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

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the availability of the Final Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for the CDC Chamblee Campus 2025 Master Plan.

The Food and Drug Administration (FDA or the 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, 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 ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.''

The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.

HHS is hereby giving notice that the charter for the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the renewed charter is October 31, 2017.

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.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This final notice announces our decision to approve the Joint Commission (TJC) for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.

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, 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 provisions of the dispute resolution procedures for science-based decisions on products regulated by the Center for Veterinary Medicine (CVM).

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) is announcing a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision making may use. The methods and approaches would be considered relevant and objective, and ensure that collected data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act), and as part of commitments made by FDA under the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI). FDA will publish a discussion document approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion document. FDA is also interested in input on examples where the approaches proposed in the discussion document have been successfully applied that could be illustrated in the draft guidance.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (50); the toll-free dial-in number is 1-877-951-7311, with a pass code of 2208740.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the State, Tribal, Local and Territorial Subcommittee, Centers for Disease Control and Prevention (STLT, CDC). This meeting is open to the public, limited only by 100 ports for audio phone lines access available. The public is also welcome to listen to the meeting by (866) 917-2712, passcode 9418625. The public comment period is from 03:50 p.m.-03:55 p.m. EST. Please register for public comment by December 8, 2017 via email to acdirector@cdc.gov.