{"description":"Documents matching 'govern manufacture processing packing finished'","count":297,"total_pages":15,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=govern+manufacture+processing+packing+finished&format=json&page=2","results":[{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program","type":"Notice","abstract":"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 the information collection associated with CGMP for drugs, finished pharmaceuticals, including active pharmaceutical ingredients (APIs), and the advanced manufacturing technologies (AMT) designation program.","document_number":"2026-03326","html_url":"https://www.federalregister.gov/documents/2026/02/20/2026-03326/agency-information-collection-activities-proposed-collection-comment-request-current-good","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-20/pdf/2026-03326.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03326.pdf?1771508709","publication_date":"2026-02-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"appropriate, and other forms of information technology. \n Current Good <span class=\"match\">Manufacturing</span> Practice (CGMP): <span class=\"match\">Manufacturing</span>, <span class=\"match\">Processing</span>, <span class=\"match\">Packing</span>, and Holding of Drugs; GMP for <span class=\"match\">Finished</span> Pharmaceuticals (Including Active Pharmaceutical Ingredients), and the Advanced <span class=\"match\">Manufacturing</span> Technologies Designation Program \n OMB Control Number 0910-0139—Revision \n This information collection supports statutory and regulatory requirements that <span class=\"match\">govern</span> the <span class=\"match\">manufacture</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span>, or holding of <span class=\"match\">finished</span> pharmaceuticals, including active pharmaceutical ingredients (APIs)"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program","type":"Notice","abstract":"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.","document_number":"2026-10188","html_url":"https://www.federalregister.gov/documents/2026/05/21/2026-10188/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-21/pdf/2026-10188.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10188.pdf?1779281115","publication_date":"2026-05-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"collection of information to OMB for review and clearance. \n Current Good <span class=\"match\">Manufacturing</span> Practice (CGMP): <span class=\"match\">Manufacturing</span>, <span class=\"match\">Processing</span>, <span class=\"match\">Packing</span>, and Holding of Drugs; GMP for <span class=\"match\">Finished</span> Pharmaceuticals (Including Active Pharmaceutical Ingredients), and the Advanced <span class=\"match\">Manufacturing</span> Technologies Designation Program \n OMB Control Number 0910-0139—Revision \n This information collection supports statutory and regulatory requirements that <span class=\"match\">govern</span> the <span class=\"match\">manufacture</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span>, or holding of <span class=\"match\">finished</span> pharmaceuticals, including active pharmaceutical ingredients (APIs)"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).","document_number":"2024-29954","html_url":"https://www.federalregister.gov/documents/2024/12/18/2024-29954/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-18/pdf/2024-29954.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-29954.pdf?1734443165","publication_date":"2024-12-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"pharmaceutical industry or other drug/\n \n biologic developers. FDA regulations in 21 CFR parts 210 and 211 <span class=\"match\">govern</span> current good <span class=\"match\">manufacturing</span> practice in the <span class=\"match\">manufacturing</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span>, or holding of drugs and <span class=\"match\">finished</span> pharmaceuticals (including medical gases and active pharmaceutical ingredients), respectively. Applicable information collection and attendant burden are currently discussed, accounted for, and approved in OMB control number 0910-0139.\n \n \n We are revising the information collection to include the AMT Designation Program within"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","document_number":"2024-13190","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"the facilities or controls used for, its <span class=\"match\">manufacture</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span>, or holding do not conform to or are not operated or administered in conformity with current good <span class=\"match\">manufacturing</span> practice. For purposes of section 501(a)(2)(B), “current good <span class=\"match\">manufacturing</span> practice” includes the implementation of oversight and controls over the <span class=\"match\">manufacture</span> of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the <span class=\"match\">manufacturing</span> of drugs, and <span class=\"match\">finished</span> drug products. \n Section 502 of the FD&amp;C"},{"title":"Requirements for Tobacco Product Manufacturing Practice","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2023-04591","html_url":"https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04591.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04591.pdf?1678283117","publication_date":"2023-03-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"would require <span class=\"match\">finished</span> and bulk tobacco product manufacturers to establish and maintain procedures for incoming and for in-<span class=\"match\">process</span> and/or final acceptance activities, including acceptance criteria, to ensure that products meet established specifications. The production <span class=\"match\">processes</span> and controls section would require <span class=\"match\">finished</span> and bulk tobacco product manufacturers to establish and maintain procedures for production <span class=\"match\">processes</span>, including <span class=\"match\">process</span> specifications and <span class=\"match\">process</span> controls, <span class=\"match\">process</span> validation, and manual methods and <span class=\"match\">manufacturing</span> material. The"},{"title":"New Source Performance Standards for the Synthetic Organic Chemical Manufacturing Industry and National Emission Standards for Hazardous Air Pollutants for the Synthetic Organic Chemical Manufacturing Industry and Group I & II Polymers and Resins Industry","type":"Rule","abstract":"This action finalizes amendments to the New Source Performance Standards (NSPS) that apply to the Synthetic Organic Chemical Manufacturing Industry (SOCMI) and amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) that apply to the SOCMI (more commonly referred to as the Hazardous Organic NESHAP or HON) and Group I and II Polymers and Resins (P&R I and P&R II, respectively) Industries. The EPA is finalizing decisions resulting from the Agency's technology review of the HON and the P&R I and P&R II NESHAP, and its review of the NSPS that apply to the SOCMI. The EPA is also finalizing amendments to the NSPS for equipment leaks of volatile organic compounds (VOC) in SOCMI based on its reconsideration of certain issues raised in an administrative petition for reconsideration. Furthermore, the EPA is finalizing emission standards for ethylene oxide (EtO) emissions and chloroprene emissions after considering the results of a risk assessment for the HON and for Neoprene Production processes subject to the P&R I NESHAP, and is finalizing a fenceline monitoring work practice standard for certain hazardous air pollutants (HAP). Lastly, the EPA is finalizing the removal of exemptions from standards for periods of startup, shutdown, and malfunction (SSM), adding work practice standards for such periods where appropriate, finalizing standards for previously unregulated HAP, and adding provisions for electronic reporting of performance test reports and periodic reports.","document_number":"2024-07002","html_url":"https://www.federalregister.gov/documents/2024/05/16/2024-07002/new-source-performance-standards-for-the-synthetic-organic-chemical-manufacturing-industry-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-16/pdf/2024-07002.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-07002.pdf?1715777115","publication_date":"2024-05-16","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"resins <span class=\"match\">manufacturing</span> source categories. The SOCMI source category includes chemical <span class=\"match\">manufacturing</span> <span class=\"match\">processes</span> producing commodity chemicals while the polymers and resins <span class=\"match\">manufacturing</span> source categories covered in this action include elastomers production <span class=\"match\">processes</span> and resin production <span class=\"match\">processes</span> that use epichlorohydrin feedstocks (see sections I.B and II.B of this preamble for detailed information about these source categories). The EPA has previously promulgated maximum achievable control technology (MACT) standards for certain <span class=\"match\">processes</span> in the SOCMI"},{"title":"Phasedown of Hydrofluorocarbons: Restrictions on the Use of Certain Hydrofluorocarbons Under the American Innovation and Manufacturing Act of 2020","type":"Rule","abstract":"The U.S. Environmental Protection Agency is issuing regulations to implement certain provisions of the American Innovation and Manufacturing Act, as enacted on December 27, 2020. This rulemaking restricts the use of hydrofluorocarbons in specific sectors or subsectors in which they are used; establishes a process for submitting technology transitions petitions; establishes recordkeeping and reporting requirements; and addresses certain other elements related to the effective implementation of the American Innovation and Manufacturing Act. These restrictions on the use of hydrofluorocarbons address petitions granted on October 7, 2021, and September 19, 2022.","document_number":"2023-22529","html_url":"https://www.federalregister.gov/documents/2023/10/24/2023-22529/phasedown-of-hydrofluorocarbons-restrictions-on-the-use-of-certain-hydrofluorocarbons-under-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-24/pdf/2023-22529.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-22529.pdf?1698065118","publication_date":"2023-10-24","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"\n Industrial Mold <span class=\"match\">Manufacturing</span>. \n \n \n 333912 \n Air and Gas Compressor <span class=\"match\">Manufacturing</span>. \n \n \n 333999 \n All Other Miscellaneous General Purpose Machinery <span class=\"match\">Manufacturing</span>. \n \n \n 334419 \n Other Electronic Component <span class=\"match\">Manufacturing</span>. \n \n \n 335220 \n Major Household Appliance <span class=\"match\">Manufacturing</span>. \n \n \n 336120 \n Heavy Duty Truck <span class=\"match\">Manufacturing</span>. \n \n \n 336212 \n Truck Trailer <span class=\"match\">Manufacturing</span>. \n \n \n 336214 \n Travel Trailer and Camper <span class=\"match\">Manufacturing</span>. \n \n \n 3363 \n Motor Vehicle Parts <span class=\"match\">Manufacturing</span>. \n \n \n 3364 \n Aerospace Product and Parts <span class=\"match\">Manufacturing</span>. \n \n \n 336411 \n Aircraft"},{"title":"Phasedown of Hydrofluorocarbons: Review and Renewal of Eligibility for Application-Specific Allowances","type":"Proposed Rule","abstract":"The U.S. Environmental Protection Agency is undertaking this rulemaking to assess the eligibility of six applications to receive priority access to allowances allocated pursuant to the American Innovation and Manufacturing Act of 2020. This rulemaking proposes the framework for how EPA will assess whether to renew the eligibility of applications to receive application-specific allowances; decisions to renew or not renew each of the six applications that currently receive application-specific allowances; revisions to the Technology Transitions regulations as relevant to the specific applications under review; a procedural process for submitting a petition to designate a new application as eligible for priority access to allowances; narrow revisions to the methodology used to allocate allowances to application-specific allowance holders for calendar years 2026 and beyond; and limited revisions to existing regulations. EPA is also proposing to authorize an entity to produce regulated substances for export. Lastly, EPA is proposing certain confidentiality determinations for newly reported information if this rulemaking is finalized as proposed.","document_number":"2024-20602","html_url":"https://www.federalregister.gov/documents/2024/09/16/2024-20602/phasedown-of-hydrofluorocarbons-review-and-renewal-of-eligibility-for-application-specific","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20602.pdf?1726231521","publication_date":"2024-09-16","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":" Industrial Gas <span class=\"match\">Manufacturing</span>. \n \n \n 325199 \n All Other Basic Organic Chemical <span class=\"match\">Manufacturing</span>. \n \n \n 325211 \n Plastics Material and Resin <span class=\"match\">Manufacturing</span>. \n \n \n 325412 \n Pharmaceutical Preparation <span class=\"match\">Manufacturing</span>. \n \n \n 325414 \n Biological Product (except Diagnostic) <span class=\"match\">Manufacturing</span>. \n \n \n 325998 \n All Other Miscellaneous Chemical Product and Preparation <span class=\"match\">Manufacturing</span>. \n \n \n 326220 \n Rubber and Plastics Hoses and Belting <span class=\"match\">Manufacturing</span>. \n \n \n 326150 \n Urethane and Other Foam Product. \n \n \n 326299 \n All Other Rubber Product <span class=\"match\">Manufacturing</span>. \n \n \n \n 333415"},{"title":"Medical Devices; Quality System Regulation Amendments","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.","document_number":"2024-01709","html_url":"https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-02/pdf/2024-01709.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-01709.pdf?1706708714","publication_date":"2024-02-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"addressed in ISO 13485.\n \n (Comment 38) Two comments suggested that replacing the term “<span class=\"match\">manufacturing</span> material” in the QS regulation with “<span class=\"match\">process</span> agent” in the QMSR would create a conflict with ISO 13485. These comments seemed to interpret Clause 7.5.2 of ISO 13485 to require that <span class=\"match\">process</span> agents be removed from the product during <span class=\"match\">manufacture</span>, but that the definition for “<span class=\"match\">process</span> agent” in the QMSR suggests that the <span class=\"match\">process</span> agent may be “present in or on the <span class=\"match\">finished</span> device as a residue or impurity not by design or intent of the manufacturer.” \n (Response)"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Under FDA regulations, any “person who designs, <span class=\"match\">manufactures</span>, fabricates, assembles, or <span class=\"match\">processes</span> a <span class=\"match\">finished</span> device” is a manufacturer (§ 820.3(o)). Thus, laboratories that design, <span class=\"match\">manufacture</span>, fabricate, assemble, or <span class=\"match\">process</span> IVDs are manufacturers subject to FDA requirements.\n \n \n \n 58 \n  In particular, FDA disagrees that the need for specific equipment and personnel for validation is unique to laboratory manufacturers. Validation of each clinical test, regardless of whether that test is <span class=\"match\">manufactured</span> by a laboratory or a non-laboratory manufacturer"},{"title":"National Emission Standards for Hazardous Air Pollutants: Polyether Polyols Production Industry Review","type":"Rule","abstract":"The U.S. Environmental Protection Agency (EPA) is finalizing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Polyether Polyols (PEPO) Production source category (\"PEPO NESHAP\") under Clean Air Act (CAA) section 112. Specifically, the EPA is finalizing certain ethylene oxide (EtO)- specific standards pursuant to CAA section 112(d)(6) rather than finalizing the proposed second residual risk review and corresponding amendments pursuant to CAA section 112(f)(2). In addition, the EPA is taking final action addressing certain issues raised in an administrative petition for reconsideration. Lastly, the EPA is finalizing maximum achievable control technology (MACT) standards for certain emission points, work practice standards for certain activities where alternatives are appropriate, performance testing requirements once every five years for certain process vents, and electronic reporting requirements for performance test reports, flare management plans, and periodic reports.","document_number":"2026-05261","html_url":"https://www.federalregister.gov/documents/2026/03/18/2026-05261/national-emission-standards-for-hazardous-air-pollutants-polyether-polyols-production-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05261.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05261.pdf?1773751512","publication_date":"2026-03-18","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"112(d)(6) for <span class=\"match\">process</span> vents that emit EtO. For these <span class=\"match\">process</span> vents, the EPA is finalizing the term “in ethylene oxide service” at 40 CFR 63.1423(b) to mean each <span class=\"match\">process</span> vent in a <span class=\"match\">process</span> that, when uncontrolled, contains a concentration of greater than or equal to 1 ppmv undiluted EtO, and when combined, the sum of all these <span class=\"match\">process</span> vents within the <span class=\"match\">process</span> would emit uncontrolled EtO emissions greater than or equal to 100 lb/yr (45.4 kilograms per year, kg/yr). The EPA is finalizing at 40 CFR 63.1425(g) a requirement that PEPO <span class=\"match\">process</span> vents in EtO"},{"title":"Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients","type":"Proposed Rule","abstract":"The NMFS Office of International Affairs, Trade, and Commerce proposes to revise its current implementing regulations to improve the uniformity and reliability of seafood inspection services by adopting recognized best practices for inspection. NMFS has not significantly revised or updated the existing regulations since first issuing them in 1971, though it has modified many operating procedures since implementation of the current regulations. NMFS anticipates that these revisions will benefit the seafood industry by streamlining seafood inspection services and providing improved, more accurate inspection results, as described below.","document_number":"2024-08676","html_url":"https://www.federalregister.gov/documents/2024/04/25/2024-08676/inspection-and-certification-of-establishments-fishery-products-and-other-marine-ingredients","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08676.pdf?1713962728","publication_date":"2024-04-25","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"National Oceanic and Atmospheric Administration","name":"National Oceanic and Atmospheric Administration","id":361,"url":"https://www.federalregister.gov/agencies/national-oceanic-and-atmospheric-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/361","parent_id":54,"slug":"national-oceanic-and-atmospheric-administration"}],"excerpts":"Food <span class=\"match\">Manufacturing</span> \n 650 employees \n 4 \n 4 \n \n \n 311412 \n Frozen Specialty Food <span class=\"match\">Manufacturing</span> \n 1250 employees \n 5 \n 5 \n \n \n 311423 \n Dry and Dehydrated Food <span class=\"match\">Manufacturing</span> \n 750 employees \n 2 \n 2 \n \n \n 311615 \n Poultry <span class=\"match\">Processing</span> \n 1250 employees \n 3 \n 3 \n \n \n 311710 \n Seafood Product and Preparation and Packaging \n 750 employees \n 80 \n 78 \n \n \n 311942 \n Spice and Extract <span class=\"match\">Manufacturing</span> \n 650 employees \n 1 \n 1 \n \n \n 311999 \n All Other Miscellaneous Food <span class=\"match\">Manufacturing</span> \n 700 employees \n 5 \n 5 \n \n \n 325311 \n Nitrogenous Fertilizer <span class=\"match\">Manufacturing</span> \n 1050"},{"title":"Requirements for Additional Traceability Records for Certain Foods","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).","document_number":"2022-24417","html_url":"https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-24417.pdf?1668528919","publication_date":"2022-11-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"requirements apply not just to “facilities” that <span class=\"match\">manufacture</span>, <span class=\"match\">process</span>, pack, or hold FTL foods, but to all “persons” who do so. This includes, except where an exemption applies, farms, restaurants, RFEs, and other persons engaged in the <span class=\"match\">manufacture</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span>, or holding of FTL foods. \n (Comment 155) One comment asks that we define the role of persons who own food but do not <span class=\"match\">manufacture</span>, <span class=\"match\">process</span>, pack, or hold the food. \n (Response 155) The final rule covers persons who <span class=\"match\">manufacture</span>, <span class=\"match\">process</span>, pack or hold an FTL food. Therefore, as discussed"},{"title":"Trichloroethylene (TCE); Regulation Under the Toxic Substances Control Act (TSCA)","type":"Proposed Rule","abstract":"The Environmental Protection Agency (EPA) is proposing to address the unreasonable risk of injury to human health presented by trichloroethylene (TCE) under its conditions of use as documented in EPA's November 2020 Risk Evaluation for TCE and January 2023 revised risk determination for TCE pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used as a solvent in a variety of industrial, commercial and consumer applications including for hydrofluorocarbon (HFC) production, vapor and aerosol degreasing, and in lubricants, greases, adhesives, and sealants. TSCA requires that when EPA determines a chemical substance presents unreasonable risk that EPA address by rule the unreasonable risk of injury to health or the environment and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. EPA determined that TCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to TCE, including non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, immunotoxicity, reproductive toxicity, and developmental toxicity) as well as cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic inhalation and dermal exposures to TCE. TCE is a neurotoxicant and is carcinogenic to humans by all routes of exposure. The most sensitive adverse effects of TCE exposure are non-cancer effects (developmental toxicity and immunosuppression) for acute exposures and developmental toxicity and autoimmunity for chronic exposures. To address the identified unreasonable risk, EPA is proposing to: prohibit all manufacture (including import), processing, and distribution in commerce of TCE and industrial and commercial use of TCE for all uses, with longer compliance timeframes and workplace controls for certain processing and industrial and commercial uses (including proposed phaseouts and time-limited exemptions); prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works, with a time-limited exemption for cleanup projects; and establish recordkeeping and downstream notification requirements.","document_number":"2023-23010","html_url":"https://www.federalregister.gov/documents/2023/10/31/2023-23010/trichloroethylene-tce-regulation-under-the-toxic-substances-control-act-tsca","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-31/pdf/2023-23010.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23010.pdf?1698669915","publication_date":"2023-10-31","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"Heat Exchanger <span class=\"match\">Manufacturing</span> (NAICS code 332410); \n • Metal Tank (Heavy Gauge) <span class=\"match\">Manufacturing</span> (NAICS code 332420); \n • Metal Can <span class=\"match\">Manufacturing</span> (NAICS code 332431); \n • Other Metal Container <span class=\"match\">Manufacturing</span> (NAICS code 332439); \n • Hardware <span class=\"match\">Manufacturing</span> (NAICS code 332510); \n • Spring <span class=\"match\">Manufacturing</span> (NAICS code 332613); \n • Other Fabricated Wire Product <span class=\"match\">Manufacturing</span> (NAICS code 332618); \n • Machine Shops (NAICS code 332710); \n • Precision Turned Product <span class=\"match\">Manufacturing</span> (NAICS code 332721); \n • Bolt, Nut, Screw, Rivet and Washer <span class=\"match\">Manufacturing</span> (NAICS code"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing new regulations that would amend the requirements concerning current good manufacturing practice (CGMP) and postmarketing safety reporting that apply to certain medical gases. FDA further proposes to establish regulations regarding certification of designated medical gases and amend the labeling regulations that apply to certain medical gases. This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area. This proposed rule is intended to establish requirements that are more specifically tailored to the medical gas industry.","document_number":"2022-10458","html_url":"https://www.federalregister.gov/documents/2022/05/23/2022-10458/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-23/pdf/2022-10458.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10458.pdf?1653050713","publication_date":"2022-05-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"the facilities or controls used for, its <span class=\"match\">manufacture</span>, <span class=\"match\">processing</span>, <span class=\"match\">packing</span> or holding do not conform to or are not operated or administered in conformity with current good <span class=\"match\">manufacturing</span> practice. For purposes of section 501(a)(2)(B), “current good <span class=\"match\">manufacturing</span> practice” includes the implementation of oversight and controls over the <span class=\"match\">manufacture</span> of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the <span class=\"match\">manufacturing</span> of drugs, and <span class=\"match\">finished</span> drug products. Section 502 of the FD&amp;C"},{"title":"Energy Conservation Program: Energy Conservation Standards for Oil, Electric, and Weatherized Gas Consumer Furnaces","type":"Rule","abstract":"The Energy Policy and Conservation Act, as amended (\"EPCA\"), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including non- weatherized oil-fired furnaces (\"NWOFs\"), mobile home oil-fired furnaces (\"MHOFs\"), weatherized gas furnaces (\"WGFs\"), weatherized oil-fired furnaces (\"WOFs\"), and electric furnaces (\"EFs\"). EPCA also requires the U.S. Department of Energy (\"DOE\") to periodically review its existing standards to determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would result in significant energy savings. In this final determination, DOE has determined that the energy conservation standards for EFs, NWOFs, MHOFs, WOFs, and WGFs do not need to be amended.","document_number":"2024-23906","html_url":"https://www.federalregister.gov/documents/2024/10/18/2024-23906/energy-conservation-program-energy-conservation-standards-for-oil-electric-and-weatherized-gas","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-18/pdf/2024-23906.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23906.pdf?1729169118","publication_date":"2024-10-18","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"burner system/gas train, exhaust subassembly, fan system, controls) and summarized these costs in a spreadsheet BOM. DOE repeated this same <span class=\"match\">process</span> for every physical and catalog teardown in the engineering analysis.\n \n \n Analytical inputs related to manufacturer practices and cost structure play an important role in estimating the final cost of a product. DOE used inputs regarding the <span class=\"match\">manufacturing</span> <span class=\"match\">process</span> parameters (\n e.g., \n equipment use, labor rates, tooling depreciation, and cost of purchased raw materials) to determine the value for each"},{"title":"Inclusive Competition and Market Integrity Under the Packers and Stockyards Act","type":"Rule","abstract":"The U.S. Department of Agriculture's (USDA or Department) Agricultural Marketing Service (AMS or the Agency) amends its Packers and Stockyards Act, 1921, regulations to prohibit undue prejudice and unjust discrimination against individuals on a prohibited basis unrelated to the quality of the service or product provided. The rule also identifies retaliatory practices that interfere with lawful communications, assertion of rights, and associated participation, among other protected activities, as unjust discrimination prohibited by the law. Finally, the rule identifies deceptive practices that violate the Packers and Stockyards Act with respect to contract formation, contract performance, contract termination, and contract refusal. The purpose of this rule is to promote inclusive competition and market integrity in the livestock, meats, poultry, and live poultry markets.","document_number":"2024-04419","html_url":"https://www.federalregister.gov/documents/2024/03/06/2024-04419/inclusive-competition-and-market-integrity-under-the-packers-and-stockyards-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04419.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-04419.pdf?1709646316","publication_date":"2024-03-06","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Agricultural Marketing Service","name":"Agricultural Marketing Service","id":9,"url":"https://www.federalregister.gov/agencies/agricultural-marketing-service","json_url":"https://www.federalregister.gov/api/v1/agencies/9","parent_id":12,"slug":"agricultural-marketing-service"}],"excerpts":"packers.\n \n \n AMS expects that packers <span class=\"match\">processing</span> more than one species of livestock will not incur additional costs for each species. That is, AMS expects that each packer will require one hour of attorney's time and one hour of management time regardless of how many species of livestock it <span class=\"match\">processes</span>. To allocate costs across (1) beef, (2) pork, and (3) lamb <span class=\"match\">processors</span>, AMS allocated one-third of the costs to each of (1) beef, (2) pork, and (3) lamb for packers that <span class=\"match\">processed</span> all three species. For packers <span class=\"match\">processing</span> any two, AMS allocated one half the"},{"title":"Updates to Marine Engineering Standards","type":"Rule","abstract":"The Coast Guard is updating marine engineering standards that are incorporated by reference and eliminating outdated or unnecessarily prescriptive regulations in the Code of Federal Regulations. This regulatory action is consistent with the standards currently used by industry and supports the Coast Guard's maritime safety mission.","document_number":"2024-10341","html_url":"https://www.federalregister.gov/documents/2024/06/12/2024-10341/updates-to-marine-engineering-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-12/pdf/2024-10341.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-10341.pdf?1718109921","publication_date":"2024-06-12","agencies":[{"raw_name":"DEPARTMENT OF HOMELAND SECURITY","name":"Homeland Security Department","id":227,"url":"https://www.federalregister.gov/agencies/homeland-security-department","json_url":"https://www.federalregister.gov/api/v1/agencies/227","parent_id":null,"slug":"homeland-security-department"},{"raw_name":"Coast Guard","name":"Coast Guard","id":53,"url":"https://www.federalregister.gov/agencies/coast-guard","json_url":"https://www.federalregister.gov/api/v1/agencies/53","parent_id":227,"slug":"coast-guard"}],"excerpts":"free entry at all times to those parts of the plant where material subject to this subchapter is being <span class=\"match\">manufactured</span>. The manufacturer must provide marine inspectors all reasonable facilities to satisfy them that the material is being <span class=\"match\">manufactured</span> in accordance with the requirements of the Commandant. \n (c) Unless otherwise authorized, required tests and inspections described in applicable specifications must be made at the place of <span class=\"match\">manufacture</span> prior to shipment. \n \n \n \n 13. Revise and republish subpart 50.30 to read as follows: \n \n \n Subpart 50"},{"title":"Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2023","type":"Proposed Rule","abstract":"Publication of the Fall 2023 Unified Agenda of Federal Regulatory and Deregulatory Actions represents a key component of the regulatory planning mechanism prescribed in Executive Order (\"E.O.\") 12866, \"Regulatory Planning and Review,\" (58 FR 51735, as amended) and reaffirmed in E.O. 13563, \"Improving Regulation and Regulatory Review,\" (76 FR 3821) and E.O. 14094, \"Modernizing Regulatory Review,\" (88 FR 21879). The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete publication of the Fall 2023 Unified Agenda contains the Regulatory Plans of 29 Federal agencies and 69 Federal agency regulatory agendas available to the public at www.reginfo.gov. The Fall 2023 Unified Agenda publication appearing in the Federal Register includes the Regulatory Plan and agency Regulatory Flexibility Agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency Regulatory Flexibility Agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.","document_number":"2024-00476","html_url":"https://www.federalregister.gov/documents/2024/02/09/2024-00476/introduction-to-the-unified-agenda-of-federal-regulatory-and-deregulatory-actions-fall-2023","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-09/pdf/2024-00476.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-00476.pdf?1707399919","publication_date":"2024-02-09","agencies":[{"raw_name":"REGULATORY INFORMATION SERVICE CENTER","name":"Regulatory Information Service Center","id":449,"url":"https://www.federalregister.gov/agencies/regulatory-information-service-center","json_url":"https://www.federalregister.gov/api/v1/agencies/449","parent_id":null,"slug":"regulatory-information-service-center"}],"excerpts":"aspect of the Department's rulemaking <span class=\"match\">process</span>, as well as an important vehicle to assist the Department in streamlining its regulatory priorities. DOE's existing ex parte communication <span class=\"match\">process</span> provides an avenue for stakeholders and members of the public to meet with the Department to discuss regulatory practices, either during or not during a rulemaking. This <span class=\"match\">process</span> is intended to encourage the public to provide the Department with all information necessary to develop rules that advance public interest. The <span class=\"match\">process</span> serves to increase public participation"},{"title":"Energy Conservation Program: Energy Conservation Standards for Oil, Electric, and Weatherized Gas Consumer Furnaces","type":"Proposed Rule","abstract":"The Energy Policy and Conservation Act, as amended (\"EPCA\"), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including non- weatherized oil-fired furnaces (\"NWOFs\"), mobile home oil-fired furnaces (\"MHOFs\"), weatherized gas furnaces (\"WGFs\"), weatherized oil-fired furnaces (\"WOFs\"), and electric furnaces (\"EFs\"). EPCA also requires the U.S. Department of Energy (\"DOE\") to periodically review its existing standards to determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would result in significant energy savings. In this notification of proposed determination (\"NOPD\"), DOE has initially determined that amended energy conservation standards for EFs, NWOFs, MHOFs, WOFs, and WGFs do not need to be amended. DOE requests comment on this proposed determination and the associated analyses and results.","document_number":"2023-25869","html_url":"https://www.federalregister.gov/documents/2023/11/29/2023-25869/energy-conservation-program-energy-conservation-standards-for-oil-electric-and-weatherized-gas","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-29/pdf/2023-25869.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25869.pdf?1701179121","publication_date":"2023-11-29","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"burner system/gas train, exhaust subassembly, fan system, controls) and summarized these costs in a spreadsheet BOM. DOE repeated this same <span class=\"match\">process</span> for every physical and catalog teardown in the engineering analysis.\n \n \n Analytical inputs related to manufacturer practices and cost structure play an important role in estimating the final cost of a product. DOE used inputs regarding the <span class=\"match\">manufacturing</span> <span class=\"match\">process</span> parameters (\n e.g., \n equipment use, labor rates, tooling depreciation, and cost of purchased raw materials) to determine the value for each"}]}