Compliance Alert – March 2023
- March 22nd, 2023
- in Newsletter
Final Rules
Official Transition to Issuing Electronic Patent Grants in 2023
The United States Patent and Trademark Office (USPTO) is implementing electronic patent issuance to reduce pendency of patent applications, foster a green economy by reducing paper waste, and permit complete issued patents to be viewable and printable by both the applicants as well as the public immediately upon issuance in Patent Center, the USPTO’s electronic patent application filing and management system. Patent grants will no longer be issued on paper, and as a result, they will no longer be mailed to the correspondence address of record as part of the patent issuance process. During a transition period, the USPTO will provide a paper copy of the electronic patent grant as a courtesy ceremonial copy, delivered to the patentee’s correspondence address of record. After the transition period, a selection of patent grant copies, including the ceremonial copy, will be available for purchase at a nominal charge. The electronic patent grant will be the official statutory patent grant.
Federal Agency: Patent and Trademark Office
Affected Area: ORED
This action finalizes the proposal of the Office of Federal Contract Compliance Programs (OFCCP) to rescind the final rule titled “Implementing Legal Requirements Regarding the Equal Opportunity Clause’s Religious Exemption,” which took effect on January 8, 2021. This rescission removes the regulations established by that rule.
Federal Agency: Office of Federal Contract Compliance Programs, Labor
Affected Area: HR, EEO/Title IX
This final rule will revise the Department of Veterans Affairs (VA) regulations that govern the Program for the Repayment of Educational Loans (PREL) and Specialty Education Loan Repayment Program (SELRP) by adding the Office of Management and Budget approval number for the associated collections of information. VA is also making technical corrections to its regulation that governs VA’s urgent care benefit.
Federal Agency: Department of Veteran’s Affairs
Affected Area: Student Financial Aid
Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
The Office of the Secretary of Transportation is updating the DOT regulation that adopts the Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. This amendment responds to the 2020 changes to the Office of Management and Budget Guidance for Grants and Agreements, which amended OMB’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, by revising section cross-references.
Federal Agency: Department of Transportation
Affected Area: OSP
Visas: Procedures for Issuing Visas
The Department of State is updating its regulation regarding visa applicants’ furnishing of signed photographs as required under Section 221(b) of the Immigration and Nationality Act. These updates reflect changes in technology, including the ability to upload digital photographs electronically as part of the online visa application process.
Federal Agency: Department of State
Affected Area: Capstone International
Proposed Rules
Direct Grant Programs, State-Administered Formula Grant Programs
The U.S. Department of Education (we or the Department) proposes to rescind regulations related to religious student organizations at certain public institutions of higher education (IHEs) that prescribe a novel role for the Department in enforcing grant conditions related to religious student organizations. These regulations apply to public IHEs that receive a direct grant from the Department or a subgrant from a State-administered formula grant program of the Department. The Department proposes to rescind the regulations because they are not necessary to protect the First Amendment right to free speech and free exercise of religion; have created confusion among institutions; and prescribe an unduly burdensome role for the Department to investigate allegations regarding IHEs’ treatment of religious student organizations.
Federal Agency: Department of Education
Affected Area: Student Life
Comments Due: 3/24/23
Notices
Borrowers who have defaulted on their Direct Loan or FFEL Program loans may remove those loans from default through a process called rehabilitation. Loan rehabilitation requires the borrower to make 9 payments within 10 months. The payment amount is set according to one of two formulas. The second of the two formulas uses the information that is collected in this form. The form makes it easier for borrowers to complete through simplified language, and easier for loan holders through a uniform, common format.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 5/1/2023
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of December 19, 2022. In that notice, FDA requested comments on draft guidance for industry (GFI) #152 entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Federal Agency: Food and Drug Administration, HHS
Affected Area: ORED
Comments Due: 5/19/2023
Items of Interest
Health and Human Services oversees about 2,300 U.S.-based IRBs through routine or for-cause inspections to assess if they are following federal laws when reviewing research. But few IRBs are inspected. For example, one HHS agency aims to do just 3-4 routine inspections each year. Also, HHS agencies haven’t examined how many inspections are needed or if inspections could be changed to further reduce risks to human subjects. Our recommendations address this.
House Republicans Want Information on Foreign Gifts
House Republicans want more information from the Education Department about its enforcement of the federal law that requires the reporting of foreign gifts to universities. North Carolina representative Virginia Foxx, the Republican who chairs the House Committee on Education and the Workforce, wrote in a letter signed by several other lawmakers that she was concerned about the department’s decision to shift enforcement of the law, known as Section 117, from the Office of General Counsel to Federal Student Aid.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committees regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.
Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
The Secretary of the U.S. Department of Health and Human Services (HHS) is planning for the Federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. The extramural community is reminded that as of that date NIH will no longer be able to grant single IRB exceptions for multi-site research that is subject to the revised Common Rule cooperative research provision under the Office for Human Research Protections (OHRP) Determination of “Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
ACE, Higher Ed Groups Ask Again for Clarification on Foreign Gift and Contract Reporting
Along with a number of other higher education associations [*including COGR], ACE sent comments to the Department of Education (ED) Feb. 27 in response to the December Federal Register notice requesting feedback on recent changes to how colleges and universities report foreign gifts and contracts as specified in Section 117 of the Higher Education Act.
Keeping Your Federally-Funded Inventions: Requirements to Comply with the Bayh-Dole Act
Importantly, during due diligence investigations, failures to comply with Bayh-Dole requirements can raise red flags and cast doubts as to ownership of intellectual property because the government could potentially have the right to take title due to non-compliance. Here are some key requirements and deadlines to watch out for, including a few that were changed as of May 14, 2018.
Biden’s Budget Calls for $820 Pell Increase
The administration also wants $90 billion over 10 years to make two years of community college free.