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

Request For Public Comment: 30-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
Document Number: 2010-7253
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (74 FR 63754) on December 4, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2010-7251
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
Establishment of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2010-7232
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services announces establishment of the Presidential Commission for the Study of Bioethical Issues (the ``Commission''), as directed by Executive Order 13521.
Call for Co-Sponsors for Office of Healthcare Quality's Programs to Strengthen Coordination and Impact National Efforts in the Prevention of Healthcare-Associated Infections (HAIs)
Document Number: 2010-7227
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), Office for Healthcare Quality (OHQ) announces the opportunity to collaborate with the U.S. Department of Health and Human Services (HHS). HHS invites public and private professional health related organizations to participate as collaborating co-sponsors in the development and implementation of an innovative program that advances the goals enumerated in the HHS Action Plan to prevent Healthcare-Associated Infections.
Medicaid and CHIP Programs; Meeting of the CHIP Working Group-April 26, 2010
Document Number: 2010-7225
Type: Notice
Date: 2010-03-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Employee Benefits Security Administration, Department of Labor
This notice announces the first meeting of the Medicaid, Children's Health Insurance Program (``CHIP''), and Employer-Sponsored Coverage Coordination Working Group (referred to as the ``CHIP Working
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2010-7187
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2010-7184
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2010-7181
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2010-7180
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2010-7178
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2010-7171
Type: Notice
Date: 2010-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Substances To Be Evaluated for Set 24 Toxicological Profiles
Document Number: 2010-7169
Type: Notice
Date: 2010-03-31
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the list of proposed substances that will be evaluated for Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) Set 24 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public comments on the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, substances, not on this list, that may have public health implications.
Pharmaceutical Supply Chain; Public Workshop
Document Number: 2010-7151
Type: Notice
Date: 2010-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop Enough Talk: Let's Find and Implement Solutions.'' The workshop, cosponsored with the Parenteral Drug Association (PDA), will focus on solutions to reduce the risk to product quality in the pharmaceutical supply chain.
Antiviral Drugs Advisory Committee; Notice of Meeting
Document Number: 2010-7114
Type: Notice
Date: 2010-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2010-7113
Type: Notice
Date: 2010-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates
Document Number: 2010-7111
Type: Notice
Date: 2010-03-31
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 information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA-regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended.
New Animal Drugs; Removal of Obsolete and Redundant Regulations
Document Number: 2010-7108
Type: Rule
Date: 2010-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is removing portions of a regulation that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation.
FY 2010 Special Diabetes Program for Indians Community-Directed Grant Program
Document Number: 2010-7103
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, Indian Health Service
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2010-7088
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2010-6999
Type: Notice
Date: 2010-03-31
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice Of Amendment-OS ARRA Expansion of Research Capabilities To Study CE Complex Patients (R24) SEP Meeting
Document Number: 2010-6784
Type: Notice
Date: 2010-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Common Formats for Patient Safety Data Collection and Event Reporting
Document Number: 2010-6781
Type: Notice
Date: 2010-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The purpose of this notice is to announce the availability of the expanded and enhanced Common Formats Version 1.1including updated event descriptions, reports, data elements, and technical specifications for software developers and the process for their continued refinement.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-6780
Type: Notice
Date: 2010-03-31
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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) Health Plan Survey Comparative Database.'' 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: 2010-6778
Type: Notice
Date: 2010-03-31
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: ``Reductions of Infection Caused by Carbapenem Resistant Enterobacteriaceae (KPC) Producing Organisms through the Application of Recently Developed CDC/HICPAC Recommendations.'' 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: 2010-6776
Type: Notice
Date: 2010-03-31
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: ``Studying the Implementation of a Chronic Care Toolkit and Practice Coaching In Practices Serving Vulnerable Populations.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2010-7123
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2010-7119
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feeds
Document Number: 2010-7095
Type: Rule
Date: 2010-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2010-7089
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-7087
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Process Evaluation of the NIH's Roadmap Interdisciplinary Research Work Group Initiatives
Document Number: 2010-7086
Type: Notice
Date: 2010-03-30
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 (insert name of NIH Institute or IC), the National Institutes of Health 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 January 5, 2010 (p. 382) and allowed 60 days for public comment. One comment was received, which included a request for additional information, and additional information was provided. No additional questions were 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.
Revision of the Requirements for Constituent Materials
Document Number: 2010-7073
Type: Proposed Rule
Date: 2010-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under a section of the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of licensed biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2010-7065
Type: Notice
Date: 2010-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2010-7042
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Mental Health; Notice of Meeting
Document Number: 2010-6972
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels; Notice of Public Meeting
Document Number: 2010-6967
Type: Notice
Date: 2010-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: 2010-6966
Type: Notice
Date: 2010-03-30
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. 207 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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2010-6957
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2010-6956
Type: Notice
Date: 2010-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2010-7033
Type: Notice
Date: 2010-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2010-7027
Type: Notice
Date: 2010-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
Document Number: 2010-6996
Type: Proposed Rule
Date: 2010-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act (the act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA is also proposing, as directed by FDAAA, standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2010-6903
Type: Notice
Date: 2010-03-29
Agency: Department of Health and Human Services
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2010-6902
Type: Notice
Date: 2010-03-29
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2010-6880
Type: Notice
Date: 2010-03-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Privacy Act of 1974; Report of an Altered System of Records
Document Number: 2010-6878
Type: Notice
Date: 2010-03-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Health Professions Planning and Evaluation (SORN 09-15-0046; 63FR14124).
Veterinary Feed Directive
Document Number: 2010-6872
Type: Proposed Rule
Date: 2010-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the agency) is announcing an advance notice of proposed rulemaking (ANPRM) to solicit comments from the public regarding potential changes to its current regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is undertaking a review of these requirements in an effort to identify possible changes to improve efficiency. Therefore, the agency is requesting public comment on all aspects of the VFD regulation, particularly suggestions relating to improving efficiency. This information may be used to help draft a proposed rule in the near future.
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