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

Results 151 - 200 of 337
Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements
Document Number: 2013-08855
Type: Proposed Rule
Date: 2013-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health
Document Number: 2013-08850
Type: Notice
Date: 2013-04-16
Agency: Department of Health and Human Services
The Department of Health and Human Service (HHS), Office of Minority Health (OMH), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of OMH designed to improve the health status and outcomes of racial and ethnic minorities. Nominations of qualified candidates are being sought to fill upcoming vacancies on the Committee.
Announcement of Requirements and Registration for “Apps4Tots Health Challenge”
Document Number: 2013-08821
Type: Notice
Date: 2013-04-16
Agency: Department of Health and Human Services
As part of the Department of Health and Human Services digital services strategy, the Health Resources and Services Administration (HRSA), the Office of the National Coordinator for Health Information Technology (ONC), and Healthdata.gov are joining forces in an attempt to leverage two key assets recently made available to the public. The Apps4TotsHealth Challenge is a call for developers, researchers, and other innovators to make use of the Healthdata.gov data API and integrate the TXT4Tots message library into a new or existing platform. TXT4Tots is a library of short, evidence-based messages focused on nutrition and physical activity. The library is targeted to parents and caregivers of children, ages 1-5 years, and is available in English and Spanish. Content for the messages was derived from American Academy of Pediatrics (AAP) Bright Futures: Guidelines for Health Supervision of Infants, Children and Adolescents, which uses a developmentally based approach to address children's health needs in the context of family and community. Healthdata.gov (www.healthdata.gov) is the Department's open data catalog, housing metadata records on close to 400 HHS datasets. Recently, Healthdata.gov has enabled a publicly-accessible data application programming interface (API) that allows programmatic access to the TXT4Tots message library. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. No 111-358).
Generic Drug Facilities, Sites, and Organizations
Document Number: 2013-08806
Type: Notice
Date: 2013-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that the generic drug facility self-identification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites, and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-08802
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-08801
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2013-08800
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-08799
Type: Notice
Date: 2013-04-15
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: 2013-08798
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-08797
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-08796
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Proposed collection; 60-day comment request: NLM PEOPLE LOCATOR® System
Document Number: 2013-08788
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Special Fraud Alert: Physician-Owned Entities
Document Number: 2013-08749
Type: Notice
Date: 2013-04-15
Agency: Department of Health and Human Services, Office of Inspector General
This document sets forth a correction to the OIG Federal Register notice published on March 29, 2012 (78 FR 19271), on our recently issued Special Fraud Alert on Physician-Owned Entities. Specifically, the Special Fraud Alert addressed physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers. An inadvertent error appeared in the DATES caption of that document regarding the effective date. Accordingly, we are removing the language regarding the effective date to ensure technical correctness of the document.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-08730
Type: Notice
Date: 2013-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk; Availability
Document Number: 2013-08723
Type: Notice
Date: 2013-04-15
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 entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Initial Review
Document Number: 2013-08716
Type: Notice
Date: 2013-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-08410
Type: Notice
Date: 2013-04-15
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: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 28th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-08409
Type: Notice
Date: 2013-04-15
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: ``The Feasibility of Alternative Models for Collecting New Data on Physicians and Their Practices.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Extension of Public Comment Period for Request for Information on the FY 2013-2018 Strategic Plan for the Office of Disease Prevention
Document Number: 2013-08683
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Disease Prevention (ODP), National Institutes of Health (NIH), is amending the due date for responses to its Request for Information (RFI), published in Vol. 78, Issue 49, of the Federal Register on March 13, 2013. The due date has been extended from April 14, 2013, to April 30, 2013, to allow more time for review. Comments must be submitted electronically using the web-based form available at http://prevention.nih.gov/aboutus/strategic_plan/rfi.aspx.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-08677
Type: Notice
Date: 2013-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-08676
Type: Notice
Date: 2013-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-08672
Type: Notice
Date: 2013-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-08635
Type: Notice
Date: 2013-04-12
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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0001, which expires on September 30, 2013. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-08607
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, as provided for under 42 U.S.C. Sec. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-08579
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Baker Brothers site in Toledo, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-08577
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Battelle Laboratories King Avenue facility in Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute of Allergy And Infectious Diseases; Notice of Meeting
Document Number: 2013-08565
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-08564
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-08563
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-08562
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review ; Notice of Closed Meetings
Document Number: 2013-08561
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-08560
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Non-Competitive One-Year Extension With Funds for Black Lung/Coal Miner Clinics Program (H37) Current Grantee
Document Number: 2013-08482
Type: Notice
Date: 2013-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be issuing a non-competitive one-year extension with funds for the Black Lung/Coal Miner Clinics Program awards to the current grantees (included in attached chart), in amounts between $299,000 and $1.5 million over the one-year extension project period. The level of support is at the same annual rate that was authorized in fiscal year (FY) 2012. The Black Lung/Coal Miner Clinics Program supports projects that seek to prevent, monitor, and treat pulmonary and respiratory diseases in active and inactive miners. This extension with funds will allow the Office of Rural Health Policy (ORHP) to reassess the priorities and scope of the program. The extension will also allow for greater pre-application technical assistance and opportunity to ensure funding levels can adequately address target population needs in various parts of the country.
Notice of Hearing: Reconsideration of Disapproval of Maine State Plan Amendments (SPA) 12-010
Document Number: 2013-08524
Type: Notice
Date: 2013-04-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on May 23, 2013, at the CMS Boston Regional Office, JFK Federal Building, 15 N. Sudbury Street, Room 2050, Boston, Massachusetts 02203-0003 to reconsider CMS' decision to disapprove Maine SPA 12-010.
Stakeholder Listening Session in Preparation for the 66th World Health Assembly
Document Number: 2013-08513
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services
Delegation of Authority
Document Number: 2013-08512
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services
Meeting of the President's Council on Fitness, Sports, and Nutrition
Document Number: 2013-08494
Type: Notice
Date: 2013-04-11
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 President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.
Expansion Funds for the Support of the Senior Medicare Patrol (SMP) Program
Document Number: 2013-08485
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services
The Administration for Community Living is announcing the availability of expansion funds for the support of the Senior Medicare Patrol (SMP) Program. This additional funding opportunity will be used to expand the reach of the SMP program with the explicit purpose of expanding current program capacity to recruit, train, and support the SMP volunteer network. In addition, this funding opportunity will increase targeted collaborative efforts with the Centers for Medicare and Medicaid Services, Office of Inspector General and other law enforcement entities in identified high fraud states. Funding Opportunity Title/Program Name: Health Care Fraud Prevention Program Expansion and SMP Capacity Building Grants. Announcement Type: Health Care Fraud Prevention Program Expansion Capacity. Funding Opportunity Number: Program Announcement No. HHS-2013-ACL- AoA-SP-0049
National Institute for Occupational Safety and Health Partnership Opportunity on a Research Project To Evaluate the Performance of Isolation Gowns
Document Number: 2013-08461
Type: Notice
Date: 2013-04-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The NIOSH National Personal Protective Technology Laboratory is initiating a research study in support of American Society for Testing and Materials (ASTM) International standards development to establish minimum performance requirements for isolation gowns for health care workers. NIOSH is seeking to identify currently marketed isolation gown products. All manufacturers are requested to submit samples to NIOSH free of charge for testing. There will be no cost to the manufacturers for testing. Not all submitted products may be tested, depending on the response to this announcement and the results of screening tests. Each manufacturer that submits gowns that are tested will receive the test results from their gowns. Through submission of the gown samples, manufacturers will be making an important contribution to ASTM, International's process to establish an important standard for evaluating the protection provided for health care workers by isolation gowns. Participating manufacturers will be recognized as contributing to the establishment of the performance standard. Manufacturers whose products are tested will also receive the results of all gowns tested in a blinded format. Gown Criteria: Candidate gowns for inclusion in the research program must meet the following criteria: (1) The gowns must be identified (labeled) as ``isolation gowns'' and have full coverage in the back to provide protection for the health care worker and the patient; (2) A minimum of 100 units for each code (model) of disposable (single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed, unused, unwashed) reusable gowns for each model submitted. Reusable gown submissions must include a labeling recommendation for the maximum number of laundering cycles to be included in this study. Half of the gown samples will be tested after one laundering and drying cycle and half of the gown samples will be tested as laundered for the maximum number of cycles claimed by the manufacturer; and, (4) Samples should be provided in finished package format, with any claims that may not be noted on the packaging or labels provided by the manufacturer. NIOSH will not return any gowns submitted for this testing.
Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability
Document Number: 2013-08443
Type: Notice
Date: 2013-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product. This guidance finalizes the draft guidance issued on September 19, 2011.
Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-08442
Type: Notice
Date: 2013-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015
Document Number: 2013-08441
Type: Notice
Date: 2013-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients' input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2013-08420
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-08419
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-08418
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-08417
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-08416
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-08415
Type: Notice
Date: 2013-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-08414
Type: Notice
Date: 2013-04-11
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.