October 2017 – Federal Register Recent Federal Regulation Documents

Results 851 - 900 of 2,664
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-22825
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2017-22824
Type: Notice
Date: 2017-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Procurement List; Procurement List; Proposed Addition and Deletions
Document Number: 2017-22823
Type: Notice
Date: 2017-10-20
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to add a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes a product and service previously furnished by such agencies.
Fisheries Off West Coast States; Fisheries of the Exclusive Economic Zone Off Alaska; Seabird Cable Strike Mitigation Workshop; Public Meeting
Document Number: 2017-22822
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Emerging seabird mitigation technologies will be discussed at the Seabird Cable Strike Mitigation Workshop.
New Postal Products
Document Number: 2017-22820
Type: Notice
Date: 2017-10-20
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submission for OMB Review, Comment Request, Proposed Collection: Museums for All Program Evaluation
Document Number: 2017-22819
Type: Notice
Date: 2017-10-20
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, Institute of Museum and Library Services
The Institute of Museum and Library Services announces that the following information collection will be submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.
Advisory Board on Toxic Substances and Worker Health
Document Number: 2017-22818
Type: Notice
Date: 2017-10-20
Agency: Department of Labor, Office of Workers' Compensation Programs
The Advisory Board will meet November 16-17, 2017, in Santa Fe, New Mexico. Comments, requests to speak, submissions of materials for the record, and requests for special accommodations: You must submit (postmark, send, transmit) comments, requests to address the Advisory Board, speaker presentations, and requests for special accommodations for the meetings by November 9, 2017.
Chesapeake and Indiana Railroad Company-Amended Operation Exemption-Town of North Judson, Ind.
Document Number: 2017-22817
Type: Notice
Date: 2017-10-20
Agency: Surface Transportation Board, Department of Transportation
Agency Information Collection Activities; Comment Request; Information Collections: The Family and Medical Leave Act of 1993, as Amended
Document Number: 2017-22816
Type: Notice
Date: 2017-10-20
Agency: Wage and Hour Division, Employment Standards Administration, Department of Labor
The Department of Labor (DOL) is soliciting comments concerning a proposed extension of the information collection request (ICR) titled, ``The Family and Medical Leave Act of 1993, As Amended.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information request can be obtained by contacting the office listed below in the FOR FURTHER INFORMATION CONTACT section of this Notice.
Proposed Information Collection; Comment Request; Manufacturers' Shipments, Inventories, and Orders (M3) Survey
Document Number: 2017-22814
Type: Notice
Date: 2017-10-20
Agency: Census Bureau, Department of Commerce
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
Document Number: 2017-22813
Type: Rule
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
Medicare and Medicaid Programs; Application by Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Accreditation Program
Document Number: 2017-22812
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Analyses, Research and Studies To Address the Impact of CMS Programs on American Indian/Alaska Native (AI/AN) Beneficiaries and the Health Care System Serving These Beneficiaries
Document Number: 2017-22811
Type: Notice
Date: 2017-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice supports expansion of research on the impact of CMS programs on the Indian health care system through a single source award. The Indian Health Service (IHS), Tribes and Tribal Organizations and Urban programs, deliver health care services to American Indian/ Alaska Native (AI/AN) people through a network of hospitals, clinics and other providers. This award expands research on the impact of CMS programs and the delivery of health care to AI/AN beneficiaries.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Georgia
Document Number: 2017-22810
Type: Notice
Date: 2017-10-20
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for public assistance only for the state of Georgia (FEMA-4338-DR), dated 09/28/2017. Incident: Hurricane Irma. Incident Period: 09/07/2017 through 09/20/2017.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Texas
Document Number: 2017-22809
Type: Notice
Date: 2017-10-20
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA- 4332-DR), dated 09/04/2017. Incident: Hurricane Harvey. Incident Period: 08/23/2017 through 09/15/2017.
Presidential Declaration Amendment of a Major Disaster for the State of Texas
Document Number: 2017-22808
Type: Notice
Date: 2017-10-20
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4332-DR), dated 08/25/2017. Incident: Hurricane Harvey. Incident Period: 08/23/2017 through 09/15/2017.
Non-Malleable Cast Iron Pipe Fittings From the People's Republic of China: Notice of Rescission of Antidumping Duty Administrative Review; 2016-2017
Document Number: 2017-22807
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) is rescinding its administrative review of non-malleable cast iron pipe fittings from the People's Republic of China (PRC) for the period or review (POR) April 1, 2016, through March 31, 2017.
Polyethylene Terephthalate Resin From Canada: Notice of Rescission of Antidumping Duty Administrative Review; 2015-2017
Document Number: 2017-22806
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) is rescinding its administrative review of polyethylene terephthalate resin from Canada for the period or review (POR) October 15, 2015, through April 30, 2017.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Florida
Document Number: 2017-22805
Type: Notice
Date: 2017-10-20
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4337-DR), dated 09/21/2017. Incident: Hurricane Irma. Incident Period: 09/04/2017 and continuing.
Notice of Scope Rulings
Document Number: 2017-22804
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) hereby publishes a list of scope rulings and anticircumvention determinations made between July 1, 2016, and September 30, 2016, inclusive. We intend to publish future lists after the close of the next calendar quarter.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2017-22802
Type: Notice
Date: 2017-10-20
Agency: Department of Energy, Energy Information Administration
EIA intends to extend with changes for three years with the Office of Management and Budget (OMB) its Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' under OMB Control No. 1905-0210. As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, this generic clearance enables EIA to collect customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to ensure that our programs are effective, meet our customers' needs, and receive feedback on improving service delivery to the public.
Agency Information Collection Activities; Extension
Document Number: 2017-22801
Type: Notice
Date: 2017-10-20
Agency: Department of Energy, Energy Information Administration
EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend without changes for three years with the Office of Management and Budget (OMB) Form EIA-111, Quarterly Electricity Imports and Exports Report. Form EIA-111 collects U.S. electricity import and export data for the purpose of measuring the flow of electricity into and out of the United States from Canada and Mexico.
Implementation of Revised Lacey Act Provisions
Document Number: 2017-22800
Type: Notice
Date: 2017-10-20
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
The Food, Conservation, and Energy Act of 2008 amended the Lacey Act to provide, among other things, that importers submit a declaration at the time of importation for certain plants and plant products. The declaration requirements of the Lacey Act became effective on December 15, 2008, and enforcement of those requirements is being phased in. In 2009, we initiated a blanket declaration pilot program for participants in U.S. Customs and Border Protection's expedited border release programs. In this notice, we are announcing the end of the blanket declaration pilot program and providing guidance on how participants in the program may continue to file declarations as required by the Lacey Act.
Agency Information Collection Extension/Revision
Document Number: 2017-22799
Type: Notice
Date: 2017-10-20
Agency: Department of Energy
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Notice and Request for Comments
Document Number: 2017-22798
Type: Notice
Date: 2017-10-20
Agency: Department of Energy, U.s. Energy Information Administration
EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend with changes for three years with the Office of Management and Budget (OMB) Form EIA-63C Densified Biomass Fuel Report. Form EIA- 63C collects data on pellet fuel and other densified biomass fuel production, sales, and inventory levels from operators of U.S. pellet fuel manufacturing facilities. The data collected is used for the purpose of estimating densified biomass fuel consumption in the United States, as well as production, sales, and inventory at state, regional, and national levels.
Notice and Request for Comments
Document Number: 2017-22797
Type: Notice
Date: 2017-10-20
Agency: National Highway Traffic Safety Administration, Department of Transportation
The Department of Transportation (DOT) invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
Submission for OMB Review; Comment Request
Document Number: 2017-22793
Type: Notice
Date: 2017-10-20
Agency: Department of Agriculture
Membership of the Performance Review Board for EDA, NTIA and BIS
Document Number: 2017-22792
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, Economic Development Administration, National Telecommunications and Information Administration, Bureau of Industry and Security
The EDA, NTIA and BIS, Department of Commerce (DOC), announce the appointment of those individuals who have been selected to serve as members of the Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and Senior Level (SL) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES and SL members. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.
Membership of the Performance Review Board for the Office of the Secretary
Document Number: 2017-22791
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, Office of the Secretary
The Office of the Secretary, the Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and Senior Level (SL) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.
Membership of the International Trade Administration Performance Review Board
Document Number: 2017-22790
Type: Notice
Date: 2017-10-20
Agency: Department of Commerce, International Trade Administration
The International Trade Administration (ITA), Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of ITA's Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.
Advisory Committee on Arlington National Cemetery, Honor Subcommittee and the Remember and Explore Subcommittee Meeting Notice
Document Number: 2017-22788
Type: Notice
Date: 2017-10-20
Agency: Department of Defense, Department of the Army
The Department of the Army is publishing this notice to announce the following Federal advisory subcommittee meetings of the Honor subcommittee and the Remember and Explore subcommittee of the Advisory Committee on Arlington National Cemetery (ACANC). These meetings are open to the public. For more information about the Committee and the Subcommittees, please visit: https:// www.arlingtoncemetery.mil/About/Advisory-Committee-on-Arlingt on- National-Cemetery/ACANC-Meetings.
Foreign Endangered Species and Marine Mammals; Issuance of Permits
Document Number: 2017-22787
Type: Notice
Date: 2017-10-20
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and the Marine Mammal Protection Act (MMPA).
International Product Change-GEPS 9 Contracts
Document Number: 2017-22786
Type: Notice
Date: 2017-10-20
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add Global Expedited Package Services 9 to the Competitive Products List.
Advisory Committee on Arlington National Cemetery Meeting Notice
Document Number: 2017-22785
Type: Notice
Date: 2017-10-20
Agency: Department of Defense, Department of the Army
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Advisory Committee on Arlington National Cemetery (ACANC). The meeting is open to the public. For more information about the Committee, please visit: https://www.arlingtoncemetery.mil/About/Advisory-Committee-on- Arlington-National-Cemetery/ACANC-Meetings.
Proposed Extension of Information Collection Request Submitted for Public Comment; Material Advisors of Reportable Transactions, Lists of Advisees
Document Number: 2017-22784
Type: Notice
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the requirements relating to lists of advisees kept by material advisors of reportable transactions.
Proposed Extension of Information Collection Request Submitted for Public Comment; Form 12854, Government Service Information
Document Number: 2017-22783
Type: Notice
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the requirements relating to completing Form 12854, Government Service Information.
Elimination of Regulations Implementing Community Trade Adjustment Assistance Program
Document Number: 2017-22782
Type: Rule
Date: 2017-10-20
Agency: Department of Commerce, Economic Development Administration
Through this final rule, the Economic Development Administration (``EDA''), U.S. Department of Commerce, eliminates the regulations implementing the Community Trade Adjustment Assistance (``CTAA'') Program. Established in 2009 under the Trade Act of 1974, the CTAA Program was subsequently eliminated by Congress in 2011. Implementing regulations for this now-defunct Program are thus unnecessary. This final rule is a ``deregulatory action'' pursuant to the April 5, 2017, Office of Management and Budget (``OMB'') guidance memorandum implementing Executive Order 13771.
Proposed Extension of Information Collection Request Submitted for Public Comment; Form CT-2, Employee Representative's Quarterly Railroad Tax Return
Document Number: 2017-22781
Type: Notice
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the requirements relating to completing Form CT-2, Employee Representative's Quarterly Railroad Tax Return.
Proposed Extension of Information Collection Request Submitted for Public Comment; Split-Dollar Life Insurance Arrangements
Document Number: 2017-22780
Type: Notice
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the requirements relating to Split-Dollar Life Insurance Arrangements.
Definition of Political Subdivision
Document Number: 2017-22777
Type: Proposed Rule
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document withdraws a notice of proposed rulemaking regarding the definition of a political subdivision for purposes of tax-exempt bonds.
Estate, Gift, and Generation-Skipping Transfer Taxes; Restrictions on Liquidation of an Interest
Document Number: 2017-22776
Type: Proposed Rule
Date: 2017-10-20
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document withdraws proposed regulations concerning the estate, gift and generation-skipping transfer (GST) tax treatment of lapses of liquidation rights in family-controlled entities, as well as the valuation of interests in family-controlled corporations and partnerships for estate, gift, and GST tax purposes. Specifically, the proposed regulations would have treated certain lapses of liquidation rights as transfers occurring at death. The proposed regulations also addressed the treatment of restrictions on liquidation and withdrawal in determining the value of transferred interests in family-controlled entities. This withdrawal affects certain transferors of interests in corporations and partnerships.
Fixing America's Surface Transportation (FAST) Act; Solicitation for Candidate Projects in the Interstate System Reconstruction and Rehabilitation Pilot Program (ISRRPP)
Document Number: 2017-22775
Type: Notice
Date: 2017-10-20
Agency: Federal Highway Administration, Department of Transportation
The FHWA invites State transportation departments to submit applications for candidate projects in the Interstate System Reconstruction and Rehabilitation Pilot Program (ISRRPP), authorized in the Transportation Equity Act for the 21st Century and amended by the Fixing America's Surface Transportation (FAST) Act. Under the ISRRPP, FHWA may permit up to three States to collect tolls on a facility on the Interstate System for the purpose of reconstructing or rehabilitating Interstate highway corridors that could not otherwise be adequately maintained or functionally improved without the collection of tolls. This notice describes general program provisions, eligibility and selection criteria, and the application submission and evaluation process.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-22774
Type: Notice
Date: 2017-10-20
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 provide comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Respiratory Protective Devices information collection project.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22773
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-22772
Type: Notice
Date: 2017-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Modernizing Common Carrier Rules
Document Number: 2017-22770
Type: Rule
Date: 2017-10-20
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Federal Communications Commission (Commission) adopted a Report and Order that eliminates certain rules from which the Commission has granted unconditional forbearance for all carriers, and eliminates references to telegraph service from certain sections of the Commission's rules. The Report and Order updates our rules to remove outmoded regulations from the Code of Federal Regulations (CFR) that no longer reflect current requirements or technology. In so doing, we further our goals of reducing regulatory burdens, eliminating unnecessary rule provisions, and making the agency as efficient and effective as possible.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
Document Number: 2017-22769
Type: Rule
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes
Document Number: 2017-22768
Type: Notice
Date: 2017-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs).
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