2014 – Federal Register Recent Federal Regulation Documents

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Harley-Davidson Motor Company, Inc., Grant of Petition for Decision of Inconsequential Noncompliance
Document Number: 2014-27583
Type: Notice
Date: 2014-11-21
Agency: National Highway Traffic Safety Administration, Department of Transportation
Harley-Davidson Motor Company, Inc. (Harley-Davidson) has determined that certain model year (MY) 2009-2014 Harley-Davidson FL Touring motorcycles do not fully comply with paragraph S6.1.3 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, reflective devices, and associated equipment. Harley-Davidson has filed an appropriate report dated April 7, 2014, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports.
Oreion Motors, LLC, Receipt of Petition for Decision of Inconsequential Noncompliance
Document Number: 2014-27582
Type: Notice
Date: 2014-11-21
Agency: National Highway Traffic Safety Administration, Department of Transportation
Oreion Motors, LLC (Oreion) has determined that certain 2011- 2013 Oreion Reeper low speed vehicles, do not fully comply with paragraph S5.(b)(10) of Federal Motor Vehicle Safety Standard (FMVSS) No. 500 which requires installation of seat belts that conform to FMVSS No. 209, Seat Belt Assemblies. Oreion has filed an appropriate report dated August 13, 2014, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports.
Wait-Time Goals of the Department for the Veterans Choice Program
Document Number: 2014-27581
Type: Notice
Date: 2014-11-21
Agency: Department of Veterans Affairs
In an interim final rule published by the Department of Veterans Affairs (VA) implementing the Veterans Choice Program (``the Program'') authorized by the Veterans Access, Choice, and Accountability Act of 2014, VA established start dates for participation in the Program for different groups of veterans depending upon their basis of eligibility to participate in the Program. In those regulations, VA stated that veterans who are eligible based upon being unable to schedule an appointment within the wait-time goals of the Veterans Health Administration, will be able to start receiving hospital care and medical services under the Program no later than December 5, 2014. VA also stated that if the start date for these veterans would be sooner than December 5, 2014, VA would publish a notice in the Federal Register advising the public of the faster implementation schedule. This Notice announces that November 17, 2014, is the start date for veterans eligible to participate in the Program.
Medicare Program; Town Hall Meeting on FY 2016 Applications for New Medical Services and Technology Add-On Payments
Document Number: 2014-27579
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2016 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment systems (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2016 new medical services and technologies applications meet the substantial clinical improvement criterion.
Medicare Program; Prior Authorization of Non-Emergent Hyperbaric Oxygen (HBO) Therapy
Document Number: 2014-27578
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a 3-year Medicare Prior Authorization model for non-emergent hyperbaric oxygen therapy services in the states of Illinois, Michigan, and New Jersey where there have been high incidences of improper payments for these services.
Medicare and Medicaid Programs: Continued Approval of The Joint Commission's Ambulatory Surgical Center Accreditation Program
Document Number: 2014-27577
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Continued Approval of DNV GL-Healthcare (DNV GL) Critical Access Hospital (CAH) Accreditation Program
Document Number: 2014-27576
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve DNV GL Healthcare (DNV GL) \1\ for continued recognition as a national accrediting organization (AO) for critical access hospitals (CAH) that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Crew Member's Declaration
Document Number: 2014-27575
Type: Notice
Date: 2014-11-21
Agency: Department of Homeland Security, U.S. Customs and Border Protection
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Crew Member's Declaration (CBP Form 5129). CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Agency Information Collection Activities: Crew's Effects Declaration
Document Number: 2014-27574
Type: Notice
Date: 2014-11-21
Agency: Department of Homeland Security, U.S. Customs and Border Protection
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Crew's Effects Declaration (CBP Form 1304). CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-27573
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2014-27569
Type: Notice
Date: 2014-11-21
Agency: Department of the Treasury
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Alternative Method of Compliance for Certain Simplified Employee Pensions
Document Number: 2014-27567
Type: Notice
Date: 2014-11-21
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ``Alternative Method of Compliance for Certain Simplified Employee Pensions,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Documenting and Evaluating Initial Results of the Office of Disability Employment Policy's Getting to Work Curriculum
Document Number: 2014-27566
Type: Notice
Date: 2014-11-21
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Office of Disability Employment Policy (ODEP) sponsored information collection request (ICR) proposal titled, ``Documenting and Evaluating Initial Results of the Office of Disability Employment Policy's Getting to Work Curriculum,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2014-27563
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
International Mail Contract
Document Number: 2014-27562
Type: Notice
Date: 2014-11-21
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning a Type 2 rate adjustment and the filing of a related negotiated service agreement with PostNL. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-27561
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Certain Windshield Wipers and Components Thereof Institution of Investigation Pursuant to 19 U.S.C. 1337
Document Number: 2014-27560
Type: Notice
Date: 2014-11-21
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on October 15, 2014, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Valeo North America, Inc. of Troy, Michigan and Delmex de Juarez S. de R.L. de C.V. of Mexico. A letter supplementing the complaint was filed on October 29, 2014. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain windshield wipers and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,891,044 (``the '044 patent'') and U.S. Patent No. 7,937,798 (``the '798 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-27558
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, Administration for Children and Families
Investigations Regarding Eligibility To Apply for Worker Adjustment Assistance
Document Number: 2014-27556
Type: Notice
Date: 2014-11-21
Agency: Employment and Training Administration, Department of Labor
Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization
Document Number: 2014-27553
Type: Notice
Date: 2014-11-21
Agency: Department of Energy, Federal Energy Regulatory Commission
Avista Corporation; Notice of Petition for Declaratory Order
Document Number: 2014-27550
Type: Notice
Date: 2014-11-21
Agency: Department of Energy, Federal Energy Regulatory Commission
Commission Information Collection Activities (FERC-725F); Comment Request; Extension
Document Number: 2014-27549
Type: Notice
Date: 2014-11-21
Agency: Department of Energy, Federal Energy Regulatory Commission
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-725F (Mandatory Reliability Standard for Nuclear Plant Interface Coordination: Reliability Standard NUC-001-3).
PJM Interconnection, L.L.C.; Notice of Filing
Document Number: 2014-27547
Type: Notice
Date: 2014-11-21
Agency: Department of Energy, Federal Energy Regulatory Commission
Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization
Document Number: 2014-27546
Type: Notice
Date: 2014-11-21
Agency: Department of Energy, Federal Energy Regulatory Commission
Twenty-Ninth Meeting: RTCA Special Committee 224, Airport Security Access Control Systems
Document Number: 2014-27545
Type: Notice
Date: 2014-11-21
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of the twenty-ninth meeting of the RTCA Special Committee 224, Airport Security Access Control Systems.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Respiratory Protection Standard
Document Number: 2014-27544
Type: Notice
Date: 2014-11-21
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Respiratory Protection Standard,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.
Endangered and Threatened Species; Take of Anadromous Fish
Document Number: 2014-27543
Type: Notice
Date: 2014-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This notice announces the availability of the Final Environmental Assessment (EA) on the application from the California Department of Fish and Wildlife (CDFW), Region 1 for a Scientific Purposes and Enhancement of Survival Permit for a Hatchery and Genetic Management Plan (HGMP) for take of a threatened species in accordance with the Endangered Species Act (ESA). This notice also announces that NMFS has made a decision to issue a permit (Permit No. 15755) to CDFW for activities described in their HGMP, and has authorized the Hatchery and Genetic Management Plan (HGMP) for the Iron Gate Hatchery coho salmon program in the Klamath River watershed in California. This notice is provided under National Environmental Policy Act (NEPA) regulations and NMFS ESA permit regulations to inform the public that the Final EA, HGMP, responses to public comments, and associated documents are available for review.
Actuarial Advisory Committee With Respect to the Railroad Retirement Account
Document Number: 2014-27542
Type: Notice
Date: 2014-11-21
Agency: Railroad Retirement Board, Agencies and Commissions
Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings
Document Number: 2014-27541
Type: Notice
Date: 2014-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
North Pacific Fishery Management Council; Public Meetings
Document Number: 2014-27540
Type: Notice
Date: 2014-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council (Council) and its advisory committees will hold public meetings, December 10-16, 2014.
Certain Kitchen Appliance Shelving and Racks From China; Scheduling of Expedited Five-Year Reviews
Document Number: 2014-27539
Type: Notice
Date: 2014-11-21
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to section 751(c)(3) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(3)) (the Act) to determine whether revocation of the countervailing duty order and the antidumping duty order on certain kitchen appliance shelving and racks (``KASAR'') from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Marine Mammals; File No. 18824
Document Number: 2014-27538
Type: Notice
Date: 2014-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Briana Witteveen, Ph.D., of the University of Alaska, Fairbanks, Kodiak Seafood and Marine Science Center (118 Trident Way, Kodiak, AK, 99615), has applied in due form for a permit to take multiple cetacean species for purposes of scientific research, with additional takes of several pinniped species by incidental harassment, within the Gulf of Alaska.
Radio Broadcasting Services; Various Locations
Document Number: 2014-27535
Type: Rule
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
The Audio Division amends the FM Table of Allotments to remove certain vacant FM allotments that were auctioned in FM Auction 94 that are currently considered authorized stations. We are also removing certain vacant allotments that were auctioned in FM Auction 79, FM Auction 91 and FM Auction 93 that are currently considered authorized stations. FM assignments for authorized stations and reserved facilities will be reflected solely in Media Bureau's Consolidated Database System (CDBS).
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; National Listing of Fish Advisories (Renewal)
Document Number: 2014-27534
Type: Notice
Date: 2014-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), National Listing of Fish Advisories, (EPA ICR Number 1959.05, OMB Control Number 2040-0226) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through November 30, 2014. Public comments were previously requested via the Federal Register (79 FR 33188) on June 10, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; 2015 Hazardous Waste Report, Notification of Regulated Waste Activity, and Part A Hazardous Waste Permit Application and Modification (Renewal)
Document Number: 2014-27533
Type: Notice
Date: 2014-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR), 2015 Hazardous Waste Report, Notification of Regulated Waste Activity, and Part A Hazardous Waste Permit Application and Modification (Renewal) (EPA ICR No. 0976.17, OMB Control No. 2050-0024) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through December 31, 2014. Public comments were previously requested via the Federal Register (79 FR 34733) on June 18, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2014-27528
Type: Notice
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collections Being Reviewed by the Federal Communications Commission
Document Number: 2014-27527
Type: Notice
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2014-27526
Type: Notice
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communication Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2014-27525
Type: Notice
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communication Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2014-27524
Type: Notice
Date: 2014-11-21
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Developing and Using Precision Therapies in the “Omics” Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop
Document Number: 2014-27523
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ``Developing and Using Precision Therapies in the `Omics' Era: Generating and Interpreting Evidence for Rare Subsets.'' This public workshop is being cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible.
Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction
Document Number: 2014-27522
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice entitled ``Report on the Standardization of Risk Evaluation and Mitigation Strategies'' that appeared in the Federal Register of September 23, 2014. The document misstated the name of an organization. This document corrects that error.
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability
Document Number: 2014-27521
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry'' dated December 2014. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance).
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