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

Results 151 - 200 of 354
AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR
Document Number: 2016-08894
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for ADVICOR (niacin extended-release (ER) and lovastatin) tablets and SIMCOR (niacin ER and simvastatin) tablets. The holder of these two applications, AbbVie Inc., has requested that FDA withdraw approval of the applications and has waived its opportunity for a hearing. The Agency has also determined that ADVICOR and SIMCOR were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated new drug applications (ANDAs) that reference ADVICOR or SIMCOR.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
Document Number: 2016-08893
Type: Notice
Date: 2016-04-18
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.
Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period
Document Number: 2016-08888
Type: Proposed Rule
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments.
AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules
Document Number: 2016-08887
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the indications related to the coadministration with a statin for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules. Affected applications include one new drug application (NDA) and seven abbreviated new drug applications (ANDAs) for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing.
Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy
Document Number: 2016-08881
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for neuropathic pain associated with peripheral neuropathies. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.
Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Document Number: 2016-08880
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2016-08879
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.'' This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2016-08878
Type: Notice
Date: 2016-04-18
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 ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2016-08877
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-08864
Type: Notice
Date: 2016-04-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-08856
Type: Notice
Date: 2016-04-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments of the public. The purpose of this notice is to allow an additional 30 days for public comment.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: 2016-08827
Type: Rule
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2016-08802
Type: Notice
Date: 2016-04-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-08801
Type: Notice
Date: 2016-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-08800
Type: Notice
Date: 2016-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2016-08810
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, National Institutes of Health
The NIH OSP is amending portions of the NIH Guidelines in order to provide investigators with biosafety guidance regarding the standards for containment of non-human primates (NHPs) in biosafety level (BL) 4 laboratories and to make such guidance consistent with the expectations articulated in the Centers for Disease Control and Prevention (CDC)/NIH Biosafety in Microbiological and Biomedical Laboratories 5th edition (BMBL). Specifically, the NIH Guidelines will allow for housing of NHPs in open caging in a dedicated animal holding room provided there are two physical barriers between that animal holding room and non-containment space within the laboratory, the animal holding room has negative air pressure with respect to any adjacent non-containment corridors, and there are specific decontamination protocols in place before the door to the animal holding room is opened to allow for the periodic transfer of new animals into the room. These amendments do not change the current containment requirements in the NIH Guidelines but rather offer an alternative for achieving primary containment without compromising safety. In addition, the recertification requirement for biosafety cabinets in BL4 laboratories is updated in recognition of the technological standards for modern biosafety cabinets. The NIH OSP also is updating the validation requirements for equipment responsible for centralized heat decontamination of liquid effluents in laboratories working with large animals. These amendments to the NIH Guidelines will be implemented immediately upon publication in the Federal Register. These changes were developed after extensive consultation with biosafety experts, directors of and principal investigators in BL4 facilities working with NHPs, and CDC's Division of Select Agent and Toxins (DSAT) leadership at a public workshop and discussion at a public Recombinant DNA Advisory Committee (RAC) meeting. Publication in the Federal Register will inform the scientific and biosafety communities.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
Document Number: 2016-08792
Type: Rule
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-08784
Type: Notice
Date: 2016-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2016-08737
Type: Notice
Date: 2016-04-15
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 Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the National Resources Center on Domestic Violence, Inc. (NRCDV) in Harrisburg, PA
Document Number: 2016-08716
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
ACF/ACYF/FYSB/DFVPS, in collaboration with CDC/NIPC/DVP announce the award of $686,000 to NRCDV in Harrisburg, Pennsylvania. The grantee is a technical assistance (TA) provider that assists FVPSA service providers to build the capacity of domestic violence programs, continuums of care, homeless service providers, and housing service providers.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-08715
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; CYRAMZA
Document Number: 2016-08692
Type: Notice
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for CYRAMZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2016-08691
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of Health and Human Services. HRSA is seeking nominations of qualified candidates to fill three positions on the Committee.
Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction
Document Number: 2016-08689
Type: Notice
Date: 2016-04-15
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 of March 10, 2014 (79 FR 13308). The document withdrew approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of NDA 017507, held by Xanodyne Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the Agency to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. FDA confirms the withdrawal of approval of NDA 017507.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Center for Devices and Radiological Health Appeals Processes
Document Number: 2016-08685
Type: Notice
Date: 2016-04-15
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.
Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability
Document Number: 2016-08684
Type: Rule
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.
Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
Document Number: 2016-08683
Type: Notice
Date: 2016-04-15
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 ``Data Integrity and Compliance With CGMP.'' The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2016-08682
Type: Notice
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information
Document Number: 2016-08681
Type: Notice
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-08679
Type: Notice
Date: 2016-04-15
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Proposed Collection; 60-Day Comment Request; NLM PEOPLE LOCATOR® System
Document Number: 2016-08659
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NLM People Locator System 0925-0612, Expiration Date: 07/31/2016, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: This collection of data is intended to assist in the reunification of family members and friends who are separated during a disaster. Experience in operational drills and during real-world disasters such as the January 2010 earthquakes in Haiti demonstrates that family members and loved ones are often separated during disasters and have significant difficulty determining each other's safety, condition, and location. Reunification can not only improve their emotional well-being during the recovery period, but also improve the chances that injured victims will be cared for once they are released from urgent medical care. Family and friends are also a valuable source of medical information that may be important to the care of injured victims (e.g., by providing family or personal medical history, information about allergies). The National Library of Medicine (NLM) aims to assist Federal, State and Local agencies in disaster relief efforts and to serve its mission of supporting national efforts to the response to disasters via the PEOPLE LOCATOR[supreg] system and related mobile app (ReUniteTM) developed as part of the intramural Lost Person Finder (LPF) R&D project. The information collection would support efforts to reunite family and friends who are separated during a disaster. Information about missing (``lost'') people would be collected from family members or loved ones who are searching for them. Information about recovered (``found'') people could be provided by medical personnel, volunteers and other relief workers assisting in the disaster recovery effort. Information collected about missing and recovered persons would vary including any one of the following and possibly all: A photograph, name (if available for a found person), age group (child, adult) and/or range, gender, status (alive and well, injured, deceased, unknown), and location. The information collection would be voluntary. It would be activated only during times of declared emergencies, training and demonstration support activities, and would operate in declared emergencies until relief efforts have ceased in response to a particular disaster. This data collection is authorized pursuant to sections 301, 307, 465 and 478A of the Public Health Service Act [42 U.S.C. 241, 242l, 286 and 286d]. NLM has in its mission the development and coordination of communication technology to improve the delivery of health services. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 7,500.
Proposed Collection; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-Wave 4 of Data Collection (NIDA)
Document Number: 2016-08658
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing or request more information on the proposed project, contact: Kevin P. Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 5185; or call non-toll-free number (301) 443-8755; or Email your request, including your address to: PATHprojectofficer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Population Assessment of Tobacco and Health (PATH) StudyWave 4 of Data Collection (NIDA)0925-0664, expiration date 8/31/2018REVISIONNIDA, NIH, in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the fourth wave of data collection. The PATH Study is a large national longitudinal cohort study on tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. On an annual basis, the PATH Study conducts interviews with and collects biospecimens from adults and youth to help inform the development, implementation, and evaluation of tobacco-product regulations by FDA in meeting its mission under the Family Smoking Prevention and Tobacco Control Act (TCA) to regulate tobacco products, including tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. The longitudinal design of the PATH Study provides it with the capacity to measure and report within-person changes and between-person differences in tobacco product use behaviors and health effects within the cohort over time. These data will help to inform regulatory decisions and actions by FDA and FDA's evaluations of associations between its regulations and tobacco use behaviors and health indicators in the population. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 105,079.
Announcement of the Award of a Single-Source Expansion Supplement Grant to National Safe Place Network in Louisville, KY
Document Number: 2016-08654
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source expansion supplement grant of $852,000 to the National Safe Place Network located in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under its award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).
Announcement of the Award of a Single-Source Expansion Supplement Grant to the Washington State Department of Social and Health Services in Lacey, WA
Document Number: 2016-08649
Type: Notice
Date: 2016-04-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), Division of Program Innovation, announces the award of a single-source program expansion supplement grant in the amount of $34,568 to the Washington State Department of Social and Health Services in Lacey, WA, to support the development of additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of the Behavioral Interventions for Child Support Services of the Behavioral Interventions for Child Support Services (BICS) Demonstration. In FY 2014, OCSE competitively awarded a cooperative agreement to the Washington State Department of Social and Health Services to conduct a 5-year evaluation of OCSE's national demonstration called Behavioral Interventions for Child Support Services (BICS) under Funding Opportunity Announcement (FOA) number HHS-2014-ACF-OCSE-FD- 0822. Under this FOA, a total of $1.7 million of 1115 funds are made available over the five year project period to conduct this evaluation. The Washington State Department of Social and Health Services was the only grantee that received funding under this FOA.
Antimicrobial Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-08637
Type: Notice
Date: 2016-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Extension of Comment Period
Document Number: 2016-08678
Type: Notice
Date: 2016-04-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of March 14, 2016. In the notice, FDA requested comments on the Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Award of Single-Source Program Expansion Supplements to the Yakima Valley Farm Workers Clinic, Toppenish, WA, and the Confederated Salish and Kootenai Tribes, Pablo, MT
Document Number: 2016-08588
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB), announces the award of two single-source program expansion supplements in the amount of $69,481 each to the Yakima Valley Farm Workers Clinic, Toppenish, WA, and the Confederated Salish and Kootenai Tribes, Pablo, MT, to support expansion activities to better meet the national need for prevention services to migrant and Native American children and their families.
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to the American Bar Association Fund for Justice and Education, Washington, DC
Document Number: 2016-08545
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single-source program expansion supplement in the amount of $500,000 to the American Bar Association Fund for Justice and Education, Washington, DC, to provide expanded tailored capacity building services to state and tribal Court Improvement Programs and to enhance collaborative work with the other CB funded capacity building providers through the national Child Welfare Capacity Building Center for Courts (CBCC).
Announcing the Award of a Single-Source Program Expansion Supplement to University of Denver (Colorado Seminary), in Denver, CO, for the Capacity Building Center for Tribes
Document Number: 2016-08544
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB), announces the award of a single-source program expansion supplement in the amount of $350,000 to University of Denver (Colorado Seminary), Denver, CO, for the expansion of the Capacity Building Center for Tribes (CBCT) to provide expanded tailored technical assistance to Tribes across the nation and allow for expanded and enhanced collaboration with the other centers that form the Child Welfare Capacity Building Collaborative.
Announcing the Award of a Single-Source Grant to the Pennsylvania Coalition Against Domestic Violence in Harrisburg, PA
Document Number: 2016-08534
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces the award of $175,000 as a single-source grant to the Pennsylvania Coalition Against Domestic Violence (PCADV) in Harrisburg, PA, to support activities by Women of Color Network Inc. (WOCN). The grantee, funded under the FVPSA program, is a technical assistance provider that assists FVPSA service providers to build the capacity of domestic violence programs.
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2016-08523
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, National Institutes of Health
Announcing the Award of a Single-Source Program Expansion Supplement to Zero to Three in Washington, DC, for the Quality Improvement Center for Research-Based Infant-Toddler Court Teams
Document Number: 2016-08521
Type: Notice
Date: 2016-04-14
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB), announces the award of a single-source program expansion supplement in the amount of $3,000,000 to Zero to Three, Washington, DC, for the expansion of the Quality Improvement Center for Research- Based Infant-Toddler Court Teams to promote collaboration with the courts and state, county, or tribal child welfare systems, and other community-based agencies to increase their capacity to incorporate evidence-based practices (EBPs) to strengthen parenting and promote healthy development for infants and toddlers involved with child welfare.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2016-08530
Type: Notice
Date: 2016-04-13
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2016-08525
Type: Notice
Date: 2016-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2016-08524
Type: Notice
Date: 2016-04-13
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2016-08520
Type: Notice
Date: 2016-04-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH)
Document Number: 2016-08519
Type: Notice
Date: 2016-04-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-08518
Type: Notice
Date: 2016-04-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices: Notice of Charter Renewal
Document Number: 2016-08516
Type: Notice
Date: 2016-04-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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