HHS found that systematically, over a
period of several years, when Determinations of Exceptional
Circumstances (DECs) were executed, additional legal protection for
the patent and data rights of third parties beyond those covered by
FAR were necessary. A decision was made to add two
clauses--352.227-11 Patent Rights--Exceptional Circumstances and
352.227-14 Rights in Data--Exceptional Circumstances--to the HHS
supplement to the FAR, the HHS Acquisition Regulation (HHSAR), to
provide the additional legal protection required. These clauses
would ensure that providers of proprietary material(s) to the
government will retain all their preexisting rights to their
material(s), and rights to any inventions made under a contract or
subcontract (at all tiers), when a DEC has been executed. Rights in
data regulations concern the rights of the Government, and
organizations with which the Government contracts, to information
developed under such contracts. The delineation of such rights is
necessary in order to protect the contractor's rights to not
disclose proprietary data and to insure that non-proprietary data
developed with public funds is available to the public.
PL:
Pub.L. 96 - 517 401 Name of Law: Patent and Trademark Act
US Code: 35
USC 200-212 Name of Law: Bayh-Dole Act
EO: EO 12591 Name/Subject of EO: Facilitating Access
to Science and Technology
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.