden Including Annualized Hourly Costs

Approximately 16,000 individuals annually apply to one or more of the aforementioned programs administered by the OITE. Most graduate and postdoctoral applicants have already prepared or secured most of the required application documents (e.g., curriculum vitae, list of publications, reference information, etc.) in anticipation of applying for such training positions, either at the NIH or at other research institutions. Therefore it is estimated that it would take these applicants approximately one hour to complete the application process. For high school and undergraduate students, approximately one hour is needed to prepare the documents as well. Applicants may provide "placeholder" data when answering required questions and return to provide the actual data later, via the Modify Application Tool. (Also, the SIP, BESIP, Postbaccalaureate IRTA, and NIH Academy applications were recently modified to enable users to submit partial applications and complete them over multiple sessions.) Estimates of the number of respondents for the various applications are based on past data, as is the estimated number of respondents for the Race/Gender/Ethnicity survey, and the estimated number of postdoctoral application responses per respondent. There is no data available regarding the number of respondents for the various Modify Application tools, so these estimates are based on an informal sampling of current applications.

The following table displays the estimated hour burden for each form included in this project.

Table A12.1: Estimates of Hour Burden

Program	Estimated number of respondents	Estimated number of responses annually per respondent	Average burden hours per response	Estimated total annual burden hours
Postdoctoral Fellowship application	2,050	2	1	4,100
Modify Postdoctoral Fellowship Application tool	1,374	2	1	2,748
SIP application	8,500	1	1	8,500
Modify SIP Application tool	5,667	1	1	5,667
BESIP application	100	1	1	100
Modify BESIP Application tool	67	1	1	67
Postbaccalaureate IRTA application	2,300	1	1	2,300
Modify Postbaccalaureate IRTA Application tool	1,533	1	1	1,533
NIH Academy application	550	1	1	550
Modify NIH Academy Application tool	367	1	1	367
CRTP application	140	1	1	140
Modify CRTP Application tool	93	1	1	93
Technical IRTA application	140	1	1	140
Modify Technical IRTA Application tool	93	1	1	93
Year-Off Training Program application	50	1	1	50
Modify Year-Off Program Application tool	33	1	1	33
CEP application	100	1	1	100
Modify CEP Application tool	67	1	1	67
NGSRF application	825	1	1	825
Modify NGSRF Application tool	550	1	1	550
References for all categories	38,725	1	1	38,725
Race/Gender/Ethnicity survey	4,307	1	0.25	1,077
Total	67,631(71,055)			67,825

The following table indicates the annualized cost to respondents. Hourly wage rates for trainees are based on 2009-2010 NIH IRTA/Visiting Fellow Trainee Stipends that became effective on May 1, 2009. See http://www1.od.nih.gov/oma/manualchapters/person/2300-320-7/.

Table A12.2: Annualized Cost to Respondents

Type of Respondent	Estimated number of respondents	Estimated total annual burden hours	Hourly wage rate	Respondent cost
Postdoctoral Fellowship application	2,050	4,100	$24.50	$100,450
Modify Postdoctoral Fellowship Application tool	1,374	2,748	$24.50	$67,326
SIP application	8,500	8,500	$13.75	$116,875
Modify SIP Application tool	5,667	5,667	$13.75	$77,921
BESIP application	100	100	$13.75	$1,375
Modify BESIP Application tool	67	67	$13.75	$921
Postbaccalaureate IRTA application	2,300	2,300	$13.00	$29,900
Modify Postbaccalaureate IRTA Application tool	1,533	1,533	$13.00	$19,929
NIH Academy application	550	550	$13.00	$7,150
Modify NIH Academy Application tool	367	367	$13.00	$4,771
CRTP application	140	140	$19.50	$2,730
Modify CRTP Application tool	93	93	$19.50	$1,814
Technical IRTA application	140	140	$13.00	$1,820
Modify Technical IRTA Application tool	93	93	$13.00	$1,209
Year-Off Training Program application	50	50	$18.25	$913
Modify Year-Off Program Application tool	33	33	$18.25	$602
CEP application	100	100	$19.50	$1,950
Modify CEP Application tool	67	67	$19.50	$1,307
NGSRF application	825	825	$19.50	$16,088
Modify NGSRF Application tool	550	550	$19.50	$10,725
References for all categories	38,725	38,725	$40.00	$1,549,000
Race/Gender/Ethnicity survey	4,307	1,077	$17.00	$18,309
Total	67,631	67,825		$2,033,085

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 online application systems referenced in this document are covered by two separate contracts: OITE's Web Site Maintenance contract, which covers all systems except BESIP, and a separate contract managed through the National Institute of Biomedical Imaging and Bioengineering (NIBIB). OITE's Web Site Maintenance contract is a one-year contract with four option years.

The cost of the base year of the contract is approximately $370,600, with an average cost increase of 3.5% each option year. The systems referenced here represent approximately 68% of the total cost of the two contracts combined. Thus, the approximate cost to the Federal government is as follows:

$251,967 Base year (9/29/05 - 9/28/06)

$260,791 Option year 1 (9/29/06 - 9/28/07)

$269,928 Option year 2 (9/29/07 - 9/28/08)

$279,354 Option year 3 (9/29/08 - 9/28/09)

$289,141 Option year 4 (9/29/09 - 9/28/10)

$1,351,181 Total cost

The annualized cost to the Federal government is approximately $270,236.

A15. Explanation for Program Changes or Adjustments

The number of applications submitted via OITE's online system has grown considerably over the last three years—a 30% increase overall. As the number of applications has increased, OITE has streamlined the online system in several ways. For example, the Summer Internship Program (SIP) and the former Summer Research Fellowship Program (SRFP) applications have been combined into a single system, eliminating redundancy. Also, the SIP, BESIP, Postbaccalaureate IRTA, and NIH Academy applications have been modified to enable users to submit partial applications and complete them over multiple sessions, making it unnecessary for users to spend time submitting placeholder data when the required information is not readily available. Ultimately, however, these changes were primarily aimed at making the application process easier for users and did not have a significant effect on the total time required to complete the forms. The marked increase in the total number of applications received outpaced all streamlining efforts and necessitated the increase in burden.

A16. Plans for Tabulation and Publication and Project Time Schedule

There are no plans for statistical analyses in publications.

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

The OMB No. 0925-0299, Expiration 8/31/2009 and the Burden Disclosure Statement are listed on each electronic application form. See Attachment 1.

A18. Exceptions to Certification for Paperwork Reduction Act Submissions

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

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