Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents

This final notice announces our decision to approve an application from Accreditation Association of Hospitals/Health SystemsHealthcare Facilities Accreditation Program for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Self-Determination and Education Assistance Act Contracts,'' Office of Management and Budget (OMB) Control Number 0917-0037. IHS is requesting OMB to approve an extension for this collection, which expires on February 29, 2020.

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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC, the 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.

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.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Airline and Vessel and Traveler Information Collection (42 CFR part 71) that enables CDC to order air carriers and maritime vessels to provide certain contact information for travelers in the event there is a confirmed illness onboard that poses a public health risk.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enterprise Laboratory Information Management System which is a system used to record specimen metadata and patient data related to test order requests submitted by external partners (state public health laboratories, International organizations, federal institutions, hospitals, doctor's offices, etc.) to the CDC Infectious Diseases testing laboratories.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``2019 Lung Injury Response Understanding Vaping Practices In the United States.'' This is a formative study to identify why people are getting sick after vaping/ dabbing, in order to narrow the list of products, substances, and risk factors requiring further public health action.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. If the rule is finalized as proposed, States or certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity. The rule, when finalized, would contain all requirements necessary for a State or other non-federal governmental entity and its co-sponsors, if any, to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the proposed rule would require that the State or non-federal governmental entity and its co-sponsors, if any, explain why their program would be expected to result in a significant reduction in the cost of covered products to the American consumer.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.'' This guidance complements and expands on the 1998 guidance entitled ``Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products'' (the 1998 guidance). Although FDA's evidentiary standard for effectiveness has not changed since 1998, the evolution of drug development and science has led to changes in the types of drug development programs submitted to the Agency. Specifically, there are more programs studying serious diseases lacking effective treatment, more programs in rare diseases, and more programs for therapies targeted at disease subsets. There is a need for more Agency guidance on the flexibility in the amount and type of evidence needed to meet the substantial evidence standard in these circumstances.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry.'' The guidance document provides recommendations intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States. The guidance document provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2018.

The Food and Drug Administration (FDA) is issuing a final order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat anxiety and/or insomnia, a preamendments class III device, into class II (special controls) and subject to premarket notification. FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for CES devices intended to treat depression (product code JXK) and clarify the device identification of the CES device to include it as a prescription device.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bridging for Drug-Device and Biologic-Device Combination Products.'' This draft guidance, when finalized, will represent the Agency's thinking on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or co-packaged combination products and will help to fulfill the performance goals under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). For the purposes of this guidance, the term bridging refers to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or another development program to support the combination product for which an applicant is seeking approval. Once the applicant has established the relevance of such information to (i.e., bridged to) its product, the applicant may be able to leverage that information to streamline the development program.