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

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Reimbursement Rates for Calendar Year 2017
Document Number: 2017-01075
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, Indian Health Service
Determination That SYMMETREL (Amantadine Hydrochloride), Syrup, 50 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-01064
Type: Notice
Date: 2017-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that SYMMETREL (amantadine hydrochloride), Syrup, 50 milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to SYMMETREL, and it will allow FDA to continue to approve ANDAs that reference SYMMETREL if all other legal and regulatory requirements are met.
Considerations in Demonstrating Interchangeability With a Reference Product; Draft Guidance for Industry; Availability
Document Number: 2017-01042
Type: Notice
Date: 2017-01-18
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations in Demonstrating Interchangeability With a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product (proposed interchangeable product or proposed product) is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Notice of Availability of the Draft Programmatic Environmental Assessment (Draft PEA) for Mosquito Control Activities Funded by HHS/CDC To Combat Zika Virus Transmission in the United States
Document Number: 2017-01027
Type: Notice
Date: 2017-01-18
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), is issuing this notice to request public comment on a draft Programmatic Environmental Assessment (Draft PEA) for mosquito control activities funded by HHS/ CDC to Combat Zika Virus transmission in the United States. HHS/CDC prepared the draft PEA in accordance with the National Environmental Policy Act of 1969 (NEPA) as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR parts 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.
Assessment of Abuse Potential of Drugs; Guidance for Industry; Availability
Document Number: 2017-01024
Type: Notice
Date: 2017-01-18
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 guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, this guidance provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. Drug products with abuse potential generally contain drug substances that are active within the CNS and produce psychoactive effects such as euphoria and hallucinations. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act (CSA). This guidance finalizes the draft guidance of the same name issued on January 27, 2010.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; NURSE Corps Loan Repayment Program
Document Number: 2017-00998
Type: Notice
Date: 2017-01-18
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).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-00982
Type: Notice
Date: 2017-01-18
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-00980
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry; Availability
Document Number: 2017-00969
Type: Notice
Date: 2017-01-18
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 ``The Prohibition of Distributing Free Samples of Tobacco Products; Draft Guidance for Industry.'' The draft guidance, when finalized, would provide information intended to assist manufacturers, distributors, and retailers in complying with the regulations prohibiting the distribution of free samples of tobacco products.
Medicaid Program; The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems
Document Number: 2017-00916
Type: Rule
Date: 2017-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule finalizes changes to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). This final rule prevents increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established, in the final Medicaid managed care regulations effective July 5, 2016.
Office of the Director; Notice of Charter Renewal
Document Number: 2017-00900
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-00899
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2017-00898
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meetings
Document Number: 2017-00897
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meetings
Document Number: 2017-00896
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-00895
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2017-00894
Type: Notice
Date: 2017-01-18
Agency: Department of Health and Human Services, National Institutes of Health
Confidentiality of Substance Use Disorder Patient Records
Document Number: 2017-00742
Type: Proposed Rule
Date: 2017-01-18
Agency: Department of Health and Human Services, Office of the Secretary
On Feb. 9, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a Notice of Proposed Rulemaking (NPRM) that proposed policy changes to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR part 2). SAMHSA explained in the NPRM that these changes were intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. The last substantive update to these regulations was in 1987. SAMHSA is issuing this Supplemental Notice of Proposed Rulemaking (SNPRM) to propose additional clarifications to the part 2 regulations as amended by the concurrently issued final rule. As noted in the final rule, 42 CFR part 2 Confidentiality of Substance Use Disorder Patient Records, questions raised by commenters highlighted varying interpretations of the 1987 rule's restrictions on lawful holders and their contractors and subcontractors' use and disclosure of part 2-covered data for purposes of carrying out payment, health care operations, and other health care related activities. In consideration of this feedback and given the critical role that third-party payers, other lawful holders, and their contractors, subcontractors, and legal representatives play in the provision of health care services, SAMHSA is issuing this SNPRM to seek further comments on our proposals to address and help clarify these matters before establishing any appropriate restrictions on disclosures to contractors, subcontractors and legal representatives.
Confidentiality of Substance Use Disorder Patient Records
Document Number: 2017-00719
Type: Rule
Date: 2017-01-18
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS) is issuing this final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations and facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These modifications also help clarify the regulations and reduce unnecessary burden.
Proposed Information Collection Activity; Submission for OMB Review; Comment Request; Protection and Advocacy Annual Program Performance Report and Statement of Goals and Priorities
Document Number: 2017-00880
Type: Notice
Date: 2017-01-17
Agency: Department of Health and Human Services
The Administration on Disability is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report
Document Number: 2017-00879
Type: Notice
Date: 2017-01-17
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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. This notice collects comments on the information collection requirements relating to an existing collection previously in use without an OMB Control Number: Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-00863
Type: Notice
Date: 2017-01-17
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-00860
Type: Notice
Date: 2017-01-17
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.
Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Draft Guidance for Industry; Availability
Document Number: 2017-00855
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The draft guidance, when finalized, is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages, in complying with the warning statement requirements in FDA's regulations deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The draft guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-00833
Type: Notice
Date: 2017-01-17
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection titled ``Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications.'' From this information collection project, NIOSH seeks to provide insight into what the most important barriers are from the perspective of the organizations that must purchase, use, approve, and manufacture these safety technologies.
Public Hearing: Strategic Partnerships To Enhance the Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition; Request for Comments
Document Number: 2017-00821
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public hearing regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. The hearing will focus on partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk- based decisionmaking; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation's entire food safety system. In addition, we are seeking information from a variety of viewpoints, including from competent authorities in other countries and from private entities, to help inform FDA regarding risk-based decisionmaking, commodity-specific export control programs in other countries, and systems recognition.
Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability
Document Number: 2017-00820
Type: Notice
Date: 2017-01-17
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 ``Referencing Approved Drug Products in ANDA Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA submission.
Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for Industry; Availability
Document Number: 2017-00819
Type: Proposed Rule
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Control of Listeria monocytogenes in Ready-To-Eat Foods.'' The revised draft guidance is intended for any person who is subject to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help such persons comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-00815
Type: Notice
Date: 2017-01-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability
Document Number: 2017-00795
Type: Notice
Date: 2017-01-17
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 ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Hospital Organ Donation Campaign's Activity Scorecard
Document Number: 2017-00792
Type: Notice
Date: 2017-01-17
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 has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability
Document Number: 2017-00773
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
Document Number: 2016-32058
Type: Rule
Date: 2017-01-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
Cardiovascular Devices
Document Number: 2017-00796
Type: Rule
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2017-00766
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) considered a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (http://www.osp.od.nih.gov/sites/default/files/ NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-00735
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is 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 of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2017-00734
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2017-00733
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2017-00732
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00731
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-00730
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request For Scientific Data, Information, and Comments; Reopening of Comment Period
Document Number: 2017-00725
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the document requesting scientific data, information, and comments entitled ``Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates'' that appeared in the Federal Register of November 23, 2016 (81 FR 84595). In the document, we requested scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label. We also announced in the document the availability for comment of a scientific literature review document that we conducted that summarizes clinical studies associated with 26 specific isolated or synthetic non- digestible carbohydrates. We are taking this action in response to requests to allow interested persons additional time to submit comments.
Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2017-00724
Type: Proposed Rule
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition'' that appeared in the Federal Register of November 23, 2016. The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability
Document Number: 2017-00723
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.'' This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products.
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; Availability
Document Number: 2017-00722
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders; Availability
Document Number: 2017-00721
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and other stakeholders entitled ``Emergency Use Authorization of Medical Products and Related Authorities.'' The purpose of this guidance is to explain FDA's current thinking on the authorization of the emergency use of certain medical products under certain sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats.
Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability
Document Number: 2017-00695
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This draft guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well- recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug's effects.
Nonproprietary Naming of Biological Products; Guidance for Industry; Availability
Document Number: 2017-00694
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonproprietary Naming of Biological Products.'' The guidance describes our current thinking on the need for biological products previously and newly licensed under the Public Health Service Act (PHS Act) to bear nonproprietary names that include FDA-designated suffixes. Accordingly, we intend to designate nonproprietary names for originator biological products, related biological products, or biosimilar products which will include a core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. This guidance finalizes the draft guidance issued on August 28, 2015. FDA is also 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.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-00655
Type: Notice
Date: 2017-01-13
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) and the National Treasury Employees Union (NTEU) have renewed the ACF Labor Management Committee Charter.
Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a Docket
Document Number: 2017-00646
Type: Notice
Date: 2017-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on policy issues that may be considered by the FDA Combination Product Policy Council (Council). These comments will help the Agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or other means.