Department of Health and Human Services November 2017 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 263
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24315
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24314
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24313
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Guidance for Industry; Availability
Document Number: 2017-24308
Type: Notice
Date: 2017-11-08
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 guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes labialis (RHL). The guidance also addresses prevention of RHL. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of RHL. This guidance finalizes the draft guidance of the same name issued on July 1, 2016.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24305
Type: Notice
Date: 2017-11-08
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; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
Document Number: 2017-24296
Type: Notice
Date: 2017-11-08
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 revision 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 in the guidance for industry ``Expedited Programs for Serious ConditionsDrugs and Biologics.''
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-24267
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meeting
Document Number: 2017-24266
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-24265
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Amended Notice of Meeting
Document Number: 2017-24264
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24263
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2017-24262
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Intent To Review an Analysis Data Reviewer's Guide; Notice of Availability, Request for Comments
Document Number: 2017-24237
Type: Notice
Date: 2017-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Analysis Data Reviewer's Guide (ADRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE ADRG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE ADRG template for regulatory submissions.
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2017-24195
Type: Notice
Date: 2017-11-07
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 guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance finalizes the draft guidance of the same name issued on May 4, 2016.
Listing of Color Additives Exempt From Certification; Calcium Carbonate
Document Number: 2017-24194
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; Availability
Document Number: 2017-24192
Type: Notice
Date: 2017-11-07
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 guidance for industry entitled ``Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery.'' The guidance is intended to promote the safe use of nonprescription (also referred to as over-the- counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular-related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart.
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Document Number: 2017-24191
Type: Proposed Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2017-24189
Type: Notice
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Document Number: 2017-24163
Type: Notice
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
Document Number: 2017-24162
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
Document Number: 2017-24161
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test 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 total 25-hydroxyvitamin D mass spectrometry test 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.
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System
Document Number: 2017-24159
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment 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 genetic health risk assessment 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.
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)
Document Number: 2017-24155
Type: Notice
Date: 2017-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of World Trade Center (WTC) responders as well as representatives of certified-eligible WTC survivors. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of STAC objectives https://www.cdc.gov/wtc/stac.html.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-24144
Type: Notice
Date: 2017-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24143
Type: Notice
Date: 2017-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24134
Type: Notice
Date: 2017-11-07
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.
Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
Document Number: 2017-23935
Type: Rule
Date: 2017-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.
Notice of Final Issuance Adopting Administration for Native Americans Program Policies and Procedures
Document Number: 2017-24124
Type: Notice
Date: 2017-11-06
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Native Americans (ANA) is issuing final interpretive rules, general statements of policy and rules of agency organization, procedure, or practice relating to the following six proposed FY2018 Funding Opportunity Announcements (FOAs): Environmental Regulatory Enhancement (HHS-2018-ACF-ANA-NR-1344); Native American Language Preservation and MaintenanceEsther Martinez Immersion (HHS- 2018-ACF-ANA-NB-1343); Native American Language Preservation and Maintenance (HHS-2018-ACF-NA-NL-1342); Social and Economic Development Strategies (HHS-2018-ACF-ANA-NA-1339); Social and Economic Development StrategiesAlaska (HHS-2018-ACF-ANA-NK-1340); and Native Youth Initiative for Leadership, Empowerment, and Development (HHS-2018-ACF- ANA-NC-1341).
Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2017-24123
Type: Notice
Date: 2017-11-06
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 the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2017-24121
Type: Notice
Date: 2017-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2017-24106
Type: Notice
Date: 2017-11-06
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.
Abbreviated New Drug Applications: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence); Draft Guidance for Industry; Availability
Document Number: 2017-24099
Type: Notice
Date: 2017-11-06
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 revised draft guidance for industry entitled ``ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).'' FDA is revising the draft guidance because, after issuance of the original draft guidance, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the FDA Reauthorization Act of 2017, which resulted in changes to the pre-submission of facility information. Pre- submitting facility information enables the Agency to determine whether inspection of a facility is necessary and, if so, to begin inspection planning in advance of an abbreviated new drug application (ANDA) receipt.
Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability
Document Number: 2017-24098
Type: Rule
Date: 2017-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.'' The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019.
Formal Dispute Resolution: Sponsor Appeals Above the Division Level; Guidance for Industry and Review Staff; Availability
Document Number: 2017-24096
Type: Notice
Date: 2017-11-06
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 guidance for industry and review staff entitled ``Formal Dispute Resolution: Sponsor Appeals Above the Division Level.'' This guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. This guidance describes the formal dispute resolution procedures for sponsors that wish to appeal a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes. This guidance finalizes the revised draft guidance entitled ``Formal Dispute Resolution: Appeals Above the Division Level'' issued September 9, 2015, and replaces the guidance of the same name issued February 2000.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2017-24034
Type: Notice
Date: 2017-11-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-24033
Type: Notice
Date: 2017-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24032
Type: Notice
Date: 2017-11-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24013
Type: Notice
Date: 2017-11-03
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.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
Document Number: 2017-24008
Type: Notice
Date: 2017-11-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Decision To Lift the Temporary Moratorium on Enrollment of Non-Emergency Ground Ambulance Suppliers in Texas
Document Number: 2017-24007
Type: Notice
Date: 2017-11-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces that on September 1, 2017, the statewide temporary moratorium on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers in Texas was lifted. This announcement also applies to the temporary moratorium on enrollment of non-emergency ground ambulance suppliers in Medicaid and the Children's Health Insurance Program in Texas.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-23970
Type: Notice
Date: 2017-11-03
Agency: Department of Health and Human Services, Administration for Children and Families
Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-23952
Type: Notice
Date: 2017-11-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that REVEX (nalmefene hydrochloride injection), 0.1 milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed
Document Number: 2017-23948
Type: Notice
Date: 2017-11-03
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 existing FDA regulations concerning substances prohibited for use in animal food or feed.
Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability
Document Number: 2017-23947
Type: Notice
Date: 2017-11-03
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 ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA' controlled correspondence response and the Agency's process for responding to those requests. This draft guidance revises the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.
Medicaid Program; Final FY 2015 and Preliminary FY 2017 Disproportionate Share Hospital Allotments, and Final FY 2015 and Preliminary FY 2017 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2017-23933
Type: Notice
Date: 2017-11-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2015 and the preliminary federal share DSH allotments for FY 2017. This notice also announces the final FY 2015 and the preliminary FY 2017 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Request for Nominations on the Pediatric Advisory Committee
Document Number: 2017-23903
Type: Notice
Date: 2017-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Assessment of Food and Drug Administration Hiring and Retention; Public Meeting; Request for Comments
Document Number: 2017-23899
Type: Notice
Date: 2017-11-02
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 meeting entitled ``Assessment of FDA Hiring and Retention''. The purpose of the public meeting is to share high-level findings from a recently completed diagnostic assessment of FDA's hiring process conducted by a qualified, independent contractor with expertise in assessing human resources operations and transformation. The purpose also is to outline a set of near-term actions FDA will or can take to improve the hiring process, provide an update on FDA's progress toward Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) user fee hiring and retention commitments, and solicit input on actions FDA is taking and any further recommendations or priorities FDA should pursue with regard to the hiring process.
Advisory Committee; Patient Engagement Advisory Committee, Renewal
Document Number: 2017-23884
Type: Notice
Date: 2017-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Patient Engagement Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Patient Engagement Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 6, 2019.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2017-23865
Type: Notice
Date: 2017-11-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2017-23864
Type: Notice
Date: 2017-11-02
Agency: Department of Health and Human Services, National Institutes of Health