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

This notice requests nominations to fill vacancies on the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel). The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on issues related to clinical diagnostic laboratory tests (CDLTs). As announced in the notice published in the Federal Register on June 16, 2017, entitled ``Medicare Program; Rechartering, Membership, and Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on August 1, 2017'' (82 FR 27705), the Secretary approved the rechartering of the Panel on April 25, 2017 for a 2-year period effective through April 25, 2019.

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553). HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA's newly established Opioid Policy Steering Committee (OPSC). Opioid addiction and the resulting overdoses and deaths have created a national crisis, which requires action by federal agencies that may in some instances be unprecedented in order to address the situation and attempt to turn the tide on the crisis. As a public health agency responding to the crisis, FDA seek public input as it considers how its authorities can or should be used to address this crisis. This information will help the Agency understand areas of focus important to the public and identify and address opioid product and policy issues that need clarification. FDA is especially interested in hearing from interested parties in three key areas: What more can FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented?

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.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2018. The calendar year 2018 AIC threshold amounts are $160 for ALJ hearings and $1,600 for judicial review.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2018.

The Food and Drug Administration (FDA or we) 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 requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on October 25, 2017. The subject of the meeting will be ``Enhancing Opportunities in Addressing Obesity and Type 2 Diabetes Disparities.'' The meeting is open to the public.

This non-competitive supplemental funding award will provide a phone consultation line staffed by clinicians dedicated to providing technical support and real-time clinical consultation to health professionals who treat people living with HIV (PLWH) who are coinfected with the hepatitis C virus (HCV).

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ .

The Department of Health and Human Services (HHS) is seeking public comment on its draft Strategic Plan for Fiscal Years 2018-2022.

In compliance 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 0917-0036, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act. This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to the Office of Management and Budget (OMB) for approval and solicits 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-[insert number]).

This non-competitive award will provide Secretary's Minority AIDS Initiative Fund (SMAIF) supplemental funding to the Jurisdictional Approach to Curing Hepatitis C among HIV/HCV Coinfected People of ColorEvaluation and Technical Assistance Center (ETAC), RAND Corporation. This supplemental funding will allow RAND Corporation to provide evaluation and technical assistance to cooperative agreement recipients and subrecipient clinical sites under HRSA-17-047 Curing Hepatitis C among People of Color Living with HIV.

This non-competitive supplemental award to the University of California, San Francisco (UCSF), the Evaluation and Technical Assistance Center (ETAC) for the Culturally Appropriate Interventions of Outreach, Access and Retention among Latino/a Populations initiative, will support the costs of analysis, publication, and dissemination of findings and best practices learned from the initiative.

The Health Resources and Services Administration's (HRSA's) Maternal and Child Health Bureau (MCHB) announces a prize competition to support the development and testing of low-cost, scalable technology-based innovations to improve the ability of prenatal care providers to monitor the health and wellbeing of pregnant women remotely, especially women who live in rural and medically-underserved areas who have limited access to on-site prenatal care. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010. This challenge, structured in three phases, will reach a diverse population of innovators and problem solvers including families, coders, public health experts, community leaders, individuals affiliated with academic institutions, research and development communities in the private sector, and others. All submissions will be evaluated; separate prizes will be awarded for each of the three phases below.

The Health Resources and Services Administration's (HRSA's) Maternal and Child Health Bureau (MCHB) announces a prize competition to support the development and testing of low-cost, scalable technology-based innovations to meet the needs of families and health care providers of children with special health care needs (CSHCN), particularly children with medical complexity (CMC), to improve the quality of care, patient empowerment, and family experiences while saving costs to the health care system.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Classification of Products as Drugs and Devices & Additional Product Classification Issues.'' This guidance provides the Agency's current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 HIV Outpatient Study (HOPS).

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 the Import Permit Applications information collection project.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information by the agency. 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, 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 a proposed revision to an existing data collection related to the National Survey of Older Americans Act Participants (NSOAAP)(ICR Rev).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The guidance is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in FDA's regulations deeming other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a guidance entitled ``Minutes of Institutional Review Board Meetings; Guidance for Institutions and Institutional Review Boards.'' The guidance is intended for institutions and Institutional Review Boards (IRBs) that are responsible for the review and oversight of human subject research conducted or supported by the U.S. Department of Health and Human Services (HHS) or regulated by FDA. The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The guidance also provides general recommendations on the type and amount of information to be included in the minutes. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2015.

The Food and Drug Administration (FDA or we) is announcing that Idemitsu Kosan, Cp. Ltd. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for flavors for use in animal feed.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Statistical Approaches to Evaluate Analytical Similarity.'' This draft guidance, when finalized, will provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products. Specifically, this draft guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.

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 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 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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.

HRSA announces the award of an extension in the amount of $2,000,000 for the Severe Combined Immunodeficiency (SCID) Newborn Screening program at the Jeffrey Modell Foundation (JMF). The extension will allow JMF, the cooperative agreement recipient, during the budget period of May 1, 2017 to April 30, 2018, to provide technical assistance and support to states for the implementation of population based newborn screening for SCID.

The Food and Drug Administration (FDA) is withdrawing approval of 27 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 Dermatologic and Ophthalmic 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.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 75 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see Contact Person for More Information) no later than 12:00 noon (EDT) on Tuesday, October 23, 2017:

The Food and Drug Administration (FDA or the Agency) is announcing that Akzo Nobel Surface Chemistry AB has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 reinstatement of the data collection project titled ``Congenital Heart Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG).'' CDC collects CHSTRONG data to provide public health question insight, aid in the development of services, and inform for the proper allocation of resources to improve long-term health and wellbeing.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 The National Intimate Partner and Sexual Violence Survey (NISVS) to collect information about individual's experiences of sexual violence, stalking and intimate partner violence and information about the health consequences of these forms of violence. CDC produces national and state level prevalence estimates of these types of violence.

The Health Center Program Compliance Manual (Compliance Manual) has been developed as a comprehensive, significantly streamlined, and web-based guidance document to assist health centers in understanding and demonstrating compliance with Health Center Program requirements. As such, this guidance document will reduce burden for current and prospective health centers and look-alikes and further strengthen HRSA's oversight of the Health Center and Health Center Federal Tort Claims Act (FTCA) Programs. It also responds to recommendations contained within the Government Accountability Office report, Health Center Program: Improved Oversight Needed to Ensure Grantee Compliance with Requirements, GAO-12-546, for increased transparency, clarity, and consistency in Health Center Program oversight. The Bureau of Primary Health Care (BPHC) released a draft Compliance Manual on August 23, 2016, for a 90-day public comment period. Individuals and groups submitted over 700 comments regarding the draft Compliance Manual. After thorough review and consideration of all comments received, HRSA made a substantial number of updates to the Compliance Manual to incorporate suggestions and requests for further clarification. HRSA has also posted a summary of comments for each corresponding section and chapter of the Compliance Manual and HRSA's responses to these comments. HRSA's ``Summary of Comments and HRSA Responses on the Draft Health Center Program Compliance Manual'' is available online at https://bphc.hrsa.gov/programrequirements/pdf/ healthcentercompliancemanual-comments.pdf. The Compliance Manual, which was effective August 28, 2017, is available online at https:// bphc.hrsa.gov/programrequirements/pdf/healthcentercompliancem anual.pdf. All Health Center Program non-regulatory policy issuances that remain in effect after release of the Compliance Manual are listed in Appendix A of the Compliance Manual. With the exception of these policies, the Compliance Manual supersedes other previous Health Center Program non- regulatory policy issuances related to Health Center Program compliance or eligibility requirements.

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 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 found in the guidance entitled ``Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry.''

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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 the ``Leveraging the Emerging Field of Disaster Citizen Science to Enhance Community Resilience to Improve Disaster Response'' project. This project will include individual and group interviews of citizen scientists and their partners and will field a nationally representative survey of local health departments to understand experiences and perceptions of citizen science for disaster preparedness.

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.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by room seating available. The public is also welcome to listen to the meeting by 866-836-4010, passcode: 18307719, and, and 100 teleconference lines are available.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by webcast https://cdclabtraining.adobeconnect.com/cliac.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' This proposed information collection was previously published in the Federal Register on May 30, 2017 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

Government owned intellectual property covering imaging agents with improved renal clearance available for licensing and commercialization.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Extension Without Changes of a Currently Approved Information Collection (ICR Ext) (OMB approval number 0985-0023). The extension would allow ACL to continue to collect information necessary to determine grantee compliance with Title VII of the Rehabilitation Act of 1973, as Amended by the Workforce Innovation and Opportunity Act of 2014. ACL received a large number of public comments resulting from a 60- day Federal Register notice for the 704 Part II report. In response to the comments, ACL is proposing to extend the currently approved forms for one year while we work on a revision that addresses all the comments from the 60-day notice regarding the updated form.

This notice announces the next public meeting date for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on September 25, 2017. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on issues related to clinical diagnostic laboratory tests (CDLTs).

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2018.

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 Centers for Disease Control and Prevention, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 240 people. We will be broadcasting the meeting live via Webcast at https://www.cms.gov/live/.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This draft guidance is intended to assist developers of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This draft guidance is intended to provide recommendations for a pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs.

Government owned intellectual property covering imaging agents with improved renal clearance available for licensing and commercialization.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of August 14, 2017. In the notice, FDA requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center), Office of Compliance (OC) and Office of In Vitro Diagnostics and Radiological Health (OIR) is announcing its Premarket Approval Application Critical to Quality (PMA CtQ) pilot program. Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA's ongoing Case for Quality effort to apply innovative strategies that promote medical device quality and is a joint effort between the FDA's CDRH and Office of Regulatory Affairs (ORA). The pilot program is intended to provide qualifying PMA applicants with the option to engage FDA on development of CtQ controls for their device and forego the standard PMA preapproval inspection. FDA would in turn, focus on the PMA applicant's implementation of the CtQ controls during a postmarket inspection.