Department of Health and Human Services 2017 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 3,146
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's `Fresh Empire' Multicultural Youth Tobacco Prevention Campaign
Document Number: 2017-27712
Type: Notice
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an extension of the time period for the outcome evaluation of FDA's multicultural youth tobacco public education campaign, the addition of two rounds of data collection with the original youth surveyed for the outcome evaluation, and recruitment of new youth to participate in those two additional surveys.
Determination of Regulatory Review Period for Purposes of Patent Extension; STRIVERDI RESPIMAT
Document Number: 2017-27710
Type: Notice
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for STRIVERDI RESPIMAT 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-27688
Type: Notice
Date: 2017-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-27687
Type: Notice
Date: 2017-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO
Document Number: 2017-27684
Type: Notice
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SIVEXTRO 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Notice of Meeting
Document Number: 2017-27664
Type: Notice
Date: 2017-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Each Special Emphasis Panel (SEP) meeting will commence in open session before closing to the public for the duration of the meeting ``AHRQ RFA-HS17-011, National Research Service Award (NRSA) Institutional Research Training Grant (T32) .''
Notice of an Upcoming Challenge Competition
Document Number: 2017-27663
Type: Notice
Date: 2017-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to conduct a Challenge Competition in Fall 2018 to develop user-friendly technical tools to collect and integrate patient-reported outcome data in electronic health records or other health information technology products.
Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
Document Number: 2017-27650
Type: Proposed Rule
Date: 2017-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research, is announcing a proposed program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary formthe Voluntary Malfunction Summary Reporting Program. This proposed voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Commitment Letter). These goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format. In addition, this proposed program reflects FDA's findings from a pilot program the Agency conducted to study summary reporting formats for malfunction MDRs.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-27646
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-27645
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2017-27644
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-27643
Type: Notice
Date: 2017-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH)
Document Number: 2017-27617
Type: Notice
Date: 2017-12-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-27606
Type: Notice
Date: 2017-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Wednesday, December 13, 2017, the Centers for Medicare & Medicaid Services (CMS) published a notice document entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request''. That notice invited public comments on two separate information collection requests, under Document Identifiers: CMS-R-262 and CMS-10398. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled, ``Contract Year 2019 Plan Benefit Package (PBP) Software and Formulary Submission.'' The associated form number is CMS-R-262 (OMB control number: 0938-0763). The comment period for CMS-10398 (OMB control number: 0938-1148) titled, ``Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions'' remains in effect and ends on January 12, 2018.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-27605
Type: Notice
Date: 2017-12-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.''
Submission for OMB Review; Comment Request
Document Number: 2017-27600
Type: Notice
Date: 2017-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-27599
Type: Notice
Date: 2017-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry; Availability
Document Number: 2017-27589
Type: Notice
Date: 2017-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry.'' The draft guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The draft guidance provides applicants and manufacturers general and administrative information on reporting and evaluating changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The draft guidance, when finalized, is intended to supersede the document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products'' dated July 1997 (July 1997 guidance).
Proposed Information Collection Activity; Comment Request
Document Number: 2017-27578
Type: Notice
Date: 2017-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
Amendment to “Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;” Draft Guidance for Industry; Availability
Document Number: 2017-27569
Type: Notice
Date: 2017-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments with revised recommendations intended to reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products by revising and removing certain recommended deferrals for geographic risk of bovine spongiform encephalopathy (BSE) exposure and recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present. The recommendations apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma. The draft guidance, when finalized, will amend the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry'' updated January 2016 (``2016 vCJD Guidance'') by incorporating into an updated final guidance any new recommendations adopted. All other recommendations in the 2016 vCJD Guidance will remain unchanged.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2017-27559
Type: Notice
Date: 2017-12-22
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
Document Number: 2017-27538
Type: Notice
Date: 2017-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting nominations of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC will be an ongoing, collaborative forum coordinated through the Patient Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of the Commissioner, and will be hosted by CTTI. Through the PEC, the patient community and regulators will be able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in certain aspects of the medical product development and FDA review process.
Establishment of the Health Information Technology Advisory Committee
Document Number: 2017-27412
Type: Notice
Date: 2017-12-22
Agency: Department of Health and Human Services
The Health Information Technology Advisory Committee (HITAC) is established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The Health information Technology Advisory Committee, among other things, shall identify priorities for standards adoption and make recommendations to the National Coordinator of Health Information Technology (National Coordinator) on a policy framework to advance an interoperable health information technology infrastructure. The HITAC will hold public meetings throughout 2018 with its first public meeting scheduled for January 18, 2018, from approximately 9:30 a.m. to 2:30 p.m./Eastern Time at the Omni Shoreham Hotel, 2500 Calvert Street NW, Washington, DC 20008.
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2017-27508
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-27507
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-27506
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Matching Program
Document Number: 2017-27487
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement (HHS/ACF/OCSE), is providing notice of a re-established matching program between OCSE and state agencies administering Temporary Assistance for Needy Families (TANF). The matching program will compare state TANF agency records with new hire, quarterly wage, and unemployment insurance information from OCSE's National Directory of New Hires (NDNH) system of records. The matching program will assist state TANF agencies in establishing or verifying eligibility for assistance, reducing payment errors, and maintaining program integrity.
Privacy Act of 1974; Matching Program
Document Number: 2017-27486
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement (HHS/ACF/OCSE), is providing notice of a re-established matching program between OCSE and state workforce agencies (SWAs) administering the Unemployment Compensation (UC) Program. The matching program will provide SWAs with new hire (i.e., employment status) and quarterly wage information from OCSE's National Directory of New Hires (NDNH) system of records, for the purpose of assisting SWAs in preventing, detecting, and addressing program violations and errors, and for related secondary purposes.
Keith J. Pierce: Debarment Order
Document Number: 2017-27485
Type: Notice
Date: 2017-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Keith J. Pierce for a period of 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Pierce was convicted of a misdemeanor under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the FD&C Act. Dr. Pierce was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Pierce failed to request a hearing. Dr. Pierce's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-27482
Type: Notice
Date: 2017-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emerging Infections Program, a population-based surveillance via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-27481
Type: Notice
Date: 2017-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enhanced Surveillance for Histoplasmosis. CDC will collect state health department and patient furnished histoplasmosis case data.
Correction to Notice Published 12/13/2017
Document Number: 2017-27479
Type: Notice
Date: 2017-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss
Document Number: 2017-27443
Type: Rule
Date: 2017-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability
Document Number: 2017-27435
Type: Notice
Date: 2017-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of over 200,000 in the United States), unless the use of the drug in the pediatric subpopulation meets the regulatory criteria for an orphan subset, or unless the disease in the pediatric subpopulation is considered a different disease from the disease in the adult population. This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric-subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-27417
Type: Notice
Date: 2017-12-20
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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 an Exclusive Patent License: The Development of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer
Document Number: 2017-27416
Type: Notice
Date: 2017-12-20
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.
Proposed Collection; 60-Day Comment Request Division of Cancer Epidemiology and Genetics Fellowship Program and Summer Student Applications (DCEG) (National Cancer Institute)
Document Number: 2017-27415
Type: Notice
Date: 2017-12-20
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2017-27399
Type: Notice
Date: 2017-12-20
Agency: Department of Health and Human Services
Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.
National Institute of Neurological Disorders and Stroke Notice of Closed Meetings
Document Number: 2017-27329
Type: Notice
Date: 2017-12-20
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2017-27324
Type: Notice
Date: 2017-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Document Number: 2017-27317
Type: Rule
Date: 2017-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE). FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the Agency's attention. This final rule finalizes the 1994 tentative final monograph (TFM) for OTC health care antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM) as amended by the proposed rule published in the Federal Register (FR) of May 1, 2015 (2015 Health Care Antiseptic Proposed Rule (PR)).
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability
Document Number: 2017-27157
Type: Notice
Date: 2017-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-27306
Type: Notice
Date: 2017-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device
Document Number: 2017-27280
Type: Rule
Date: 2017-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the tear electrostimulation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products; Public Workshop; Request for Comments
Document Number: 2017-27279
Type: Notice
Date: 2017-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products.'' The purposes of the workshop are to present the outcomes from the research projects conducted under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research Program; discuss how regulatory science initiatives have helped address regulatory science knowledge gaps by providing insights on factors that influence the performance of generic orally inhaled and nasal drug products (OINDPs); share the Agency's experience on the utility of novel analytical tools and methods developed under the regulatory science initiative for generic OINDP product development and bioequivalence assessments; and obtain input from the public on what, when, where, and how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs) for complex OINDPs.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator
Document Number: 2017-27277
Type: Rule
Date: 2017-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
Document Number: 2017-27276
Type: Notice
Date: 2017-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reprocessed, single-use device labeling.
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-27275
Type: Notice
Date: 2017-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff.'' The draft guidance document recognizes the value of standards and encourages the use of appropriate standards to facilitate the evaluation of products regulated by the Center for Biologics Evaluation and Research (CBER). The guidance describes CBER's recommendations on the use of standards in product development and the use of such standards in CBER's managed review process. The draft guidance does not endorse the activities of specific Standards Development Organizations or recommend specific standards for use in regulatory submissions.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2017-27258
Type: Notice
Date: 2017-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 a proposed revision of the information collection project titled Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Study of Long-Term Care Providers. CDC seeks to collect data for the residential care community and adult day services center components for the 2018 wave of the National Study of Long-Term Care Providers.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-27257
Type: Notice
Date: 2017-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services