Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 284
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
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 information collection requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.
National Biodefense Science Board; Call for Nominees
The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the National Biodefense Science Board (NBSB). Six members have membership expiration dates of December 31, 2013; therefore six new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry, Academia, Healthcare Consumer Organizations, and Organizations Representing Other Appropriate Stakeholders. Please visit the NBSB Web site at www.phe.gov/nbsb for all application submission information and instructions. The deadline for all application submissions is July 7, 2013, at 11:59 p.m.
Submission for OMB Review; 30-day Comment Request; Web-Based Media Literacy Parent Training for Substance Use Prevention in Rural Locations
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 27, 2013, pages 18612-18613 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
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.
Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025% and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurandrenolide ointment, 0.025% and 0.05%, if all other legal and regulatory requirements are met.
Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Electron Beam and X-Ray Sources for Irradiation of Poultry Feed and Poultry Feed Ingredients; Correction
The Food and Drug Administration (FDA) is correcting a document amending the regulations for irradiation of animal feed and pet food that appeared in the Federal Register of May 10, 2013 (78 FR 27303). That document used incorrect style for the strength units describing radiation sources. This correction is being made to improve the accuracy of the animal drug regulations.
Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for Detecting Hematomas
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive evaluation option license to practice the inventions embodied in: HHS Ref. No. E-010-2010/0, U.S. Provisional Patent Application No. 61/286,626, filed December 15, 2009, International Patent Application PCT/US2010/060506 filed December 15, 2010 (published as WO2011084480), European Patent Application 10798422.1 filed December 15, 2010, and U.S. Patent Application 13/ 516,480 filed June 15, 2012, to ArcheOptix, having its principle place of business in Kingston, Ontario (Canada). The United States of America is an assignee to the patent rights of these inventions. The contemplated exclusive license may be limited to devices for the detection of hematomas. Upon the expiration or termination of the start-up exclusive evaluation license, ArcheOptix will have the right to execute a start-up exclusive patent commercialization license with no greater field of use and territory than granted in the evaluation license.
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 (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.
Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products,'' dated June 2013. The final guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title dated April 2009 and published under Docket No. FDA-2009-D-0179.
Technical Corrections to the HIPAA Privacy, Security, and Enforcement Rules
These technical corrections address certain inadvertent errors and omissions in the HIPAA Privacy, Security, and Enforcement Rules that are located at 45 CFR parts 160 and 164.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
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.
``Script Your Future'' Medication Adherence Campaign
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the continuing support of a national effort to promote the importance of medication adherence to enhance the health of Americans. Medication adherence is taking medicine as directed to treat an illness or disease in order to get the best health outcome possible for each patient. Nearly three out of four Americans report that they do not take their medication as directed. One in three people never fill their prescriptions. The annual price tag for medication adherence failure is estimated to be $290 billion, and the impact on the medical system and patients from this lack of adherence may result in relapses or recurrences of medical symptoms, increases in hospital visits, or even death. FDA is committed to addressing this issue, which has enormous implications for public health and the U.S. economy, by, in part, continuing its financial and other contributions to a carefully planned, well-executed effective national campaign begun in 2010 by the National Consumers League (NCL) called ``Script Your Future''. To continue and enhance this important public health initiative, the Division of Health Communications (DHC)/Office of Communications (OCOMM)/Center for Drug Evaluation and Research (CDER) in FDA seeks to assist the National Consumers League in the development of new online resources and tools for patients, engagement of public and private partners to build on and complement existing medication adherence programs, education of health care professionals with strategies to share with patients, continuous evaluation of the campaign to enhance and improve it, expansion of public-private partnerships, strengthening of this national forum focused on informing consumers about medication adherence, and tailoring messaging to subpopulations of consumers who may need adaptations or special efforts to inform and educate them.
Determination That SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SUBOXONE (buprenorphine hydrochloride (HCl) and naloxone HCl) sublingual tablets, 2 milligrams (mg)/0.5 mg and 8 mg/2 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for buprenorphine HCl and naloxone HCl sublingual tablets, 2 mg/0.5 mg and 8 mg/2 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Proposed Collection; Comment Request; University Centers for Excellence in Developmental Disabilities Education, Research, and Service-Annual Report
The Administration on Intellectual and Developmental Disabilities (AIDD), now part of the Administration for Community Living, 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``A Prototype Consumer Reporting System For Patient Safety Events.'' In accordance with the Paperwork Reduction Act; 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 11th, 2012 and allowed 60 days for public comment. AHRQ received 45 substantive comments and 64 personal stories from members of the public. These comments and personal stories raised 37 issues in the wording of the intake form, two issues with wording in other supporting documentation to the intake form, and 69 design issues that we categorized into 18 types of design concerns. To address these comments substantial revisions were made to the data collection tools and supporting documentation. The purpose of this notice is to allow an additional 30 days for public comment.
Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On May 29, 2013, the Secretary determined 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 United States citizens living abroad and that involves Middle East respiratory syndrome coronavirus (MERS-CoV). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Middle East respiratory syndrome coronavirus (MERS-CoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Request for Information: Solicits Public Input on the Renewal of “Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis”
The Department of Health and Human Services (HHS) is seeking broad public input as it begins efforts to renew the 2011 Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis to include actions which can be undertaken over the course of the next three years, 2014-2016.
New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.
Request for Comments on Issues Related to Incidental Findings That Arise in the Clinical, Research, and Direct-To-Consumer Contexts
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts.
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