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

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Document Number: 2014-08947
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08907
Type: Notice
Date: 2014-04-18
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), the 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: Dr. David Thomas, Director of the NIH Centers of Excellence in Pain Education Program, National Institute on Drug Abuse, 6001 Executive Blvd., Room 3165, Rockville, MD 20852, or call non-toll free number (301) 435-1313, or Email your request, including your address to: dthomas1@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Document Number: 2014-08898
Type: Notice
Date: 2014-04-18
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Document Number: 2014-08897
Type: Notice
Date: 2014-04-18
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.
Document Number: 2014-08884
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08883
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08882
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08881
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Document Number: 2014-08831
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services
Pursuant to 42 U.S.C. 300u, notice is given that the Office on Women's Health (OWH) is soliciting proposals from entities and organizations for the opportunity to exclusively license the trademarks and service marks which are critical to communicating the messages of the Best Bones Forever! public health awareness campaign.
Document Number: 2014-08830
Type: Notice
Date: 2014-04-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration, Department of Health and Human Services, is announcing a decrease in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank (NPDB). The new fee will be $3.00 for both continuous and one-time queries and $5.00 for self- queries.
Document Number: 2014-08784
Type: Notice
Date: 2014-04-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08826
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.
Document Number: 2014-08762
Type: Notice
Date: 2014-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08761
Type: Notice
Date: 2014-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08760
Type: Notice
Date: 2014-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08758
Type: Notice
Date: 2014-04-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice reopens the application period and provides information on new dates for the submission of the Comprehensive ESRD Care initiative letters of intent and application. The letter of intent submission date for End-stage Renal Disease Seamless Care Organizations (ESCOs) that include a dialysis facility from a large dialysis organization (LDO) is June 23, 2014, and the submission deadline for the LDO application is June 23, 2014. The letter of intent submission date for ESCOs that include a non-LDO facility is September 15, 2014, and the submission deadline for the non-LDO application is September 15, 2014.
Document Number: 2014-08711
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.'' National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs to mitigate future outbreaks of TASS. This draft guidance is not final nor is it in effect at this time.
Document Number: 2014-08710
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.'' This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA's regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the United States. This draft guidance is not final nor is it in effect at this time.
Document Number: 2014-08709
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on voluntary customer satisfaction service surveys to implement Executive Order 12862.
Document Number: 2014-08708
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations.
Document Number: 2014-08707
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment. This notice solicits comments on the information collection provisions of our recordkeeping and records access requirements for food facilities.
Document Number: 2014-08706
Type: Notice
Date: 2014-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Quidel Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Document Number: 2014-08681
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08680
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08679
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08678
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08677
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08676
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08675
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08674
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-08593
Type: Notice
Date: 2014-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08551
Type: Notice
Date: 2014-04-17
Agency: Department of Health and Human Services
Document Number: 2014-08602
Type: Proposed Rule
Date: 2014-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this proposed rule would adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions. It would also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions. We are providing the LSC citation, a description of the 2012 requirement, and an explanation of its benefits for health care facilities, patients, staff, and visitors over the 2000 version in each occupancy section.
Document Number: 2014-08592
Type: Notice
Date: 2014-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-08591
Type: Notice
Date: 2014-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rescheduling of a February 13, 2014, public workshop convened by the Institute of Medicine (IOM) entitled ``Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making,'' published in the Federal Register of January 10, 2014. Due to inclement weather, the Federal Government was closed on February 13, 2014. We are rescheduling the public workshop to May 12, 2014, and extending the comment period for the public docket.
Document Number: 2014-08590
Type: Notice
Date: 2014-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling) and Generally Recognized as Safe (GRAS) affirmations, submission of information to a master file in support of petitions, and electronic submission using FDA Form 3503.
Document Number: 2014-08589
Type: Notice
Date: 2014-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Orphan Drug Products: Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671).
Document Number: 2014-08561
Type: Notice
Date: 2014-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08560
Type: Notice
Date: 2014-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08558
Type: Notice
Date: 2014-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08557
Type: Notice
Date: 2014-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08533
Type: Notice
Date: 2014-04-15
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 of Mental Health (NIMH), 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: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: kshropsh@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: NIMH Database of Cognitive Training and Remediation Studies, 0925-New; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMH Database of Cognitive Training and Remediation Studies (DCTRS) is an integrated database that includes study- and subject-level data from studies of cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH staff and interested investigators to examine the ways in which various patient characteristics, intervention approaches and features, and treatment combinations affect responses to remediation. The DCTRS Study Information Form and Data Submission Agreement are necessary for the ``Submitter'' to request permission to submit study data to the NIMH DCTRS for general research purposes. The primary use of this information is to collect submitter information and study information for inclusion in the NIMH DCTRS database. The DCTRS data submission agreement includes two forms: (1) The data submission form that includes the terms, agreement, submitter information and certifications, and (2) the study information form which collects de- identified data for each study. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 60.
Document Number: 2014-08446
Type: Notice
Date: 2014-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-08445
Type: Rule
Date: 2014-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2014. 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 a change of sponsorship for an ANADA.
Document Number: 2014-08428
Type: Notice
Date: 2014-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of the Compliance Policy Guide (CPG) Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee ProductsHypoglycin A Toxin. The CPG provides guidance for FDA staff on our enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin A.
Document Number: 2014-08395
Type: Proposed Rule
Date: 2014-04-15
Agency: Department of Health and Human Services
This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''
Document Number: 2014-08390
Type: Notice
Date: 2014-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-08389
Type: Notice
Date: 2014-04-15
Agency: Department of Health and Human Services, National Institutes of Health