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

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Document Number: 2015-09610
Type: Notice
Date: 2015-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice announces the receipt of an application from the American Association of Diabetes Educators for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries.
Document Number: 2015-09609
Type: Notice
Date: 2015-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the renewal of the Advisory Panel (the Panel) on Hospital Outpatient Payment (HOP) charter. The charter was approved on November 6, 2014 for a 2-year period effective through November 6, 2016. This notice publicly announces the renewal of the HOP Panel for another 2-year period. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Document Number: 2015-09607
Type: Notice
Date: 2015-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 22, 2015. This meeting will specifically focus on lower extremity peripheral artery disease. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Document Number: 2015-09606
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living announces a priority for the Disability and Rehabilitation Research Projects (DRRPs) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, we announce a priority for a DRRP on Promoting Universal Design in the Built Environment. The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to strengthened evidence-base for UD standards and strategies and improved access to the built environment for individuals with disabilities.
Document Number: 2015-09602
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Document Number: 2015-09592
Type: Notice
Date: 2015-04-24
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: 2015-09591
Type: Notice
Date: 2015-04-24
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: 2015-09557
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services, Administration for Children and Families, Administration for Native Americans (ANA) will host a Tribal Consultation to consult on the Community Native Language Coordination Initiative, an expansion of funding for ANA proposed in the President's fiscal year 2016 budget.
Document Number: 2015-09539
Type: Notice
Date: 2015-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Document Number: 2015-09524
Type: Notice
Date: 2015-04-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 proposed information collection entitled Metal and Nonmetal Miner Health Program (MNMHP). The MNMHP proposes to gather health data on metal and nonmetal miners to identify opportunities for reducing the incidence and severity of disease.
Document Number: 2015-09523
Type: Proposed Rule
Date: 2015-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Document Number: 2015-09522
Type: Notice
Date: 2015-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for KYNAMRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Document Number: 2015-09521
Type: Notice
Date: 2015-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for FLUBLOK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Document Number: 2015-09505
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09504
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09503
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09502
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09501
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09500
Type: Notice
Date: 2015-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09487
Type: Rule
Date: 2015-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Document Number: 2015-09473
Type: Notice
Date: 2015-04-23
Agency: Department of Health and Human Services
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the recommendation sections of the 2015 Report to the President (RTP). The topic of the PCPID 2015 RTP will be on the roles of technology in the lives of individuals with intellectual and developmental disabilities and their families. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format. The public can register to attend this webinar/conference call at https://aoa-events.webex.com/aoa-events/onstage/ g.php?MTID=e9c2bd91a90e7ed853b85f3ba0b1b62a2.
Document Number: 2015-09441
Type: Notice
Date: 2015-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09440
Type: Notice
Date: 2015-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces the availability of a draft NTP Technical Report (TR) scheduled for peer review: Pentabromodiphenyl ether mixture [DE-71 (technical grade)]. The peer review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/36051.
Document Number: 2015-09415
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Public Law 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2014 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2014. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at http:// www.whitehouse.gov/sites/default/files/omb/procurement/memo/s ervice- contract-inventories-guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: http://www.hhs.gov/grants/servicecontracts/.
Document Number: 2015-09412
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is issuing a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to Ebola Virus Disease Therapeutics consistent with the terms of the Declaration.
Document Number: 2015-09366
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the 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 February 5, 2015, page 6522 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 Office of Extramural Research (OER), National Institutes of Health (NIH), 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. Comment 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.
Document Number: 2015-09362
Type: Notice
Date: 2015-04-22
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 Library of Medicine (NLM), 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: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@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: Generic Clearance to Conduct Voluntary Customer/Partner Surveys (NLM), 0925-0476, Expiration Date 07/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: In 1994, the NLM was designated a ``Federal Reinvention Laboratory'' with a major objective of improving its methods of delivering information to the public. At a minimum, necessary elements in improving the delivery of information include: (1) Development of easy-to-use access and delivery mechanisms that promote the public's understanding of health information, drawing on research in lay terminology, graphical and multimedia presentations; (2) assisting those providing health information to the public to make effective use of electronic services through Internet connections, training, and other means, with an emphasis on those serving minority groups, low income populations, and seniors; (3) promoting integrations of NLM services with other electronic services covering regional, state, or local health information; and (4) conducting and supporting research, development, and evaluation of the public's health information needs, information seeking behavior and learning styles, information systems that meet the public's needs, and the impact of access to information. NLM has become an international leader in health informatics research and development, especially in consumer health informatics. As a result, NLM needs to remain contemporary in consumer health informatics research by utilizing research methods that yield a better understanding of the predictors of consumer satisfaction. Without ongoing insights into the predictors of consumer satisfaction, NLM will lack the research findings to make evidence-based changes in the content, design and editorial management of its consumer Web sites and will not optimally serve the public. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 750.
Document Number: 2015-09359
Type: Notice
Date: 2015-04-22
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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 to address 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) the quality, utility, and clarity of the information to be collected; and (4) 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. Jack Moye, 6100 Executive Boulevard, Rockville Pike, MD 20891 or call 301- 594-8624 or Email your request, including your address to: moyej@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Document Number: 2015-09351
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services, Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE) will host a Tribal Consultation to consult on the implementation of Section 302 of Public Law 113-183, the Preventing Sex Trafficking and Strengthening Families Act of 2014 (Act).
Document Number: 2015-09303
Type: Notice
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications for the treatment of non- small cell lung cancer. This guidance focuses on endpoints specifically for lung cancer trials to support drug approval or labeling claims. This guidance should speed the development and improve the quality of protocols submitted to FDA to support anticancer effectiveness claims. This guidance finalizes the draft guidance issued on June 17, 2011.
Document Number: 2015-09302
Type: Notice
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for COMETRIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Document Number: 2015-09301
Type: Rule
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule entitled ``Administrative Detention of Drugs Intended for Human or Animal Use'' that appeared in the Federal Register of May 29, 2014 (79 FR 30716). The rule sets forth the procedures for detention of drugs believed to be adulterated or misbranded and amends the scope of FDA's part 16 regulatory hearing procedures to include the administrative detention of drugs. The rule published with incorrect statements regarding the impact of the final rule on small entities. This document corrects those errors.
Document Number: 2015-09300
Type: Notice
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain comments on the interim assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). FDA is also announcing a public meeting where the interim assessment will be discussed and public stakeholders may present their views on the Program to date. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which enables FDA to collect user fees for the review of human drug and biologics applications for fiscal years (FYs) 2013-2017. The Program is described in detail in section II.B entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017.'' The Program is being evaluated by an independent contractor with expertise in assessing the quality and efficiency of pharmaceutical and biopharmaceutical development and regulatory review programs. As part of FDA's performance commitments, FDA is providing a period for public comment on the interim assessment of the Program.
Document Number: 2015-09299
Type: Notice
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that OXYTOCIN 5 United States Pharmacopeia (USP) Units in Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500 milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL, (2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL); and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable, injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter ``these oxytocin drug products'') were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve an abbreviated new drug application (ANDA) for these oxytocin drug products, if all other legal and regulatory requirements are met.
Document Number: 2015-09298
Type: Notice
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Document Number: 2015-09297
Type: Notice
Date: 2015-04-22
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 ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This draft guidance explains how manufacturers, packers, and distributors (firms) that may either be the applicant or acting on behalf of the applicant, should make submissions pertaining to promotional materials for human prescription drugs and biologic products (``drugs'') to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This draft guidance describes the various types of submissions of promotional materials and general considerations for submissions. In addition, this draft guidance discusses the specific aspects of submission of promotional materials using module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file. This guidance does not address the more general requirements for a valid electronic submission using eCTD or the specifications for module 1 of the eCTD. This guidance contains both binding and nonbinding provisions.
Document Number: 2015-09248
Type: Proposed Rule
Date: 2015-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by E. & J. Gallo Winery, proposing that the color additive regulations be amended to provide for the safe use of mica-based pearlescent pigments as color additives in certain distilled spirits.
Document Number: 2015-09237
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09236
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services
Document Number: 2015-09235
Type: Notice
Date: 2015-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-09192
Type: Notice
Date: 2015-04-21
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-09191
Type: Notice
Date: 2015-04-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-09189
Type: Notice
Date: 2015-04-21
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-09176
Type: Notice
Date: 2015-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance articulates FDA's current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability to populations within the United States and study design issues and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards to support approval or clearance of the device in the United States. This guidance is not intended to announce new policy, but to describe FDA's existing approach to this topic. This draft guidance is not final nor is it in effect at this time.
Document Number: 2015-09172
Type: Notice
Date: 2015-04-21
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues is requesting public comment on deliberation and bioethics education.
Document Number: 2015-09092
Type: Notice
Date: 2015-04-21
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 proposed extension of an existing collection of information pertaining to registration and product listing for owners and operators of domestic tobacco product establishments and listing of ingredients in tobacco products.
Document Number: 2015-09091
Type: Notice
Date: 2015-04-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting on the Generic Drug User Fee Amendments of 2012 (GDUFA). The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization; we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the Generic Drug User Fee Act Program Performance Goals and Procedures (i.e., the Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's Web site. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program.
Document Number: 2015-09090
Type: Notice
Date: 2015-04-21
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 Cancer Institute (NCI), 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: Kelly Yu, Ph.D., Division of Cancer Prevention, 9609 Medical Center Drive, Room 5E230, Rockville, MD 20850 or call non-toll-free number 240-276-7041 or Email your request, including your address to: yuke@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: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), 0925-0407, Extension, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for a revision of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO). This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which caused an estimated 253,320 deaths in the U.S. in 2014. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then. Recruitment was completed in 2001, baseline cancer screening was completed in 2006, and data collection continues on the current cohort of 77,281 participants who are actively being followed. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of cancer screening in high versus low risk individuals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 26,320.
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