Department of Health and Human Services June 25, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
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.
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' It replaces the draft of the same name that was published on March 14, 2014. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.
List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations; Correction
The Food and Drug Administration is correcting a notice entitled ``List of Bulk Drug Substances That May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations'' that appeared in the Federal Register of May 19, 2015 (80 FR 28622). The document announced the intention to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' The document was published with an incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Hearing, Aging, and Direct-to-Consumer Television Advertisements
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 research entitled, ``Hearing, Aging, and Direct-to-Consumer Television Advertisements''. This study will examine how changes to hearing across the lifespan affect the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed extension of the ``Formative Research and Tool Development'' information collection. Project activities are designed to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) to conduct formative research information collection activities used to inform many aspects of surveillance, communications, health promotion, and research project development for NCHHSTP's four priority diseases (HIV/AIDS), sexually transmitted diseases/infections (STD/STI), viral hepatitis, tuberculosis elimination (TB), and school and adolescent health (DASH).
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the collection of Minimum Data Elements (MDE) for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). CDC collects information about the cancer screening services provided through the NBCCEDP to support program management.
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