Supporting Statement -A- International Research Fellowship Award Program

Supporting Statement A for

International Research Fellowship Award Program

of the National Institute on Drug Abuse

National Institutes of Health

September 7, 2015

Steve W. Gust PhD

Director, NIDA International Program

National Institute on Drug Abuse

National Institutes of Health

6001 Executive Blvd.

Bethesda, Maryland 20892-0234

Phone: 301-443-6480

Fax: 301-443-6277

E-mail: [email protected]

Table of Contents

A1. Circumstances Making the Collection of Information Necessary 4

A2. Purpose and Use of the Information Collection 5

A3. Use of Information Technology and Burden Reduction 7

A4. Efforts to Identify Duplication and Use of Similar Information 7

A5. Impact on Small Businesses or Other Small Entities 8

A6. Consequences of Collecting the Information Less Frequently 8

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 8

A8. Comments in Response to Federal Register Notice & Efforts to Consult Outside Agency 8

A9. Explanation of Any Payment or Gift to Respondents 9

A10. Assurance of Confidentiality Provided to Respondents 9

A11. Justification for Sensitive Questions 9

A12. Estimates of Hour Burden Including Annualized Hourly Costs 10

A13. Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers 11

A14. Annualized Cost to the Federal Government 11

A15. Explanation for Program Changes or Adjustments 12

A16. Plans for Tabulation and Publication and Project Time Schedule 12

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate 12

A18. Exceptions to Certification for Paperwork Reduction Act Submissions 12

Attachments

1. Attachment 1- Form - Application for International Research and Fellowship Award Program

2. Attachment 2- Form - Applicant Consent Form

3. Attachment 3 – Form – Application Part II – Mentor Information and Agreement Form

4. Attachment 4 - NIH Privacy Act Officer Memo

5. Attachment 5 - 30-day Federal Register Notice

Abstract.

Initially this collection was part of a clearance request for the application forms for

two programs, and due to protracted delays in the readiness of one of the programs

it became necessary to create a stand-alone request for this program. The request is for the Application Forms for this new research training program in HIV/AIDS and drug use. The Program will fund post-doctorates and researchers in this research area. The application

forms for this Program will be web-based. This Program is for foreign nationals.

A1. Circumstances Making the Collection of Information Necessary

The National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH),

requests a three-year clearance for the application form that the Institute will use for its

new International Research and Fellowship Award Program. This program will recruit

post-doctoral researchers into a new fellowship research training program for HIV and

drug use. The program will train new researchers in research to advance the science of

HIV and drug use and foster multinational research in this disease area. The program is

open to all foreign nationals.

The legal authority granted to NIH to train future biomedical scientists comes from several sources.  Title 42 of the U.S. Code, Sections 241 and 282(b)(13) 282 (11)B authorize the Director, NIH, to conduct and support research training for which fellowship support is not provided under Part 487 of the Public Health Service (PHS) Act (i.e., National Research Service Awards), and that is not residency training of physicians or other health professionals.  Sections 405(b)(1)(C) of the PHS Act and 42 U.S.C. Sections 284(b)(1)(C)]

and 285-287 grant this same authority to the Director of each of the Institutes/Centers at

NIH. NIDA considered the need to increase research training for the treatment and prevention of HIV/AIDS and a new Program was added to the training portfolio in 2014. Clearance for the application form for this training program is needed. 

Details of the Program are as follows:

This program will offer annually, awards to junior scientist for post-doctoral training, at

leading institutions of foreign countries excelling in research in the HIV-related and drug

use field.

Identification of participants to matriculate into the program comes from the application

form, and this will be hosted at the NIDA Web site http://www.drugabuse.gov/ , upon

receiving OMB clearance for this request. The proposed information collection activity is necessary in order to determine the eligibility and quality of potential awardees for the

research training opportunity of this program. The form for this program was developed by NIDA staff.

Prospective trainees for the fellowship opportunity must apply directly to the NIH/NIDA,

using the application form. Participation in this program is restricted to non-U.S. citizens,

and the principal appointment authority for this program comes from the Authority

mentioned above.

The awards of this program will be made annually. The application form may be renewed annually through an internal process, for changes that may be needed and to prevent any duplication of information. The financial support provided to the awardees comes from NIDA.

Application Guidelines

The guidelines for this Program will be available upon obtaining OMB clearance and no later than April 2016, on the NIDA website http://www.drugabuse.gov/. The Guidelines will comply with the Plain Writing Act of 2010, to provide clear communication that the public can understand and use. For future guidelines and changes the Federal Plain Language Guidelines will be followed similarly.

A2. Purpose and Use of the Information Collection

The purpose of the proposed information is for the selection of the best applicants for this fellowship program. An application form to obtain information about the potential of fellows for successful training in HIV and drug use research is necessary. NIDA will request clearance for any additional forms that may be needed if new programs or program components are added to this program in the future, or if the form for this new program may need some modifications for better clarity of information.

The information ensures that fellows applying to these programs meet eligibility requirements for research; indicates their potential as future scientists; determines where mutual research interests exist; and enables decision-making regarding which applicants will be proposed and approved for investigator rewards. In each case, completing an application is voluntary, but in order to receive due consideration, the prospective applicant must complete all fields required by the program.

Information included in the forms is:

• Personal information (name, year of birth);

• Eligibility information (country of citizenship, certification questions, previous or current affiliation with NIH, trainee status, financial aid);

• Contact information (mailing, e-mail, phone for current, permanent and future address);

• Research interests;

• Educational history (university, academic major, attendance dates, degree awarded);

• Employment history and interests (type of employment, organization, department, address, title, category);

• Reference information (name, contact information); or Letters of Reference

• Resume components (position title, name and address of institution, name and address of mentor and contact information, , research experience, publications, presentations, awards /honors, extracurricular activities, personal statement / research proposal);

• Dissertation research information;

• Letter of recommendation (letter and evaluation form); Mentor Certification and Acceptance (as relevant);

• List of publications;

• Future contact information;

• Question on gender

For this program contact information and research experience history is also asked of the proposed mentor.

The NIDA staff review the applications and determine the applicants eligible for the awards, and processes the information to be sent to the applicants.

The information may also be used by NIDA for strategic planning, performance analysis, and to provide information to the Administration and to Congress if needed, on the overall program.

A3. Use of Information Technology and Burden Reduction

The applications will be Web based and will be made accessible through the NIDA site at http://www.drugabuse.gov/ . A Privacy Impact Assessment will be conducted annually, as indicated by NIH Privacy Act Office (see Attachment 4). The information requested is for the purpose of identifying applicants with the best and most needed research that would be productive from training for research on HIV/AIDS, the best capacity for research training, and strong interests in a biomedical research career.

Features of the online applications include, but are not limited to the following elements:

• Edit submitted application to ensure up-to-date information for evaluation

• E-mail confirmation of start of an application

• E-mail confirmation of successful submission of application,

• Request for resubmission of recommendations and/or other information via e-mail program

• E-mail notification of application status

In addition, prospective applicants will be able to review Web pages hosting Application, Instructions, and Program Policies and Procedures prior to submitting an application for admission consideration. The details to be posted on the site will enable applicants to carefully complete and submit a well-organized application. The estimated time to complete an application of this program is 60 minutes based on the similarity of the information and number of items asked, to the US PHS- 398 grant application form.

The NIDA 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 (there is no application fee for these programs).

A4. Efforts to Identify Duplication and Use of Similar Information

Applicants to the programs must submit an application through the NIDA system because there are no duplicate sources available for the information needed.

A5. Impact on Small Businesses or Other Small Entities

No small business or other small entities will be affected by this program. Some applicants for the program may be small non-profit organizations or entities such as clinicians. Every effort has been made to streamline processes and instructions and to simplify the application and reporting processes. The Institute’s internal clearance process ensures that no undue burden is placed on any applicant for these kinds of funding programs.

A6. Consequences of Collecting the Information Less Frequently

This program will be implemented annually in the sense that each year a new set of participants is selected and funded. The information is collected only once for an award. It cannot be collected less frequently.

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

This information collection is consistent with these guidelines. Submitting an application to this program is voluntary.

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

Notification of information collection for the Training Programs was published on October 8, 2014, in the Federal Register Notice, Vol. 79, No.195, on page 60895. During the 60-day notice period, no comments were received.

The application form for this program was developed by Dr. Steve Gust, and NIDA cooperating scientists among NIDA program staff.

A9. Explanation of Any Payment or Gift to Respondents

No payments or gifts are provided to respondents for completing an application form.

A10. Assurance of Confidentiality Provided to Respondents

The information collected is available to NIH staff via an internal SharePoint site. The staff includes science and program officials who recommend or approve awards, administrative staff, human resources staff, financial officials who prepare the necessary documentation to arrange for stipend payments and to activate, renew, and terminate approved awards. Access to the applications will be via protected login credentials. Privacy is assured to the extent provided by law. Applicants will be able to access the application site via a link, and will enter their information after establishing login credentials that include "strong" passwords that conform to standards used by the NIH Center for Information Technology. Applicants will have access to only their own applications once they have been uploaded to the site. Letters of recommendation that may be submitted to NIDA will be stored in the protected NIH/NIDA protected servers with restricted access. .

The information is collected and maintained in accordance with the DHHS Automated Information Systems Security Program Handbook. For all applications the software used is on an internal shared NIH server residing inside the NIH firewall. The NIH Privacy Act Office has determined that the Privacy Act will apply to this information collection. (See Attachment 4).

A11. Justification for Sensitive Questions

No sensitive information on sexual orientation, risk behaviors, religious beliefs, or other personal matters is asked.

A12.1 Estimated Annualized Burden Hours

The estimated time to complete the online application for the HIV and drug use research training is 60 minutes, based on its length and information items that are similar to the PHS-398 grant application form that has OMB clearance. The estimated time to complete the consent form for the application is 30 minutes. The estimated time to complete the mentor agreement form is 20 minutes. The expected number of applicants for this program is 45, the expected number of applicants signing the consent form is 45, the expected number of mentors for this program is 45, the total expected number of respondents is 135.

Table A12-1. Estimated Annualized Burden Hours

Form Name	Type of Respondent	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Annual Burden Hours
A. Application	Applicant Scientists	45	1	1	45
B. Consent Information	Applicant Scientists	45	1	30/60	23
C. Mentor Information and Agreement	Scientists	45	1	20/60	15
	Totals	135	135		83

A.12.2 Annualized Cost to Respondents

There are no costs to respondents other than their time to complete the forms. The costs to respondents for this time is in Table A12.2 below.

Table A12-2. Annualized Cost to Respondents

Type of Respondent	Number of Respondents	Burden Hours		Hourly Wage 1	Respondent Cost
Applicant Scientists	45	45		$36.64		$1,648.80
Applicant Scientists	45	23		$36.64		$847.72
Scientists	45	15		$36.64		$549.60
Totals	135		83		$3,046.12

1. Mean hourly wage estimates (calculated with data collected from employers in all industry sectors in’

methopolitan and nonmetropolitan areas in every state and the District of Columbia) for Healthcare

Practitioners and Technical Occupations, -29-0000, Occupational Employment Statistics, May 2014

National Occupational Employment and Wage Estimates Unites States, Bureau of LaborStatistics.

Retrieved from http://www.bls.gov/ooh/life-physical-and-social-science/medical-scientists.htm on 09/07/2015.

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 cost to the Federal Government of these programs is approximately $300,000 a year for the HIV and drug use research training program. The time of the NIDA Program Official for this program is five percent at a cost of $5,600, and the Contractor cost is $2,500. The total annual cost to the Federal Government is approximately $308,100.00.

Table A.14. Annualized Cost to the Federal Government

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight – Program Analyst	13/10	$112,000	5		$5,600
Contractor Cost		$50,000	5		$2,500
Program Fellowships and Awards					$300,000
Travel
Other Cost
Total					$308,100

A15. Explanation for Program Changes or Adjustments

This is a new information collection request.

A16. Plans for Tabulation and Publication and Project Time Schedule

 Table A.16   Plans for Tabulation and Publication and Project Time Schedule

Activity	Time Schedule
Program Applicant Recruitment	The month of May after OMB clearance
Participant Enrollment and Data Collection (annually)	June - July
Data Management and Analysis (annually)	Ongoing through December

           

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

The OMB control number and expiration date will be displayed.

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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