Compliance Alert – May 2022
- May 24th, 2022
- in Compliance, Newsletter, Regulations
| Legislative Updates HB46: This bill establishes the State Seal of Biliteracy program to recognize graduates who have attained a high level of proficiency in speaking, reading, and writing in one or more languages in addition to English, and would provide for the seal to be awarded to the graduate by the State Department of Education. Including American sign language. Passed on 2022-29-03. SB15: State Textbook Committee, publishers permitted to provide standards correlation evidence to State Dept. of Education, State Superintendent of Education to convene other instructional materials review committees to review and rate materials and to establish evaluation criteria, Sec. 16-36-73 added; Secs. 16-13B-2, 16-36-60, 16-36-60.1, 16-36-65 am’d. Passed on: 2022-02-10. Assigned Act No. 2022-80. SB119: Colleges and Universities, Alabama G.I. and Dependents’ Educational Benefit Act, use of scholarship benefits at 2 year or 4 year public or private institutions of higher education physically located in state provided, Sec. 31-6-8 repealed; Secs. 31-6-2, 31-6-2.1, 31-6-3, 31-6-4, 31-6-5, 31-6-6, 31-6-9, 31-6-11, 31-6-12, 31-6-13, 31-6-14, 31-6-15, 31-6-15.1, 31-6-16 am’d. Passed on 2022-03-01 – Assigned Act No. 2022-91. Final Rules This regulatory action finalizes an interim final rule and revises certain provisions of other Environmental Protection Agency (EPA) financial assistance regulations to make non-substantive technical corrections to the text of the rules. Revisions to these rules are exempt from the notice and comment requirements of the Administrative Procedure Act (APA) because it is a matter relating to agency management concerning grants. Federal Agency: Environmental Protection Agency (EPA) Affected Area: ORED, OSP, EHS Proposed Rules As authorized by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 25(b), the EPA has exempted from the requirement of registration certain pesticide products if they are composed of specified ingredients (recognized active and inert substances which are listed in the regulations) and labeled according to the EPA’s regulations in 40 CFR 152.25(f). The EPA created the exemption for minimum risk pesticides to eliminate the need for the Agency to expend significant resources to regulate products that were deemed to be of minimum risk to human health and the environment. Prior to submission of these aquatic toxicity reports, the EPA received a petition from Tidal Vision Products, LLC, requesting that the substance commonly known as chitosan (also known by its chemical name poly-D-glucosamine) (CAS Reg. No. 9012-76-4) be added to the list of active ingredients allowed in exempted minimum risk pesticide products under 40 CFR 152.25(f)(1). This matter was the subject of a proposed regulation (85 FR 69307) (FRL-10009-24). The EPA is considering the information submitted by Tidal Vision in its decision regarding whether to finalize the proposal to add chitosan to the list of permitted active ingredients, and if so, whether and how to address chitosan salts in the exemption. Federal Agency: Environmental Protection Agency Affected Area: EHS, Facilities and Grounds Comments Due: 6/6/2022 Asbestos; Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA) The Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for asbestos under the Toxic Substances Control Act (TSCA). EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) in the four years prior to the date of publication of the final rule to electronically report certain exposure-related information. This action would result in a one-time reporting obligation. EPA emphasizes that this proposed requirement would include asbestos that is a component of a mixture. The information sought includes quantities of asbestos (including asbestos that is a component of a mixture) and asbestos-containing articles that were manufactured (including imported) or processed, types of use, and employee data. Reported information would be used by EPA and other Federal agencies in considering potential future actions, including risk evaluation and risk management activities. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input. Federal Agency: Environmental Protection Agency Affected Area: EHS Comments Due: 7/5/2022 Air Plan Approval; Alabama; NOX The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), in a letter dated October 18, 2021. The revision includes corrections to deficiencies to Alabama’s regulation titled “NOX Budget Program Monitoring and Reporting” (AL NOX SIP Call Monitoring Rule), which EPA previously conditionally approved into the SIP. Specifically, the AL NOX SIP Call Monitoring Rule establishes monitoring and reporting requirements for units subject to the nitrogen oxides (NOX) SIP Call, including alternative monitoring options for certain sources of NOX. EPA is also proposing to convert the conditional approval to a full approval. In addition, EPA is proposing to approve other minor changes into the SIP. Federal Agency: Environmental Protection Agency (EPA) Affected Area: EHS Comments Due: 6/15/2022 Notices Forty-First Update of the Federal Agency Hazardous Waste Compliance Docket Since 1988, the Environmental Protection Agency (EPA) has maintained a Federal Agency Hazardous Waste Compliance Docket (“Docket”) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). CERCLA requires EPA to establish a Docket that contains certain information reported to EPA by Federal facilities that manage hazardous waste or from which a reportable quantity of hazardous substances has been released. This notice identifies the Federal facilities not previously listed on the Docket and identifies Federal facilities reported to EPA since the last update on October 27, 2021. In addition to the list of additions to the Docket, this notice includes a section with revisions of the previous Docket list and a section of Federal facilities that are to be deleted from the Docket. Thus, the revisions in this update include eleven additions, zero deletions, and zero corrections to the Docket since the previous update. Federal Agency: Environmental Protection Agency Affected Area: EHS
The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) regulations apply to either the demolition and/or renovation of facilities; the disposal of asbestos waste; asbestos milling, manufacturing and fabricating; the use of asbestos on roadways; asbestos waste converting facilities; and the use of asbestos insulation and sprayed-on materials. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Federal Agency: Environmental Protection Agency Affected Area: EHS Comments Due: 5/25/2022 EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA regulations at 40 CFR part 26 protect subjects of “third-party” research (i.e., research that is not conducted or sponsored by EPA). In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to the EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional exposure of human subjects, these individuals (respondents) are required to submit study protocols to the EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to the EPA. This renewal ICR estimates the third-party response burden from complying with the requirements in 40 CFR part 26. Federal Agency: Environmental Protection Agency Affected Area: EHS, ORED Comments Due: 5/25/2022 The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Federal Agency: Food and Drug Administration Affected Area: UMC In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval new information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on May 7, 2019. The collection involves manufacturers of small unmanned aircraft providing a safety statement to owners of the UAS they produce. This is a statutory requirement. To minimize the burden on small businesses, the FAA has developed an example safety statement that can be used to satisfy the requirement. Federal Agency: Federal Aviation Administration (FAA), DOT Affected Area: CERA Comments Due: 5/27/2022 In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on an extension concerning bid guarantees, performance and payment bonds, and alternative payment protections. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through August 31, 2022. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date. Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) Affected Area: Procurement, Construction Administration Comments Due: 6/28/2022 This is a request for an extension of the Office of Management and Budget (OMB) approval of information collection requirements associated with the forms of the Health Education Assistance Loan (HEAL) Program, currently approved under OMB No. 1845-0126, which expires June 30, 2022. Clearance of this information collection is necessary to provide borrowers with information on the cost of their loan(s) including Truth in Lending information and to provide the Department with information to monitor the financial status of the HEAL program and to identify which lenders may have excessive delinquencies and defaulted loans. The information collection is essential for reporting and retaining information for sound and responsible program management. Federal Agency: Federal Student Aid (FSA), Department of Education (ED) Affected Area: Student Financial Aid Comments Due: 5/31/2022 The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) invites the general public and other Federal agencies to comment on this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, this information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments. Federal Agency: U.S. Immigration and Customs Enforcement, Department of Homeland Security Affected Area: Admissions Comments Due: 6/27/2022 The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657). Falls are a leading cause of death for employees. According to 2019 Bureau of Labor Statistics data, falls accounted for 418 of the 1,061 construction fatalities, and 880 of the 5,333 fatalities in all recorded industries. The National Fall Safety Stand-Down to Prevent Falls in Construction raises fall hazard awareness across the country in an effort to stop fall fatalities and injuries. The Stand-Down is the biggest safety outreach event ever conducted by the agency. OSHA has collaborated with countless industry leaders and employers over the last eight years to reach over 10 million workers during Stand-Downs. For additional substantive information about this ICR, see the related notice published in the Federal Register on 2/15/2022 (87 FR 8614). This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6. DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review. Federal Agency: Department of Labor Affected Area: HR, Construction Administration, EHS Comments Due: 5/31/2022 Submission for OMB Review; Federal Acquisition Regulation Part 23 Requirements Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Federal Acquisition Regulation (FAR) part 23 requirements. Federal Agency: Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) Affected Area: ORED, ORC Comments Due: 6/1/2022 Subpart K within 40 CFR part 262 provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories owned by colleges and universities, including teaching hospitals and non-profit research institutes that are either owned by or formally affiliated with a college or university. In addition, eligible academic entities have the discretion to determine the most appropriate and effective method of compliance with these requirements—by allowing them the choice of either managing their hazardous wastes in accordance with the alternative regulations as set forth in Subpart K, or remaining subject to the existing generator regulations. Federal Agency: Environmental Protection Agency Affected Area: EHS Comments Due: 7/1/2022 This request is to conduct the 2023-24 National Postsecondary Student Aid Study Institution Contacting and List Collection Field Test (NPSAS:24 FT). This study is being conducted by the National Center for Education Statistics (NCES), within the Institute of Education Sciences (IES), part of the U.S. Department of Education. This submission covers materials and procedures related to institution sampling, enrollment list collection, and matching to administrative data files as part of the NPSAS:24 FT data collection, and includes details about the full-scale institution sampling and enrollment list data collection. NCES will submit a separate clearance package covering the student FT data collection, including the student record data abstraction and student surveys, in the summer of 2022. The materials and procedures for NPSAS:24 are based on those developed for previous institution-based data collections, including the 2019-20 National Postsecondary Student Aid Study (NPSAS:20) [OMB #1850-0666 v. 23], and the 2017-18 National Postsecondary Student Aid Study Administrative Collection (NPSAS:18-AC) [1850-0666 v.21]. The first NPSAS was implemented by NCES during the 1986-87 academic year to meet the need for national data about significant financial aid issues. Since 1987, NPSAS has been fielded every 2 to 4 years, most recently during the 2019-20 academic year (NPSAS:20). NPSAS:24 will be nationally-representative. The NPSAS:24 field test sample size will be 6,000 students, and the full-scale sample will include 137,000 nationally representative undergraduate and 25,000 nationally representative graduate students who will be asked to complete a survey and for whom we will collect student records and administrative data. If the full-scale budget allows, we will include state-representative sampling for the full-scale collection, and provide the budget for a state-representative sampling plan in the 30-day full-scale package, planned for 2023. Also, if exercised, NPSAS:24 will serve as the base year for the 2024 cohort of the Baccalaureate and Beyond (B&B) Longitudinal Study and will include a nationally representative sample of students who will complete requirements for the bachelor’s degree during the NPSAS year (i.e., completed at some point between July 1, 2022 and June 30, 2023 for the field test and July 1, 2023 to June 30, 2024 for the full-scale). Subsets of questions in the student survey will focus on describing aspects of the experience of students in their last year of postsecondary education, including student debt and education experiences. This submission is designed to adequately justify the need for and overall practical utility of the full study, presenting the overarching plan for all of the phases of the institution sampling and enrollment list data collection and providing as much detail about the measures to be used as is available at the time of this submission. As part of this submission, NCES is publishing a notice in the Federal Register allowing first a 60- and then a 30-day public comment period. Field test materials, procedures, and results will inform the full-scale study. After completion of this field test, NCES will publish a notice in the Federal Register allowing additional 30-day public comment period on the final details of the NPSAS:24 full-scale institution sampling and enrollment list study. Federal Agency: Department of Education Affected Area: Student Financial Aid Comments Due: 7/5/2022 This request for written third-party comments concerning the performance of accrediting agencies under review by the Secretary of Education is required by 496(n)(1)(A) of the Higher Education Act (HEA) of 1965, as amended, and pertains to the summer 2023 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The meeting date and location have not been determined, but will be announced in a later Federal Register notice. In addition, a later Federal Register notice will describe how to register to provide oral comments at the meeting. Agencies Under Review and Evaluation: The Department requests written comments from the public on the following accrediting agencies, which are currently undergoing review and evaluation by the Accreditation Group, and which will be reviewed at the summer 2023 NACIQI meeting. The agencies are listed by the type of application each agency has submitted. Please note, each agency’s current scope of recognition is indicated below. If any agency requests a change to its scope of recognition, identified are both the current scope of recognition and the requested scope of recognition. Federal Agency: Department of Education Affected Area: Office of Institutional Effectiveness
The collection of information is necessary under section 485 of the Higher Education Act of 1965, as amended, with the goal of increasing transparency surrounding college athletics for students, prospective students, parents, employees and the general public. The survey is a collection tool to compile the annual data on college athletics. The data is collected from the individual institutions by ED and is made available to the public through the Equity in Athletics Data Analysis Cutting Tool as well as the College Navigator. Federal Agency: Department of Education Affected Area: Athletics Comments Due: 7/5/2022 The purpose of the Lead in Construction Standard and its collection of information (paperwork) requirements is to reduce occupational lead exposure in the construction industry. Lead exposure can result in both acute and chronic effects and can be fatal in severe cases of lead toxicity. The major collection of information requirements of the Standard are: Conducting worker exposure assessments; notifying workers of their lead exposures; establishing, implementing and reviewing a written compliance program annually; labeling containers of contaminated protective clothing and equipment; providing medical surveillance to workers; providing examining physicians with specific information; ensuring that workers receive a copy of their medical surveillance results; posting warning signs; establishing and maintaining exposure monitoring, medical surveillance, medical removal and objective data records; and providing workers with access to these records. The records are used by employees, physicians, employers and OSHA to determine the effectiveness of the employer’s compliance efforts. Federal Agency: Occupational Safety and Health Administration (OSHA), Labor Affected Area: Campus Development, EHS Comments Due: 7/5/2022 The Wage and Hour Division of the Department of Labor administers the Davis-Bacon Act (DBA) and Davis-Bacon Related Acts (DBRA), 40 U.S.C. 3141 et seq., and the Contract Work Hours and Safety Standards Act (CWHSSA), 40 U.S.C. 3701 et seq. Regulations at 29 CFR part 5 prescribe labor standards for federally financed and federally assisted construction contracts subject to DBA, DBRA, and labor standards for all contracts subject to CWHSSA. The DBA and DBRA require payment of locally prevailing wages and fringe benefits, as determined by the Department, to laborers and mechanics on most federally financed or assisted construction projects. CWHSSA requires the payment of one and one-half times the basic rate of pay for hours worked over 40 in a week on most federal contracts involving the employment of laborers or mechanics. The requirements of this information collection consist of (1) reports of conformed classifications and wage rates, and (2) requests for approval of unfunded fringe benefit plans. For additional substantive information about this ICR, see the related notice published in the Federal Register on February 7, 2022 (87 FR 6894). Federal Agency: Department of Labor Affected Area: Construction Administration, Procurement Comments Due: 6/13/2022 This request is for an extension of the information collection of the requirements in the policies and procedures related to the eligibility of foreign schools to apply to participate in Title IV, HEA programs that were added by the Higher Education Opportunity Act of 2008 (HEOA). The information in 34 CFR 600.54, 600.55, 600.56, and 600.57 is used by the Department during the initial review for eligibility certification, recertification and annual evaluations. These regulations help to ensure that all foreign institutions participating in the Title IV, HEA programs are meeting the minimum participation standards. Federal Agency: Federal Student Aid (FSA), Department of Education (ED) Affected Area: Student Financial Aid Comments Due: 7/8/2022 The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires OSHA to obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657). OSHA is requesting approval from OMB pursuant to the Paperwork Reduction Act (PRA), to conduct validity and reliability analyses of a safety and health program (SHP) assessment worksheet, the Draft Revised Form 33 (DRF33), that will replace the current SHP Assessment Worksheet, OSHA Form 33, used by the OSHA On-Site Consultation Program (OMB #1218-0110). The studies that will be conducted on the DRF33 will enable OSHA to ensure that a valid, reliable, and efficient tool is provided to On-Site Consultation programs in the 50 states, the District of Columbia, and several United States territories to replace the current OSHA Form 33, thereby, enhancing the quality of consultative services. The studies for which OSHA is requesting approval will comprise a pretest, Pilot Study (consultation visits to assess the validity and reliability of the DRF33), a follow-up study (consultation visits to assess any updates to the DRF33 resulting from Pilot Study findings), and a Prospective Analysis (conducted after the Pilot Study to assess any impact of the DRF33 at workplaces that received consultation visits during the Pilot Study). After completing the Pilot Study OSHA will request OMB approval before implementing the DRF33 for use by state On-Site Consultation programs nationwide to replace the current Form 33. Similarly, OSHA will seek OMB approval if any additional updates are made to the approved worksheet, following the Prospective Analysis. For additional substantive information, see the submission at https://www.reginfo.gov, ICR Reference Number=202202-121002. Federal Agency: Department of Labor Affected Area: HR, Risk Management, Campus Development Comments Due: 6/21/2022 Agency Information Collection Activities; Comment Request; Guaranty Agency Financial Report The Department of Education (ED) is requesting renewal by extension of the information collection 1845-0026 for the Guaranty Agency Financial Report. There has been no change to the underlying statute or regulations. The Guaranty Agency Financial Report is used by a guaranty agency to request payments of reinsurance for defaulted student loans; make payments for amounts due ED, for collections on default and lender of last resort loan (default) claims on which reinsurance has been paid and for refunding amounts previously paid for reinsurance claims. The form is also used to determine required reserve levels for agencies; and to collect debt information as required for the “Report on Accounts and Loans Receivable Due from the Public,” SF 220-9 (Schedule 9 Report) as required by the U.S. Department of Treasury. Federal Agency: Federal Student Aid (FSA), Department of Education (ED) Affected Area: Student Financial Aid Comments Due: 7/18/2022 Agency Information Collection Activities; Comment Request; FERPA and PPRA E-Complaint Forms The Student Privacy Policy Office (SPPO) reviews, investigates, and processes complaints of alleged violations of Family Education Rights and Privacy Act (FERPA) and Protection of Pupil Rights Amendment (PPRA) filed by parents and eligible students. SPPO’s authority to investigate, review, and process complaints extends to allegations of violations of FERPA by any recipient of United States Department of Education (Department) funds under a program administered by the Secretary (e.g., schools, school districts, postsecondary institutions, state educational agencies, and other third parties that receive Department funds). Federal Agency: Office of Management (OM), Department of Education (ED) Affected Area: CERA, Registrar Comments Due: 7/18/2022 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The guidance focuses on safety aspects of the container label and carton labeling design for human prescription drug and biological products. The guidance provides sponsors of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product. This guidance finalizes the draft guidance of the same title issued on April 24, 2013. Federal Agency: Food and Drug Administration, HHS Affected Area: UMC
On April 8, 2022, the Department of Health and Human Services (HHS) published into the Federal Register a Request for Information (RFI) which is located at 87 FR 20876 to receive input from the public on HHS’s draft outline to further the development of the 2022 Environmental Justice Strategy and Implementation Plan. Consistent with the policy of this administration directing HHS to make achieving environmental justice part of its mission, HHS would like to identify priority actions and strategies to best address environmental injustices and health inequities for people of color, disadvantaged, vulnerable, low-income, marginalized, and indigenous populations. With the engagement of and input from the public, the 2022 Environmental Justice Strategy and Implementation Plan will serve as a guide to confront environmental and health disparities and implement a multifaceted approach that will serve vulnerable populations and communities disproportionately impacted by environmental burdens. Federal Agency: Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS) Affected Area: UMC Comments Due: 6/18/2022 Items of Interest ARAC was established on January 22, 1991, under the Federal Advisory Committee Act (FACA) pursuant to Title 5 of the United States Code, Appendix 2. The purpose of ARAC is to provide information, advice, and recommendations to the Secretary of Transportation, through the FAA Administrator, concerning rulemaking activities, such as aircraft operations, airman and air agency certification, airworthiness standards and certification, airports, maintenance, noise, and training. Comments Due: 5/18/2022 Internal Revenue Service Advisory Council (IRSAC); Nominations The Internal Revenue Service (IRS) is seeking new members to serve on the Internal Revenue Service Advisory Council (IRSAC). Applications are currently being accepted for appointments that will begin in January 2023. IRSAC members are drawn from substantially diverse backgrounds representing a cross-section of the taxpaying public with substantial, disparate experience in: Tax preparation for individuals, small businesses and large, multi-national corporations; tax-exempt and government entities; information reporting; and taxpayer or consumer advocacy. Nominations of qualified individuals may come from individuals or organizations; applications should describe and document the proposed member’s qualifications for IRSAC. Comments Due: 6/3/2022 Haley signs letter demanding American universities divest from China The letter, drafted by the Athenai Institute, requests university officials push their schools to divest entirely from their Chinese financial ties in protest of Chinese human rights abuses and international security threats. Haley’s signature is among the most prominent attached to the Athenai Letter. “American universities must ensure they’re not sending a single dollar to fund genocide,” Haley told Fox News Digital. “Communist China is imprisoning millions of Uyghurs, forcing them to work and subjecting them to rape, sterilization and torture.”
Medical regulators: look beyond animal tests Within ten months of scientists identifying SARS-CoV-2, the European Commission and the US Food and Drug Administration (FDA) had authorized vaccines for emergency use, thus beginning immunization programmes that are saving many lives. Regulatory approval for vaccines usually takes ten years. Much of the speed was achieved by prioritizing COVID-19 programmes; another innovation was allowing human studies to begin before all standard animal tests had been concluded. Before clinical trials of the two messenger RNA vaccines began in 2020, pharmaceutical companies presented regulators with historical data from work on animal models, which studied similar technology in vaccines against diseases including rabies. Other data came from cell-based tests and computational assessments of the experimental vaccines. Non-animal techniques, including the use of monoclonal antibodies, cultured cells and physico-chemical analysis, were also used to ensure the quality of each vaccine batch.
FBI chief says espionage threat posed by China ‘unprecedented in history’ FBI Director Christopher Wray said on Sunday that the current scale of espionage and cybersecurity threats from China were “unprecedented in history.” “The biggest threat we face as a country from a counterintelligence perspective is from the People’s Republic of China and especially the Chinese Communist Party,“ Wray said during an interview on CBS News’s “60 Minutes.” “They are targeting our innovation, our trade secrets, our intellectual property, on a scale that’s unprecedented in history,” he added, noting that China’s hacking program is larger “than that of every other major nation combined.”
The gap between federal and state marijuana policies continues to widen and shows no signs of stopping, congressional researchers said in a new report that also lays out options for how lawmakers could address the growing schism. The Congressional Research Service (CRS) published the 101-page analysis just days after the U.S. House of Representatives approved a bill to federally legalize cannabis. It covers a wide range of policy implications caused by the ongoing prohibition of marijuana under federal law as more states move to legalize for medical and adult use. New Biomed Unit Under Pressure to Use Untried Drug Patent Grabs There’s been a push, particularly among progressives, for the NIH to exercise what’s known as march-in rights to temper drug prices—most recently on Astellas’ cancer drug Xtandi. Established under the 1980 Bayh-Dole Act, march-in allows the government to seize patents for inventions created with government funding and license them to other entities for commercialization.
Biden Wants to Attract Russian Scientists President Biden has asked Congress to suspend, for four years, the requirement that Russian scientists applying for visas have a sponsoring employer, eliminating a major obstacle for many seeking to come to the United States, The New York Times reported. The measure would apply only to Russian citizens “with master’s or doctoral degrees in science or engineering fields like artificial intelligence, nuclear engineering or quantum physics,” the Times reported. The move comes at a time when many Russian scientists already want to leave their home country.
We Don’t Necessarily Need a Scientist at the Head of the Office of Science and Technology Policy President Biden came into office promising to restore the role of science in government after the Trump administration’s rocky relationship with scientific advice. (You might remember an incident involving a hurricane forecast and a Sharpie.) A key tool for the White House to implement its ambitious science-related agenda is the Office of Science and Technology Policy, or OSTP—a relatively small outfit that oversees policies about science, including budget requests for agencies that conduct science and the coordination of major scientific endeavors across the federal government. Since Biden took office, OSTP has taken on a variety of sorely needed priorities, including reinvigorating government processes for scientific integrity, future pandemic preparedness, and exploring what artificial intelligence means for human rights. But these good causes have been overshadowed by controversies over OSTP’s leadership.
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates with expertise in the areas of toxicology, bioethics, and statistics to be considered for appointment to its Human Studies Review Board (HSRB) federal advisory committee. Submission of nominations will be made via the HSRB website at: https://www.epa.gov/osa/human-studies-review-board. Comments Due: 5/31/2022 Solicitation of Nominations for Membership on the National Vaccine Advisory Committee The Office of Infectious Disease and HIV/AIDS Policy (OIDP), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), solicits nominations of qualified candidates to be considered for appointment to the National Vaccine Advisory Committee (NVAC). The activities of this committee are governed by the Federal Advisory Committee Act (FACA). The NVAC serves an advisory role, providing recommendations to the Assistant Secretary for Health in her capacity as the Director of the National Vaccine Program. The committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States, as well as research priorities and other measures to enhance the safety and efficacy of vaccines. The committee also advises the Assistant Secretary for Health on the implementation of sections 300aa-2, 300aa-3, and 300aa-4 of the Public Health Service (PHS) Act, including government and non-government cooperation. A copy of the NVAC charter that describes its structure and functions and lists of the current members can be reviewed on the NVAC website at: http://www.hhs.gov/nvpo/nvac/index.html. Submission Process: Please email all submissions to nvac@hhs.gov. All nominations for membership on the committee must be received no later than 5:00 p.m. EDT on June 24, 2022. Comments Due: 6/24/2022 Biden Orders Quantum Computing Push as China Challenge Grows President Joe Biden will sign directives on Wednesday aimed at preparing the U.S for a new era of quantum computing, as Chinese agencies and companies pour billions of dollars into the next-generation technology…. Federal agencies will have to develop comprehensive plans to safeguard American intellectual property, research and other sensitive technology from acquisition by America’s adversaries, plus educate industry and academia on the threats they face, the White House said, without naming specific countries.
President Biden Announces Two Presidential Directives Advancing Quantum Technologies Today, President Biden will sign two Presidential directives that will advance national initiatives in quantum information science (QIS), signaling the Biden-Harris Administration’s commitment to this critical and emerging technology. Together, the two directives lay the groundwork for continued American leadership in an enormously promising field of science and technology, while mitigating the risks that quantum computers pose to America’s national and economic security.
Risky ‘gain-of-function’ studies need stricter guidance, say US researchers Researchers and biosecurity specialists are calling on the US government to issue clearer guidance about experiments it might fund that would make pathogens more transmissible or deadly. They made these pleas on 27 April, during the first of a series of public listening sessions organized by the US National Institutes of Health (NIH). The sessions are part of a months-long review, conducted by the National Science Advisory Board for Biosecurity (NSABB), of US policies governing risky pathogen research.
Duke’s Klotman is under consideration as the next NIH head Mary Klotman, a Duke University scientist and senior leader, is a strong contender to be the next director of the National Institutes of Health, according to three people with knowledge of the selection. A physician known for her research into HIV, Klotman has served as dean of the Duke University School of Medicine since 2017. She has had conversations with several senior administration officials, said the three people, who spoke on the condition of anonymity because they were not authorized to discuss the selection. If selected by President Biden and confirmed by the Senate, she would replace Francis S. Collins, who stepped down as NIH director last year but returned to government this year to advise Biden on science policy. Lawrence A. Tabak, a longtime federal official, has served as the agency’s interim head since Collins’s departure.
Research universities are shortchanging their storytelling Higher Ed unequivocally sits at the tip of the spear for ideation and invention. And research universities are its leading incubators, moving the world forward in every field. But on the whole, universities’ research stories aren’t being told well enough, broadly enough, or consistently enough. Universities often struggle to make the case for how research contributes to their educational mission when speaking to prospective students and their families, despite research, learning, and discovery being intrinsically linked. They’ve historically had a hard time translating research endeavors to alumni [and alumni donors], a presumably friendly audience when it comes to showcasing and celebrating university successes. And similarly, universities have fumbled efforts to powerfully convey research ROI to legislators. Yet each of these constituent groups are incredibly important to ensure ongoing support and investment. Putin’s Failure to Hold on to the Educated Could Be the World’s Gain (New York Times, Opinion) Russia has suffered from brain drain for at least a century, in part because it produces top-notch university graduates but usually hasn’t had an economy capable of putting their skills to good use….. The United States has been tougher to get into because visas are scarce. In March the Department of Homeland Security granted Ukrainians temporary protected status for 18 months, enabling them to stay and work in the United States without a visa — but it has not done so for Russians. In a shift, however, the Biden administration asked Congress last week to suspend for four years the requirement that Russian scientists applying for H1-B visas have a sponsoring employer. The measure would apply only to Russian citizens with master’s or doctoral degrees in science or engineering fields such as artificial intelligence, nuclear engineering and quantum physics. They would have to undergo security vetting. Request for nominations for Mobile Sources Technical Review Subcommittee The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its Mobile Sources Technical Review Subcommittee (MSTRS). Vacancies are anticipated to be filled by October 17, 2022. Sources in addition to this Federal Register Notice may also be utilized in the solicitation of nominees. Comments Due: 7/11/2022 Stop squandering data: make units of measurement machine-readable Humans struggle to interpret numbers with sloppy or missing units, and it is much more difficult when computers are involved. Most software packages, data-management tools and programming languages lack built-in support for associating units with numeric data (with the exception of the language F#). This means that information is essentially stored and managed as ‘unitless’ values. Disciplines including bioscience and aerospace engineering have adopted conventions for unit representation, such as the Unified Code for Units of Measure (UCUM) and the Quantities, Units, Dimensions, and Types (QUDT) Ontology. But there are no broadly agreed technical specifications for how to represent quantities and their associated units without confusing machines.
Gearing Up for 2023 Part II: Implementing the NIH Data Management and Sharing Policy NIH has a long history of developing consent language and, as such, our team worked across the agency – and with you! – to develop a new resource that shares best practices for developing informed consents to facilitate data/biospecimen storage and sharing for future use. It also provides modifiable sample language that investigators and IRBs can use to assist in the clear communication of potential risks and benefits associated with data/biospecimen storage and sharing. In developing this resource, we engaged with key federal partners, as well as scientific societies and associations. Importantly, we also considered the 102 comments from stakeholders in response to a RFI that we issued in 2021. As for our second resource, we are requesting public comment on protecting the privacy of research participants when data is shared. I think I need to be upfront and acknowledge that we have issued many of these types of requests over the last several months and NIH understands the effort that folks take to thoughtfully respond. With that said, we think the research community will greatly benefit from this resource and we want to hear your thoughts on whether it hits the mark or needs adjustment.
NIH gains new power to police sexual harassment Now, thanks to a provision Congress added to NIH’s 2022 spending legislation, reporting harassment will be mandatory. In addition, the trigger for reporting is not just a change in grant personnel, but any disciplinary action. As of 9 July, institutions must inform NIH within 30 days if key grant personnel “are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions,” the agency announced in a 10 May notice.
OIG report is critical of information security at academic and research contractors The OIG report, “Audit of the Protection of Military Research Information and Technologies Developed by Department of Defense Academic and Research Contractors”, found that universities and research contractors omitted to consistently implement the necessary cybersecurity protocols to protect CUI stored on their networks from internal and external cyber threats. The OIG report made eight findings on research contractor protocols used to store, process, and transmit CUI. Out of the ten contractors reviewed, the OIG specifically found that: One failed to create an incident response plan; One failed to monitor network traffic and scan its network for viruses; Two failed to implement physical security protocols (e.g., security guards, biometric readers, access card readers, and physical access control logs); Two failed to encrypt workstation hard drives to safeguard CUI from unauthorized disclosure or access; Three failed to identify and resolve system and network vulnerabilities in a timely fashion; Four failed to deactivate user accounts after prolonged periods of inactivity; Four failed to enforce the use of multifactor authentication or enforce the use of strong passwords to access their systems and networks; and Five failed to use automatic controls to restrict the use of removable media to protect CUI stored on removable media.
The 1,968 page 2022 Compliance Supplement was posted on May 11th (at least three months early compared to previous years) on the OMB, Office of Federal Financial Management (OFFM) website. Comments on the 2022 Compliance Supplement, as specified in the Federal Register Notice, are due to OMB by July 11, 2022 (late comments will be considered to the extent practicable). Comments will be addressed in the development of the 2023 Compliance Supplement––however, COGR’s view is that if significant, we will advocate for comments to be addressed sooner. Several items of note are: • Applicability of 2 CFR Part 200 FAQs (p. 28 and p. 1778) . As COGR requested upon the original release of 2 CFR 200, the FAQs applicable to 2 CFR Part 200 (the Uniform Guidance) are recognized in the Compliance Supplement. • Part V: R&D and SFA Clusters (p. 1776 and p. 1781). COGR reviews the Compliance Supplement for updates to the R&D Cluster––there appear to be no significant changes to the R&D Cluster. • Appendix IV: “Higher Risk” programs (p. 1931). This section updates the list of COVID-19 programs that have been determined as “higher risk.” • Appendix VII: Federal Audit Clearinghouse transition (p. 1959). This section provides the timing for the Federal Audit Clearinghouse transition from Census to GSA, effective October 1, 2022. Notice is hereby given of a change in the solicitation of CDC’s Advisory Committee to the Director (ACD) Data and Surveillance Workgroup (DSW). In the Federal Register notice published on May 4, 2022, nominations for appointment to CDC’s ACD DSW workgroup were due May 16, 2022. Nominations are now due May 27, 2022. Comments Due: 5/27/2022 Solicitation of Nominations for Membership to the Advisory Committee on Transportation Equity Solicitation of nominations for membership to the Advisory Committee on Transportation Equity. Comments Due: 6/16/2022 Revision of NSF Award Terms and Conditions (NSF) The entire suite of NSF Award Terms and Conditions have been revised to implement the requirements of the Build America, Buy America provisions of the Infrastructure Investment and Jobs Act (P.L. 117-58). The revised terms and conditions will apply to all new NSF awards and funding amendments to existing NSF awards made on or after May 13, 2022. All sets of award conditions are accompanied by a summary of changes made to that document. Comments Due: June 2022 Updated eRA RPPR Module and Instruction Guide: Action Required for In-Progress Budget Forms The Research Performance Progress Report (RPPR) Module in eRA Commons is moving to the new visual appearance being adopted by other eRA modules, because of a required technology upgrade that enhances the security and stability of the module. The upgrade includes adding the new unique entity identifier (UEI) fields where applicable and required FORMS-G changes, including updated budget forms. These upgrades are expected to be released on June 23, 2022. Hot Off the Presses: Updated RPPR Instruction Guide Available (NIH Extramural Nexus) An updated RPPR Instruction Guide is now available. The instruction guide reflects changes associated with recently issued guide notices on Other Support and Biosketch format pages, human subjects, Trainee Diversity Report and NRSA childcare costs reporting (see NOT-OD-22-130 for details). Note that a final RPPR Instruction Guide will be published on June 23 to reflect the revised screenshots accompanying the new look and feel of the RPPR module.
Action Required for In-Progress RPPR Budget Forms By or Before June 22 The Research Performance Progress Report (RPPR) module in eRA Commons is moving June 23 to the new visual appearance of other eRA modules. This is part of a required technology upgrade that will enhance the security and stability of the module. The release will include the addition of the new unique entity identifiers (UEI) where applicable as well as required FORMS-G changes, including updated budget forms. |