Department of Health and Human Services August 2013 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 283
Consolidation of Wound Care Products Containing Live Cells
Document Number: 2013-19685
Type: Notice
Date: 2013-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is transferring oversight responsibilities for certain wound care products containing live cells from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER). This consolidation initiative provides the opportunity to further develop and coordinate scientific and regulatory activities between CDRH and CBER. FDA believes that as more wound care products containing live cells are developed such consolidation is necessary for both efficient and consistent Agency action.
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop
Document Number: 2013-19684
Type: Notice
Date: 2013-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).'' Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission
Document Number: 2013-19683
Type: Notice
Date: 2013-08-14
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.
National Institute for Occupational Safety and Health Personal Protective Technology Program and National Personal Protective Technology Laboratory Conformity Assessment Public Meeting
Document Number: 2013-19676
Type: Notice
Date: 2013-08-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Conformity Assessment Meeting on Non-Respiratory Personal Protective Equipment (PPE).'' To view the notice and related materials, visit www.regulations.gov and enter CDC-2013-0015 in the search field and click ``search.'' Stakeholder Meeting Time and Date: 8:00 a.m. to 12:00 p.m. EDT, September 17, 2013. Place: NIOSH Pittsburgh Research Center located at 626 Cochrans Mill Road, Building 140, Pittsburgh, Pennsylvania 15236. This meeting will also be available by remote participation through ``live meeting.'' Purpose of the Meeting: This meeting is being held to provide 1) a summary of the work conducted by the NIOSH Personal Protective Technology (PPT) Conformity Assessment Working Group 2) provide an overview of model Conformity Assessment programs, and 3) solicit input to define a national framework for PPE conformity assessment. This meeting will include presentations on Product and Standards, Risk Assessment, Surveillance and Compliance and Enforcement targeting General Industry, Healthcare, Public Safety, and Mining stakeholders. Moderated breakout sessions will discuss preferred Conformity Assessment (CA) components (as detailed in the background below); existing U.S. CA infrastructure capabilities; and gaps in legislation, standards, and infrastructure that need to be filled to define the framework. These breakout discussions will not be available through remote participation; however, the breakout reports will be available to remote participants when the groups reconvene. Status: The meeting is open to the public, limited only by the capacity (150) of the conference room. Registration will be accepted on a first-come first-served basis. Participants are encouraged to consider remote participation through ``live meeting.'' Registration by September 13, 2013 is required for both attendance in person and ``live meeting'' participation. Registration for both options is available on the NIOSH Web site. Non-U.S. citizens, attending in person, need to register on or before August 16, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH to all participants. Government-issued photo identification is required to obtain entrance to the NIOSH location. An opportunity for individuals or organization representatives wishing to offer verbal comments (five minute time limit) will be provided as time permits after the breakout reports. Time slots are limited and available on a first-come first-served basis. Preregistration for providing verbal comment can be requested when registering for the meeting. Submit electronic comments through www.regulations.gov. All information received in response to this notice and meeting must include the agency name and docket number (CDC-2013-0015; NIOSH 237-A). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. All electronic comments should be formatted in Microsoft Word. Please make reference to CDC-2013-0015 and NIOSH Docket Number 237-A. Background: In response to recommendations made by the National Academies of Science during a programmatic review, the NIOSH Personal Protective Technology Conformity Assessment Working Group was established in 2011. The goal of this group is to prepare a national framework establishing criteria, including comprehensive and consistent processes, to address conformity assessment of non-respiratory personal protective equipment. Conformity assessment is defined as the ``demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.'' Conformity assessment processes for PPT products are focused on product effectiveness and include the following primary components: Certification (ISO/IEC 17065), Inspection (ISO/IEC 17020), Testing (ISO/IEC 17025), Accreditation (ISO/IEC 17011), Surveillance (ISO/IEC 17011, ISO/IEC 17065), Supplier's Declaration of Conformity (ISO/IEC 17050), Registration (ISO/IEC 17021) and Quality Management Systems (ISO/9001). The Conformity Assessment Project Report and preliminary framework documents will be available at www.regulations.gov.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-19675
Type: Notice
Date: 2013-08-14
Agency: Department of Health and Human Services
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-19648
Type: Notice
Date: 2013-08-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2013-19644
Type: Notice
Date: 2013-08-14
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss the Ryan White Program. The meeting will be open to the public.
Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
Document Number: 2013-19639
Type: Notice
Date: 2013-08-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for a revision of an approved collection of information titled, ``Application for Participation in the IHS Scholarship Program (OMB Control Number 0917-0006),'' with an expiration date of August 31, 2013. This proposed information collection project was previously published in the Federal Register (78 FR 36197) on June 17, 2013, and allowed 60 days for public comment, as required by 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: ``Application for Participation in the IHS Scholarship Program (OMB Control Number 0917-0006).'' Type of Information Collection Request: Revision of the currently approved information collection, ``Application for Participation in the IHS Scholarship Program, (OMB Control No. 0917-0006).'' Form Number(s): IHS-856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS- 817, and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current Information Collection Request. Reporting forms are found on the IHS Web site at www.ihs.gov/ scholarship. Form Numbers: IHS-856, IHS-856-2, IHS-856-4, IHS-856-20, IHS-815, and IHS-816 have been deleted from the previous Information Collection Request in an effort to comply with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to: solicit, process, and award IHS Pre-graduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHS Scholarship Program streamlined the application process by converting the IHS-856 to an electronic tool and reduced the number of required supplemental application and reporting forms to minimize the time needed by applicants and recipients to complete the application process and provide required information after receiving a scholarship from the IHSSP. The IHSSP application is electronically available on the internet at the IHS Web site at: https://www.ihs.gov/scholarship/apply_ now.cfm. Affected Public: Individuals, not-for-profit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours.
Child Care and Development Fund (CCDF) Program; Reopening of Comment Period
Document Number: 2013-19704
Type: Proposed Rule
Date: 2013-08-13
Agency: Department of Health and Human Services
The Administration for Children and Families within the U.S. Department of Health and Human Services (HHS) is reopening and extending the period to submit comments on the proposed rule for the Child Care and Development Fund (CCDF), published in the Federal Register of May 20, 2013. The proposed rule makes changes to the CCDF regulatory provisions in order to strengthen health and safety requirements for child care providers, reflect current State and local practices to improve the quality of child care, infuse new accountability for Federal tax dollars, and leverage the latest knowledge and research in the field of early care and education to better serve low-income children and families.
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2013-19576
Type: Notice
Date: 2013-08-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members
Document Number: 2013-19574
Type: Notice
Date: 2013-08-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-19569
Type: Notice
Date: 2013-08-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Listing of Color Additives Exempt From Certification; Spirulina Extract
Document Number: 2013-19550
Type: Rule
Date: 2013-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum. This action is in response to a petition filed by Mars, Inc.
Fiscal Year (FY) 2013 Funding Opportunity
Document Number: 2013-19533
Type: Notice
Date: 2013-08-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $1,895,388 (total costs) for up to five years to CADCA for the National Community Anti-Drug Coalition Institute (NCI). This is not a formal request for applications. Assistance will be provided only to CADCA based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-13-009. Catalog of Federal Domestic Assistance (CFDA) Number: 93.276.
Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability
Document Number: 2013-19532
Type: Notice
Date: 2013-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' The draft guidance, when finalized, will provide responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Communicating Composite Scores in Direct-to-Consumer Advertising
Document Number: 2013-19523
Type: Notice
Date: 2013-08-13
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 ``Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2013-19522
Type: Notice
Date: 2013-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-19521
Type: Notice
Date: 2013-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-19453
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2013-19452
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Collection; 60-day Comment Request: Outcomes Evaluation of the National Cancer Institute (NCI) Cancer Prevention Fellowship Program (CPFP)
Document Number: 2013-19425
Type: Notice
Date: 2013-08-12
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, National Cancer Institute (NCI), 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) Ways to enhance 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, contact: Jessica Faupel- Badger, Ph.D., MPH, Cancer Prevention Fellowship Program, National Cancer Institute, 9609 Medical Center Drive, Room 2W136 MSC 9712, Bethesda, Maryland 20892-9712 or call non-toll-free number 240-276-5650 or Email your request, including your address to: badgerje@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013
Document Number: 2013-19378
Type: Rule
Date: 2013-08-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 16, 2012, entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013.''
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-19375
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-19374
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-19373
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2013-19370
Type: Notice
Date: 2013-08-12
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-19379
Type: Notice
Date: 2013-08-09
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.
Medicare Program; Comprehensive ESRD Care Initiative; Extension of the Submission Deadlines for the Letters of Intent and Applications
Document Number: 2013-19351
Type: Notice
Date: 2013-08-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice reopens the Comprehensive ESRD Care Initiative Letters of Intent submission period and extends the deadlines for the submission of the Comprehensive ESRD Care Initiative Letters of Intent and Applications to August 30, 2013. All potential applicants must submit a Letter of Intent to be eligible to submit an application.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-19337
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-19321
Type: Notice
Date: 2013-08-09
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.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods
Document Number: 2013-19302
Type: Proposed Rule
Date: 2013-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,'' that appeared in the Federal Register of January 16, 2013. We are taking this action to allow interested persons an opportunity to consider the interrelationships between this proposal and the two proposals announced in July 2013 on the Foreign Supplier Verification Program and on Accreditation of Third-Party Auditors/Certification Bodies. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
Document Number: 2013-19300
Type: Proposed Rule
Date: 2013-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,'' that appeared in the Federal Register of January 16, 2013. We are taking this action to allow interested persons an opportunity to consider the interrelationships between this proposal and the two proposals announced in July 2013 on the Foreign Supplier Verification Program and on Accreditation of Third-Party Auditors/ Certification Bodies. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-19285
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-19284
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2013-19283
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug User Fee Cover Sheet; Form FDA 3397
Document Number: 2013-19276
Type: Notice
Date: 2013-08-09
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 ``Prescription Drug User Fee Cover Sheet; Form FDA 3397'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug Administration: An Exploration of Drug Development Hosted by the Food and Drug Administration Office of Health and Constituent Affairs, Formerly the Office of Special Health Issues
Document Number: 2013-19275
Type: Notice
Date: 2013-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a meeting for patients, caregivers, patient advocates, as well as patient advocate and health professional groups, to provide a primer on drug product development and explore patient involvement in drug development. The meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals, academia, and industry to learn about FDA's role in, and various regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in drug development and regulatory decision making. Specifically, this meeting will provide information and facilitate a discussion about: FDA's role in drug development and where and how patients can take an active role.
National Institute for Occupational Safety and Health (NIOSH) Personal Protective Technology (PPT) Program; Framework Document for the Healthcare Worker Personal Protective Equipment Action Plan
Document Number: 2013-19273
Type: Notice
Date: 2013-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of a document titled ``Framework for Setting the NIOSH PPT Program Action Plan for Healthcare Worker Personal Protective Equipment: 2013-2018'', now available for public comment at https://www.regulations.gov.
Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge
Document Number: 2013-19272
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 9, 2013. The challenge will be open until September 9, 2013. Million Hearts[supreg] is a national initiative to prevent 1 million heart attacks and strokes by 2017. Achieving this goal means that 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to care, as well as community approaches, such as strengthening tobacco control, and lowering sodium consumption. To support improved blood pressure control, HHS/CDC is announcing the Million Hearts[supreg] Hypertension Control Challenge. This challenge recognizes organizations that invest in hypertension control, improve understanding of successful implementation strategies at the health system level, and motivate providers and health systems to strengthen their hypertension control efforts. The challenge will identify clinicians, clinical practices, and health systems that have achieved exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive a cash prize and local and national recognition.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-19271
Type: Notice
Date: 2013-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-19270
Type: Notice
Date: 2013-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-19253
Type: Notice
Date: 2013-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-19252
Type: Notice
Date: 2013-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-19250
Type: Notice
Date: 2013-08-09
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0221, scheduled to expire on January 31, 2014. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Board of Scientific Counselors, National Center for Health Statistics
Document Number: 2013-19156
Type: Notice
Date: 2013-08-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
Document Number: 2013-19138
Type: Notice
Date: 2013-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-19137
Type: Notice
Date: 2013-08-08
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0001, scheduled to expire on September 30, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-19135
Type: Notice
Date: 2013-08-08
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number OS-0937-0191, which expired on May 31, 2011. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-19124
Type: Notice
Date: 2013-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
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