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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.'' This guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time FDA does not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the guidance alerting consumers that the use of acetaminophen may cause severe skin reactions.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments, and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2017. This notice is issued under the Controlled Substances Act (CSA).

In compliance with Section 3507(a)(1)(D) 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.

The Department of Health and Human Services published a final rule in the Federal Register on September 30, 2016 that revised regulations for the Child Care and Development Fund (CCDF) program. The final rule inadvertently included incorrect numbering of two paragraphs. This document corrects the numbering of those two paragraphs.

This is a Request for Information (RFI) about business models, existing, under development or planned, that support health care providers for any of the components related to private-sector immunization services (e.g., excluding vaccines provided through federal and state programs, such as the Vaccines for Children Program, Children's Health Insurance Program, Medicaid, and Medicare): Vaccine purchase, distribution, storage and handling, inventory management, reporting to Immunization Information Systems (IIS), including models for populating IIS directly/automatically from electronic health records (EHRs), immunization coverage assessment, forecasting vaccine demand, and billing. The RFI is being issued by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services. The NVPO is located in the Office of the Assistant Secretary for Health (ASH), Office of the Secretary (OS), U.S. Department of Health and Human Services (HHS). The NVPO is responsible for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The National Vaccine Program was established in compliance with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2101) (42 U.S. Code 300aa-et seq (PDF78 KB)) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Development of a National Vaccine Plan (NVP) has been mandated to the NVPO as a mechanism for the Director of the National Vaccine Program (the Assistant Secretary for Health) to communicate priorities for both federal and non-federal stakeholders regarding vaccine research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines in order to carry out the program's responsibilities. Goal 4 of the plan, Ensure a Stable Supply of, Access to, and Better Use of Recommended Vaccines in the United States, focuses in part on increasing and improving access to vaccines in health care provider settings. This RFI seeks information on innovative business models to support health care providers to increase and improve their ability to provide immunization services, as described below. In its efforts to promote vaccination coverage across the lifespan, the NVPO is seeking information about business models, existing, under development or planned, that enable health care providers to offer vaccines to their privately-insured/private-pay patients. The NVPO is most interested in innovative business models aimed at reducing any of the barriers to implementing vaccination services such as vaccine purchase, billing, storage and handling, IIS reporting, including models for populating IIS directly/automatically from EHRs, forecasting vaccine demand, and managing private vaccine inventories. In addition, the NVPO is interested in models that can demonstrate improvements in the immunization coverage rates of the patients seen in the health care settings utilizing such models as well as improvements in reporting to IIS.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.'' The guidance document notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest'' (OMB Control Number 0917-NEW), which expired September 23, 2016. This proposed information collection project was recently published in the Federal Register (81 FR 48437) on July 25, 2016, and allowed 60 days for public comment. The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0003).

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.

This Request for Information (RFI) seeks recommendations for future work with and on behalf of American Indian and Alaska Native (AI/AN) leadership, tribes, tribal organizations, and populations in accord with ACF's vision of ``children, youth, families, individuals, and communities who are resilient, safe, healthy, and economically secure.''

The Food and Drug Administration (FDA) has determined the regulatory review period for ADYNOVATE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) is seeking information and public comment, in anticipation of the passage of Generic Drug User Fee Amendments reauthorization (GDUFA II), relevant to FDA's planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This includes requests for comment and information regarding FDA's initial inventory of approved abbreviated new drug application sponsors and application numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA program fees in a timely manner.

This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.

HHS gives notice of a determination concerning a petition to add a class of employees from the Blockson Chemical Co. site in Joliet, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).

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 proposed information collections for the National Center for Health Statistics (NCHS) Youth Outreach Program. This generic information collection plan would capture outreach activities involving young people (K through college) and those who support them, such as parents, teachers, counselors etc.

The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as ``specialized surgical instrumentation for use with urogynecologic surgical mesh.'' FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.