Department of Health and Human Services June 2010 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 316
Government-Owned Inventions; Availability for Licensing
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.
National Health and Nutrition Examination Survey (NHANES) DNA Samples: Guidelines for Proposals To Use Samples and Cost Schedule
The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian non-institutionalized population. To add to the extensive amount of information collected for the purpose of describing the health of the population, DNA specimens were collected during three NHANES surveys. DNA is available in the form of crude lysates of cell lines derived from 7,159 participants enrolled in Phase II of NHANES III (1991-1994). In addition, DNA purified from whole blood is also available from 7,839 participants enrolled in the NHANES 1999-2002 and 4,615 participants enrolled in NHANES 2007-2008. All specimens (NHANES III, NHANES 1999-2002 and NHANES 2007-2008) were sent to the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH) for processing. DNA samples from these specimens are being made available to the research community for genetic analyses.
Procedures and Costs for Use of the Research Data Center
This notice provides information about the Research Data Center (RDC) operated by the National Center for Health Statistics (NCHS) within the Centers for Disease Control and Prevention (CDC). The Research Data Center was established in 1998 to provide a mechanism whereby researchers can access detailed data files in a secure environment, without jeopardizing the confidentiality of respondents. Historically, the data files accessed in the RDC have consisted of NCHS survey data and vital statistics. RDC has recently begun accepting data files that were not produced from NCHS survey data. In order to assure that all data files are processed in a consistent manner, the original guidelines for accessing files in the RDC are being reviewed and revised as necessary. As part of the revision process, potential users are being given the opportunity to provide input on how the procedures of the RDC can best serve their research needs. This notice describes how to submit proposals requesting use of the data, mechanisms to access the RDC, requirements, use of outside data sets, costs for using the RDC, and other pertinent topics. We are seeking comments on these procedures and will post the final procedures on the NCHS Web site.
Safeguarding Child Support Information
The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal Child Support Enforcement databases under title IV-D of the Social Security Act and significantly enhanced access to information for title IV-D child support purposes. States are moving toward more integrated service delivery to better serve the families and further the mission of the child support enforcement program, while protecting confidential data. This Notice of Proposed Rulemaking (NPRM) proposes requirements for: State Parent Locator Service responses to authorized location requests; and State Child Support Enforcement program safeguards for confidential information and authorized disclosures of this information. This proposed rule would revise certain aspects of the final rule State Parent Locator Service; Safeguarding Child Support Information Final Rule published on September 26, 2008 and effective December 30, 2010. This NPRM will prohibit disclosure of confidential and personally identifiable information to private collection agencies and expand disclosure to child welfare programs and the Supplemental Nutrition Assistance Program (SNAP).
Office of Biotechnology Activities; Recombinant DNA Research: Amended Notice of Meeting
Notice of a discussion of a proposed action under Section III- A-1 published on May 24, 2010 (75 FR 28811) is withdrawn. The discussion that was to be held at the June 16-17, 2010 meeting of the NIH Recombinant DNA Advisory Committee has been deferred at the request of the principal investigator.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the United States 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.
Substances Generally Recognized as Safe Added to Food for Animals; Notice of Pilot Program
The Food and Drug Administration (FDA) is seeking participants for a voluntary pilot program whereby persons submit to FDA notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is generally recognized as safe (GRAS). FDA intends to evaluate these notices and will inform each participant (notifier) in writing either that the notice provides a sufficient basis for the GRAS determination or that FDA has identified questions as to whether the intended use of the substance is GRAS.
Determination That Cysteine Hydrochloride Injection, USP, 7.25%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that Cysteine Hydrochloride Injection, USP, 7.25% (Cysteine HCl), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cysteine HCl if all other legal and regulatory requirements are met.
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability
The Food and Drug Administration (FDA) is announcing the availability of an information sheet guidance entitled, ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This information sheet guidance provides FDA's responses to the most frequently asked questions.
Indian Self-Determination Act Contracts and Annual Funding Agreements-Appeal Procedures
The Bureau of Indian Affairs (BIA) in the Department of the Interior (DOI) and the Indian Health Service (IHS) in the Department of Health and Human Services (HHS) are making limited technical amendments to their joint regulations governing contracts and annual funding agreements under the Indian Self-Determination and Education Assistance Act to update the appeals procedures.
Memorandum of Understanding by and Between the United States Food and Drug Administration and the International Anesthesia Research Society for the Safety of Key Inhaled and Intravenous Drugs in Pediatrics Public-Private Partnership
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the International Anesthesia Research Society (IARS). The purpose of this MOU is to establish a framework for collaboration between FDA and IARS and to support their shared interest of promoting the safe use of anesthetics and sedatives in children.
Office of Child Support Enforcement; Privacy Act of 1974; Computer Matching Agreement
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and State agencies administering unemployment compensation (UC) programs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
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 reinstatement 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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, the U.S. Department of Health & Human Services (HHS) is proposing to establish a new system of records (SOR) titled ``Early Retirement Reinsurance Program (ERRP),'' System No. 09-90-0250. Under authority of Section 1102 of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148) the Early Retiree Reinsurance Program is established. The program provides reimbursement to participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses and dependents. The system will collect and maintain information on individuals associated with plan sponsors who perform key tasks on behalf of the sponsor in order for the sponsor to participate in and receive reimbursement under the program. The system will also collect and maintain information on early retirees, and their spouses, etc., so that sponsors' eligibility to receive reimbursement for the claims of such specific individuals can be verified. The system will also collect and maintain information related to the documentation of actual medical costs of claims for health benefits submitted to the Department, to ensure accurate reimbursement under the program.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Medicare Program; Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Supplemental Proposed Fiscal Year 2011 Rates; Correction
This document corrects technical errors that appeared in the supplementary proposed rule entitled ``Medicare Program; Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Supplemental Proposed Fiscal Year 2011 Rates'' which was filed for public inspection on May 21, 2010.
National Biodefense Science Board; Call for Nominees
The Office of the Secretary is accepting resumes or curricula vitae from qualified individuals who wish to be considered for membership on the National Biodefense Science Board. Six members have membership expiration dates of December 31, 2010. Nominees are being accepted in the following categories: industry; academia, health care consumers, and from State and local governments and public health agencies, emergency responders and organizations representing other appropriate stakeholders. Submit a resume or curriculum vitae to nbsb@hhs.gov by June 30, 2010.
Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
Statutorily Mandated Single Source Award Program Name: National Indian Health Board
The IHS announces the award of supplemental projects under the existing single source cooperative agreement award to the NIHB, Inc. The Office of Direct Service and Contracting Tribes (ODSCT) has designated supplemental funds for the single source award to the NIHB to further health program objectives in the American Indian/Alaska Natives (AI/AN) community with outreach and education efforts in the interest of improving Indian health care. The NIHB is the only national Indian organization with expertise on the variety of issues related to the provision of health care to the Indian population.
General Mills, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 7M4770) proposing that the food additive regulations be amended to provide for the safe use of ultraviolet radiation for the reduction of pathogens and other microorganisms in aqueous sugar solutions and potable water intended for use in food production.
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