Department of Health and Human Services June 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 200 of 346
National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; Formative Research Methodology Studies for the National Children's Study
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 of Child Health and Human Development (NICHD), 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. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23608-23609, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study specifically and of federally funded biomedical research overall. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Formative Research Studies for the National Children's Study (NCS) Type of Information Collection Request: RENEWAL of OMB Clearance 0925-0590, Expiration June 30, 2011 Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
Agency Information Collection Activities: Proposed Collection: Comment Request
The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of June 20, 2011 (FR Doc. 2011-15194), on page 35900, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193).
Notice of Availability of Proposed Data Collection Standards for Race, Ethnicity, Primary Language, Sex, and Disability Status Required by Section 4302 of the Affordable Care Act
The Department of Health and Human Services (DHHS) is seeking public comment on the proposed data collection standards for race, ethnicity, sex, primary language and disability status, as required by Section 4302 of the Affordable Care Act. The proposed data collection standards are now available on the HHS Web site minorityhealth.hhs.gov/ section4302.
Assessing the Current Research, Policy, and Practice Environment in Public Health Genomics
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is announcing the opening of a docket to solicit comments, data, and other information helpful to assess the current research, policy, and practice environment in public health genomics. HHS/CDC is currently leading a process to assess the most important steps for public health genomics in the next five years.
Medicare Program; Clinical Laboratory Fee Schedule: Signature on Requisition
This proposed rule would retract the policy adopted in the calendar year 2011 Physician Fee Schedule final rule with comment period that requires the signature of a physician or qualified non- physician practitioner on a requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS). In addition, this proposed rule would reinstate the prior policy that the signature of a physician or qualified non-physician practitioner is not required on a requisition for Medicare purposes for a clinical diagnostic laboratory test paid under the CLFS.
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: ``Medical Expenditure Panel SurveyInsurance Component 2012-2013.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study
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 of Child Health and Human Development (NICHD), 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. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23603-23605, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study specifically and of federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment.
New Proposed Collection; Comment Request; Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study
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 of Child Health and Human Development (NICHD), 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. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study and federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:
International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall Regulations
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 reporting requirements on FDA recalls.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Cooperative Agreement With the World Health Organization Department of Food Safety and Zoonoses in Support of Strategies That Address Food Safety Problems That Align Domestically and Globally (U01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source cooperative agreement with the World Health Organization (WHO). The goal of the Food and Drug Administration, Office of the Commissioner and the Office of International Programs, Center for Food Safety and Nutrition, and the Center for Veterinary Medicine is to contribute to the knowledge base of the current state of food safety globally, including challenges, risks and emerging trends, through an integrated information system based on WHO's existing network efforts.
Cooperative Agreement To Support Shellfish Safety Assistance Project
The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety is announcing its intent to award a single source cooperative agreement to support the Interstate Shellfish Sanitation Conference (ISSC). The purpose of this cooperative agreement is to enhance the FDA molluscan shellfish sanitation program and provide the public greater assurance of the quality and safety of these products.
Proyecto Informar: Food and Drug Administration Hispanic Outreach Initiative (U01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement for the National Alliance for Hispanic Health. The goal of the Food and Drug Administration, Office of the Commissioner, is to support initiatives that will communicate risk and emergency public health information to millions of Spanish-speaking consumers within the targeted populations (socially disadvantaged, underserved populations, ethnic and racial populations, health professionals, patients and caregivers, pediatrics, adolescents, and disabled and older Americans).
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses
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 reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Uses.''
CooperVision, Inc.; Filing of Color Additive Petitions
The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed two petitions proposing that the color additive regulations be amended to provide for the safe use of 1,4- bis[4-(2-methacryloxyethyl)phenlyamino] anthraquinone (C.I. Reactive Blue 246) and 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additives are intended to be copolymerized with various monomers for use as colored contact lens materials.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fifth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
Submission for OMB review; comment request Health Information National Trends Survey 4 (HINTS 4) (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 April 22, 2011 (76 FR 22714) and allowed 60-days for public comment. One public comment was received on April 23, 2011 which commented on the number of previous surveys and expense. An e-mail response was sent on April 25, 2011, stating, ``Thank you for your comments. We will take your comments into consideration.'' 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: Health Information National Trends Survey 4 (HINTS 4) (NCI) (OMB 0925-0538, Exp 11/30/2008). Type of Information Collection Request: Reinstatement with Change. Need and Use of Information Collection: HINTS 4 will provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of cancer-related behavior. The Public Health Services Act, Sections 411 (42 U.S.C. 285a) and 412 (42 U.S.C. 285a-1.1 and 285a-1.3), outline the research and information dissemination mission of the NCI which authorizes the collection of this information. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 18+). The annual reporting burden is documented in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of April, 6, 2011 (76 FR 19238). To implement the vending machine labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), FDA proposed requirements for providing calorie information for certain articles of food sold from vending machines. The document published with several errors including an incorrect contact phone number and an incomplete address. This document corrects those errors.
Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL
The Food and Drug Administration (FDA) has determined the regulatory review period for XYZAL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; INVEGA SUSTENNA
The Food and Drug Administration (FDA) has determined the regulatory review period for INVEGA SUSTENNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-August 10, 2011 Through August 12, 2011
This notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2011. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2012.
Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes
This document contains amendments to interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under provisions of the Affordable Care Act. These rules are intended to respond to feedback from a wide range of stakeholders on the interim final regulations and to assist plans and issuers in coming into full compliance with the law through an orderly and expeditious implementation process.
Manual Materials Handling (MMH) Workshop
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) in partnership with the University of Cincinnati, Department of Environmental Health, will be holding a two-day Manual Materials Handling (MMH) Workshop. The Workshop is a National Occupational Research Agenda (NORA) activity organized by the Wholesale and Retail Trade Sector and the Transportation, Warehouse and Utilities Sector. The MMH Workshop goal is to stimulate through roundtable discussions the wider adoption of current, effective MMH equipment, and the development of the next generation of MMH equipment for the purposes of reducing both worker fatigue from overexertion and strains/sprains, as well as improving overall efficiency. The purpose of MMH Workshop is to develop cost effective engineering solutions for manual materials handling jobs in Retail, Wholesale and Warehouse industries.
Development of Best Practices for Community Health Needs Assessment and Implementation Strategy; Public Forum
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), will hold a public forum from July 11-13, 2011 on processes relating to community health needs assessment (CHNA) and implementation strategy/plan development and execution. HHS/CDC is developing best practices designed to support state and local health departments to meet public health accreditation standards, and by other entities who may wish to utilize them in their community health planning processes. This notice announces the public forum.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located at 110 Hopkins Street, Buffalo, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Wah Chang facility in Albany, Oregon, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Chapman Valve Manufacturing Company (i.e., Building 23 and Dean Street facility) in Indian Orchard, Massachusetts, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Dow Chemical Company in Madison, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Linde Ceramics Plant in Tonawanda, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment
The Food and Drug Administration (FDA) is amending the device regulations to clarify the applicability of the device classification for human dura mater. This action is being taken to improve the accuracy of the regulations.
Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed Consent.'' This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).
Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F-18) Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SODIUM FLUORIDE F 18 (sodium fluoride F-18) injection, 10 to 200 millicuries per milliliter (mCi/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SODIUM FLUORIDE F 18 injection, 10 to 200 mCi/mL, if all other legal and regulatory requirements are met.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7(R2) on Dissolution Test General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): Dissolution Test General Chapter'' (Q4B Annex 7(R2)). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Q4B Annex 7(R2) is a revision of the previously published ICH guidance, ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions, updates the considerations for implementation, and updates the references used for the Q4B evaluation. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).
Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER), Office of Compliance. This reorganization includes the organizations and substructure components as listed in this document. This document is announcing availability of the Staff Manual Guide that explains the details of this reorganization.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Pharmacogenomic Data Submissions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Pharmacogenomic Data Submissions'' 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; Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
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.
Timothy J. Rosio: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Timothy J. Rosio, M.D. for 4 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. Rosio was convicted of misdemeanors 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. Rosio was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Rosio failed to respond. Dr. Rosio's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE) July 28, 2011
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare, Medicaid, and Children's Health Insurance (CHIP) programs. This meeting is open to the public.
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: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' 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 April 18th, 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.
Guidelines for Determining Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Revision of Guidelines on Non-Radiogenic Cancers; Extension of Comment Period
On March 21, 2011, the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking proposing to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupations Illness Compensation Program Act (EEOICPA) of 2000. The public comment period was scheduled to end on June 20, 2011. We have received a request asking to extend the public comment period. In consideration of this request, HHS is extending the public comment period by 30 days to July 20, 2011.
Determination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT
The Food and Drug Administration (FDA) has determined the regulatory review period for DEXILANT (previously KAPIDEX) 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 a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BROVANA
The Food and Drug Administration (FDA) has determined the regulatory review period for BROVANA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin
The Food and Drug Administration (FDA) has determined the regulatory review period for Fusilev (Levoleucovorin) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Announcement of Availability of the Report on Carcinogens, Twelfth Edition
The Department of Health and Human Services released the 12th RoC to the public on June 10, 2011. The report is available on the RoC Web site at: https://ntp.niehs.nih.gov/go/roc12 or in printed text or electronically from the Office of the RoC (see ADDRESSES below).
Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC): Notice of Cancellation
The NTP BSC meeting, scheduled for July 21, 2011, and announced in the Federal Register (76 FR 28785), has been cancelled.
Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA
The Food and Drug Administration (FDA) has determined the regulatory review period for METVIXIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Advertisements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Scientific Information Request on Insulin Delivery and Glucose Monitoring Devices for Diabetes Mellitus
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers of insulin pumps and continuous glucose monitors. Scientific information is being solicited to inform our Comparative Effectiveness and Safety of Insulin Delivery and Glucose Monitoring Methods for Diabetes Mellitus review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.
Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the-Counter Human UseRevision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling requirements applicable to all OTC topical acne products marketed under the monograph (75 FR 9767, March 4, 2010) (final rule). The guidance describes the requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.
Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low Glucose Suspend Device Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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.
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.
Prospective Grant of Exclusive License; The Development of Ulipristal Acetate for the Treatment of Symptomatic Uterine Fibroids
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to PregLem SA of an exclusive patent license to practice the inventions embodied in US Patent Application 12/021,610 entitled, ``Method for Treating Uterine Fibroids'' [HHS Ref. E-057-2008/0-US-01], and all continuing applications and foreign counterparts. The patent rights in this invention have been assigned to the Government of the United States of America and to Laboratoire HRA Pharma. The exclusive license contemplated in this notice is solely to the patent rights assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: The use of ulipristal acetate for the treatment of symptomatic uterine fibroids.
Prospective Grant of Exclusive License; Devices for Clearing Mucus From Endotracheal Tubes
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the invention embodied in: HHS Ref. No. E-074-2005/0 ``Mucus Slurping Endotracheal Tube''; U.S. Patent 7,503,328 to Oculus Innovative Sciences, Inc., a company incorporated under the laws of the State of California having its headquarters in Petaluma, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices for clearing mucus from endotracheal tubes.
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.
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.
Required Warnings for Cigarette Packages and Advertisements
The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.
Amendments to Sterility Test Requirements for Biological Products
The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.
Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues; and Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing the availability of two related draft guidances for industry and FDA staff entitled ``Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.'' These draft guidances provide the Agency's current thinking on approaches for classifying products as drugs and devices, certain additional product classification issues, and the interpretation of the term ``chemical action'' under the FD&C Act.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYFORTIC
The Food and Drug Administration (FDA) has determined the regulatory review period for MYFORTIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
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; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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 proposed collection of information resulting from the guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP).
Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics.'' This draft guidance provides recommendations to applicants on endpoints for lung cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. This draft guidance should speed the development and improve the quality of protocols submitted to the Agency to support anticancer effectiveness claims.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' 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; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals
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.
Proposed Collection; Comment Request; Healthy Communities Study: How Communities Shape Children's Health (HCS)
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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3-15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and non-profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/ policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 32,958. The annualized cost to respondents is estimated at $213,764.58. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection
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 SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.
Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to ``50+.'' We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness.
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms
We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.
Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.
Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).
Medicare Program; Conditions of Participation (CoPs) for Community Mental Health Centers
This proposed rule would establish, for the first time, conditions of participation (CoPs) that community mental health centers (CMHCs) would have to meet in order to participate in the Medicare program. These proposed CoPs would focus on the care provided to the client, establish requirements for staff and provider operations, and encourage clients to participate in their care plan and treatment. The new CoPs would enable CMS to survey CMHCs for compliance with health and safety requirements.
Proposed Collection; Comment Request; NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source Questionnaire (Survey of Authors)
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 of Nursing Research (NINR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB). Proposed Collection: Title: NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source Questionnaire (Survey of Authors). Type of Information Collection Request: NEW. Need and Use of Information Collection: The NINR End-of-Life Science Palliative Care (EOL PC) Needs Assessment: Funding Source Questionnaire will obtain information on funding sources of EOL PC research published studies for which a funding source is not cited or the information is unclear. Target participants are authors of publically-available EOL PC research studies published between 1997-2010 for whom a funding source is unknown or unclear. The questionnaire inquires about the funding source of the published study, type of funding received, year of funding, and duration of funded study. This is a 7-item questionnaire that takes approximately 5 minutes to complete. Data collected is part of a needs assessment to address the breadth and depth of EOL PC scientific issues for use in stimulating research capacity in the field. Frequency of Response: One time. Affected Public: Individual authors of publically available EOL PC research publications who do not list a funding source or the source is unclear within their publication. Type of Respondents: EOL PC researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1840; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .08; and Estimated Total Annual Burden Hours Requested: 147. There are no Capital Costs, 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.
Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities; Correction
The Indian Health Service published a document in the Federal Register on June 8, 2011, concerning competitive cooperative agreement applications to establish Tribal Epidemiology Centers serving American Indian/Alaska Native Tribes and urban Indian communities. The document contained one incorrect date.
Award of an Urgent Single-Source Grant to Heartland Alliance, Chicago, IL
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source grant for training and technical assistance on incoming Lesbian, Gay, Bi- Sexual and Transgender (LGBT) refugee cases to Heartland Alliance, Chicago, IL, for a total of $250,000. The additional funding provided by the award will support services to refugees through May 31, 2012. The current resettlement network has limited understanding of the issues and subgroups. Heartland Alliance will develop training and technical assistance resources, including capacity building and service delivery, specifically targeted at assisting newly arriving LGBT refugees. Heartland Alliance will have the opportunity to receive a continuation award at the same amount in FY 2012, which will provide the grantee with a two-year project period.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; 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 the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based Devices.'' This draft guidance document provides industry and Agency staff with recommendations for studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of methicillin-resistant S. aureus (MRSA), including those for the detection or detection and differentiation of MRSA versus S. aureus (SA) in either human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time.
Vaccine To Protect Children From Anthrax-Public Engagement Workshop
The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. This meeting is open to the public and prior registration is required. The public may attend in-person or by teleconference.
Privacy Act of 1974; System of Records
On May 27, 2011, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a Notification of Proposed Altered System of Records for its system of records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH.'' This document offers clarifications to the May publication.
Proposed Establishment of a Federally Funded Research and Development Center-Third Notice
This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the third 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.
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