Results 1 - 50 of 26,414
Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2018-13047
Type: Notice
Date: 2018-06-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio phone lines (100 audio lines available and 100 web conference lines available).
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry; Availability
Document Number: 2018-12976
Type: Notice
Date: 2018-06-18
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this draft guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB). There is an unmet medical need for EB patients due to the paucity of effective treatment options.
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-12975
Type: Notice
Date: 2018-06-18
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 ``S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance consists of questions and answers that were developed to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was published in 2010 (ICH S9 (2010)), as well as to continue progress in the 3Rs of Reduction, Refinement, and Replacement in the use of animals.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-12972
Type: Notice
Date: 2018-06-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-12971
Type: Notice
Date: 2018-06-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Technical Specifications for Electronic Submissions; Establishment of a Public Docket
Document Number: 2018-12969
Type: Notice
Date: 2018-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's publication of technical specifications, which explain, clarify, and define the specific use of data standards in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This docket is intended for general comments related to technical specifications that are not specific to documents or issues that are the subject of other dockets, or for comments specific to electronic submission guidances.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
Document Number: 2018-12968
Type: Notice
Date: 2018-06-18
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 formal meetings between FDA and biosimilar biological product sponsors or applicants.
Foods Produced Using Animal Cell Culture Technology; Public Meeting; Request for Comments
Document Number: 2018-12939
Type: Notice
Date: 2018-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Foods Produced Using Animal Cell Culture Technology.'' FDA is holding the public meeting to provide the public with an opportunity to provide comments related to the production of foods using animal cell culture technology.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-12921
Type: Notice
Date: 2018-06-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12920
Type: Notice
Date: 2018-06-18
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Award a Single-Source Supplement
Document Number: 2018-12978
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2018-12897
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability
Document Number: 2018-12894
Type: Notice
Date: 2018-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for the supply-chain program under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''
The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability
Document Number: 2018-12867
Type: Rule
Date: 2018-06-15
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 Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of ``dietary fiber'' through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of ``dietary fiber,'' and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-12865
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-12864
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
Document Number: 2018-12843
Type: Rule
Date: 2018-06-15
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 Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.''
Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program
Document Number: 2018-12840
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12839
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection
Document Number: 2018-12838
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2018-12837
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12836
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 22, 2018
Document Number: 2018-12831
Type: Notice
Date: 2018-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
Document Number: 2018-12829
Type: Rule
Date: 2018-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Councils on Developmental Disabilities-Annual Program Performance Report (PPR) (OMB Control Number-0985-0033)
Document Number: 2018-12826
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the State Councils on Developmental DisabilitiesAnnual Program Performance Report (PPR) [Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)].
Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-12825
Type: Notice
Date: 2018-06-15
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 ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.
Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-12824
Type: Notice
Date: 2018-06-15
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 ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings Labeling Considerations.'' This draft guidance addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. The purpose of this draft guidance is to provide recommendations for information to be included in device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for class III and class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in clinical settings. This draft guidance is not final nor is it in effect at this time.
Final National Occupational Research Agenda for Agriculture, Forestry, and Fishing
Document Number: 2018-12821
Type: Notice
Date: 2018-06-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System
Document Number: 2018-12794
Type: Rule
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Zika Virus Pilot Project, OMB No. 0906-xxxx-NEW
Document Number: 2018-12782
Type: Notice
Date: 2018-06-14
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-12767
Type: Notice
Date: 2018-06-14
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 ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on March 14th, 2018 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two Abbreviated New Drug Applications
Document Number: 2018-12762
Type: Notice
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from Ferring Pharmaceuticals, Inc. (Ferring). Ferring notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability
Document Number: 2018-12761
Type: Notice
Date: 2018-06-14
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 guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research (CDER) at FDA for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.
Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
Document Number: 2018-12760
Type: Rule
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12735
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-12730
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Meeting
Document Number: 2018-12729
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-12728
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12727
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Prepare an Environmental Impact Statement, Public Scoping Meeting, and Request for Comments; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia
Document Number: 2018-12660
Type: Notice
Date: 2018-06-14
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 (HHS), in cooperation with the General Services Administration (GSA), announces its intent to prepare an Environmental Impact Statement (EIS) to analyze and assess the environmental impacts of the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement of the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The current acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off of U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia. This notice is pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). CDC, in cooperation with GSA, also intends to initiate consultation, as required by Section 106 of the National Historic Preservation Act (NHPA), to evaluate the potential effects, if any, of the Proposed Action on historic properties. Following the scoping meeting, a Draft EIS will be prepared and circulated for public comment. CDC is the lead federal agency for this Proposed Action.
Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin
Document Number: 2018-12726
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that are used to detect the presence of BoNT and measure potency of BoNT preparations.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-12675
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-12674
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health: Notice of Meeting
Document Number: 2018-12673
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12671
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2018-12662
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http:/ /www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.
Charter Renewal of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2018-12661
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) has been renewed.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-12637
Type: Notice
Date: 2018-06-13
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 the National Notifiable Diseases Surveillance System (NNDSS). The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under standard surveillance.
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
Document Number: 2018-12636
Type: Notice
Date: 2018-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance (Guidance 1) is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.
Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability
Document Number: 2018-12635
Type: Notice
Date: 2018-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Limited Population Pathway for Antibacterial and Antifungal Drugs.'' This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).