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

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Document Number: 2014-09274
Type: Notice
Date: 2014-04-23
Agency: Department of Education, Department of Health and Human Services, Department of Labor
Through this Request for Information (RFI), the Departments of Education (ED), Health and Human Services (HHS), and Labor (DOL) (the Departments) seek to further support the development of high-quality career pathways systems by jointly soliciting information and recommendations from a broad array of stakeholders in the public and private sectors, as well as in State, regional, tribal, and local areas. The Departments will analyze the career pathways information collected from the RFI to: (1) Inform and coordinate policy development, strategic investments, and technical assistance activities; and (2) improve coordination of Federal policy development with investments at the State, tribal and local levels.
Document Number: 2014-09224
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09223
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09222
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09221
Type: Notice
Date: 2014-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09220
Type: Notice
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations.'' The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.
Document Number: 2014-09216
Type: Proposed Rule
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Excentials B.V. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of L- selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.
Document Number: 2014-09202
Type: Notice
Date: 2014-04-23
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.
Document Number: 2014-09201
Type: Notice
Date: 2014-04-23
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.
Document Number: 2014-09200
Type: Notice
Date: 2014-04-23
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.
Document Number: 2014-09190
Type: Notice
Date: 2014-04-23
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 the draft guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This draft guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. This draft guidance is not final nor is it in effect at this time.
Document Number: 2014-09189
Type: Notice
Date: 2014-04-23
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 the draft guidance entitled ``Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions.'' This draft guidance outlines FDA's proposal for a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA). FDA believes that the Expedited Access PMA (EAP) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval, consistent with the Agency's mission to protect and promote public health. The document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework. This draft guidance is not final nor is it in effect at this time.
Document Number: 2014-09188
Type: Notice
Date: 2014-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Food and Drug Administration Transparency Initiative: Increasing Public Access to FDA's Compliance and Enforcement Data.'' This report summarizes findings and recommendations from eight FDA working groups established to enhance the transparency and public accessibility of the Agency's compliance and enforcement data.
Document Number: 2014-09175
Type: Notice
Date: 2014-04-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-007, Patient-Centered Outcomes Research (PCOR) for Deliberative Approaches: Patient and Consumer Input for Implementing Evidence-Based Health Care (R21)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Document Number: 2014-09172
Type: Notice
Date: 2014-04-23
Agency: 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: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Document Number: 2014-09150
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-09149
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-09148
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-09147
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-09146
Type: Notice
Date: 2014-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-09001
Type: Proposed Rule
Date: 2014-04-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau reviews a state's substantial conformity with titles IV-B and IV-E of the Social Security Act through the Child and Family Services Reviews (CFSRs). Statewide data indicators are used to inform the Children's Bureau's determination of a state's substantial conformity relative to certain safety and permanency outcomes. This document advises the public of the Children's Bureau's plan to replace the statewide data indicators and the methods for calculating associated national standards on those indicators. We invite the public to comment on these indicators and methods before their use in CFSRs scheduled for Federal Fiscal Years (FFY) 2015 through FY 2018.
Document Number: 2014-09193
Type: Notice
Date: 2014-04-22
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.
Document Number: 2014-09187
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-09186
Type: Notice
Date: 2014-04-22
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.
Document Number: 2014-09177
Type: Notice
Date: 2014-04-22
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 Clinical Center (CC), 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: Daniel Hobbs, National Institutes of Health, Clinical Research Center, 6100 Executive Blvd. Suite 3C01 MSC 7515, Bethesda, MD 20892-7515 or call non-toll-free number 301-496-3817 or Email your request, including your address to: daniel.hobbs@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: The SSA-NIH Collaboration to Improve the Disability Determination Process: Calibration II & Predictive Validity Testing of IRT-CAT Tools, 0925-New, Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The Social Security Administration (SSA) entered into an interagency agreement (IAA) with the National Institutes of Health (NIH), Clinical Center (CC), Rehabilitation Medicine Department (RMD), to explore innovative methods of functional assessment to improve SSA's disability determination process. As part of its study, NIH recommended item response theory (IRT) coupled with computer adaptive testing (CAT) as a promising approach to efficiently and consistently capture claimant functional information to assist SSA adjudicators. IRT is a framework for the design, analysis, and scoring of tests, questionnaires, and similar instruments measuring abilities, aptitudes, and other variables. It is often the preferred method for the development of tests such as the Graduate Record Examination (GRE) and the Graduate Management Admission Test (GMAT). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 11,361.
Document Number: 2014-09168
Type: Notice
Date: 2014-04-22
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: ``SelectMD 2.0 Clinician Choice Experiment.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January, 29th 2014 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-09132
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Awarding Agency Grants Management Manual (AAGAM) Chapter 1.03.103, the Bureau of Primary Health Care (BPHC) requests a class deviation to award low-cost extensions of up to 6 months or, when necessary, administrative supplements to minimize disruption of services for specific health center program service areas. Per the requirements for low-cost extensions outlined in the AAGAM Chapter 2.04.104B-4A.1.a.(5)(b), these extensions may not exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding requested) or $100,000. Likewise, per the requirements for administrative supplements outlined in the AAGAM Chapter 2.04.104B-4A.4.b, these supplements may not exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding) or $250,000, whichever is less. In each case, the Health Resources and Services Administration (HRSA) is required to publish a notice in the Federal Register in advance of, or concurrent with, the awarding of the funds. BPHC is requesting a class deviation to the requirements for low- cost extensions to allow HRSA to award extensions that exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding requested) and/or $100,000 in cases where the grantee would not receive future continued support under the Health Center Program. Likewise, BPHC is requesting a class deviation to the requirements for administrative supplements to allow HRSA to award supplements that exceed 25 percent of the approved federal direct cost budget authorized for the budget period (exclusive of the additional funding) and/or $250,000 in cases where the award is to a currently funded grantee located in or adjacent to the service area of a grantee that will not receive continued support under the Health Center Program. BPHC is also requesting that the deviation allow for the publication of a consolidated notice in the Federal Register annually that summarizes the actions taken in the prior fiscal year. The sole purpose of these low-cost extensions or administrative supplements is to avoid a gap in the provision of critical health care services for a funded service area by providing a ``bridge'' until HRSA is able to make an award to an eligible applicant under a Service Area Competition (SAC) and/or to assure an orderly phase-out of Health Center Program activities by the current grantee. BPHC is not requesting that this class deviation cover single source replacement awards and will continue to request single case deviations for such non-competitive actions if necessary.
Document Number: 2014-09131
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.
Document Number: 2014-09124
Type: Notice
Date: 2014-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 3 new drug applications and 41 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Document Number: 2014-09123
Type: Notice
Date: 2014-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to obtain stakeholder input on the design and conduct of the postmarketing requirements (PMRs) for the class-wide extended-release/ long-acting (ER/LA) opioid analgesic drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA is seeking input on these issues from stakeholders, including patients, academia, researchers, State and other Federal regulators, health care organizations, health care providers, the pharmaceutical industry, and others from the general public.
Document Number: 2014-09043
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09042
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09041
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09040
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09039
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-09038
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services
Document Number: 2014-09033
Type: Notice
Date: 2014-04-22
Agency: Department of Health and Human Services
Document Number: 2014-09016
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-08977
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2014-08970
Type: Notice
Date: 2014-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-08969
Type: Notice
Date: 2014-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-08968
Type: Notice
Date: 2014-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the period for industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the pharmaceutical manufacturing industry and the pharmacy compounding industry on the Pharmacy Compounding Advisory Committee for the Center for Drug Evaluation and Research to notify FDA of such interest. FDA announced a request for notification of interest in selection of industry representatives and for nominations in the Federal Register on January 13, 2014. This notice requested industry organizations that were interested in participation in the selection process to notify FDA in writing by February 12, 2014, and stated that nominations would be accepted for the two nonvoting vacancies by the same date. Industry organizations that did not notify FDA by the deadline of their interest in participating in the selection of nonvoting pharmacy compounding and pharmaceutical manufacturing industry representatives have now expressed interest in participating. Therefore, FDA is reopening the notification period for an additional two weeks so that any interested industry organizations wanting to participate can notify the Agency of their interest.
Document Number: 2014-08959
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-08958
Type: Notice
Date: 2014-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-08957
Type: Notice
Date: 2014-04-21
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study, Risk and Benefit Perception Scale Development. The study is designed to test different ways of measuring consumers' benefit and risk perceptions after exposure to direct-to-consumer (DTC) prescription drug advertising.
Document Number: 2014-08946
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08945
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08944
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08943
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08941
Type: Notice
Date: 2014-04-21
Agency: Department of Health and Human Services, National Institutes of Health