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

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Fostering Digital Health Innovation: Developing the Software Precertification Program.'' The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take into account real world evidence while incorporating principles established through international harmonization.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.'' This draft guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Oncology Center of Excellence (OCE): Listening Session.'' The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' available at https://www.fda.gov/downloads/forindustry/ userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Rare DiseasesA Collaborative Approach for Drug Development Using Gaucher Disease as a Model.'' This draft guidance focuses on drug development for pediatric patients with Gaucher disease. In particular, it proposes for consideration a novel approach to improve the efficiency of drug development in pediatric rare diseases using Gaucher disease as an example. The emergence of concomitant trials for multiple investigational drug products for the treatment of rare diseases can pose significant challenges to effective drug development, because there are limited numbers of patients for any given rare condition worldwide. This approach discusses the feasibility of the development of multiple drug products in a time-efficient manner while minimizing the number of patients necessary to be treated with placebo.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document provides recommendations to blood collection establishments regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance announced in this notice supersedes the guidance entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) and finalizes the draft guidance entitled ``Amendment to `Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'; Draft Guidance for Industry'' dated November 2016 (2016 Draft Chagas Guidance). The guidance incorporates recommendations for blood donor testing, deferral, and donor reentry from the 2016 Draft Chagas Guidance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' FDA has developed this leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. This guidance outlines technical considerations associated with additive manufacturing processes as well as testing and characterization for final finished devices fabricated using additive manufacturing.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from legal and aging/disability service professionals. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of Information and to allow 60 days for public comment in response on the proposed action. This notice solicits comments on proposed information collection requirements relating to ACL funded training, case consultation, and technical assistance for aging/disability networks assisting older adults in social or economic need facing legal issues.

The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.

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 Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.

This notice announces a $569.00 calendar year (CY) 2018 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2018 and on or before December 31, 2018.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the opening of a public docket to obtain comment on the draft Vessel Sanitation Program (VSP) Operations Manual and the VSP Construction Guidelines. Information about locating these documents can be found in the supporting materials section and on the VSP Web site. VSP established the public health standards found in the VSP Operations Manual and Construction Guidelines to target the control and prevention of gastrointestinal illnesses on cruise ships. The VSP Operations Manual and Construction Guidelines were last updated in 2011. New technology, advanced food science, and emerging pathogens require updates to these documents.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 68 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.