Compliance Alert – December 2022/January 2023
- January 26th, 2023
- in Newsletter
Final Rules
Date of Receipt of Electronic Submissions of Patent Correspondence
The United States Patent and Trademark Office (USPTO or Office) is amending the patent rules of practice to provide that the receipt date of correspondence officially submitted electronically by way of the USPTO patent electronic filing system is the date in the Eastern time zone of the United States (Eastern Time) when the USPTO received the correspondence rather than the date on which the correspondence is received at the correspondence address in Alexandria, Virginia. This change is necessary because the USPTO is expecting to provide servers for receiving electronic submissions in locations that are separate from the USPTO headquarters in Alexandria, Virginia. This change will ensure consistency and predictability with respect to correspondence receipt dates, as the date of receipt accorded to correspondence submitted electronically will not depend on the location of USPTO servers. The USPTO is also amending the patent rules of practice to make other clarifying changes regarding the receipt of electronic submissions, including providing a definition for Eastern Time. These changes harmonize the patent rules with the trademark rules and provide clarity regarding the date of receipt of electronic submissions.
Federal Agency: United States Patent and Trademark Office, Department of Commerce
Affected Area: ORED
Standards and Practices for All Appropriate Inquiries
EPA is taking final action to amend the Standards and Practices for All Appropriate Inquiries to reference a standard practice recently made available by ASTM International, a widely recognized standards developing organization. Specifically, this final rule amends the All Appropriate Inquiries Rule (AAI rule) to reference ASTM International’s E1527-21 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process” and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation and Liability Act, and to remove after one year recognition of the previous version of that standard, ASTM E1527-13, as compliant with the AAI rule.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Proposed Rules
Medications for the Treatment of Opioid Use Disorder
The Department of Health and Human Services (HHS or “the Department”) is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations regarding medications for the treatment of opioid use disorder.
Federal Agency: Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services
Affected Area: CCHS
Comments Due: 02/14/2023
This rule proposes to amend the United States Department of Justice (“DOJ” or “Department”) Privacy Act implementation regulations, including its Privacy Act record access and amendment procedures. Additionally, this rule includes procedures regarding processing Privacy Act requests to access or amend covered records, as designated under the Judicial Redress Act of 2015, and expands protections on the Department’s maintenance of Social Security account numbers, in accordance with the Social Security Number Fraud Prevention Act of 2017.
Federal Agency: Department of Justice
Affected Area: Privacy
Comments Due: 03/07/2023
On October 18, 2022, the Department of the Interior (DOI) published in the Federal Register (87 FR 63202) a proposed rule to amend the regulations to improve implementation of the Native American Graves Protection and Repatriation Act of 1990. These proposed regulations would clarify and improve upon the systematic process for the disposition and repatriation of Native American human remains, funerary objects, sacred objects, or objects of cultural patrimony. The proposed changes would provide a step-by-step roadmap for museums and Federal agencies to comply with requirements within specific timelines to facilitate the required disposition and repatriation. The proposed changes would describe the processes in accessible language with clear timelines and terms, reduce ambiguity, and improve efficiency in meeting the requirements. In addition, the proposed changes emphasize consultation in every step and defer to the customs, traditions, and Native American traditional knowledge of lineal descendants, Indian Tribes, and Native Hawaiian organizations. The public comment period for this proposal is scheduled to close on Tuesday, January 17, 2023. In order to give the public additional time to review and comment on the proposal, the DOI is extending the public comment period until Tuesday, January 31, 2023. Comments previously submitted on the proposed rule need not be resubmitted, as they will be fully considered in preparing the final rule.
Federal Agency: Department of the Interior
Affected Area: Campus Development, Moundville
Comments Due: 01/31/2023
Improving Income-Driven Repayment for the William D. Ford Federal Direct Loan Program
The Secretary proposes to amend the regulations governing income-contingent repayment plans by amending the Revised Pay as You Earn (REPAYE) repayment plan, and to restructure and rename the repayment plan regulations under the William D. Ford Federal Direct Loan (Direct Loan) Program, including combining the Income Contingent Repayment (ICR) and the Income-Based Repayment (IBR) plans under the umbrella term of “Income-Driven Repayment (IDR) plans.”
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 02/10/2023
Notices
This request is for an extension of the current information collection 1845-0038 that is expiring. This collection pertains to the recordkeeping requirements contained in the regulations related to the administration of the Subpart K—Cash Management section of the Student Assistance General Provisions. The regulatory language has not changed. These program regulations are designed to provide benefits to Title IV, HEA applicants, and protect the taxpayers’ interest. The information collection requirements in these regulations are necessary to provide students with required information about their eligibility to receive funding under the federal student financial aid programs and to prevent fraud and abuse of program funds by allowing students to reduce or reject aid being offered as well as being made aware of when such funding can be expected to be available.
Federal Agency: Federal Student Aid (FSA), Department of Education (ED)
Affected Area: CERA, Student Financial Aid, Student Account Services
Comments Due: 01/20/2023
On January 31, 2022, the Department of Education (Department) published in the Federal Register a notice announcing the 2022-23 Award Year deadline dates (the “Deadline Dates notice”) for the submission of requests and documents from postsecondary institutions for the Federal Perkins Loan (Perkins Loan) Program, Federal Work-Study (FWS), and Federal Supplemental Educational Opportunity Grant (FSEOG) programs (collectively, the “Campus-Based programs”). We are correcting the Deadline Dates notice by providing updated mailing addresses for submission of documents. All other information in the Deadline Dates notice remains the same.
Federal Agency: Federal Student Aid, Department of Education
Affected Area: Student Financial Aid
President Joe Biden has pledged that every American will have access to affordable, reliable, high speed internet. Digital equity—devices, skills and affordability that bring the internet to life—are a critical part of that mission. As part of that work, the Rural Utilities Service (RUS or the Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), announce the acceptance of applications under the Distance Learning and Telemedicine (DLT) grant program for Fiscal Year (FY) 2023, subject to the availability of funding. This notice is being issued prior to passage of a FY 2023 Appropriations Act in order to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications within FY 2023. Based on FY 2022 appropriated funding, the Agency estimates that approximately $64 million will be available for FY 2023. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available through appropriations. All applicants are responsible for any expenses incurred in developing their applications.
Federal Agency: Rural Utilities Service, USDA
Affected Area: OSP
Comments Due: 01/30/2023
Request for Information Regarding Higher Education Act (HEA) Pooled Evaluation
The U.S. Department of Education (Department) is requesting information in the form of written comments that may include information, research, and suggestions regarding the Department’s implementation of the new authority provided to the Department in the Consolidated Appropriations Act, 2022, to reserve funding from certain programs authorized by the Higher Education Act of 1965, as amended (HEA), for the purpose of carrying out rigorous and independent evaluations and conducting data collection and analysis of such programs. The Office of Planning, Evaluation and Policy Development (OPEPD) solicits these comments to identify potential evaluation, data collection, and analysis activities that could be undertaken with these funds that would increase knowledge about, and improve administration of, programs authorized under the HEA, and build evidence of effective practices to improve student outcomes in these programs. To use and build evidence to support opportunities for students, the Department is particularly interested in evaluation, data collection, and analysis activities that can inform efforts to make higher education more inclusive and affordable and ensure pathways through higher education lead to successful careers. The Department is particularly interested in activities aligned to Administration priorities including but not limited to strengthening community college capacity; holistic student supports; promoting postsecondary retention and completion; and strengthening alignment across institutions of higher education, K-12, and the public workforce system.
Federal Agency: Office of Planning, Evaluation and Policy Development, Department of Education
Affected Area: ORIA
Comments Due: 02/17/2023
This is a request for an extension without change to the current respondent/response/burden hour assessment in OMB Control Number 1845-0014—Repayment Plan Request: Standard Repayment Plan/Extended Repayment Plan/Graduated Repayment Plan—William D. Ford Federal Direct Loan (Direct Loan) Program. The Department files this request with the same total annual number of respondents for this renewal collection used in the prior filing. Due to the effects of the COVID-19 pandemic and the suspension of the collection of loans, the Department lacks sufficient data to allow for more accurate updates to the usage of these forms.
Federal Agency: Federal Student Aid (FSA), Department of Education (ED)
Affected Area: Student Financial Aid
Comments Due: 02/21/2023
This notice lists the Federal education assistance funds for qualifying students that proprietary institutions of higher education must include as Federal revenue in their non-Federal revenue calculation (known as “90/10”).
Federal Agency: Office of Postsecondary Education, Department of Education
Affected Area: Student Financial Aid
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified in the Occupational Exposure to Noise Standard.
Federal Agency: Occupational Safety and Health Administration (OSHA), Labor
Affected Area: EHS, HR
Comments Due: 02/21/2023
Agency Information Collection Activities; Comment Request; Foreign Gifts and Contracts Disclosures
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Federal Agency: Federal Student Aid (FSA), Department of Education (ED)
Affected Area: Student Financial Aid
Comments Due: 02/27/2023
There have been significant developments in the CCBHC program and in the broader mental health and substance use disorder field since the development of the existing Certification Criteria. States and providers now have six years of experience with the CCBHC model and lessons learned related to the implementation of the Certification Criteria. SAMHSA is seeking to make minor revisions to the Criteria to respond to these developments and lessons learned, while still maintaining the overarching requirements for program areas and scope of services outlined in PAMA.
Federal Agency: Substance Abuse and Mental Health Services Administration
Affected Area: CCHS
The National Institutes of Health (NIH) announces publication of the updated Significant Changes that have already been made to the NIH Grants Policy Statement (NIHGPS) in fiscal year 2022 that will be reflected in the GPS for fiscal year 2023. The NIHGPS provides both up-to-date policy guidance that serves as NIH standard terms and conditions of award for all NIH grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants. This update incorporates significant changes for FY 2023, such as new and modifiedrequirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated December 2021.
Federal Agency: National Institutes of Health, HHS
Affected Area: ORED, OSP
List of Countries Requiring Cooperation with an International Boycott
In accordance with section 999(a)(3) of the Internal Revenue Code of 1986, the Department of the Treasury is publishing a current list of countries which require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986). On the basis of the best information currently available to the Department of the Treasury, the following countries require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986).
Federal Agency: Treasury Department
Affected Area: Finance, Export Control
The data collection is sponsored by DOC/NOAA/National Weather Service (NWS)/Analyze, Forecast, and Support Office (AFSO). Heat continues to be the leading weather-related killer with the Centers for Disease Control and Prevention (CDC) estimating more than 700 deaths and 9,000 hospitalizations a year resulting from heat exposure. In particular, historically underserved communities, as defined and highlighted in Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, typically experience higher rates of poverty, homelessness, disabilities, and language barriers, which increase their vulnerability to heat impacts. The NWS has articulated a priority to enhance services for these historically underinvested and underserved communities that are at greater risk for experiencing negative health impacts related to extreme heat.
Federal Agency: National Oceanic & Atmospheric Administration (NOAA), Commerce
Affected Area: ORED
Comments Due: 03/07/2023
This information collection for the Direct Loan (DL) Program regulations is related to regulations for forbearance in § 685.205 and reasonable and affordable loan rehabilitation in § 685.211. The Department of Education is requesting an extension without change of the current burden calculated for this information collection. Due to the COVID-19 pandemic and loan payment pause, there is not sufficient information to estimate burden changes. These regulations provide additional flexibilities for DL borrowers and permit oral requests for forbearance, as well as allow a borrower to object to the initially established reasonable and affordable loan repayment amount. In addition, if a borrower incurs changes to his or her financial circumstances, the borrower can provide supporting documentation to change the amount of the reasonable and affordable loan monthly repayment amount. There has been no change to the regulatory language.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 02/08/2023
The U.S. Department of Education Supplemental Information form for the SF-424 is used together with the SF-424, Application for Federal Assistance. Several years ago ED made a decision to switch from the Application for Federal Education Assistance or ED 424 (1890-0017) collection (now 1894-0007) to the SF-424, in order to adhere with Federal-wide forms standardization and streamlining efforts, especially with widespread agency use of Grants.gov. There were several data elements/questions on the ED 424 that were required for applicants and were not included on the SF-424. Therefore, ED put these questions that were already cleared as part of the 1894-0007 collection on a form entitled the, U.S. Department of Education Supplemental Information for the SF-424. The questions on this form deal with the following areas: Project Director identifying and contact information; New Potential Grantee or Novice Applicants; Human Subjects Research, and Infrastructure Programs and Build America, Buy America Act Applicability (BABAA). The ED supplemental information form can be used with any of the SF-424 forms in the SF-424 forms family, as applicable.
Federal Agency: Department of Education
Affected Area: OSP
Comments Due: 03/06/2023
The Foreign Language and Area Studies (FLAS) Fellowships program is authorized by 20 U.S.C. 1121(b) and provides allocations of academic year and summer fellowships to institutions of higher education or consortia of institutions of higher education to assist meritorious undergraduate and graduate students undergoing training in modern foreign languages and related area or international studies. This information collection is a survey of FLAS fellows required by 20 U.S.C. 1121(d) which states “The Secretary shall assist grantees in developing a survey to administer to students who have completed programs under this subchapter to determine postgraduate employment, education, or training. All grantees, where applicable, shall administer such survey once every two years and report survey results to the Secretary.”
Federal Agency: Department of Education
Affected Area: Academic Affairs
Comments Due: 03/13/2023
Items of Interest
Federal Trade Commission Proposes Rule to Ban Non-Compete Clauses
On January 5, 2023, the Federal Trade Commission (“FTC”) issued a notice of proposed rulemaking (“NPRM”) to ban the use of non-compete clauses with all workers. Although not yet enforceable, the proposed rule marks a dramatic departure from the current regulatory landscape, which is primarily dictated by state law. A non-compete clause is a contractual term that prohibits an individual from competing against the other party—either by working for or starting a competing business—for a certain period within a given geographic area. If finalized and enforced as-is, the proposed rule’s categorical prohibition of non-compete clauses would set a national standard, resulting in the preemption of the vast majority of states’ current regulation of non-compete clauses and abrogating decades of case law.
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective January 1, 2023, with this notice. FDA seeks to include the views of women and men, 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.
Comments Due: 01/30/2023
Federal research and development (R&D) funding has increased since 2012—most recently because of COVID-19 stimulus funding. Five agencies obligated the majority of federal R&D funding with the Departments of Defense (DOD) and Health and Human Services (HHS) accounting for nearly 80 percent in fiscal year 2021…This report describes (1) trends in federal R&D funding over the last 10 years and (2) the funding and organization for selected multi-agency R&D initiatives, among other objectives.
Fiscal Year 2023 Guidance on Federal Information Security and Privacy Management Requirements
This memorandum provides agencies with Fiscal Year (FY) 2023 reporting guidance and deadlines in accordance with the Federal Information Security Modernization Act of 2014 (FISMA) [and rescinds M-22-05, Fiscal Year 2021-22 Guidance on Federal Information Security and Privacy Management Requirements and M-02-09 Reporting Instructions for the Government Information Security Reform Act and Updated Guidance on Security Plans of Action and Milestones.]
Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) is issuing this Bulletin to highlight the obligations of Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities1 and business associates2 (“regulated entities”) under the HIPAA Privacy, Security, and Breach Notification Rules (“HIPAA Rules”) when using online tracking technologies (“tracking technologies”).3 OCR administers and enforces the HIPAA Rules, including by investigating breach reports and complaints about regulated entities’ noncompliance with the HIPAA Rules. A regulated entity’s failure to comply with the HIPAA Rules may result in a civil money penalty.4
The Environmental Protection Agency (EPA or “Agency”) is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of two draft documents entitled: “Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act” and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substance Control Act.” The two draft documents will be submitted to the SACC and released for public review and comment in late February 2023. EPA is also announcing the scheduling of a 4-day virtual public meeting for the SACC to consider and review the two draft documents.
Notification of Request for Nominations to the National Environmental Justice Advisory Council
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). The NEJAC was chartered to provide advice regarding broad, cross-cutting issues related to environmental justice. This notice solicits nominations to fill approximately ten (10) new vacancies for terms through September 2024. To maintain the representation outlined by the charter, nominees will be selected to represent: academia, business and industry; community-based; non-governmental organizations; state and local governments; and tribal governments and indigenous organizations. We are interested in adding members located in in all EPA regions. Vacancies are anticipated to be filled by September 2023. Sources in addition to this Federal Register Notice will be utilized in the solicitation of nominees.
Comments Due: 03/17/2023
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Comments Due: 03/15/2023 and yearly thereafter
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2023, with this notice. FDA seeks to include the views of women and men, 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.
Comments Due: 02/21/2023
National Advisory Committee on Occupational Safety and Health (NACOSH); Request for Nominations
OSHA invites interested persons to submit nominations for membership on the National Advisory Committee on Occupational Safety and Health (NACOSH).
Comments Due: 02/02/2023
Workforce Information Advisory Council
The Department of Labor invites interested parties to submit nominations for individuals to serve on the Workforce Information Advisory Council (WIAC) and announces the procedures for those nominations. From the nominations received, the Department will fill all 14 slots on the Council.
Comments Due: 02/27/2023
Data Users Advisory Committee; Request for Nominations
The BLS is soliciting new members for its Data Users Advisory Committee (DUAC). The current membership expires on May 1, 2023.
Comments Due: 02/08/2023
likely to make big news in 2023
Update on U.S. Department of Education Federal Regulations
The U.S. Department of Education released its latest regulatory agenda indicating that this spring they intend to release a notification of another rulemaking to address a wider range of higher education and student loan policies. The issues they shared are very complex and diverse. It will be difficult to find negotiators with deep expertise on more than a few of the issues they plan to address.
- Federal TRIO programs which may include technical improvements to programmatic eligibility and operations. The Secretary intends to solicit further input on potential changes the Department may pursue via future public forums.
- Third-party servicers and related issues: the description indicates amending regulations related to existing guidance which seems to point directly to addressing requirements around
- Distance education: Given the withdrawal of the proposed language from the recent final regulations for Change of Ownership, we wonder if their intention is to clarify and revise the language they put in the July 2022 NPRM.
- Student loan forbearances: regulations associated with the standards and requirements for issuing forbearances and deferments, particularly in relation to income-driven repayment. You may wish to note that distance education has a higher standard for Last Day of Attendance calculations than face to face students face.
- Accreditation and Related issues: Regulations associated with the standards relating to the Secretary’s recognition of accrediting agencies and accreditation procedures as a component of institutional eligibility for participation in Federal student financial aid.
- State authorization: Here we go again!!! The Department indicates the desire to amend 34 CFR 600.9 State Authorization and 34 CFR 600.2 Definitions. While 600.2 is a definition section, we believe the definition they wish to address is a state authorization reciprocity agreement.
- Return to Title IV: Student withdrawal rules.
- Cash management: to ensure that students have and maintain timely access to student aid disbursed by their institutions of higher education.