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

Results 451 - 500 of 2,822
Announcement of the Intent To Award Four Single-Source Grants
Document Number: 2021-21418
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Administration for Children and Families
The ACF, OHSEPR announces the intent to award four single- source grants in the amount of up to $300,000 to the following recipients: United Way Worldwide, Alexandria, VA; National Association of Social Workers, Washington, DC; American Public Human Services Association, Arlington, VA; and National Association of County Human Services Administrators, Washington, DC. The purpose of these awards is to facilitate the coordination of human services to U.S. Citizens and their dependents evacuating to the United States from Afghanistan. These organizations are key players in the leadership, coordination, or direct provision of human services after an emergency and have direct access to their constituencies and networks. U.S. citizens and their dependents (repatriates) eligible for temporary assistance under the U.S. Repatriation Program can receive up to 90 days of temporary assistance which includes transportation, food, medical care, cash assistance, temporary lodging, and case management. These awards will ensure appropriate training and technical assistance, coordination, and subject matter expertise as repatriates connect to human services entities.
Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments; Extension of Comment Period
Document Number: 2021-21403
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled ``Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments'' that appeared in the Federal Register of August 9, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-21402
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2021-21397
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-21396
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-21386
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Document Number: 2021-21382
Type: Notice
Date: 2021-10-01
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 requests comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21381
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2021-21380
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Sitesh Bansi Patel: Final Debarment Order
Document Number: 2021-21375
Type: Notice
Date: 2021-10-01
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 Sitesh Bansi Patel 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. Patel 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. Patel was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 8, 2021 (30 days after receipt of the notice), Mr. Patel has not responded. Mr. Patel's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications; Correction
Document Number: 2021-21371
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 25, 2021. The document announced the withdrawal of approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants as of July 26, 2021. The document indicated that FDA was withdrawing approval of the following ANDA, after receiving a withdrawal request from Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed FDA that it did not want the approval of the ANDA withdrawn. Because Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 065152 is still in effect.
Public/Private Refugee Cash Assistance Inflationary Increase
Document Number: 2021-21369
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Office of Refugee Resettlement
In accordance with ORR regulations, the Director of ORR is announcing an inflationary increase to the public/private Refugee Cash Assistance (RCA) program's monthly payment ceilings, effective October 1, 2021. The current payment ceilings have remained fixed since March 22, 2000, despite inflation. The new payment ceilings accommodate that inflation and will provide arriving ORR-eligible populations greater economic stability as they transition to self-sufficiency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards
Document Number: 2021-21367
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Request for Public Comment: 60 Day Notice for Extension of Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys
Document Number: 2021-21350
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0036, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This notice announces our intent to submit this previously approved information collection, which expires January 31, 2022, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.
Center for Indigenous Innovation and Health Equity Tribal Advisory Committee; Solicitation of Nominations for Delegates
Document Number: 2021-21253
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) hereby gives notice that OMH is establishing a Center for Indigenous Innovation and Health Equity Tribal Advisory Committee (CIIHE TAC) and accepting nominations of qualified candidates to serve as primary and alternate delegates for the CIIHE TAC, in alignment with the 12 geographic areas served by the Indian Health Service (IHS).
Final Policy: Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement
Document Number: 2021-21241
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Services Act requires that RWHAP Part A, B, and C recipients expend not less than 75 percent of Parts A, B, and C grant funds on core medical services for individuals with HIV/AIDS identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management (CQM) costs. The statute also grants the Secretary of HHS authority to waive this requirement if certain requirements are met. HRSA has simplified the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C'' with Policy Notice 21-01, ``Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement.''
Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022
Document Number: 2021-21329
Type: Notice
Date: 2021-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to sponsors of rare pediatric disease product applications that meet all the requirements of this program and are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022
Document Number: 2021-21328
Type: Notice
Date: 2021-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug and biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the sponsors of certain tropical disease product applications submitted after September 27, 2007, the enactment date of FDAAA, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability
Document Number: 2021-21324
Type: Notice
Date: 2021-09-30
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 final guidance entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.'' The guidance document provides FDA's current thinking on certain criteria that help determine sameness of human gene therapy products for the purpose of orphan-drug designation and orphan-drug exclusivity. The guidance is intended to assist stakeholders, including industry and academic sponsors who seek orphan-drug designation and orphan-drug exclusivity, in the development of gene therapies for rare diseases. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2020.
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial; Draft Guidance for Industry; Availability
Document Number: 2021-21322
Type: Notice
Date: 2021-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry.'' The draft guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial, where each version is a distinct product that should be submitted to FDA in a separate investigational new drug application (IND). The draft guidance describes the regulatory framework for conducting such studies, including recommendations on how to organize and structure the INDs, submit new information, and report adverse events.
Request for Information on Research Opportunities and Operational Activities Related to the NIH Strategic Plan To Advance Research on the Health and Well-Being of Sexual & Gender Minorities Fiscal Years 2021-2025
Document Number: 2021-21319
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities and operational activities related to the NIH Strategic Plan to Advance Research on the Health and Well-Being of Sexual and Gender Minorities fiscal years (FY) 2021-2025. The goal of this request for information is to provide SGM focused organizations, researchers, non-profits, and community members an opportunity to identify potential research opportunities and operational activities related to the NIH mission.
Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022
Document Number: 2021-21317
Type: Notice
Date: 2021-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all the requirements of this program and upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability
Document Number: 2021-21316
Type: Notice
Date: 2021-09-30
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 ``Investigator ResponsibilitiesSafety Reporting for Investigational Drugs and Devices.'' The draft guidance provides recommendations to help clinical investigators comply with the safety reporting requirements of investigational new drug application (IND) studies and investigational device exemption (IDE) studies. The guidance is intended to help clinical investigators of drugs identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) and to help clinical investigators of devices identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and to IRBs.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2021-21315
Type: Notice
Date: 2021-09-30
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 ``Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This draft guidance is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2021-21311
Type: Notice
Date: 2021-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2022
Document Number: 2021-21288
Type: Notice
Date: 2021-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2022. The calendar year 2022 AIC threshold amounts are $180 for ALJ hearings and $1,760 for judicial review.
Submission for OMB Review; Services Provided to Unaccompanied Children (0970-0553)
Document Number: 2021-21282
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to provide services to UC as required by statute and ORR policy.
Submission for OMB Review; Release of Unaccompanied Children From ORR Custody (OMB #0970-0552)
Document Number: 2021-21281
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to process release of UC from ORR custody and provide services after release.
Submission for OMB Review; Mental Health Care Services for Unaccompanied Children (New Collection)
Document Number: 2021-21280
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to provide mental health care services to UC.
Charter Renewal for the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)
Document Number: 2021-21277
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Committee on Infant Mortality has been renamed the Advisory Committee on Infant and Maternal Mortality (ACIMM) and has been renewed.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2021-21275
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 72nd full Council meeting utilizing virtual technology on Monday, November, 15 and Wednesday, November, 17, 2021 from 1:00- 5:00 p.m. (ET) on both days. The meeting will be open to the public; a public comment session will be held during the meeting. Pre- registration is required to provide public comment during the meeting. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, November 8, 2021. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Wednesday, November 24, 2021. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability
Document Number: 2021-21222
Type: Notice
Date: 2021-09-30
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 ``Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.'' The purpose of this guidance is to assist manufacturers in assuring the microbiological quality of their non- sterile drugs (NSDs). This guidance discusses product development considerations, risk assessments, and certain current good manufacturing practice (CGMP) requirements that are particularly relevant to microbiological control in a manufacturing operation for an NSD.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The HRSA Community-Based Outreach Reporting Module, OMB #0906-0064, Revision
Document Number: 2021-21207
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA at the U.S. Department of Health and Human Services (HHS) requests a revision to the data collection for the Community- Based Workforce for COVID-19 Vaccine Outreach Programs (CBO Programs) (OMB # 0906-0064). In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Clinical Center; Notice of Closed Meeting
Document Number: 2021-21204
Type: Notice
Date: 2021-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2021-21194
Type: Notice
Date: 2021-09-30
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 ``Benefit- Risk Assessment for New Drug and Biological Products.'' FDA has developed this guidance document in accordance with commitments associated with the Prescription Drug User Fee Act of 2017 (PDUFA VI) under the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act (Cures Act). The intent of this guidance is to provide drug sponsors and other stakeholders with a clearer understanding of how considerations about a drug's benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions about new drug applications (NDAs) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biologics license applications (BLAs).
Submission for OMB Review; The Study of Disability Services Coordinators and Inclusion in Head Start (New Collection)
Document Number: 2021-21166
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, Administration for Children and Families
This is a primary data collection request for the Study of Disability Services Coordinators and Inclusion in Head Start (New Collection). The study aims to provide a nationally representative picture of the Early Head Start (EHS) and Head Start (HS) Disability Services Coordinator (DSC) workforce, as well as services provided to children with disabilities and their families within these programs and how EHS/HS collaborates with services in the community, including health providers, Local Education Agencies, and Part C. This is the first study of the HS/EHS DSC workforce and will contain three Phases of data collection using surveys and qualitative interviews.
Submission for OMB Review; Child and Family Services Reviews (OMB #0970-0214)
Document Number: 2021-21139
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting reinstatement of the activities associated with the Child and Family Services Reviews (CFSR) collection (OMB #0970-0214). Revisions have been made to the forms to clarify instructions and incorporate new guidance. The activities associated with the Title IV-E Foster Care Eligibility Reviews and Anti-Discrimination Enforcement Corrective Action Plans were removed from this collection.
Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-21135
Type: Notice
Date: 2021-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electronic Submission Template for Medical Device 510(k) Submissions.'' FDA is issuing this draft guidance to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510(k) electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it in effect at this time.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21134
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21133
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21132
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21131
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-21130
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21129
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-21128
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2021-21127
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-21126
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-21125
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-21124
Type: Notice
Date: 2021-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2021-21115
Type: Notice
Date: 2021-09-29
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 ``Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).