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

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Health Resources and Services Administration
Document Number: 2012-30835
Type: Notice
Date: 2012-12-26
Agency: Department of Health and Human Services
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's function, (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.
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2012-30729
Type: Rule
Date: 2012-12-26
Agency: Department of Health and Human Services
In this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update the definitions for interstate quarantine regulations to reflect modern terminology and plain language used by private industry and public health partners. These updates will not affect current practices. As part of the update, we are updating two existing definitions and adding eight new definitions to clarify existing provisions, as well as updating regulations to reflect the most recent Executive Order addressing quarantinable communicable diseases.
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2012-30726
Type: Proposed Rule
Date: 2012-12-26
Agency: Department of Health and Human Services
In this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update the definitions for interstate quarantine regulations to reflect modern terminology and plain language used by private industry and public health partners. These updates will not affect current practices. As part of the update, we are updating two existing definitions and adding eight new definitions to clarify existing provisions, as well as updating regulations to reflect the most recent Executive Order addressing quarantinable communicable diseases.
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2012-30725
Type: Proposed Rule
Date: 2012-12-26
Agency: Department of Health and Human Services
Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update and reorganize the Scope and Definitions for foreign quarantine regulations and add a new section to contain definitions for Importations. This NPRM proposes to update the Scope and Definitions to reflect modern terminology and plain language used globally by industry and public health partners. As part of the proposed updates, we are updating five existing definitions; adding thirteen new definitions to help clarify existing provisions; creating a new scope and definitions section for Importations under a new section by reorganizing existing definitions into this new section; and updating regulations to reflect the language used by the most recent Executive Order regarding quarantinable communicable diseases.
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2012-30723
Type: Rule
Date: 2012-12-26
Agency: Department of Health and Human Services
Through this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is updating and reorganizing the Scope and Definitions for foreign quarantine regulations and add a new section to contain definitions for Importations. This Direct Final Rule (DFR) will update the scope and definitions to reflect modern terminology and plain language used globally by industry and public health partners. As part of the update, we are updating five existing definitions; adding thirteen new definitions to help clarify existing provisions; creating a new scope and definitions section for Importations under a new section by reorganizing existing definitions into this new section; and updating regulations to reflect the language used by the most recent Executive Order regarding quarantinable communicable diseases.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-30631
Type: Notice
Date: 2012-12-26
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 changes to the currently approved information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2012-30750
Type: Notice
Date: 2012-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-30749
Type: Notice
Date: 2012-12-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-30748
Type: Notice
Date: 2012-12-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application; Extension
Document Number: 2012-30738
Type: Notice
Date: 2012-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension and to allow 60 days for public comment in response to the notice. This notice solicits comments on the medicated feed mill licensing system.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-30718
Type: Notice
Date: 2012-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-30717
Type: Notice
Date: 2012-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-30716
Type: Notice
Date: 2012-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Notice of Closed Meeting
Document Number: 2012-30715
Type: Notice
Date: 2012-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2012-30714
Type: Notice
Date: 2012-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Baldev Raj Bhutani; Denial of Hearing on Application for Special Termination of Debarment
Document Number: 2012-30709
Type: Notice
Date: 2012-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Baldev Raj Bhutani's application for special termination of debarment under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Mr. Bhutani has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities: Submission for OMB Review and Approval; Public Comment Request
Document Number: 2012-30690
Type: Notice
Date: 2012-12-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at 301-443-1984.
Proposed Information Collection Activity; Comment Request
Document Number: 2012-30686
Type: Notice
Date: 2012-12-20
Agency: Department of Health and Human Services, Administration for Children and Families
Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability
Document Number: 2012-30651
Type: Notice
Date: 2012-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE StudiesSmall Entity Compliance Guide.'' These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled ``Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,'' published in the Federal Register on September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses understand and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence (BE) studies.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-30564
Type: Notice
Date: 2012-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2012-30563
Type: Notice
Date: 2012-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-30562
Type: Notice
Date: 2012-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2012-30560
Type: Notice
Date: 2012-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2012-30517
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
Document Number: 2012-30516
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.
Silver Nanoparticles (AgNPs); Information and Comment Request
Document Number: 2012-30515
Type: Notice
Date: 2012-12-19
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), as part of its mission to investigate new and emerging hazards, has initiated an evaluation of the scientific data on silver nanoparticles (AgNPs) to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted. NIOSH has identified a number of relevant publications on AgNPs. This listing (Evaluation of the scientific data on silver nanoparticles (AgNPs) can be found in Docket CDC-2012-0014 at http://www.regulations.gov. NIOSH is requesting additional information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with AgNPs, (2) information on possible health effects observed in workers exposed to AgNPs, (3) information on workplaces and products in which AgNPs can be found, (4) description of work tasks and scenarios with a potential for exposure, (5) information on measurement methods and, workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, PPE) that are being used in workplaces where potential exposures to AgNPs occur.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products
Document Number: 2012-30513
Type: Notice
Date: 2012-12-19
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.
Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments
Document Number: 2012-30511
Type: Notice
Date: 2012-12-19
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 statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013-2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment will be conducted by an independent contractor in two phases. FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment.
Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability
Document Number: 2012-30510
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA's Center for Drug Evaluation and Research (CDER).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-30465
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2012-30458
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2012-30457
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2012-30456
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse Notice of Closed Meetings
Document Number: 2012-30454
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2012-30453
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Comment Request
Document Number: 2012-30367
Type: Notice
Date: 2012-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2012-30390
Type: Notice
Date: 2012-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-30386
Type: Notice
Date: 2012-12-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-30385
Type: Notice
Date: 2012-12-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Draft Guidance for Industry on Certification of Designated Medical Gases; Availability
Document Number: 2012-30382
Type: Notice
Date: 2012-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Certification Process for Designated Medical Gases.'' This draft guidance describes the new certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to implement that process.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2012-30353
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-30352
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Assistant Secretary for Planning and Evaluation; Meeting of the Advisory Council on Alzheimer's Research, Care, and Services
Document Number: 2012-30345
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. Representatives of the three federal subgroups (Research, Clinical Care, Long-Term Services and Supports) will provide updates on the implementation of the National Plan to Address Alzheimer's Disease. The Advisory Council will hear a presentation on work underway by the Department of Veterans Affairs to support Veterans with Alzheimer's disease and their caregivers. The subcommittee chairs will present recommendations for adoption by the Advisory Council as formal recommendations to the Secretary of HHS and Congress.
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2012-30337
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2012-30336
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2012-30335
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-30334
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2012-30333
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2012-30332
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-30331
Type: Notice
Date: 2012-12-17
Agency: Department of Health and Human Services, National Institutes of Health