**[DEPARTMENT OF HEALTH AND HUMAN SERVICES]{.smallcaps}**

**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, Extramural Inventions and Technology Resources
Branch, 6701 Rockledge Drive MSC 7750, Bethesda, Maryland 20892-7750,
Telephone: (301) 435-1986.

The original and one copy 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: (1) the person responsible for the grant or
award concerned, and (2) 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. 4/98) --- Instructions

+----------------------+----------------------+----------------------+
|                      | Form Approved        |                      |
|                      | Through 2/28/01      |                      |
|                      |                      |                      |
|                      | OMB No. 0925-0001    |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| **Department of      | DHHS Grant or Award  |                      |
| Health and Human     | No.                  |                      |
| Services**           |                      |                      |
|                      |                      |                      |
| **Final Invention    |                      |                      |
| Statement and        |                      |                      |
| Certification**      |                      |                      |
|                      |                      |                      |
| *(For Grant or       |                      |                      |
| Award)*              |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| ** A. ** We hereby   |                      |                      |
| certify that, to the |                      |                      |
| best of our          |                      |                      |
| knowledge and        |                      |                      |
| belief, all          |                      |                      |
| inventions are       |                      |                      |
| listed below which   |                      |                      |
| were                 |                      |                      |
|                      |                      |                      |
| conceived and/or     |                      |                      |
| first actually       |                      |                      |
| reduced to practice  |                      |                      |
| during the course of |                      |                      |
| work under the       |                      |                      |
| above-referenced     |                      |                      |
| DHHS                 |                      |                      |
|                      |                      |                      |
| grant or award for   |                      |                      |
| the period.          |                      |                      |
|                      |                      |                      |
| [ ]{.underline}      |                      |                      |
| through [            |                      |                      |
| ]{.underline}.       |                      |                      |
|                      |                      |                      |
| * original effective |                      |                      |
| date date of         |                      |                      |
| termination*         |                      |                      |
+----------------------+----------------------+----------------------+
| ** B. Inventions **  |                      |                      |
| (Note: If no         |                      |                      |
| inventions have been |                      |                      |
| made under the grant |                      |                      |
| or award, insert the |                      |                      |
| word *"NONE"* under  |                      |                      |
| Title                |                      |                      |
|                      |                      |                      |
| below.)              |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| NAME OF INVENTOR     | TITLE OF INVENTION   | DATE REPORTED TO     |
|                      |                      | DHHS                 |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| *(Use continuation   |                      |                      |
| sheet if necessary)* |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| ** C. First          |                      |                      |
| Signature ---**The   |                      |                      |
| person responsible   |                      |                      |
| for the grant or     |                      |                      |
| award is required to |                      |                      |
| sign (in ink). Sign  |                      |                      |
| in the block         |                      |                      |
|                      |                      |                      |
| opposite the         |                      |                      |
| applicable type of   |                      |                      |
| grant or award.      |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| TYPE OF GRANT OR     | WHO MUST SIGN*       | SIGNATURE            |
| AWARD                | (title)*             |                      |
+----------------------+----------------------+----------------------+
| Research Grant       | Principal            |                      |
|                      | Investigator         |                      |
|                      |                      |                      |
|                      | or Project Director  |                      |
+----------------------+----------------------+----------------------+
| Health Services      | Director             |                      |
| Grant                |                      |                      |
+----------------------+----------------------+----------------------+
| Research Career      | Awardee              |                      |
| Program Award        |                      |                      |
+----------------------+----------------------+----------------------+
| All other types      | Responsible Official |                      |
| (*specify*):         |                      |                      |
|                      |                      |                      |
| [\_\_\_\_\_\_\_\_\_  |                      |                      |
| \_\_\_\_\_\_\_\_\_\_ |                      |                      |
| \_\_\_\_\_\_\_\_\_\_ |                      |                      |
| ]{.underline}        |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| ** D. Second         |                      |                      |
| Signature** --- This |                      |                      |
| block ***must*** be  |                      |                      |
| signed by an         |                      |                      |
| official authorized  |                      |                      |
| to sign on behalf of |                      |                      |
| the institution.     |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| Title                | Name and Mailing     |                      |
|                      | Address of           |                      |
|                      | Institution          |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| Typed Name           |                      |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+
| Signature            | Date                 |                      |
+----------------------+----------------------+----------------------+
|                      |                      |                      |
+----------------------+----------------------+----------------------+

HHS 568 (Rev. 4/98)

**Privacy Act Statement**

+----------------------------------+----------------------------------+
| The PHS maintains application    | d\. the United States or any     |
| and grant records as part of a   | agency thereof, where the        |
| system of records as defined by  |                                  |
| the Privacy Act: 09-25-0112,     | DHHS determines that the         |
| "Grants and Cooperative          | litigation is likely to affect   |
| Agreements: Research, Research   |                                  |
| Training, Fellowship, and        | the DHHS or any of its           |
| Construction Applications and    | components.                      |
| Re-                              |                                  |
|                                  | 8\. A record may also be         |
| lated Awards." The Privacy Act   | disclosed for a research         |
| of 1974 (5 USC 522a) allows      | purpose,                         |
| disclosures for "routine uses"   |                                  |
| and permissible disclosures.     | when the DHHS:                   |
|                                  |                                  |
| Some routine uses may be:        | a\. has determined that the use  |
|                                  | or disclosure does not           |
| 1\. To the cognizant audit       |                                  |
| agency for auditing.             | violate legal or policy          |
|                                  | limitations under which the      |
| 2\. To a Congressional office    |                                  |
| from a record of an individual   | record was provided, collected,  |
|                                  | or obtained;                     |
| in response to an inquiry from   |                                  |
| the Congressional office         | b\. has determined that the      |
|                                  | research purpose (1) cannot be   |
| made at the request of that      |                                  |
| individual.                      | reasonably accomplished unless   |
|                                  | the record is provided           |
| 3\. To qualified experts, not    |                                  |
| within the definition of DHHS    | in individually identifiable     |
|                                  | form, and (2) warrants the       |
| employees as prescribed in DHHS  |                                  |
| regulations (45 CFR              | risk to the privacy of the       |
|                                  | individual that additional       |
| 5b.2) for opinions as part of    |                                  |
| the application review           | exposure of the record might     |
|                                  | bring;                           |
| process.                         |                                  |
|                                  | c\. has secured a written        |
| 4\. To a Federal agency, in      | statement attesting to the       |
| response to its request, in con- |                                  |
|                                  | recipient's understanding of,    |
| nection with the letting of a    | and willingness to abide         |
| contract or the issuance of      |                                  |
|                                  | by, these provisions; and        |
| a license, grant, or other       |                                  |
| benefit by the requesting agen-  | d\. has required the recipient   |
|                                  | to:                              |
| cy, to the extent that the       |                                  |
| record is relevant and necessary | \(1\) establish reasonable       |
|                                  | administrative, technical, and   |
| to the requesting agency's       |                                  |
| decision on the matter;          | physical safeguards to prevent   |
|                                  | unauthorized use or              |
| 5\. To organizations in the      |                                  |
| private sector with whom PHS     | disclosure of the record;        |
|                                  |                                  |
| has contracted for the purpose   | \(2\) remove or destroy the      |
| of collating, analyzing,         | information that identifies      |
|                                  |                                  |
| aggregating, or otherwise        | the individual at the earliest   |
| refining records in a system.    | time at which removal or         |
|                                  |                                  |
| Relevant records will be         | destruction can be accomplished  |
| disclosed to such a contractor,  | consistent with the              |
|                                  |                                  |
| who will be required to maintain | purpose of the research project, |
| Privacy Act safeguards           | unless the recipient             |
|                                  |                                  |
| with respect to such records.    | has presented adequate           |
|                                  | justification of a research or   |
| 6\. To the sponsoring            |                                  |
| organization in connection with  | health nature for retaining such |
| the                              | information; and                 |
|                                  |                                  |
| review of an application or      | \(3\) make no further use or     |
| performance or admini-           | disclosure of the record,        |
|                                  |                                  |
| stration under the terms and     | except (a) in emergency          |
| conditions of the award, or      | circumstances affecting the      |
|                                  |                                  |
| in connection with problems that | health or safety of any          |
| might arise in perform-          | individual, (b) for use in       |
|                                  |                                  |
| ance or administration if an     | another research project, under  |
| award is made.                   | these same conditions,           |
|                                  |                                  |
| 7\. To the Department of         | and with written authorization   |
| Justice, to a court or other     | of the DHHS, (c) for             |
| tribunal,                        |                                  |
|                                  | disclosure to a properly         |
| or to another party before such  | identified person for the        |
| tribunal, when one of the        |                                  |
|                                  | purpose of an audit related to   |
| following is a party to          | the research project, if         |
| litigation or has any interest   |                                  |
| in                               | information that would enable    |
|                                  | research subjects to be          |
| such litigation, and the DHHS    |                                  |
| determines that the use of       | identified is removed or         |
|                                  | destroyed at the earliest        |
| such records by the Department   |                                  |
| of Justice, the tribunal,        | opportunity consistent with the  |
|                                  | purpose of the audit,            |
| or the other party is relevant   |                                  |
| and necessary to the             | or (d) when required by law.     |
|                                  |                                  |
| litigation and would help in the | The Privacy Act also authorizes  |
| effective representation         | discretionary disclosures where  |
|                                  | determined appropriate by the    |
| of the governmental party.       | PHS, including to law            |
|                                  | enforcement agencies, to the     |
| a\. the DHHS, or any component   | Congress acting within its       |
| thereof;                         | legislative authority, to the    |
|                                  | Bureau of the Census, to the     |
| b\. any DHHS employee in his or  | National Archives, to the        |
| her official capacity;           | General Accounting Office,       |
|                                  | pursuant to a court order, or as |
| c\. any DHHS employee in his or  | required to be disclosed by the  |
| her individual                   | Freedom of Information Act of    |
|                                  | 1974 (5 USC 552) and the         |
| capacity where the Department of | associated DHHS regulations (45  |
| Justice (or the                  | CFR Part 5).                     |
|                                  |                                  |
| DHHS, where it is authorized to  |                                  |
| do so) has agreed to             |                                  |
|                                  |                                  |
| represent the employee; or       |                                  |
+----------------------------------+----------------------------------+
|                                  |                                  |
+----------------------------------+----------------------------------+

HHS 568 (Rev. 4/98)---Privacy Act