Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents
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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.
Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; Correction and Reopening of the Comment Period
The Food and Drug Administration (FDA) is correcting notices concerning FDA's determination of the regulatory review period for PRISTIQ that appeared in the Federal Registers of August 31, 2010 (75 FR 53314) and September 2, 2010 (75 FR 53969). The documents omitted docket number FDA-2009-E-0086. This document corrects those omissions. Because the comment period for the notices closed on February 28, 2011, FDA is reopening the comment period to allow interested parties to submit comments or petitions to docket number FDA-2009-E-0086.
Medicare and Medicaid Programs; Opportunities for Alignment Under Medicaid and Medicare
This document is a request for comments on opportunities to more effectively align benefits and incentives to prevent cost-shifting and improve access to care under the Medicare and Medicaid programs for individuals with both Medicare and Medicaid (``dual eligibles''). The document also reflects CMS' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''
Submission for OMB Review; Comment Request; Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study (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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 14, 2011 (76 FR 13647) and allowed 60-days for public comment. There were no public comments in response to the notice. 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: Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The AARP-based study is one component of a multi-center biomarker validation study project involving two other large cohorts in the United States. The iDATA study involves large cohorts and provides the necessary sample size to evaluate the measurement error structure of the diet and physical activity assessment instruments and the heterogeneity of the measurement error structure across multiple and diverse study populations. The iDATA study will include 1,500 participants from the NIH-AARP Diet and Health Study and current AARP membership. The data collection instruments adhere to The Public Health Service Act, which provides authority to the Risk Factor Monitoring and Methods Branch in the Division of Cancer Control and Population Sciences and the Division of Cancer Epidemiology and Genetics. Both divisions work to reduce cancer in the U.S. population by establishing and supporting programs for the detection, diagnosis, prevention and treatment of cancer; and by collecting, identifying, analyzing and disseminating information on cancer research, diagnosis, prevention and treatment. Dietary and physical activity data will be gathered using the instruments as detailed below. In addition, biospecimen and clinic data will be also gathered. Frequency of Response: Monthly. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50- 74). The annual reporting burden is provided for each study component as shown in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid conjugate by subcutaneous injection for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.
Memorandum of Understanding Between the Food and Drug Administration and the International Anesthesia Research Society for the Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots Public-Private Partnership
The Food and Drug Administration (FDA) is providing notice of an amendment to memorandum of understanding (MOU) 222-09-0014 between the International Anesthesia Research Society (IARS) and FDA. The purpose of this MOU is to establish the framework for collaboration between the parties and to support their shared interest of promoting the safe use of anesthetics and sedatives in children. This is an amendment to this MOU to rename the SAFEKIDS (Safety of Key Inhaled and Intravenous Drugs in Pediatrics) Public-Private Partnership (PPP) to SmartTots (Strategies for Mitigating Anesthesia Related Neuro-Toxicity in Tots) PPP.
Determination That XIBROM (Bromfenac Ophthalmic Solution) 0.09% Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that XIBROM (bromfenac ophthalmic solution) 0.09% was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for bromfenac ophthalmic solution 0.09% if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
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; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Announcement of Notice; Proposed Establishment of a Federally Funded Research and Development Center-Second Notice
This notice announces our intention to sponsor a Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the second of three notices which must be published over a 90-day period in order to advise the public of the agency's intention to sponsor an FFRDC.
Medicare and Medicaid Programs; Application by the Joint Commission for Continued Deeming Authority for Critical Access Hospitals
This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
A proposal to certify Kluyveromyces lactis as a host-vector 1 system has been reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director. This decision is based upon the determination that the K. lactis host-vector 1 system affords a moderate degree of biological containment equal to other certified host-vector 1 systems presently listed in the NIH Guidelines. Moreover, it has been determined that certain research with this host-vector system does not present a significant risk to health and the environment and therefore will be exempt from the NIH Guidelines (See Section III-F-6 and Appendix C). Appendix C has been modified to indicate the nature of the research that is exempt when performed in a K. lactis certified host-vector 1 system. In addition, the Office of Biotechnology Activities is updating Appendix D of the NIH Guidelines to include additional lines of experimentation approved by the NIH Director; in this case an experiment involving the introduction of tetracycline resistance into Chlamydia trachomatis that falls under Section III-A-1-a of the NIH Guidelines.
HIV/AIDS Bureau Policy Notice 11-01 (Replaces Policy Notice 99-02)
The Health Resources and Services Administration, HIV/AIDS Bureau (HAB) Policy Notice 99-02 established policies for the use of Ryan White HIV/AIDS Program funds authorized under Title XXVI of the Public Health Service (PHS) Act, for housing referral services and short-term or emergency housing needs. Amendment 1 to Policy Notice 99-02, effective March 27, 2008, modified Policy Notice 99-02 by imposing a 24-month cumulative cap on short-term and emergency housing assistance. The limit on benefits would have taken effect on March 27, 2010, and would have impacted individuals who were users of the funds for housing assistance. HRSA received comments from the public concerning the potential impact of the cap and the threat to the ability of clients receiving Ryan White HIV/AIDS Program funded services to receive housing services. In response, HRSA's Administrator directed that Policy Notice 99-02 Amendment 1 be rescinded, as published in the February 10, 2010, Federal Register notice, Volume 75, Issue 27, pages 6672-6673. In addition, the notice indicated that HRSA was conducting a comprehensive review of the Housing Policy. As a result of a thorough vetting and comprehensive review, HRSA is issuing a final notice of Housing Policy Notice 11-01 which replaces HAB Policy Notice 99-02, effective May 12, 2011.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Regulations
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.
Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing
The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing.'' This draft guidance document provides industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for C. trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. This draft guidance is not final nor is it in effect at this time.
Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals
NIH is further extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) The adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by an additional 30 days and thus will end on May 24, 2011. Additionally, character limits on the comment form fields have been removed.
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: ``Pre-test of an Assisted Living Consensus Instrument.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Submission for OMB Review; Comment Request
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 August 25, 2010, page 52351 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 July 31, 2005, unless it displays a currently valid OMB control number. Proposed Collection: Title: Special Volunteer and Guest Researcher Assignment for use in NIH facilities. Type of Information Collection Request: Reinstatement, 0MB 0925-0177, Expiration Date July 31, 2005. Need and Use of Information Collection Request: Form Number: NIH-590. A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. Frequency of Response: once. Affected Public: Individuals. Type of Respondents: Non- federal scientific professionals and/or individuals. The annual Reporting burden is as follows: Estimated Number of Respondents: 1660; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.1; and Estimated Total Annual Burden Hours Requested: 166. The estimated annualized cost to respondents is $2,275. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: 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.
Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Vaccine Safety Working Group for Consideration by the National Vaccine Advisory Committee on the Federal Vaccine Safety System
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Section 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC ``To review the current federal vaccine safety system and develop a White Paper describing the infrastructure needs for a federal vaccine safety system to fully characterize the safety profile of vaccines in a timely manner, reduce adverse events whenever possible, and maintain and improve public confidence in vaccine safety.'' On behalf of the NVAC, the Vaccine Safety Working Group (VSWG) has developed a draft report and draft recommendations for the consideration by the NVAC in developing the NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group draft report and draft recommendations for the federal vaccine safety system to be considered by the NVAC. Individuals and organizations are encouraged to submit their comments on the draft report and draft recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented in mid to late 2011 to the NVAC for deliberation and decision on their final recommendations.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Information From United States Firms and Processors That Export to the European Community
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Information From United States Firms and Processors That Export to the European Community'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
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.
Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Request for Comments
The Food and Drug Administration (FDA or the Agency) is issuing this document to request comments relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications submitted under the Public Health Service Act (PHS Act). FDA is requesting input on the identified principles for development of a 351(k) user fee program, FDA's proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program. FDA plans to review the comments submitted to the docket, hold meetings with public stakeholders, and hold industry stakeholder meetings to develop proposed recommendations for a user fee program for 351(k) applications for fiscal years (FYs) 2013 through 2017.
Medicare Program; Hospice Wage Index for Fiscal Year 2012
This notice announces a CMS Ruling that was signed on April 14, 2011 regarding CMS's determination to grant relief to any hospice provider that has a properly pending appeal (as defined in the Ruling) in any administrative appeals tribunal (that is, the Provider Reimbursement Review Board (PRRB), the Administrator of CMS, the Medicare fiscal intermediary hearing officer, or the CMS reviewing official) that seeks review of an overpayment determination for any hospice cap year (the period November 1 to October 31) ending on or before October 31, 2011 by challenging the validity of the beneficiary counting methodology set forth in 42 CFR 418.309(b)(1).
Medicare Program; Hospice Wage Index for Fiscal Year 2012
This proposed rule would set forth the hospice wage index for fiscal year 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This proposed rule would change the hospice aggregate cap calculation methodology. This proposed rule also would revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this proposed rule would begin implementation of a hospice quality reporting program.
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