Department of Health and Human Services September 17, 2014 – Federal Register Recent Federal Regulation Documents

Announcement of the Intent To Award a Single-Source Cooperative Agreement to the Gerontology Institute, University of Massachusetts Boston
Document Number: 2014-22185
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $75,000 to the Gerontology Institute, University of Massachusetts Boston (UMass Boston) to support and stimulate the expansion of work already underway by UMass Boston in providing pension counseling services to residents of the State of Illinois.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evidence-Based Falls Prevention Program Standardized Data Collection
Document Number: 2014-22184
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services
The Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-22135
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2014-22134
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-22133
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-22132
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-22131
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-22130
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2014-22129
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-22128
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2014-22123
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Electronic Cigarettes and the Public Health; Public Workshop
Document Number: 2014-22122
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Proper Justification of Impurity Limits; Availability
Document Number: 2014-22110
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsRefuse to Receive for Lack of Proper Justification of Impurity Limits.'' This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements) for which the applicant is seeking approval of a new strength of the drug product. The draft guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent
Document Number: 2014-22089
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Exception From General Requirements for Informed Consent'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug
Document Number: 2014-22088
Type: Notice
Date: 2014-09-17
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
Document Number: 2014-22086
Type: Notice
Date: 2014-09-17
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 Ebola Zaire virus (detected in the West Africa outbreak in 2014). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola 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.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-22071
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive Standards; Availability
Document Number: 2014-22068
Type: Notice
Date: 2014-09-17
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 ``ANDA Submissions Refuse-to-Receive Standards.'' It finalizes the draft guidance with the same name that published on October 1, 2013. This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements for new strengths). The guidance represents the FDA's current thinking regarding the types of serious deficiencies that may cause FDA to refuse-to-receive the submission.