Health Care Week in Review: FDA Released Its User Fee Amendments For FY 2023

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, FDA released its user fee amendments for FY 2023, and CMS issued an RFI on establishing a national directory of healthcare providers and released the MA and Part D star ratings for 2023. Read more about this action and other news below.

I. Regulations, Notices & Guidance

• On October 3, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff and another entitled, FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff. The Medical Device User Fee Amendments of 2022 (MDUFA V) authorized FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2022, including premarket notification submissions (510(k)s) and De Novo classification requests (De Novo requests). These user fees will be used to improve the device review process to meet certain performance goals and implement improvements for the medical device review process. These guidances describe: (1) the different FDA actions that may be taken on 510(k)s and on De Novo requests; (2) the effect each action has on goals under MDUFA IV for 510(k)s and De Novo requests received in fiscal year (FY) 2018- 2022; (3) the effect each action has on goals under MDUFA V for 510(k)s and De Novo requests received in FY 2023- 2027; and (4) the different industry actions that may be taken on 510(k)s and De Novo requests.
• On October 5, 2022, FDA issued guidance entitled, Infant Formula Transition Plan for Exercise of Enforcement Discretion. FDA is issuing this guidance document to protect public health by helping to stabilize the supply of infant formula in the U.S. and to maintain a consistent supply of a variety of infant formula products. Under the guidance, FDA intends to exercise enforcement discretion until January 6, 2023, for infant formula products that are listed in letters of enforcement discretion that FDA has issued or will issue to specific manufacturers, in response to information provided under the May 2022 Infant Formula Enforcement Discretion Policy: Guidance for Industry, which remains in effect until November 14, 2022. For those manufacturers that wish to continue to market specific products in the U.S. under enforcement discretion after January 6, 2023, the guidance further details additional steps that manufacturers can take toward lawful marketing of such products—and the timeline under which such steps should be taken—for FDA to consider the continued exercise of enforcement discretion. This guidance document will help infant formula manufacturers meet applicable regulatory requirements while ensuring that consumers have continued access to formulas that are currently fulfilling the needs of infants consuming such products. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
• On October 5, 2022, the Administration for Community Living (ACL) issued a notice entitled, 2022 National Strategy to Support Family Caregivers. In accordance with the requirements of the Recognize, Assist, Include, Support and Engage (RAISE) Family Caregivers Act of 2017, ACL is making the 2022 National Strategy to Support Family Caregivers (the Strategy) available for public comment for a period of 60 days. Public comments received will be used to inform the ongoing work of the Family Caregiving Advisory Council and the Advisory Council to Support Grandparents Raising Grandchildren, as well as to inform future updates to the Strategy. Comments are due on or before November 30, 2022.
• On October 5, 2022, the Centers for Medicare & Medicaid Services (CMS) released a request for information (RFI) entitled, National Directory of Healthcare Providers and Services. This request for information solicits public comments on establishing a National Directory of Healthcare Providers & Services (NDH) that could serve as a “centralized data hub” for healthcare provider, facility, and entity directory information nationwide. Comments to the RFI are due on December 6, 2022.
• On October 5, 2022, FDA issued final guidance entitled, Competitive Generic Therapies: Guidance for Industry. The FDA Reauthorization Act of 2017 created a pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT). At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.
• On October 5, 2022, FDA issued final guidance entitled, Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry. This guidance provides recommendations to industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the FD&C Act. For purposes of this guidance, a post-CRL clarification teleconference is a meeting that is requested in writing by an ANDA applicant pursuant to the procedures described in this guidance following receipt of a CRL. It is important that there are efficient, consistent procedures for the timely and effective conduct of post-CRL clarification teleconferences. This guidance will assist applicants in generating and submitting a request for a post-CRL clarification teleconference and the associated meeting package to FDA as contemplated in the Generic Drug User Fee Amendments (GDUFA) of 2022, reauthorizing GDUFA for FY 2023- 2027.
• On October 5, 2022, FDA issued a notice entitled, Biosimilar User Fee Rates for Fiscal Year 2023. The FDA is announcing the rates for biosimilar user fees for FY 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2022, through September 30, 2023.
• On October 5, 2022, FDA issued a notice entitled, Medical Device User Fee Rates for Fiscal Year 2023. FDA is announcing the fee rates and payment procedures for medical device user fees for FY 2023. The FD&C Act, as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2023, which apply from October 1, 2022, through September 30, 2023, and provides information on how the fees for FY 2023 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
• On October 5, 2022, FDA issued a notice entitled, Prescription Drug User Fee Rates for Fiscal Year 2023. FDA is announcing the rates for prescription drug user fees for FY 2023. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2023. These fees apply to the period from October 1, 2022, through September 30, 2023.
• On October 5, 2022, FDA issued a notice entitled, Fee Rate for Using a Priority Review Voucher in Fiscal Year 2023. FDA is announcing the fee rate for using a priority review voucher for FY 2023. The FD&C Act, as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2023 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees. This rate is effective on October 1, 2022 and will remain in effect through September 30, 2023.
• On October 6, 2022, FDA issued a proposed rule entitled, Administrative Destruction. FDA is proposing a regulation to implement its new authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation), that has been refused admission into the U.S. under the FD&C Act, by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. Once finalized, this regulation will allow FDA to better protect the public health by preventing re-importation and deterring future shipments of refused devices subject to administrative destruction. FDA also discusses its intent to change FDA’s procedures for administrative destruction of drugs and, if this proposed rule is finalized, these procedures will also include devices subject to administrative destruction. FDA described its current procedures in the proposed and final rules entitled “Administrative Destruction of Certain Drugs Refused Admission to the United States.”
• On October 6, 2022, FDA issued guidance entitled, Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability. This draft guidance provides information to applicants on how FDA will use information related to a facility’s readiness for inspection as certified on Form FDA 356h to set a goal date for an original ANDA submitted under the FD&C Act. This guidance incorporates a program enhancement agreed upon by the agency and industry as part of the negotiations relating to reauthorization of GDUFA and as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).
• On October 6, 2022, FDA issued guidance entitled, Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; and Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is announcing the availability of the final guidance documents entitled “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” and “Procedures for Handling Post-Approval Studies Imposed by PMA [Premarket Approval Application] Order.” These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling postmarket surveillance requirements and of Post-Approval Studies (PAS), respectively. Additionally, these guidance documents are intended to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of postmarket surveillance orders and of PAS requirements. The final guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” is intended to update and replace the guidance issued in May 2016; the final guidance “Procedures for Handling Post-Approval Studies Imposed by PMA Order” is intended to update and replace the guidance issued in June 2009.
• On October 6, 2022, CMS published the 2023 Medicare Advantage and Part D Star Ratings. The Star Ratings system helps Medicare consumers compare the quality of Medicare health and drug plans being offered so they are empowered to make the best health care decisions for them.
• On October 6, 2022, FDA issued a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2023. The FD&C Act, as amended by GDUFA III, authorizes FDA to assess and collect fees for ANDAs; drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing FY 2023 rates for GDUFA III fees. These fees are effective on October 1, 2022 and will remain in effect through September 30, 2023.

Event Notices

• October 25, 2022: The National Institutes of Health (NIH) announced a partially open public meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). The open agenda will include discussions of program policies and issues. The closed agenda will include review and evaluation of grant applications.
• October 26-27, 2022: FDA announced a public advisory committee meeting of the General and Plastic Surgery Devices Panel (GPSDP) of the Medical Devices Advisory Committee (MDAC). On day one, in the morning, the committee will discuss and make recommendations on the classification proposal for tissue expanders and accessories, which are currently unclassified preamendments devices, to be class III (general controls and premarket approval) and class II (general and special controls), and mammary sizers, which are currently unclassified preamendments devices, to be class II (general and special controls). In the afternoon on the first day, the committee will discuss and make recommendations on the classification proposals for wound dressings with animal-derived materials, absorbable synthetic wound dressings, and hemostatic wound dressings with or without thrombin, which are all currently unclassified preamendments devices, to be class II (general and special controls). On day 2, the committee will discuss and make recommendations on the classification proposals for nail prostheses, which are currently unclassified preamendments devices, to be class I (general controls); and ultrasonic surgical instruments, single-use reprocessed ultrasonic surgical instruments, and neurosurgical ultrasonic instruments, which are all currently unclassified preamendments devices, to be class II (general and special controls).
• October 26 and October 31, 2022: NIH announced two public online forums of the National Institute of Neurological Disorders and Stroke (NINDS). The forums will enable public discussion of the Institute’s proposals to reorganize its Division of Translational Research (DTR), Division of Clinical Research, and functions within its Division of Extramural Activities. The proposals seek to more accurately represent the activities performed within the NINDS’s Extramural Research Programs, clarify roles and responsibilities, and improve the coordination of the scientific activities within the Institute. The online forums will allow members of the public to review the reorganization proposals and submit comments.
• November 2, 2022: NIH announced a meeting of the Interagency Pain Research Coordinating Committee (IPRCC). The meeting will cover committee business items and IPRCC member updates. Items discussed will include updates on pain workforce enhancement, pain research, patient engagement, and diversity efforts.
• November 3-4, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). The agenda will include: (1) a presentation on phase two of the Krabbe disease evidence review; (2) a presentation on the Department of Defense’s (DOD’s) newborn screening system; (3) a presentation on the process for states to implement conditions recently added to the Recommended Uniform Screening Panel (RUSP); (4) a presentation on Blueprint for Change for a system of services for children and youth with special health care needs; (5) a Committee discussion on advancing state newborn screening systems; (6) workgroup updates; and (7) a potential update on the Duchenne muscular dystrophy (DMD) condition nomination and a potential vote on whether to move it forward to full evidence-based review.
• November 10, 2022: FDA announced a meeting of the Ophthalmic Devices Panel (ODP) of MDAC. The committee will discuss and make recommendations on the classification of ophthalmic dispensers, which are currently unclassified pre-amendment devices to class I (general controls). This will include a discussion of the known risks and safety/effectiveness concerns and a general classification recommendation for ophthalmic dispensers.
• November 15-17, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Tribal Technical Advisory Committee (TTAC). The meeting will include remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions.
• November 17, 2022: The Department of Health and Human Services (HHS) announced a meeting of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The committee will discuss and vote on a recommendation related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation.
• December 7, 2022: CMS announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent, and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary.
• December 13, 2022: FDA announced a public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). The committee will discuss new drug application 216401, for omecamtiv mecarbil tablets, submitted by Cytokinetics, Inc. The proposed indication is to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction.
• December 14, 2022: FDA announced a public advisory committee meeting of the CRDAC. The committee will discuss the available data for supplemental new drug application 021845-S025, REVATIO (sildenafil citrate tablets), submitted by Viatris Specialty, LLC, to support an indication for pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (World Health Organization Group I) to improve exercise ability and pulmonary hemodynamics.
• February 7, 2023: The National Library of Medicine (NLM) announced a partially open meeting of the Board of Regents of NLM. The open agenda will include program discussion and the closed agenda will include review and evaluation of grant applications.
• April 27, 2023: NLM announced a partially open meeting of the Board of Scientific Counselors. The open agenda will include program discussion and investigator reports. The closed agenda will include review and evaluation of personal qualifications, performance, and competence of individual investigators.

II. Reports, Studies & Analyses

• On October 3, 2022, HHS’ Office of Inspector General (OIG) released a report entitled, UPICs Hold Promise To Enhance Program Integrity Across Medicare and Medicaid, But Challenges Remain. Unified Program Integrity Contractors (UPICs) are CMS’s only program integrity contractors that safeguard both the Medicare fee-for-service (FFS) and the Medicaid programs from fraud, waste, and abuse. OIG analyzed program integrity workload data for each of the five UPICs in 2019 and surveyed the UPICs on challenges they faced and effects of the COVID-19 pandemic on their work. OIG also asked CMS about the effects of the unification of Medicare and Medicaid program integrity activities; how CMS measures the effectiveness of UPICs; and any challenges UPICs face in conducting their work. OIG found that in 2019, UPICs conducted much more program integrity work for the Medicare fee-for-service (FFS) program than for Medicaid; UPICs faced challenges such as limited Medicaid data availability and state variability in programs that may limit their program integrity activities in Medicaid; and that CMS and UPICs have identified vulnerability and initiated reforms in their program integrity activities. OIG recommended that CMS (1) implement a plan to increase UPICs' Medicaid program integrity activities, particularly related to managed care; (2) make improvements to the Unified Case Management (UCM) system; (3) improve the Major Case Coordination (MCC) initiative for Medicaid referrals; and (4) identify the reasons for the unexplained variation in program integrity activities across UPICs.
• On October 4, 2022, the Government Accountability Office (GAO) published a report entitled, Tracking the Funds: Specific Fiscal Year 2022 Provisions for Department of Health and Human Services. GAO issued this study to track the $1.3 billion distributed from Congress to HHS for 901 specific projects through the FY 2022 Consolidated Appropriations Act. In this report, GAO describes information about (1) the intended uses for these funds (e.g., upgrading health facilities, supporting mental and behavioral health programs, improving water and sanitation infrastructure, and supporting programs to reduce family poverty); (2) the recipients to whom they were designated (e.g., higher education and other nonprofit organizations as well as tribal, state, territorial, and local governments); and (3) that HHS expects to obligate all funds to recipients by the end of September 2022. Finally, the report also discusses risks and challenges HHS may face in distributing and monitoring the funds.
• On October 4, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Analysis of Recent National Trends in Medicaid and CHIP Enrollment. KFF examined national and state Medicaid and the Children's Health Insurance Program (CHIP) data and found that after declines in enrollment from 2017 to 2019, enrollment has steadily increased since February 2020. In fact, from February 2020 to June 2022, Medicaid and CHIP enrollment grew by 18.2 million enrollees, or 25.6 percent. Increases in enrollment may reflect changes in policy (e.g., recent adoption of the Medicaid expansion in the Affordable Care Act and the temporary continuous enrollment requirement that prohibited states from disenrolling enrollees during the COVID-19 public health emergency (PHE)) and changes in the economy. The report noted that almost all of enrollment growth was concentrated in Medicaid (not in CHIP) and that monthly increases in enrollment have slowed in recent months when compared to earlier in the pandemic. Authors also highlight that they estimate between 5.3 and 14.2 million Medicaid enrollees could lose their coverage at the end of the PHE due to states resuming normal eligibility and enrollment operations.
• On October 5, 2022, KFF published an issue brief entitled, National Data Show Continuing Disparities in Monkeypox (MPX) Cases and Vaccinations Among Black and Hispanic People. The monkeypox outbreak, which primarily affected men who have sex with men, peaked over the summer of 2022 and cases have since been declining. National data from the Centers for Disease Control and Prevention (CDC) shows that MPX cases have also disproportionately affected Black and Hispanic people, a pattern also seen with HIV and COVID-19. Black and Hispanic people also have lower rates of vaccination for MPX than White people. In their analysis, KFF specifically found that MPX case rates among Black people are over five times those of White people (14.4 vs. 2.6 per 100,000) and that as of September 27, over half (51 percent) of MPX first doses of vaccinations have gone to White people as compared to 13 percent to Black people and 22 percent to Hispanic people. These disparities are further recognized when assessing case rates – about 30 percent of MPX cases are among White people, 30 percent are among Hispanic people, and 35 percent are among Black people. KFF notes that data limitations make it difficult to track complete demographic patterns and highlights the importance of centering equity in MPX response efforts.
• On October 7, 2022, HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) published a report entitled, Reductions in Deaths and Hospitalizations Associated with COVID-19 Vaccinations Among Medicare Beneficiaries: Full Year 2021 Estimates. ASPE found that the Biden Administration’s COVID-19 vaccination program was successful in reducing COVID-19 related hospitalizations and deaths for all Medicare beneficiaries, regardless of racial and ethnic group or state. Specifically, ASPE noted vaccines were associated with 670,000-680,000 fewer hospitalizations and 330,000-370,000 fewer deaths among Medicare beneficiaries in 2021 (a 39-47 percent reduction), with the largest reductions during the summer Delta surge. ASPE estimates that these reductions in hospitalizations resulted in an estimated savings of over $16 billion in direct hospitalization costs to the Medicare program and prevented 1.7 million COVID-19 hospitalizations and 700,000 deaths among Medicare beneficiaries in 2021.

III. Other Health Policy News

• On October 3, 2022, HHS, through HRSA, announced nearly $27 million to improve and expand mental health care for children. This funding will offer timely mental health support to children and adolescents by training pediatricians and other providers in providing mental health care and by supporting pediatric providers with tele-consultation support from other mental health experts. This funding is critical and timely, as rates of mental, emotional, developmental, and behavioral disorders, particularly among children, were exacerbated over the COVID-19 pandemic. Specifically, 48 Pediatric Mental Health Access Program (PMHCA) awardees will each receive $300,000 from the Bipartisan Safer Communities Act to expand their programs; three national organizations will receive $3.2 million to provide technical assistance to grantees to expand and improve behavioral health services in pediatric practices, schools, and emergency departments; and $9 million of funding from the American Rescue Plan (ARP) will help launch new mental health programs. More information on this announcement can be found here.
• On October 3, 2022, HHS, through the Office of Minority Health (OMH), announced nearly $5 million in grants to 10 organizations under its Community-Driven Approaches to Address Factors Contributing to Structural Racism in Public Health initiative. Recipients of the awards will be able to identify new and innovative ways to address policies that may create or perpetuate health disparities and may contribute to structural racism. The project period began on September 30, 2022 for three-years. More information on this announcement can be found here.
• On October 3, 2022, HHS’ Office of the National Coordinator for Health Information Technology (ONC) announced $2 million for two awards under the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. This award sought applicants to advance two areas of interest: (1) address health equity and social determinants of health (SDOH) through innovative, open-source technology tools, and electronic health records (EHRs); (2) demonstrate the use of equity-enhancing patient-generated health data (PGHD) for clinical care and research. One awardee was selected for each area of interest; they will use the funds to create partnerships between service providers and safety-net settings and to develop their technology infrastructure. More information on this announcement can be found here.
• On October 4, 2022, HHS, through the Office of Population Affairs (OPA), announced over $6.2 million for three types of grants as part of its work to protect and expand access to reproductive health care. One, the Title X Family Planning Research grants will support awardees’ research and analysis to improve equitable delivery of family planning services offered under Title X of the Public Health Service Act. Two, the Teenage Pregnancy Prevention Evaluation and Research grants will allow grantees to conduct research on best practices to improve teen pregnancy prevention programs and to reduce existing disparities, as well as scale emerging adolescent sexual health innovations to generate data and prepare for impact evaluation. Three, the Research-to-Practice Center grants will support awardees expand delivery of trauma-informed and inclusive adolescent sexual and reproductive health programming, improve research, and ultimately improve adolescent health and reduce teen pregnancy. More information on this announcement can be found here.
• On October 6, 2022, HHS announced a number of steps to improve language access and meaningful communication with limited English proficient (LEP) speakers through HHS programs and advance the Biden-Harris Administration’s goal of overcoming barriers to equity in health care and human services. One, HHS is relaunching the Language Access Steering Committee (Steering Committee) to support HHS’s implementation of language access obligations under President Joe Biden’s recent Executive Orders (EOs). Two, HHS OMH announced $4 million in grant funding to 11 organizations for the Promoting Equitable Access to Language Services in Health and Human Services initiative, which will help develop and test methods of informing individuals with LEP about the availability of language access services in health care-related settings. More information on this announcement can be found here.

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