Department of Health and Human Services June 5, 2015 – Federal Register Recent Federal Regulation Documents
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Announcement of Requirements and Registration for “Up For A Challenge (U4C)-Stimulating Innovation in Breast Cancer Genetic Epidemiology”
The National Cancer Institute's (NCI) Division of Cancer Control and Population Sciences (DCCPS) announces that they are partnering with Sage Bionetworks to launch ``Up For A Challenge (U4C) Stimulating Innovation in Breast Cancer Genetic Epidemiology'' (the ``Challenge'') to encourage unique approaches to more fully decipher the genomic basis of breast cancer. Utilizing innovative approaches, the goal of this Challenge is to identify new genes or combinations of genes, genetic variants, or sets of genomic features involved in breast cancer susceptibility. In addition, the NCI aims to advance innovation in the field of genetic epidemiology by making data more widely available, increasing the amount and diversity of minds approaching a difficult scientific problem, and promoting broader collaborations. This Challenge is being launched under the America COMPETES Reauthorization Act of 2010.
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 Assessing and Evaluating Human Systems Integration needs in mining. CDC objective is to conduct research to improve working conditions to prevent accidents and occupational disease in underground coal and metal/nonmetal mines in the U.S.
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 reinstatement of an information collection entitled ``Interventions to Reduce Shoulder MSDs in Overhead Assembly''. This information collection is part of a study to assess the effectiveness and cost- benefit of occupational safety and health (OSH) interventions to prevent musculoskeletal disorders (MSDs) among workers in the Manufacturing (MNF) sector.
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 Monitoring and Reporting System for the National Tobacco Control Program. CDC will use the information collected to monitor cooperative agreement awardees and to identify facilitators and challenges to program implementation and achievement of outcomes.
Notice of Request for Information
The Indian Health Service (IHS) is seeking broad public input as it begins efforts to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, and Transgender (LGBT) community.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and criteria for reinstatement of eligibility. We are issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for in vitro diagnostic devices for detection of the Ebola virus in response to the Ebola virus outbreak in West Africa. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and Cepheid. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow 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 Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Blood Establishment Registration and Product Listing, Form FDA 2830
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices for Finished Pharmaceuticals
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices for Finished Pharmaceuticals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
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 (the PRA).
Final Revised Vaccine Information Materials for Td, Tdap, Hib, and Rotavirus Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On June 25, 2014, CDC published a notice in the Federal Register (79 FR 36068) seeking public comments on proposed new vaccine information materials for Td, Tdap, Haemophilus influenzae type b (Hib), and rotavirus vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for Td, Tdap, Hib, and rotavirus are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https:// www.regulations.gov (see Docket Number CDC-2014-0007).
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