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: 2018-15751
Type: Notice
Date: 2018-07-24
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 ``Medical Office Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on May 10th, 2018 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-15749
Type: Notice
Date: 2018-07-24
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: 2018-15747
Type: Notice
Date: 2018-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Final National Occupational Research Agenda for Construction
Document Number: 2018-15741
Type: Notice
Date: 2018-07-24
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 Construction.
Draft Indian Health Service Strategic Plan Fiscal Year 2018-2022
Document Number: 2018-15740
Type: Notice
Date: 2018-07-24
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service (IHS) is developing an Agency-wide Strategic Plan to guide the work and strengthen partnerships with Tribes and Urban Indian Organizations. The IHS is seeking public comment on its Draft IHS Strategic Plan fiscal year (FY) 2018-2022 (Draft IHS Strategic Plan FY 2018-2022). Additionally, notice is given that the IHS will conduct a Tribal Consultation and Urban Indian Confer regarding the Draft IHS Strategic Plan FY 2018-2022. In addition to the virtual town hall sessions, the IHS will seek other opportunities to solicit input from Tribal and Urban Indian programs on the Draft IHS Strategic Plan FY 2018-2022 during the comment period. For IHS Strategic Plan events during the comment period, please check the IHS Event Calendar at: https://www.ihs.gov/ihscalendar/.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-15739
Type: Notice
Date: 2018-07-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-15607
Type: Notice
Date: 2018-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2018-15735
Type: Notice
Date: 2018-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Notice of Hearing: Reconsideration of Disapproval Minnesota Medicaid State Plan Amendment (SPA) 12-0014-B
Document Number: 2018-15681
Type: Notice
Date: 2018-07-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on August 21, 2018, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health Insurance Program Services, Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, Illinois 60601-5519, to reconsider CMS's decision to disapprove Minnesota's Medicaid SPA 12- 0014-B.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-15677
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-15620
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-15619
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2018-15610
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-15606
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-15605
Type: Notice
Date: 2018-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2018-15568
Type: Notice
Date: 2018-07-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Submission for OMB Review; Comment Request
Document Number: 2018-15537
Type: Notice
Date: 2018-07-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-15530
Type: Notice
Date: 2018-07-20
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 ``Surveillance of Nonfatal Injuries Among On-Duty Law Enforcement Officers.'' The purpose of this project is to collect follow-back telephone interview data from injured and exposed law enforcement officers treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-15529
Type: Notice
Date: 2018-07-20
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 Communities Organized to Prevent Arboviruses: Assessment of Knowledge, Attitudes, and Vector Control Practices and Sero-Prevalence and Incidence of Arboviral Infection in Ponce, Puerto Rico (COPA Study). The purpose of this study is to establish longitudinal follow-up of a community cohort and evaluate the impact of vector control interventions in 14 communities in southern Puerto Rico.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-15528
Type: Notice
Date: 2018-07-20
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 Knowledge, Attitudes, and Practices of US Large Animal Veterinarians Concerning Common Veterinary Infection Control Measures When Working with Animal Obstetric Cases. The goals of this survey are to better describe veterinarians' current knowledge of zoonotic infectious diseases that cause abortion in large animals, determine common veterinary infection control practices when working up obstetric cases, and identify common barriers to personal protective equipment use.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-15527
Type: Notice
Date: 2018-07-20
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 Assessing impact of the NIOSH research. The goal of the generic information collection request is to improve the ability of NIOSH to assess and demonstrate the extent to which its various research efforts are likely to or have led to improvements in workplace safety and health.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-15526
Type: Notice
Date: 2018-07-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-15525
Type: Notice
Date: 2018-07-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-15524
Type: Notice
Date: 2018-07-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Document Number: 2018-15512
Type: Notice
Date: 2018-07-20
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 requirements on content and format of labeling for human prescription drug and biological products.
Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2018-15508
Type: Notice
Date: 2018-07-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the ``Metered Dose Inhaler and Dry Powder Inhaler Drug ProductsQuality Considerations; Draft Guidance for Industry,'' published in the Federal Register of April 19, 2018. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Proposed Collection; 60-Day Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys (NLM)
Document Number: 2018-15490
Type: Notice
Date: 2018-07-20
Agency: Department of Health and Human Services, National Institutes of Health
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 Library of Medicine (NLM) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-15489
Type: Notice
Date: 2018-07-20
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2018-15488
Type: Notice
Date: 2018-07-20
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-15466
Type: Notice
Date: 2018-07-20
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.
Notice of Availability of Final Environmental Impact Statement; Site Acquisition and Campus Consolidation for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH), Cincinnati, Ohio
Document Number: 2018-15410
Type: Notice
Date: 2018-07-20
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 U.S. General Services Administration (GSA), announces the availability of the Final Environmental Impact Statement (EIS) for the proposed acquisition of a site in Cincinnati, Ohio, and the development of this site into a new, consolidated CDC/National Institute for Occupational Safety and Health (NIOSH) campus (Proposed Action). The site being considered for acquisition and development is bounded by Martin Luther King Drive East to the south, Harvey Avenue to the west, Ridgeway Avenue to the north, and Reading Road to the east. The Final EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations.
Meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC)
Document Number: 2018-15246
Type: Notice
Date: 2018-07-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on August 2, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC).
Substance Abuse and Mental Health Services Administration
Document Number: 2018-15450
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-15437
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Per- or Polyfluoroalkyl Substances (PFAS) Exposure Assessments.'' ATSDR and the CDC National Center for Environmental Health (NCEH) will conduct a minimum of eight exposure assessments (EAs) at current or former military installations with known PFAS contamination in drinking water, groundwater, or another water source.
E17 General Principles for Planning and Design of Multiregional Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-15395
Type: Notice
Date: 2018-07-19
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 entitled ``E17 General Principles for Planning and Design of Multiregional Clinical Trials.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance describes general principles for planning and designing multiregional clinical trials (MRCTs). The guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and thereby facilitate more efficient drug development and earlier access to medicines.
Humic Product Trade Association; Withdrawal of Food Additive Petition (Animal Use)
Document Number: 2018-15394
Type: Proposed Rule
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2290) proposing that the food additive regulations be amended to provide for the safe use of humate, fluvic acid, and humic substances as a source of iron in animal feed.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-15393
Type: Notice
Date: 2018-07-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the 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 EPIDIOLEX (cannabidiol oral solution) manufactured by GW Research Ltd., meets the criteria for a priority review voucher.
Labeling for Biosimilar Products; Guidance for Industry; Availability
Document Number: 2018-15391
Type: Notice
Date: 2018-07-19
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 ``Labeling for Biosimilar Products.'' This guidance is intended to help applicants develop draft labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). This guidance provides an overview of FDA's recommendations for labeling for biosimilar products. This guidance finalizes the draft guidance issued on April 4, 2016.
Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry; Availability
Document Number: 2018-15390
Type: Notice
Date: 2018-07-19
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 ``Use of Electronic Health Record Data in Clinical Investigations.'' The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.
Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2018-15389
Type: Notice
Date: 2018-07-19
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 ``Field Alert Report Submission: Questions and Answers.'' This draft guidance, when finalized, will provide the Agency's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and will outline FDA's recommendations for FAR submissions to help increase their consistency and relevancy. The draft guidance also addresses certain frequently asked questions about FARs.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-15359
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2018-15358
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-15357
Type: Notice
Date: 2018-07-19
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS
Document Number: 2018-14986
Type: Proposed Rule
Date: 2018-07-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it proposes a rebasing of the ESRD market basket for CY 2019. This proposed rule also proposes to update requirements for the ESRD Quality Incentive Program (QIP), and to make technical amendments to correct existing regulations related to the CBP for certain DMEPOS. Finally, this proposed rule proposes changes to bidding and pricing methodologies under the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program (CBP); adjustments to DMEPOS Fee Schedule amounts using information from competitive bidding for items furnished from January 1, 2019 through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi-function ventilators or ventilators that perform functions of other durable medical equipment (DME); and payment methodology revisions for mail order items furnished in the Northern Mariana Islands. This rule also includes a request for information related to establishing fee schedule amounts for new DMEPOS items and services. It also includes Requests for Information on promoting interoperability and electronic healthcare information exchange, and improving beneficiary access to dialysis facility and DMEPOS charge information.
Submission for OMB Review; Comment Request; Evaluation of the Transitional Living Program (TLP)-Extension
Document Number: 2018-15307
Type: Notice
Date: 2018-07-18
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Document Number: 2018-15298
Type: Notice
Date: 2018-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 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 information collection for drug establishment registration and product listing.
Advisory Committee; Science Board to the Food and Drug Administration; Renewal
Document Number: 2018-15297
Type: Notice
Date: 2018-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the renewal of the Science Board to the Food and Drug Administration (Committee) by the Commissioner of Food and Drugs (Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 26, 2020.
Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability
Document Number: 2018-15296
Type: Notice
Date: 2018-07-18
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 ``Innovative Approaches for Nonprescription Drug Products.'' This draft guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: The development of labeling in addition to the DFL and the implementation of additional conditions so that consumers appropriately self-select and use the product.
Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-15294
Type: Notice
Date: 2018-07-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Metal Expandable Biliary StentsPremarket Notification (510(k)) Submissions.'' This draft guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree. This draft guidance is not final nor is it in effect at this time.