Department of Health and Human Services July 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16326
Type: Notice
Date: 2021-07-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' This proposed information collection was previously published in the Federal Register on May 12, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee-September 22, 2021
Document Number: 2021-16314
Type: Notice
Date: 2021-07-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 22, 2021. The MEDCAC panel will examine relevant health outcomes in studies for cerebrovascular disease treatment with a particular focus on new technologies of interest to CMS. Given the increased emphasis on new and innovative medical products for treating diseases that have few proven therapies, studies on certain medical technologies have focused on intermediate and surrogate outcomes rather than longer-term data. As a result, there are more frequent evidence gaps with respect to the clinically meaningful health outcomes for CMS beneficiaries, and these gaps impact our assessments of medical technologies. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of cerebrovascular disease treatment technologies, appropriate measurement instruments and follow-up durations to help to provide clarity and transparency of National Coverage Analyses (NCAs). This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16307
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2021-16306
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2021-16305
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Community Health Aide Program: Tribal Planning & Implementation
Document Number: 2021-16283
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities
Document Number: 2021-16281
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
Community Health Aide Program: Tribal Assessment & Planning
Document Number: 2021-16280
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
National Institue of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2021-16262
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-16261
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Notice of a Supplemental Award to the University of Arkansas System Telehealth Focused Rural Health Research Center
Document Number: 2021-16255
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces a supplemental award in the amount of $100,000 annually through fiscal year 2024. This funding will support the University of Arkansas Telehealth Focused Rural Health Research Center (TF RHRC), a current HRSA-funded cooperative agreement. The supplemental request is for the remaining period of performance of the current cooperative agreement, subject to the availability of funds and successful performance of the activities in a given budget year.
Proposed Information Collection Activity; Intergovernmental Reference Guide (IRG) (OMB No.: 0970-0209)
Document Number: 2021-16244
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), with content revisions, for an additional three years. The IRG contains state and tribal child support information that assists child support enforcement (CSE) agencies in the administration of their respective programs. The current OMB approval expires on January 31, 2022.
Matthew Hebert: Final Debarment Order
Document Number: 2021-16211
Type: Notice
Date: 2021-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Matthew Hebert for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Hebert was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Hebert was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 5, 2021 (30 days after receipt of the notice), Mr. Hebert has not responded. Mr. Hebert's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16208
Type: Notice
Date: 2021-07-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Regulatory Agenda
Document Number: 2021-14870
Type: Proposed Rule
Date: 2021-07-30
Agency: Department of Health and Human Services, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16205
Type: Notice
Date: 2021-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow 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 Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16202
Type: Notice
Date: 2021-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow 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 Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16200
Type: Notice
Date: 2021-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow 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 Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Document Number: 2021-16199
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2021-16195
Type: Notice
Date: 2021-07-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List found at www.atsdr.cdc.gov/SPL/. ATSDR also accepts nominations for substances not on the Substance Priority List (SPL) that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) National Priorities List (see CERCLA Section 104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B)). For more information on the CERCLA National Priorities List, visit www.epa.gov/superfund/ superfund-national-priorities-list-npl. The agency accepts these nominations in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects
Document Number: 2021-16192
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, 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 information collection associated with a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects.
The National Institutes of Health (NIH) Scientific Workshop on Violence & Related Health Outcomes in Sexual & Gender Minority Communities Open Session
Document Number: 2021-16190
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) will hold the Phase IV open session for the NIH Scientific Workshop on Violence and Related Health Outcomes in Sexual and Gender Minority (SGM) Communities to enhance our understanding of violence against SGM individuals and identify opportunities in violence-related research. The primary objectives of NIH's Phase IV meeting are: (1) To allow the public to participate, and (2) to further refine research opportunities.
Availability of Six Draft Toxicological Profiles
Document Number: 2021-16188
Type: Notice
Date: 2021-07-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on drafts of six updated Toxicological Profiles: Acetone, Aldrin/Dieldrin, Chlorophenols, 3,3- Dichlorobenzidine, Disulfoton, and Pentachlorophenol.
Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date
Document Number: 2021-16187
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the effective date for Electronic Common Technical Document (eCTD) validations referenced in FDA's ``Technical Rejection Criteria for Study Data'' (TRC).
Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications
Document Number: 2021-16178
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 85 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for Industry; Availability
Document Number: 2021-16175
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.'' The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-16162
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-16161
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-16160
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-16159
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report-National Ombudsman Reporting System; OMB #0985-0005
Document Number: 2021-16132
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the State Annual Long-Term Care Ombudsman Report-National Ombudsman Reporting System [OMB #0985-0005].
Notice of Federal Review of the Missouri Protection and Advocacy System (P&A)
Document Number: 2021-16131
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services
Representatives of the Administration on Disabilities (AoD), Administration for Community Living (ACL), will be conducting a federal review of the Missouri Protection and Advocacy System (P&A) on September 13-17, 2021. AoD is soliciting comments from interested parties on your experiences with the program, and strategies employed by P&A in meeting the needs of individuals with developmental disabilities and their families in Missouri. You are encouraged to share your experiences by way of email or telephone.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2021-16120
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public. The committee will discuss recommendations to improve the supply chain and data infrastructure that supports the blood industry, especially during public health emergencies. To facilitate this discussion, key stakeholders from across the nation and around the world will present on hemovigilance, preparedness, inventory management systems and other relevant issues.
Workshop on Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework
Document Number: 2021-16118
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
This 2-day, virtual workshopExploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Frameworkfocuses on the functional state-of-the-science of biologically active human milk components and analogs and the implications for safety assessments when used in infant formula.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16112
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Biosimilar User Fee Rates for Fiscal Year 2022
Document Number: 2021-16084
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2021, through September 30, 2022.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-16079
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-16075
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-16073
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-16072
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2021-16069
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2022
Document Number: 2021-16062
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.
Outsourcing Facility Fee Rates for Fiscal Year 2022
Document Number: 2021-16057
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2022 rates for the small business establishment fee ($5,824), the non-small business establishment fee ($18,999), and the reinspection fee ($17,472) for outsourcing facilities; provides information on how the fees for FY 2022 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2021, and will remain in effect through September 30, 2022.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
Document Number: 2021-16056
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the fiscal year (FY) 2022 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2021, and will remain in effect through September 30, 2022.
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2022
Document Number: 2021-16053
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2022 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective August 1, 2021, and will remain in effect through September 30, 2022.
Determination That CECLOR CD (Cefaclor Extended-Release Tablets) 375 Milligrams and 500 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, Except the Indication of Secondary Bacterial Infections of Acute Bronchitis, Which Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-16050
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that CECLOR CD (cefaclor extended-release tablets) 375 milligrams (mg) and 500 mg were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of secondary bacterial infections of acute bronchitis (SBIAB) that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of any abbreviated new drug application (ANDA) that refers to this drug product and has removed the indication for SBIAB. This determination also will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that include SBIAB as an indication.
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
Document Number: 2021-16047
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability
Document Number: 2021-16046
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for olodaterol hydrochloride; tiotropium bromide inhalation spray.
Jacobo Geissler: Final Debarment Order
Document Number: 2021-16045
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jacobo Geissler for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Geissler was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Geissler was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of April 7, 2021 (30 days after receipt of the notice), Mr. Geissler has not responded. Mr. Geissler's failure to respond and request a hearing constitutes a waiver of Mr. Geissler's right to a hearing concerning this matter.
Justin Ash: Final Debarment Order
Document Number: 2021-16044
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Ash for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Ash was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Ash's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Ash was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 4, 2021 (30 days after receipt of the notice), Mr. Ash had not responded. Mr. Ash's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.