Department of Health and Human Services May 2019 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 312
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Section 503A Bulks List Final Rule Questions and AnswersSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Immediate Office of the Secretary; ReImagine HHS Accelerate Clinical Innovation Initiative; Public Hearing, June 20-21, 2019
The Department of Health and Human Services (HHS) is announcing a public meeting to seek public input and comment on opportunities to leverage departmental resources, increase collaboration, and to partner with private stakeholders in the service of accelerating the process for clinical innovation in the United States. HHS is specifically interested in how to decrease the overall time for a new medical product (drug, medical device, biologic) to go from discovery to widespread patient access and use while maintaining the critical public health standards of the Department. HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, patients, physicians, researchers, medical product developers, commercial health insurance plan sponsors and carriers, private investors, and the community at large. This meeting and the written comments are intended to assist HHS, in developing programs and procedures for assessing and accelerating the pace of the clinical innovation enterprise throughout the United States. HHS is seeking input on specific questions identified below but is interested in any other pertinent information participants in the public meeting would like to share. This meeting is open to the public.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of April 24, 2019. The amendment is being made to reflect a change in the DATES portion of the document. There are no other changes.
Electronic Nicotine Delivery System Device and E-Liquid Manufacturer Site Tours Program
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Electronic Nicotine Delivery System (ENDS) Device and E- Liquid Manufacturer Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities that develop, manufacture, or test ENDS devices or e-liquids (including pods or cartridges) to gain a better understanding of the processes involved in the development, manufacturing, and testing of ENDS devices and e- liquids. The site tours in this program are not intended as regulatory inspections. The purpose of this document is to invite ENDS device or e-liquid manufacturers that can demonstrate assembly process and present supply chain information, and laboratories that conduct ENDS aerosol and e-liquid testing, that are interested in participating in the ENDS Device and E-Liquid Manufacturer Site Tours Program to submit requests to CTP.
Announcement of an Unsolicited Single-Source Grant Award to the Woodson Center in Washington, DC
The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation announces the award of a grant in the amount of $150,000 to the Woodson Center of Washington, DC, to support an environmental scan of models of service for privately managed foster care.
Determination of Regulatory Review Period for Purposes of Patent Extension; EDWARDS INTUITY ELITE AORTIC VALVE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS INTUITY ELITE AORTIC VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Findings of Research Misconduct
Findings of research misconduct have been made against William W. Cruikshank, Ph.D. (Respondent), former Professor of Medicine, Pulmonary Center, Boston University (BU) School of Medicine. Dr. Cruikshank engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA122737-01A2. The administrative actions, including debarment for a period of five (5) years, were implemented beginning on May 13, 2019, and are detailed below.
World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP, STAC); Notice of Charter Renewal
This gives notice that under Public Law 111-347 (the James Zadroga 9/11 Health and Compensation Act of 2010), as amended by Public Law 114-113, and the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, the World Trade Center Health Program Scientific/ Technical Advisory Committee, the Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 12, 2021.
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the WTCHP STAC. The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, (42 U.S.C. 300mm-1(a)(2)), is seeking nominations for membership on the World Trade Center (WTC) Health Program STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine or environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of WTC responders, as well as representatives of certified-eligible WTC survivors. The STAC reviews scientific and medical evidence and makes recommendations to the Administrator of the WTC Health Program on additional Program eligibility criteria and additional WTC-related health conditions, reviews and evaluates policies and procedures used to determine whether sufficient evidence exists to support adding a health condition to the list of WTC-Related Health Conditions, makes recommendations regarding individuals to conduct independent peer reviews of the scientific and technical evidence underlying a final rule adding a condition to the List of WTC- Related Health Conditions, and provides consultation on research regarding certain health conditions related to the September 11, 2001 terrorist attacks. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to accomplishing the committee's objectives. The Administrator of the WTC Health Program is seeking nominations for members fulfilling the following categories: Occupational physician who has experience treating WTC rescue and recovery workers; Mental health professional; Industrial hygienist; Representative of WTC responders; and Representative of certified-eligible WTC survivors; Physician with expertise in pulmonary medicine. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of STAC objectives. More information on the committee is available at https://www.cdc.gov/wtc/stac.html.
Proposed Information Collection Activity; Extension of Assets for Independence (AFI) Performance Progress Report (PPR) (OMB #0970-0483)
The Office of Community Services (OCS), Administration for Children and Families (ACF) is requesting approval of a three-year extension of the Assets for Independence (AFI) Performance Progress Report (PPR) Long Form and AFI PPR Short Form (OMB #0970-0483, expiration 8/31/2019). There are no changes requested to the forms.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Study to Explore Early Development (SEED) Phase 3. This study evaluates potential risk factors for Autism Spectrum Disorders (ASD) and the behavioral and health characteristics of children with autism by conducting a case control study to compare them with children who have other developmental disabilities and children from the general population.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``An Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting.'' This new data collection effort is an essential component to determine the impact of CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative on falls, emergency department visits, and hospitalizations due to falls.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 ``Enhanced Surveillance for Cases Linked to a Multistate Outbreak of Multidrug-resistant Campylobacter Infections Linked to Contact with Pet Store Puppies.'' This investigation will determine the scope of multidrug-resistant infections caused by contact with pet store dogs during a 2016-2018 outbreak to inform infection prevention recommendations and interventions.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 Amyotrophic Lateral Sclerosis (ALS) Registry.'' The National ALS Registry collects information from persons with ALS to better describe the prevalence and potential risk factors for ALS.
National Vaccine Injury Compensation Program: List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 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: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System (DGIS), OMB No. 0915-0298-Revision
In compliance with of 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Submission for OMB Review; 30-Day Comment Request: Hazardous Waste Worker Training Grantee Data Collection-42 CFR Part 65 (National Institute of Environmental Health Sciences)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Prospective Grant of an Exclusive Patent License: The Development and Use of a Therapeutic STAT3 Inhibitor, GLG-302, in All Proliferative Diseases, Where STAT3 Is Present
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 (U.S.) Patents and Patent Applications listed in the Supplementary Information section of this notice to GLG Pharma LLC located in Jupiter, Florida, USA.
Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services
The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for five (5) new non-Federal members of the Advisory Council to replace the five members whose terms will end September 30, 2019. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Submission for OMB Review; Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS)
The Office of Planning, Research, and Evaluation and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families propose data collection activities as part of the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS). The goal of the study is to collect, analyze, and report on performance measures data for SRAE programs.
Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses
This final rule amends the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans' negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees. These amendments will improve the regulatory framework to facilitate development of Part C and Part D products that better meet the individual beneficiary's healthcare needs and reduce out-of-pocket spending for enrollees at the pharmacy and other sites of care.
Proposed Changes to the Scholarships to Disadvantaged Students Program
The Scholarships for Disadvantaged Students (SDS) program is authorized by the Public Health Service Act (PHS Act) and administered by HRSA. The program promotes diversity among the health professions and nursing workforce by providing awards to eligible health professions and nursing schools for use in awarding scholarships to students from disadvantaged backgrounds. This notice seeks public comment to inform and guide policy and planning associated with the SDS program.
Submission for OMB Review; National Directory of New Hires
The Office of Child Support Enforcement; Administration for Children and Families (ACF) is requesting a three-year extension of the National Directory of New Hires (OMB #0970-0166, expiration 7/31/2019). The NDNH Guide for Data Submission/Record Specifications and the Multistate Employer Registration form underwent minor revisions.
Establishment of the Interdepartmental Substance Use Disorders Coordinating Committee and Solicitation of Nominations for Committee Members; Correction
The U.S. Department of Health and Human Services (HHS) published a document in the Federal Register of May 15, 2019, concerning the establishment of the Interdepartmental Substance Use Disorders Coordinating Committee and Solicitation of Nominations for Committee Members. The document contained an inadvertent omission of the following membership category from the list of non-federal members that the Secretary of HHS will appoint to the committee: Public safety officer with extensive experience in interacting with adults with a substance use disorder.
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.'' This draft guidance describes the Agency's recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, this draft guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under the PHS Act. This draft guidance revises the guidance entitled ``Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product'' that was published on April 30, 2015.
Decision To Evaluate a Petition To Designate a Class of Employees From the West Valley Demonstration Project in West Valley, New York, To Be Included in the Special Exposure Cohort
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the West Valley Demonstration Project in West Valley, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Submission for OMB Review; Child Care and Development Fund (CCDF) for States and Territories for FFY 2019-2021 (ACF-118)
The Administration for Children and Families (ACF) is requesting a reinstatment of the form ACF-118: Child Care and Development Fund for States and Territories for FFY 2019-2021 (OMB #0970-0114; expired 11/30/2018). There are no changes to the form requested.
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