Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 200 of 363
Medicare Program; Notification of Closure of St. Vincent's Medical Center
This notice announces the closure of St. Vincent's Medical Center and the initiation of an application process for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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 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 provisions of FDA's Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals.
Cooperative Arrangement Between the United States Food and Drug Administration and the Inter-American Institute for Cooperation in Agriculture
The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between FDA and the Inter-American Institute for Cooperation in Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to facilitate the exchange of information and the development of projects of mutual interest.
Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA
The Food and Drug Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.
Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes
Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this rule proposes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also proposes to address the status of ONC- Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.
HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act
The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's standard for accounting of disclosures of protected health information. The purpose of these modifications is, in part, to implement the statutory requirement under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to require covered entities and business associates to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record. Pursuant to both the HITECH Act and its more general authority under HIPAA, the Department proposes to expand the accounting provision to provide individuals with the right to receive an access report indicating who has accessed electronic protected health information in a designated record set. Under its more general authority under HIPAA, the Department also proposes changes to the existing accounting requirements to improve their workability and effectiveness.
Privacy Act of 1974; System of Records
The Department of Health and Human Services (HHS) proposes to alter System of Records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH'' In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is publishing notice of the amendment of the categories of individuals covered by the system of records; the categories of records; the authorities; and the purposes for maintenance of the system of records. In addition, we are proposing to add new routine uses. The purpose of these modifications is to provide notice that the National Institute for Occupational Safety and Health (NIOSH) is complying with the Privacy Act in executing its responsibilities under the James Zadroga 9/11 Health and Compensation Act of 2010 found at Title XXXIII of the Public Health Service Act, 42 U.S.C. 300mm300mm-61 (Title XXXIII). To reflect these changes, NIOSH is also revising the name of the system of records to ``Occupational Health Epidemiological Studies, EEOICPA Program Records and WTC Health Program Records, HHS/CDC/NIOSH.'' The entire resulting system of records notice, as amended, appears below.
Advisory Commission on Childhood Vaccines; Notice of Meeting
The Health Resources and Services Administration published a notice in the Federal Register, 76 FR 27651 (May 12, 2011), announcing the meeting of the Advisory Commission on Childhood Vaccines, June 9- 10, 2011, in the Parklawn Building (and via audio conference call), Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.
Stephen Lee Seldon: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Stephen Lee Seldon, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Seldon was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Seldon failed to respond. Dr. Seldon's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Adrien E. Aiache: Debarment Order
The Food and Drug Administration (FDA) (the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adrien Aiache, M.D. for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Aiache was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Aiache was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Aiache failed to respond. Dr. Aiache's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
HRSA will award non-competitively Ryan White HIV/AIDS Program, Part C funds to the Tutwiler Clinic, Tutwiler, Mississippi, to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/education services in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in Marks, Mississippi, and the surrounding counties.
Meeting of the Presidential Advisory Council on HIV/AIDS; Correction
The Department of Health and Human Services published a notice in the Federal Register of May 11, 2011 to announce a meeting of the Presidential Advisory Council on HIV/AIDS that will be held on Thursday, May 26, 2011, and Friday, May 27, 2011. The meeting is to be held from 10 a.m. to approximately 5 p.m. on May 26, 2011, and from 9 a.m. to approximately 3 p.m. on May 27, 2011. The meeting is scheduled to be held in the Department of Health and Human Services; Room 705A Hubert H. Humphrey Building; 200 Independence Avenue, SW.; Washington, DC 20201. The meeting dates have been changed.
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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, e-mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization and e-mail address.
Meeting of the National Vaccine Advisory Committee; Vaccine Safety Working Group
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Vaccine Safety Working Group (VSWG) of the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for public attendance. Individuals who wish to attend the meeting should register at https:// www.hhs.gov/nvpo/nvac, e- mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization and e-mail address.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled: ``Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages.''
Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Inspections and Compliance.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of inspections and compliance under the recently enacted FDA Food Safety Modernization Act (FSMA). More specifically, the public will have an opportunity to provide information and share views that will inform FDA's FSMA implementation strategies relative to enforcement authorities; frequency and targeting of facility inspections; manner of inspection in a preventive controls environment; and improving the reportable food registry (RFR).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act
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 (the PRA).
Meeting of the Task Force on Community Preventive Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Task Force on Community Preventive Services (Task Force). The Task Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research who are appointed by the CDC Directorwas convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Announcement of the Award of a Replacement Grant
The Administration of Children and Family (ACF), Office of Community Services (OCS), announces the award of a replacement grant under the Strengthening Communities Fund (SCF) for the State, Local, and Tribal Government Capacity Building Program grant to Humboldt State University Sponsored Programs Foundation, Arcata, CA. Humboldt State is an eligible designate of the Governor's Office on Economic Development in California. California Volunteers, Inc., Sacramento CA was originally awarded an FY 2009 grant as the result of a competition under the SCF program. In October 2010, California Volunteers submitted a letter relinquishing their grant. Humboldt State University Sponsored Programs Foundation submitted their letter along with their grant application requesting approval as the replacement grantee. OCS reviewed the application from Humboldt State University Sponsored Programs Foundation and found that the proposed project is significantly similar to the one initially chosen for the award. ACF, OCS now announces that Humboldt State University Sponsored Programs Foundation has been awarded the grant in the amount of $233,866 as the permanent successor grantee for the remainder of the project period, which will end on September 29, 2011. Under the award, Humboldt State University Sponsored Programs Foundation will continue to provide coordinated, timely capacity- building outreach, training and technical assistance to faith-based and community organizations in California.
Announcement of the Publication of Funding Opportunity Announcements under the Runaway and Homeless Youth Act
As required under 45 CFR 1351.17, the Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces the publication of the following Funding Opportunity Announcements (FOAs) to the ACF Funding Opportunities Web site (https://www.acf.hhs.gov/ grants/) on 4/25/2011:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Color Additive Certification Requests and Recordkeeping
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Color Additive Certification Requests and Recordkeeping'' 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; Experimental Study of Nutrition Facts Label Formats
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Nutrition Facts Label Formats'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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: ``Comparative Effectiveness Research-Continuing Education.'' 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 February 28th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period until July 5, 2011, for a proposed rule that was published in the Federal Register of April 6, 2011 (76 FR 19192). In that document, FDA proposed requirements for providing nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The Agency is extending the comment period in response to several requests to give interested parties additional time to comment.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Correction
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of April, 6, 2011 (76 FR 19192). To implement the menu labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), FDA proposed requirements for providing certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The document published with several errors in cross references, an incomplete address, and a typographical error in the codified section of the document. This document corrects those errors.
Proposed collection; comment request; Web-Based Skills Training for SBIRT (Screening Brief Intervention and Referral to Treatment)
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 Institute on Drug Abuse, 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.
Submission for OMB review; Comment Request; Process Evaluation of the NIH Roadmap Epigenomics Program
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register in Vol. 76, No. 49, pages 13648-13649 on March 14, 2011, and allowed 60 days for public comment. No public comments were received on the planned study or any of the specific topics outlined in the 60-day notice. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). 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 Panel will discuss the short- term (10 year) projection methods and assumptions in projecting Medicare health spending for Parts A, B, C and D and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy.
Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 9, 2001.
Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators.
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: ``Health IT Tool Evaluation.'' 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 March 11, 2011 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
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: ``Pilot Test of the Proposed Pharmacy Survey on Patient Safety Culture.'' 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 March 11th, 2011 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Healthy Tomorrows Partnership for Children Program
The Health Resources and Services Administration (HRSA) will transfer remaining Special Projects of Regional and National Significance (SPRANS) discretionary grant funds in H17MC08971 from the Southern Nevada Area Health Education Center, the current grantee of record, to the University of Nevada School of Medicine, Department of Pediatrics, in order to continue Healthy Tomorrows supported prevention and intervention services to low-income, underserved women, children and adolescents in Clark County and Southern Nevada.
Rate Increase Disclosure and Review
This final rule with comment period implements requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The final rule establishes a rate review program to ensure that all rate increases that meet or exceed a specified threshold are reviewed by a State or CMS to determine whether they are unreasonable and that certain rate information be made public.
Call for Participation in Pillbox Patient-Safety Initiative
The National Library of Medicine (NLM) invites the participation of manufacturers, including repackagers, and private label distributors of solid oral dosage form medications in the development of Pillbox, a publicly accessible online repository of digital images and descriptive information for solid oral dosage form medications. This project seeks to promote utilization of the SPLIMAGE element of the Food and Drug Administration (FDA) Structured Product Label (SPL) through development and use of imaging standards and methodologies. Through this Call for Participation, NLM seeks to evaluate the photography methodology and procedures it has developed for creating standardized high-resolution images of solid oral dosage form medications that are appropriate for inclusion in the SPL. Participating organizations will be invited to submit samples of their solid oral dosage form medications to NLM for imaging. Resulting image files will be provided to participants, who may choose to voluntarily include them in their subsequent SPL submissions to FDA. Image files that are voluntarily submitted to FDA as part of an SPL listing submission will be included in the publicly accessible, production version of Pillbox. This initiative is an important element of ongoing efforts to enhance patient safety, reduce adverse drug events, and improve the quality and availability of drug information.
Nomination of In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens; Data Request for Substances Evaluated by These Test Methods
On behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests public comment on nominations received for (1) Three in vitro test methods proposed for detecting and quantifying botulinum neurotoxin (BoNT), and (2) an in vitro test method proposed for detecting non-endotoxin pyrogens. NICEATM seeks data generated using alternative test methods for detecting and quantifying BoNT, including but not limited to three test methods nominated by BioSentinel Pharmaceuticals, Inc. (BioSentinel). Data from the standardized mouse LD50 assay currently used for these endpoints are requested for comparison. In addition, NICEATM seeks data generated using alternative test methods for identifying non-endotoxin pyrogens, including but not limited to the monocyte activation test (MAT), which was nominated by Biotest AG. Data on non-endotoxin pyrogens tested in the rabbit pyrogen test (RPT) are requested for comparison. NICEATM received nominations for validation studies on each of the above test methods, which have the potential to reduce or replace animal use for regulatory testing. At this time, ICCVAM requests public comments on the appropriateness and relative priority of these activities.
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice of public workshop published in the Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA announced a public workshop that took place on February 15 and 16, 2011, and requested public comment regarding the topics discussed at the workshop on determining system attributes for tracking and tracing prescription drugs. The workshop provided a forum for discussing possible approaches to developing a track-and-trace system and for obtaining input from supply chain partners on potential attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages. FDA is reopening the comment period to allow additional time for interested persons both to consider all the information provided by the Agency related to the workshop and to submit additional comments.
Preventive Controls for Registered Human Food and Animal Food/Feed Facilities; Request for Comments
The Food and Drug Administration (FDA) is announcing the opening of a docket to obtain information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. FDA is establishing this docket to provide an opportunity for interested parties to provide information and share views that will inform the development of guidance on preventive controls for food facilities that manufacture, process, pack, or hold human food or animal food/feed (including pet food).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Food and Nutrition Product Communications, as Used by the Food and Drug Administration
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; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Disclosure of Amounts of Vitamins and Minerals
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled ``Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Disclosure of Amounts of Vitamins and Minerals.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antiparasitic Resistance and Combination New Animal Drugs Survey
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey
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; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
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; Proposed Collection; Comment Request; Manufacturer's Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007
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 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 eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer's intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the inspections by the Accredited Persons (AP) Program.
Office of Planning, Research and Evaluation; Advisory Committee on Head Start Research and Evaluation
This notice announces a forthcoming meeting of a public advisory committee of the Administration for Children and Families (ACF). The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback op the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.
Part F Special Projects of National Significance Program Cooperative Agreement Under the Ryan White HIV/AIDS Program
This Federal Register notice announces the non-competitive extension with funds of the Enhancing Linkages to HIV Care and Treatment in Jail Settings Initiative, Demonstration Sites (hereafter referred to as the SPNS Enhancing Linkages Initiative) in order to complete linkages to HIV medical care and support services for HIV positive individuals returning from jail settings to the community, follow-up data collection, analysis and dissemination of findings and lessons learned. The findings generated by this Initiative are capable of impacting service delivery systems and increasing linkages to critical HIV care and support services if the model programs can be adapted in jails and HIV service delivery settings across the United States, as well as to demonstrate that HIV testing and linkage to care in jail settings, and transitioning individuals to HIV care and treatment in the community is feasible and effective.
Part F Special Projects of National Significance Program Cooperative Agreement Under the Ryan White HIV/AIDS Program
This Federal Register notice announces the non-competitive extension of Emory University, the Enhancing Linkages to HIV Care and Treatment in Jail Settings Initiative, Evaluation and Support Center (hereafter referred to as the Enhancing Linkages ESC), in order to complete data collection, analysis, and dissemination of effective models for linking HIV positive individuals in jail settings to HIV care and services in the community upon their release. The findings generated by this Initiative are capable of impacting service delivery systems and increase linkages to critical HIV care and support services if the model programs can be adapted in jails and HIV service delivery settings across the United States, as well as to demonstrate that HIV testing and linkage to care in jail settings, and transitioning individuals to HIV care and treatment in the community is feasible and effective.
Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program
The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the ``Affordable Care Act''), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program.
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2011 (76 FR 22805). The document announced that FDA is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. The document published inadvertently used outdated contact information. This document corrects that error.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR 22906). The document announced the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for Extremities.'' The document published inadvertently with outdated information in the ADDRESSES, FOR FURTHER INFORMATION CONTACT, and Electronic Access sections. This document corrects those errors.
Medicare Program; Pioneer Accountable Care Organization Model: Request for Applications
This notice announces a request for applications for organizations to participate in the Pioneer Accountable Care Organization Model for a period beginning in 2011 and ending December 2016.
Submission for OMB Review; Comment Request; A Generic Submission for Formative Research, Pre-Testing, Stakeholder Measures and Advocate Forms at NCI
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 15, 2011 (76 FR 14034) and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI. Type of Information Collection Request: New. Need and Use of Information Collection: In order to carry out NCI's legislative mandate, the Office of Advocacy Relations (OAR) disseminates cancer- related information to a variety of stakeholders, seeks their input and feedback, and facilitates collaboration between the Institute and these external partners to advance NCI's authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities and materials while they are under development. Additionally, administrative forms may be part of this generic submission since they are a necessary part of collecting demographic information and areas of interest for advocates. Pre-testing, or formative evaluation, helps ensure that the products and services developed by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR's effortsensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for profit; Not- for-profit institutions and organizations; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult cancer research advocates; members of the public; health care professionals; organizational representatives. Table 1 outlines the estimated burden hours required for a three-year approval of this generic submission. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Medicare Program; Accelerated Development Sessions for Accountable Care Organizations-June 20, 21, and 22, 2011
This notice announces the first of four accelerated development sessions (ADSs) that will provide executives with the opportunity to learn about core functions of an Accountable Care Organization (ACO) and ways to build their organization's capacity to succeed as an ACO. This 3-day, in-person ADS is to help new ACOs deliver better care and reduce costs. We invite all new or newly emerging ACOs to register a team of senior executives to participate.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing a new system of records. The Countermeasures Injury Compensation Program (CICP), authorized by the Public Readiness and Emergency Preparedness Act (PREP Act), provides compensation to certain individuals for serious physical injuries or deaths resulting from the administration or use of pandemic, epidemic, or security countermeasures identified in declarations issued by the Secretary of the U.S. Department of Health and Human Services (the Secretary) pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-6d). The Secretary has issued several declarations specifying covered countermeasures, such as the pandemic 2009 H1N1 influenza vaccines, antiviral medications (e.g., Tamiflu), anthrax vaccines, and smallpox vaccines. The PREP Act directs the Secretary to establish administrative procedures to compensate individuals who sustained serious injuries as the direct result of the administration or use of covered countermeasures. This system of records is required to comply with the implementation directives of the PREP Act, Public Law 109-148. The records will be used for the CICP's resource planning, administrative implementation (e.g., making medical and/or financial eligibility determinations), compensating requesters, evaluation, scientific research, monitoring, and document storage purposes.
Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of an In Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical Screening: Notice of Availability and Request for Public Comments
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel (hereafter, Panel) on March 29-30, 2011, to evaluate the validation status of the LUMI-CELL[supreg] (BG1Luc ER TA) test method, an in vitro transcriptional activation (TA) assay used to identify chemicals that can interact with human estrogen receptors (ERs). The Panel report is now available on the NICEATM-ICCVAM Web site at: http:/ / iccvam.niehs.nih.gov/docs/endodocs/EDPRPRept2011.pdf or by contacting NICEATM (see ADDRESSES). The report contains (1) the Panel's evaluation of the validation status of the test method and (2) the Panel's comments on the draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel report.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial review.
Strategy To Address Recommendations Issued by the Institute of Medicine in November 2010 Report; Comment Request
The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), requests input on the NIOSH, NPPTL strategy to address the recommendations issued by the Institute of Medicine (IOM) in the November 2010 report Certifying Personal Protective Technologies: Improving Worker Safety. The report focuses on the need for a consistent and risk-based approach to Personal Protective Technology (PPT) conformity assessment.
Draft Alert Entitled “Preventing Occupational Respiratory Disease From Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of a draft Alert entitled ``Preventing Occupational Respiratory Disease from Dampness in Office Buildings, Schools, and other Nonindustrial Buildings'' now available for public comment. The draft document and instructions for submitting comments can be found at: https://nioshdev.cdc.gov/niosh/docket/review/docket238/ default.html. The purpose of this Alert is to provide workers and employers with information necessary for prevention of respiratory disease and proper response to damp building conditions. This guidance does not have the force and effect of the law. Public Comment Period: Comments must be received by July 12, 2011.
Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would establish as a special control limitations on the distribution of this device. FDA is publishing in this document the recommendations of the Panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of the draft guidance document that FDA proposes to designate as a special control for this device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify in vitro diagnostic devices for Bacillus spp. detection into class II, subject to special controls. This draft guidance is not final nor is it in effect at this time.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Grand Junction Operations Office in Grand Junction, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Wah Chang facility in Albany, Oregon, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Norton Co. (or any subsequent owner) in Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Vitro Manufacturing facility in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Submission for OMB Review; Comment Request; NCI Cancer Genetics Services Directory Web-Based Application Form and Update Mailer
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), and the National Institutes of Health (NIH), have submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 15, 2011 (76 FR 14034) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer. Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The purpose of the online application form and the Web-based update mailer is to collect information about genetics professionals to be included in the NCI Cancer Genetics Services Directory on NCI's Cancer.gov Web site. The information collected includes name, practice locations, professional qualifications, and areas of specialization. Frequency of Response: Information is collected once via the online application form, and then updated annually via the Web-based mailer. Affected Public: Individuals. Type of Respondents: Genetics professionals including nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The annual reporting burden is estimated at 180 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Compliance Policy Guide: Surgeons' Gloves and Patient Examination Gloves; Defects-Criteria for Direct Reference Seizure
The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination Gloves; DefectsCriteria for Direct Reference Seizure (the CPG). The CPG, which was originally issued in 1991, provides guidance to FDA staff on the submission of seizure recommendations for medical gloves that exceed the defect levels in FDA regulations. The CPG has been revised to remove an appendix that became obsolete when the regulations were amended, and to make other minor changes for clarity and consistency with the amended regulation.
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