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

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Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
Document Number: 2018-14057
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the 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 supporting the Agency's Biosimilars User Fee Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2018-14056
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
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 provisions of the recommended labeling of certain beers subject to our labeling jurisdiction.
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability
Document Number: 2018-14055
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in nonclinical studies and product labeling, and reduce the conduct of nonclinical studies that are not informative for product use.
The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments
Document Number: 2018-14052
Type: Proposed Rule
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2018-14051
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction
Document Number: 2018-14050
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2018. The notice announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, effective April 13, 2018. In particular, the notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 076045, Lorazepam Tablets USP, 0.5 milligram (mg), 1 mg, and 2 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 076045 is still in effect.
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Guidance for Industry; Availability
Document Number: 2018-14049
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain changes in policies and procedures surrounding its application.
Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments
Document Number: 2018-14048
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
Proposed Information Collection Activity
Document Number: 2018-14037
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach To Address the Opioid Crisis
Document Number: 2018-14031
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, National Institutes of Health
This Request for Information (RFI) is intended to gather broad public input on the conduct of a multi-site national research effort to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (e.g., Hepatitis C and HIV), increase the number of individuals receiving medication-assisted treatment (MAT), increase the proportion retained in treatment beyond 6 months, and increase the number of individuals receiving needed recovery support services.
Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry
Document Number: 2018-14006
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER staff experiential learning site visit program specific to FDA's Quality Metrics Program. FDA is proposing this program, in part, in response to input from a variety of stakeholders over the past couple of years. The purpose of this 2018 Quality Metrics Site Visit Program is to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program. This notice invites pharmaceutical companies interested in participating in this program to submit a Quality Metrics Site Visit proposal.
Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program
Document Number: 2018-14005
Type: Notice
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) Center for Drug Evaluation and Research (CDER) is announcing two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. These efforts include Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply (e.g., active pharmaceutical ingredients (API) establishments, contract manufacturing organizations, over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments). Participation in either of these efforts is voluntary and the programs are intended to foster the joint efforts of FDA and stakeholders to further develop an FDA Quality Metrics Program. The FDA Quality Metrics Program aims to evaluate a new approach for regulatory oversight of pharmaceutical products through the collection of certain quality information developed and maintained in the course of manufacturing drugs under current good manufacturing practices. FDA intends to use quality metrics data to further develop the Agency's risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments) to improve the efficiency and effectiveness of establishment inspections, improve FDA's evaluation of drug manufacturing and control operations, and identify situations in which there may be a risk for drug supply disruption.
Submission for OMB Review; Comment Request
Document Number: 2018-13998
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2018-13996
Type: Notice
Date: 2018-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.
Healthcare Infection Control Practices Advisory Committee (HICPAC); Notice of Charter Amendment
Document Number: 2018-13995
Type: Notice
Date: 2018-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to increase the number and meetings from approximately three times per year to up to eight times per year. Also, this amendment gives notice to change the name of the DNV Healthcare to DNV-GL; to add the American Society of Nephrology (ASN), the American Association of Kidney Patients (AAKP), the Pediatric Infectious Disease Society (PIDS), and the National Association of Directors of Nursing Administration (NADONA) as non-voting liaison organizations to the committee, and to include expertise in environmental microbiology; and increase the number of meetings up to eight times a year. The amended filing date is May 4, 2018.
National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS); Notice of Charter Renewal
Document Number: 2018-13994
Type: Notice
Date: 2018-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2020.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR); Notice of Charter Renewal
Document Number: 2018-13993
Type: Notice
Date: 2018-06-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 21, 2020.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-13967
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-13966
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13965
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Faculty Loan Repayment Program, OMB No. 0915-0150-Extension
Document Number: 2018-13955
Type: Notice
Date: 2018-06-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Office of the Secretary; Amended Notice of Meeting
Document Number: 2018-13895
Type: Notice
Date: 2018-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-13894
Type: Notice
Date: 2018-06-28
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development of an Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer
Document Number: 2018-13893
Type: Notice
Date: 2018-06-28
Agency: Department of Health and Human Services, National Institutes of Health
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 U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Atara Biotherapeutics Inc. (``Atara'') located in South San Francisco, CA.
Notice of Meetings
Document Number: 2018-13878
Type: Notice
Date: 2018-06-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meetings on July 22-23, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Tribal Technical Advisory Committee (TTAC); on July 23 and July 25, 2018, of the Centers for Disease Control and Prevention (CDC)/ Agency for Toxic Substances and Disease Registry (ATSDR) Tribal Advisory Committee (TAC); and on July 24, 2018, of the Joint Tribal Advisory Committee (JTAC).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
Document Number: 2018-13868
Type: Notice
Date: 2018-06-28
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-13845
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-13844
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-13842
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13841
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Removing Outmoded Regulations Regarding the National Health Service Corps Program
Document Number: 2018-13837
Type: Rule
Date: 2018-06-27
Agency: Department of Health and Human Services
This action removes outmoded regulations for the National Health Service Corps (NHSC) Program. The regulations were promulgated to implement Section 338G of the Public Health Service (PHS) Act, relating to private practice loans. The regulations have not been updated since they were issued in 1986. The regulations are no longer relevant or needed as the NHSC has not made private practice loan opportunities available since the 1980s, and does not plan to do so in the foreseeable future. The removal of these regulations will not create any challenges for other programs, as the law and regulations apply solely to NHSC clinicians.
Removing Outmoded Regulations Regarding the Ricky Ray Hemophilia Relief Fund Program
Document Number: 2018-13836
Type: Rule
Date: 2018-06-27
Agency: Department of Health and Human Services
This action removes the outmoded regulations for the Ricky Ray Hemophilia Relief Fund Program. The program and its implementing regulation have been rendered obsolete by the statutory language in the authorizing legislation stating that the Fund should terminate on the expiration of the 5-year period beginning on the date of the enactment of the Act. The statute was enacted on November 12, 1998; thus, the fund expired on November 12, 2003.
Removing Outmoded Regulations Regarding the Rural Physician Training Grant Program, Definition of “Underserved Rural Community”
Document Number: 2018-13835
Type: Rule
Date: 2018-06-27
Agency: Department of Health and Human Services
This action removes the outmoded regulations for the Rural Physician Training Grant Program, Definition of ``Underserved Rural Community.'' Funding was authorized at section 749B(i) Public Health Service Act for fiscal years 2010-2013, but never appropriated for the Rural Physician Training Grant Program, and the program was not implemented. Therefore, this regulation is no longer relevant, and HRSA suggested the regulations defining underserved rural communities for the Rural Physician Training Grant Program be removed.
The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments
Document Number: 2018-13831
Type: Notice
Date: 2018-06-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's nutrition innovation strategy, including: A standard icon or symbol for the claim ``healthy''; a more efficient review strategy for evaluating qualified health claims; statements or claims that could facilitate innovation to promote healthful eating patterns; approaches for modernizing standards of identity; possible changes that could make ingredient information more consumer friendly; and FDA's educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace.
Meeting of the Tick-Borne Disease Working Group
Document Number: 2018-13812
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) announces the seventh meeting of the Tick-Borne Disease Working Group (Working Group) on July 24, 2018, from 10:00 a.m. to 4:00 p.m., Eastern Time. The seventh meeting will be an on-line meeting held via webcast. The Working Group will review and vote on the content of the five chapters that will be included in the Working Group's Report to Congress.
Availability of Program Application Instructions for Tribal MIPPA Program Funds
Document Number: 2018-13811
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-13793
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Environmental Health and Land Reuse Certification'' This certification is a joint collaboration with National Environmental Health Association (NEHA); ATSDR will jointly co-produce the course with NEHA.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-13789
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-13788
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-13787
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2018-13786
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2018-13785
Type: Notice
Date: 2018-06-27
Agency: Department of Health and Human Services, National Institutes of Health
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-13711
Type: Notice
Date: 2018-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 document.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-13710
Type: Notice
Date: 2018-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
Document Number: 2018-13688
Type: Notice
Date: 2018-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-13636
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-13635
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-13634
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-13633
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-13632
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health