Amendment to the Egg Research and Promotion Rules and Regulations To Update Patents, Copyrights, Trademarks, and Information Provisions, 90185-90186 [2016-29988]
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90185
Rules and Regulations
Federal Register
Vol. 81, No. 240
Wednesday, December 14, 2016
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1250
[Doc. No. AMS–LPS–15–0042]
Amendment to the Egg Research and
Promotion Rules and Regulations To
Update Patents, Copyrights,
Trademarks, and Information
Provisions
AGENCY:
Agricultural Marketing Service,
USDA.
ACTION:
Final rule.
This final rule amends the
Patents, Copyrights, Trademarks,
Publications, and Product Formulations
(IP) language of the Egg Research and
Promotion Rules and Regulations
(Regulations) to conform with
commodity research and promotion
program orders created under the
Commodity Promotion, Research, and
Information Act of 1996 (1996 Act).
DATES: Effective January 13, 2017.
FOR FURTHER INFORMATION CONTACT:
Kenneth R. Payne, Research and
Promotion Division; Livestock, Poultry,
and Seed Program; AMS, USDA; 1400
Independence Avenue SW., Room
2610–S; Washington, DC 20250;
telephone (202) 720–5705; fax (202)
720–1125; or email Kenneth.Payne@
ams.usda.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
rmajette on DSK2TPTVN1PROD with RULES
Executive Order 12866
The Office of Management and Budget
(OMB) has waived the review process
required by Executive Order 12866 for
this action.
Executive Order 12988
This rule was reviewed under
Executive Order 12988, Civil Justice
Reform. It is not intended to have a
retroactive effect. This action will not
VerDate Sep<11>2014
15:29 Dec 13, 2016
Jkt 241001
preempt any state or local laws,
regulations, or policies unless they
present an irreconcilable conflict with
this rule. The Egg Research and
Consumer Information Act (Act) [7
U.S.C. 2701 et seq.] provides that
administrative proceedings be filed
before parties may consider suit in
court. Under section 14 of the Act [7
U.S.C. 2713], a person subject to the Egg
Promotion and Research Order (Order)
may file a petition with the Department
of Agriculture (USDA) stating that the
Order, any provision of the Order, or
any obligation imposed in connection
with the Order, is not in accordance
with the law and request a modification
of the Order or an exemption from the
Order. The petitioner is afforded the
opportunity for a hearing on the
petition. After a hearing, USDA would
rule on the petition. The Act provides
that district courts of the U.S. in any
district in which such person is an
inhabitant, or has their principal place
of business, has jurisdiction to review
USDA’s ruling on the petition, if a
complaint for this purpose is filed
within 20 days after the date of the entry
of the ruling.
Regulatory Flexibility Act
In accordance with the Regulatory
Flexibility Act (RFA) [5 U.S.C. 601–
612], the Agricultural Marketing Service
(AMS) has determined that this rule will
not have a significant economic impact
on a substantial number of small entities
as defined by RFA. The purpose of RFA
is to fit regulatory action to scale on
businesses subject to such action so that
small businesses will not be
disproportionately burdened. As such,
these changes will not impose a
significant impact on persons subject to
the program.
According to the American Egg Board
(Board), in 2015, approximately 181 egg
producers were subject to the provisions
of the Order, including paying
assessments. Under the current Order,
producers in the 48 contiguous States of
the U.S. and the District of Columbia
who own more than 75,000 laying hens
currently pay a mandatory assessment
of 10 cents per 30-dozen case of eggs
sold. Egg handlers are responsible for
collecting and remitting assessments to
the Board. According to the Board, of
those 181 egg producers, about 138 egg
handlers collect assessments.
Assessments under the program are
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
used by the Board to finance promotion,
research, and consumer information
programs designed to increase consumer
demand for eggs in domestic and
international markets.
In 13 CFR part 121, the Small
Business Administration (SBA) defines
small agricultural producers as those
having annual receipts of no more than
$750,000 and small agricultural service
firms as those having annual receipts of
no more than $7 million. Under this
definition, the vast majority of egg
producers that would be affected by this
rule would not be considered small
entities. Producers owning 75,000 or
fewer laying hens are eligible to be
exempt from this program. This rule
does not impose additional
recordkeeping requirements on egg
producers or handlers. There are no
Federal rules that duplicate, overlap, or
conflict with this rule.
Paperwork Reduction Act
In accordance with OMB regulation 5
CFR part 1320, which implements the
Paperwork Reduction Act of 1995 [44
U.S.C. Chapter 35], the information
collection and recordkeeping
requirements that are imposed by the
Order and Rules and Regulations have
been approved previously under OMB
control number 0581–0093. This rule
does not result in a change to those
information collection and
recordkeeping requirements.
Background
The Act established a national egg
research and promotion program—
administered by the Board—that is
financed through industry assessments
and subject to oversight by USDA’s
AMS. This program of promotion,
research, and consumer information is
designed to strengthen the position of
eggs in the marketplace and to establish,
maintain, and expand markets for eggs.
Under the current Regulations
initially established in 1976, any IP
financed by assessment funds or other
revenues of the Board shall become
property of the U.S. Government as
represented by the Board. The language
does not allow for alternative ownership
arrangements. In addition, there is no
explicit allowance for alternative
ownership arrangements in cases where
the Board is not providing all of the
funding for a project. According to the
Board, the current language in the Order
has made negotiating contracts for
E:\FR\FM\14DER1.SGM
14DER1
90186
Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations
shared ownership of IP rights with
research entities difficult and in some
cases impossible. Specifically, a
majority of university policies typically
reflect a requirement for the university
to own any IP created under research
projects they conduct, even if the
project is funded with outside money.
These university policies have made it
difficult for the Board to contract with
universities for research due to the IP
ownership requirements contained in
the Order.
As a result, USDA is amending
§ 1250.542 of the Regulations to
incorporate language utilized by
research and promotion boards created
under the 1996 Act that would provide
the Board with flexibility in negotiating
over the ownership of IP rights. The
research and promotion boards created
under the 1996 Act have utilized this
language to negotiate ownership rights
over IP to effectively expend assessment
funds to promote agricultural
commodities.
Summary of Comments
AMS published the notice of
proposed rulemaking in the Federal
Register on March 16, 2016 [81 FR
14021]. The comment period ended on
May 16, 2016. AMS received one timely
comment from a university. The
commenter expressed that it is the
policy of the university to retain
ownership of intellectual property
generated through research funded by
external parties and encouraged AMS to
adopt policies and rules that closely
follow the standard approaches
articulated in Federal Government
grants. However, the egg research and
promotion program is not a grant
program and is not subject to Federal
grants policy. In addition, the Board
does not receive Federal funding. All
funds are received from egg producers
required under the enabling legislation
to pay an assessment to the Board to
fund programs designed to increase
demand for eggs and egg products both
domestically and internationally.
Accordingly, AMS did not incorporate
the Federal grants policy into the final
rule.
rmajette on DSK2TPTVN1PROD with RULES
List of Subjects in 7 CFR Part 1250
Administrative practice and
procedure, Advertising, Agricultural
research, Eggs and egg products,
Reporting and recordkeeping
requirements.
15:29 Dec 13, 2016
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. The authority citation of 7 CFR part
1250 continues to read as follows:
Food and Drug Administration
■
Authority: 7 U.S.C. 2701–2718; 7 U.S.C.
7401.
2. Revise § 1250.542 to read as
follows:
■
§ 1250.542 Patents, Copyrights,
Inventions, Trademarks, Information,
Publications, and Product Formulations.
(a) Except as provided in paragraph
(b) of this section, any patents,
copyrights, inventions, trademarks,
information, publications, or product
formulations developed through the use
of funds collected by the Board under
the provisions of this subpart shall be
the property of the U.S. Government, as
represented by the Board, and shall,
along with any rents, royalties, residual
payments, or other income from the
rental, sales, leasing, franchising, or
other uses of such patents, copyrights,
inventions, trademarks, information,
publications, or product formulations,
inure to the benefit of the Board; shall
be considered income subject to the
same fiscal, budget, and audit controls
as other funds of the Board; and may be
licensed subject to approval by the
Secretary. Upon termination of this
subpart, § 1250.358 shall apply to
determine disposition of all such
property.
(b) Should patents, copyrights,
inventions, trademarks, information,
publications, or product formulations be
developed through the use of funds
collected by the Board under this
subpart and funds contributed by
another organization or person, the
ownership and related rights to such
patents, copyrights, inventions,
trademarks, information, publications,
or product formulations shall be
determined by an agreement between
the Board and the party contributing
funds towards the development of such
patents, copyrights, inventions,
trademarks, information, publications,
or product formulations in a manner
consistent with paragraph (a) of this
section.
Dated: December 8, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing
Service.
For the reasons set forth in the
preamble, 7 CFR part 1250 is amended
as follows:
VerDate Sep<11>2014
PART 1250—EGG RESEARCH AND
PROMOTION
[FR Doc. 2016–29988 Filed 12–13–16; 8:45 am]
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Fmt 4700
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21 CFR Part 1
[Docket No. FDA–2011–N–0146]
RIN 0910–AH23
Amendments to Accreditation of ThirdParty Certification Bodies To Conduct
Food Safety Audits and To Issue
Certifications To Provide for the User
Fee Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is amending its regulations on
accreditation of third-party certification
bodies to conduct food safety audits and
to issue certifications to provide for a
reimbursement (user fee) program to
assess fees for the work FDA performs
to establish and administer the thirdparty certification program under the
FDA Food Safety Modernization Act
(FSMA).
SUMMARY:
DATES:
This rule is effective January 13,
2017.
FOR FURTHER INFORMATION CONTACT:
Sylvia Kim, Office of Foods and
Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3212, Silver Spring,
MD 20993–0002, 301–796–7599.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. FDA Food Safety Modernization Act
and Section 808 of the Federal Food,
Drug, and Cosmetics Act
B. Third-Party Certification Regulation
C. Purpose of This Rulemaking
D. The Proposed Rule
E. Public Comments
II. Legal Authority
III. Comments on Who Is Subject to a User
Fee Under This Subpart (§ 1.700)
IV. Comments on What User Fees Are
Established Under This Subpart (§ 1.705)
V. Comments on How Will FDA Notify the
Public About the Fee Schedule (§ 1.710)
VI. Comments on When a User Fee Required
by This Subpart Must Be Submitted
(§ 1.715)
VII. Comments on Whether User Fees Under
This Subpart Are Refundable (§ 1.720)
VIII. Comments on the Consequences of Not
Paying a User Fee Under This Subpart on
Time (§ 1.725)
IX. Comments on Possible Exemptions
X. Economic Analysis of Impacts
XI. Paperwork Reduction Act of 1995
XII. Analysis of Environmental Impact
XIII. Federalism
E:\FR\FM\14DER1.SGM
14DER1
]]>Agencies
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Rules and Regulations]
[Pages 90185-90186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29988]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 /
Rules and Regulations
[[Page 90185]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1250
[Doc. No. AMS-LPS-15-0042]
Amendment to the Egg Research and Promotion Rules and Regulations
To Update Patents, Copyrights, Trademarks, and Information Provisions
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the Patents, Copyrights, Trademarks,
Publications, and Product Formulations (IP) language of the Egg
Research and Promotion Rules and Regulations (Regulations) to conform
with commodity research and promotion program orders created under the
Commodity Promotion, Research, and Information Act of 1996 (1996 Act).
DATES: Effective January 13, 2017.
FOR FURTHER INFORMATION CONTACT: Kenneth R. Payne, Research and
Promotion Division; Livestock, Poultry, and Seed Program; AMS, USDA;
1400 Independence Avenue SW., Room 2610-S; Washington, DC 20250;
telephone (202) 720-5705; fax (202) 720-1125; or email
Kenneth.Payne@ams.usda.gov.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
The Office of Management and Budget (OMB) has waived the review
process required by Executive Order 12866 for this action.
Executive Order 12988
This rule was reviewed under Executive Order 12988, Civil Justice
Reform. It is not intended to have a retroactive effect. This action
will not preempt any state or local laws, regulations, or policies
unless they present an irreconcilable conflict with this rule. The Egg
Research and Consumer Information Act (Act) [7 U.S.C. 2701 et seq.]
provides that administrative proceedings be filed before parties may
consider suit in court. Under section 14 of the Act [7 U.S.C. 2713], a
person subject to the Egg Promotion and Research Order (Order) may file
a petition with the Department of Agriculture (USDA) stating that the
Order, any provision of the Order, or any obligation imposed in
connection with the Order, is not in accordance with the law and
request a modification of the Order or an exemption from the Order. The
petitioner is afforded the opportunity for a hearing on the petition.
After a hearing, USDA would rule on the petition. The Act provides that
district courts of the U.S. in any district in which such person is an
inhabitant, or has their principal place of business, has jurisdiction
to review USDA's ruling on the petition, if a complaint for this
purpose is filed within 20 days after the date of the entry of the
ruling.
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C.
601-612], the Agricultural Marketing Service (AMS) has determined that
this rule will not have a significant economic impact on a substantial
number of small entities as defined by RFA. The purpose of RFA is to
fit regulatory action to scale on businesses subject to such action so
that small businesses will not be disproportionately burdened. As such,
these changes will not impose a significant impact on persons subject
to the program.
According to the American Egg Board (Board), in 2015, approximately
181 egg producers were subject to the provisions of the Order,
including paying assessments. Under the current Order, producers in the
48 contiguous States of the U.S. and the District of Columbia who own
more than 75,000 laying hens currently pay a mandatory assessment of 10
cents per 30-dozen case of eggs sold. Egg handlers are responsible for
collecting and remitting assessments to the Board. According to the
Board, of those 181 egg producers, about 138 egg handlers collect
assessments. Assessments under the program are used by the Board to
finance promotion, research, and consumer information programs designed
to increase consumer demand for eggs in domestic and international
markets.
In 13 CFR part 121, the Small Business Administration (SBA) defines
small agricultural producers as those having annual receipts of no more
than $750,000 and small agricultural service firms as those having
annual receipts of no more than $7 million. Under this definition, the
vast majority of egg producers that would be affected by this rule
would not be considered small entities. Producers owning 75,000 or
fewer laying hens are eligible to be exempt from this program. This
rule does not impose additional recordkeeping requirements on egg
producers or handlers. There are no Federal rules that duplicate,
overlap, or conflict with this rule.
Paperwork Reduction Act
In accordance with OMB regulation 5 CFR part 1320, which implements
the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the
information collection and recordkeeping requirements that are imposed
by the Order and Rules and Regulations have been approved previously
under OMB control number 0581-0093. This rule does not result in a
change to those information collection and recordkeeping requirements.
Background
The Act established a national egg research and promotion program--
administered by the Board--that is financed through industry
assessments and subject to oversight by USDA's AMS. This program of
promotion, research, and consumer information is designed to strengthen
the position of eggs in the marketplace and to establish, maintain, and
expand markets for eggs.
Under the current Regulations initially established in 1976, any IP
financed by assessment funds or other revenues of the Board shall
become property of the U.S. Government as represented by the Board. The
language does not allow for alternative ownership arrangements. In
addition, there is no explicit allowance for alternative ownership
arrangements in cases where the Board is not providing all of the
funding for a project. According to the Board, the current language in
the Order has made negotiating contracts for
[[Page 90186]]
shared ownership of IP rights with research entities difficult and in
some cases impossible. Specifically, a majority of university policies
typically reflect a requirement for the university to own any IP
created under research projects they conduct, even if the project is
funded with outside money. These university policies have made it
difficult for the Board to contract with universities for research due
to the IP ownership requirements contained in the Order.
As a result, USDA is amending Sec. 1250.542 of the Regulations to
incorporate language utilized by research and promotion boards created
under the 1996 Act that would provide the Board with flexibility in
negotiating over the ownership of IP rights. The research and promotion
boards created under the 1996 Act have utilized this language to
negotiate ownership rights over IP to effectively expend assessment
funds to promote agricultural commodities.
Summary of Comments
AMS published the notice of proposed rulemaking in the Federal
Register on March 16, 2016 [81 FR 14021]. The comment period ended on
May 16, 2016. AMS received one timely comment from a university. The
commenter expressed that it is the policy of the university to retain
ownership of intellectual property generated through research funded by
external parties and encouraged AMS to adopt policies and rules that
closely follow the standard approaches articulated in Federal
Government grants. However, the egg research and promotion program is
not a grant program and is not subject to Federal grants policy. In
addition, the Board does not receive Federal funding. All funds are
received from egg producers required under the enabling legislation to
pay an assessment to the Board to fund programs designed to increase
demand for eggs and egg products both domestically and internationally.
Accordingly, AMS did not incorporate the Federal grants policy into the
final rule.
List of Subjects in 7 CFR Part 1250
Administrative practice and procedure, Advertising, Agricultural
research, Eggs and egg products, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR part 1250 is
amended as follows:
PART 1250--EGG RESEARCH AND PROMOTION
0
1. The authority citation of 7 CFR part 1250 continues to read as
follows:
Authority: 7 U.S.C. 2701-2718; 7 U.S.C. 7401.
0
2. Revise Sec. 1250.542 to read as follows:
Sec. 1250.542 Patents, Copyrights, Inventions, Trademarks,
Information, Publications, and Product Formulations.
(a) Except as provided in paragraph (b) of this section, any
patents, copyrights, inventions, trademarks, information, publications,
or product formulations developed through the use of funds collected by
the Board under the provisions of this subpart shall be the property of
the U.S. Government, as represented by the Board, and shall, along with
any rents, royalties, residual payments, or other income from the
rental, sales, leasing, franchising, or other uses of such patents,
copyrights, inventions, trademarks, information, publications, or
product formulations, inure to the benefit of the Board; shall be
considered income subject to the same fiscal, budget, and audit
controls as other funds of the Board; and may be licensed subject to
approval by the Secretary. Upon termination of this subpart, Sec.
1250.358 shall apply to determine disposition of all such property.
(b) Should patents, copyrights, inventions, trademarks,
information, publications, or product formulations be developed through
the use of funds collected by the Board under this subpart and funds
contributed by another organization or person, the ownership and
related rights to such patents, copyrights, inventions, trademarks,
information, publications, or product formulations shall be determined
by an agreement between the Board and the party contributing funds
towards the development of such patents, copyrights, inventions,
trademarks, information, publications, or product formulations in a
manner consistent with paragraph (a) of this section.
Dated: December 8, 2016.
Elanor Starmer,
Administrator, Agricultural Marketing Service.
[FR Doc. 2016-29988 Filed 12-13-16; 8:45 am]
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