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

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Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-01463
Type: Notice
Date: 2020-01-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request; Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
Document Number: 2020-01408
Type: Notice
Date: 2020-01-28
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-01387
Type: Notice
Date: 2020-01-28
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 Capacity Building Assistance Program: Data Management, Monitoring, and Evaluation. The purpose of this data collection is to evaluate the CDC cooperative agreement program entitled CDC-RFA-PS19-1904: Capacity Building Assistance (CBA) for High Impact HIV Prevention Program Integration.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-01385
Type: Notice
Date: 2020-01-28
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: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Database.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2020-01384
Type: Notice
Date: 2020-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-01383
Type: Notice
Date: 2020-01-28
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 Hospital Ambulatory Medical Care Survey (NHAMCS). NHAMCS collects facility and visit information on ambulatory care services utilization in non-Federal, short stay hospitals in the United States.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-01382
Type: Notice
Date: 2020-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-01380
Type: Notice
Date: 2020-01-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-01379
Type: Notice
Date: 2020-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-01378
Type: Notice
Date: 2020-01-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2020-01377
Type: Notice
Date: 2020-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-01348
Type: Notice
Date: 2020-01-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-01342
Type: Notice
Date: 2020-01-28
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 ``Arthroscopy Pump Tubing Sets Intended for Multiple Patient UsePremarket Notification (510(k)) Submissions.'' FDA has developed this draft guidance document to assist in the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use. This draft guidance is not final nor is it in effect at this time.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2020-01336
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 66th full Council meeting in Washington, DC. Agenda items will include: Discussion of Ending the HIV Epidemic: A Plan for America (EHE) Jurisdictional Plans, Focusing on the Four Pilot Sites: DeKalb County, Georgia; Baltimore, Maryland; East Baton Rouge, Louisiana; and the Cherokee Nation of Oklahoma; the Ready, Set, PrEP National Program; Stigma as a BarrierShared Experiences and Challenges from International and Domestic Perspectives; and Women and HIV. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to PACHA@hhs.gov. Pre-Registration must be complete by Monday, February 3, 2020.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2020-01322
Type: Notice
Date: 2020-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled ``Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 20, 2019. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
Document Number: 2020-01319
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Guidance for Industry; Availability
Document Number: 2020-01312
Type: Notice
Date: 2020-01-27
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 ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies. An analysis of marketing applications showed inconsistent quality of MRD data. Based on this analysis and discussion at various public workshops on MRD, FDA identified a need to provide guidance on the use of MRD as a biomarker in regulatory submissions. This guidance finalizes the draft guidance of the same title issued on October 16, 2018.
Submission for OMB Review; Domestic Victims of Human Trafficking Program Data (New Collection)
Document Number: 2020-01265
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing to collect data for the Domestic Victims of Human Trafficking Program (DVHT). The DVHT Program is inclusive of three distinct programs: The Domestic Victims of Human Trafficking and Services Outreach Program, Demonstration Grants to Strengthen the Response to Victims of Human Trafficking in Native Communities Program, and the Strengthen the Health Care Response for Victims of Human Trafficking Program grants. The data collection instruments are intended to collect information for all three DVHT programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-01261
Type: Notice
Date: 2020-01-27
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 ``Evaluation of Patient-Centered Outcomes Research Trust Fund Training Program.'' This proposed information collection was previously published in the Federal Register on December 13th, 2019 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2020-01259
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-01258
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-01257
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-01256
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-01255
Type: Notice
Date: 2020-01-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-01210
Type: Notice
Date: 2020-01-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Closed Meeting
Document Number: 2020-01208
Type: Notice
Date: 2020-01-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2020-01207
Type: Notice
Date: 2020-01-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
Document Number: 2020-01157
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
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 Exclusive Patent License: Antibody-Based Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2
Document Number: 2020-01154
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Stanford University, (``Stanford''), a non-profit university located in California, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2020-01152
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-01151
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-01150
Type: Notice
Date: 2020-01-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the 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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-01138
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-01137
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-01134
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-01133
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Amended Notice of Meeting
Document Number: 2020-01132
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Infant Mortality
Document Number: 2020-01129
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant Mortality (ACIM). The ACIM provides advice to the Secretary of HHS on Department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants. With a focus on life course, ACIM addresses disparities in maternal health to improve maternal health outcomes, including preventing and reducing maternal mortality and severe maternal morbidity. HRSA is seeking nominations of qualified candidates to fill positions on the ACIM.
Submission for OMB Review; Form ACF-196, TANF Quarterly Financial Report (OMB #0970-0247)
Document Number: 2020-01124
Type: Notice
Date: 2020-01-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to revise expenditure data for fiscal years (FYs) prior to FY 2015. ACF will use the financial data provided by states to assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce (BHW) Substance Use Disorder (SUD) Evaluation, OMB No. 0906-xxxx-New
Document Number: 2020-01119
Type: Notice
Date: 2020-01-24
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.
Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard
Document Number: 2020-00551
Type: Rule
Date: 2020-01-24
Agency: Department of Health and Human Services, Office of the Secretary
This final rule adopts a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs, by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification enables covered entities to distinguish whether a prescription is a ``partial fill,'' where less than the full amount prescribed is dispensed, or a refill, where the full amount prescribed is dispensed, in the HIPAA retail pharmacy transactions. This modification is important to ensure the availability of a greater quantum of data that may help prevent impermissible refills of Schedule II drugs, which will help to address the public health concerns associated with prescription drug abuse in the United States.
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
Document Number: 2020-00422
Type: Rule
Date: 2020-01-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
Document Number: 2020-00421
Type: Rule
Date: 2020-01-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
Document Number: 2020-01084
Type: Notice
Date: 2020-01-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Document Number: 2020-01082
Type: Notice
Date: 2020-01-23
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 provisions of FDA's animal drug and animal generic drug user fee programs.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906-xxxx-New
Document Number: 2020-01075
Type: Notice
Date: 2020-01-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
Document Number: 2020-01073
Type: Notice
Date: 2020-01-23
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 requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.
Product-Specific Guidance for Levonorgestrel; Intrauterine Device; Revised Draft Guidance for Industry; Availability
Document Number: 2020-01072
Type: Notice
Date: 2020-01-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled ``Draft Guidance for Levonorgestrel.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device.
Clinical Drug Interaction Studies-Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and In Vitro Drug Interaction Studies-Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions; Guidance for Industry; Availability
Document Number: 2020-01064
Type: Notice
Date: 2020-01-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances for industry entitled ``Clinical Drug Interaction StudiesCytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions'' and ``In Vitro Drug Interaction StudiesCytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.'' These guidances finalize the draft guidances entitled ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' and ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' published in October 2017. The final guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs.