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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.'' When finalized, this draft guidance will provide recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product's licensed conditions of use. Additionally, when finalized, this draft guidance will also provide recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T- Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance document provides blood collection establishments with recommendations regarding the use of serological tests to reduce the risk of HTLV-I/II transmission by blood and blood components. The guidance announced in this notice finalizes the draft guidance entitled ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)'' dated September 2018. The guidance also consolidates FDA's other previously issued recommendations on HTLV-I/II into one document. Therefore, the guidance also supersedes the recommendations specific to HTLV-1 contained in the memorandum to blood establishments entitled ``Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T- Lymphotropic Virus Type I (HTLV-I)'' dated July 1996. In addition, the guidance supersedes the memorandum to blood establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated November 1988; the memorandum to blood establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated July 1989; and the document entitled ``Guidance for Industry: Donor Screening for Antibodies to HTLV-II'' dated August 1997.

HRSA is soliciting comments and recommendations regarding HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and is seeking nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA TAC. The HRSA TAC will engage in regular and meaningful collaboration and consultation with tribal officials on policies that have tribal implications and a substantial direct effect on Indian tribes. The HRSA TAC will be the vehicle for acquiring a broad range of tribal views, determining the impact of HRSA programs on the American Indian/Alaska Native (AI/AN) health systems and population, developing innovative approaches to deliver health care and assisting with effective tribal consultations. HRSA is also seeking nominations of qualified candidates to fill up to 12 positions on the HRSA TAC; one authorized tribal representative (and one designated alternate) from each of the 12 Indian Health Service geographic areas.

NIOSH announces the availability of the final National Occupational Research Agenda for Healthy Work Design and Well-Being.

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with the notice requirements of NAPA, ANA herein describes proposed general statements of policy that relate to the Native American Language Preservation and MaintenanceEsther Martinez Immersion (EMI) funding opportunity announcement (FOA) in fiscal year (FY) 2020.

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 ``2019 Novel Coronavirus Airport Entry Questionnaires and Aircraft Contact Investigations Information Collection,'' which will provide CDC with the ability to perform enhanced public health assessments of travelers from China, or other areas affected by the 2019 Novel Coronavirus (2019-nCoV) outbreak, to determine risk of infection with 2019-nCoV, and to facilitate any necessary public health follow-up.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's Voluntary Qualified Importer Program (VQIP).

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations.'' This research consists of a survey examining the health care providers' current perceptions, understanding, and behaviors related to opioid analgesic abuse deterrent formulations (ADFs) and a study exploring the effectiveness of different terminology and descriptions for these products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment.'' The purpose of this draft guidance is to foster greater efficiency in drug development in this rare disease with the goal of enhancing clinical trial data quality and supporting the development of treatments for mucopolysaccharidosis type III. Specifically, the draft guidance provides the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical development programs of investigational drugs to treat mucopolysaccharidosis type III.

The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The purpose of the public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to inform data standards initiatives, FDA Information Technology (IT) Strategic Plan, and electronic submissions gateway target timeframes.

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: ``Evaluating the Dissemination and Implementation of PCOR to Increase Referral, Enrollment, and Retention through Automatic Referral to Cardiac Rehabilitation (CR) with Care Coordination.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar ProductsQuestions and Answers.'' FDA is issuing this guidance to provide manufacturers, packers, distributors, and their representatives (firms) with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act (PHS Act). Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars.

The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), is proposing to collect data on the child welfare workforce as part of the third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW III). Previous and current data collections for NSCAW have been approved by OMB under OMB #0970-0202. This request is for additional data collection.