Department of Health and Human Services October 30, 2017 – Federal Register Recent Federal Regulation Documents

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 Information Collection for Evaluation of Education, Communication, and Training Activities for Mobile Populations. This data collection will enable to evaluate its mobile populations and stakeholders communication, training, and education material's effectiveness.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.

The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.'' FDA developed this guidance to clarify our position regarding manufacturers appropriately and responsibly sharing ``patient-specific information''information unique to an individual patient or unique to that patient's treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical devicewith that patient at that patient's request. This guidance provides information and recommendations to industry, health care providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with individual patients when they request it.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the Survey of Alumni Commissioner's Fellowship Program Fellows.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Acceptance Review for De Novo Classification Requests.'' The purpose of this draft guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This draft guidance discusses De Novo acceptance review policies and procedures, ``Refuse to Accept'' principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the newborn screening test for SCID's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the acute kidney injury test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.