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

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 reporting requirements for firms that intend to export certain unapproved medical devices.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products: Update.'' This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, ``Nonproprietary Naming of Biological Products,'' dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.

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 information collection associated with the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). 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 document.

In compliance with the requirement for an 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). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled public meetings for the 2019 calendar year (CY). Information about NACNEP, agendas, and materials for these meetings can be found on the NACNEP website at https:// www.hrsa.gov/advisory-committees/nursing/.

This document announces the release of data underlying the proposed policies regarding the use of extrapolation in Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) audits and the Fee-for-Service (FFS) Adjuster.

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 Environmental Assessment Reporting System (NEARS) to collect data from foodborne illness outbreak environmental assessments routinely conducted by local, state, territorial, or tribal food safety programs during outbreak investigations.

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The Agency has determined based on established factors that these devices, which are currently regulated by FDA under product code OYE, no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other class II devices classified under FDA's automated differential cell counter regulation would continue to be subject to premarket notification requirements. FDA is publishing this proposed order to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a revision to an existing Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the revision of the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 associated with the guidance on informed consent for in vitro diagnostic (IVD) device studies using leftover human specimens that are not individually identifiable.

This notice is to advise the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/Referred Care (PRC) Delivery Area (DA) for the Havasupai Tribe in Arizona. The Havasupai Tribe's PRCDA is currently Coconino County in the State of Arizona. The IHS proposes to expand the Tribe's PRCDA to include Mojave County, which is adjacent to the Tribe's existing PRCDA in the State of Arizona.

The Administration for Community Living 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 Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Revision of a Currently Approved Collection (ICR Rev) and solicits comments on the information collection requirements related to the annual Program Performance Report (PPR) for the American Indian, Alaskan Natives and Native Hawaiian Programs under Title VI of the Older Americans Act.

The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) intends to provide a Single Source Three Year Cooperative Agreement to the Pan American Health Organization (PAHO). The Cooperative Agreement will continue to improve operational capabilities to provide timely, coordinated, and quality medical response to disasters in the Americas region by supporting the WHO Emergency Medical Teams (EMT) Initiative. The collaboration between ASPR and PAHO will focus on supporting PAHO's strategy to develop and train national emergency medical teams with a set of global standards in each country in the region to ensure they can respond to emergencies within their own borders. PAHOs regional strategy for the EMT Initiative concentrates on building emergency medical teams domestically, for each country in the region, to ensure they can respond to emergencies within their own borders first, thereby reducing dependence on U.S. medical assets/capabilities. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $1 million over the three-year life of the Cooperative Agreement.

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 the Agency) is announcing the availability of a final guidance for industry entitled ``Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes policies that FDA intends to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

The Department of Health and Human Services (HHS) solicits written comments from the public on specific topics and questions that will inform the development of the National Youth Sports Strategy.

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 Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). The purpose of BD- STEPS is to identify modifiable maternal exposures in pregnancy that may increase the risk for having a pregnancy affected by certain major, structural birth defects. This revision proposes to add stillbirths without defects to the study population for two Centers and implement a supplemental telephone interview for these two Centers' stillbirths (with and without birth defects) and their controls.

The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. Accordingly, OPA amends the Title X regulations to clarify grantee responsibilities under Title X, to remove the requirement for nondirective abortion counseling and referral, to prohibit referral for abortion, and to clarify compliance obligations with state and local laws. In addition, Title X regulations are amended to clarify access to family planning services where an employer exercises a religious or moral objection. Finally, Title X regulations are amended to require physical and financial separation to ensure clarity regarding the purpose of Title X and compliance with statutory program integrity provisions, and to encourage family participation in family planning decisions, as required by Federal law.

This proposed rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers.

The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.'' This public meeting is intended to obtain patients' and caregivers' perspectives on impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. Developing a treatment for a rare disease can present unique challenges, such as the small number of individuals affected and heterogenous etiologies and manifestations. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases. The goal of this meeting is to identify common issues and symptoms in rare diseases to help advance medical product development, potentially through the creation of novel endpoints or trial designs that focus on commonalities across a variety of rare diseases.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enforcement Policy for Certain Marketed Tobacco Products.'' FDA is issuing this draft guidance to provide information regarding FDA's enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE) order. This policy primarily involves ``provisional'' tobacco products that become subject to NSE orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (provisional tobacco products are tobacco products that were first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence report (SE Report) was submitted no later than March 22, 2011). The draft guidance also provides information on FDA's enforcement policy when an applicant files a request for supervisory review of an NSE order.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2019 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.