Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents

The National Institute of Dental and Craniofacial Research (NIDCR) is drafting its Strategic Plan for Fiscal Years (FY) 2020-2025 to help guide the research it supports over the next six years. NIDCR 2030 established five priority areas and accompanying goals, which we're now using to organize the 2020-2025 Strategic Plan. Through this Request for Information, NIDCR invites researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public to provide feedback on NIDCR's next strategic plan.

This proposed rule would remove the regulatory text that sets forth the current required process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist enough providers to assure beneficiary access to covered care and services consistent with the Medicaid statute. States have raised concerns over the administrative burden associated with the current regulatory requirements. While we believe the process described in the current regulatory text is a valuable tool for states to use to demonstrate the sufficiency of provider payment rates, we believe mandating states to collect the specific information as described excessively constrains state freedom to administer the program in the manner that is best for the state and Medicaid beneficiaries in the state.

The Food and Drug Administration is announcing the cancellation of a public workshop entitled ``Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients'' that was previously scheduled for August 8, 2019, from 8:30 a.m. to 4:30 p.m. This public workshop was announced in the Federal Register of May 2, 2019. The meeting has been cancelled due to unforeseen changes in the adenovirus drug development landscape.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Population Pharmacokinetics.'' This revised draft guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA's current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs) and biologic license applications (BLAs). The revised draft guidance also provides expectations regarding the format and content of the population PK report as well as any labeling recommendations resulting from such analyses.

The Administration for Children and Families (ACF) is requesting a three year extension of the form National Medical Support Notice (NMSN) Part A (OMB #0970-0222 expiration 8/31/2019). Changes were made to the form based on comments received during the 60 day Notice.

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 Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.

HHS gives notice of a decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.'' This guidance assists applicants (or drug substance master file (MF) holders referenced in an application) in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA's evaluation of a drug substance master file or drug product application. This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Allergenic Products Advisory Committee; Notice of Meeting'' that appeared in the Federal Register of June 24, 2019. The document announced a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The document was published with the incorrect name of the committee in the Agenda portion of the notice. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.'' The purpose of this guidance is to provide institutional review boards (IRBs), industry, clinical investigators, and FDA staff with factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.

In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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 Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revise the animal drug regulations for tolerances for residues of approved new animal drugs. This final rule is necessary to standardize, simplify, and clarify the determination standards of tolerances and provide definitions for key terms. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.

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 or Agency) is announcing the availability of a final guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA's review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.

This document corrects the information provided for [Document Identifier: CMS-10328] titled ``Medicare Self-Referral Disclosure Protocol.''

NIOSH announces the availability of Technical Report: The NIOSH Occupational Exposure Banding Process for Chemical Risk Management.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. 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 the Proposed Revision and solicits comments on the information collection requirements related to ACL's Chronic Disease Self-Management Education grant program.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs.'' This public meeting and request for comments is intended to support FDA guidance development as required by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. The topics to be discussed will inform the development of guidance to assist sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is seeking comments from stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers.

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency.'' This guidance describes FDA's policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency. FDA developed this guidance in response to communications from pharmacists and caregivers regarding the use of oxitriptan to treat patients with BH4 deficiency following issuance of a final rule that placed oxitriptan on the list of substances that cannot be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration is correcting a notice entitled ``Providing Regulatory Submissions in Electronic Format Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 5, 2017. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. Previously submitted comments will be transferred to the correct docket number.

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 National HIV Behavioral Surveillance System (NHBS). CDC is requesting approval for a revision to the previously approved project to continue collecting standardized HIV-related behavioral data from persons at risk for HIV, selected from up to 25 Metropolitan Statistical Areas (MSAs) throughout the United States.

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 Resources and Services Database of the CDC National Prevention Information Network (NPIN) (OMB Control No. 0920-0255 Exp. 2/29/2020). The NPIN Resources and Services Database contains entries on approximately 10,000 organizations and is the most comprehensive listing of HIV/AIDS, viral hepatitis, STD, and TB resources and services available throughout the country. The American public can also access the NPIN Resources and Services database through the NPIN websites.

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 EVALUATION OF THE DP18-1815 COOPERATIVE AGREEMENT PROGRAM: IMPROVING THE HEALTH OF AMERICANS THROUGH PREVENTION AND MANAGEMENT OF DIABETES AND HEART DISEASE AND STROKE. The purpose of data collection is to determine CDC-funded recipients' progress towards using DP18-1815 funds to implement evidence-based strategies, and to determine how those efforts are contributing to state level and health system level changes to support prevention and management of diabetes and heart disease.

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 State and Local Public Health Laboratory Antibiotic Resistance Testing. This collection will assist public health laboratories to improve detection and characterization of two urgent antibiotic resistant threats in healthcare-associated infections, carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA).

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 new drug applications (NDAs) from multiple applicants. The applicants 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) has determined that CLAFORAN (cefotaxime sodium) for injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, 2 g/vial and 10 g/vial, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notices (requests for information) that published in the Federal Register of April 15, 2016, and April 28, 2017. FDA is requesting comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from reopening of the comment period will allow supply chain stakeholders to share information about relevant piloting activities that are conducted outside of FDA's DSCSA Pilot Project Program to inform DSCSA implementation by FDA and supply chain stakeholders.

The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.

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 or Agency) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH or the Center) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). This final rule codifies the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also finalizing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.

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 Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or Agency) 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 ``Instructions for UsePatient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination ProductsContent and Format.'' This draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drugs and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. The recommendations in this draft guidance are intended to help develop consistent content and format across IFUs and to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use of prescription drug products.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB). This guidance focuses on drug development and trial design issues specific to the treatment of EB, including FDA's current thinking on clinical trial endpoint considerations. There is not yet sufficient clinical trial experience to establish definitive endpoints. This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on June 18, 2018.

The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), announces the opportunity for inventors, researchers, and/or respirator manufacturers to participate, through a collaborative agreement, in a project titled ``New Generation Powered Air-Purifying Respirators,'' to develop new designs of powered air-purifying respirators (PAPRs) for healthcare workers.

This notice announces the rechartering and appointment of seven new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the CDLT Panel). The purpose of the CDLT Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of time during the July 29, 2019 meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations will include updates on the latest biomedical research findings, an overview of the Healthy Brain Initiative: The Road Map for Indian Country, and a discussion of the progress made since 2011 through the National Plan to Address Alzheimer's Disease. Federal workgroups will also provide updates.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Treatment for Heart Failure: Endpoints for Drug Development.'' This draft guidance clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for approving drugs to treat heart failure. It also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations concerning the use of master files for biological products. This action, if finalized, will allow certain biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files after those products are deemed to be licensed under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule also codifies FDA's practice of permitting applications for biological products submitted under the PHS Act to incorporate by reference information other than drug substance, drug substance intermediate, or drug product information contained in a master file. In addition, the proposed rule codifies FDA's practice of permitting investigational new drug applications to incorporate by reference any information contained in a master file for products subject to licensure under the PHS Act.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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 (the Court) is charged by statute with responsibility for considering and acting upon the petitions.

In FY 2019, HRSA received funding from the Minority HIV/AIDS Fund from the Office of Secretary. The purpose of Minority HIV/AIDS Fund is to reduce new HIV infections, improve HIV-related health outcomes, and to reduce HIV-related health disparities for racial and ethnic minority communities by supporting innovation, collaboration, and the integration of best practices, effective strategies, and promising emerging models in the response to HIV among minority communities. HRSA will be providing supplemental funds to support activities for the Association of State and Territorial Health Officials (ASTHO), to support the Ending the HIV Epidemic: A Plan for America (EtHE) initiative to eliminate new HIV infections by providing communities most severely affected by HIV with critical resources to address the HIV epidemic. The supplemental funds will be used to augment the awardee's current activities to improve access to quality services, support a skilled health workforce, develop innovative programs, and prevent and suppress communicable diseases to preserve and improve public health through the National Organizations for State and Local Officials program. The purpose of this supplement is to identify key stakeholders in the seven southern states that have a substantial rural HIV burden and establish collaborative partnerships in each state by convening leadership meetings with State Health Officials, Ryan White HIV/AIDS Program Part B Directors, HIV Surveillance Coordinators, HIV Prevention Directors, and other partners engaged in EtHE efforts.

In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) has scheduled a public meeting. Information about COGME and the agenda for this meeting can be found on the COGME website at: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/index.h tml.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or postmarketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The draft guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M10 Bioanalytical Method Validation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes the method validation expectations for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions. The draft guidance also describes the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. The draft guidance is intended to provide industry with the regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions.

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

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 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 administrative procedures for Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization of certain in vitro diagnostic tests.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.'' The draft guidance document, when finalized, will make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of FDA's serious concern with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts and provide FDA's recommendations to firms throughout the production chain of seed for sprouting.

This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2019. The lists are available on HRSA's HPSAFind website.

The Food and Drug Administration (FDA) 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 FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this meeting.

On March 18, 2019 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register announcing that NIOSH had recently established a research program to address the rapidly expanding area of automation and associated technologies in mining, and that NIOSH was requesting information to inform the prioritization of research to be undertaken by The Institute's Mining Program. NIOSH is seeking input on priority gaps in knowledge regarding the safety and health implications of humans working with automated equipment and associated technologies in mining, with an emphasis on worker safety and health research in which NIOSH has the comparative advantage, and is unlikely to be undertaken by other federal agencies, academia, or the private sector. Written comments were to be received by May 17, 2019. In response to a request from an interested party, NIOSH is announcing the reopening of the comment period.

The National Toxicology Program (NTP) announces the availability of the Draft NTP Monograph on Systematic Review of Traffic-Related Air Pollution and Hypertensive Disorders of Pregnancy for public comment. The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), prepared the monograph.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the ``small business'' definition.

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.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT). ACOT shall: (1) Advise the Secretary, acting through the HRSA Administrator, on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed Organ Procurement and Transplantation Network (OPTN) policies submitted for the Secretary's approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating, and ensuring the validity, accuracy, timeliness, and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation. Authority: As provided by 42 CFR 121.12, the Secretary established ACOT. ACOT is governed by the Federal Advisory Committee Act (FACA; 5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of May 6, 2019. The amendment is being made to reflect a change in the DATES, Agenda, and Procedure portions of the document. There are no other changes.

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 requests for data needed to evaluate requests for threshold of regulation exemptions for substances used in food-contact articles.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new department-wide system of records, titled HHS Correspondence, Customer Service, and Contact List Records, system no. 09-90-1901. The new system of records replaces 13 existing systems of records which are rescinded in this notice, and it includes additional records not currently covered by any SORN. Two other related systems of records are also rescinded in this notice, but not replaced by the new SORN, because those records no longer exist.