Department of Health and Human Services March 9, 2016 – Federal Register Recent Federal Regulation Documents

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-05267
Type: Notice
Date: 2016-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-05266
Type: Notice
Date: 2016-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2016-05265
Type: Notice
Date: 2016-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-State, Tribal, Local and Territorial (STLT) Subcommittee Meeting
Document Number: 2016-05264
Type: Notice
Date: 2016-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Reimbursement Rates for Calendar Year 2016
Document Number: 2016-05252
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, Indian Health Service
Notice is given that the Principal Deputy Director of the Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2016 for Medicare and Medicaid beneficiaries, beneficiaries of other Federal programs, and for recoveries under the Federal Medical Care Recovery Act (42 U.S.C. 2651- 2653). The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient per diem rates set forth below do not include all physician services and practitioner services, additional payment shall be available to the extent that those services are provided.
Submission for OMB Review; Comment Request
Document Number: 2016-05240
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-05235
Type: Notice
Date: 2016-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs
Document Number: 2016-05233
Type: Notice
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.'' This study will examine how the size and presentation of superimposed text (supers) influences the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs.
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability
Document Number: 2016-05224
Type: Notice
Date: 2016-03-09
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 ``Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.'' This draft guidance provides a statement of qualification for exploratory use for the evaluating respiratory symptoms in chronic obstructive pulmonary disease (E-RS: COPD), a patient-reported outcome instrument, and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation and Research's (CDER's) drug development tool (DDT) qualification program. Qualification for exploratory use of the E-RS: COPD represents a conclusion that within the stated COU, the instrument can be relied on to have a specific interpretation and application in drug development and regulatory review. This draft guidance is an attachment to the guidance for industry entitled ``Qualification Process for Drug Development Tools.''
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Draft Guidance for Industry; Availability
Document Number: 2016-05223
Type: Notice
Date: 2016-03-09
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 ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.'' This draft guidance is intended to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance revises the draft guidance entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans'' issued July 15, 2013.
Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Guidance for Industry; Availability
Document Number: 2016-05222
Type: Notice
Date: 2016-03-09
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 (GFI) # 203 entitled ``Ensuring Safety of Animal Feed Maintained and Fed On-Farm.'' This guidance is intended to help animal producers (persons who feed animals) develop and implement on-farm practices to ensure the safety of animal feed maintained and fed to animals on the farm.
Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments
Document Number: 2016-05221
Type: Proposed Rule
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing that will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2017 Regulatory Science Plan.
Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Request for Comments
Document Number: 2016-05220
Type: Notice
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.'' The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass- spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices.
Tenth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2016; Public Conference
Document Number: 2016-05219
Type: Notice
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in co-sponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Tenth Annual DIA/Food and Drug Administration Statistics Forum2016.'' This public conference is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop and review new drugs and biologics. A primary focus for this public conference will be to establish an ongoing dialogue between industry and regulatory Agenciesemphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials and measuring the progress being made in designing and implementing innovative solutions.
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Document Number: 2016-05215
Type: Notice
Date: 2016-03-09
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 ``Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.'' The guidance document provides establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A. The guidance supplements section XXII of FDA's guidance entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011 and supersedes the guidance entitled ``Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated November 2005. The guidance announced in this notice finalizes the draft guidance of the same title dated February 2015.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
Document Number: 2016-05214
Type: Notice
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, 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 (the 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 collection of information associated with Medicated Feed Mill License Applications.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2016-05213
Type: Notice
Date: 2016-03-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2016-05209
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on March 29, 2016. The subject of the meeting will be initiatives in natural experiments for diabetes prevention and control being sponsored by the Centers for Disease Control and Prevention, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Patient-Centered Outcomes Research Institute. The meeting is open to the public.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2016-05201
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-05200
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-05199
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2016-05198
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2016-05197
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-05196
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-05195
Type: Notice
Date: 2016-03-09
Agency: Department of Health and Human Services, National Institutes of Health