[Federal Register Volume 61, Number 205 (Tuesday, October 22, 1996)]
[Rules and Regulations]
[Pages 54743-54744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 6 and 8

RIN 0925-AA15


Removal of Obsolete Patent Regulations

AGENCY: Office of the Secretary, HHS.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) is 
rescinding the regulations concerning inventions and patents generally 
and inventions resulting from research grants and contracts and 
fellowship awards, because the regulations are obsolete.

EFFECTIVE DATE: October 22, 1996.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Lambert, Office of the 
General Counsel, Building 31, Room 2B-50, 31 Center Dr MSC 2111, 
Bethesda, MD 20892-2111, telephone (301) 496-6043 (this is not a toll-
free number).

SUPPLEMENTARY INFORMATION: The Bayh-Dole Act, 35 U.S.C. 200-212 (Public 
Law 96-517 (Dec. 12, 1980)) and implementing regulations issued by the 
Department of Commerce, 37 CFR Part 401, established Government-wide 
patent policies that superseded the HHS policies codified in 45 CFR 
Parts 6 and 8. Prior to the passage of the Bayh-Dole Act, HHS made 
determinations of ownership and disposition of inventions made under 
grants and contracts funded by HHS. The general policy was to obtain 
rights to inventions made with Federal funding and to dedicate such 
inventions, along with those of Government employees, to the public 
through publication or by providing licenses to Government-owned 
patents on a royalty-free, nonexclusive basis.
    The Bayh-Dole Act adopted a different philosophy of patenting. 
Based on the premise that commercialization of inventions will best 
promote the public interest, the Bayh-Dole Act provides that small 
business and nonprofit recipients of Federal funds can elect to retain 
title to an invention, subject to a nonexclusive, nontransferable, 
irrevocable, paid-up license to the Government to use and license 
others to use the invention for Government purposes. In 1983, by a 
memorandum to the Heads of Executive Departments and Agencies, 
President Reagan extended to all recipients of Federal funding the same 
right to elect title to inventions and that memorandum was reaffirmed 
in 1987 by Executive Order 12591.
    The Bayh-Dole Act, and its implementing regulations at 37 CFR Part 
401, have made obsolete the HHS regulations at 45 CFR Parts 6 and 8. In 
addition, 45 CFR Part 6 is obsolete because it does not accurately 
reflect the policies or organizational structure of HHS. Accordingly, 
this final rule rescinds HHS regulations that have been superseded by 
statutes, regulations and policies that provide for the transfer of 
Government-funded technology to the private sector through the 
elimination of Government control over inventions made under Federal 
grants and contracts. HHS is considering whether it is necessary to 
replace Parts 6 and 8 of title 45 CFR or whether new HHS regulations 
are unnecessary in light of the Department of Commerce regulations.
    Notice, public comment, and delayed effective date have been waived 
for this amendment based on a finding of good cause. The parts being 
removed are obsolete, and their removal will not in any way affect 
funding recipients or others adversely.

Executive Order 12866

    Executive Order No. 12866 requires that all regulatory actions 
reflect consideration of the costs and benefits they generate and that 
they meet certain standards, such as avoiding the imposition of 
unnecessary burdens on the affected public. If a regulatory action is 
deemed to fall within the scope of the definition of the term 
``significant regulatory action'' contained in section 3(f) of the 
Order, pre-publication review by the Office of Management and Budget's 
(OMB) Office of Information and Regulatory Affairs (OIRA) is necessary. 
This rule was deemed ``not significant'' by OIRA.

Regulatory Flexibility Act

    This final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, a regulatory 
flexibility analysis, as defined under the Regulatory Flexibility Act 
of 1980 (5 U.S.C. chapter 6), is not required.

[[Page 54744]]

Paperwork Reduction Act

    This final rule does not contain any information collection 
requirements subject to OMB review and approval under the Paperwork 
Reduction Act of 1995 (44 U.S.C. chapter 35).

List of Subjects in 45 CFR Parts 6 and 8

    Inventions and patents.

    Dated: October 3, 1996.
Harold Varmus,
Director, NIH.

    For the reasons set out in the preamble and under the authority of 
5 U.S.C. 301, subtitle A of title 45 of the Code of Federal Regulations 
is amended as follows:

PART 6--INVENTIONS AND PATENTS (GENERAL) [REMOVED AND RESERVED]

    1. Part 6 of 45 CFR is removed and reserved.

PART 8--INVENTIONS RESULTING FROM RESEARCH GRANTS, FELLOWSHIP 
AWARDS, AND CONTRACTS FOR RESEARCH [REMOVED AND RESERVED]

    2. Part 8 of 45 CFR is removed and reserved.
[FR Doc. 96-26975 Filed 10-21-96; 8:45 am]
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