Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of class II devices. The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting entitled ``Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an opportunity for public comment. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA- sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period. This meeting is intended to satisfy FDA's commitment to host a public meeting about the assessment no later than March 2021.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Centers for Medicare and Medicaid Services (CMS) is requesting that a new information collection request (ICR) related to the Medicare Current Beneficiary Survey (MCBS) (OMB clearance 0938- 0568) be processed under the emergency clearance process. Due to CMS' determination that this collection of information is needed prior to the expiration of time periods established under its regulations, an emergency clearance is requested. Once the emergency information collection request is approved, CMS plans to seek public comments during the required 60-day and 30-day notice and comment periods associated with obtaining a standard (non-emergency) OMB approval for extending the information collection request as part of the MCBS (collected under 0938-0568). The approval of this information collection package is necessary because of the urgent need to obtain timely data to assess the impact of the coronavirus pandemic on the Medicare population. Adding a COVID-19 Supplement to the MCBS data collection in October 2020 will provide critical information to CMS and the public.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by The National Council on Aging for the project Piloting the Remote Delivery of Falls Prevention Programs. The purpose of this supplement is to scale-up research activities for falls prevention interventions delivered remotely/virtually.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Awardee Lead Profile Assessment (ALPA).'' The ICR includes a survey to collect information to identify jurisdictional legal frameworks governing funded childhood lead poisoning prevention programs in the United States, and strategies for implementing childhood lead poisoning prevention activities in the United States.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Respiratory Protective Devices 42 CFR part 84Regulation. The purpose of the data collection is to enable 42 CFR part 84 respirator approval certification activities.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Reducing Fatigue Among Taxi Drivers'' with the goal of evaluating two interventions, a training and a wrist-device that provides personalized daily fatigue scores, designed to enable taxi drivers to reduce their fatigue levels. This research study involves two parts: Development of a fatigue management eLearning training tool designed for drivers-for-hire (e.g., taxi drivers; ride sourcing drivers); and an evaluation of the effectiveness of this training alone and paired with the wrist-device that provides personalized daily fatigue scores.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Breast Cancer in Young Women (ACBCYW), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 17, 2022.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new department-wide system of records, 09-90-2001, Records Used for Surveillance and Study of Epidemics, Preventable Diseases and Problems. The new system of records replaces, and is broader than, a similar system of records maintained by HHS' Centers for Disease Control and Prevention (CDC), which HHS is rescinding in this notice, 09-20-0113 Epidemic Investigation Case Records.

The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The currently approved method measures quinoxaline-2-carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. CVM is proposing to revoke the approved method for carbadox based on our determination that it is inadequate to monitor residue of carcinogenic concern in compliance with FDA's operational definition of no residue because there is no established relationship between QCA measured by the approved method and the residue of carcinogenic concern.

This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Administration for Children and Families (ACF) has realigned functions under the Office of the Deputy Assistant Secretary for Administration (ODASA). This realignment establishes the Office of Transformation, Business, and Management; establishes the Office of Government Contracting Services; realigns functions currently organized under the Immediate Office, Office of Workforce Planning and Development, and Office of Financial Services; and renames the Office of Financial Services to the Office of Grants Policy.

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) charter has been renewed. The effective date of the renewed charter is July 20, 2020.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records, 09-90-2002, ``COVID-19 Insights Collaboration Records.'' HHS will use the records in this system of records to create and maintain a new database to be used by HHS to understand, track, and respond to the novel coronavirus known as SARS- CoV-2 and the outbreak of COVID-19 (the disease caused by SARS-CoV-2) which the Secretary of Health and Human Services declared a public health emergency effective January 27, 2020, and the World Health Organization (WHO) declared a pandemic on March 11, 2020. Creating and maintaining the new database may include retrieving identifiable records about patients by the patients' personal identifiers in order to connect, combine, or de-duplicate records that are about the same individual; however, at this time, HHS does not plan to retrieve records by personal identifier when using the resulting database for research, analysis, or other public health activities.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve proposed updates to the approved information collection project ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2018-2019. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2018 through December 2019.

HHS is publishing this Request for Information (RFI) to seek public input on the development of a federal interagency Council on Economic Mobility (Council). HHS and the Council will analyze information collected in this RFI to gather feedback from our stakeholders to better inform the Council's priorities and how the Council can promote economic mobility, recovery, and resilience.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to withdraw approval of the new drug application (NDA) for Vioform-Hydrocortisone Cream, Ointment, and Lotion containing Iodochlorhydroxyquin and Hydrocortisone (Vioform), is the final decision of the Commissioner by operation of law. Several parties to the hearing, including the NDA holder and identical, related, or similar (IRS) product manufacturers, and a non-party participant timely filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the NDA application, the IRS product manufacturers, and the non-party participant that had timely filed exceptions, or their successors-in-interest, affirm within a specific timeframe their interest in pursuing their appeals of the ALJ's Initial Decision. The NDA holder responded within the timeframe and withdrew its appeal. No other appellants that received actual notice of the Agency's request responded within the timeframe. Accordingly, FDA now deems any exceptions filed by appellants that received notice of the Agency's request to be withdrawn. FDA is, however, offering an opportunity to other IRS product manufacturers, or successors-in- interest, that submitted exceptions to the ALJ's Initial Decision and did not receive notice of FDA's request, to affirm their desire to pursue the appeal. The ALJ's Initial Decision is the final decision of the Commissioner by operation of law; however, if FDA receives a valid request to affirm the appeal, as described in this notice, we will withdraw this notice.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Proposed Revised Collection and solicits comments on the information collection requirements related to the extension of the Title VI Program Performance Report.

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket number FDA-2008-N-0567 between October 1, 2018, and June 30, 2019, has analyzed whether coccidioidomycosis meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations, and whether there is ``no significant market'' for drugs that prevent or treat coccidioidomycosis infections in developed countries. The Agency has determined that coccidioidomycosis does not meet the statutory criteria for designation as a tropical disease eligible for PRV consideration because of the potential market for preventive products (such as vaccines), and therefore declines to designate it as an addition to the list of tropical disease PRV- eligible diseases at this time.

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket FDA-2008-N-0567, between June 20, 2018, and November 21, 2018, has analyzed whether the foodborne trematode infection clonorchiasis meets the statutory criteria for designation as a ``tropical disease'' for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is ``no significant market'' for drugs that prevent or treat clonorchiasis in developed countries. The Agency has determined at this time that clonorchiasis does not meet the statutory criteria for addition to the tropical diseases list under the FD&C Act. Although clonorchiasis disproportionately affects poor and marginalized populations, it is an infectious disease for which there is a significant market in developed nations; therefore, FDA declines to add it to the list of tropical diseases.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain pre- submissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not later than 1 year after the close of the public comment period, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates, and issuing a draft guidance on the topic. No later than 12 months after the close of the public comment period, the Agency will issue a final guidance. This guidance is intended to satisfy the final guidance documents referenced in the FDA&C Act and the MDUFA IV Commitment Letter.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #266 entitled ``Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #268 entitled ``Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.'' The draft guidance, if finalized, will describe FDA's current thinking with respect to assisting sponsors in incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July 20, 2020 meeting, an invited panel will present on emergency preparedness for people with dementia with a special focus on the COVID-19 pandemic. The chairs of the subcommittees (Research, Clinical Care, and Long-Term Services and Supports) will present recommendations for adoption by the full Advisory Council.

This document is a notice of proposed rulemaking regarding grandfathered group health plans and grandfathered group health insurance coverage that would, if finalized, amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of cost-sharing requirements without causing a loss of grandfather status.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this Final Rule (FR) to amend two provisions within its Foreign Quarantine regulations to best protect the public health of the United States. The provisions in this Final Rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States from threats posed by human remains.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Clinical Decision Support (CDS) for Chronic Pain Management.''

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Chembio Diagnostic Systems, Inc. (``Chembio'') for the DPP COVID-19 IgM/IgG System. FDA revoked this Authorization on June 16, 2020, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of new information from three evaluations performed since the Authorization of the device that demonstrate its performance may be both inconsistent and lower than that described in the request for Authorization. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the current version of Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) and an update to the FDA Data Standards Catalog for the submission of nonclinical data in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). This update does not apply to noncommercial INDs for a product that is not intended for commercial distribution (research and investigator-sponsored INDs); INDs and BLAs for devices that are regulated by CBER as biological products under the Public Health Services (PHS) Act; and submissions for blood and blood components, including Source Plasma.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Peripheral Vascular Atherectomy DevicesPremarket Notification (510(k)) Submissions.'' FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document ``Peripheral Vascular Atherectomy DevicesPremarket Notification (510(k)) Submissions.'' This draft guidance is not final nor is it in effect at this time.

In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CARTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Brain Metastases.'' This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.'' This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations on the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) infections, and hepatitis C virus (HCV) infections. Exclusion of patients with HIV, HBV, or HCV infections from cancer clinical trials remains common in most studies of investigational drugs. Expanding cancer clinical trial eligibility to be more inclusive of patients with HIV, HBV, or HCV infections is justified in many cases and may accelerate the development of effective therapies in cancer patients with these chronic infections. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.

The Food and Drug Administration (FDA, the Agency, or we) is holding a virtual meeting entitled ``FDA Hiring and Retention Interim Assessment'' and an opportunity for public comment. The topic to be discussed is FDA's hiring and retention interim assessment which was an independent assessment performed by Booz Allen Hamilton, published on June 5, 2020. This public meeting will take place virtually due to extenuating circumstances and will be held by webcast only.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension to continue collecting data for the study, Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS). Data collection has been delayed due to the COVID-19 pandemic and will not be complete by the current expiration date of October 31, 2020. There are no changes proposed to the current instruments.

The Food and Drug Administration (FDA) is 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.

The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit input and comments from stakeholders interested in informing strategic priorities for the Office of Women's Health (OWH). This will help the Agency ensure that important health concerns are carefully considered in establishing OWH's scientific, educational, and outreach priorities.

The Food and Drug Administration (FDA) is 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.

In accordance with the Federal Advisory Committee Act, section 1111(g) of the Public Health Service Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to extend approval for data collection using the current Refugee Data Submission System for Formula Funds Allocations (ORR-5) until January 31, 2021, and revise the current form for use after Fiscal Year (FY) 2020. The revised form will collect additional client-level data.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit a Supplemental Information Request (SIR), described below, to the Office of Management and Budget (OMB). Prior to submitting the SIR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the SIR.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, healthcare professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new collection of information to collect entitled ``Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.''

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials.''

Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ index.html.

The Food and Drug Administration (FDA or we) is 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.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug.''

The Food and Drug Administration (FDA) is 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).

This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

Pursuant to its authority under Federal regulations for the National Practitioner Data Bank (NPDB), HRSA's Division of Practitioner Data Bank announces a continuation of its temporary waiver of user fees for NPDB queries from March 1, 2020, through September 30, 2020, to support our eligible entities in making credentialing, hiring, privileging, and licensing decisions in combatting the COVID-19 pandemic. The waiver includes all one-time queries and continuous queries during the waiver time period. Fees for self-queries will not be waived. The NPDB is a confidential information clearinghouse created by Congress and is intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, providers, and suppliers. In response to President Trump's declaration of a national emergency and associated emergency declarations by all states, the Federal Government, state governments, and many health care entities have taken unprecedented steps regarding licensure portability and the deployment of health workforce resources, including the expansion of telemedicine and granting of disaster privileges. HRSA's NPDB is in a unique position to temporarily waive fees, granting NPDB access to the nation's hospitals, health centers, health plans, state licensing boards, Federal agencies, and other eligible health care entities in support of their efforts to mobilize and appropriately deploy health workforce professionals.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Oral Health Basic Screening Survey for Children. The project provides state-specific data on dental caries (tooth decay) and dental sealants from a state-representative sample of elementary school children or children enrolled in Head Start programs and has been used by states to monitor oral health status of children and evaluate public health programs and policies.

The Food and Drug Administration (FDA or Agency) has determined that ZOVIRAX (acyclovir) oral capsules, 200 milligrams (mg), was 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 this drug product, and it will also allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is 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.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Breast Reconstruction after Mastectomy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), has added a definition of the term ``emergency response employees'' to the definitions section of the document entitled ``Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements.'' This list of potentially life-threatening infectious diseases to which emergency response employees may be exposed and companion guidelines has been re-published by the National Institute for Occupational Safety and Health (NIOSH) and is available on the NIOSH website.