Department of Health and Human Services 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 200 of 3,146
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
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 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.
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (hereafter referred to as products). The previous guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009, and the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' published March 11, 2015, have been withdrawn.
Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes expectations on appropriate methods and frequency of such communications. This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND. This guidance finalizes the draft guidance issued on December 9, 2015.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is also welcome to listen to the meeting by dialing 888-946-7207, passcode: 5023213. A total of 200 lines will be available. To register for this call, please go to www.cdc.gov/hicpac.
Office for State, Tribal, Local and Territorial Support (OSTLTS), Tribal Advisory Committee (TAC) Meeting and 18th Biannual Tribal Consultation Session
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the following meeting and Tribal Consultation Session. The meetings are being hosted by CDC/ATSDR in-person only and are open to the public. Attendees must pre-register for the event by March 2, 2018, at the following link: www.cdc.gov/tribal/meetings.html.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the 75 telephone ports available. There will be a public comment period at the end of the meeting day from 3:30 p.m.-3:45 p.m., February 26, 2018.
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Amendment
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to include a non- voting liaison representative; American Immunization Registry Association. The amended filing date is October 17, 2017.
Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot Program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem. The CfQ Pilot Program also intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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.
Council on Graduate Medical Education
In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) will hold a public meeting.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
This document corrects technical and typographical errors in the proposed rule that appeared in the November 28, 2017 issue of the Federal Register titled ``Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program''.
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing pathogen reduction technology in the manufacture of pathogen-reduced blood components. The guidance also provides answers to frequently asked questions concerning the implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The recommendations apply to licensed blood establishments that intend to manufacture pathogen-reduced blood components using an FDA approved pathogen reduction device.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.''
Agency Information Collection Request. 30-Day Public Comment Request
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.
Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization 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 rectal balloon for prostate immobilization'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.
Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms
The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms 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 flow cytometric test system for hematopoietic neoplasms' 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.
Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache 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 external vagal nerve stimulator for headache'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.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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.
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders
The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders 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 computerized behavioral therapy device for psychiatric disorders' 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.
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 21, 2017, proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Patient Safety Organizations: Voluntary Relinquishment From the Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO)
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO) of its status as a PSO, and has delisted the PSO accordingly.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the Federal anti- kickback statute (Sec. 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition, published in the Federal Register of September 21, 2017, revising food additive regulations to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
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 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.
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use); Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of petition that appeared in the Federal Register of September 22, 2017, proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed. FDA is reopening the comment period to allow additional time for comments on environmental impacts.
Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid
The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid 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 external negative pressure airway aid'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.
Final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention (CRC)
NIOSH announces the availability of the final National Occupational Research Agenda for Cancer, Reproductive, Cardiovascular and Other Chronic Disease Prevention (CRC).
Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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 the information collection requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYKADIA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYKADIA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Data Collections Submitted for Public Comment and Recommendations
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 The National Survey of Family Growth (NSFG), designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive health.
Decision To Evaluate a Petition To Designate a Class of Employees From the Ames Laboratory in Ames, Iowa, To Be Included in the Special Exposure Cohort
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Ames Laboratory in Ames, Iowa, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
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
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
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO
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
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
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
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.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH)
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
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
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.''
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 (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
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).
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
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
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
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
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.
Privacy Act of 1974; Matching Program
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
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
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
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
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.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss
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
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
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
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)
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
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.
Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
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
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.
Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device
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
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
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
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
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
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 Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
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 Request. 30-Day Public Comment Request
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.
Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds Tobacco Company; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Co.
Invitation to Manufacturers of Pertussis Serological Kits
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces an opportunity for commercial manufacturers to work with CDC's National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the Food and Drug Administration (FDA) for marketing authorization. CDC is interested in the development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin (PT) enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard (such as FDA Reference Standard Lot #3, World Health Organization (WHO) International Standard 06/140, or equivalents). The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. CDC will be able to provide guidance, materials, and evaluation support for the manufacturer; however, the manufacturer will be responsible for submitting a premarket submission to FDA with adequate information, including any analytical or clinical data needed to support the submission, to demonstrate to FDA that FDA can grant marketing authorization to the product.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal; Correction
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2019.
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.'' The purpose of this guidance is to describe the FDA's current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials; and general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time.
Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug Products, Including Biological Products, that Contain Nanomaterials.'' This draft guidance has been developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. When finalized, this document will supersede ``Replacement Reagent and Instrument Family Policy,'' issued on December 11, 2003. This draft guidance is not final nor is it in effect at this time.
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Information Requests and Discipline Review Letters Under GDUFA.'' This draft guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the review of an original abbreviated new drug application (ANDA).
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 approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that MEPSEVII (vestronidase alfa-vjbk), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.
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 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.
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 Rocky Flats Plant, in Golden, Colorado, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (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 Carborundum Company, in Niagara Falls, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Idaho National Laboratory (INL) in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Opioid Program Grant Performance Measures, OMB No. 0906-xxxx-New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Least Burdensome Provisions: Concept and Principles'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Findings of Research Misconduct
Findings of research misconduct have been made on the part of Matthew Endo, former graduate student, Department of Chemistry, University of Illinois at Urbana-Champaign. The questioned research was supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM080436. The administrative actions, including three (3) years of supervision, which are implemented beginning on November 16, 2017, are detailed below.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date.
Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment (Office of Intramural Research, Office of the Director)
In compliance with 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.
Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction
The Food and Drug Administration is correcting a notice entitled ``Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop'' that appeared in the Federal Register of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.'' The date of the meeting has changed.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
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 the information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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 the information collection for the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
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 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.
Advisory Committee; Food Advisory Committee; Termination
The Food and Drug Administration (FDA) is announcing the termination of the Food Advisory Committee. This document removes the Food Advisory Committee from the Agency's list of standing advisory committees.
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gluten in Drug Products and Associated Labeling Recommendations.'' This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
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 the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing entitled, ``Opioid Policy Steering Committee: Prescribing InterventionExploring a Strategy for Implementation.'' The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the proposed extension of the existing information Message Testing for Tobacco Communication Activities (MTTCA). CDC's Office on Smoking and Health has used the MTTCA clearance to support the development and testing of tobacco-related health messages, including messages supporting CDC's National Tobacco Education Campaign (NTEC) called the Tips from Former Smokers[supreg] campaign.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns. Thus, CDC seeks to request Office of Management and Budget (OMB) approval to reinstatement OMB Control Number 0920-0800.
Proposed Data Collections Submitted for Public Comment and Recommendations
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 the National Vital Statistics Report Forms. These are the data collection forms used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths at the end of each month and (b) annual counts of marriages and divorces/ annulments in support of the National Vital Statistics System. This submission contains no changes to the actual data collection forms. However, the number of respondent for the monthly and annual forms have shifted from 91 and 58 respectively to 58 and 91, since the 33 New Mexico Counties only send marriage and divorce information that is now only captured in the annual report.
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 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.
New Animal Drugs; Approval of New Animal Drug Applications
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports
This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
Meeting of the Chronic Fatigue Syndrome Advisory Committee; Amendment
A notice was published in the Federal Register on November 27, 2017, announcing an in-person meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) on Wednesday, December 13, 2017, from 9:00 a.m. until 3:30 p.m. and Thursday, December 14, 2017, from 9:00 a.m. until 5:00 p.m. The meeting will be held at the U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Room 800, 200 Independence Avenue SW, Washington, DC 20201. The notice is being amended to provide security procedures to enter the Hubert H. Humphrey Building. Individuals interested in attending the meeting in person need to show a state or federal government issued I.D. with a photograph. Individuals can also email the CFSAC inbox (cfsac@hhs.gov) in order to have their names added to a list of attendees. However, it is still necessary for individuals to present a photo I.D. to gain entrance to Hubert H. Humphrey Building. All participants will be escorted to the meeting room. Space is limited.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held on January 24, 2018, of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/ash/carb/ and must be completed by January 15, 2018; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https:// www.hhs.gov/ash/carb/ on the Meetings page.
Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.'' The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. This guidance finalizes the revised draft guidance issued on November 20, 2013 (``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling''). FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2018 Proposed Guidance Development
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that CDRH (or the Center) intends to publish in fiscal year (FY) 2018. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion
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 (PRA).
Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for norfloxacin tablets, 400 mg, if all other legal and regulatory requirements are met.
Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Refusal of Inspection by a Foreign Food Establishment or Foreign Government.'' This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA, the Agency, or we) 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 the information collection requirements for declaring major food allergens under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
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 information collection provisions for calorie labeling of articles of food in vending machines.
Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Submission for 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 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.
National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored sera, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) for use and the fee schedule for such use. The National Health and Nutrition Examination Survey (NHANES) is one of a series of health- related surveys conducted by CDC's National Center for Health Statistics (NCHS).
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 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.
Agency Information Collection Request; 60-Day Public Comment Request
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship Programs
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.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Conduct Formative Research (NIAID)
In compliance with 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.
Prospective Grant of Exclusive Patent License: N-Acetyl Mannosamine as a Therapeutic Agent
The National Human Genome Research 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 Leadiant Biosciences, Inc, located in Gaithersburg, Maryland, USA.
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 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.
Submission for OMB Review; 30-Day Comment Request; A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI (National Cancer Institute)
In compliance with 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.
CLASS Condition of the Head Start Designation Renewal System
OHS invites public comment on several specific changes being considered for the CLASS condition of the Designation Renewal System (DRS) as outlined in the Head Start Program Performance Standards. We are considering changes to the CLASS condition with a goal of improving implementation and transparency of the DRS. Changes being considered include removal of the ``lowest 10 percent'' provision of the CLASS condition, an increase of the minimum thresholds for the Emotional Support and Classroom Organization domains to a score of 5, removal of the minimum threshold for the Instructional Support domain, and establishment of authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain prior to the start of each fiscal year to be applied for DRS CLASS reviews in the same fiscal year. OHS requests feedback on these possible changes as well as alternative changes to the CLASS condition, particularly ways the Instructional Support threshold could be set and/or adjusted that would incentivize program improvement while acknowledging the current state of the field. OHS also invites feedback on other conditions of the DRS.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.
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