Amendment to the Egg Research and Promotion Rules and Regulations To Update Patents, Copyrights, Trademarks, and Information Provisions, 90185-90186 [2016-29988]

Download as PDF 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] BILLING CODE P PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 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]
BILLING CODE P