CFR(Code of Federal Regulations)とは

FDAについて研究するページです。
*万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
 本文書の改訂は予告なく行われることがあります。

CFRは、Code of Federal Regulations(連邦行政規則集)の略であり、米国には50ものCFRが存在する。
CFRの第1巻は「President」であり、第2巻は「Financial」である。
21巻が「Food and Drug」であり、FDAが受け持っている。
また21 CFRにはPart(章)が1から1,499まで用意されており、それぞれカテゴリによって区別されている。

CFR制定のステップ

米国では、政府が何を考え、何をしようとしているのかを、常に国民が知る権利を持っている。
そのため、FDAは「規則(regulation)」の立案等に際して、連邦広報
(Federal Register:FR)という日本における「官報」に相当するものを用いて、広く国民に知らせなければならない義務がある。
規制当局が規則を施行させるまでには、以下のような段階を踏まなければならない。

第一段階:「規則制定の事前通告」を行う
第二段階:「規則案の通告」とパブリックコメントの募集を行う
最終段階:「最終規則の公示」とパブリックコメントに対する回答、規則の施行日を通告

21 CFR Part 11を例にとってみると、1992年に第一段階である「規則制定の事前通告」がFRに掲載された。
その後、第二段階として1994年8月31日のFRに「21 CFR Part11電子記録・電子署名」の規則案(Draft Rule)を発表した。
同時に90日間、パブリックコメントの募集を行った。

規則案をFRに公示しても、案に対する業界からの反対が多くて最終規則にまで至らないか、ボツになるか、規則がいつまでも実現しないことがよくある。
最終段階である「最終規則の公示」では、「21 CFR Part11電子記録・電子署名」の最終規則(Final Rule)が1997年3月27日のFRに掲載された。
この最終規則の発表時には、規制当局がパブリックコメントをどう考え、規則案をどのように修正したかをpreambleと呼ばれる前文に記載しなければならない。
Part 11の場合は、条文本体が3ページ弱なのに比べ、このpreambleが35ページにも及ぶ。
またこの最終段階では同時に規則の施行日を指定しなければならない。
Part 11は、1997年8月20日がその施行日と指定された。
このように米国では、政府の規則立案にあたっては、透明性を求められる。

ガイダンス

CFR以外にも、FDAはGuidanceを発行することがある。GuidanceはCFRの下位に位置し、業界向けガイダンス(Guidance for Industry)とFDA職員向けガイダンス(Guidance for Staff)の2通りがある。
Guidanceの内容はあくまでもFDAの推奨事項であり、代替方法の採用は構わないと記載されていることが多い。
ガイダンスには、業界向け(Guidance for Industry)とFDAスタッフ向け(Guidance for Staff)またはその両者向けがある。
Part11発行後には、関連するガイダンスとしてGlossary of Terms、 Validation、Time Stamps、 Maintenance of Electronic Recordsなどのガイダンスが発行された。
またPart11の改定を示唆した「Guidance for Industry Part11, Electronic Records; Electronic Signatures – Scope and Application」は重要である。

CFR Title 21 – Food and Drugs: Parts 1 to 1499

(1) General enforcement regulations 
(2) General administrative rulings and decisions
(3) Product jurisdiction
(5) Organization
(7) Enforcement policy
(10) Administrative practices and procedures
(11) Electronic records; electronic signatures
(12) Formal evidentiary public hearing
(13) Public hearing before a public board of inquiry
(14) Public hearing before a public advisory committee
(15) Public hearing before the commissioner
(16) Regulatory hearing before the food and drug administration
(17) Civil money penalties hearings
(19) Standards of conduct and conflicts of interest
(20) Public information
(21) Protection of privacy
(25) Environmental impact considerations
(26) Mutual recognition of pharmaceutical good manufacturing prac …
(50) Protection of human subjects
(54) Financial disclosure by clinical investigators
(56) Institutional review boards
(58) Good laboratory practice for nonclinical laboratory studies
(60) Patent term restoration
(70) Color additives
(71) Color additive petitions
(73) Listing of color additives exempt from certification
(74) Listing of color additives subject to certification
(80) Color additive certification
(81) General specifications and general restrictions for provisio …
(82) Listing of certified provisionally listed colors and specifi …
(83-98) [reserved]
(99) Dissemination of information on unapproved/new uses for mark …
(100) General
(101) Food labeling
(102) Common or usual name for nonstandardized foods
(104) Nutritional quality guidelines for foods
(105) Foods for special dietary use
(106) Infant formula quality control procedures
(107) Infant formula
(108) Emergency permit control
(109) Unavoidable contaminants in food for human consumption and f …
(110) Current good manufacturing practice in manufacturing, packin …
(111) Current good manufacturing practice in manufacturing, packag
(113) Thermally processed low-acid foods packaged in hermetically …
(114) Acidified foods
(115) Shell eggs
(119) Dietary supplements that present a significant or unreasonab …
(120) Hazard analysis and critical control point (haccp) systems
(123) Fish and fishery products
(129) Processing and bottling of bottled drinking water
(130) Food standards: general
(131) Milk and cream
(133) Cheeses and related cheese products
(135) Frozen desserts
(136) Bakery products
(137) Cereal flours and related products
(139) Macaroni and noodle products
(145) Canned fruits
(146) Canned fruit juices
(150) Fruit butters, jellies, preserves, and related products
(152) Fruit pies
(155) Canned vegetables
(156) Vegetable juices
(158) Frozen vegetables
(160) Eggs and egg products
(161) Fish and shellfish
(163) Cacao products
(164) Tree nut and peanut products
(165) Beverages
(166) Margarine
(168) Sweeteners and table sirups
(169) Food dressings and flavorings
(170) Food additives
(171) Food additive petitions
(172) Food additives permitted for direct addition to food for hum …
(173) Secondary direct food additives permitted in food for human …
(174) Indirect food additives: general
(175) Indirect food additives: adhesives and components of coating …
(176) Indirect food additives: paper and paperboard components
(177) Indirect food additives: polymers
(178) Indirect food additives: adjuvants, production aids, and san …
(179) Irradiation in the production, processing and handling of fo …
(180) Food additives permitted in food or in contact with food on …
(181) Prior-sanctioned food ingredients
(182) Substances generally recognized as safe
(184) Direct food substances affirmed as generally recognized as s …
(186) Indirect food substances affirmed as generally recognized as …
(189) Substances prohibited from use in human food
(190) Dietary supplements
(191-199) [reserved]
(200) General
(201) Labeling
(202) Prescription drug advertising
(203) Prescription drug marketing (205) Guidelines for state licensing of wholesale prescription dru …
(206) Imprinting of solid oral dosage form drug products for human …
(207) Registration of producers of drugs and listing of drugs in c …
(208) Medication guides for prescription drug products
(210) Current good manufacturing practice in manufacturing, proces …
(211) Current good manufacturing practice for finished pharmaceuti …
(216) Pharmacy compounding
(225) Current good manufacturing practice for medicated feeds
(226) Current good manufacturing practice for type a medicated art …
(250) Special requirements for specific human drugs
(290) Controlled drugs
(299) Drugs; official names and established names
(300) General
(310) New drugs
(312) Investigational new drug application
(314) Applications for fda approval to market a new drug
(315) Diagnostic radiopharmaceuticals
(316) Orphan drugs
(320) Bioavailability and bioequivalence requirements
(328) Over-the-counter drug products intended for oral ingestion t …
(330) Over-the-counter (otc) human drugs which are generally recog …
(331) Antacid products for over-the-counter (otc) human use
(332) Antiflatulent products for over-the-counter human use
(333) Topical antimicrobial drug products for over-the-counter hum …
(335) Antidiarrheal drug products for over-the-counter human use
(336) Antiemetic drug products for over-the-counter human use
(338) Nighttime sleep-aid drug products for over-the-counter human …
(340) Stimulant drug products for over-the-counter human use
(341) Cold, cough, allergy, bronchodilator, and antiasthmatic drug …
(343) Internal analgesic, antipyretic, and antirheumatic drug prod …
(344) Topical otic drug products for over-the-counter human use
(346) Anorectal drug products for over-the-counter human use
(347) Skin protectant drug products for over-the-counter human use
(348) External analgesic drug products for over-the-counter human …
(349) Ophthalmic drug products for over-the-counter human use
(350) Antiperspirant drug products for over-the-counter human use
(352) Sunscreen drug products for over-the-counter human use [stay …
(355) Anticaries drug products for over-the-counter human use
(357) Miscellaneous internal drug products for over-the-counter hu …
(358) Miscellaneous external drug products for over-the-counter hu …
(361) Prescription drugs for human use generally recognized as saf …
(369) Interpretative statements re warnings on drugs and devices f …
(370-499) [reserved]
(500) General
(501) Animal food labeling
(502) Common or usual names for nonstandardized animal foods
(509) Unavoidable contaminants in animal food and food-packaging m …
(510) New animal drugs
(511) New animal drugs for investigational use
(514) New animal drug applications
(515) Medicated feed mill license
(516) New animal drugs for minor use and minor species
(520) Oral dosage form new animal drugs
(522) Implantation or injectable dosage form new animal drugs
(524) Ophthalmic and topical dosage form new animal drugs
(526) Intramammary dosage forms
(529) Certain other dosage form new animal drugs
(530) Extralabel drug use in animals
(556) Tolerances for residues of new animal drugs in food
(558) New animal drugs for use in animal feeds
(564) [reserved]
(570) Food additives
(571) Food additive petitions
(573) Food additives permitted in feed and drinking water of anima …
(579) Irradiation in the production, processing, and handling of a …
(582) Substances generally recognized as safe
(584) Food substances affirmed as generally recognized as safe in …
(589) Substances prohibited from use in animal food or feed
(590-599) [reserved]
(600) Biological products: general
(601) Licensing
(606) Current good manufacturing practice for blood and blood comp …
(607) Establishment registration and product listing for manufactu …
(610) General biological products standards
(630) General requirements for blood, blood components, and blood …
(640) Additional standards for human blood and blood products
(660) Additional standards for diagnostic substances for laborator …
(680) Additional standards for miscellaneous products
(700) General
(701) Cosmetic labeling
(710) Voluntary registration of cosmetic product establishments
(720) Voluntary filing of cosmetic product ingredient composition …
(740) Cosmetic product warning statements
(741-799) [reserved]
(800) General
(801) Labeling
(803) Medical device reporting
(806) Medical devices; reports of corrections and removals
(807) Establishment registration and device listing for manufactur …
(808) Exemptions from federal preemption of state and local medica …
(809) In vitro diagnostic products for human use
(810) Medical device recall authority
(812) Investigational device exemptions
(813) [reserved]
(814) Premarket approval of medical devices
(820) Quality system regulation(邦訳版)
(821) Medical device tracking requirements
(822) Postmarket surveillance
(860) Medical device classification procedures
(861) Procedures for performance standards development
(862) Clinical chemistry and clinical toxicology devices
(864) Hematology and pathology devices
(866) Immunology and microbiology devices
(868) Anesthesiology devices
(870) Cardiovascular devices
(872) Dental devices
(874) Ear, nose, and throat devices
(876) Gastroenterology-urology devices
(878) General and plastic surgery devices
(880) General hospital and personal use devices
(882) Neurological devices
(884) Obstetrical and gynecological devices
(886) Ophthalmic devices
(888) Orthopedic devices
(890) Physical medicine devices
(892) Radiology devices
(895) Banned devices
(898) Performance standard for electrode lead wires and patient ca …
(900) Mammography
(1000) General
(1002) Records and reports
(1003) Notification of defects or failure to comply
(1004) Repurchase, repairs, or replacement of electronic products
(1005) Importation of electronic products
(1010) Performance standards for electronic products: general
(1020) Performance standards for ionizing radiation emitting produc …
(1030) Performance standards for microwave and radio frequency emit …
(1040) Performance standards for light-emitting products
(1050) Performance standards for sonic, infrasonic, and ultrasonic …
(1210) Regulations under the federal import milk act
(1230) Regulations under the federal caustic poison act
(1240) Control of communicable diseases
(1250) Interstate conveyance sanitation
(1251-1269) [reserved]
(1270) Human tissue intended for transplantation
(1271) Human cells, tissues, and cellular and tissue-based products
(1272-1299) [reserved]
(1300) Definitions
(1301) Registration of manufacturers, distributors, and dispensers …
(1302) Labeling and packaging requirements for controlled substance …
(1303) Quotas
(1304) Records and reports of registrants
(1305) Orders for schedule i and ii controlled substances
(1306) Prescriptions
(1307) Miscellaneous
(1308) Schedules of controlled substances
(1309) Registration of manufacturers, distributors, importers and e …
(1310) Records and reports of listed chemicals and certain machines
(1311) Digital certificates
(1312) Importation and exportation of controlled substances
(1313) Importation and exportation of list i and list ii chemicals
(1314) Retail sale of scheduled listed chemical products
(1315) Importation and production quotas for ephedrine, pseudoephed …
(1316) Administrative functions, practices, and procedures
(1400) [reserved]
(1401) Public availability of information
(1402) Mandatory declassification review
(1403) Uniform administrative requirements for grants and cooperati …
(1404) Governmentwide debarment and suspension (nonprocurement)
(1405) Governmentwide requirements for drug-free workplace (financi …
(1406-1499) [reserved]

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