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

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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Document Number: 2018-19909
Type: Notice
Date: 2018-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry
Document Number: 2018-19907
Type: Notice
Date: 2018-09-13
Agency: Department of Agriculture, Food Safety and Inspection Service, Food and Drug Administration, Department of Health and Human Services
The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are hosting a joint public meeting to discuss the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry tissue. FSIS and FDA officials will make presentations on their roles and responsibilities relative to the production and labeling of safe and wholesome food and their respective regulatory frameworks, including their inspection systems, as a basis for discussing what oversight framework might be most appropriate for cell cultured food products derived from livestock and poultry. Representatives of industry, interested individuals, and other stakeholders are invited to participate in the meeting.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Document Number: 2018-19906
Type: Notice
Date: 2018-09-13
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 Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906-New
Document Number: 2018-19903
Type: Notice
Date: 2018-09-13
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-19902
Type: Notice
Date: 2018-09-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19901
Type: Notice
Date: 2018-09-13
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 Hospital Care Survey, an electronic data collection that describes hospital care utilization in the U.S.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program
Document Number: 2018-19898
Type: Notice
Date: 2018-09-13
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 associated with the Food Contact Substance Notification Program.
Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format
Document Number: 2018-19865
Type: Proposed Rule
Date: 2018-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, this action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Public Information
Document Number: 2018-19864
Type: Proposed Rule
Date: 2018-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is proposing to amend its public information regulations. The proposed rule will revise the current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the proposed rule will update the current regulations to reflect changes to the organization, to make the FOIA process easier for the public to navigate, and to make provisions clearer.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Document Number: 2018-19855
Type: Rule
Date: 2018-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.
Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Document Number: 2018-19845
Type: Proposed Rule
Date: 2018-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to repeal a regulation that requires an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation would mean that over- the-counter (OTC) drug products that are generally recognized as safe and effective, that are not misbranded, and that comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is proposing to take this action because the irradiation regulation is out of date and unnecessary. The technology of controlled nuclear radiation for sterilization of drugs is now well understood, and our regulations require that OTC drugs be manufactured in compliance with current good manufacturing practices (CGMPs). Appropriate and effective sterilization of drugs, including by irradiation, is adequately addressed by the CGMP requirements. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments
Document Number: 2018-19816
Type: Notice
Date: 2018-09-12
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 ``Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.'' This public workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients' immunologic risk for organ rejection or tolerance. The public workshop will include discussion of the biomarker qualification process and how it could be used to develop biomarkers for use in clinical trials in transplantation, to develop new drugs to address unmet needs, and in clinical practice to guide patient treatment selection. Speakers will be patients who will provide perspective on the challenges of living with a transplant, managing immunosuppression and perspectives on tolerability, adherence, and risk that may inform patient-reported outcome (PRO) and patient-focused drug development.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2018-19811
Type: Notice
Date: 2018-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2018-19799
Type: Notice
Date: 2018-09-12
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19796
Type: Notice
Date: 2018-09-12
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 Meetings
Document Number: 2018-19795
Type: Notice
Date: 2018-09-12
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: 2018-19794
Type: Notice
Date: 2018-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19793
Type: Notice
Date: 2018-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
Document Number: 2018-19743
Type: Notice
Date: 2018-09-12
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 ``Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
Document Number: 2018-19742
Type: Notice
Date: 2018-09-12
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.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-19741
Type: Notice
Date: 2018-09-12
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 Oncologic 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.
Submission for OMB Review; Comment Request
Document Number: 2018-19709
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
Document Number: 2018-19674
Type: Notice
Date: 2018-09-11
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.
Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-19670
Type: Notice
Date: 2018-09-11
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 Gastrointestinal 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.
Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-19669
Type: Notice
Date: 2018-09-11
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 Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-19668
Type: Notice
Date: 2018-09-11
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 Anesthetic and Analgesic Drug Products 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.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-19667
Type: Notice
Date: 2018-09-11
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 Anesthetic and Analgesic Drug Products 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.
Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability
Document Number: 2018-19666
Type: Notice
Date: 2018-09-11
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 ``Postapproval Changes to Drug Substances.'' This draft guidance provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The draft guidance applies to synthetic drug substances and the synthetic steps involved in the preparation of semisynthetic drug substances. The draft guidance covers facility, scale, and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates, and the unfinished and final drug substance; synthetic manufacturing process changes; changes in the source of drug substance; and change to container closure system of the drug substance.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Document Number: 2018-19664
Type: Notice
Date: 2018-09-11
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 the information collection for tobacco product user fees.
Determination That CEFZIL (Cefprozil) Tablets, 250 Milligrams and 500 Milligrams, and for Oral Suspension, 125 Milligrams/5 Milliliters and 250 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-19663
Type: Notice
Date: 2018-09-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CEFZIL (cefprozil) tablets, 250 milligrams (mg) and 500 mg and CEFZIL (cefprozil) for oral suspension, 125 mg/5 milliliters (mL) and 250 mg/5 mL were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) that refer to these drugs as long as they meet relevant legal and regulatory requirements.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-19609
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse Amended; Notice of Meeting
Document Number: 2018-19608
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-19607
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2018-19606
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19605
Type: Notice
Date: 2018-09-11
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Photoactivatable Liposomal Nanoparticle for the Delivery of an Immunotherapeutic or Immunotherapeutic-Enabling Agent
Document Number: 2018-19604
Type: Notice
Date: 2018-09-11
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 Nano Red LLC (``Nano Red'') located in Milwaukee, Wisconsin.
Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions; Public Meeting; Request for Comments
Document Number: 2018-19612
Type: Notice
Date: 2018-09-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.'' The purpose of the meeting is to give stakeholders, including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages, and make recommendations for actions to prevent or mitigate drug shortages. Members of Congress have asked the Agency to examine the root causes and drivers of these shortages, and to recommend measures that will provide more enduring solutions. To this end, the Commissioner has convened an inter-Agency task force of senior Federal officials of FDA, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and the Department of Defense. After receiving input from stakeholders, the task force intends to provide a report to Congress regarding the root causes of drug shortages. The report will also include recommendations regarding new authorities FDA or other Federal agencies could use to help provide enduring solutions to shortages.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-19561
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, Administration for Children and Families
Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children
Document Number: 2018-19536
Type: Notice
Date: 2018-09-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19485
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19484
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19483
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-19482
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-19481
Type: Notice
Date: 2018-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the Food and Drug Administration; Revised Draft; Availability
Document Number: 2018-19461
Type: Notice
Date: 2018-09-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability for public comment of a revised draft standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration'' (revised draft standard MOU). The revised draft standard MOU describes the responsibilities of a State that chooses to sign the MOU in investigating and responding to complaints related to compounded drug products compounded in the State and distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded drug products. FDA is also announcing the withdrawal of an earlier draft standard MOU entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration,'' which was issued in February 2015 (2015 draft standard MOU). The 2015 draft standard MOU is superseded by the revised draft standard MOU.
Charter Renewal for the Advisory Committee on Organ Transplantation
Document Number: 2018-19454
Type: Notice
Date: 2018-09-07
Agency: Department of Health and Human Services
HHS is hereby giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been rechartered. The effective date of the renewed charter is August 31, 2018.
Meeting of the Community Preventive Services Task Force (CPSTF)
Document Number: 2018-19442
Type: Notice
Date: 2018-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on October 17- 18, 2018, in Atlanta, Georgia.
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)
Document Number: 2018-19418
Type: Notice
Date: 2018-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, 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 and provides consultation on research regarding certain health conditions related to the September 11, 2001 terrorist attacks.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-19383
Type: Notice
Date: 2018-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 22, 2018 for public comment.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19382
Type: Notice
Date: 2018-09-07
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.