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

Results 101 - 150 of 263
Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations
Document Number: 2017-24951
Type: Proposed Rule
Date: 2017-11-17
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of revising the regulations concerning importation of animals and animal products.
Total Inward Leakage Requirements for Respirators
Document Number: 2017-24950
Type: Proposed Rule
Date: 2017-11-17
Agency: Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for half- mask, air-purifying particulate respirators approved by NIOSH.
Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability; Correction
Document Number: 2017-24948
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of November 3, 2017. The document announced the availability of a draft guidance for industry. The document was published with the incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development
Document Number: 2017-24926
Type: Notice
Date: 2017-11-17
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 Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2017-24925
Type: Notice
Date: 2017-11-17
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 procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2017-24924
Type: Notice
Date: 2017-11-17
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 Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
Document Number: 2017-24923
Type: Notice
Date: 2017-11-17
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 FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.
Cardiac Troponin Assays; Public Workshop; Request for Comments; Extension of Comment Period
Document Number: 2017-24922
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Cardiac Troponin Assays; Public Workshop; Request for Comments'' that appeared in the Federal Register on July 31, 2017. That notice announced the public workshop and requested comments by November 28, 2017; FDA is extending the public workshop's comment period by 30 days to December 28, 2017, in response to requests for an extension to allow interested persons additional time to submit comments.
Medical Gas Regulation; Public Workshops; Request for Comments
Document Number: 2017-24918
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.
Proposed Information Collection Activity: Comment Request
Document Number: 2017-24905
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-24902
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2017-24901
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2017-24899
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-24898
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-24897
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-24896
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-24895
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2017-24876
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will be held virtually by webcast.
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability
Document Number: 2017-24839
Type: Rule
Date: 2017-11-17
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 document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.'' The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-24838
Type: Rule
Date: 2017-11-17
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 document entitled ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.'' The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability
Document Number: 2017-24837
Type: Notice
Date: 2017-11-17
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 document entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.'' The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA's current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as ``regenerative medicine advanced therapy'' (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address unmet medical needs in patients with serious or life- threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.
Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability
Document Number: 2017-24836
Type: Notice
Date: 2017-11-17
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 document entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.'' The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, as required by the 21st Century Cures Act (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-24883
Type: Notice
Date: 2017-11-16
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.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2017-24871
Type: Notice
Date: 2017-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting for BSC, NCHS. This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov, or Charles Rothwell, cjr4@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.
Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability
Document Number: 2017-24845
Type: Proposed Rule
Date: 2017-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Best Practices for Convening a GRAS Panel.'' This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts (``GRAS panel'') to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a ``GRAS panel report''), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-24832
Type: Notice
Date: 2017-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability
Document Number: 2017-24831
Type: Notice
Date: 2017-11-16
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 ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its application.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-24830
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-24816
Type: Notice
Date: 2017-11-16
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.
Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision
Document Number: 2017-24806
Type: Notice
Date: 2017-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine HCl), is the final decision of the Commissioner by operation of law. In the Initial Decision, the ALJ found that MFC had not been shown to be supported by substantial evidence consisting of adequate and well- controlled studies to be effective for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms; that the drug did not satisfy the combination drug policy; and that it is a ``new drug.'' The sNDA applicant filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ's Initial Decision; however, the applicant did not affirm its desire to pursue the appeal within the specified timeframe. Accordingly, FDA now deems those exceptions as withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ's Initial Decision had been filed; therefore, the ALJ's Initial Decision has become the final decision of the Commissioner by operation of law.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24804
Type: Notice
Date: 2017-11-16
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 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 ``Strengthening United States Response to Resistant Gonorrhea (SURRG).'' The goal of the study is to strengthen the U.S response to resistant gonorrhea by enhancing state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea, and advance the understanding of epidemiological factors contributing to antibiotic- resistant gonorrhea.
Submission for OMB Review; 30-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer (National Cancer Institute)
Document Number: 2017-24786
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Support the Safe To Sleep® Campaign (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction
Document Number: 2017-24776
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 9, 2017. That Notice inadvertently contained an error in the Supplementary Information section.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction
Document Number: 2017-24775
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 9, 2017. That Notice inadvertently contained an error in the Supplementary Information section.
Prospective Grant of Exclusive Patent Commercialization License: Direct Reading Detection Kits for Surface Contamination by Antineoplastic Drugs
Document Number: 2017-24774
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to Becton, Dickinson and Company, located in Franklin Lakes, New Jersey, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-24773
Type: Notice
Date: 2017-11-16
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 in the U.S.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-24762
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-24761
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-24760
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24759
Type: Notice
Date: 2017-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year
Document Number: 2017-24067
Type: Rule
Date: 2017-11-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This final rule with comment period provides updates for the second and future years of the Quality Payment Program. In addition, we also are issuing an interim final rule with comment period (IFC) that addresses extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria.
Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
Document Number: 2017-24719
Type: Notice
Date: 2017-11-15
Agency: Department of Health and Human Services
This notice announces the next meeting of the Physician- Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') which will be held in Washington, DC. This meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
Delegation of Authority
Document Number: 2017-24718
Type: Notice
Date: 2017-11-15
Agency: Department of Health and Human Services, Office of the Secretary, Administration for Children and Families
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2017-24717
Type: Notice
Date: 2017-11-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
Document Number: 2017-24688
Type: Notice
Date: 2017-11-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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 proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our infant formula regulations, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping. The notice also invites comment on a pilot electronic form that allows manufacturers of infant formula to submit reports and notifications in a standardized format.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24685
Type: Notice
Date: 2017-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2017-24671
Type: Notice
Date: 2017-11-15
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program
Document Number: 2017-23953
Type: Rule
Date: 2017-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
Submission for OMB Review; Comment Request
Document Number: 2017-24609
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2017-24603
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services