Department of Health and Human Services January 10, 2017 – Federal Register Recent Federal Regulation Documents

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).