Department of Health and Human Services July 2016 – Federal Register Recent Federal Regulation Documents
Results 251 - 279 of 279
Center for Substance Abuse Prevention; Advisory Committee; Drug Testing Advisory Board; Renewal
The Substance Abuse and Mental Health Services Administration (SAMHSA) is announcing the renewal of SAMHSA's Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB).
World Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and WTC-Related Acute Traumatic Injury to the List of WTC-Related Health Conditions
The World Trade Center (WTC) Health Program conducted a review of published, peer-reviewed epidemiologic studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were responders to or survivors of the September 11, 2001, terrorist attacks. The Administrator of the WTC Health Program (Administrator) found that these studies provide substantial evidence to support a causal association between each of these health conditions and 9/11 exposures. As a result, the Administrator is publishing a final rule to add both new-onset COPD and WTC-related acute traumatic injury to the List of WTC-Related Health Conditions eligible for treatment coverage in the WTC Health Program.
Medicare and Medicaid Programs; CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
This proposed rule would update 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, 2017. This proposed rule also: Implements the last year of the 4- year phase-in of the rebasing adjustments to the HH PPS payment rates; updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 2nd-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 CY 2012 and CY 2014; proposes changes to the methodology used to calculate outlier payments (with regards to payments made under the HH PPS for high-cost ``outlier'' episodes of care (that is, episodes of care with unusual variations in the type or amount of medically necessary care)); proposes changes in payment for Negative Pressure Wound Therapy (NPWT) performed using a disposable device for patient's under a home health plan of care; discusses our efforts to monitor the potential impacts of the rebasing adjustments mandated; includes an update on subsequent research and analysis as a result of the findings from the home health study; solicits comments on a potential process for grouping HH PPS claims centrally during claims processing; and proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model, which was implemented on January 1, 2016; and proposes updates to the Home Health Quality Reporting Program (HH QRP).
Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
This proposed rule would revise the procedures that the Department of Health and Human Services would follow at the Administrative Law Judge level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage 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 proposed rule would revise procedures that the Department of Health and Human Services would follow at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the Administrative Law Judge level.
Agency Information Collection Activities: Proposed Collection: Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443- 1984.
Elemental Impurities in Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Elemental Impurities in Drug Products.'' This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry ``Q3D Elemental Impurities.'' This draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft 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. The guidance also addresses prevention of recurrent herpes labialis. 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 recurrent herpes labialis.
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the ``single window'' for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
This notice advises the public of the published lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 13, 2016, available on the Health Resources and Services Administration (HRSA) Web site at https:// www.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the Secretary of Health and Human Services (HHS) under the authority of section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.
Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic paliperidone palmitate extended-release injectable suspension, entitled ``Draft Guidance on Paliperidone Palmitate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.
Erythropoietic Protoporphyria; Scientific Workshop
The Food and Drug Administration (FDA or Agency) is announcing a public workshop and an opportunity for public comment on Erythropoietic Protoporphyria (EPP). The public workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for, and gain perspective from, patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The input from this public workshop will help in developing topics for further discussion.
Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Vulvovaginal Candidiasis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated vulvovaginal candidiasis (VVC).
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other persons likely to be infected and providing therapy for latent tuberculosis infection in an effort to eliminate Tuberculosis in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers. CDC is requesting approval for revision to the previously approved project to continue testing HIV/AIDS prevention and treatment messages to be included in social marketing campaigns targeting consumers.
Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Fourth Wave of Data Collection
Under the provisions of Section 3507(a)(1)(D) of 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. This proposed information collection was previously published in the Federal Register on April 15, 2016, pages 2229022291 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_Submission@omb.eop.gov or by fax to (202) 395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a guidance for industry entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' The guidance explains to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.
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