Form Approved Through 11/30/2010

![](media/image1.png){width="0.9in" height="0.8847222222222222in"}OMB
No. 0925-0001

**Procedure for Submission of**

**Final Invention Statement and Certification (For Grant or Award)**

**Form HHS 568**

A Final Invention Statement and Certification (Form HHS 568) shall be
executed and submitted within 90 days following the expiration or
termination of a grant or award. The Statement shall include all
inventions which were conceived or first actually reduced to practice
during the course of work under the grant or award, from the original
effective date of support through the date of completion or termination.
The Statement shall include any inventions reported previously for the
grant or award as part of a non-competing application. This reporting
requirement is applicable to grants and awards by Department of Health
and Human Services in support of research.

The Final Invention Statement and Certification does not in any way
relieve the person responsible for the grant or award, or the
institution, of the obligation to assure that all inventions are
promptly and fully reported directly to the National Institutes of
Health, as required by terms of the grant or award. Information
regarding the reporting of inventions, including the reporting form to
be followed, may be obtained from the Office of Policy for Extramural
Research Administration, Division of Extramural Inventions and
Technology Resources, 6701 Rockledge Drive MSC 7750, Bethesda, Maryland
20892-7750, Telephone: (301) 435-1986.

The original of the completed Final Invention Statement and
Certification is to be returned to the awarding component that funded
the grant or award. The entire grant or award number must appear in the
designated box on the form. The period covered by the Final Invention
Statement is the project period of the grant or award at a particular
grantee institution. If no inventions were involved, insert the word
"None" in the first block under item Title of Invention. Each Statement
requires the signature of an institution official authorized to sign on
behalf of the institution.

The PHS estimates that it will take from 5 to 10 minutes to complete
this form. This includes time for reviewing the instructions, gathering
needed information, and completing and reviewing the form. 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. If you have comments regarding this burden estimate or
any other aspects of this collection of information, including
suggestions for reducing this burden, send comments to: NIH, Project
Clearance Office, 6701 Rockledge Drive MSC 7730, Bethesda, MD
20892-7730, ATTN: PRA (0925-0001). ***Do not send this form to these
addresses; they are for comments only.***

HHS 568 (Rev. 11/07) --- Instructions

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<tbody>
<tr class="odd">
<td colspan="7"></td>
<td colspan="3"><p>Form Approved Through 11/30/2010</p>
<p>OMB No. 0925-0001</p></td>
</tr>
<tr class="even">
<td colspan="7"><p><strong>Department of Health and Human
Services</strong></p>
<p><strong>Final Invention Statement and Certification</strong></p>
<p><em>(For Grant or Award)</em></p></td>
<td colspan="3"><p>DHHS Grant or Award No.</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="10"><p><strong>A.</strong> We hereby certify that, to the
best of our knowledge and belief, all inventions are listed below which
were</p>
<p>conceived and/or first actually reduced to practice during the course
of work under the above-referenced</p>
<p>DHHS grant or award for the period</p></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2">     </td>
<td colspan="2" rowspan="2">through</td>
<td colspan="4">     </td>
<td>.</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2"><em>original effective date</em></td>
<td colspan="5"><em>date of termination</em></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="5"></td>
</tr>
<tr class="odd">
<td colspan="10"><p><strong>B. Inventions</strong> (Note: If no
inventions have been made under the grant or award, insert the word
<em>“NONE”</em> under</p>
<p>Title below.)</p></td>
</tr>
<tr class="even">
<td colspan="2">NAME OF INVENTOR</td>
<td colspan="6">TITLE OF INVENTION</td>
<td colspan="2">DATE REPORTED TO DHHS</td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2">     </td>
<td colspan="6">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="6" rowspan="2">     </td>
<td colspan="2" rowspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2"><em>(Use continuation sheet if necessary)</em></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="6"></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="6"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="10"><strong>C. Signature</strong> — This block
<em><strong>must</strong></em> be signed by an official authorized to
sign on behalf of the institution.</td>
</tr>
<tr class="even">
<td colspan="6">Title</td>
<td colspan="4" rowspan="4"><p>Name and Mailing Address of
Institution</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="6"><p>Typed Name</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="4">Signature</td>
<td colspan="2"><p>Date</p>
<p>     </p></td>
</tr>
</tbody>
</table>

HHS 568 (Rev. 11/07)

**Privacy Act Statement**

The PHS maintains application and grant records as part of a system of
records as defined by the Privacy Act: 09-25-0112, Grants and
Cooperative Agree­ments: Research, Research Training, Fellowship, and
Construction Applications and Related Awards." The Privacy Act of 1974
(5 USC 522a) allows disclosures for "routine uses" and permissible
disclosures.

Some routine uses may be:

1\. To the cognizant audit agency for auditing.

2\. To a Congressional office from a record of an individual in response
to an inquiry from the Congressional office made at the request of that
individual.

3\. To qualified experts, not within the definition of DHHS employees as
prescribed in DHHS regulations (45 CFR 5b.2) for opinions as part of the
application review process.

4\. To a Federal agency, in response to its request, in connection with
the letting of a contract or the issuance of a license, grant, or other
benefit by the requesting agency, to the extent that the record is
relevant and necessary to the requesting agency's decision on the
matter;

5\. To organizations in the private sector with whom PHS has contracted
for the purpose of collating, analyzing, aggregating, or otherwise
refining records in a system. Relevant records will be disclosed to such
a contractor, who will be required to maintain Privacy Act safeguards
with respect to such records.

6\. To the sponsoring organization in connection with the review of an
application or performance or administration under the terms and
conditions of the award, or in connection with problems that might arise
in performance or administration if an award is made.

7\. To the Department of Justice, to a court or other tribunal, or to
another party before such tribunal, when one of the following is a party
to litigation or has any interest in such litigation, and the DHHS
determines that the use of such records by the Department of Justice,
the tribunal, or the other party is relevant and necessary to the
litigation and would help in the effective representation of the
governmental party.

a\. the DHHS, or any component thereof;

b\. any DHHS employee in his or her official capacity;

c\. any DHHS employee in his or her individual capacity where the
Department of Justice (or the DHHS, where it is authorized to do so) has
agreed to represent the employee; or

d\. the United States or any agency thereof; where the DHHS determines
that the litigation is likely to affect the DHHS or any of its
components.

8\. A record may also be disclosed for a research purpose, when the
DHHS:

a\. has determined that the use or disclosure does not violate legal or
policy limitations under which the record was provided, collected, or
obtained;

b\. has determined that the research purpose (1) cannot be reasonably
accomplished unless the record is provided in individually identifiable
form, and (2) warrants the risk to the privacy of the individual that
additional exposure of the record might bring;

c\. has secured a written statement attesting to the recipient's
understanding of; and willingness to abide by, these provisions; and

d\. has required the recipient to:

\(1\) establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized use or disclosure of the record;

\(2\) destroy the information that identifies the individual at the
earliest time at which removal or destruction can be accomplished
consistent with the purpose of the research project, unless the
recipient has presented adequate justification of a research or health
nature for retaining such information; and

\(3\) make no further use or disclosure of the record, except (a) in
emergency circumstances affecting the health or safety of any
individual, (b) for use in another research project, under these same
conditions, and with written authorization of the DHHS, (c) for
disclosure to a properly identified person for the purpose of an audit
related to the research project, if information that would enable
research subjects to be identified is removed or destroyed at the
earliest opportunity consistent with the purpose of the audit, or (d)
when required by law.

The Privacy Act also authorizes discretionary disclosures where
determined appropriate by the PHS, including to law enforcement
agencies, to the Congress acting within its legislative authority, to
the Bureau of the Census, to the National Archives, to the General
Accounting Office, pursuant to a court order, or as required to be
disclosed by the Freedom of Information Act of 1974(5 USC 552) and the
associated DHHS regulations (45 CFR Part 5).