**Important SBIR/STTR Information and FAQs**

Please be sure that you are using the CURRENT PHS 2003-2 SBIR/STTR
Omnibus Solicitation or Phase II SBIR/STTR Instructions, as appropriate
(available at URL <http://grants.nih.gov/grants/funding/sbir.htm#sol>):

**[ELIGIBILITY]{.underline}**

**Q. My company is a wholly-owned subsidiary of another
company/corporation. Am I eligible to participate in the SBIR/STTR
Program?**

A. No. Each organization submitting an SBIR/STTR grant application must
qualify as a Small Business Concern (SBC) as defined in the PHS 2003-2
SBIR/STTR Omnibus Solicitation. The Small Business Administration takes
the current position with regard to wholly-owned subsidiaries:

The express terms of §121.702(a) require that the owners of the SBIR
participant be "individuals" who are "citizens of, or permanent resident
aliens in, the United States." The regulations nowhere provide that
corporations or artificial entities may qualify as "individuals" who are
U.S. citizens, nor do they suggest that indirect ownership of an
SBIR/STTR participant by a U.S. citizen satisfies the ownership
requirements of § 121.702(a).

***[Example 1.]{.underline}*** An applicant to the SBIR/STTR Program is
**owned 100% by Company A.** Company A is owned 100% by U.S. citizens.
The applicant is *[not eligible]{.underline}* for the program because it
is not directly owned and controlled 51% by citizens of or permanent
resident aliens in the United States.

***[Example 2.]{.underline}*** An applicant to the SBIR/STTR Program is
**owned 51% by U.S. citizens** and permanent resident aliens of the
United States and 49% by a corporation. The applicant *[is
eligible]{.underline}* for the program, assuming it meets the other
eligibility requirements (such as size) because 51% of the ownership
rests directly with U.S. citizens and permanent resident aliens of the
United States.

The SBA has submitted a proposed Rule Change to the Office of Management
and Budget that addresses this issue (see
<http://www.sba.gov/size/sbir-pr.pdf>). The rule proposes to modify the
small business eligibility requirements so that the SBIR awardee must
meet one of the two following additional criteria:

1)  It must be a for-profit business concern that is at least 51% owned
    and controlled by one or more individuals who are citizens of, or
    permanent resident aliens in, the United States (as the regulations
    currently requires); or

2)  It must be a for-profit business concern that is 100% owned and
    controlled by another for-profit business concern that is itself at
    least 51% owned and controlled by one or more individuals who are
    citizens of, or permanent resident aliens in, the United States.

Until SBA issues a notice that the eligibility criteria to participate
in the SBIR or STTR program has been modified, NIH will continue to
comply with the eligibility criteria as stated. Additional information
regarding eligibility may be obtained from Mr. Maurice Swinton,
Assistant Administrator for Technology, U.S. Small Business
Administration (<Maurice.swinton@sba.gov>).

**Q. Am I permitted to submit a Phase II application if I have not yet
received my Phase I award?**

**A.** No. Small business concerns that have [received]{.underline} an
SBIR Phase I grant or an STTR Phase I grant are eligible to apply for
SBIR or STTR Phase II funding, respectively, of that program.

**Q. Must the Principal Investigator be a U.S. citizen?**

A. No. The PI, the individual who is responsible for the scientific and
technical direction of the project, is not required to have US
citizenship BUT the PI must be here legally in the United States and
must be available to perform the research proposed for the duration of
the project. The responsibility to meet these requirements for
individuals who do not have permanent resident status in the U.S. rests
with the small business concern.

NOTE: The applicant small business concern MUST be at least 51 percent
owned and controlled by one or more ***individuals*** who are **citizens
of, or permanent resident aliens in, the United States** and must also
meet the other eligibility criteria as described in the Solicitation.

**MAILING ADDRESS and APPLICATION SUBMISSION INFORMATION**

**Q. Must the application [be received by]{.underline} the posted
Solicitation receipt dates (April 1/August 1/December 1) or is a
postmark date acceptable?**

A. A postmark date of April 1/August 1/Decemebr 1 is acceptable. Grant
applications (**[NEW or REVISED]{.underline}**) submitted in response to
this SBIR/STTR Omnibus Grant Solicitation will be considered \"on time\"
if received by or mailed on or before the published receipt date and a
proof of mailing is provided. Proof of timely mailing consists of one of
the following: a legibly dated U.S. Postal Service postmark or a dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks are not acceptable.

**Q. If I am using an overnight courier, does the postmark date still
apply?**

A. Yes. A grant application submitted under this SBIR/STTR Phase I Grant
Solicitation will be considered **on time** if it is **received by or
mailed on or before the published receipt date and a proof of mailing is
provided.** Proof of timely mailing consists of one of the following: a
legibly dated U.S. Postal Service **postmark or a dated receipt from a
commercial carrier or the U.S. Postal Service.**

**Q. How many copies do I submit? What if my application overlaps with
more than one IC?**

A. The original plus 5 copies. PERIOD. We will make the additional
copies if your application is assigned to more than one IC.

**Q. To what address do I send my application?**

A. All applications sent via the **United States Postal Service**
**EXPRESS or REGULAR MAIL** should be sent to the following address:

CENTER FOR SCIENTIFIC REVIEW

NATIONAL INSTITUTES OF HEALTH

6701 ROCKLEDGE DRIVE

ROOM 1040 -- MSC 7710

BETHESDA, MD **20892-7710**

**All applications sent via a courier delivery service (non-USPS) should
be sent to the following address (Note [ZIP CODE change):]{.underline}**

CENTER FOR SCIENTIFIC REVIEW

NATIONAL INSTITUTES OF HEALTH

6701 ROCKLEDGE DRIVE

ROOM 1040

BETHESDA, MD **20817**

Applications may not be delivered by individuals to the Center for
Scientific Review but must be sent via a courier delivery service or the
USPS.

**FORMS/INSTRUCTIONS**

**Q. What Forms/Instructions do I use?**

A. You must use the PHS 398 forms
(<http://grants.nih.gov/grants/funding/phs398/phs398.html#forms>) for a
Phase I or Phase II SBIR/STTR application.

The forms are also linked from the PHS 2003-2 SBIR/STTR Omnibus
Solicitation (see above).

**PHASE I** Instructions: Follow the instructions provided directly
within the PHS 2003-2 Omnibus Solicitation (PAGES 16-49) .

(Word Doc: <http://grants.nih.gov/grants/funding/sbirsttr1/index.doc>)

(PDF Doc: <http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf>)

**Phase II** instructions: Follow the instructions located at:

(Word Doc:
<http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc>)

(PDF Doc:
<http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf> )

**Q. Are there type size, font size, and page limit requirements?**

A. YES. Type size, font size and page limit specifications must be
observed. PERIOD.

**At least 10% of the SBIR/STTR applications were RETURNED last round
due to non-compliance with type size/page limitations.** Please check
the size on the PRINTED document, paying particular attention to the
Research Plan, Biographical Sketches, Introduction, if necessary, and
Literature Citations.

Page Limitation for Research Plan:

Sections A-D of the **Phase I** Research Plan are limited to 15 pages.

Sections A-D of the **Phase II** Research Plan are limited to 25 pages.

NOTE: Font sizes on some of the PHS 398 FORM pages vary due to field or
space limitations. The PHS 398 Rich Text File (RTF) and Portable
Document File (PDF) Form pages as provided are acceptable by NIH.

**Q. Are there sample Biographical Sketch and Budget pages to which I
can refer?**

**A.** Yes!

  ------------------------------------------------------------ -------------------------------------------------------------------------------- --------------------------------------------------------------------------------
  Biographical Sketch Sample                                   [RTF](http://grants.nih.gov/grants/funding/phs398/biosketchsample.rtf)           [PDF](http://grants.nih.gov/grants/funding/phs398/biosketchsample.pdf)

  Modular Budget Sample - SBIR                                 [RTF](http://grants.nih.gov/grants/funding/phs398/modbudgetsample_sbir.rtf)      [PDF](http://grants.nih.gov/grants/funding/phs398/modbudgetsample_sbir.pdf)

  Modular Budget Sample - STTR                                 [RTF](http://grants.nih.gov/grants/funding/phs398/modbudgetsample_sttr.rtf)      [PDF](http://grants.nih.gov/grants/funding/phs398/modbudgetsample_sttr.pdf)

  Non-Modular Budget Sample - SBIR (STTR Under Development)    [RTF](http://grants.nih.gov/grants/funding/phs398/nonmodbudgetsample_sbir.rtf)   [PDF](http://grants.nih.gov/grants/funding/phs398/nonmodbudgetsample_sbir.pdf)
  ------------------------------------------------------------ -------------------------------------------------------------------------------- --------------------------------------------------------------------------------

**(<http://grants.nih.gov/grants/funding/phs398/phs398.html>)**

**Q. How do I identify proprietary information in the application?**

**A.  **You are discouraged from submitting information considered
proprietary unless it is deemed essential for proper evaluation of the
application. However, when the application contains information that
constitutes trade secrets, information that is commercial or financial,
or information that is confidential or privileged, *include a legend on
Form Page 3 to identify the appropriate page numbers. Also identify the
information by asterisks (\*) and page number in the Research Plan*.

Include the following legend in the research plan of the application or
on PHS 398 Form Page 3 to identify the appropriate page numbers:

"These data shall not be disclosed outside the Government and shall not
be duplicated, used, or disclosed in whole or in part for any purpose
other than evaluation of this application. If a funding agreement is
awarded to this applicant as a result of or in connection with the
submission of these data, the Government shall have the right to
duplicate, use, or disclose the data to the extent provided in the
funding agreement and pursuant to applicable law. This restriction does
not limit the Government's right to use information contained in the
data if it is obtained from another source without restriction. The data
subject to this restriction are contained in pages \_\_\_\_\_\_ of this
application."

A bit more...

Information contained in unfunded grant applications will remain the
property of the applicant. The Government may, however, retain copies of
all applications submitted. Public release of information in any
application submitted will be subject to existing statutory and
regulatory requirements. *[Confidential, proprietary information must be
clearly identified in the application by asterisks (\*)]{.underline}*.
When the application contains information that constitutes trade
secrets; or information that is commercial or financial; or information
that is confidential or privileged, it will be treated in confidence.

**Q.** I **use Windows XP and am using the fillable RTF form.  I opened
the individual Face page in RTF, and it overlaps onto a second page. How
can I make it a single page?**

A. The following steps will correct the pagination problem.

  1. Open the RTF document with MS Word.\
  2. From the Tools menu, select \"Unprotect Document\".\
  3. Then immediately re-protect the document by selecting: Tools,
Protect Document, and click the Forms button and then the OK button.

  4. Save the document as a Word (\*.doc) document to preserve this
formatting. (If you save the document as an rtf file and then re-open
the document, you will experience the same pagination problem and will
have to repeat the steps above.)

Before re-protecting the document, you may also want to select the
\"Final\" View from the pulldown on the Reviewing menu bar, which will
hide the comments on the page so you see the form as it will print. (You
can still review the comments by clicking the \"Reviewing Pane\" button
also on the Reviewing menu bar.)

**Q. Are there special instructions for submission of a revised
SBIR/STTR application?**

A. Yes.

First read your Summary Statement closely. If it is not what you wanted
to "hear" then put it away for a day...then re-read it.

Second, discuss the reviewers' concerns/comments with your Program
Director (listed in the upper right hand corner of the Summary
Statement).

Third, in addition to following the standard Phase I or Phase II
instructions, you need to include an "Introduction" and you need to
address the reviewer's criticisms/concerns/comments within the Research
Plan or other sections of the application as appropriate. See the PHS
2003-2 instructions on Revised Applications. In brief....

-   For Phase I, you need to include a one-page Introduction Page
    **[just before]{.underline}** the Research Plan.

-   For **Phase IIs**, you are **allowed a 3-page "Introduction", which
    should be inserted before the Phase II Research Plan.**

-   For **Fast Track Applications**, include a one page Introduction in
    the Phase I (just before the Phase I Research Plan) and no more than
    3 pages of Introduction in the Phase II application (just before the
    Phase II Research Plan).

In the "Introduction," summarize any substantial additions, deletions,
and changes that have been made. Include responses to criticisms in the
previous summary statement. **Identify these changes within the text of
the Research Plan by appropriate bracketing, indenting, or *changing of
typography*.** Do not shade changes.

**Q. Do I need to identify an Institute or Center to submit the
application to or do I need to submit a Cover Letter?**

A. No. You do not need to identify an IC to which the application should
be assigned. We have a dedicated office, the Center for Scientific
Review/Receipt and Referral Office, that refers applications to the
appropriate Institute/Center (IC).

If you know that your proposed research overlaps with several ICs, then
you are encouraged to include a cover letter and request that your
application be assigned to those ICs. CSR makes the final call as to
assignments.

**Q. Do I need to include letters from consultants and collaborators
with my application?**

A. Yes. And... if this is a revised application, the letters must be
newly signed/dated.

**[Face Page]{.underline}**

**Q. What do I enter in Line 2 on the face page, which asks if our grant
is in \"Response to Specific Request for Applications or Program
Announcement of Solicitation?\"**

A. Check Yes (This is in response to the SBIR/STTR Solicitation) Enter
in Line 2 \"**PHS 2003-2 SBIR**\" (or STTR).

Do not type PHS 398 in this line.

For Phase II SBIR/STTR applications, check "Yes" and type **PHS 2003-2
\"Phase II SBIR**\" or \"Phase II STTR,\" as appropriate.

(If you are submitting an application in response to a special NIH Guide
Announcement, then enter THAT Announcement number (e.g., PA-03-085) and
type in the title of the Announcement.)

**Q. What do I enter in Line 3 of the Face Page?**

A***.*** The Name of the Principal Investigator. Name the ONE person
responsible to the applicant small business concern for the scientific
and technical direction of the project.

**Q. Is it acceptable to list a Research Institution (e.g. university)
in Item 9 for the applicant organization?**

A. NO. The small business concern is ALWAYS the applicant organization
for an SBIR or STTR award.

**Q. How do I know what the estimated start date of my project is?**

[**A.** To select an appropriate beginning date for a **new**
application, consult the following schedule:]{.underline}

+------------------------------+---------------------------------------+
| SBIR and STTR\               | Estimated                             |
| Receipt Dates\               |                                       |
| Phase I and Phase II         | Award Date                            |
+------------------------------+---------------------------------------+
| April 1                      | November 1                            |
+------------------------------+---------------------------------------+
| August 1\*                   | March 1                               |
+------------------------------+---------------------------------------+
| December 1                   | July 1                                |
+------------------------------+---------------------------------------+

PHS awarding components may not always be able to honor the requested
start date. No commitments or obligations should be made until
confirmation of the actual start date by the awarding component.

**[BUDGET]{.underline}**

**Q. Is it my imagination or are the budget instructions clearer this
year than they have been in the past?**

**A.** No. It is not your imagination... in the PHS 2003-2 SBIR/STTR
Omnibus Solicitation and in the Phase II SBIR/STTR instructions, we took
great strides to clarify the instructions for preparing the budget as
this is the section that has in past generated the most questions.

We also have included a summary chart of the necessary budget forms for
both modular and non-modular applications. Use this chart (on page 25 of
the PHS 2003-2 Solicitation) to assure you are submitting the correct
forms appropriate to your specific type of application.

**Q. Is it permissible to submit a budget that deviates from the time
and dollars normally awarded to Phase I or Phase II?**

A. Yes. Deviations from the guidelines are acceptable, *[but must be
well justified]{.underline}.* We recognize that not all types of
biomedical/behavioral research can be performed under the prescribed
amounts of time and dollars. Propose a reasonable budget and project
period that is appropriate for completion of the research project and
justify the need to go beyond the "norm." ***You are encouraged to
discuss budgetary deviations with [NIH Program
Staff](http://grants.nih.gov/grants/funding/sbirsttr1/SBIR_STTR_ContactInfo.pdf)
prior to submission of the application.* (CDC and FDA do not make awards
greater than the stated guidelines.)**

**Q. If my budget qualifies as "Modular" (\$100,000 or less for total
costs \[direct, F&A, and fee/profit\], do I submit the Modular Budget
Format Page AND Form Pages 4 and 5?**

A. No. Submit only the Modular Budget Format Page. Form pages 4 and 5
are used only for those applications requesting more than \$100,000.

**Q. Do I use \$250,000 as the threshold for Modular Grants?**

A. NOOOOOO. The \$250,000 threshold does not apply to SBIR/STTR
Applications. IF YOU ARE REQUESTING A TOTAL BUDGET (Direct+F/A+Fee) OF
\$100,000 OR LESS, THEN YOU FOLLOW THE MODULAR FORMAT AS DESCRIBED IN
CHAPTER IV of the PHS 2003-2 SBIR/STTR Solicitation.

In this case, you do not submit FP4 and FP5; you only submit the Modular
Budget Format Page for your budget.

IF YOU ARE REQUESTING A TOTAL BUDGET OF MORE THAN \$100,000, THEN YOU
FOLLOW THE NON-MODULAR BUDGET FORMAT AS DESCRIBED IN THE PHS 2003-2
PHASE I or PHASE II Instructions.

In this case, you will need to submit FP 4 and FP5.

**Q. Do I REALLY only enter Total DIRECT Costs on the Modular Budget
Page?**

A. YES. The table on the Modular Budget Page requests Total Direct
Costs. If your total direct costs are \$64,524, then enter this amount.
(The \$25,000 increments do NOT Apply to SBIR/STTR Modular Budgets)

**Q. I am submitting a Phase I for 6 months and my total DIRECT costs
will be \$74,652. On the Modular Budget Format Page, I entered \$74,652
in the box for "Initial Budget Period". What do I enter in the other
boxes on the Modular Budget Table?**

A. Nothing. You enter only the Direct Costs in the far left box for
"Initial Budget Period" and enter the same amount in the box for "Total
Direct Costs Requested for Entire Budget Period" since your budget
request does not exceed one year. Provide a narrative justification for
Personnel, Consultant/Contractual/Consortium Costs and Fee as described
in the instructions.

**Q. Where do I enter F&A (Indirect) Costs?**

A. On The Checklist Page.

Phase I: See page 46 in the PHS 2003-2 SBIR/STTR Solicitation
(<http://grants.nih.gov/grants/funding/sbirsttr1/index.doc>).

Phase II: See page 42 in the Phase II instructions
<http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc>

**Phase I applicants**

If you do not have currently effective negotiated F&A cost rates with a
Federal agency, then propose estimated F&A costs at a rate not to exceed
40% of the total direct costs.

1\. Complete line 3a (Initial Budget Period) and, if applicable (e.g.,
2-year Phase I), complete subsequent year(s).

2\. Under "*[Explanation]{.underline}*," insert "*[Estimated F&A costs
allocable (applicable) to this project are shown in line
3a]{.underline}*" if you do not have a currently negotiated F&A costs
rate with a Federal Agency.

Only actual F&A costs are to be charged to projects. If awarded at a
rate of 40% or less, the rate used to charge actual F&A costs to
projects cannot exceed the awarded rate.

**Phase II applicants**

1\. Complete line 3a (Initial Budget Period) for first 12-month budget
period, line 3b (-02 Year) for second budget period, and subsequent
year(s) as appropriate.

2\. Under "Explanation", insert "Rate to be negotiated with NIH" if you
do not have a currently negotiated F&A cost rate with a Federal Agency.
If you have a currently effective negotiated F&A cost rate with a
Federal agency, it should be used when calculating proposed F&A costs.

If the requested F&A rate is 25 percent or less, F&A costs will be
awarded at the requested rate. However, applicant organizations are
reminded that only actual F&A costs are to be charged to projects. If
awarded at a rate of 25% or less of total direct costs, the rate used to
charge actual F&A costs to projects cannot exceed the awarded rate. *[If
the requested F&A rate is greater than 25 percent, additional
information will be required prior to award to justify the requested
rate]{.underline}*.

**Q. Where do I show the TOTAL (Direct +F&A (Indirect)+ Fee) Costs that
I am requesting?**

A. On the Face Page, you enter in 7b the Total Costs for the Initial
Period and in 8b you enter the total costs for the entire proposed
project period.

**Q. Face Page: Do I enter the same cost numbers in Item 8 as I did for
Item 7 on the Face Page?**

A. Phase I : For Phase I SBIR/STTR applications that do not exceed one
year, the direct and total costs for the entire \"proposed period of
support\" (Item 8) will be the same as the direct and total costs for
the \"initial budget period\" (Item 7).

**Q. Face Page: Item 8b request Total Costs\... what does this
include?**

A. This is the SUM of (a) the total direct costs from Form Page 5 (or
Modular Budget); (b) the amount requested for \"Total fee requested for
entire proposed period\" on Form Page 5 or the \"Modular Budget Format
Page;\" and (c) the indirect costs (F&A) derived from the Checklist Form
Page.

**Q. Do I need to include Form Pages 4 and 5 for my subcontractors?**

A. If you are Non-Modular, then you must obtain/submit Form Page 4 for
each participating consortium/contractual organization a separate
detailed budget and, if consortium activity exceeds one year, also
submit Form Page 5 for the entire proposed project period.

If you are Modular, then NO. The subcontracts/consultant/consortia costs
are discussed in narrative on the Modular Budget Page.

**Q. What is Fee/Profit?**

A. A reasonable profit/fee is available to small business concerns
receiving awards under the SBIR/STTR program; **however, this profit/fee
must be included in your budget request at the time of application.** .
*[The amount of the fee approved by the agencies participating in this
solicitation normally will not exceed **7% of total costs** (direct and
indirect) for each Phase (I and II) of the project]{.underline}*. The
fee is not a "cost" item and may be used by the small business concern
for any purpose, including additional effort under the SBIR/STTR award.
The fee is intended to be a reasonable profit factor available to
for-profit organizations, consistent with normal profit margins provided
to profit-making firms for research and development work. The profit/fee
applies solely to the small business concern receiving the SBIR/STTR
award and not to any other participant in the project. However, the
grantee may pay a profit/fee to a contractor providing routine goods or
services in accordance with normal commercial practice.

**Q. The Biographical Sketch seems to include Research Support, but the
instructions say NOT to include \"Other Support.\" Is there a
difference?**

A. Yes. Research Support includes selected ongoing and completed (during
the last three years) research projects (federal or non-federal
support). As part of the biosketch section of the application, "Research
Support" highlights your accomplishments, and those of your colleagues,
as scientists. It is used by reviewers for the "investigator" review
criterion. Briefly indicate the overall goals of the projects and
responsibilities of the key person identified on the Biographical
Sketch. **Do not include percent of effort or direct costs.**

"Other Support" information is required for all applications that are
selected to receive grant awards. Other Support goes beyond includes all
active and pending support AND requires that you provide percent effort
and costs associated with each grant/award. NIH staff will request
complete and up-to-date "other support" information from you
*[after]{.underline}* peer review. This information will be used to
check that the proposed research has not already been funded.

**[HUMAN SUBJECTS]{.underline}**

**OHRP's Website: <http://ohrp.osophs.dhhs.gov/index.htm>**

**Q. I will be subcontracting ALL of the Human Subjects work to a
University, so do I still need to address the points delineated in
Section E. of the Research Plan?**

A. YES.YES. YES. This is the one area that, if not addressed, will
result in your application being returned.

Carefully read the instructions (p. 34) in Section e. of the Research
Plan and follow these instructions to the \'T\'.

You do NOT need to have IRB approval or an assurance at the time of
submission, *but* Information under the *[following headings MUST be
included]{.underline}* in Section e. of the Research Plan:

####### **Protection of Human Subjects**

1\. ***[Risks to the Subjects]{.underline}***

2\. ***[Adequacy of Protection Against Risks]{.underline}***

3\. ***[Potential Benefits of the Proposed Research to the Subjects and
Others.]{.underline}***

4\. ***[Importance of the Knowledge to Be Gained.]{.underline}***

####### **Inclusion of Women**

####### **Inclusion of Minorities**

####### **Inclusion of Children**

####### **Data and Safety Monitoring**

**REMINDER:**  Required Education in the Protection of Human Research
Subjects. See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html>.See
also Frequently Asked Questions
<http://grants.nih.gov/grants/policy/hs_educ_faq.htm> regarding this
policy.

**Q. I will be using Human Subjects in my research but do not have
approval by an Institutional Review Board yet. Is this required at the
time of submission?**

A. No. Your company will be required to obtain an Assurance (typically a
Single Project Assurance) by the time an award is made. Our NIH staff
will initiate that process if you do not have an assurance, and you will
work closely with your Program director and OHRP staff to negotiate such
an assurance.

**Q. Where can I obtain information regarding the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and
progress monitoring of grants, cooperative agreements, and research
contracts?**

A. See
<http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html>

It is important to note that the Privacy Rule does not replace or act in
lieu of existing regulations for the protection of human subjects found
in 45 CFR 46. Therefore, instructions in the Human Subjects section of
the PHS 398 remain the same. Researchers should continue to consider
issues of privacy and confidentiality as they affect the adequacy of
protections of human subjects from research risks, and when appropriate,
address these issues in the Human Subjects section of the research plan.

Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(<http://www.hhs.gov/ocr/>) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on can be found at
<http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html>.

**[Vertebrate Animals]{.underline}**

**Q. I will be using vertebrate animals in my research. Do I need to
have an IACUC approval at the time of submission or within 60 days of
submission?**

A. No. This is also done prior to award. The certification of IACUC
approval is not required at the time of application, **but you must
address the points under the Vertebrate Animal section of the Research
Plan.** IACUC approval may be submitted in a \"just-in-time\" fashion
prior to award (as is now permitted for IRB approval.) Additional
information is available on the following NIH Guide Notice:
<http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-064.html>

Note: DO NOT TYPE IN THE IACUC NUMBER OF COLLABORATING INSTITUTIONS.

**[Inventions]{.underline}**

**Q. Am I required to inventions made in the course of, or under, my NIH
SBIR/STTR research grant?**

**A.** Yes. Inventions must be promptly and fully disclosed to NIH
within 2 months after the inventor provides written disclosure to the
grantee\'s authorized official.

NIH has developed an optional online Extramural Invention Information
Management System, known as "IEdison," to facilitate grantee compliance
with the disclosure and reporting requirements of 37 CFR 401.14(h) See
[http://www.iedison.gov](http://www.iedison.gov/). *Information from
these reports is not made publicly available*. Additional details are
included in the Phase I and Phase II SBIR/STTR instructions.

**[STTR]{.underline}**

**Q. I am submitting a Phase I STTR that is Non-Modular (\>\$100,000).
What forms does the Small Business and the Research Institution (RI)
need to include?**

A. The Small Business completes/submits Form Page 4 and Form Page 5. The
RI completes/submits the STTR Research Institution Budget Form Page.

**Q. I am submitting a Phase II STTR that is Non-Modular (\>\$100,000).
What forms does the Small Business and the Research Institution (RI)
need to include?**

A. The Small Business completes/submits Form Page 4 and Form Page 5. The
RI completes/submits the STTR Research Institution Budget Form Page (for
the Initial Year of the Budget) and Form Page 5 (for the additional
years). See

If there are any subcontractors (for STTR or SBIR), use an additional
Form Page 4 (and Form Page 5 for projects greater than 1 year) and type
the names of these organizations at the top of the Forms to distinguish
them from the Small company's budget pages. Be sure to justify the
contractual/consortium costs in the budget justification.

**Q. The STTR Research Institution Budget Form Page has the role of the
first personnel slot pre-labeled \"Principal Investigator\" (PI).  In
the case where the PI is paid by the applicant small business concern
(SBC), is the top row on the Research Institution Budget Form Page to be
left blank?**

A. This can be left blank or you can enter "See SBC budget page". The PI
should be paid by either the research institution or the small business,
not both. Therefore, the PI's name should not be listed on both the
small business and the research institution budget pages.

[Phase II Awardees: Submission of your (Non-Competing)PHS 2590 Grant
Progress Report]{.underline}

### Non-Competing Grant Progress Reports

(<http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html>)

Phase II SBIR/STTR awardees should be aware of the following information
regarding submission of your Non-Competing Grant Progress Report (PHS
2590). NIH continues to transition the notification of Non-Competing
Grant Progress Reports from a hard copy mailing of preprinted electronic
PHS 2590 face pages to an electronic format. As discussed in the May 2,
2002 Notice on this topic
([http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-047.html](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-047.html)),
the last hard copy mailing of pre-printed face pages was mailed in late
June 2002 for those progress reports with November 2002 start dates.

Beginning with December 2002 start dates and beyond; e.g., those
progress reports due on/after October 1, 2002, grantees will need to
access a website to determine which progress reports are due. Progress
reports should continue to be mailed directly to the NIH awarding
Institute/Center. A list of Institute/Center mailing addresses for
progress reports is found at:
[http://grants.nih.gov/grants/type5_mailing_addresses.htm](http://grants1.nih.gov/grants/type5_mailing_addresses.htm).

I hope this is helpful. If you have questions that I did not address
above, feel free to email them DIRECTLY to me at: <goodnigj@od.nih.gov>

File Updated: July 2003