Submission for OMB Review; Strengthening Relationship Education and Marriage Services (STREAMS) Evaluation (OMB#0970-0481)
The Office of Family Assistance (OFA) within the Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services has issued grants to organizations to provide healthy marriage and relationship education (HMRE) services. Under a previously approved data collection activity (OMB#0970-0481), the Office of Planning, Research, and Evaluation (OPRE) within ACF is conducting the Strengthening Relationship Education and Marriage Services (STREAMS) evaluation with five HMRE grantees. The purpose of STREAMS is to measure the effectiveness and quality of HMRE programs designed to strengthen intimate relationships. This data collection request is for an extension of previously approved data collection instruments and for two additional data collection instruments.
Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry.'' The guidance document provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. The issuance of this guidance fulfills the statutory requirement set forth in a certain section of the 21st Century Cures Act (Cures Act). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2017.
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry.'' The guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life- threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. The guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions, including those products designated as regenerative advanced therapies (which FDA refers to as ``regenerative medicine advanced therapy'' (RMAT) designation). The guidance also describes considerations in the clinical development of regenerative medicine therapies and opportunities for sponsors of regenerative medicine therapies to interact with the Center of Biologics Evaluation and Research (CBER) review staff. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2017.
National Toxicology Program; Notice of Public Meeting: Converging on Cancer Workshop
The National Toxicology Program (NTP) announces a workshop titled ``Converging on Cancer'' on April 29-30, 2019, to bring together researchers working in the area of cancer biology, assay development, mixtures toxicology, in silico modeling, and cancer risk assessment. The objectives of the workshop are to identify technologies and models that can be used in a systems toxicology approach for cancer risk assessment. Specific applications to understanding the joint effects of multiple chemical exposures will be discussed. The workshop will consist of plenary sessions (webcast), breakout discussion sessions, and a poster session. This workshop is open to the public. Members of the public can register to attend the workshop in person as observers or view the plenary proceedings via webcast.
Request for Information (RFI) on Assays and Approaches for Evaluating Chemical Effects on Cancer Pathways
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences is seeking input on assays and approaches for evaluating chemical effects on cancer pathways, specifically, pathways that map to the hallmarks of cancer and key characteristics of carcinogens.
Application From the Joint Commission (TJC) for Continued Approval of Its Psychiatric Hospital Accreditation Program
This final notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2018
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Patient Safety Organizations: Voluntary Relinquishment From Healthcare Improvement, Inc. PSO
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Healthcare Improvement, Inc. PSO, PSO number P0123, of its status as a PSO, and has delisted the PSO accordingly.
Proposed Information Collection Activity; ACF's Generic Clearance for Grant Reviewer Recruitment Forms (OMB #0970-0477)
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) is proposing an extension of a currently approved generic clearance (OMB no. 0970-0477) for Grant Reviewer Recruitment (GRR) forms. The GRR forms will be used to select reviewers who will participate in the grant review process for the purpose of selecting successful applications.
Meeting of the Advisory Committee on Infant Mortality
The Secretary's Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https:// www.hrsa.gov/advisory-committees/infant-mortality/index.html.
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Nonbinding Feedback After Certain FDA Inspections of Device Establishments.'' The FDA Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft guidance specifying how FDA provides nonbinding feedback to the owner, operator, or agent in charge of a device establishment after an inspection of such establishment within 45 days of FDA's receipt of a request for such feedback if the request meets certain statutory criteria. This draft guidance describes FDA's proposed approach for providing nonbinding feedback, including the procedures for requesting nonbinding feedback and FDA's review of requests for nonbinding feedback. This draft guidance is not final nor is it in effect at this time.
Competitive Generic Therapies; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Competitive Generic Therapies.'' On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a section was added to the FD&C Act that established a new process to designate, and expedite the development and review of, certain drugs intended for submission or submitted in an abbreviated new drug application (ANDA) and for which there is ``inadequate generic competition.'' This draft guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. This draft guidance also includes information on the actions FDA may take to expedite the development and review of an ANDA for a drug designated as a CGT. This draft guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as CGTs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
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.
List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or the Agency) is issuing a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency is placing six bulk drug substances on the list. This final rule also identifies four bulk drug substances that FDA has considered and is not including on the list. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.
Framework for a Real-World Evidence Program; Availability; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled ``Framework for a Real-World Evidence Program; Availability'' that appeared in the Federal Register on December 7, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
Retail Pharmacy Interest in Utilization of Innovative Educational Technology To Increase Human Papillomavirus (HPV) Vaccination Rates in Rural Areas
This request for information (RFI) is issued for informational and planning purposes only. This RFI is not a solicitation; nor does it commit the Department of Health and Human Services (HHS) to issue a solicitation, make any award, or pay any costs associated with responding to this announcement. The RFI is being issued by the National Vaccine Program Office (NVPO) of the U.S. Department of Health and Human Services. The NVPO is located in the Office of the Assistant Secretary for Health (ASH), Office of the Secretary (OS), U.S. Department of Health and Human Services (HHS). The NVPO provides strategic leadership and management, policy scholarship and recommendations, and encourages collaboration and coordination among federal agencies and other stakeholders whose mission is to reduce the burden of preventable infectious disease through immunization. NVPO offers thorough reporting, unbiased advice and expertise to other agencies in identifying and responding to gaps in the vaccine system. Prevention of cancers associated with Human Papillomavirus (HPV) infections continues to be a public health challenge in the United States. Vaccination is an effective, primary medical intervention for prevention of infection from these viruses. Despite this, HPV vaccination series completion rates remain low nationwide, with adolescents living in rural communities (per census definition of
Blood Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on regulatory issues related to blood and products derived from blood. Matters considered at the meeting will include testing of the blood supply for Zika virus, topics relevant to blood donation by men who have sex with men, and an overview of research programs in the Laboratory of Biochemistry and Vascular Biology. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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 export notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco that may not be marketed or sold in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With New Animal Drug Applications and Veterinary Master Files
The Food and Drug Administration (FDA, Agency, or we) 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 collection of information associated with new animal drug applications.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Prospective Grant of an Exclusive Patent License: “Treatment of Acute Lymphoblastic Leukemia, T-Cell Lymphoma, and Non-Small Cell Lung Cancer Using the 4A10 Antibody and Fragments Thereof”
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 Patent Applications listed in the Supplementary Information section of this notice to Fannin Partners L.L.C., (``Fannin'') of Houston, Texas.