Department of Health and Human Services February 2016 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 347
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-03123
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-03122
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-03121
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03120
Type: Notice
Date: 2016-02-17
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Correction
Document Number: 2016-03106
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register, 80 FR 55861 (September 17, 2015) announcing the Bridging the Word Gap Competition Challenge. This correction notice extends the deadline for Phase 1 submissions by approximately 4 weeks to allow for additional submissions. Accordingly, the remaining timelines for all subsequent phases and judging periods will also be extended by approximately 4 weeks.
Notice of Availability of the Final Environmental Assessment and a Finding of No Significant Impact for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, Georgia
Document Number: 2016-03059
Type: Notice
Date: 2016-02-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this notice to advise the public that HHS/CDC has prepared and signed on February 9, 2016 a Finding of No Significant Impact (FONSI) based on the Final Environmental Assessment (Final EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Final EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-03046
Type: Notice
Date: 2016-02-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Patient Safety Organizations: Voluntary Relinquishment From Verge Patient Safety Organization
Document Number: 2016-03034
Type: Notice
Date: 2016-02-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a 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 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 Verge Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2016-03015
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-03014
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-03011
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2016-03010
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability
Document Number: 2016-02978
Type: Notice
Date: 2016-02-16
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 ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This draft guidance revises the draft guidance for industry entitled ``Allergic Rhinitis: Clinical Development Programs for Drug Products'' issued April 2000.
Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments
Document Number: 2016-02977
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).'' This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The information gathered from the workshop and the public comments submitted to the docket will further inform FDA's development of its pilot project program.
Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability
Document Number: 2016-02976
Type: Notice
Date: 2016-02-16
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 ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this draft guidance is to assist applicants in the development of drug and biological products for the treatment of nonallergic rhinitis (NAR).
Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability
Document Number: 2016-02975
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled ``Draft Guidance on Cyclosporine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02974
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-02973
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-02972
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-02971
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-02970
Type: Notice
Date: 2016-02-16
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.
Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability
Document Number: 2016-02969
Type: Notice
Date: 2016-02-16
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 guidance for industry entitled ``Completeness Assessments for Type II API DMFs Under GDUFA''. It finalizes the draft guidance entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA'', which published on October 2, 2012. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).
Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments
Document Number: 2016-02967
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Evaluation of the Safety of Drugs and Biological Products used during Lactation.'' The purpose of this workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.
Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments
Document Number: 2016-02966
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled ``Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.'' The objective of the workshop is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The promise of using real- world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and healthcare data systems integration.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop
Document Number: 2016-02965
Type: Notice
Date: 2016-02-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Educational Conference Co- Sponsored With the Society of Clinical Research Associates (SOCRA).'' The public workshop on FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA, clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRBs, and of research sponsors.
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Draft Guidance for Industry; Availability
Document Number: 2016-02964
Type: Notice
Date: 2016-02-16
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 ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled ``Inhalational Anthrax (Post- Exposure)Developing Antimicrobial Drugs'' issued in March 2002.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
Document Number: 2016-02889
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Document Number: 2016-02888
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Manufactured Food Regulatory Program Standard.''
Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase
Document Number: 2016-02887
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The invention listed in this document is owned by an Agency of the U.S. Government and is available for licensing in accordance with Federal regulations to achieve expeditious commercialization of results of Federally funded research and development.
Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
Document Number: 2016-02884
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Samples and Protocols
Document Number: 2016-02882
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Samples and Protocols'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Document Number: 2016-02881
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2016-02880
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-02879
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices''. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. This draft guidance is not final nor is it in effect at this time.
Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
Document Number: 2016-02878
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Annual Computational Science Symposium; Conference
Document Number: 2016-02877
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration, in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE) is announcing a public conference entitled ``The FDA/PhUSE Annual Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.
Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
Document Number: 2016-02876
Type: Rule
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.
Gastrointestinal Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-02857
Type: Notice
Date: 2016-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-02853
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-02852
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-02851
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2016-02850
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-02849
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2016-02848
Type: Notice
Date: 2016-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Reporting and Returning of Overpayments
Document Number: 2016-02789
Type: Rule
Date: 2016-02-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date that is 60 days after the date on which the overpayment was identified; or the date any corresponding cost report is due, if applicable. The requirements in this rule are meant to ensure compliance with applicable statutes, promote the furnishing of high quality care, and to protect the Medicare Trust Funds against fraud and improper payments. This rule provides needed clarity and consistency in the reporting and returning of self-identified overpayments.
Notice of Kidney Interagency Coordinating Committee Meeting
Document Number: 2016-02809
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, National Institutes of Health
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on March 11, 2016, on the programmatic implications of the United States Renal Data System (USRDS) to federal agencies. The meeting is open to the public.
Medicare Program: Notice of Seven Membership Appointments to the Advisory Panel on Hospital Outpatient Payment
Document Number: 2016-02798
Type: Notice
Date: 2016-02-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces seven new membership appointments to the Advisory Panel on Hospital Outpatient Payment (the Panel). The seven new appointments to the Panel will each serve a 4-year period. The new members have terms that begin in Calendar Year (CY) 2016 and end in CY 2020. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system. The Secretary rechartered the Panel in 2014 for a 2-year period effective through November 6, 2016.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2016-02794
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Pharmacy Compounding Advisory Committee; Notice of Meeting
Document Number: 2016-02786
Type: Notice
Date: 2016-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pharmacy Compounding Advisory Committee (PCAC). General Function of the Committee: To provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. Date and Time: The meeting will be held on March 8, 2016, from 8:30 a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Office of the Assistant Secretary, Office of the Deputy Assistant Secretary for Early Childhood Development, Office of Head Start, Office of Child Care; Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-02784
Type: Notice
Date: 2016-02-11
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of organization, functions, and delegations of authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Early Childhood Development (ODAS-ECD) within the Office of the Assistant Secretary (OAS), the Office of Head Start (OHS), and the Office of Child Care (OCC). This reorganization will transfer reporting authority of OCC and OHS in their entirety from OAS to the ODAS-ECD. This reorganization creates within ODAS-ECD the Division of Policy and Budget; the Division of Comprehensive Services and Training and Technical Assistance; the Division of Research, Analysis, and Communications; and the Division of Interagency and Special Initiatives. Additionally, this reorganization will realign and combine several functions currently separately managed within OHS, OCC, and ODAS-ECD. The ODAS-ECD reviewed the programmatic and administrative similarities and differences between OHS and OCC and is proposing a new organizational structure that will not only retain the autonomy of the Head Start and Child Care programs and retain the best parts of how they provide services, but will also demonstrate a clear message to the field about the alignment of the Head Start and Child Care program offices, the unified focus of ensuring children receive quality services regardless of their program option, and a common message about the quality and expectations for services to children and families. Internally, the proposed reorganization will generate a more integrated alignment of standards through Head Start and Child Care programs, the development of a unified training and technical assistance system, consistent access to resources at the ACF level for both programs, and a shared use of research resources and agenda. Additionally, the proposed reorganization will result in greater collaborative efforts among both offices thereby leveraging best practices across both offices (monitoring, program outreach, content development, etc.). Moreover, both staffs will gain a broader understanding of the early childhood field and the inter-dependencies between programs. Within OHS, this reorganization eliminates the Education and Comprehensive Services Division and moves some of the functions to the newly created Division of Comprehensive Services and Training and Technical Assistance and the Division of Research, Analysis, and Communications within ODAS-ECD. It eliminates the Policy and Planning Division in OHS and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to a new OHS Division of Planning, Oversight, and Policy. It eliminates the State Initiatives Division in OHS and moves some of those functions to each of the newly created Division of Interagency and Special Initiatives and the Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also deletes the Grants and Contracts Division in OHS and moves the functions to two newly created and separate Divisions within OHSthe Division of Contracts and the Division of Grants. It combines the previous OHS Quality Assurance Division and OHS Policy and Planning Division to create the OHS Division of Planning, Oversight, and Policy. The OHS Program Operations Division remains the OHS Division of Program Operations. Within OCC, this reorganization eliminates the Division of Technical Assistance and moves most of its functions to the newly created Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also eliminates the Division of Policy in OCC and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to the new OCC Division of Planning, Data, and Policy. Within OCC, it creates a new Divisionthe Division of Oversight and Accountability. The OCC Division of Program Operations remains the Division of Program Operations. The goal of this reorganization is to more closely align early childhood programs, policies, and support functions in order to improve collaboration between OHS, OCC, and other federal agencies as appropriate. This will leverage best practices, generating more integrated and aligned standards through Head Start and Child Care, and improving access to ACF resources for OHS and OCC grantees while fully supporting the fundamental responsibility of operating Head Start and the Child Care and Development Fund to ensure the authorized purposes of each program and its funding are fully realized. This notice amends Part K of the Statement of Organization Functions, and Delegations of Authority of the Department of Health and Human Services, Administration for Children and Families: Chapter K, Administration for Children and Families, as last amended 77 FR 23250- 23260, April 18, 2012; Chapter KA, Office of the Assistant Secretary, as last amended 80 FR 33269-33270, June 11, 2015, and 75 FR 60471- 60473, September 30, 2010; Chapter KU, Office of Head Start (OHS), as last amended 75 FR 81280-81282, December 27, 2010; Chapter KV, Office of Child Care (OCC) as last amended 75 FR 60471-60473, September 30, 2010.