Department of Health and Human Services July 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 247
Proposed Change in State Title V Maternal and Child Health Block Grant Allocations
This notice seeks comments on proposed changes in the State Title V Maternal and Child Health (MCH) Block Grant allocations. Through the Health Resources and Services Administration's Maternal and Child Health Bureau (MCHB), Title V MCH Block Grant funds are allocated to States based in part on a calculation of the number of children living in poverty (in an individual State) as compared to the total number of children living in poverty in the United States, using data for the number of children in poverty in each State from the U.S. Census Bureau's official decennial census. As the Census Bureau has replaced the decennial census long-form sample questionnaire with the American Community Survey (ACS), MCHB likewise plans to use the ACS as its source for this data. The ACS offers broad, comprehensive information on social, economic, and housing data and is designed to provide this information at many levels of geography. ACS child poverty estimates are produced annually and will allow the Block Grant allocation proportions to be updated more frequently than every 10 years. The Census Bureau produces annual State-level poverty estimates based on the most recent 1, 3, and 5 years of ACS data as well as annual model-based Small Area Income and Poverty Estimates (SAIPE). It is proposed that MCHB implement annual changes to the State Title V MCH Block Grant allocations using the 3-year ACS poverty estimates, wherein each annual change is buffered by sharing 2 of 3 data years in a 3-year rolling period estimate.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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.
Patient Safety Organizations: Delisting for Cause for The Steward Group PSO
AHRQ has delisted The Steward Group PSO as a Patient Safety Organization (PSO) due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.
Patient Safety Organizations: Voluntary Relinquishment From the Coalition for Quality and Patient Safety of Chicagoland (CQPS PSO)
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42 U.S.C. 299b-21-b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Coalition for Quality and Patient Safety of Chicagoland (CQPS PSO) of its status as a PSO, and has delisted the PSO accordingly.
Request for Information on Quality Measurement Enabled by Health IT
The Agency for Healthcare Research and Quality (AHRQ) requests information from the Public, including diversified stakeholders (health information technology (IT) system developers, including vendors; payers, quality measure developers, end-users, clinicians, health care consumers) regarding current successful strategies and challenges regarding quality measurement enabled by health IT. Quality measurementthe assessment of the timeliness, completeness and appropriateness of preventive services, diagnostic services, and treatment provided in health carehas been most generally conducted via paper chart information capture, manual chart abstraction, and the analysis of administrative claims data.
Common Formats for Patient Safety Data Collection and Event Reporting
As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs). The purpose of this notice is to announce the availability of a new Common FormatReadmissions Version 0.1 Beta for public review and comment.
Designation of a Class of Employees for Addition to the Special Exposure Cohort; Correction
HHS published a notice in the Federal Register (Volume 77, Number 130, Page 40059) on July 6, 2012 to give notice of a decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, also known as the Fernald Environmental Management Project (FEMP), as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. The designation was incorrect. Therefore, HHS has published this notice of correction. On June 27, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of “Health Care Providers' Responses to Medical Device Labeling”
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Survey of ``Health Care Providers' Responses to Medical Device Labeling'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Examination of Online Direct-to-Consumer Prescription Drug Promotion
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Examination of Online Direct-to- Consumer Prescription Drug Promotion'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Prospective Grant of Exclusive License: Development of a Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application No. PCT/US2005/12289, U.S. Patent No. 7,901,881, U.S. Patent Application No. 13/024,845 and foreign equivalents thereof entitled ``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions'' (HHS Ref. No. E-124-2004/0,1,2) and PCT Patent Application No. PCT/US2008/010139 and U.S. Patent Application No. 12/ 675,209 entitled ``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions'' (HHS Ref. No. E-326-2007/0) to Veracyte, Inc., which is located in San Francisco, California. The patent rights in these inventions have been assigned to the United States of America. Other than license applications submitted as objections to this Notice of Intent to Grant an Exclusive License, no further license applications will be considered for the exclusive field of use set forth below if Veracyte, Inc. is granted an exclusive license pursuant to this Notice of Intent to Grant an Exclusive License. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the diagnosis and prognosis of thyroid cancer.
Establish a Patient-Based Registry To Evaluate the Association of Gadolinium Based Contrast Agents Exposure and Nephrogenic Systemic Fibrosis
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the development of a patient-based registry to evaluate the association of gadolinium based contrast agents (GBCAs) exposure and nephrogenic systemic fibrosis (NSF). The goal of the GBCA project is to study the safety of the GBCAs when used as indicated.
Recharter of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
The U.S. Department of Health and Human Services announces the recharter of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health.
Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza; Filing of Food Additive Petition; Correction
The Food and drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 13, 2012 (77 FR 35317). The document announced that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza had jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour. The document was published with an error in the title of the document signer's signature. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet
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.
Representative Edward J. Markey; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Representative Edward J. Markey has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. FDA expressly requests comments on the petitioner's request.
Indirect Food Additives: Polymers
The Food and Drug Administration (FDA or the Agency) is amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. The action is in response to a petition filed by the American Chemistry Council.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues will conduct its tenth meeting in August. At this meeting, the Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children. The Commission will also develop and finalize recommendations regarding access to, and privacy of human genome sequence data.
Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)
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 Cancer Institute (NCI), the 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. Proposed Collection: Title: Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) (NCI). Type of Information Collection Request: Revision (OMB : 0925-0407, current expiration date 9/ 30/2014). Need and Use of Information Collection: This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since. The main change to this submission is that the Supplemental Questionnaire is being replaced with the Medication Use Questionnaire. As PLCO participants now range from 74-94 years of age, the focus is now on collecting additional information regarding medications that are particularly common among older adults. Additionally, the contracts for 8 of the 10 Screening Centers (SCs) ended in 2011 and the remaining two sites will close in 2012 and 2014. NCI has awarded a contract for continuation of participant follow-up activities to one data collection site named the PLCO Central Data Collection Center (CDCC). In 2011, participants were re-consented for at least an additional five years of follow-up. The current number of respondents is limited to the approximately 94,000 participants being actively followed up. The reports on cancer screening and prostate, lung, colorectal, and ovarian cancer mortality based on this trial have been published in peer review medical journals. The additional follow- up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of cancer screening in high versus low risk individuals. Frequency of Response: Annually. Affected Public: Individuals. Type of Respondents: Adult men and women. The annual reporting burden is provided for each study component as shown in Table 1 below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Prospective Grant of Co-Exclusive License: The Development of Human Anti-CD22 Monoclonal Antibodies for the Treatment of Human Cancers and Autoimmune Disease
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a co-exclusive license to practice the inventions embodied in U.S. Patent Application 61/042,239 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT Application PCT/ US2009/124109 entitled ``Human and Improved Murine Monoclonal Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], US patent application 12/934,214 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-03], and all related continuing and foreign patents/patent applications for the technology family, to Customized Therapeutics. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective co-exclusive licensed territory may be worldwide, and the field of use may be limited to:
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