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

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Draft National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Strategic Plan for FY 2020-2024
Document Number: 2019-13462
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is updating its Strategic Plan for Fiscal Years (FY) 2020-2024 to help guide the research it supports over the next five years. The Institute issued a previous Request for Information (RFI) (NOT-AR-19-009) to solicit initial comments on how the previous plan for Fiscal Years 2015-2019 should be modified to reflect progress over the past five years. The Institute also gathered additional input through listening sessions with the community. Based on this feedback, along with input from the NIAMS Advisory Council and its Working Group for the Strategic Plan, the Institute has drafted the NIAMS Strategic Plan for FY 2020-2024. We are now seeking input on this draft. Through this RFI, NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public on the draft NIAMS Strategic Plan for FY 2020-2024. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. The final draft of the Strategic Plan will be presented at the September 2019 meeting of the NIAMS Advisory Council and the final plan will be posted on the NIAMS website once it is approved.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-13368
Type: Notice
Date: 2019-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2019-13356
Type: Notice
Date: 2019-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
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 (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 ZOLGENSMA (onasemnogene abeparvovec-xioi), manufactured by AveXis, Inc., meets the criteria for a priority review voucher.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-13355
Type: Notice
Date: 2019-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial 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 meeting.
Allergenic Products Advisory Committee; Notice of Meeting
Document Number: 2019-13354
Type: Notice
Date: 2019-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.
Mining Automation and Safety Research Prioritization; Reopening of Comment Period
Document Number: 2019-13351
Type: Notice
Date: 2019-06-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On March 18, 2019 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register announcing that NIOSH had recently established a research program to address the rapidly expanding area of automation and associated technologies in mining, and that NIOSH was requesting information to inform the prioritization of research to be undertaken by The Institute's Mining Program. NIOSH is seeking input on priority gaps in knowledge regarding the safety and health implications of humans working with automated equipment and associated technologies in mining, with an emphasis on worker safety and health research in which NIOSH has the comparative advantage, and is unlikely to be undertaken by other federal agencies, academia, or the private sector. Written comments were to be received by May 17, 2019. In response to a request from an interested party, NIOSH is announcing the reopening of the comment period.
Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry; Availability
Document Number: 2019-13350
Type: Notice
Date: 2019-06-24
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 ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This guidance outlines the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. This guidance finalizes the draft guidance issued in April 2015.
Draft NTP Monograph on Systematic Review of Traffic-Related Air Pollution and Hypertensive Disorders of Pregnancy; Availability of Document; Request for Comments
Document Number: 2019-13338
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces the availability of the Draft NTP Monograph on Systematic Review of Traffic-Related Air Pollution and Hypertensive Disorders of Pregnancy for public comment. The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), prepared the monograph.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13335
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-13334
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2019-13331
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13330
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2019-13323
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services
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.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2019-13316
Type: Notice
Date: 2019-06-24
Agency: Department of Health and Human Services
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.
Privacy Act of 1974; Matching Program
Document Number: 2019-13242
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is providing notice of a re-established matching program between HHS/ACF/OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP). The matching program compares state SNAP agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies with establishing or verifying eligibility for applicants and recipients of SNAP benefits; reducing SNAP benefit errors; and, maintaining program integrity.
Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability
Document Number: 2019-13223
Type: Rule
Date: 2019-06-21
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 describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the ``small business'' definition.
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability
Document Number: 2019-13221
Type: Notice
Date: 2019-06-21
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 draft guidance for industry entitled ``Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.'' The purpose of this guidance is to describe the benefit- risk framework the Agency uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a new drug application (NDA) for an opioid analgesic drug to facilitate the Agency's benefit-risk assessment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
Document Number: 2019-13220
Type: Notice
Date: 2019-06-21
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.
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing
Document Number: 2019-13219
Type: Proposed Rule
Date: 2019-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation
Document Number: 2019-13213
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT). ACOT shall: (1) Advise the Secretary, acting through the HRSA Administrator, on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed Organ Procurement and Transplantation Network (OPTN) policies submitted for the Secretary's approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating, and ensuring the validity, accuracy, timeliness, and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation. Authority: As provided by 42 CFR 121.12, the Secretary established ACOT. ACOT is governed by the Federal Advisory Committee Act (FACA; 5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Small Rural Hospital Transition Project (SRHT), OMB No. 0906-0026-Extension
Document Number: 2019-13195
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Notice of Closed Meeting
Document Number: 2019-13178
Type: Notice
Date: 2019-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-13172
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-13171
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-13169
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2019-13168
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-13167
Type: Notice
Date: 2019-06-21
Agency: Department of Health and Human Services, National Institutes of Health
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice
Document Number: 2019-13142
Type: Notice
Date: 2019-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of May 6, 2019. The amendment is being made to reflect a change in the DATES, Agenda, and Procedure portions of the document. There are no other changes.
Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising
Document Number: 2019-13128
Type: Notice
Date: 2019-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 (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 Oncology Indications in Direct-to-Consumer Television Advertising.'' This research consists of two studies examining the presentation of oncology indications in direct-to-consumer (DTC) television ads.
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2019-13117
Type: Notice
Date: 2019-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 requests for data needed to evaluate requests for threshold of regulation exemptions for substances used in food-contact articles.
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Extension of Comment Period
Document Number: 2019-13122
Type: Notice
Date: 2019-06-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of April 3, 2019. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. We are extending the comment period to give interested parties more time to comment.
Privacy Act of 1974; System of Records
Document Number: 2019-13112
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new department-wide system of records, titled HHS Correspondence, Customer Service, and Contact List Records, system no. 09-90-1901. The new system of records replaces 13 existing systems of records which are rescinded in this notice, and it includes additional records not currently covered by any SORN. Two other related systems of records are also rescinded in this notice, but not replaced by the new SORN, because those records no longer exist.
Privacy Act of 1974; System of Records
Document Number: 2019-13091
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, the HHS is modifying a system of records maintained by HRSA, Healthcare Systems Bureau (HRSA/HSB), System No. 09-15-0056, ``National Vaccine Injury Compensation Program'' (VICP), and renaming it ``Injury Compensation Programs, HHS/HRSA/HSB.'' The primary purpose of the modification is to include records covered by a related system of records also maintained by HRSA/HSB, System No. 09-15-0071, ``Countermeasures Injury Compensation Program, HHS/HRSA/HSB'' (CICP), in order to consolidate the two systems of records and rescind System No. 09-15-0071.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2019-13065
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-13064
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-13063
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-13062
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13061
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-13060
Type: Notice
Date: 2019-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-13055
Type: Notice
Date: 2019-06-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Maternal Mortality Review Information Application (MMRIA). MMRIA is a standardized data collection system that allows Maternal Mortality Review Committees (MMRCs) to abstract relevant data from a variety of sources, document committee decisions, and analyze data to better understand the contributing factors and preventability of maternal deaths in order to develop recommendations for prevention.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-13054
Type: Notice
Date: 2019-06-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-13053
Type: Notice
Date: 2019-06-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products; Guidance for Industry; Availability
Document Number: 2019-12983
Type: Rule
Date: 2019-06-20
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 industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, Other Single- Ingredient Sugars and Syrups, and Certain Cranberry Products.'' This guidance provides clarification on the labeling requirements for single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, which are not required to bear the words ``Includes Xg Added Sugars,'' but must still include the percent Daily Value for added sugars on their labels. This guidance is also intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use of a ``[dagger]'' symbol immediately following the percent Daily Value for added sugars on single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups; the ``[dagger]'' symbol would lead the consumer to a statement that is truthful and not misleading in a footnote at the bottom of the Nutrition Facts label. The guidance also advises food manufacturers of our intent to exercise enforcement discretion with respect to the use of a ``[dagger]'' symbol immediately after the added sugars percent Daily Value information that leads the consumer to a statement that is truthful and not misleading outside of the Nutrition Facts label on certain dried cranberry and cranberry beverage products that are made up of cranberry juice sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. Further, this guidance advises of our intent to exercise enforcement discretion regarding compliance with Nutrition Facts label final rule and Serving Size final rule requirements until July 1, 2021, for the single-ingredient sugars and syrups as well as the cranberry products discussed in the guidance document.
Supplemental Evidence and Data Request on End-Stage Renal Disease in the Medicare Population
Document Number: 2019-12650
Type: Notice
Date: 2019-06-20
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 End-stage Renal Disease in the Medicare Population, 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.
Health Reimbursement Arrangements and Other Account-Based Group Health Plans
Document Number: 2019-12571
Type: Rule
Date: 2019-06-20
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document sets forth final rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through changes to rules under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code (Code) regarding health reimbursement arrangements (HRAs) and other account-based group health plans. Specifically, the final rules allow integrating HRAs and other account-based group health plans with individual health insurance coverage or Medicare, if certain conditions are satisfied (an individual coverage HRA). The final rules also set forth conditions under which certain HRAs and other account-based group health plans will be recognized as limited excepted benefits. Also, the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) are finalizing rules regarding premium tax credit (PTC) eligibility for individuals offered an individual coverage HRA. In addition, the Department of Labor (DOL) is finalizing a clarification to provide assurance that the individual health insurance coverage for which premiums are reimbursed by an individual coverage HRA or a qualified small employer health reimbursement arrangement (QSEHRA) does not become part of an ERISA plan, provided certain safe harbor conditions are satisfied. Finally, the Department of Health and Human Services (HHS) is finalizing provisions to provide a special enrollment period (SEP) in the individual market for individuals who newly gain access to an individual coverage HRA or who are newly provided a QSEHRA. The goal of the final rules is to expand the flexibility and use of HRAs and other account-based group health plans to provide more Americans with additional options to obtain quality, affordable healthcare. The final rules affect employees and their family members; employers, employee organizations, and other plan sponsors; group health plans; health insurance issuers; and purchasers of individual health insurance coverage.
Medicare Program; Secure Electronic Prior Authorization for Medicare Part D
Document Number: 2019-13028
Type: Proposed Rule
Date: 2019-06-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule proposes a new transaction standard for the Medicare Prescription Drug Benefit program's (Part D) e-prescribing program as required by the ``Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act'' or the ``SUPPORT for Patients and Communities Act.'' Under the SUPPORT for Patients and Communities Act, the Secretary is required to adopt standards for Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. If finalized, the proposals in this rule would amend the Part D e-prescribing regulations to require Part D plan sponsors' support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in electronic Prior Authorization (ePA) transactions with prescribers regarding Part D covered drugs to Part D-eligible individuals.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-13027
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-13026
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13025
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-13024
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13023
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices
Document Number: 2019-13004
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection requirements for postmarket surveillance of medical devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Document Number: 2019-13001
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2019-12996
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2019-12986
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 64th full Council meeting in Jackson, Mississippi. Members will hear a panel presentation regarding Ending the HIV Epidemic: A Plan for America and will discuss possible recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to Caroline Talev, MPA, at Caroline.Talev@hhs.gov. Pre-Registration must be complete by Monday, July 1, 2019.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Teaching Health Center Graduate Medical Education Program Eligible Resident/Fellow FTE Chart, OMB No. 0915-0367-Extension
Document Number: 2019-12961
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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: Public Comment Request Information Collection Request Title: Ryan White HIV/AIDS Program Recipient Compilation of Best Practice Strategies and Interventions, OMB No. 0906-xxxx-New
Document Number: 2019-12960
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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: Public Comment Request; Information Collection Request Title: Standardized Work Plan Form for Use With Applications to the Bureau of Health Workforce Research and Training Grants and Cooperative Agreements, OMB No. 0906-xxxx-New
Document Number: 2019-12959
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
Document Number: 2019-12906
Type: Proposed Rule
Date: 2019-06-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the proposed rule that appeared in the May 3, 2019, issue of the Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals.''
Agency Information Collection Activities: Proposed Collection: Comment Request Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915-0176-Extension
Document Number: 2019-12894
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 or any other aspect of the ICR.
Senior Executive Service Performance Review Board
Document Number: 2019-12819
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA, an Operating Division of HHS, is publishing a list of persons appointed to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA for the Fiscal Year 2019 and 2020 review period.
Submission for OMB Review; Formative Data Collections for ACF Program Support (New Collection)
Document Number: 2019-12801
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), in the Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to request approval from the Office of Management and Budget (OMB) for a generic clearance to conduct a variety of formative data collections with more than nine respondents. These information collections would not be highly systematic or intended to be statistically representative or otherwise generalizable. ACF programs promote the economic and social well-being of families, children, individuals and communities. Many ACF program offices need to learn more about funded program services so that an understanding of program or grantee processes and potential for improvements can inform ACF decision-making and program support. Information collected under this generic would help address these needs.
Meeting of the the Substance Abuse and Mental Health Services Administration's National Advisory Council
Document Number: 2019-12797
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services
Notice is hereby given of the meeting on July 1, 2019, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). This notice may publish with less than 15 days prior to the meeting due to a change in schedule for the committee chair and unexpected calendar changes. The meeting is open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members.
Proposed Information Collection Activity; Assessing the Implementation and Cost of High Quality Early Care and Education: Field Test (0970-0499)
Document Number: 2019-12796
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Administration for Children and Families
This information request is part of the project, Assessing the Implementation and Cost of High Quality Early Care and Education (ECE- ICHQ). The project's goal is to create a technically sound and feasible instrument that will provide consistent, systematic measures of the implementation and costs of education and care in center-based settings that serve children from birth to age 5. The resulting measures will inform research, policy, and practice by improving understanding of variations in what centers do to support quality, their associated costs, and how resources for ECE may be better aligned with expectations for quality.
Proposed Information Collection Activity; Head Start (HS) Connects: Individualizing and Connecting Families to Family Support Services (New Collection)
Document Number: 2019-12795
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Administration for Children and Families
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, parents/ guardians, and community providers at six Head Start programs for case studies that explore case management and coordination of family support services.
Proposed Information Collection Activity; 45 CFR 303.7-Provision of Services in Intergovernmental IV-D; Federally Approved Forms (OMB #0970-0085)
Document Number: 2019-12794
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Administration for Children and Families
This is a revision to an existing data collection which expires December 31, 2019. This data collection consists of 13 intergovernmental forms used by states and other entities to process intergovernmental child support cases. This request is for minor revisions to the approved forms.
Submission for OMB Review; Survey of Head Start Grantees on Training and Technical Assistance (New Collection)
Document Number: 2019-12783
Type: Notice
Date: 2019-06-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct a statistically representative survey of directors and managers/ coordinators from Head Start grantee organizations regarding their access to and use of training and technical assistance (T/TA) from multiple sources, including ACF's Early Childhood Training and Technical Assistance system. The purpose of the data collection is to inform ACF on three aspects of grantee directors and managers/ coordinators T/TA experience: (1) Search and selection of T/TA; (2) receipt of T/TA; (3) and potential relationships between T/TA received and perceived change in practice.
Proposed Information Collection Activity; Child Care and Development Fund (CCDF) Tribal Annual Report-ACF-700 (0970-0430)
Document Number: 2019-12782
Type: Notice
Date: 2019-06-18
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 form ACF-700: Child Care and Development Fund (CCDF) Tribal Annual Report (OMB #0970-0430, expiration 11/30/2019) with changes.
Proposed Collection; 60-Day Comment Request; Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report. Office of the Director (OD)
Document Number: 2019-12734
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. The purpose of this notice is to allow 60 days for public comment.
Center for State, Tribal, Local and Territorial Support (CSTLTS), CDC/ATSDR Tribal Advisory Committee (TAC) Meeting and 19th Biannual Tribal Consultation Session
Document Number: 2019-12724
Type: Notice
Date: 2019-06-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the following meeting and Tribal Consultation Session. The meetings are being hosted by CDC/ATSDR in-person only and are open to the public. Attendees must pre-register for the event by Friday, July 19, 2019, at the following link: https://www.cdc.gov/tribal/consultation-support/ tac/index.html.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-12714
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-12713
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-12712
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2019-12711
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-12710
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-12709
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors
Document Number: 2019-12708
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating amending an existing license to include a exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the patent application listed in the SUPPLEMENTARY INFORMATION section of this notice.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2019-12707
Type: Notice
Date: 2019-06-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Tailored Therapeutics, LLC. (``Tailored''), located in Potomac, MD.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
Document Number: 2019-12703
Type: Notice
Date: 2019-06-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Allergenic Products Advisory Committee
Document Number: 2019-12678
Type: Notice
Date: 2019-06-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Allergenic Products Advisory Committee (APAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the APAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer Training Programs
Document Number: 2019-12677
Type: Notice
Date: 2019-06-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection aspects of the Guidance for Tobacco Retailers on Tobacco Retailer Training Programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12636
Type: Notice
Date: 2019-06-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ is re-issuing this Request for Information to extend the date for receipt of comments. AHRQ invites public comment on its Request for Information (RFI) to inform potential revisions to the Consumer Assessment of Healthcare Providers and Systems Health Plan Survey 5.0. The Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Health Plan Survey 5.0 is one of the CAHPS family of surveys that assess patients' experiences with health care providers, in different settings, and with health plans. The CAHPS surveys cover topics that are important to patients and that they are best able to assess, such as the communication with providers and access to health care services. This RFI requests public comment regarding (1) the relevance and validity of the questions on CAHPS Health Plan Survey 5.0 (the Survey), and (2) any user concerns about revisions to the Survey.
Removing Outdated Regulations Regarding the National Hansen's Disease Program
Document Number: 2019-12578
Type: Rule
Date: 2019-06-17
Agency: Department of Health and Human Services
This action removes the outmoded HHS regulations for the National Hansen's Disease Program (NHDP). Due to superseding events and statutory changes, NHDP's regulations are obsolete.
Removing Outmoded Regulations Regarding the Health Education Assistance Loan (HEAL) Program
Document Number: 2019-12577
Type: Rule
Date: 2019-06-17
Agency: Department of Health and Human Services
This action removes the outmoded HHS regulations for the HEAL Program. As of July 1, 2014, this program transferred from HHS to the Department of Education (ED). On November 15, 2017, ED published HEAL Program regulations within its own regulatory framework. With the publication of ED's regulations, the HHS HEAL Program regulations are rendered obsolete.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12606
Type: Notice
Date: 2019-06-14
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 ``Systematic Review Data Repository.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.
Solicitation of Nominations for Membership To Serve on the National Advisory Council on Migrant Health
Document Number: 2019-12592
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health (NACMH/Council). The NACMH consults with and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of migrant health centers (MHC) and other entities, under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill up to five positions on the NACMH with individuals served by nominating health centers.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2019-12566
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
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. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee
Document Number: 2019-12565
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a non-voting industry representative(s) to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee Blood Products Advisory Committee. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry; Availability
Document Number: 2019-12564
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.'' The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations.
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Document Number: 2019-12560
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-12559
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis 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.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-12558
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic 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.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-12528
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-12527
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-12526
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-12525
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Nondiscrimination in Health and Health Education Programs or Activities
Document Number: 2019-11512
Type: Proposed Rule
Date: 2019-06-14
Agency: Department of Health and Human Services, Office of the Secretary, Centers for Medicare and Medicaid Services
The Department of Health and Human Services (``the Department'') is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act. The Department proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2019-11484
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12489
Type: Notice
Date: 2019-06-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Meeting of the Pain Management Best Practices Inter-Agency Task Force; Correction
Document Number: 2019-12482
Type: Notice
Date: 2019-06-13
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register of June 3, 2019, announcing the Pain Management Best Practices Inter-Agency Task Force's virtual public meeting. This document is announcing a change in the meeting date.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Extension of Comment Period
Document Number: 2019-12478
Type: Proposed Rule
Date: 2019-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of April 2, 2019. The Agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12474
Type: Notice
Date: 2019-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2019-12472
Type: Notice
Date: 2019-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection ``Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.''
Mouse Embryo Assay for Assisted Reproduction Technology Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-12430
Type: Notice
Date: 2019-06-13
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 ``Mouse Embryo Assay for Assisted Reproduction Technology Devices.'' This draft guidance document provides recommendations on conducting the Mouse Embryo Assay (MEA) to support premarket submissions and lot release of assisted reproduction technology devices. This draft guidance is not final nor is it in effect at this time.
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Guidance for Industry; Availability
Document Number: 2019-12389
Type: Rule
Date: 2019-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This guidance is intended to assist applicants to prepare PMTAs for ENDS products.
Proposed Collection; 60-Day Comment Request: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research (Clinical Center)
Document Number: 2019-12387
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-12369
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-12368
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-12367
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-12366
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12365
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12348
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meeting
Document Number: 2019-12345
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12340
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
Document Number: 2019-12323
Type: Notice
Date: 2019-06-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2019.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products
Document Number: 2019-12321
Type: Notice
Date: 2019-06-12
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; Proposed Collection; Comment Request; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species
Document Number: 2019-12316
Type: Notice
Date: 2019-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 reporting associated with designation under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; ALUNBRIG
Document Number: 2019-12320
Type: Notice
Date: 2019-06-11
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 ALUNBRIG 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12312
Type: Notice
Date: 2019-06-11
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: ``Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 19, 2019, and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-12308
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, 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 allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12306
Type: Notice
Date: 2019-06-11
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: ``The AHRQ Safety Program for Improving Antibiotic Use.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 1, 2019 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; KISQALI
Document Number: 2019-12305
Type: Notice
Date: 2019-06-11
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 KISQALI 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA TABLETS-NDA 208610
Document Number: 2019-12299
Type: Notice
Date: 2019-06-11
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 BAXDELA TABLETS under NDA 208610 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 a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION-NDA 208611
Document Number: 2019-12298
Type: Notice
Date: 2019-06-11
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 BAXDELA IV INJECTION under new drug application (NDA) 208611 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 a patent which claims that human drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12293
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability; Reopening of Comment Period
Document Number: 2019-12292
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of February 27, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12291
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
Document Number: 2019-12288
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, 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.
Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Document Number: 2019-12287
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-12278
Type: Notice
Date: 2019-06-11
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
Document Number: 2019-12266
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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 investigational device exemptions reports and records.
Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop
Document Number: 2019-12256
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled ``Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.'' The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
Opportunity To Collaborate on National Youth Sports Initiative To Increase Youth Sports Participation; Correction
Document Number: 2019-12251
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of June 3, 2019, concerning the opportunity to collaborate on National Youth Sports Initiative to increase youth sports participation with the President's Council on Sports, Fitness & Nutrition (PCSFN). The document contained an incorrect date.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-12227
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12226
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12225
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-12224
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-12223
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12222
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Extension of Timeline for Publication of the Final Rule
Document Number: 2019-12216
Type: Proposed Rule
Date: 2019-06-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of the timeline for publication of the ``Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care'' final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule, its substantive nature, and the scope of comments received all warrant the extension of the timeline for publication.
Request for Information; Reducing Administrative Burden To Put Patients Over Paperwork
Document Number: 2019-12215
Type: Proposed Rule
Date: 2019-06-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
CMS is committed to transforming the health care delivery systemand the Medicare and Medicaid programsby putting additional focus on patient-centered care, innovation, and outcomes. As part of our continuing Patients over Paperwork initiative, we have actively solicited feedback from the medical community through Requests for Information (RFIs), listening sessions, and clinical onsite engagements with front-line clinicians and staff to learn how our administrative requirements and processes affect their daily work and ability to innovate in care delivery. This RFI solicits additional public comment on ideas for regulatory, subregulatory, policy, practice, and procedural changes that reduce unnecessary administrative burdens for clinicians, providers, patients and their families. Through these efforts, we aim to increase quality of care, lower costs, improve program integrity, and make the health care system more effective, simple, and accessible.
Delegation of Authority
Document Number: 2019-12141
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services
Delegation of Authority
Document Number: 2019-12140
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-12137
Type: Notice
Date: 2019-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Prevalence Survey of Healthcare- Associated Infections and Antimicrobial Use in U.S. Acute Care Hospitals. This project examines the numbers and types of Healthcare- Associated Infections and causative pathogens, types of antimicrobial drugs (such as antibiotics) used, and the quality of antimicrobial prescribing in U.S. acute care hospitals.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-12136
Type: Notice
Date: 2019-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-12118
Type: Notice
Date: 2019-06-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Leveraging Randomized Clinical Trials To Generate Real-World Evidence for Regulatory Purposes; Public Workshop
Document Number: 2019-12113
Type: Notice
Date: 2019-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.'' Convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke Margolis) and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to explore key considerations for using randomized designs, such as large simple trials or those that incorporate pragmatic elements to generate real- world evidence (RWE).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-12109
Type: Notice
Date: 2019-06-10
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; Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Document Number: 2019-12108
Type: Notice
Date: 2019-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-12106
Type: Notice
Date: 2019-06-10
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: 2019-12105
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request: 30-Day Public Comment Request
Document Number: 2019-12098
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services
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.
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-12075
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development Amended; Notice of Meeting
Document Number: 2019-12073
Type: Notice
Date: 2019-06-10
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: 2019-12072
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-12071
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-12070
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Center For Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-12069
Type: Notice
Date: 2019-06-10
Agency: Department of Health and Human Services, National Institutes of Health
Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
Document Number: C1-2019-09667
Type: Rule
Date: 2019-06-07
Agency: Department of Health and Human Services, Office of the Secretary
Agency Information Collection Request; 60-day Public Comment Request
Document Number: 2019-12018
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services
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.
Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability
Document Number: 2019-11978
Type: Notice
Date: 2019-06-07
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 draft guidance for industry entitled ``Enhancing the Diversity of Clinical Trial PopulationsEligibility Criteria, Enrollment Practices, and Trial Designs.'' This draft guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials. The draft guidance reflects FDA policy encouraging inclusion in clinical trials of participants representative of the broad population of patients who will be exposed to a marketed drug and is being issued to satisfy the FDA Reauthorization Act of 2017 (FDARA) mandate.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2019-11955
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2019-11954
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-11953
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-11952
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Nonalcoholic Steatohepatitis With Compensated Cirrhosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2019-11951
Type: Notice
Date: 2019-06-07
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 draft guidance for industry entitled ``Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.'' The purpose of this draft guidance is to provide the Agency's current recommendations regarding the important components of a drug development program for nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. This draft guidance focuses on the enrollment criteria, trial design, efficacy endpoints, and safety considerations for phase 3 trials.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-11949
Type: Notice
Date: 2019-06-07
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 ``Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 1, 2019 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Black Lung Clinics Program Performance Measures, OMB No. 0915-0292-Extension
Document Number: 2019-11935
Type: Notice
Date: 2019-06-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Correction
Document Number: 2019-11923
Type: Rule
Date: 2019-06-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the April 16, 2019 Federal Register titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee- For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021''.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2019-11812
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services
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.
Medicare Program; Explanation of Federal Fiscal Year (FY) 2004, 2005, and 2006 Outlier Fixed-Loss Thresholds as Required by Court Rulings
Document Number: 2019-11796
Type: Rule
Date: 2019-06-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004, 2005, and 2006 outlier fixed-loss threshold (FLT) rulemakings, this document provides further explanation of certain methodological choices made in the FLT determinations for those years.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-11787
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2019-11784
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11783
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11782
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-11781
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11780
Type: Notice
Date: 2019-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; the Announcement of the Annual Advisory Panel on Hospital Outpatient Payment (HOP Panel) Meeting in August 2019 and New Panel Members
Document Number: 2019-11756
Type: Notice
Date: 2019-06-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual public meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2019. In addition, it announces 6 new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The recommendations provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11671
Type: Notice
Date: 2019-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-11667
Type: Notice
Date: 2019-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Amended Notice of Meeting
Document Number: 2019-11665
Type: Notice
Date: 2019-06-05
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; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
Document Number: 2019-11659
Type: Notice
Date: 2019-06-05
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; Exemptions From Substantial Equivalence Requirements for Tobacco Products
Document Number: 2019-11658
Type: Notice
Date: 2019-06-05
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; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
Document Number: 2019-11657
Type: Notice
Date: 2019-06-05
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 (PRA).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-11650
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-11649
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Annual Reporting of the Rape Prevention and Education (RPE) Program: CE19-1902 Cooperative Agreement.'' Information will be collected annually from RPE recipients and will provide crucial data for performance monitoring and program evaluation of the implementation of prevention strategies and approaches, outcomes, and budget of the cooperative agreement.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-11648
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Promoting Adolescent Health through School-Based HIV Prevention. CDC will use a web-based system to collect data on the strategies that funded Local Education Agencies (LEAs) are using to meet their goals related to three strategies: Deliver sexual health education emphasizing HIV and other STD prevention (SHE); Increase adolescent access to key sexual health services (SHS); and Establish safe and supportive environments for students and staff (SSE).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-11647
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Lyme and other Tickborne Diseases Knowledge, Attitudes, and Practices Surveys. This will allow for survey development, pre-testing activities, and survey administration to be carried out during the years 2020-2022 by the Division of Vector-Borne Diseases (DVBD), National Center for Emerging and Zoonotic Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). The data collection for which approval is sought will allow DVBD to use survey results to inform implementation of future TBD prevention interventions.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-11646
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-11645
Type: Notice
Date: 2019-06-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-11630
Type: Notice
Date: 2019-06-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability
Document Number: 2019-11603
Type: Notice
Date: 2019-06-04
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 draft guidance for industry entitled ``Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' The draft guidance, when finalized, will provide recommendations on the factors that covered farms should consider if they are selecting an alternate curriculum training to meet the requirements of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (Produce Safety Rule) and for educators when developing or evaluating alternate curricula.
Solicitation for Written Comments on an Updated Health Literacy Definition for Healthy People 2030
Document Number: 2019-11571
Type: Notice
Date: 2019-06-04
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) provides notice of a request for comments about the proposed update to the definition of health literacy. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for Healthy People 2030 used the following working definition: ``Health literacy occurs when a society provides accurate health information and services that people can easily find, understand, and use to inform their decisions and actions.''
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-11548
Type: Notice
Date: 2019-06-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-11535
Type: Notice
Date: 2019-06-04
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; Sanitary Transportation of Human and Animal Food
Document Number: 2019-11532
Type: Notice
Date: 2019-06-04
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; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-11526
Type: Notice
Date: 2019-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
Document Number: 2019-11522
Type: Notice
Date: 2019-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (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 issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that MAYZENT (siponimod) approved March 26, 2019, meets the redemption criteria.
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products
Document Number: 2019-11519
Type: Notice
Date: 2019-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the approval of five abbreviated new drug applications (ANDAs) for products containing pemoline. The holders of the applications requested withdrawal of the applications and have waived their opportunity for a hearing.