regulations是什么意思_百度作业帮
regulations是什么意思
regulations是什么意思
名词 n.1.规章;规则,规定;条例[C]He was fined for breaking traffic regulations.他因违反交通规则而被罚款.2.管理;调整,调节;校准[U]the regulation of heat 调节暖气 形容词 a.1.标准的;正规的,正式的drive at a regulation speed 按规定速度行驶 2.普通的,一般的From Wikipedia, the free encyclopedia
Title 21 is the portion of the
that governs food and drugs within the
(FDA), the
(DEA), and the
It is divided into three chapters:
Chapter I —
Chapter II —
Chapter III —
Most of the Chapter I regulations are based on the .
Notable sections:
— electronic records and
50 Protection of human subjects in
54 Financial Disclosure by Clinical Investigators
56 Institutional Review Boards that oversee
58 Good Laboratory Practices (GLP) for nonclinical studies
The 100 series are regulations pertaining to food:
101, especially 101.9 —
(c)(2)(ii) — Requirement to include
(c)(8)(iv) —
106-107 requirements for infant formula
110 et seq.
for food products
170 food additives
The 200 and 300 series are regulations pertaining to pharmaceuticals :
202-203 Drug advertising and marketing
210 et seq.
for pharmaceuticals
310 et seq. Requirements for new drugs
328 et seq. Specific requirements for over-the-counter (OTC) drugs.
The 500 series are regulations for animal feeds and animal medications:
510 et seq. New animal drugs
556 Tolerances for residues of drugs in food animals
The 600 series covers biological products (e.g. vaccines, blood):
601 Licensing under section 351 of the Public Health Service Act
606 et seq.
for human blood and blood products
The 700 series includes the limited regulations on :
701 Labeling requirements
The 800 series are for medical devices:
803 Medical Device Reporting
814 Premarket Approval of Medical Devices
820 et seq. Quality system regulations (analogous to , but structured like )
860 et seq. Listing of specific approved devices and how they are classified
The 900 series covers mammography quality requirements enforced by .
The 1000 series covers radiation-emitting device (e.g. , , ); requirements enforced by the .
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act:
1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as:
Requirements for
Interstate shipment of
Interstate shipment of African
that may carry .
Sanitation on interstate conveyances (i.e. airplanes and ships)
1271 Requirements for human cells, tissues, and cellular and tissue-based products (i.e. the ).
Notable sections:
1308 — Schedules of controlled substances
1308.03(a) —
1308.11 —
1308.12 —
1308.13 —
1308.14 —
1308.15 —
Notable sections:
1405 Governmentwide requirements for drug-free workplaces
- Food and Drugs
(medicinal products in the European Union)
(current “Electronic CFR”)Code of Federal Regulations, Title 37 | U.S. Copyright Office
Code of Federal Regulations
Code of Federal Regulations
Title 37 — Patents, Trademarks, and Copyrights
Copyright Office regulations codified in the Code of Federal Regulations (CFR).
Subchapter A—Copyright Office and Procedures
Preregistration and Registration of Claims to Copyright
Privacy Act: Policies and procedures
Compulsory License for Making and Distributing physical and Digital Phonorecords for Nondramatic Musical Works
Protection of vessel hull designs
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21_code_of_federal_regulations_parts
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i请填写生词本名称!NRC: Regulations Title 10, Code of Federal Regulations
& NRC Regulations - Title 10, Code of Federal Regulations
NRC Regulations
Title 10, Code of Federal Regulations
Search Regulations
Requirements binding on all persons and organizations who receive
a license from NRC to use nuclear materials or operate nuclear facilities
See also NRC's regulations, Title 10, Chapter I, of the Code of Federal Regulations, which the
maintains and updates annually.
Title 10 (ZIP archive file):
[9,899 KB],
[12,647 KB]
Quick links to parts:
Chapter I -- Nuclear Regulatory Commission
Statement of organization and general information
Agency Rules of Practice and Procedure
Nondiscrimination in Federally assisted programs or activities receiving Federal financial
assistance from the Commission
Nondiscrimination on the basis of sex in education programs or activities receiving Federal
financial assistance
Advisory committees
Interpretations
Public records
Criteria and procedures for determining eligibility for access to restricted data or national security information or an
employment clearance
Criteria and procedures for determining eligibility for access to or control over special nuclear material
Implementation of the Equal Access to Justice Act in agency proceedings
Program fraud civil remedies
Administrative claims under Federal Tort Claims Act
Debt collection procedures
Salary offset procedures for collecting debts owed by Federal employees to the Federal government
Notices, instructions and reports to workers: inspection and investigations
Standards for protection against radiation
Reporting of defects and noncompliance
Access authorization
Fitness for duty programs
Rules of general applicability to domestic licensing of byproduct material
General domestic licenses for byproduct material
Specific domestic licenses to manufacture or transfer certain items containing byproduct material
Specific domestic licenses of broad scope for byproduct material
Licenses for industrial radiography and radiation safety requirements for industrial radiographic operations
Medical use of byproduct material
Licenses and radiation safety requirements for irradiators
Physical protection of category 1 and category 2 quantities of radioactive material
Licenses and radiation safety requirements for well logging
Domestic licensing of source material
Domestic licensing of production and utilization facilities
Environmental protection regulations for domestic licensing and related regulatory functions
Licenses, certifications, and approvals for nuclear power plants
[Reserved]
Requirements for renewal of operating licenses for nuclear power plants
Operator's licenses
Disposal of high-level radioactive wastes in geologic repositories
Licensing requirements for land disposal of radioactive waste
Criteria and procedures for emergency access to non-federal and regional low-level waste disposal facilities
Disposal of high-level radioactive wastes in a geologic repository at Yucca Mountain, Nevada
Domestic licensing of special nuclear material
Packaging and transportation of radioactive material
Licensing requirements for the independent storage of spent nuclear fuel and high-level radioactive waste, and reactor-
related greater than Class C waste
Physical protection of plants and materials
Material control and accounting of special nuclear material
Safeguards on nuclear material-implementation of US/IAEA agreement
Certification of gaseous diffusion plants
Standard specifications for the granting of patent licenses
Facility security clearance and safeguarding of national security information and restricted data
Reactor site criteria
Export and import of nuclear equipment and material
Financial protection requirements and indemnity agreements
Exemptions and continued regulatory authority in Agreement States and in offshore waters under section 274
Trespassing on Commission property
Fees for facilities, materials, import and export licenses, and other regulatory services under the Atomic Energy Act of
1954, as amended
Annual fees for reactor licenses and fuel cycle licenses and materials licenses, including holders of certificates of
compliance, registrations, and quality assurance program approvals and government agencies licensed by the NRC
[Reserved]
Page Last Reviewed/Updated Thursday, December 31, 2015
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