Department of Health and Human Services April 2012 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 279
Meeting of the National Biodefense Science Board
Document Number: 2012-9497
Type: Notice
Date: 2012-04-20
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be rescheduling its April 30, 2012, closed session by teleconference under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. section 552b(c), to May 23, 2012.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-9489
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-9488
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-9484
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-9482
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2012-9478
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2012-9464
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2012-9462
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2012-9460
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2012-9458
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot Study
Document Number: 2012-9435
Type: Notice
Date: 2012-04-19
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the survey entitled ``Medical Device Decision Analysis: A Risk-Tolerance Pilot Study.''
Submission for OMB Review; Comment Request
Document Number: 2012-9303
Type: Notice
Date: 2012-04-19
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-9356
Type: Notice
Date: 2012-04-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2012-9337
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2; Corrections
Document Number: 2012-9331
Type: Proposed Rule
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors and typographical errors in the proposed rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 2'' which appeared in the March 7, 2012, Federal Register.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE; Correction
Document Number: 2012-9325
Type: Notice
Date: 2012-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 2, 2007 (72 FR 15699). The document concerned FDA's determination of the regulatory review period for KEPIVANCE. The document cited an incorrect statute under which the KEPIVANCE biologics license application was submitted. This document corrects the citation.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2012-9323
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services
Determination That FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2012-9292
Type: Notice
Date: 2012-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluorescein sodium injection, 25%, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-9259
Type: Notice
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-9258
Type: Notice
Date: 2012-04-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations
Document Number: 2012-9251
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services
Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on May 4, 2011. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created four (4) workgroups to analyze the areas of clinical quality, clinical operations, implementation, and privacy and security. Other groups are convened to address specific issues as needed, such as the Nationwide Health Information Network Power Team, the Consumer/Patient Engagement Power Team, and the Vocabulary Task Force. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) an assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) Accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) Assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to: Quality measurement; the extended portfolio of standards for the nationwide health information network; distributed queries and results; radiology; consumer-mediated information exchange; public health; data portability; and a process for the maintenance of standards. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC web site at https://healthit.hhs.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification
Document Number: 2012-9241
Type: Notice
Date: 2012-04-18
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 Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Statement of Organization, Functions, and Delegations of Authority; Administration for Community Living
Document Number: 2012-9238
Type: Notice
Date: 2012-04-18
Agency: Department of Health and Human Services
The Department of Health and Human Services establishes the Administration for Community Living in order to achieve several important objectives: reduce the fragmentation that currently exists in Federal programs addressing the community living service and support needs of both the aging and disability populations; enhance access to quality health care and long-term services and supports for all individuals; promote consistency in community living policy across other areas of the Federal government; and complement the community infrastructure, as supported by both Medicaid and other Federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-9105
Type: Notice
Date: 2012-04-18
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: ``CHIPRA Pediatric Quality Measures Program Candidate Measure Submission Form.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2012-9232
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Non-Competitive Program Expansion Supplement To Revise, Update, and Disseminate Educational Curricula Regarding Alzheimer's Disease and Related Dementias
Document Number: 2012-9231
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will be issuing a non-competitive program expansion supplement to 45 Geriatric Education Centers (GEC) Program grantees to revise, update, and disseminate educational curricula regarding Alzheimer's Disease and related dementias (AD). Approximately $2,000,000 will be available in Fiscal Year (FY) 2012 and $4,000,000 in FY 2013 from the Prevention and Public Health Fund, created by the Affordable Care Act. The GEC grantees have the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the AD initiative within their existing educational programming. The programmatic supplements will allow the Bureau of Health Professions to consolidate resources and provide enhanced technical assistance, grant funds, grant monitoring and oversight to the AD initiative within currently existing grants.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2012-9229
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-9224
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2012-9217
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2012-9213
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Breast Cancer in Young Women (ACBCYW); Correction
Document Number: 2012-9212
Type: Notice
Date: 2012-04-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2012-9208
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feeds; Tiamulin
Document Number: 2012-9196
Type: Rule
Date: 2012-04-17
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 the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine.
Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin
Document Number: 2012-9195
Type: Notice
Date: 2012-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine. This action is being taken at the sponsor's request because this product is no longer marketed for these uses.
Submission for OMB Review; Comment Request
Document Number: 2012-9162
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Administration for Children and Families
``Low Income Levels'' Used for Various Health Professions and Nursing Programs Included in Titles III, VII and VIII of the Public Health Service Act
Document Number: 2012-9137
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low-income'' families.
Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2012-9136
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
Document Number: 2012-9135
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-9134
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
HIT Policy Committee Advisory Meeting; Notice of Meeting
Document Number: 2012-9133
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services
HIT Standards Committee Advisory Meeting; Notice of Meeting
Document Number: 2012-9132
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2012-9118
Type: Notice
Date: 2012-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD-10-CM and ICD-10-PCS Medical Data Code Sets
Document Number: 2012-8718
Type: Proposed Rule
Date: 2012-04-17
Agency: Department of Health and Human Services, Office of the Secretary
This proposed rule would implement section 1104 of the Patient Protection and Affordable Care Act (hereinafter referred to as the Affordable Care Act) by establishing new requirements for administrative transactions that would improve the utility of the existing Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions and reduce administrative burden and costs. It proposes the adoption of the standard for a national unique health plan identifier (HPID) and requirements or provisions for the implementation of the HPID. This rule also proposes the adoption of a data element that will serve as an other entity identifier (OEID), an identifier for entities that are not health plans, health care providers, or ``individuals,'' that need to be identified in standard transactions. This proposed rule would also specify the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose an NPI. Finally, this rule proposes to change the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2012-9111
Type: Notice
Date: 2012-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-9110
Type: Notice
Date: 2012-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2012-9109
Type: Notice
Date: 2012-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2012-9087
Type: Notice
Date: 2012-04-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2012-9085
Type: Notice
Date: 2012-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank
Document Number: 2012-9083
Type: Notice
Date: 2012-04-16
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 Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 9, 2012 (Vol. 77, No. 27, p. 6808) and allowed 60-days for public comment. A single 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.
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