Department of Health and Human Services November 2015 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 270
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade ``A'' milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.
Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act
This document contains final regulations regarding grandfathered health plans, preexisting condition exclusions, lifetime and annual dollar limits on benefits, rescissions, coverage of dependent children to age 26, internal claims and appeal and external review processes, and patient protections under the Affordable Care Act. It finalizes changes to the proposed and interim final rules based on comments and incorporates subregulatory guidance issued since publication of the proposed and interim final rules.
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ``gluten- free'' labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten-free.'' There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a ``gluten-free'' claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is ``gluten-free'' in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the ``gluten-free'' claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.
Health and Human Services Acquisition Regulations
The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation (HHSAR), to update its regulation to current FAR requirements; to remove information from the HHSAR that consists of material that is internal, administrative, and procedural in nature; to add or revise definitions; to correct certain terminology; and to delete outdated material or material duplicative of the FAR.
Proposed Data Collection Submitted for Public Comment and Recommendations
The notice ``Proposed Data Collection Submitted for Public Comment and Recommendations'' on Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement (80 FR 68543, November 5, 2015) is cancelled. This notice invited comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement,'' where CDC would use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes. This proposed data collection also received publication for public comment on November 9, 2015 under Docket ID 60Day-16-16BZ; Docket No. CDC-2015-0095.
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseLabeling for Products That Contain Acetaminophen.'' The guidance is intended to inform manufacturers of certain nonprescription (also referred to as over-the- counter or OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances for which FDA does not intend to object to the inclusion of a liver warning that differs from that required under FDA regulations, provided the warning appears as described in the guidance.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that STRENSIQ (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. FDA is publishing in this proposed rule the recommendations of the Panel regarding the classification of the devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care. CDC is requesting a 3-year approval for revision to the previously approved project to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for extension to the previously approved project used to collect data from participants to monitor and evaluate performance and practices among national laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works-Best Practice, Promising Practice, and Local Effort (BPPPLE) Form
In compliance with the Paperwork Reduction Act of 1995, Public Law (Pub. L.) 104-13 [44 United States Code (U.S.C.) Sec. 3507(a)(1)(D)], the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection titled, ``Indian Health Service (IHS) Sharing What Works Best Practice, Promising Practice, and Local Effort (BPPPLE) Form,'' Office of Management and Budget (OMB) Control Number 0917-0034. This previously approved information collection project was last published in the Federal Register (80 FR 61215) on October 9, 2015, and allowed 60 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit this collection, which expires January 31, 2016, to OMB for approval of an extension, and to solicit comments on specific aspects for the proposed information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0008). Proposed Collection: Title: 0917- 0034, Indian Health Service (IHS) Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Type of Information Collection Request: Extension, without revision, of the currently approved information collection, 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. There are no program changes or adjustments in burden hours. Form(s): 0917-0034, IHS Sharing What WorksBest Practice, Promising Practice, and Local Effort (BPPPLE) Form. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission and encourage the creation and utilization of performance driven products/ services by IHS, Tribal, and urban Indian health (I/T/U) programs, the Office of Preventive and Clinical Services' program divisions (i.e., Behavioral Health, Health Promotion/Disease Prevention, Nursing, and Dental) have developed a centralized program database of best practices, promising practices and local efforts (BPPPLE) and resources. The purpose of this collection is to further the development of a database of BPPPLE, resources, and policies which are available to the public on the IHS.gov Web site. This database will be a resource for program evaluation and for modeling examples of various health care projects occurring in AI/AN communities. All information submitted is on a voluntary basis; no legal requirement exists for collection of this information. The information collected will enable the Indian health systems to: (a) Identify evidence based approaches to prevention programs among the I/T/Us when no system is currently in place, and (b) Allow the program managers to review BPPPLEs occurring among the I/T/Us when considering program planning for their communities. Affected Public: Individuals. Type of Respondents: I/T/U health programs' staff. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
Proposed Collection; 60-Day Comment Request; Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Cancer Therapy Evaluation Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), 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. Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact, Charles Hall, RPh, M.S., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, RM 5W240, MSC 9725, Bethesda, Maryland 20892. Or call non-toll-free number (240) 276-6575, or email your request, include your address to: hallch@mail.nih.gov. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Title: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer, 0925-0613, Expiration Date 03/31/ 2016, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: Revision. The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. The frequency of Response is up to 16 times per year. The affected public is private sector including businesses, other for-profit organizations, and non-profit institutions. The type of respondents are investigators, pharmacists, nurses, pharmacy technicians, and data managers. OMB approval is requested for 3 years. There are no capital costs, operating costs or maintenance costs. The total estimated annualized burden hours are 22,645 hours.
National Advisory Council on Migrant Health Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the National Advisory Council on Migrant (NACMH). The NACMH is authorized under 42 U.S.C. 218, section 217 of the Public Health Service (PHS) Act, as amended and governed by provisions of Public Law 92-463, as amended, (5 U.S.C. Appendix 2).
National Advisory Council on Nurse Education and Practice; Notice for Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the National Advisory Council on Nurse Education and Practice (NACNEP). The NACNEP is in accordance with the provisions of 42 United States Code (U.S.C.) 297t; Section 851 of the Public Health Service Act, as amended. The Council is governed by provisions of Public Law 92-463, which sets forth standards for the formation and use of advisory committees.
Medicare Program; CY 2016 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2016 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2016, the inpatient hospital deductible will be $1,288. The daily coinsurance amounts for CY 2016 will be: (1) $322 for the 61st through 90th day of hospitalization in a benefit period; (2) $644 for lifetime reserve days; and (3) $161.00 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2016
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2016. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2016, the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts, and the transfer amount equal to the reduction in premiums payable as a result of amendments made by the Bipartisan Budget Act of 2015. The monthly actuarial rates for 2016 are $237.60 for aged enrollees and $282.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2016 is $121.80, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2015 standard premium rate was $104.90.) The Part B deductible for 2016 is $166.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60. Section 1844(d) of the Social Security Act, as added by section 601(b) of the Bipartisan Budget Act of 2015, provides for a transfer from the general fund to the Part B account of the SMI Trust Fund. This transfer of $7,440,648,000 consists of $5,237,880,000 in reduced premium revenue for enrollees age 65 and older, and $2,202,768,000 in reduced premium revenue for enrollees under age 65.
Notice of Opportunity for Public Comment on the Dietary Supplement Label Database
This document, originally published on October 29, 2015 (80 FR 66549), has been amended to extend the comment receipt date to December 31, 2015. The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at http:/ /dsld.nlm.nih.gov.
Medicare Program; CY 2016 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2016. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2016, for these individuals will be $411. The premium for certain other individuals as described in this notice will be $226.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Submission for OMB Review; 30-Day Comment Request Scientific Information Reporting System (SIRS) NIGMS
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 23, 2015, page 48549 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of General Medical Sciences (NIGMS), 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. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
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 a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
The National Advisory Council on the National Health Service Corps; Notice for Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on The National Advisory Council on the National Health Service Corps (hereafter referred to as NACNHSC). The NACNHSC was established under 42 U.S.C. 254j (Section 337 of the Public Health Service Act), as amended by Section 10501 of the Affordable Care Act. The NAC is governed by provisions of 92 (5 U.S.C. App. 2), also known as the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees.
Independent Living Services and Centers for Independent Living
This proposed rule would implement the Workforce Innovation and Opportunity Act enacted on July 22, 2014 and reflects the transfer of Independent Living Services and Centers for Independent Living programs from the Department of Education to the Department of Health and Human Services. The previous regulations were issued by the Department of Education. This proposed rule will consolidate the Independent Living (IL) regulations into a single part, align the regulations with the current statute and HHS policies, and will provide guidance to IL grantees.
Center for Devices and Radiological Health: Experiential Learning Program; General Training Program
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH or Center) is announcing the 2015 Experiential Learning Program (ELP) General Training Program. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP General Training Program.
Drugs for Human Use; Drug Efficacy Study Implementation; Nitroglycerin Transdermal Systems; Withdrawal of Hearing Request; Withdrawal of Applications; Final Resolution of Hearing Requests Regarding Transdermal Systems Under Docket
The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests regarding nitroglycerin drug products in transdermal systems under Docket No. FDA-1977-N-0356 (formerly 77N-0240) (DESI 1786) have been withdrawn. Therefore, shipment in interstate commerce of any nitroglycerin drug product in a transdermal system identified in this docket, or any identical, related, or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the effective date of this notice.
Eighth Annual Sentinel Initiative; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Eighth Annual Sentinel Initiative Public Workshop.'' Convened by the Center for Health Policy at the Brookings Institution and supported by a cooperative agreement with FDA, this 1- day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System, and key activities and uses of the Sentinel System accomplished in 2015. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects.
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions; Correction
The Food and Drug Administration (FDA or we) is correcting the preamble to a final rule that appeared in the Federal Register of September 24, 2015. This final rule provided FDA with categorical exclusions from the requirement to prepare environmental assessments for certain actions regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule also included amendments to certain environmental impact regulations to include tobacco products, where appropriate, in light of its authority under the Tobacco Control Act. The document published with technical errors in reference numbers cited in the document. This document corrects those errors. We are placing a corrected copy of the rule in the docket.
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is canceling the November 18, 2015, session and postponing the November 19, 2015, session of the Gastroenterology and Urology Devices Panel meeting. The meeting was announced in the Federal Register of October 7, 2015 (80 FR 60686). The November 19, 2015, session has been postponed due to the cancellation of the November 18, 2015, meeting. Future meeting dates will be announced in the Federal Register.
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