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

Results 201 - 250 of 347
Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop
Document Number: 2013-03323
Type: Notice
Date: 2013-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ``Global Quality SystemsAn Integrated Approach to Improving Medical Product Safety.'' This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.
Documents To Support Submission of an Electronic Common Technical Document; Availability
Document Number: 2013-03319
Type: Notice
Date: 2013-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the following revised final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1, version 2.1'' (which includes the U.S. regional document type definition, version 3.1), and ``Comprehensive Table of Contents Headings and Hierarchy, version 2.1.'' Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.1 by September 2013 and will give 30 days advanced notice to industry.
Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting
Document Number: 2013-03316
Type: Proposed Rule
Date: 2013-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related public meetings announced in the January 31, 2013, Federal Register. These public meetings will be held along with the February 28 to March 1, 2013, Washington, DC public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk- based preventive controls for human food (the preventive controls proposed rule). These proposed rules are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes
Document Number: 2013-03315
Type: Notice
Date: 2013-02-13
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.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-03295
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C funds to the Hoboken Community Healthcare, Inc., Hoboken, New Jersey.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-03293
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will be providing a one-time noncompetitive Part C funds award to DFHS, Lagrange, Georgia.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-03292
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C funds to the Aaron E. Henry Community Health Center (AEHCHC), Clarksville, Mississippi.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-03291
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Ryan White HIV/AIDS Program (Part C) funds to the University of Pittsburgh Medical Center, Presbyterian Shadyside, Pittsburgh, Pennsylvania.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-03270
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Submission for OMB Review; Comment Request
Document Number: 2013-03253
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, Administration for Children and Families
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-03243
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center For Complementary & Alternative Medicine; Notice of Closed Meetings
Document Number: 2013-03242
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-03240
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-03239
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-03238
Type: Notice
Date: 2013-02-13
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: 2013-03237
Type: Notice
Date: 2013-02-13
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: 2013-03235
Type: Notice
Date: 2013-02-13
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: 2013-03234
Type: Notice
Date: 2013-02-13
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: 2013-03233
Type: Notice
Date: 2013-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-03217
Type: Notice
Date: 2013-02-13
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: ``Patient-Reported Health Information Technology and Workflow.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments
Document Number: 2013-03198
Type: Notice
Date: 2013-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-03197
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-03196
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-03195
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-03194
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-03193
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-03180
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current Traumatic Brain Injury State Implementation Partnership Grantees; Non-Competitive One-Year Extension Funds
Document Number: 2013-03153
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will issue funding for a non-competitive one-year extension for the State Implementation Partnerships (H21) awards to current grantees whose awards are scheduled to end in fiscal year (FY) 2013. Up to $250,000 per grantee will be awarded over a one-year extended project period. The HRSA TBI Program was initially authorized by the Traumatic Brain Injury Act of 1996 (Pub. L. 104-166) and was most recently reauthorized by the Traumatic Brain Injury Act of 2008 (Pub. L. 110- 206). Under this authority, the HRSA TBI Program is charged with improving access to rehabilitation and other services for individuals with traumatic brain injury and their families. The TBI State Implementation Partnership Grants support activities that complement existing state infrastructure to provide needed services following TBI. Through comprehensive and periodic needs and resources assessments, activities supported by grant funds are aligned with the highest priority areas as determined by providers, individuals with TBI and their families, advocates, and other stakeholders. Recipients of grant funds are expected to modify infrastructure in such a way that improvements in service delivery will be sustained beyond the grant period. As part of this charge, grantees must specifically have or develop the following four core components: (1) A Statewide Advisory Board consisting of members of the community, and representatives of other state agencies with an interest in TBI, such as State Departments of Health, Rehabilitation, Human Services, Education, Transportation, or Labor. This board should also have strong representation from individuals with TBI and/or family members; and also organizations that serve individuals with TBI; and other service providers, medical and non-medical; (2) A designated state agency that takes responsibility for carrying out activities of the grant; (3) A statewide needs and resources assessment; and (4) A comprehensive Statewide Action Plan for assisting individuals with TBI and their families to increase access to needed services and supports.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Program Report
Document Number: 2013-03139
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 the information collection requirements relating to Title III and VII State Program Report.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-03134
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
Document Number: 2013-03133
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-03132
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-03131
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-03130
Type: Notice
Date: 2013-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-03119
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-03118
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-03117
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-03116
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-03115
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-03114
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2013-03113
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-03112
Type: Notice
Date: 2013-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-03059
Type: Notice
Date: 2013-02-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples
Document Number: 2013-02825
Type: Rule
Date: 2013-02-12
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by establishing a user fee for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. We are amending the regulations to establish a filovirus testing service at HHS/CDC, because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees.
Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products; Availability
Document Number: 2013-03019
Type: Notice
Date: 2013-02-11
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 ``Immunogenicity Assessment for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, and these responses may lead to serious or life-threatening adverse events for the patient or loss of efficacy of the product. This draft guidance is intended to assist manufacturers to develop a risk-based approach in both the preclinical and clinical phases of the development of therapeutic protein products to evaluate and mitigate immune responses that may adversely affect their safety and efficacy.
Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply Chain
Document Number: 2013-03018
Type: Notice
Date: 2013-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom of our industry to create synergies focused on finding solutions which make a difference. Every discussion, exploration, and solution is framed by the goal of delivering increased patient health and safety through topics such as a working session with the Office of the Commissioner on the implementation of the FDA Safety and Innovation Act, Business Impact of Outsourcing, Supplier Management Models that Work, Implementing Quality by Design (QbD) Successfullylike other industries, lunch with global regulators (FDA, Medicines and Healthcare products Regulatory Agency (MHRA), Fimea, and Swissmedic), and many more. The experience level of our audience has fostered engaged dialog that has led to innovative initiatives.
National Advisory Council on the National Health Service Corps; Request for Nominations
Document Number: 2013-03006
Type: Notice
Date: 2013-02-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) vacancies on the National Advisory Council (NAC) on the National Health Service Corps (NHSC). The NAC on NHSC was established in 1978.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-03005
Type: Notice
Date: 2013-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-03003
Type: Notice
Date: 2013-02-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection, Comment Request
Document Number: 2013-02998
Type: Notice
Date: 2013-02-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
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, Pub. L. 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 functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Corps Community Day Event FormNEW Abstract: Corps Community Day was created in 2011 and celebrates the National Health Service Corps (NHSC) every October during National Primary Care Week. The NHSC is a program administered by the Bureau of Clinician Recruitment and Service (BCRS) within HRSA. The goals of Corps Community Day encompass the following: increase awareness of the NHSC to potential applicants and the greater primary health community; create a sense of community and connectedness among NHSC program participants, alumni, partners, and staff; and underscore the NHSC's role in bringing primary health care services to the nation's neediest communities. Current program participants, alumni, NHSC Ambassadors, sites, primary care organizations, and professional associations plan events and report the details of their events to BCRS so that they can be added to the state-by-state map of events. In order to avoid duplication of effort, eliminate confusion regarding allowable event dates, avoid data entry errors, and implement a brief post-event satisfaction survey, BCRS would like to implement a standard form that event planners will use to report to BCRS. The fillable form will be available online and will have less than 20 fields for event planners to populate to submit for inclusion on the map. There will also be approximately five fields to populate following the event to measure satisfaction. Both the pre-event and post-event data fields will be held in one form. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: