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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.'' This draft guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the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 This draft guidance is not final nor is it in effect at this time.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

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory 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. FDA is establishing a docket for public comment on this document.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-XXXX, titled, Information Security Ticketing and Incident Reporting. The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_001).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADVANTAME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should be used and labeled.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' It describes study designs for generating data that supports both 510(k) clearance and CLIA waived categorization. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waived categorization in addition to 510(k) clearance for new In Vitro Diagnostic (IVD) devices. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA waived settings, which will better serve patients and providers. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REXULTI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XURIDEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELTASSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to BravoVax Co., Ltd located in Wuhan, China.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Senza Spinal Cord Stimulation System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZERBAXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This guidance document outlines FDA's current thinking on information that should be provided in premarket notification submissions for x-ray imaging devices that are indicated for pediatric populations or general use x-ray imaging devices for which considerable pediatric application is anticipated. FDA intends for this guidance to minimize uncertainty during the premarket review process of premarket notification submissions for x- ray imaging devices for pediatric use to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notification submissions and to provide recommendations on information to support such indications. Both new devices and modifications of existing x-ray imaging devices that require submission of a new premarket notification are included within the scope of this guidance document, regardless of whether the device is a complete x-ray imaging system, a component part of an x-ray imaging device, or an accessory (e.g., detectors and software).

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.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology.'' The purpose of the public workshop is to engage stakeholders and solicit input from experts in oncology precision medicine on how to best weigh and evaluate evidence for classification and interpretation of sequencing results for precision oncology.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place and will be open to the public.

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 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.

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 the National Hospital Ambulatory Medical Care Survey (NHAMCS). NHAMCS collects facility and visit information on ambulatory care services utilization in non-Federal, short stay hospitals in the United States.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This draft guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be exempted, as grandfathered, from certain requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the public workshop entitled ``Safety Assessment for IND Safety Reporting.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to ``Safety Assessment for Investigational New Drug (IND) Safety Reporting.'' This public workshop is organized in response to public comments received to Docket No. FDA-2015-D-4562 for the draft guidance ``Safety Assessment for IND Safety Reporting'' issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.''

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 31, 2019.

The Office of Disease Prevention and Health Promotion and the Federal Steering Committee for the Prevention of HAIs have developed a new phase of the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination (HAI Action Plan). The first three phases of the HAI Action Plan meaningfully enhanced coordination of federal efforts to address HAIs by establishing a structure to regularly share best practices, resources, and lessons learned among federal partners. Given the pressing public health threat of antibiotic resistance and the need to maximize efficiency of federal activities, the Steering Committee recognized the opportunity to leverage this existing committee and network of participants to enhance the implementation of the CARB National Action Plan goal of slowing the emergence of antibiotic resistant bacteria and preventing the spread of resistant infections through antibiotic stewardship programs. Thus, Phase Four of the HAI Action Plan focuses on the importance of antibiotic stewardship to prevent HAIs, and specifically highlights the coordination between various health agencies. Recommendations within Phase Four align and reinforce the goals and objectives of the CARB National Action Plan. This update to the HAI Action Plan reaffirms a federal commitment to improving health care quality and protecting the health of all Americans. Phase Four is titled: Coordination among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship. The Steering Committee and the Office of Disease Prevention and Health Promotion invite public and private professionals, organizations, and consumer representatives to provide comments on the most recent draft of Phase Four.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will hold a public teleconference on December 7, 2017.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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 Workplace Violence Prevention Programs in NJ Healthcare Facilities. Through nursing home administrator interviews, CDC seeks to continue measuring compliance to the state regulations for workplace violence prevention program: Violence prevention policies, reporting systems for violent events, violence prevention committee, written violence prevention plan, violence risk assessments, post incident response and violence prevention training.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Tenth Annual Sentinel Initiative Public Workshop.'' The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions.

The Food and Drug Administration (FDA) is requesting public input on updated recommendations for regulations on good manufacturing practice for electronic nicotine delivery systems (ENDS) that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' ENDS recommendations). FDA is providing an opportunity for interested parties to comment on the tobacco companies' ENDS recommendations.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA RegulationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Sanitary Transportation of Human and Animal Food.''

HRSA announces the award of a supplement in the amount of $250,000 for a HRSA-funded cooperative agreement awarded to the National Network for Oral Health Access (NNOHA). The supplement, awarded on September 25, 2017, will fund demonstration projects to increase the integration of oral health and primary care practice through the adoption of HRSA's core clinical oral health competencies for non-dental health care providers in Health Center (HC) settings, focusing on services for pregnant women and children.

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 eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer's intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the Accredited Persons (AP) Inspection Program.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2018. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2018 for these individuals will be $422. The premium for certain other individuals as described in this notice will be $232.

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.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' This previously approved information collection project was last published in the Federal Register (80 FR 23558) on April 28, 2015, and allowed 60 and 30 days for public comment. No public comment was received in response to the notices. This notice announces our intent to submit this collection, which expires July 31, 2018, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc. and Chembio Diagnostic Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of revising the regulations concerning importation of animals and animal products.

The Food and Drug Administration is correcting a notice entitled ``Controlled Correspondence Related to Generic Drug Development; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of November 3, 2017. The document announced the availability of a draft guidance for industry. The document was published with the incorrect docket number. This document corrects that error.

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 procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

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 FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.

The Food and Drug Administration (FDA, the Agency, or we) is announcing two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.'' The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.'' The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA's current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as ``regenerative medicine advanced therapy'' (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address unmet medical needs in patients with serious or life- threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Best Practices for Convening a GRAS Panel.'' This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts (``GRAS panel'') to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a ``GRAS panel report''), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its application.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Strengthening United States Response to Resistant Gonorrhea (SURRG).'' The goal of the study is to strengthen the U.S response to resistant gonorrhea by enhancing state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea, and advance the understanding of epidemiological factors contributing to antibiotic- resistant gonorrhea.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on November 9, 2017. That Notice inadvertently contained an error in the Supplementary Information section.

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to Becton, Dickinson and Company, located in Franklin Lakes, New Jersey, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This final rule with comment period provides updates for the second and future years of the Quality Payment Program. In addition, we also are issuing an interim final rule with comment period (IFC) that addresses extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria.

The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of our infant formula regulations, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping. The notice also invites comment on a pilot electronic form that allows manufacturers of infant formula to submit reports and notifications in a standardized format.