Form 1 IOTF Application

OMB No.: 0925-0761
Expiration Date: 07/31/2022
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed,
and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB 0925-0761.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0761). Do not return the completed form to this address.

Track 1: Oncology Product Research and Review for M.D. Oncology Fellows
This fellowship will train physicians in aspects of clinical trials methodology and analysis, epidemiology, clinical aspects of medical product
development, and regulation, as it relates to clinical research to facilitate the movement of drugs, biologics, and devices from the basic bench science
to commercialization.
*Selection of fellows will be dependent upon the availability of funds.

Training Goals and Outcomes
• Clinical training in an oncology subspecialty to meet the requirements for board eligibility in that subspecialty
• Understanding of the various legal and regulatory aspects of cancer product development
• Understanding the review process for regulatory pathways
• Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research
subjects and conflict of interest

• Training and experience in clinical trial design, clinical pharmacology, pharmacoepidemiology, and the product development process in the
context of clinical research

Eligibility Requirements
• Board-certified or board-eligible in internal medicine, pediatrics, surgery, and/or radiation oncology
• U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years.
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background
check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured
illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible
under state laws. Federal laws supersede all state laws.

Curricula and Responsibilities

First Year
Fellows will train in the participating oncology training programs of the NCI. During this year, fellows will undertake the primary care of both
inpatients and outpatients entered into clinical trials and develop expertise in cancer treatment as well as the specifics of clinical trial design.

Second and Third Year
During the second and third years, course work and practical experience will be provided at both agencies in a wide variety of topics such as clinical
trial design, clinical pharmacology, pharmacoepidemiology, and the legal and regulatory aspects of new product development. At both NCI and FDA,
fellows will have the opportunity to become involved in medical product development research projects, including such topics as clinical trial design
and analysis, drug regulation and post-marketing surveillance, and the basic science, epidemiology, and clinical aspects of the new agents. There will
also be the opportunity to spend approximately one day per week in continued clinical activities at NCI.

How to Apply
Applications are due January 31, 2020 for an earliest start date of July 1, 2020.
Please submit:

• Curriculum Vitae
• Personal statement of research goals
• Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for Application
(PDF)
Send application materials to:
Chanelle Case Borden, Ph.D.
IOTF Program Manager
9609 Medical Center Dr.
Rm. 2W234, MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5956
Email: casec@mail.nih.gov

Mentors

While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
Review list of mentors and projects here.
Burden Statement
OMB No.: 0925-0761
Expiration Date: 07/31/2022
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0761). Do not return the completed form to this address.
Updated: January 16, 2020
If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of
permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title;
e.g., “Track 1: Oncology Product Research and Review for M.D. Oncology Fellows was originally published by the National Cancer Institute.”

Track 2: Oncology Product Research and Review for Board Certified
Oncologists
This fellowship will train physicians in aspects of the drug, biologic, or device development and related issues and standards for assessing medical
product safety and efficacy, to facilitate the movement of drugs, biologics, and devices from basic bench science to commercialization.
Fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles and practices of FDA medical review,
including issues related to the assessment of safety and efficacy, for limited human exposure in clinical trials, and later potential exposure to the
broader patient population postmarketing approval.
*Selection of fellows will be dependent upon the availability of funds.

Eligibility Requirements
• Applicants must be Board Certified in Oncology
• Completion of clinical residency or clinical fellowship
• U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years.
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background
check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured
illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible
under state laws. Federal laws supersede all state laws.

Training Goals and Outcomes
• Training and experience in clinical trial design, clinical pharmacology, pharmacoepidemiology, and the drug development process in the context
of clinical research

• Understanding the review process for regulatory pathways
• Understanding of the various legal and regulatory aspects of cancer product development

• Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research
subjects and conflict of interest

• Understanding of mechanisms of pathogenesis and cancer biology

Curricula and Responsibilities
This is a one-year program for up to three fellows per year.
Fellows will choose one of the product or clinical divisions in FDA Centers for supplemental training. In a particular product or clinical division, these
fellows will be matched to a pre-screened pool of principal investigators for regulatory research and review or to a branch chief for regulatory review
and policies. These fellows will have the option to participate in translational research in the participating division.
Fellows will undertake and participate in various regulatory activities of the chosen division. The division director or their designee will oversee these
activities.
Regulatory activities include but are not limited to training courses and reviews of files to become proficient in the process of product,
pharmacology/toxicology or clinical reviews; and policy and guidance document development. Fellows will also participate in branch, lab, division,
and office meetings; grand rounds; and regulatory presentations offered at the participating Center. They will also participate in regulatory meetings
with investigators and sponsors.
During the training program, these fellows will be expected to attend and take and pass required tests in reviewer training and various courses
offered by participating FDA Centers.

How to Apply
Applications are due January 31, 2020 for an earliest start date of July 1, 2020.
Please submit:

• Curriculum Vitae
• Personal statement of research goals
• Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for
Application (PDF)

Send application materials to:
Chanelle Case Borden, Ph.D.
IOTF Program Manager
9609 Medical Center Dr.
Rm. 2W234, MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5956
Email: casec@mail.nih.gov

Mentors
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
Review list of mentors and projects here.
Burden Statement
OMB No.: 0925-0761
Expiration Date: 07/31/2022
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0761). Do not return the completed form to this address.
Updated: January 8, 2020
If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of
permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title;
e.g., “Track 2: Oncology Product Research and Review for Board Certified Oncologists was originally published by the National Cancer Institute.”

Track 3: Oncology Product Research and Review for Postdoctoral Research
Fellows
This fellowship will train individuals in the aspects of research and review of medical product development process to facilitate the movement of
drugs, biologics, and devices from the bench to the bedside.
Fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles, and practices of FDA medical product
review, including issues related to product development, e.g., manufacturing processes, production, purification, characterization, testing, quality
control, and quality assurance, understanding the biology, chemistry, pharmacoepidemiology, manufacturing, postmarketing surveillance, and
mechanism of action/pathogenesis of disease.
*Selection of fellows will be dependent upon the availability of funds.

Training Goals and Outcomes
• Understanding of cancer biology relevant to molecular targeted therapy
• Understanding of regulatory requirements for product development and approval process and participation in the review of regulatory files (e.g.
IND, NDA, BLA, 510k, PMA) for chemistry, manufacturing control, pharmacology/toxicology and clinical trial design

• Participation in the development of product standards and guidance document development
• Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research
subjects and conflict of interest

• Understanding the manufacturing processes, e.g., production, purification, characterization, testing, quality control, and quality assurance
• Participation in and understanding of product-related research, i.e. understanding the biology, chemistry, pharmacoepidemiology,
manufacturing, post-marketing surveillance, and mechanism of action/pathogenesi

Eligibility Requirements
• Ph.D., M.D., or M.D./Ph.D.
• Minimum of 3 years of postdoctoral training

• Must be within 5 years of the applicants most advanced degree
• U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years.
• Experience and interest in molecular targets or product development and/or design
• Fellows finishing their fourth or fifth year may qualify for a sixth year CRTA extension
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background
check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured
illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible
under state laws. Federal laws supersede all state laws.

Curricula and Responsibilities
The program time frame will be for up to two years and include up to six fellows per year.

First Year
Fellows will choose one of the product or clinical divisions in FDA Centers for supplemental training. In a particular product division, these fellows will
be matched to a pre-screened pool of principal investigators or to a branch chief for regulatory research and regulatory experience. Fellows with a
Ph.D. degree will be matched to a product division or pharmacology/toxicology branch in a clinical division.
Fellows will have the option to perform translational research in the participating division or office. These fellows will undertake and participate in
various training activities of the chosen division. The division director or their designee will oversee these activities.
Fellows will spend approximately 40% of their time in training to become proficient in the process of product or pharmacology/toxicology reviews;
and policy and guidance document development. Fellows will also participate in branch, lab, division and office meetings, grand rounds, and
regulatory presentations offered at the participating Center. They will also participate in regulatory meetings with investigators and sponsors.
Fellows are expected to conduct research activities under the guidance of principal investigators in ongoing projects in the lab. These fellows will
have option to choose their principal investigator at the beginning of program.
During the training program, fellows will be expected to attend and take and pass required tests in reviewer training and various courses offered by
participating FDA Centers.

Second Year

The first-year curricula and activities may be continued in the second year of the program based on the fellow's performance evaluated by PI, branch
chief, division director and associate directors of research at both institutions.

How to Apply
Applications are due May 31, 2020 for an earliest start date of October 1, 2020.
Please submit:

• Curriculum Vitae
• Personal statement of research goals
• Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for
Application(PDF)
Send application materials to:
Chanelle Case Borden, Ph.D.
IOTF Program Manager
9609 Medical Center Dr.
Rm. 2W234 MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5956
Email: casec@mail.nih.gov

Mentors
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
Review list of mentors and projects here.
Burden Statement
OMB No.: 0925-0761
Expiration Date: 07/31/2022

Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0761). Do not return the completed form to this address.
Updated: January 16, 2020
If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of
permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title;
e.g., “Track 3: Oncology Product Research and Review for Postdoctoral Research Fellows was originally published by the National Cancer Institute.”

Track 4: Cancer Prevention Product Research and Review for Postdoctoral
Research Fellows
This fellowship will provide training in cancer prevention (e.g., chemoprevention, vaccination, and early detection). Individuals will be trained in the
drug, biologic, or device development and approval processes and their application to study populations (including healthy subjects) to facilitate the
movement of novel approaches from the bench to the community. Combining training in public health, cancer prevention research, and researchrelated regulatory overview will allow individuals to develop expertise across these disciplines.
*Selection of fellows will be dependent upon the availability of funds.

Training Goals and Outcomes
• Understanding the design and analysis of clinical trials, familiarity with the IRB approval process, and determining appropriate clinical endpoints
in cancer prevention and early detection trials.

• Participation in multidisciplinary cancer prevention research
• Understanding the review process for regulatory pathways
• Understanding and participation in the development of product standards and guidance documents, particularly with respect to regulations for
use of agents with limited preclinical data in humans

• Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research
subjects and conflict of interest

• Understanding and developing guidelines for use of agents in chemoprevention trials that have approved indications only in the treatment
setting

• Understanding and developing criteria for "acceptable drug toxicity" in chemoprevention trials, where study subjects are often healthy
volunteers

• Understanding and developing criteria to determine acceptable surrogate clinical endpoints unique to cancer prevention trials (in contrast to
treatment endpoints: e.g., tumor response, survival)

Eligibility Requirements

• Doctoral degree (M.D., Ph.D., or equivalent)
• U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years (September 1)
• Applicants must have less than 5 years relevant postdoctoral training at the time of appointment
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background
check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured
illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible
under state laws. Federal laws supersede all state laws.

Curricula and Responsibilities
First Year
Individuals will pursue a master's degree in clinical investigation (M.S.) or in public health (M.P.H). Those already possessing a master's degree, will
come directly to the NCI/FDA and begin the activities described below.

Second Through Fourth Year
At the NCI fellows will participate in the NCI's Summer Curriculum in Cancer Prevention, Molecular Prevention Laboratory, weekly Fellows Research
Meetings and Colloquia series, Grants and Grantsmanship Workshop, Effective Presentations Workshop, and other professional development
activities.
At the FDA, depending upon research interests, fellows will choose from among the product or clinical divisions of the participating FDA Centers. In a
particular product division, fellows interested in regulatory research and related regulatory experience will work with a principal investigator or
branch chief (or designee) selected through mutual agreement. Fellows may elect to work in a product division or in a pharmacology/toxicology
branch in a clinical division. Both clinical and non-clinical fellows will have the option of performing translational research in the participating
division, branch, or office.
Fellows will participate in various regulatory activities of the division at the FDA where they undertake their research. Fellows will spend
approximately 40% of their time in product, pharmacology/toxicology, or clinical reviews and policy and guidance document development. They will
participate in grand rounds and meetings related to regulatory activities. Additionally, fellows will attend courses offered by the participating FDA
Centers and pass required testing in reviewer training.
Fellows' performance will be evaluated by Fellowship Program staff at the NCI and FDA, research mentors, and scientific staff overseeing fellows'
activities at either institution.

How to Apply
Applications are due August 25, 2020 for an earliest start date of July 1, 2021.
Please submit:

• Curriculum Vitae
• Personal statement of research goals
• Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for Application
(PDF)
Where To Submit:

• Application guidelines and further information are available at Cancer Prevention Fellowship Program.

Mentors
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
Review list of mentors and projects here.
Burden Statement
OMB No.: 0925-0761
Expiration Date: 07/31/2022
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0761). Do not return the completed form to this address.
Updated: January 16, 2020

If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of
permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title;
e.g., “Track 4: Cancer Prevention Product Research and Review for Postdoctoral Research Fellows was originally published by the National Cancer Institute.”

OMB No.: 0925-0761
Expiration Date: 07/31/2022
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed,
and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0761). Do not return the completed form to this address.

NCI-FDA Research and Regulatory Review Fellowships
Guidelines for Application
Application Materials
The following application materials are required, as described below:
•
•
•
•
•

Personal statement of research goals
Curriculum vitae
Three letters of reference
Academic transcripts
Other documentation

Personal statement of research goals. In narrative form describe your research interests and
goals and how these relate to the field of cancer research and regulatory review. Please also
provide insight into your short-and long-term career goals, and explain how the IOTF will help
you in achieving those goals. Limit your personal statement to two typed, single-spaced pages
and use 12-point font and 1” margins (approximately 1,000 words).
Curriculum Vitae. Please refer to Guidelines for Application/Information to
Include in Curriculum Vitae section.
Letters of Reference. Three current and original letters of reference must be sent directly to
the CCT Office of Training and Education by individuals in the scientific/academic
community who have knowledge of your scientific accomplishments, motivation, and skills.
Letters should be addressed to the Program Director, Dr. Chanelle Case Borden; typewritten
on official letterhead; written in English; and contain an original signature. A faxed copy is
acceptable provided that the original letter is sent by mail and postmarked on or before the
deadline for the appropriate program. Photocopies and electronic copies are not acceptable.
AcademicTranscripts. Copies of all graduate and undergraduate transcripts
(and/or translations, if applicable) must be submitted directly to the CCT Office of Training
and Education.
Other Documentation. Permanent residents of the United States must submit proof of
eligibility for citizenship. The I-551 stamp in a passport is acceptable; “Employment
Authorization” documents are not acceptable.

Information to Include in Curriculum Vitae
• Applicants are encouraged to use their current curriculum vitae and to add
any necessary information.
• Please include your name on each page of the curriculum vitae.
• Some of the information requested below will not be applicable to all
individuals.
• Please do not print or type your information on this page.

Date Prepared
__________________________________________________________
Personal Information
__________________________________________________________
Name (First middle last)
Gender (optional)
Race (optional)
Date of birth
Place of birth (city, state, country)
Home address
Work/school address
Telephone (if more than one telephone number is provided, please indicate preferred contact)
Fax
E-mail (if more than one e-mail address is provided, please indicate preferred contact)
Citizenship
__________________________________________________________
Country of citizenship
U.S. permanent resident number, if applicable

Education
__________________________________________________________
Please list all colleges and universities attended and any other relevant training. Include the
following information for each institution:
School, department, city and state, country
Dates attended, academic major, degree, year degree awarded/expected

Work Experience
__________________________________________________________
Please list current and past employment. Include the following information for each position:
Title, employer’s name, address, and telephone
Dates of employment, hours per week
Brief description of duties and accomplishments
Other Information
__________________________________________________________
Please note that the items requested below may not be relevant to all applicants.
Board certification
Committees
Grants awarded
Honors and awards
Patents
Peer-review service
Professional licenses
Professional society memberships
Scientific presentations
Teaching
Research Interests
__________________________________________________________
Please provide a few key words that describe your research interests.
Bibliography
__________________________________________________________
Please list all publications and indicate whether they are “published,” “in press,”
“submitted,” or “in preparation.” Please list full-length manuscripts and abstracts separately.

How to Submit Application Materials
If you are interested in applying to the IOTF and meet the eligibility requirements (refer to
Eligibility section), you may submit your application either:
• Email: send materials to chanelle.case@nih.gov
• Via postal mail
Please select only one method by which to submit your application. If more than one
application is received for an applicant, only the first application received will be considered.

Applying By Email
Personal Statement of Research Goals and Curriculum Vitae. Please send our Application to
chanelle.case@nih.gov. And provide your personal statement of research goals and curriculum
vitae as two separate documents. The application must be submitted on or before the
appropriate deadline for the desired program.
Letters of Reference, Academic Transcripts, and Other Documentation. Three letters of
reference, academic transcripts, and other documentation materials should be sent directly to
Dr. Case Borden (refer to Contact Information below). All application materials must be
postmarked on or before the appropriate deadline for the desired program.

Application Deadline: As Appropriate for Each program
Contact Information
Send application materials to:
Chanelle Case Borden, Ph.D.
IOTF Program Director
Center for Cancer Training
Office of Training and Education
National Cancer Institute
9609 Medical Center Drive
Rm. 2W234
Bethesda, Maryland 20892-9707
Selection for these positions will be based solely on merit, with no discrimination for non-merit reasons, such as race, color,
gender, national origin, age, religion, sexual orientation, or physical or mental disability. NIH and FDA provide reasonable
accommodations to applicants with disabilities. If you need reasonable accommodation during any part of the application and
hiring process, please notify us. The decision on granting reasonable accommodation will be handled on a case-by-case basis.
THE NIH/NCI AND FDA ARE AN EQUAL OPPORTUNITY EMPLOYER.