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

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Supplemental Evidence and Data Request on Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea in Medicare Eligible Patients
Document Number: 2020-15172
Type: Notice
Date: 2020-07-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea in Medicare Eligible Patients, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-15147
Type: Notice
Date: 2020-07-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.''
Use of The Seafood List To Determine Acceptable Seafood Names; Compliance Policy Guide; Availability
Document Number: 2020-15146
Type: Notice
Date: 2020-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names'' (the CPG). The CPG provides guidance for FDA staff regarding use of The Seafood List to determine whether a seafood name is acceptable.
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Antibodies Against SARS-CoV-2, the Virus That Causes Coronavirus Disease 2019 (COVID-19)
Document Number: 2020-15138
Type: Notice
Date: 2020-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2020-15137
Type: Notice
Date: 2020-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance and reissuance, are listed in this document, and are available on FDA's website at the links indicated.
Electronic Submissions; Data Standards; Support for Standard for the Exchange of Nonclinical Data
Document Number: 2020-15095
Type: Notice
Date: 2020-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-15089
Type: Notice
Date: 2020-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' FDA has developed this draft guidance to propose select updates to certain sections of the existing FDA guidance document ``Guidance for the Non[hyphen]Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).'' This draft guidance is not final nor is it in effect at this time.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-15087
Type: Notice
Date: 2020-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-15086
Type: Notice
Date: 2020-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-15085
Type: Notice
Date: 2020-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-15084
Type: Notice
Date: 2020-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-15083
Type: Notice
Date: 2020-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2020-15178
Type: Notice
Date: 2020-07-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Select Updates for Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-15081
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Board of Scientific Counselors, National Center for Injury Prevention and Control
Document Number: 2020-15029
Type: Notice
Date: 2020-07-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). This meeting is partially open to the public. There will be 15 minutes allotted for public comments at the end of the open session from 12:30 p.m. to 12:45 p.m. on August 20, 2020.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
Document Number: 2020-15028
Type: Notice
Date: 2020-07-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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).
Determination of Regulatory Review Period for Purposes of Patent Extension; XEPI
Document Number: 2020-15013
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XEPI 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 human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CARTIVA
Document Number: 2020-15011
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Pentaerythritol Tetranitrate; Final Decision on Proposal To Withdraw Approval From New Drug Applications and Abbreviated New Drug Applications; Availability of Final Decision
Document Number: 2020-15010
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that the initial decision of the Administrative Law Judge (ALJ), to withdraw approval of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for pentaerythritol tetranitrate (PETN), is the final decision of the Commissioner of Food and Drugs (the Commissioner) by operation of law. In the initial decision, the ALJ found that PETN had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for prophylactic treatment of angina pectoris and ordered the withdrawal of approval for all NDAs and ANDAs. Several parties to the hearing filed exceptions to the ALJ's initial decision; however, all parties who submitted exceptions have since voluntarily withdrawn them, or FDA has deemed them withdrawn after their associated NDA or ANDA was withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ's initial decision had been filed. Therefore, the ALJ's initial decision has become the final decision of the Commissioner by operation of law. Applicable Date: This notice is applicable July 13, 2020.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation
Document Number: 2020-15009
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients; Guidance for Industry and Institutional Review Boards; Availability
Document Number: 2020-14998
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and institutional review boards (IRBs) entitled ``Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients.'' 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 pediatric patients (i.e., children and adolescents) in clinical trials for cancer treatments. This guidance finalizes the draft guidance entitled ``Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients'' that published on March 13, 2019.
Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Guidance for Industry; Availability
Document Number: 2020-14997
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Cancer Clinical Trial Eligibility Criteria: Patients With Organ Dysfunction or Prior or Concurrent Malignancies; Guidance for Industry; Availability
Document Number: 2020-14996
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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 Organ Dysfunction or Prior or Concurrent Malignancies.'' 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 organ dysfunction or with prior or concurrent malignancies. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.
Cancer Clinical Trial Eligibility Criteria: Patients With Human Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus Infections; Guidance for Industry; Availability
Document Number: 2020-14995
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Trandolapril Tablets
Document Number: 2020-14981
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for trandolapril tablets. The basis for the withdrawal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA. The holder of the ANDA has waived its opportunity for a hearing.
Food and Drug Administration Hiring and Retention Interim Assessment; Public Meeting; Request for Comments
Document Number: 2020-14980
Type: Notice
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
Document Number: 2020-14671
Type: Proposed Rule
Date: 2020-07-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2021. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2
Document Number: 2020-13822
Type: Rule
Date: 2020-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14950
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14948
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2020-14946
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (0970-0535)
Document Number: 2020-14944
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Submission for OMB Review; Child and Family Services Plan (CFSP), Annual Progress and Services Report (APSR), and Annual Budget Expenses Request and Estimated Expenditures (CFS-101) (0970-0426)
Document Number: 2020-14881
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a three-year extension of the collection of information under the Child and Family Services Plan (CFSP), the Annual Progress and Services Report (APSR), and the Annual Budget Expenses Request and Estimated Expenditures (CFS-101) collection (OMB #0970-0426, expiration 1/31/2021). There are minor changes to the APSR, the burden hours for the APSR, and CFS-101 form.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption
Document Number: 2020-14880
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
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; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Document Number: 2020-14879
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Office of Women's Health Strategic Priorities; Establishment of a Public Docket; Request for Comments
Document Number: 2020-14878
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2020-14877
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2020-14876
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2020-14875
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2020-14840
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-14838
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-14837
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License: N6, a Novel, Broad, Highly Potent HIV-Specific Antibody and a Broadly Neutralizing Human Anti-HIV Monoclonal Antibody (10E8) Capable of Neutralizing Most HIV-1 Strains
Document Number: 2020-14836
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to RNAceuticals, Inc. located at 12 Indian Trail Road, Woodbridge, CT, USA to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-14810
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-14809
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-14808
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
Document Number: 2020-14797
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
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; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
Document Number: 2020-14796
Type: Notice
Date: 2020-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Notice of Purchased/Referred Care Delivery Area Redesignation for the Northwestern Band of the Shoshone Nation
Document Number: 2020-14760
Type: Notice
Date: 2020-07-10
Agency: Department of Health and Human Services, Indian Health Service
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Northwestern Band of the Shoshone Nation (NWBSN) in the State of Utah to include the Utah counties of Box Elder, Davis, Salt Lake, and Weber. The current PRCDA for the NWBSN is Box Elder County in the State of Utah. Tribal members residing on the Fort Hall Indian Reservation are provided health services through the IHS direct care facility in Fort Hall, Idaho, or by Purchased/Referred Care (PRC) referrals to private providers. NWBSN members residing outside of the PRCDA are eligible for direct care services, however, they are not eligible for PRC services. The sole purpose of this expansion would be to authorize additional Tribal members and beneficiaries to receive PRC services.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2020-14813
Type: Notice
Date: 2020-07-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
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/index.html.