2018 – Federal Register Recent Federal Regulation Documents

Results 3,401 - 3,450 of 27,748
Air Plan Approval; Ohio; Ohio Less Than 10 TPY BAT Exemption
Document Number: 2018-24815
Type: Proposed Rule
Date: 2018-11-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve, under the Clean Air Act (CAA), revisions to Ohio's State Implementation Plan (SIP) as requested by the Ohio Environmental Protection Agency (OEPA) on May 22, 2018. OEPA has submitted, for approval, revisions that exempt sources that emit less than 10 tons per year (tpy) from the need to employ Best Available Technology (BAT). EPA is proposing to approve these revisions because they are consistent with Federal regulations governing state permit programs.
Watts Bar Nuclear Plant, Unit 2
Document Number: 2018-24814
Type: Notice
Date: 2018-11-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License (FOL) No. NPF-96 for the Watts Bar Nuclear Plant (WBN), Unit 2. The proposed amendment would revise the completion date for License Condition (LC) 2.C.(5) for WBN Unit 2, regarding the completion of action to resolve the issues identified in NRC Bulletin 2012-01, ``Design Vulnerability in Electric Power System,'' from December 31, 2018, to December 31, 2019, to align with the remainder of the Tennessee Valley Authority fleet and with the nuclear industry.
Entergy Operations, Inc., River Bend Station, Unit 1
Document Number: 2018-24813
Type: Notice
Date: 2018-11-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final plant-specific Supplement 58 to the Generic Environmental Impact Statement (GEIS) for License Renewal of Nuclear Plants, NUREG-1437, regarding the renewal of operating license NPF-47 for an additional 20 years of operation for River Bend Station, Unit 1 (RBS). The RBS is located in West Feliciana Parish, Louisiana.
Hardship Distributions of Elective Contributions, Qualified Matching Contributions, Qualified Nonelective Contributions, and Earnings
Document Number: 2018-24812
Type: Proposed Rule
Date: 2018-11-14
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains proposed amendments to the regulations relating to hardship distributions from section 401(k) plans. The amendments reflect statutory changes affecting section 401(k) plans, including recent changes made by the Bipartisan Budget Act of 2018. These regulations would affect participants in, beneficiaries of, employers maintaining, and administrators of plans that contain cash or deferred arrangements or provide for employee or matching contributions.
Environmental Management Site-Specific Advisory Board, Hanford
Document Number: 2018-24811
Type: Notice
Date: 2018-11-14
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Large Diameter Welded Pipe From the People's Republic of China: Final Determination of Sales at Less Than Fair Value
Document Number: 2018-24807
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that imports of large diameter welded pipe from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less than fair value (LTFV).
Large Diameter Welded Pipe From India: Final Determination of Sales at Less Than Fair Value; 2017
Document Number: 2018-24806
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that imports of large diameter welded pipe from India are being, or are likely to be, sold in the United States at less than fair value (LTFV) for the period of investigation January 1, 2017, through December 31, 2017
Countervailing Duty Investigation of Large Diameter Welded Pipe From the People's Republic of China: Final Affirmative Determination
Document Number: 2018-24805
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers/exporters of large diameter welded pipe from the People's Republic of China (China).
Large Diameter Welded Pipe From India: Final Affirmative Countervailing Duty Determination
Document Number: 2018-24804
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers/exporters of large diameter welded pipe welded pipe from India.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2018-24803
Type: Notice
Date: 2018-11-14
Agency: Federal Reserve System, Agencies and Commissions
Notice of Proposals To Engage In or To Acquire Companies Engaged in Permissible Nonbanking Activities
Document Number: 2018-24802
Type: Notice
Date: 2018-11-14
Agency: Federal Reserve System, Agencies and Commissions
Carbon and Certain Alloy Steel Wire Rod From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017
Document Number: 2018-24801
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that sales of carbon and certain alloy steel wire rod (wire rod) from Mexico were made at less than normal value during the period of review (POR), October 1, 2016, through September 30, 2017. We invite interested parties to comment on these preliminary results.
Certain Uncoated Paper From Indonesia: Amended Final Results of Countervailing Duty Administrative Review; 2015-2016
Document Number: 2018-24800
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is amending its final results of the administrative review of the countervailing duty (CVD) order on certain uncoated paper from Indonesia to correct ministerial errors in the calculation of the countervailable subsidy rates for PT Anugrah Kertas Utama, PT Riau Andalan Kertas, APRIL Fine Paper Macao Commercial Offshore Limited, and their cross-owned affiliates (collectively APRIL). As a result of the correction of these errors, we calculated a revised subsidy rate for APRIL for 2015; however we did not revise APRIL's subsidy rate for 2016. The amended final 2015 countervailable subsidy rate is listed below in the section entitled, ``Amended Final Results.''
Agreement Suspending the Antidumping Duty Investigation on Uranium From the Russian Federation: Preliminary Results of 2016-2017 Administrative Review and Postponement of Final Results
Document Number: 2018-24799
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is conducting an administrative review of the Agreement Suspending the Antidumping Duty Investigation on Uranium from the Russian Federation (the Agreement). We preliminarily find that the State Atomic Energy Corporation ``ROSATOM'' (ROSATOM), its affiliates Joint Stock Company ``TENEX'' (TENEX) and TENAM Corporation (TENAM), and TENEX's unaffiliated reseller, Centrus Energy Corp. and United States Enrichment Corporation (collectively, Centrus), are in compliance with the Agreement.
Preliminary Results of Changed Circumstances Reviews of the Antidumping Duty Orders on Large Residential Washers From the Republic of Korea and Mexico, and the Countervailing Duty Order on Large Residential Washers From the Republic of Korea
Document Number: 2018-24798
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines not to revoke the antidumping duty (AD) orders on large residential washers (LRWs) from the Republic of Korea (Korea) and Mexico and the countervailing duty (CVD) order on large residential washers from Korea, in part, with respect to LRWs that (1) have a horizontal rotational axis; (2) are front loading; and (3) have a drive train consisting, inter alia, of (a) a controlled induction motor and (b) a belt drive (hereinafter, FL CIM/Belt washers), because Whirlpool Corporation (Whirlpool), the requestor, does not account for substantially all of the production of domestic like product to which these orders pertain.
Certain Hot-Rolled Steel Flat Products From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017
Document Number: 2018-24796
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that Hyundai Steel Company (Hyundai) and POSCO/POSCO Daewoo Co., Ltd. (collectively POSCO/PDW), the two companies selected for individual examination, sold subject merchandise in the United States at prices below normal value during the POR. We invite interested parties to comment on these preliminary results.
Certain Hot-Rolled Steel Flat Products From Republic of Turkey: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2016-2017
Document Number: 2018-24795
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that Colakoglu Metalurji A.S. and Colakoglu Dis Ticaret A.S. (collectively, Colakoglu) did not sell subject merchandise in the United States at prices below normal value during the period of review (POR). Additionally, Commerce preliminarily determines that three other companies for which we initiated reviews had no shipments during the POR. We invite interested parties to comment on these preliminary results.
Certain Hot-Rolled Steel Flat Products From Japan: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2016-2017
Document Number: 2018-24794
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that Nippon Steel & Sumitomo Metal Corporation (Nippon Steel) and Tokyo Steel Manufacturing Co., Ltd. (Tokyo Steel), the two companies selected for individual examination, sold subject merchandise in the United States at prices below normal value during the period of review (POR). Additionally, Commerce preliminarily determines that three other companies for which we initiated reviews had no shipments during the POR. We invite interested parties to comment on these preliminary results.
Certain Hot-Rolled Steel Flat Products From Australia: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017
Document Number: 2018-24793
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that sales of certain hot-rolled steel flat products from Australia were made at less than normal value during the period of review (POR), March 22, 2016, through September 30, 2017. We invite interested parties to comment on these preliminary results.
Correction To Notice of Opportunity To Request Administrative Review
Document Number: 2018-24792
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
Certain Uncoated Paper From Indonesia: Rescission of 2017 Countervailing Duty Administrative Review
Document Number: 2018-24791
Type: Notice
Date: 2018-11-14
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty (CVD) order on certain uncoated paper from Indonesia for the period of review (POR) January 1, 2017, through December 31, 2017.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Document Number: 2018-24790
Type: Notice
Date: 2018-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a small business and pay certain medical device user fees at reduced rates.
Saint Lawrence Seaway Development Corporation Advisory Board-Notice of Public Meetings
Document Number: 2018-24789
Type: Notice
Date: 2018-11-14
Agency: Department of Transportation
This notice announces the public meeting via conference call of the Saint Lawrence Seaway Development Corporation Advisory Board.
Proposed Extension of Information Collection; Health Standards for Diesel Particulate Matter Exposure
Document Number: 2018-24788
Type: Notice
Date: 2018-11-14
Agency: Department of Labor, Mine Safety and Health Administration
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. 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. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Health Standards for Diesel Particulate Matter Exposure.
Submission of Information Collection for OMB Review; Comment Request; Qualified Domestic Relations Orders Submitted to PBGC
Document Number: 2018-24787
Type: Notice
Date: 2018-11-14
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
The Pension Benefit Guaranty Corporation (PBGC) is requesting that the Office of Management and Budget extend approval (with modifications), under the Paperwork Reduction Act of 1995, of the information collection related to PBGC's booklet, Qualified Domestic Relations Orders & PBGC. This notice informs the public of PBGC's request and solicits public comment on the collection.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2018-24786
Type: Notice
Date: 2018-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
Document Number: 2018-24785
Type: Notice
Date: 2018-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
Montana; Major Disaster and Related Determinations
Document Number: 2018-24784
Type: Notice
Date: 2018-11-14
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Montana (FEMA-4405-DR), dated October 31, 2018, and related determinations.
Combined Notice of Filings
Document Number: 2018-24781
Type: Notice
Date: 2018-11-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2018-24780
Type: Notice
Date: 2018-11-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2018-24779
Type: Notice
Date: 2018-11-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Commonwealth of the Northern Mariana Islands; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2018-24778
Type: Notice
Date: 2018-11-14
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the Commonwealth of the Northern Mariana Islands (FEMA-3408-EM), dated October 23, 2018, and related determinations.
Commonwealth of the Northern Mariana Islands; Amendment No. 2 to Notice of a Major Disaster Declaration
Document Number: 2018-24777
Type: Notice
Date: 2018-11-14
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the Commonwealth of the Northern Mariana Islands (FEMA-4404-DR), dated October 26, 2018, and related determinations.
Commonwealth of the Northern Mariana Islands; Amendment No. 1 to Notice of a Major Disaster Declaration
Document Number: 2018-24776
Type: Notice
Date: 2018-11-14
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster declaration for the Commonwealth of the Northern Mariana Islands (FEMA-4404-EM), dated October 26, 2018, and related determinations.
Notice of Intent To Request To Conduct a New Information Collection
Document Number: 2018-24775
Type: Notice
Date: 2018-11-14
Agency: Department of Agriculture, National Agricultural Statistics Service
In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather data related to rates paid for custom agricultural work done on farms. This clearance will allow NASS to conduct surveys in a timely manner for the cooperating institutions who provide funding for these surveys.
Safety Zone for Fireworks Displays; Upper Potomac River, Washington Channel, DC
Document Number: 2018-24773
Type: Proposed Rule
Date: 2018-11-14
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is proposing to establish a temporary safety zone for certain waters of the Upper Potomac River. This action is necessary to provide for the safety of life on these navigable waters of the Washington Channel adjacent to The Wharf DC, Washington, DC, for recurring fireworks displays from January 12, 2019, through December 31, 2019. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Maryland-National Capital Region or a designated representative. We invite your comments on this proposed rulemaking.
Information Collection: Form 790, Classification Record
Document Number: 2018-24772
Type: Notice
Date: 2018-11-14
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 Form 790, Classification Record.''
Information Collection: NRC Form 171, “Duplication Request”
Document Number: 2018-24771
Type: Notice
Date: 2018-11-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 171, ``Duplication Request.''
Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0043, Rules Relating To Review of National Futures Association Decisions in Disciplinary, Membership Denial, Registration, and Member Responsibility Actions
Document Number: 2018-24770
Type: Notice
Date: 2018-11-14
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (``CFTC'') is announcing an opportunity for public comment on the renewal of a collection of certain information by the agency. Under the Paperwork Reduction Act (``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. This notice solicits comments on rules relating to review of National Futures Association decisions in disciplinary, membership denial, registration, and member responsibility actions.
North Dakota Pollutant Discharge Elimination System; Transfer; Correction
Document Number: 2018-24769
Type: Notice
Date: 2018-11-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) issued a document in the Federal Register on October 30, 2018, providing notice of a proposed program revision to transfer the authority to implement and enforce the North Dakota Pollutant Discharge Elimination System (NDPDES) program from the North Dakota Department of Health (NDDOH) to the newly established North Dakota Department of Environmental Quality (NDDEQ). There was an error in the Docket ID Number. This document corrects that typographical error.
Notice of Intent To Repatriate Cultural Items: Minnesota Historical Society, St. Paul, MN
Document Number: 2018-24768
Type: Notice
Date: 2018-11-14
Agency: Department of the Interior, National Park Service
The Minnesota Historical Society, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of unassociated funerary object. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Minnesota Historical Society. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Kansas State Historical Society, Topeka, KS
Document Number: 2018-24767
Type: Notice
Date: 2018-11-14
Agency: Department of the Interior, National Park Service
The Kansas State Historical Society has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Kansas State Historical Society. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: U.S. Department of the Interior, Bureau of Land Management, Idaho State Office, Boise, ID
Document Number: 2018-24766
Type: Notice
Date: 2018-11-14
Agency: Department of the Interior, National Park Service
The Bureau of Land Management, Idaho State Office (BLM) has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Bureau of Land Management, Idaho State Office. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: U.S. Army Corps of Engineers, Albuquerque District, Trinidad Lake, CO
Document Number: 2018-24765
Type: Notice
Date: 2018-11-14
Agency: Department of the Interior, National Park Service
The U.S. Army Corps of Engineers, Albuquerque District, has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian Tribes or Native Hawaiian organizations. Representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the U.S. Army Corps of Engineers, Albuquerque District. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian Tribes or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Riverside Metropolitan Museum, Riverside, CA
Document Number: 2018-24764
Type: Notice
Date: 2018-11-14
Agency: Department of the Interior, National Park Service
The Riverside Metropolitan Museum has completed an inventory of human remains, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Riverside Metropolitan Museum. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry; Availability
Document Number: 2018-24763
Type: Notice
Date: 2018-11-14
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 ``Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' This draft guidance provides recommendations to sponsors regarding the use of metastasis-free survival (MFS) as an endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer (nmCRPC) development programs for drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
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