Department of Health and Human Services March 2019 – Federal Register Recent Federal Regulation Documents
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Announcement of the Approval of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (Formerly Known as the American Osteopathic Association/Healthcare Facilities Accreditation Program) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the approval of the application of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the AAHHS/HFAP meets or exceeds the applicable CLIA requirements. We are announcing the approval and granting the AAHHS/HFAP deeming authority for a period of 4 years.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (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 SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a priority review voucher.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The April 29, 2019 meeting of the Advisory Council will focus on person-centered planning for older adults including information about implementation of care plans for people living with cognitive symptoms. There will also be discussion about the use of antipsychotic medication for people with dementia and other conditions living in community settings.
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer (HBOC), or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.
Solicitation of Nominations for Appointment to the Mine Safety and Health Research Advisory Committee (MSHRAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the MSHRAC, NIOSH. The MSHRAC consists of 13 experts in fields associated with mining safety and health. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of mining safety and health, such as mining engineering, industrial hygiene, occupational safety and health engineering, chemistry, safety and health education, ergonomics, epidemiology, statistics, and psychology. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of MSHRAC's objectives.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available, (120). The public is also welcome to listen to the meeting via teleconference at 888-455- 9748, passcode: 4373458; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 2, 2019. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties must be processed in accordance with established federal policies and procedures and may register at https://www.cdc.gov/hicpac/.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; limited only by available seating. The meeting room accommodates approximately 78 people. Requests to make oral presentations should be submitted in writing to Gwen Mustaf, 301- 458-4500, glm4@cdc.gov, or Sayeedha Uddin, isx9@cdc.gov. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by April 24, 2019.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100); the toll-free dial-in number is 1-877-951-7311, with a passcode of 2286986.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
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.
Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Review and Update of Device Establishment Inspection Processes and Standards.'' FDA is issuing this draft guidance document to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for-cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This draft guidance describes how FDA will implement uniform inspection processes and standards. The draft guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. This draft guidance is not final nor is it in effect at this time.
Proposed Collection; 60-Day Comment Request; National Cancer Institute (NCI) Generic Clearance for Application Information From Fellows, Interns, and Trainees
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee (Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 28, 2020.
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.
Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.'' This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.
Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' This draft revised guidance document, when finalized, will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation.
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.
National Firefighter Registry; Request for Information
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information regarding the development and maintenance of a voluntary registry of U.S. firefighters. The purpose of the Registry will be to collect health and occupational information for the purpose of determining cancer incidence. CDC is seeking input on approaches to maximizing firefighter participation in the Registry and coordination of data collection.
United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Amsterdam, Netherlands, scheduled for June 2 through 6, 2019. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Amsterdam.
Uralkali PSJ; Filing of Food Additive Petition
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by Uralkali PSJ, proposing that the food additive regulations be amended to provide for the safe use of yellow prussiate of soda as an anticaking agent for potassium chloride in animal food.
Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds.'' This document states the intent of FDA to exercise enforcement discretion regarding the requirements of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' regulation (Produce Safety Regulation) as they apply to entities growing, harvesting, packing, and holding hops, wine grapes, pulse crops, and almonds.
Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration
The Reagan-Udall Foundation (the Foundation) for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Administration Amendments Act of 2007, is announcing its annual public meeting. The Foundation will discuss its activities and how they support FDA.
Mammography Quality Standards Act
The Food and Drug Administration (FDA or Agency) is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are proposing updates to modernize the regulations by incorporating current science and mammography best practices. These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.
Cancellation of Meeting: The Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP), scheduled to occur March 27 and 28, 2019, at 6700B Rockledge Drive, Suite 1102, Bethesda MD 20892, has been cancelled. The Federal Register Notice announcing this meeting appeared March 11, 2019. The next meeting is scheduled for July 30 and 31, 2019.
National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking Proceedings
In accordance with the Public Health Service Act, notice is hereby given concerning the reasons for not conducting rulemaking proceedings to add autism, asthma, and tics as injuries associated with vaccines to the Vaccine Injury Table (Table). Also, this document provides reasons for not conducting rulemaking proceedings to add Pediatric Infection-Triggered, Autoimmune Neuropsychiatric Disorder (PITAND) and/or Pediatric Autoimmune Neuropsychiatric Syndrome (PANS); Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) as injuries associated with pertussis, pneumococcal conjugate and Haemophilus influenza type b vaccines; and Experimental Autoimmune Encephalomyelitis/Acute Demyelinating Encephalomyelitis as injuries associated with pertussis vaccines to the Table.
Announcement of the Renewal of the Charter for the Advisory Panel on Outreach and Education (APOE) and the April 10, 2019 Meeting of APOE
This notice announces the renewal of the Charter and the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace\SM\, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry.'' The guidance document provides the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER's managed review process. CBER recognizes the value of standards and encourages the use of appropriate standards in the development and control of CBER-regulated medical products. Sponsors' use of standards can facilitate product development and provide a more efficient evaluation of regulatory submissions. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2017.
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