Department of Health and Human Services April 2020 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces that it is extending the March 31, 2020 deadline for submissions required under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) for cigarette and smokeless tobacco products, respectively. CDC also announces that it is extending the deadline for ingredient reports for new products that are due at the time of first importation. Previous notices announced that ingredient reports are due annually on March 31, and/or upon initial importation of cigarettes and/or smokeless tobacco products. Due to the current public health response to COVID-19, CDC is not able to accept any ingredient submissions and will not be issuing Certificates of Compliance at this time. CDC is communicating this information to state government entities and will re-evaluate this approach as necessary.

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 ``Leptospirosis and melioidosis active hospital-based surveillance in Puerto Rico.'' The project aims to identify leptospirosis and melioidosis cases in Puerto Rico by establishing active surveillance for both diseases at four hospital sites for timelier disease identification and treatment and to improve understanding of leptospirosis and melioidosis epidemiology and ecology in Puerto Rico for public health control and prevention planning.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Firefighter Registry (NFR). In accordance with the Firefighter Cancer Registry Act of 2018, the National Firefighter Registry (NFR) will develop and maintain a voluntary registry of firefighters to collect relevant health and occupational information of such firefighters for purposes of determining cancer incidence.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending Bumble Bee Seafoods Inc.'s temporary permit to market test canned skinless and boneless chunk salmon packed in water that contains sodium tripolyphosphate to inhibit protein curd formation during retorting. The temporary permit is amended to allow for the canned skinless and boneless chunk salmon packed in water with or without sodium tripolyphosphate and to update the manufacturing location. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS.

This document extends the comment period for the proposed rule titled ``Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing'' that was published in the February 24, 2020 Federal Register. The comment period for the proposed rule, which would end on April 24, 2020, is extended until June 23, 2020.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 30, 2020. The topic for this meeting will be ``Improving Cardiovascular Outcomes in People with Type 1 Diabetes.'' The meeting is open to the public.

This proposed rule would amend the civil money penalty (CMP or penalty) rules of the Department of Health and Human Services (HHS or Department) Office of Inspector General (OIG) to: Incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; incorporate new CMP authorities for information blocking; and increase the maximum penalties for certain CMP violations.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry'' that appeared in the Federal Register of January 30, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The National Institute on Aging and the National Cancer Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to AevisBio, Inc. located in 814 W Diamond Ave., Suite 203, Gaithersburg, MD 20870.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA entitled ``Technical Considerations for Demonstrating Reliability of Emergency- Use Injectors Submitted under a BLA, NDA or ANDA.'' For injectable drug or biological products that are intended to treat emergent, life- threatening conditions, it is essential to ensure that the emergency- use injector will reliably deliver the drug or biological product as intended. This is particularly critical for drugs when failure of the injector may prevent adequate delivery of a life-saving drug to a patient. The draft guidance describes the technical considerations for demonstrating reliability of emergency-use injectors under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA).

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 ``Evaluation of the SHARE Approach Model.'' This proposed information collection was previously published in the Federal Register on February 4, 2020, and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. We are proposing to adopt the most recent Office of Management and Budget statistical area delineations and apply a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. We are also proposing to amend the IRF coverage requirements to remove the post-admission physician evaluation requirement and codify existing documentation instructions and guidance. Additionally, we are proposing to amend the IRF coverage requirements to allow non-physician practitioners to perform certain requirements that are currently required to be performed by a rehabilitation physician.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Safety of Vaccines Used for Routine Immunization in the United States, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

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.