Department of Health and Human Services September 2020 – Federal Register Recent Federal Regulation Documents
Results 251 - 283 of 283
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VILTEPSO (viltolarsen) manufactured by Nippon Shinyaku Co., Ltd. (NS Pharma Inc., U.S. Agent), meets the criteria for a priority review voucher.
Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing.'' In general, drug development programs should be conducted so that when products are approved, the labeling provides appropriate dosing recommendations for patients with renal impairment. This draft guidance revises and replaces the draft guidance entitled ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing and Labeling'' (March 2010) and is meant to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug and how such information can impact dosing.
Reallotment of Fiscal Year 2019 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2019 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FY 2020 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.
Promoting the Rule of Law Through Improved Agency Guidance Documents
On October 9, 2019, the President issued Executive Order (E.O.) 13891: Promoting the Rule of Law Through Improved Agency Guidance Document. This E.O. requires all Federal Agencies to establish an on-line guidance portal and to rescind any guidance documents that are no longer active or valid.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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.
Proposed Information Collection Activity; ORR Serious Medical Procedure Request (SMR) Form (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new data collection, the Serious Medical Procedure Request (SMR) Form.
Proposed Information Collection Activity; Understanding Children's Transitions From Head Start to Kindergarten (HS2K) (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff (grantee administrators, managers/coordinators, center directors, teachers, staff), parents, affiliated community providers, and partner Local Education Agency (LEA) staff (administrators, elementary school principals, staff, and kindergarten teachers) at six sites. A comparative case study design will explore varying strategies and approaches to supporting children's transitions from Head Start to kindergarten.
Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, entitled ``Control of Nitrosamine Impurities in Human Drugs.'' This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product at risk for their presence.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Proposed Information Collection Activity; Infant and Toddler Teacher and Caregiver Competencies (ITTCC) Study (New Collection)
This is a primary data collection request for the Infant and Toddler Teacher and Caregiver Competencies (ITTCC) study to examine, using qualitative case studies, different approaches to implementing competency frameworks and assessing competencies of teachers and caregivers of infants and toddlers who work in group early care and education (ECE) settings (centers and family child care homes). Each case study will focus on a specific competency framework used by states, institutions of higher education, professional organizations, or ECE programs. This study aims to present an internally valid description of the implementation of competency frameworks and assessment of competencies for up to seven purposively selected cases, not to promote statistical generalization to different sites or service populations.
Proposed Information Collection Activity; ORR-3 and ORR-4 Report Forms for the Unaccompanied Refugee Minors Program (OMB #0970-0034)
The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the ORR-3 and ORR-4 Report Forms (OMB #0970-0034, expiration 01/31/2021). ORR proposes revisions to improve clarity, secure outcome-based data, increase compliance with reporting requirements, and reduce burden.
Submission for OMB review; 30-Day Comment Request; Specimen Resource Locator (National Cancer Institute)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between September 23, 2019, and September 1, 2020, on FDA's website but not presented at the September 15, 2020, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Determination That MICRO-K LS (Potassium Chloride) Extended-Release Liquid Suspension, 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MICRO-K LS (potassium chloride) extended-release liquid suspension, 20 milliequivalents (mEq)/packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MICRO-K LS (potassium chloride) extended-release liquid suspension, 20 mEq/packet, if all other legal and regulatory requirements are met.
Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 14, 2020. The document announced the withdrawal of approval (as of June 15, 2020) of 16 new drug applications (NDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of NDA 050641, Monodox (doxycycline monohydrate) Capsules, Equivalent to (EQ) 50 milligrams (mg) base, EQ 75 mg base, and EQ 100 mg base, after receiving a withdrawal request from Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., Suite 200, Exton, PA 19341. Before FDA withdrew the approval of NDA 050641, Aqua Pharmaceuticals, LLC, informed FDA that it did not want the approval of the NDA withdrawn. Because Aqua Pharmaceuticals, LLC, timely requested that approval of the NDA not be withdrawn, the approval of NDA 050641 is still in effect.
Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
This interim final rule with comment period (IFC) revises regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary) in such form and manner, and at such timing and frequency, as the Secretary may prescribe during the Public Health Emergency (PHE).
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
Advisory Commission on Childhood Vaccines
The original Federal Register Notice announcing the September 2020 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held on September 3-4, 2020. This meeting is not being conducted over 2 days, and instead will only take place only on September 4, 2020. The ACCV will hold a public meeting on September 4, 2020, at 10:00 a.m. ET. The meeting will be held via Adobe Connect and telephone conference. This will not be an in-person meeting. The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number 888-790-1734 and providing the following information:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Coronavirus 2019 Data Report
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.
Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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, 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 extension of the collection of information concerning requirements relating to FDA's Adverse Experience Reporting System (FAERS) for licensed biological products, and general records associated with the manufacture and distribution of biological products.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMOXITI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMOXITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human biological product.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System
This document contains technical amendments to the Health and Human Services (HHS) regulation regarding the Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System. The regulatory content is being amended to correct references that are made throughout the regulation regarding delegated authorities and activities of the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH). With the abolishment of NCRR in 2011, the Director, NIH, delegated these authorities to the Office of Research Infrastructure Programs (ORIP) within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), NIH. The ORIP/DPCPSI now has the lead responsibility for coordinating all efforts on behalf of HHS concerning the sanctuary system for surplus chimpanzees from both federal and non-federal sources. The references to NCRR throughout the regulation are corrected to reflect ORIP/DPCPSI, the definition of National Primate Research Center is corrected to reflect the correct number of currently existing centers, and the office address provided for ORIP/DPCPSI in the regulation is corrected.
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