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

Results 351 - 400 of 27,522
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-20263
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20262
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2018-20261
Type: Notice
Date: 2018-09-18
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: 2018-20260
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-20248
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Behavioral Risk Factor Surveillance System (BRFSS), an annual state-based health survey that produces state-level information on health risk behaviors, health conditions, and preventive health practices that are associated with chronic diseases, infectious diseases, and injury.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-20247
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Using Social Media for Recruitment in Cancer Prevention and Control Survey-Based Research (SMFR) project. The SMFR project aims to better understand how individuals at high-risk for cancer discuss risk and genetic testing with their families, while evaluating the feasibility of using social media to conduct survey-based cancer prevention and control research for survey recruitment.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-20245
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-20244
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-20233
Type: Notice
Date: 2018-09-18
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 Endocrinologic and Metabolic 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.
Proposed Information Collection Activity
Document Number: 2018-20223
Type: Notice
Date: 2018-09-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is proposing an additional data collection activity as part of the Evaluation of Employment Coaching for TANF and Related Populations. The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs approved this information collection in March 2018 (0970-0506). ACF is proposing a second follow-up survey conducted as part of the evaluation. This study will provide an opportunity to learn more about the potential of coaching to help clients achieve self-sufficiency and other desired employment-related outcomes. It will take place over five years in the following employment programs: MyGoals for Employment Success in Baltimore, MyGoals for Employment Success in Houston, Family Development and Self-Sufficiency program in Iowa, LIFT in New York City, Chicago, and Los Angeles; Work Success in Utah; and Goal4 It! in Jefferson County, Colorado. Together, these programs will include Temporary Assistance for Needy Families (TANF) agencies and other public or private employment programs that serve low-income individuals. Each site will have a robust coaching component and the capacity to conduct a rigorous impact evaluation. This study will provide information on whether coaching helps people obtain and retain jobs, advance in their careers, move toward self-sufficiency, and improve their overall well-being. To meet these objectives, this study includes an impact and implementation study, as approved by OMB. This submission builds on the existing impact study, which randomly assigned participants to either a ``program group,'' who were paired with a coach, or to a ``control group,'' who were not paired with a coach. The effectiveness of the coaching will be determined by differences between members of the program and control groups in outcomes such as obtaining and retaining employment, earnings, measures of self-sufficiency, and measures of self-regulation. The proposed information collection activity is a second follow-up survey, which will be available to participants approximately 21 months after random assignment. The second follow-up survey will provide rigorous evidence on whether the coaching interventions are effective, for whom, and under what circumstances. Respondents: Individuals enrolled in the Evaluation of Employment Coaching for TANF and Related Populations. All participants will be able to opt out of participating in the data collection activities.
Oakshire Naturals LP; Filing of Food Additive Petition
Document Number: 2018-20217
Type: Proposed Rule
Date: 2018-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories.
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2018-20214
Type: Notice
Date: 2018-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between April 2, 2018, and September 14, 2018, on FDA's website but not presented at the September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials
Document Number: 2018-20169
Type: Notice
Date: 2018-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment titled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. To view the notice, document and related materials, visit https://www.regulations.gov and enter CDC-2016-0001 in the search field and click ``Search''.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018; Correction
Document Number: 2018-20153
Type: Notice
Date: 2018-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a technical error in the meeting notice that appeared in the August 31, 2018 Federal Register titled ``Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018.''
Agency for Healthcare Research and Quality; Notice of Meetings
Document Number: 2018-20126
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Draft Update to the Centers for Disease Control and Prevention Infection Prevention and Control Recommendation Categorization Scheme
Document Number: 2018-20118
Type: Notice
Date: 2018-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Update to the Centers for Disease Control and Prevention Infection Prevention and Control Recommendation Categorization Scheme (Draft Update). The Draft Update provides updated categories that specify the strength of CDC's Infection Prevention and Control Guideline Recommendations. The Draft Update also includes recommendation justification tables, a new component of the recommendation development process, that provide transparency into the considerations weighed when developing infection prevention and control recommendations.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20113
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-20112
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-20111
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2018-20110
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October meeting, the Long-Term Services and Supports Subcommittee will be taking charge of the theme. The topics covered will include: (1) The experience of people with dementia who have special needs due to issues like diversity, geography, and concurrent disorders; (2) How clinical care can be better integrated with community-based supports and services; and (3) Evidence-based behavioral approaches that mitigate the impact of behavioral symptoms of dementia. The meeting will also include updates on work from the previous meetings and federal workgroup updates.
Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability
Document Number: 2018-20109
Type: Rule
Date: 2018-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled ``Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry.'' This guidance explains our current thinking on how to determine whether a facility is a ``qualified facility'' that is subject to modified requirements under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' (the Preventive Controls for Human Food Rule) or under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' (the Preventive Controls for Animal Food Rule). This guidance also explains our current thinking on how a facility would submit Form FDA 3942a, attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b, attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule.
Advisory Committee; Oncologic Drugs Advisory Committee; Renewal
Document Number: 2018-20108
Type: Notice
Date: 2018-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-20092
Type: Notice
Date: 2018-09-17
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from medical specialty groups and/or medical experts regarding compounded drug products that contain certain bulk drug substances to support establishment of a list of bulk drug substances under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction
Document Number: 2018-20091
Type: Notice
Date: 2018-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of September 11, 2018. The document announced a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and establishment of a public docket for comments. The document was published with the incorrect docket number. This document corrects that error.
Pathogen Reduction Technologies for Blood Safety; Public Workshop
Document Number: 2018-20090
Type: Notice
Date: 2018-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Pathogen Reduction Technologies for Blood Safety.'' The purpose of the public workshop is to foster the development and implementation of pathogen reduction technologies for blood components intended for transfusion. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.
Submission for OMB Review; Comment Request
Document Number: 2018-20087
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, Administration for Children and Families
Temporary Assistance for Needy Families (TANF) Data Innovations (TDI) Project (New Collection)
Document Number: 2018-20085
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) proposes to collect information as part of the TANF Data Innovations (TDI) project. TDI is an investment to expand the integration, analysis, and use of TANF data to improve program administration, payment integrity, and outcomes for participants. TDI will start by assessing the needs and readiness of TANF agencies across the country to set up and operate data systems to support program improvement. A key goal of the needs assessment is to help categorize states' readiness to effectively use data and produce evidence. Informed by this assessment and discussions with key stakeholders, TDI will support a broad learning collaborative of state agencies and other entities related to the TANF program, including a range of Technical Assistance (TA) options to help states improve their use of TANF and other program data. This information collection request will consist of a needs assessment survey to be completed by state TANF agency administrators and staff to gather detailed information about their capacities and needs. These data will help HHS to better understand the challenges and barriers states face in using data and research to inform program decision-making, and they will help the TDI team design future technical assistance activities for TANF agencies to address states' challenges. Respondents: State TANF Administrators and TANF agency staff. We expect four respondents per state or territory.
Proposed Information Collection Activity; Descriptive Study of the Unaccompanied Refugee Minors Program (New Collection)
Document Number: 2018-20068
Type: Notice
Date: 2018-09-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) at the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of a project to better understand the range of child welfare services and benefits provided through the Unaccompanied Refugee Minors (URM) Program.
Privacy Act of 1974; System of Records
Document Number: 2018-20063
Type: Notice
Date: 2018-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), proposes to modify or alter an existing system of records subject to the Privacy Act, System No. 09- 70-0541, titled ``Medicaid Statistical Information System (MSIS).'' This system of records covers the Medicaid dataset. The dataset includes standardized enrollment, eligibility, and paid claims of Medicaid recipients and is used to administer Medicaid at the Federal level, produce statistical reports, support Medicaid related research, and assist in the detection of fraud and abuse in the Medicare and Medicaid programs. CMS is adding two new routine use as numbers three and 10. CMS is including two routine uses that were published on February 14, 2018, and are numbered as eight and nine in the routine use section below. In addition, CMS is changing the name of the system of records to: Transformed-Medicaid Statistical Information System (T- MSIS) and making other modifications which are explained below.
Meeting of the Advisory Committee on Minority Health
Document Number: 2018-20040
Type: Notice
Date: 2018-09-14
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by October 11, 2018. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)-CE19-001, Injury Control Research Centers; Amended Notice of Meeting
Document Number: 2018-20024
Type: Notice
Date: 2018-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2018-20018
Type: Notice
Date: 2018-09-14
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 guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (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 guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors Office of Public Health Preparedness and Response
Document Number: 2018-20017
Type: Notice
Date: 2018-09-14
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 BSC OPHPR. The BSC OPHPR consists of 11 experts in fields associated with business, crisis leadership, emergency response and management, engineering, epidemiology, health policy and management, informatics, laboratory science, medicine, mental and behavioral health, public health law, public health practice, risk communication and social science. 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 engineering, medicine, emergency response, and risk communication. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC OPHPR objectives (https:// www.cdc.gov/phpr/bsc/index.htm).
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), Subcommittee on Procedures Review (SPR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2018-20016
Type: Notice
Date: 2018-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Procedure Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2018-20015
Type: Notice
Date: 2018-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Announcement of Intent To Establish the 2020 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership
Document Number: 2018-20013
Type: Notice
Date: 2018-09-14
Agency: Department of Agriculture, Department of Health and Human Services
The Departments of Agriculture and Health and Human Services published a document in the Federal Register of September 6, 2018 concerning solicitation of nominations for membership on the 2020 Dietary Guidelines Advisory Committee. The document contained incorrect dates.
Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-19993
Type: Notice
Date: 2018-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled ``Recognition and Withdrawal of Voluntary Consensus Standards.'' This draft guidance identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. It provides information on how you may request recognition as well as circumstances under which FDA may withdraw recognition. This draft guidance also responds to a provision of the 21st Century Cures Act (Cures Act) by updating published guidance on these topics. This draft guidance is not final nor is it in effect at this time.
510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations; Availability
Document Number: 2018-19992
Type: Notice
Date: 2018-09-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third-Party (3P) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue draft guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P Review Program is intended to allow review of devices by 3P Review Organizations to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices. This draft guidance is not final nor is it in effect at this time.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-19989
Type: Notice
Date: 2018-09-14
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 entitled ``Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.'' Voluntary consensus standards can be a valuable resource for industry and FDA staff because such standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. FDA developed this document to provide guidance to industry and FDA reviewers about the appropriate use of voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This guidance applies to all articles that meet the definition of a ``device'' under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Intent To Award a Single-Source Supplement; Notice
Document Number: 2018-19925
Type: Notice
Date: 2018-09-14
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by Meals on Wheels America for the project Enhancing the Knowledge and Skills of the Aging Network.
Request for Nominations on the Tobacco Products Scientific Advisory Committee
Document Number: 2018-19922
Type: Notice
Date: 2018-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.
Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee
Document Number: 2018-19921
Type: Notice
Date: 2018-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. 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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-19920
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19919
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-19916
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-19915
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-19914
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products
Document Number: 2018-19913
Type: Notice
Date: 2018-09-13
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 exemptions from substantial equivalence requirements for tobacco products.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-19912
Type: Notice
Date: 2018-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Document Number: 2018-19911
Type: Notice
Date: 2018-09-13
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.