July 2, 2021 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2021-07-02-ReaderAids
Type: Reader Aids
Date: 2021-07-02
Sunshine Act Meetings
Document Number: 2021-14381
Type: Notice
Date: 2021-07-02
Agency: Securities and Exchange Commission, Agencies and Commissions
Sunshine Act Meeting Notice
Document Number: 2021-14331
Type: Notice
Date: 2021-07-02
Agency: Legal Services Corporation, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2021-14306
Type: Notice
Date: 2021-07-02
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Airworthiness Directives; International Aero Engines AG Turbofan Engines
Document Number: 2021-14268
Type: Rule
Date: 2021-07-02
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain International Aero Engines AG (IAE) V2522-A5, V2524-A5, V2527- A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 model turbofan engines. This AD was prompted by a review of investigative findings from an event involving an uncontained failure of a high-pressure turbine (HPT) 1st-stage disk that resulted in high-energy debris penetrating the engine cowling. This AD requires an ultrasonic inspection (USI) of affected HPT 1st-stage disks and HPT 2nd-stage disks and, depending on the results of the USI, removal of the affected HPT 1st-stage and HPT 2nd-stage disks from service. The FAA previously sent an emergency AD to all known U.S. owners and operators of these engines and is now issuing this AD to address the unsafe condition on these products.
Meetings To Implement Pandemic Response Voluntary Agreement Under Section 708 of the Defense Production Act
Document Number: 2021-14251
Type: Notice
Date: 2021-07-02
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA) is holding a series of meetings to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.
North American Industry Classification System (NAICS) Updates for 2022; Update of Statistical Policy Directive No. 8, Standard Industrial Classification of Establishments; and Elimination of Statistical Policy Directive No. 9, Standard Industrial Classification of Enterprises
Document Number: 2021-14249
Type: Notice
Date: 2021-07-02
Agency: Management and Budget Office, Executive Office of the President
The Office of Management and Budget (OMB) seeks public comment on the advisability of adopting the proposed North American Industry Classification System (NAICS) updates for 2022 recommended by its Economic Classification Policy Committee (ECPC), which comprises representatives of the Bureau of Economic Analysis, Bureau of Labor Statistics, U.S. Census Bureau, and other government agencies. The ECPC recommends an update of the industry classification system to clarify existing industry definitions and content, recognize new and emerging industries, combine industries, and correct errors and omissions. The ECPC also recommends an update of OMB Statistical Policy Directive No. 8, Standard Industrial Classification of Establishments, and to withdraw OMB Statistical Policy Directive No. 9, Standard Industrial Classification of Enterprises. In large part, this proposed series of revisions are designed to address the view of the ECPC regarding the decreasing usefulness of employing the mode of delivery (online versus in store/print) as an industry delineation criterion in the Wholesale Trade, Retail Trade, and Information sectors. In short, the internet has developed from a specialized activity to a generic method of delivery for goods and services. Therefore, the ECPC has developed recommendations that reevaluate and deemphasize the delivery method as an industry function used in NAICS classification. There are four parts in the SUPPLEMENTARY INFORMATION section below. Part I summarizes the background for the proposed revisions to NAICS 2017. Part II contains a summary of public comments regarding priorities for changes to NAICS in 2022, the ECPC recommendation to update OMB Statistical Policy Directive No. 8, Standard Industrial Classification of Establishments, and the ECPC recommendation to withdraw OMB Statistical Policy Directive No. 9, Standard Industrial Classification of Enterprises. Part III includes a list of title changes for NAICS industries that clarify, but do not change, the existing content of the industries. Part IV provides a comprehensive listing of proposed changes for national industries and their links to NAICS 2017 industries.
Interest Rates
Document Number: 2021-14248
Type: Notice
Date: 2021-07-02
Agency: Small Business Administration, Agencies and Commissions
Emergency Supplies of Drinking Water
Document Number: 2021-14247
Type: Rule
Date: 2021-07-02
Agency: Department of Defense, Department of the Army, Corps of Engineers
This final rule removes the U.S. Army Corps of Engineers' part titled, ``Emergency Supplies of Drinking Water.'' This part is mostly duplicative of an equivalent part in the agency's regulations. Where it is not duplicative this part could be misleading, as its provisions have been superseded by those in the equivalent part related to emergency water supplies due to contaminated water sources. Therefore, this part can be removed from the Code of Federal regulations (CFR).
Privacy Act of 1974; System of Records
Document Number: 2021-14246
Type: Notice
Date: 2021-07-02
Agency: Department of the Treasury
In accordance with the Privacy Act of 1974, the Department of the Treasury (``Treasury'' or the ``Department''), Treasury proposes to modify a current Treasury system of records titled, ``Department of the Treasury, Treasury .001Treasury Payroll and Personnel System'' System of Records. The records and information collected and maintained in this system includes, but are not limited to: (1) Maintaining current and historical payroll records that are used to compute and audit pay entitlement; to record history of pay transactions; to record deductions, leave accrued and taken, bonds due and issued, taxes paid; maintaining and distributing Leave and Earnings statements; commence and terminate allotments; answer inquiries and process claims; and (2) maintaining current and historical personnel records and preparing individual administrative transactions relating to education and training; classification; assignment; career development; evaluation; promotion, compensation, separation and retirement; making decisions on the rights, benefits, entitlements and the utilization of individuals; providing a data source for the production of reports, statistical surveys, rosters, documentation, and studies required for the orderly personnel administration within Treasury; (3) maintaining employment history; and (4) perform personnel and payroll functions for Federal agencies for which Treasury is a cross-services provider and to conduct activities necessary to carry-out the official HR line of business for all Federal departments and agencies that are serviced by the National Finance Center (NFC); (5) producing of reports, statistical surveys, rosters, documentation, and studies required for the orderly personnel administration within Treasury, and (6) maintaining information about Treasury personnel and their dependents for needs and status assessments to determine if they are entitled to a benefit related to a natural or man-made disaster, a public health emergency, or similar crisis.
Information Collection: NRC Online Form, Request for Alternatives
Document Number: 2021-14245
Type: Notice
Date: 2021-07-02
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, NRC Online Form, ``Request for Alternatives.''
Procurement Activities of the Corps of Engineers
Document Number: 2021-14244
Type: Rule
Date: 2021-07-02
Agency: Department of Defense, Department of the Army, Corps of Engineers
This final rule removes the U.S. Army Corps of Engineers' part titled, ``Procurement Activities of the Corps of Engineers.'' Each removed section is out-of-date, duplicative of existing regulations, and otherwise covers internal agency operations that have no public compliance component or adverse public impact. Regulations governing internal procurement activities can be found on file with the agency. Therefore, this part can be removed from the Code of Federal Regulations (CFR).
Combined Notice of Filings
Document Number: 2021-14242
Type: Notice
Date: 2021-07-02
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2021-14241
Type: Notice
Date: 2021-07-02
Agency: Department of Energy, Federal Energy Regulatory Commission
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2021-14238
Type: Notice
Date: 2021-07-02
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: 2022 School Crime Supplement (SCS) to the National Crime Victimization Survey (NCVS)
Document Number: 2021-14236
Type: Notice
Date: 2021-07-02
Agency: Department of Justice
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts: Revision of Effective Date for 2019 and 2020 Designations
Document Number: 2021-14235
Type: Notice
Date: 2021-07-02
Agency: Department of Housing and Urban Development
This document revises the effective date for designations of ``Difficult Development Areas'' (DDAs) and ``Qualified Census Tracts'' (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42 (26 U.S.C. 42) published on October 22, 2018, (83 FR 53282) and September 25, 2019, (84 FR 50465) in response to the Presidentially-declared COVID-19 emergency. This notice extends from 730 days to 910 days the period for which the 2019 and 2020 lists of QCTs and DDAs are effective for projects (1) located in an area not on subsequent lists of DDAs or QCTs; and (2) that submitted applications while the area was a 2019 or 2020 QCT or DDA.
Agency Information Collection Activities; Permanent Regulatory Program-Small Operator Assistance Program
Document Number: 2021-14234
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Agency Information Collection Activities; Surface Mining Permit Applications-Minimum Requirements for Reclamation and Operation Plan
Document Number: 2021-14233
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14232
Type: Notice
Date: 2021-07-02
Agency: National Archives and Records Administration, Agencies and Commissions
We are requesting that the Office of Management and Budget (OMB) renew its approval for us to engage in the following generic information collection request (generic ICR), and we invite you to comment on it: Generic Clearance for NARA Public and Education Program Registration. Under this information collection, we request registration and attendance information from people requesting to attend an education or other program at NARA.
Information Collection Approved by the Office of Management and Budget
Document Number: 2021-14231
Type: Notice
Date: 2021-07-02
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (Commission) has received Office of Management and Budget (OMB) approval for a revision to a currently approved public information collection pursuant to the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section below.
Special Local Regulation; Swim for Special Operations Forces; San Diego Bay, San Diego, CA
Document Number: 2021-14230
Type: Proposed Rule
Date: 2021-07-02
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is proposing to amend its special local regulations for recurring marine parades, regattas, and other events in Southern California Annual Marine Events for the San Diego Captain of the Port Zone. This proposed rule would add one new recurring special local regulation. This action is necessary to provide for the safety of life on the navigable waters during the event. This proposed rulemaking would restrict vessel traffic in the designated areas during the events unless authorized by the Captain of the Port San Diego or a designated representative. We invite your comments on this proposed rulemaking.
Notice of Intent To Rule on a Land Release Request at Ellington Field, Houston, Texas
Document Number: 2021-14229
Type: Notice
Date: 2021-07-02
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to rule and invite public comment on the release of land at Ellington Field under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Safety Zone; Ohio River, Newburgh, IN
Document Number: 2021-14228
Type: Proposed Rule
Date: 2021-07-02
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is proposing to establish a temporary safety zone for all navigable waters of the Ohio River extending the entire width of the river, from mile marker (MM) 777.3 to MM 778.3. This action is necessary to provide for the safety of life on these navigable waters near Newburgh, Indiana, during the City of Newburgh fireworks display on September 4, 2021. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector Ohio Valley or a designated representatitve. We invite your comments on this proposed rulemaking.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14227
Type: Notice
Date: 2021-07-02
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14226
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14225
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14224
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Monitoring of CDC's Core State Injury Prevention Program. The proposed study is designed to collect performance monitoring data, via a web-based tool, from recipients funded under the Core State Injury Prevention Program cooperative agreement (Core SIPP).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14223
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposal to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of Adolescent and School Health (DASH) to conduct a research information collection project titled ``Teen and Parents Surveys of Health (TAPS)''. This project serves to inform the CDC's Division of Adolescent and School Health's (DASH) key school- based programmatic strategies of improving family- and school-level protective factors, bolstering health education, and increasing adolescent access to quality health services.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-14222
Type: Notice
Date: 2021-07-02
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Prepare an Environmental Impact Statement for Proposed Wind Energy Facility Offshore Virginia
Document Number: 2021-14220
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Bureau of Ocean Energy Management
Consistent with the regulations implementing the National Environmental Policy Act (NEPA), the Bureau of Ocean Energy Management (BOEM) announces its intent to prepare an environmental impact statement (EIS) for the review of a construction and operations plan (COP) submitted by Dominion Energy, Inc. (Dominion or applicant). The COP proposes the construction and operation of a wind energy facility offshore Virginia, called the Coastal Virginia Offshore Wind Commercial Project (CVOW-C or Project), with export cables and the cable landing locations in the area of Hampton Roads, Virginia. The onshore electrical portion will connect to the Pennsylvania-New Jersey-Maryland (PJM) regional transmission grid. This notice of intent (NOI) announces the EIS scoping process for the Dominion COP. Additionally, this NOI seeks public comment and input under section 106 of the National Historic Preservation Act (NHPA) and its implementing regulations. Detailed information about the proposed wind energy facility, including the COP, can be found on BOEM's website at: https://www.boem.gov/CVOW- C.
Cayuga Nation of New York; Alcoholic Beverage Control Ordinance
Document Number: 2021-14219
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Bureau of Indian Affairs
This notice publishes the liquor control ordinance of the Cayuga Nation of New York. The liquor control statute regulates and controls the possession, sale, manufacture, and distribution of alcohol in conformity with the laws of the State of New York.
Indian Gaming; Approval of Tribal-State Class III Gaming Compact in the State of Minnesota
Document Number: 2021-14218
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Bureau of Indian Affairs
This notice publishes the approval of the class III gaming compact between the Shakopee Mdewakanton Sioux Community of Minnesota (Tribe) and the State of Minnesota (State).
Indian Gaming; Approval by Operation of Law of Tribal-State Class III Gaming Compact in the State of Indiana
Document Number: 2021-14217
Type: Notice
Date: 2021-07-02
Agency: Department of the Interior, Bureau of Indian Affairs
This notice publishes the approval by operation law of the compact between the Pokagon Band of Potawatomi Indians (Tribe) and the State of Indiana (State) providing for the conduct of Tribal class III gaming by the Tribe.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2021-14215
Type: Notice
Date: 2021-07-02
Agency: Federal Reserve System, Agencies and Commissions
Motor Carrier Safety Advisory Committee (MCSAC); Public Meeting
Document Number: 2021-14214
Type: Notice
Date: 2021-07-02
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces a meeting of the MCSAC, which will take place via videoconference.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-14212
Type: Notice
Date: 2021-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2021-14210
Type: Notice
Date: 2021-07-02
Agency: Drug Enforcement Administration, Department of Justice
United States Pharmacopeial Convention has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Procurement List; Additions and Deletions
Document Number: 2021-14209
Type: Notice
Date: 2021-07-02
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action deletes product(s) from the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Procurement List; Proposed Deletions
Document Number: 2021-14208
Type: Notice
Date: 2021-07-02
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to delete product(s) and service(s) from the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Television Broadcasting Services Peoria and Oswego, Illinois
Document Number: 2021-14207
Type: Rule
Date: 2021-07-02
Agency: Federal Communications Commission, Agencies and Commissions
On April 14, 2021, the Media Bureau, Video Division (Bureau) issued a Notice of Proposed Rulemaking (NPRM) in response to a petition for rulemaking filed by Four Seasons Peoria, LLC (Petitioner), requesting an amendment of the DTV Table of Allotments to delete channel 10 at Peoria, Illinois, substitute channel 10 at Oswego, Illinois, and modify the WAOE license to specify Oswego as its community of license. For the reasons set forth in the Report and Order referenced below, channel 10 is deleted from Peoria, Illinois, and allotted to Oswego, Illinois. Further, WAOE's community of license is modified to Oswego, Illinois.
Alert Reporting System Available for Filing of State Emergency Alert System Plans
Document Number: 2021-14206
Type: Notice
Date: 2021-07-02
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (Commission or FCC) announces that its Alert Reporting System (ARS) is now open for the filing of State Emergency Alert System (EAS) Plans.
Center for State, Tribal, Local, and Territorial Support (CSTLTS), CDC/ATSDR Tribal Consultation Session
Document Number: 2021-14205
Type: Notice
Date: 2021-07-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the 2021 CDC/ATSDR Tribal Consultation Session. CDC/ATSDR will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for the virtual tribal consultation session. The proceedings will be open to the public.
Solicitation of Nominations for Appointment to the Advisory Board on Radiation and Worker Health for the Energy Employees Occupational Illness Compensation Program Act of 2000
Document Number: 2021-14204
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Board on Radiation and Worker Health (ABRWH) for the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). The ABRWH consists of not more than 20 members appointed by the President of the United States, and shall reflect a balance of scientific, medical, and worker perspectives. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the ABRWH's objectives. Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the ABRWH may be asked to consider. Federal employees will not be considered for membership.
Advisory Committee on Immunization Practices (ACIP); Amended Notice of Meeting
Document Number: 2021-14203
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2021-14202
Type: Notice
Date: 2021-07-02
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 ``Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications.'' Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as new drug applications (NDAs) or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration. When final, this draft guidance will expand upon the recommendation for in vivo adhesion studies in section V., Special Topics, subsection A., Product Adhesion Considerations, in the draft guidance for industry Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations issued on November 21, 2019.
Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry; Availability
Document Number: 2021-14201
Type: Notice
Date: 2021-07-02
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 for industry entitled ``Providing Regulatory Submissions in Alternate Electronic Format.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this guidance to provide recommendations on an alternate electronic format for submissions covered under such exemptions and waivers. This guidance replaces the draft guidance of the same title issued on March 11, 2020.
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