Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

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Office of the National Coordinator for Health Information Technology; Health Information Technology; Request for Information Regarding the President's Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward”
Document Number: 2010-31159
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services
This document is a request for comments regarding the recently released PCAST report and its implications for the nation's health information technology (HIT) agenda and ONC's implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-31075
Type: Notice
Date: 2010-12-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; COARTEM
Document Number: 2010-31074
Type: Notice
Date: 2010-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for COARTEM 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-31071
Type: Notice
Date: 2010-12-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2010-31066
Type: Notice
Date: 2010-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ
Document Number: 2010-31064
Type: Notice
Date: 2010-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for MULTAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2010-31058
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-31057
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Public Consultation on Personnel Reliability and Culture of Responsibility Issues
Document Number: 2010-31056
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Science Advisory Board for Biosecurity (NSABB), an advisory committee to the Federal Government, is hosting a public consultation to obtain input from the scientific community and general public regarding strategies for enhancing personnel reliability and strengthening the culture of responsibility at facilities that conduct research with dangerous pathogens. The discussion will inform NSABB deliberations and ultimately the development of an NSABB report on the topic.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-31054
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health
Document Number: 2010-31053
Type: Notice
Date: 2010-12-10
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 Office of Extramural Research (OER), 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 September 13, 2010 (Volume 75, Number 176, page 55585) and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The 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. Proposed Collection: Title: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health. Type of Information Collection Request: NEW. Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds . To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. Frequency of Response: 1 response. Affected Public: Individuals. Type of Respondents: Science professionals (applicants, reviewers, Institutional Officials), adult science trainees, and the general public. The annual reporting burden is as follows: Quantitative surveys: Estimated Number of Respondents per Survey: 9,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.25; Estimated Total Annual Burden Hours Requested per Quantitative Survey: 2,455; Estimated Total Annual Burden Hours Requested for 10 Quantitative Surveys: 24,550. Qualitative surveys: Estimated Number of Respondents per Survey: 30; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.0; Estimated Total Annual Burden Hours Requested per Qualitative Survey: 30; Estimated Total Annual Burden Hours Requested for 4 Qualitative Surveys: 120. Based on an estimated 10 quantitative and 4 qualitative surveys per year: Estimated Total Combined Annual Hours of Burden Requested in Each of 3 Years: 24,670. Estimated Total Combined Cost to Respondents: $728,326. Based on an estimated 10 quantitative and 4 qualitative surveys per year over 3 years: Estimated Total Hours of Burden to Respondents for 2011, 2012, and 2013 Combined: 74,010. Estimated Total Cost to Respondents for 2011, 2012, and 2013 Combined: $2,184,978. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: 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. 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: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Gwynne L. Jenkins, Special Assistant to the Director, Office of Extramural Programs, OER, NIH, 6705 Rockledge Drive, Suite 350, Bethesda, MD 20892, or call non-toll-free number (301) 496-9232 or e-mail your request, including your address to: OEPMailbox@mail.nih.gov. 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.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); NTP Workshop: Role of Environmental Chemicals in the Development of Diabetes and Obesity
Document Number: 2010-31052
Type: Notice
Date: 2010-12-10
Agency: Department of Health and Human Services, National Institutes of Health
The NTP announces a workshop on January 11-13, 2011, to evaluate the science associating exposure to certain chemicals or chemical classes with the development of diabetes and obesity in humans. The NTP invites the submission of public comments and relevant data for consideration at the workshop. Registration to attend the workshop is closed; however, slides presented during the plenary sessions will be webcast over the Internet. Information about the workshop may be found at https://cerhr.niehs.nih.gov/evals/ diabetesobesity/.
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability
Document Number: 2010-31022
Type: Notice
Date: 2010-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings.'' We are issuing the guidance to provide information on how the public may participate at the open public hearing (OPH) portion of FDA advisory committee meetings. The guidance also provides recommendations regarding financial disclosure by persons participating in the OPH portion of advisory committee meetings.
Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL
Document Number: 2010-30995
Type: Notice
Date: 2010-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SABRIL 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ILARIS
Document Number: 2010-30992
Type: Notice
Date: 2010-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ILARIS 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEPREVE
Document Number: 2010-30991
Type: Notice
Date: 2010-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BEPREVE 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of Mental Health; Notice of Meeting
Document Number: 2010-30963
Type: Notice
Date: 2010-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-30961
Type: Notice
Date: 2010-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-30902
Type: Notice
Date: 2010-12-09
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Improving Patient Safety System Implementation for Patients with Limited English Proficiency.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2010-30894
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2010-30869
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2010-30838
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services
This notice announces a public meeting of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: December 13, 2010, 9:30 a.m. to 5 p.m. and December 14, 2010, 8:30 a.m.-1 p.m. e.t.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2010-30825
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2010-30823
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-30821
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-30818
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2010-30816
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Oral Dosage Form New Animal Drugs; Tylosin
Document Number: 2010-30814
Type: Rule
Date: 2010-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble powder in drinking water of chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2010-30813
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2010-30812
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2010-30811
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2010-30810
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2010-30808
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, National Institutes of Health
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Document Number: 2010-30769
Type: Rule
Date: 2010-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows for control of pyrexia associated with acute bovine mastitis.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2010-30764
Type: Notice
Date: 2010-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2010-30763
Type: Notice
Date: 2010-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
Document Number: 2010-30761
Type: Notice
Date: 2010-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate
Document Number: 2010-30713
Type: Notice
Date: 2010-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: 2010-30700
Type: Notice
Date: 2010-12-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The recent revisions to the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) which took effect on October 1, 2010 address the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart M-Medical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination:
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices; Correction
Document Number: 2010-30651
Type: Rule
Date: 2010-12-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a technical error in an amendatory instruction of the regulations text in the final rule that appeared in the November 17, 2010 Federal Register entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices'' final rule (75 FR 70372).
Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease
Document Number: 2010-30386
Type: Proposed Rule
Date: 2010-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between plant sterol esters and plant stanol esters and reduced risk of coronary heart disease (CHD) for use on food labels and in food labeling. The agency is taking this action based on evidence previously considered by the agency, and FDA's own review of data on esterified and nonesterified plant sterols and stanols (collectively, phytosterols) \1\ published since the agency first authorized the health claim by regulation. FDA is also taking these actions, in part, in response to a health claim petition submitted by Unilever United States, Inc. The proposal would amend the authorized use of the claim by modifying the nature of the substances that may be the subject of the claim for conventional foods to include nonesterified, or free, phytosterols, by expanding the types of foods that may bear the claim to include a broader range of foods, by modifying the daily dietary intake of the substance specified in the claim as necessary for the claimed benefit, by adjusting the minimum amount of the substance required for a food to bear the claim, and by making other minor changes.
Required Warnings for Cigarette Packages and Advertisements; Research Report
Document Number: 2010-30685
Type: Proposed Rule
Date: 2010-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it has added a document to the docket for the proposed rulemaking concerning required textual warnings and accompanying graphics to be displayed on cigarette packages and in cigarette advertisements. The document is a report entitled ``Report: Experimental Study of Graphic Cigarette Warning Labels'' (Experimental Study Report) and it describes the results from a research study that quantitatively evaluated the relative impact of certain color graphics on consumer attitudes, beliefs, perceptions, and intended behaviors related to cigarette smoking. The purpose of this notice is to provide the public an opportunity to review and comment on the Experimental Study Report.
Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, Etc.; Withdrawal of Guidance
Document Number: 2010-30679
Type: Notice
Date: 2010-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG Sec. 393.200). CPG Sec. 393.200 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on August 9, 2010.
Compliance Policy Guide Sec. 390.500 Definition of “High-Voltage Vacuum Switch”-21 CFR 1002.61(a)(3) and (b)(2); Withdrawal of Guidance
Document Number: 2010-30677
Type: Notice
Date: 2010-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 390.500 Definition of ``High-Voltage Vacuum Switch''21 CFR 1002.61(a)(3) and (b)(2) (CPG Sec. 390.500). CPG Sec. 390.500 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on August 9, 2010.
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2010-30644
Type: Notice
Date: 2010-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: 2010-30641
Type: Notice
Date: 2010-12-07
Agency: Department of Health and Human Services, National Institutes of Health
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