Form QTDP Project Information Memorandum

Form Approved Through 11/30/2010

OMB No. 1545-2175

Qualifying Therapeutic Discovery Project Program

Project Information Memorandum

Do not exceed word count restrictions indicated.

I. APPLICANT ORGANIZATION INFORMATION
1. NAME OF APPLICANT ORGANIZATION

2. TAXPAYER IDENTIFICATION NUMBER (TIN)

3. ADDRESS NUMBER AND STREET

4. ROOM/SUITE

5. CITY, TOWN, OR POST OFFICE

6. STATE

7. ZIP CODE

8. URL ADDRESS FOR APPLICANT’S WEB SITE

II. CONTACT PERSON INFORMATION
9. FIRST NAME

10. MIDDLE NAME

11. LAST NAME

13. ADDRESS NUMBER AND STREET

15. CITY, TOWN, OR POST OFFICE

12. SUFFIX

14. ROOM/SUITE

16.STATE

17. ZIP CODE 18. E-MAIL ADDRESS

TELEPHONE (Area code, number and extension) AND FAX NUMBER
19. TEL:

20. FAX:

21. TITLE OF APPLICANT’S PROJECT

22. Signature Under penalties of perjury, I declare that I have examined this submission, including the accompanying documents, and, to the best
of Authorized of my knowledge and belief, all of the facts contained herein are true, correct, and complete.
Representative
Keep a copy of
this form for your
records.

Signature of Applicant

Project Information Memorandum

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Qualifying Therapeutic Discovery Project

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Page 1

Company Name

A. OVERVIEW: Provide an overview of the project for which you are seeking a credit or grant, including a

description of the product, process or technology under development. The description may not exceed
250 words. If the project involves a new therapy, the description must include an explanation of why that
therapy is novel.

Do not exceed 250 words.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

B. Check each applicable box in the following and provide a short (not more than 50 words) statement
supporting each positive assertion (i.e., where “Yes” is checked). Check all that apply, but you need check
only one Yes for answers 1 through 4 for initial qualification.
1.

Qualifying Therapeutic Discovery Project definition
Is the project
• designed to develop a product to treat or prevent a disease or condition;
• by conducting pre-clinical activities, clinical trials, or clinical studies, or by
carrying out research protocols; and
• for the purpose of securing approval of a product under section 505(b) of
the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public
Health Service Act?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

2.

Is the project designed to diagnose a disease or condition?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

3.

Is the project designed to determine molecular factors related to diseases or
conditions by developing molecular diagnostics to guide therapeutic decisions?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

4.

Is the project designed to develop a product, process, or technology to further the
delivery or administration of therapeutics?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

Selection Criteria
5.

Is this project likely to result in one or more new therapies?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

6.

If the answer to question 5 is Yes, will the new therapy(ies):
a. treat areas of unmet medical need?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

Page 5

Company Name

If the answer to question 5 is Yes, will the new therapy(ies):
b. prevent, detect, or treat chronic or acute diseases or conditions?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box,
do not provide a narrative.

7.

Is the project likely to reduce long-term health care costs in the United States?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name
8.

Is the project likely to significantly advance the goal of curing cancer within the
next 30 years?

Yes

No

If you checked the “Yes” box, then you must explain in 50 words or less. If you checked the "No" box, do
not provide a narrative.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

For each of questions 9, 10, and 11, provide a short statement, not to exceed a total of 250 words,
including responses to bulleted items. For question 9, applicants may also submit up to five literature
citations in the specified format that will not be counted against the 250-word limit.
9.

Explain the scientific rationale, based on prior conceptual and empirical work, which supports the belief
that the proposed project will lead to the outcome the applicant has identified above. Explain the
research and development plan that will lead to the outcome identified above. Describe the scientific
evidence relied on by the applicant, including a description of any peer review of the project and a list of
no more than five literature citations using the format provided below.
(DO NOT EXCEED 250 WORDS)

Provide a short statement, not to exceed a total of 250 words.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

Literature Citations: Include a list of no more than five (5) literature citations in reference to question 9, using
the following format:
• Include the names of all authors (in the same sequence in which they appear in the publication), the
article and journal title, book title, volume number, page numbers, and year of publication.
• When citing articles that were authored or co-authored by the applicant and arose from NIH support, if
available, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the
Pubmed Central (PMC) reference number (e.g., PMCID234567) for each citation.
• Citations for which an NIH Manuscript Submission reference number is not available but are publicly
available in a free, online format should include URLs or PMCID numbers along with the full reference.
The references should be limited to relevant and current literature.

Literature citations are excluded from the 250-word limitation.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name

10. Describe the stage of development of the project, including a description of pre-clinical and clinical trial
results that are relevant to the proposal. Include in your description:
• If the project involves the development of a product that is regulated by the Food and Drug
Administration, an explanation of whether an investigational new drug application or an
investigational device exemption has been filed with the Food and Drug Administration, and
whether an application for approval, license, or clearance has been filed, and, if so, the status of
that application as of the date of application as of the date this project information memorandum
is submitted.
• If the project does not involve the development of a product that is regulated by the Food and
Drug Administration, information about any regulatory reviews or approvals that have occurred.
• If the project involves preclinical testing, a description of the testing completed and/or
contemplated.
• If the project involves testing in humans, information about the phase(s) of the testing that has
been completed and the number of subjects tested in each phase and information about trials for
which the applicant is actively recruiting subjects. Summarize the results of the trails, noting any
failed trials or successful trials.
• The planned research and development strategy for the test or treatment being researched and a
summary schedule for development of the project, including timelines and milestones planned
and completed.
(DO NOT EXCEED 250 WORDS)
Provide a short statement, not to exceed a total of 250 words, including responses to bulleted items.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

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Company Name
11. Describe the resources, management experience and organizational capacity of the applicant and

explain how applicant believes that such resources, experience and capacity will support successful
completion of the project. Include in this description:
•

A statement of the revenue levels and sources for this project over the past three years.

•

A statement of the revenue levels and sources for the proposed research and development plan
delineated in response to question 10.

•

A description of any significant public or private investment, such as by venture capitalists, in the
development or commercialization of the project.

•

A description of any strategic partnerships for the development or commercialization of the
project.

•

A statement of whether the applicant has suspended operations for the project and, if so, whether
the suspension is temporary or permanent. If the project has been suspended, terminated, or is
otherwise inactive, explain why, including whether the cause is a lack of financial resources or
other reasons.

(DO NOT EXCEED 250 WORDS)
Provide a short statement, not to exceed a total of 250 words, including responses to bulleted items.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

Page 11

Company Name

Project Information Memorandum

Qualifying Therapeutic Discovery Project

Continuation Page ____

Instructions for Completing Project Information Memorandum
Note: Font sizes and margins on some QTDP_PIM form pages may vary due to field or space limitations. The
QTDP_PIM Microsoft Word (MS Word) and Portable Document File (PDF) Form Pages as provided are acceptable to
NIH.

I. APPLICANT ORGANIZATION INFORMATION
This information is for the Applicant Organization, not a specific individual.
Field Name

Instructions

1. Name of Applicant
Organization

Enter the legal name of the applicant organization. This field is required.

2. Taxpayer Identification
Number (TIN)

Enter the TIN as assigned by the Internal Revenue Service. This field is
required.

3. Address Number and
Street

Enter the street number and street address for the applicant. This field is
required.

4. Room/Suite

Enter the room or suite number for the applicant.

5. City, Town, or Post Office

Enter the city, town, or post office for address of applicant. This field is
required.

6. State

Enter the State where the applicant is located. This field is required.

7. ZIP Code

Enter the nine-digit Postal Code (e.g., ZIP code) of applicant. This field
is required.

8. URL Address for
Applicant Organization’s
Web Site

Enter the Web site URL address for the applicant organization (e.g.,
http://www.companywebsiteurladdress.com/).

II. CONTACT PERSON INFORMATION
Person to be contacted on matters involving this application:
This information is for the Administrative or Business Official of the Applicant Organization. This person is the
individual to be notified if additional information is needed.
Field Name

Instructions

9. First Name

Enter the first (given) name of the person to contact on matters related to
this application. This field is required.

10. Middle Name

Enter the middle name of the person to contact on matters related to this
application.

11. Last Name

Enter the last (family) name of the person to contact on matters related to
this application. This field is required.

12. Suffix

Enter the suffix (e.g., Jr., Sr., Ph.D.) for the person to contact on matters
related to this application.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

Instructions

Field Name

Instructions

13. Address Number and
Street

Enter the street number and street address for the applicant. This field is
required.

14. Room/Suite

Enter the room or suite number for the applicant.

15. City, Town, or Post
Office

Enter the city, town, or post office for address of applicant. This field is
required.

16. State

Enter the State where the applicant is located. This field is required.

17. ZIP Code

Enter the nine-digit Postal Code (e.g., ZIP code) of applicant. This field
is required.

18. Email

Enter the email address for the person to contact on matters related to
this application.

19. Phone Number

Enter the daytime phone number for the person to contact on matters
related to this application. This field is required.

20. Fax Number

Enter the fax number for the person to contact on matters related to this
application.

21. Title of Applicant’s
Project

Enter a brief descriptive title of the project. This field is required.

22. Signature of Authorized
Representative

Note: If a company is submitting multiple projects, a separate
application and Project Information Memorandum must be completed
for each project.
It is the organization’s responsibility to assure that only properly
authorized individuals sign in this capacity and/or submit the application.

Complete the remainder of the Project Information Memorandum (for Items A and B (including questions 1-11) in
accordance with the instructions provided in the IRS Notice 2010-45 (http://www.irs.gov/pub/irs-drop/n-10-45.pdf). Note
that all applications must correspond to the word limits specified. Exceptions will not be granted to exceed the word
limits specified for the Overview and Questions 1-11. A Continuation Page is provided for those rare instances in which
the text will not fit in the allocated space. However, note that text beyond the word limits will not be considered. Note:
Font sizes and margins on some QTDP_PIM form pages may vary due to field or space limitations. The QTDP_PIM
Microsoft Word (MS Word) and Portable Document File (PDF) Form Pages as provided are acceptable to NIH.

Project Information Memorandum

Qualifying Therapeutic Discovery Project

Instructions