{"description":"Documents matching 'completion bioequivalence technical section generic'","count":37,"total_pages":2,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=completion+bioequivalence+technical+section+generic&format=json&page=2","results":[{"title":"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #279 entitled \"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.\" This final guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.","document_number":"2024-13690","html_url":"https://www.federalregister.gov/documents/2024/06/21/2024-13690/demonstrating-bioequivalence-for-type-a-medicated-articles-containing-active-pharmaceutical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-21/pdf/2024-13690.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13690.pdf?1718887546","publication_date":"2024-06-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"announcing the availability of a final guidance for industry (GFI) #279 entitled “Demonstrating <span class=\"match\">Bioequivalence</span> \n \n for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.” This final guidance describes an approach to satisfy the requirements for the <span class=\"match\">completion</span> of the <span class=\"match\">Bioequivalence</span> <span class=\"match\">technical</span> <span class=\"match\">section</span> for <span class=\"match\">generic</span> Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical"},{"title":"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #279 entitled \"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry.\" This draft guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this draft guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.","document_number":"2023-12206","html_url":"https://www.federalregister.gov/documents/2023/06/08/2023-12206/demonstrating-bioequivalence-for-type-a-medicated-articles-containing-active-pharmaceutical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-08/pdf/2023-12206.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-12206.pdf?1686141914","publication_date":"2023-06-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"availability of a draft guidance for industry (GFI) #279 entitled “Demonstrating <span class=\"match\">Bioequivalence</span> for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry.” This draft guidance describes an approach to satisfy the requirements for the <span class=\"match\">completion</span> of the <span class=\"match\">Bioequivalence</span> <span class=\"match\">technical</span> <span class=\"match\">section</span> for <span class=\"match\">generic</span> Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active"},{"title":"Phasedown of Hydrofluorocarbons: Review and Renewal of Eligibility for Application-Specific Allowances","type":"Proposed Rule","abstract":"The U.S. Environmental Protection Agency is undertaking this rulemaking to assess the eligibility of six applications to receive priority access to allowances allocated pursuant to the American Innovation and Manufacturing Act of 2020. This rulemaking proposes the framework for how EPA will assess whether to renew the eligibility of applications to receive application-specific allowances; decisions to renew or not renew each of the six applications that currently receive application-specific allowances; revisions to the Technology Transitions regulations as relevant to the specific applications under review; a procedural process for submitting a petition to designate a new application as eligible for priority access to allowances; narrow revisions to the methodology used to allocate allowances to application-specific allowance holders for calendar years 2026 and beyond; and limited revisions to existing regulations. EPA is also proposing to authorize an entity to produce regulated substances for export. Lastly, EPA is proposing certain confidentiality determinations for newly reported information if this rulemaking is finalized as proposed.","document_number":"2024-20602","html_url":"https://www.federalregister.gov/documents/2024/09/16/2024-20602/phasedown-of-hydrofluorocarbons-review-and-renewal-of-eligibility-for-application-specific","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20602.pdf?1726231521","publication_date":"2024-09-16","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"part of this proposed analysis, EPA is also considering the supply of HFC-152a. As further explained in <span class=\"match\">Section</span> IV.C, as part of the framework for its analysis EPA is proposing to evaluate the supply of a substitute HFC if that HFC is a safe or <span class=\"match\">technically</span> achievable substitute for an application. As outlined in the prior <span class=\"match\">section</span> (<span class=\"match\">Section</span> V.D.1), EPA's analysis suggests that HFC-152a blended with cyclopentane appears to be a safe and <span class=\"match\">technically</span> achievable substitute for this application. EPA is therefore evaluating the supply of HFC-152a to determine"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model","type":"Rule","abstract":"This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2023. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates requirements for the ESRD Quality Incentive Program and finalizes changes to the ESRD Treatment Choices Model.","document_number":"2022-23778","html_url":"https://www.federalregister.gov/documents/2022/11/07/2022-23778/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-07/pdf/2022-23778.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-23778.pdf?1667337672","publication_date":"2022-11-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"required by <span class=\"match\">section</span> 1881(b)(14) of the Act, as added by <span class=\"match\">section</span> 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). <span class=\"match\">Section</span> 1881(b)(14)(F) of the Act, as added by <span class=\"match\">section</span> 153(b) of MIPPA and amended by <span class=\"match\">section</span> 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act), established that beginning with CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket increase factor reduced by the productivity adjustment described in <span class=\"match\">section</span> 1886(b)(3)(B)(xi)(II)"},{"title":"Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2021","type":"Proposed Rule","abstract":"Publication of the Fall 2021 Unified Agenda of Federal Regulatory and Deregulatory Actions represents a key component of the regulatory planning mechanism prescribed in Executive Order (\"E.O.\") 12866, \"Regulatory Planning and Review,\" (58 FR 51735) and reaffirmed in E.O. 13563, \"Improving Regulation and Regulatory Review,\" (76 FR 3821). The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). The Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete Unified Agenda and Regulatory Plan can be found online at www.reginfo.gov and a reduced print version can be found in the Federal Register. Information regarding obtaining printed copies can also be found on the Reginfo.gov website (or below, VI. How Can Users Get Copies of the Plan and the Agenda?). The Fall 2021 Unified Agenda publication appearing in the Federal Register includes the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. The complete Fall 2021 Unified Agenda contains the Regulatory Plans of 27 Federal agencies and 67 Federal agency regulatory agendas.","document_number":"2022-00702","html_url":"https://www.federalregister.gov/documents/2022/01/31/2022-00702/introduction-to-the-unified-agenda-of-federal-regulatory-and-deregulatory-actions-fall-2021","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-31/pdf/2022-00702.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-00702.pdf?1643377519","publication_date":"2022-01-31","agencies":[{"raw_name":"REGULATORY INFORMATION SERVICE CENTER","name":"Regulatory Information Service Center","id":449,"url":"https://www.federalregister.gov/agencies/regulatory-information-service-center","json_url":"https://www.federalregister.gov/api/v1/agencies/449","parent_id":null,"slug":"regulatory-information-service-center"}],"excerpts":"\n \n Title of the Regulation \n —a brief description of the subject of the regulation. In the printed edition, the notation “<span class=\"match\">Section</span> 610 Review” following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated <span class=\"match\">completions</span> of <span class=\"match\">section</span> 610 reviews or rulemaking actions resulting from completed <span class=\"match\">section</span> 610 reviews. In the online edition, these notations appear in a separate field.\n \n \n Priority \n —an indication of the significance"},{"title":"Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19","type":"Rule","abstract":"This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy. This final rule also finalizes certain provisions of the interim final rules with comment period that CMS issued on March 31, 2020, May 8, 2020\\,\\ and September 2, 2020 in response to the Public Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID-19). This rule also establishes coding and payment for virtual check-in services and for personal protective equipment (PPE) on an interim final basis.","document_number":"2020-26815","html_url":"https://www.federalregister.gov/documents/2020/12/28/2020-26815/medicare-program-cy-2021-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-12-28/pdf/2020-26815.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-26815.pdf?1606943727","publication_date":"2020-12-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"the PHE for COVID-19 (<span class=\"match\">section</span> II.F.) \n • Scopes of Practice and Related Issues (<span class=\"match\">section</span> II.G.) \n • Valuation of Specific Codes, and the Interim Final rule with Comment Period for Coding and Payment for Personal Protective Equipment (PPE) (<span class=\"match\">section</span> II.H.) \n • Modifications related to Medicare Coverage for Opioid Use Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) (<span class=\"match\">section</span> II.I.) \n • <span class=\"match\">Technical</span> Correction to the Definition of Public Health Emergency (<span class=\"match\">section</span> II.J.) \n • Clinical Laboratory Fee Schedule (<span class=\"match\">section</span> III.A.) \n • Opioid Treatment"},{"title":"Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy","type":"Proposed Rule","abstract":"This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy.","document_number":"2020-17127","html_url":"https://www.federalregister.gov/documents/2020/08/17/2020-17127/medicare-program-cy-2021-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-08-17/pdf/2020-17127.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-17127.pdf?1596545146","publication_date":"2020-08-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"an MA-PD plan (<span class=\"match\">section</span> III.K.) \n • Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under <span class=\"match\">Section</span> 505(b)(2) of the Food, Drug, and Cosmetic Act (<span class=\"match\">section</span> III.L.) \n • Updates to Certified Electronic Health Record Technology due to the 21st Century Cures Act Final Rule (<span class=\"match\">section</span> III.M.) \n • Proposal to Establish New Code Categories (<span class=\"match\">section</span> III.N.) \n • Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy (<span class=\"match\">section</span> III.O.) \n • CY 2021 Updates to the Quality Payment Program (<span class=\"match\">section</span> IV.) \n • Planned"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements","type":"Rule","abstract":"This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2020. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also updates requirements for the ESRD Quality Incentive Program (QIP). In addition, this rule establishes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services, and a methodology for making adjustments to the fee schedule amounts established using supplier or commercial prices if such prices decrease within 5 years of establishing the initial fee schedule amounts. This rule also revises existing regulations related to the DMEPOS competitive bidding program. This rule also streamlines the requirements for ordering DMEPOS items, and develops a new list of DMEPOS items potentially subject to a face-to-face encounter, written orders prior to delivery and/or prior authorization requirements. Finally, this rule summarizes responses to requests for information on data collection resulting from the ESRD PPS technical expert panel, changing the basis for the ESRD PPS wage index, and new requirements for the competitive bidding of diabetic testing strips.","document_number":"2019-24063","html_url":"https://www.federalregister.gov/documents/2019/11/08/2019-24063/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-11-08/pdf/2019-24063.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-24063.pdf?1572552925","publication_date":"2019-11-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Prospective Payment System (PPS), a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by <span class=\"match\">section</span> 1881(b)(14) of the Social Security Act (the Act), as added by <span class=\"match\">section</span> 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). <span class=\"match\">Section</span> 1881(b)(14) (F) of the Act, as added by <span class=\"match\">section</span> 153(b) of MIPPA, and amended by <span class=\"match\">section</span> 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning calendar"},{"title":"Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding (CBP) Proposed Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements","type":"Proposed Rule","abstract":"This proposed rule would update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2020. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This proposed rule also proposes to update requirements for the ESRD Quality Incentive Program (QIP). In addition, this rule proposes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services and making adjustments to the fee schedule amounts established using supplier or commercial prices if such prices decrease within 5 years of establishing the initial fee schedule amounts. This rule also proposes to revise existing regulations related to the competitive bidding program for DMEPOS. This proposed rule also would streamline the requirements for ordering DMEPOS items, and develop a new list of DMEPOS items potentially subject to a face-to-face encounter, written orders prior to delivery and/or prior authorization requirements. Finally, this proposed rule includes requests for information on data collection resulting from the ESRD PPS technical expert panel, changing the basis for the ESRD PPS wage index, and new requirements for the competitive bidding of diabetic testing strips.","document_number":"2019-16369","html_url":"https://www.federalregister.gov/documents/2019/08/06/2019-16369/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-08-06/pdf/2019-16369.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-16369.pdf?1564431325","publication_date":"2019-08-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"qualify for TDAPA eligibility. \n (e) <span class=\"match\">Generic</span> Drugs \n We are proposing to exclude drugs approved by FDA under <span class=\"match\">section</span> 505(j) of the FD&amp;C Act, which are <span class=\"match\">generic</span> drugs, from being eligible for the TDAPA. As discussed previously in <span class=\"match\">section</span> II.B.1.b of this proposed rule, an ANDA is an application submitted by drug manufacturers and approved by FDA under <span class=\"match\">section</span> 505(j) of the FD&amp;C Act for a duplicate of a previously approved drug product. \n An ANDA generally must contain information to show that the proposed <span class=\"match\">generic</span> product: (1) Is the same as the"},{"title":"Abbreviated New Drug Applications and 505(b)(2) Applications","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.","document_number":"2016-22690","html_url":"https://www.federalregister.gov/documents/2016/10/06/2016-22690/abbreviated-new-drug-applications-and-505b2-applications","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-06/pdf/2016-22690.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-22690.pdf?1475671523","publication_date":"2016-10-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"definitions of “bioavailability” and “<span class=\"match\">bioequivalence</span>.” Therefore, we are finalizing these definitions without change, except for the <span class=\"match\">technical</span> amendment to the definition of “listed drug” described in <span class=\"match\">section</span> V.A.3 (Response 4) and the <span class=\"match\">technical</span> amendments to the definitions of “original NDA,” “resubmission,” and “therapeutic equivalents” described in <span class=\"match\">section</span> V.P.1. We also describe a <span class=\"match\">technical</span> amendment to the definition of “505(b)(2) application” in <span class=\"match\">section</span> V.P.3 and the addition of the defined term “Agency” in <span class=\"match\">section</span> V.P.1. \n V.A.1. Definitions of"},{"title":"Clinical Trials Registration and Results Information Submission","type":"Rule","abstract":"This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.","document_number":"2016-22129","html_url":"https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-21/pdf/2016-22129.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-22129.pdf?1474038928","publication_date":"2016-09-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"47].\n \n \n Limiting \n ClinicalTrials.gov \n to Objective Data\n \n \n As described in greater detail in <span class=\"match\">Section</span> III.C on Submission of <span class=\"match\">Technical</span> and Non-<span class=\"match\">technical</span> Summaries, the final rule does not require the submission of <span class=\"match\">technical</span> or non-<span class=\"match\">technical</span> narrative summaries of study results due to a lack of evidence that such summaries would always meet the statutory standard of not being misleading or promotional (<span class=\"match\">section</span> 402(j)(3)(D)(iii)(I) and <span class=\"match\">section</span> 402(j)(3)(D)(iii)(II) of the PHS Act). In fact, experts suggest that such summaries can lead to biased"},{"title":"Medicaid Program; Covered Outpatient Drugs","type":"Rule","abstract":"This final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program.","document_number":"2016-01274","html_url":"https://www.federalregister.gov/documents/2016/02/01/2016-01274/medicaid-program-covered-outpatient-drugs","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-02-01/pdf/2016-01274.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-01274.pdf?1453410923","publication_date":"2016-02-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"multiple source drug in accordance with <span class=\"match\">section</span> 1927(f) of the Act. The amendments made by <span class=\"match\">section</span> 2503(b) of the Affordable Care Act were effective October 1, 2010. \n <span class=\"match\">Section</span> 2503(c) of the Affordable Care Act amended <span class=\"match\">section</span> 1927(f) of the Act by clarifying that the survey of retail prices described in such subsection applies to retail community pharmacies. <span class=\"match\">Section</span> 2503(d) of the Affordable Care Act specified that the amendments made by <span class=\"match\">section</span> 2503 of the Affordable Care Act were effective October 1, 2010. <span class=\"match\">Section</span> 2503(d) of the Affordable Care Act"},{"title":"Abbreviated New Drug Applications and 505(b)(2) Applications","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.","document_number":"2015-01666","html_url":"https://www.federalregister.gov/documents/2015/02/06/2015-01666/abbreviated-new-drug-applications-and-505b2-applications","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-06/pdf/2015-01666.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-01666.pdf?1423144486","publication_date":"2015-02-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"For such drugs, the MMA provides that FDA may establish “alternative \n scientifically valid \n methods to show <span class=\"match\">bioequivalence</span> . . .” (see <span class=\"match\">section</span> 505(j)(8)(C) of the FD&amp;C Act (emphasis added)). <span class=\"match\">Section</span> 1103(b) of the MMA expressly states that the amendments to <span class=\"match\">section</span> 505(j)(8)(A) and (j)(8)(C) of the FD&amp;C Act “do[] not alter the standards for approval of drugs under <span class=\"match\">section</span> 505(j)” of the FD&amp;C Act.\n \n \n The amendments to <span class=\"match\">section</span> 505(j)(8)(A) and (C) of the FD&amp;C Act codify FDA's current practice, based on its existing regulations in"},{"title":"Clinical Trials Registration and Results Submission","type":"Proposed Rule","abstract":"This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.","document_number":"2014-26197","html_url":"https://www.federalregister.gov/documents/2014/11/21/2014-26197/clinical-trials-registration-and-results-submission","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-11-21/pdf/2014-26197.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-26197.pdf?1416413830","publication_date":"2014-11-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"with “expected <span class=\"match\">completion</span> date” as used in <span class=\"match\">section</span> 402(j)(2)(A)(ii)(I)(jj) of the PHS Act); and (2) update the information to indicate the actual <span class=\"match\">completion</span> date in accordance with the time frame established in § 11.64(b)(1)(viii). We note, if the estimated <span class=\"match\">completion</span> date of a clinical trial changes before or during the clinical trial, the responsible party would be required to update estimated <span class=\"match\">completion</span> date information consistent with § 11.64. \n Updating the estimated <span class=\"match\">completion</span> date promptly to reflect the actual <span class=\"match\">completion</span> date is important"},{"title":"Animal Generic Drug User Fee Act; Public Meeting; Request for Comments","type":"Notice","abstract":null,"document_number":"2012-29499","html_url":"https://www.federalregister.gov/documents/2012/12/05/2012-29499/animal-generic-drug-user-fee-act-public-meeting-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-12-05/pdf/2012-29499.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-29499.pdf?1354569431","publication_date":"2012-12-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"and predictability of the <span class=\"match\">generic</span> animal drug review program was a concern. The Animal <span class=\"match\">Generic</span> Drug User Fee Act enacted in 2008 (Pub. L. 110-316; hereinafter referred to as “AGDUFA I”) amended the Federal Food, Drug, and Cosmetic Act (the FD&amp;C Act) to authorize the FDA's first-ever <span class=\"match\">generic</span> animal drug user fee program. AGDUFA I provides FDA with additional funds to enhance the performance of the <span class=\"match\">generic</span> animal drug review process. Furthermore, the authorization of AGDUFA I enabled FDA's continued assurance that <span class=\"match\">generic</span> animal drug products are"},{"title":"Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions","type":"Proposed Rule","abstract":"The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http:// reginfo.gov. The fall 2011 Unified Agenda publication appearing in the Federal Register consists of agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.","document_number":"2012-1620","html_url":"https://www.federalregister.gov/documents/2012/02/13/2012-1620/introduction-to-the-unified-agenda-of-federal-regulatory-and-deregulatory-actions","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-02-13/pdf/2012-1620.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-01620.pdf?1328882048","publication_date":"2012-02-13","agencies":[{"raw_name":"REGULATORY INFORMATION SERVICE CENTER","name":"Regulatory Information Service Center","id":449,"url":"https://www.federalregister.gov/agencies/regulatory-information-service-center","json_url":"https://www.federalregister.gov/api/v1/agencies/449","parent_id":null,"slug":"regulatory-information-service-center"},{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"}],"excerpts":"FSMA amends <span class=\"match\">section</span> 301 of the FD&amp;C Act (21 U.S.C. 331) by adding <span class=\"match\">section</span> 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in <span class=\"match\">section</span> 805) does not have in place an FSVP in compliance with <span class=\"match\">section</span> 805. In addition, <span class=\"match\">section</span> 301(c) of FSMA amends <span class=\"match\">section</span> 801(a) of the FD&amp;C Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears from an examination of a sample of"},{"title":"Comprehensive List of Guidance Documents at the Food and Drug Administration","type":"Notice","abstract":"The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.","document_number":"2010-19342","html_url":"https://www.federalregister.gov/documents/2010/08/09/2010-19342/comprehensive-list-of-guidance-documents-at-the-food-and-drug-administration","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-08-09/pdf/2010-19342.pdf","public_inspection_pdf_url":null,"publication_date":"2010-08-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Final \n 5/2001 \n \n \n Bioavailability and <span class=\"match\">Bioequivalence</span> Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF - 519 KB) \n Draft \n \n 4/2/2003 \n 4/11/2003 \n \n \n \n • Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro <span class=\"match\">Bioequivalence</span> Data (PDF - 186 KB) \n   \n   \n \n \n Bioavailability and <span class=\"match\">Bioequivalence</span> Studies for Orally Administered Drug Products - General Considerations (PDF - 268 KB) \n Final \n 3/2003 \n \n \n Cholestyramine Powder in Vitro <span class=\"match\">Bioequivalence</span> (PDF - 35 KB) (Intermin Guidance) \n Final"},{"title":"Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications","type":"Rule","abstract":"The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.","document_number":"E8-15608","html_url":"https://www.federalregister.gov/documents/2008/07/10/E8-15608/applications-for-approval-to-market-a-new-drug-complete-response-letter-amendments-to-unapproved","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-07-10/pdf/E8-15608.pdf","public_inspection_pdf_url":null,"publication_date":"2008-07-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"60(b)(1) to state that we would not be required to review a major amendment that pertains to one <span class=\"match\">section</span> of the application if we have previously identified deficiencies in another <span class=\"match\">section</span> that prevent first-cycle approval. Two comments recommended revising § 314.60(b)(1) to state that we may defer review of a major amendment submitted within the last 3 months of the initial cycle that meets any of the following criteria: (1) It amends <span class=\"match\">technical</span> <span class=\"match\">sections</span> of an application in which we have identified deficiencies that prohibit approval during the initial"},{"title":"Annual Comprehensive List of Guidance Documents at the Food and Drug Administration","type":"Notice","abstract":"The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.","document_number":"06-2941","html_url":"https://www.federalregister.gov/documents/2006/03/28/06-2941/annual-comprehensive-list-of-guidance-documents-at-the-food-and-drug-administration","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-03-28/pdf/06-2941.pdf","public_inspection_pdf_url":null,"publication_date":"2006-03-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18) \n \n \n Revised 04/14/2000, <span class=\"match\">Section</span> 110.100, Certification for Exports (CPG7150.01) \n \n \n Deleted 03/28/2000, <span class=\"match\">Section</span> 215.100, IND Filings: <span class=\"match\">Completion</span> of Applicable… \n \n \n Reissued 03/22/2000, <span class=\"match\">Section</span> 257.100, Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis \n \n \n New 03/06/2000, <span class=\"match\">Section</span> 252.110, Volume Limits for Automated Collection of Source Plasma \n \n \n Deleted (Revoked) 01/24/2000, Sec. 305"},{"title":"Annual Comprehensive List of Guidance Documents at the Food and Drug Administration","type":"Notice","abstract":"The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.","document_number":"05-155","html_url":"https://www.federalregister.gov/documents/2005/01/05/05-155/annual-comprehensive-list-of-guidance-documents-at-the-food-and-drug-administration","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-01-05/pdf/05-155.pdf","public_inspection_pdf_url":null,"publication_date":"2005-01-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" Food-Effect Bioavailability and Fed <span class=\"match\">Bioequivalence</span> Studies \n December 2002 \n Do. \n Do. \n Do. \n \n \n Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro \n June 27, 1989 \n Do. \n Do. \n Do. \n \n \n Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo <span class=\"match\">Bioequivalence</span> and In Vitro Dissolution Testing \n March 4, 1994 \n Do. \n Do. \n Do. \n \n \n Statistical Approaches to Establishing <span class=\"match\">Bioequivalence</span> \n February 2, 2001 \n Do. \n Do. \n Do. \n \n \n Waiver of In Vivo Bioavailability and <span class=\"match\">Bioequivalence</span> Studies for Immediate-Release Solid Oral"}]}