Guidance for Industry
表示笑的词语有哪些FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act
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You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments v. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Foods and Veterinary Medicine
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
April 2014
Table of Contents
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I. Introduction
II. Background
III. Questions and Answers
小托福Guidance for Industry1
FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act
This guidance reprents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can u an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
I. Introduction
This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to access and copy records under ctions 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is a revision of FDA’s November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for records access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Respon Act of 2002; Final Guidance.” FDA’s staff manuals, the Regulatory Procedures Manual (RPM) and Investigations Operations Manual (IOM), contain operational and procedural steps for FDA staff to follow for accessing records under ctions 414 and 704 of the FD&C Act; therefore, that information has been removed from this guidance. Both the RPM and IOM are located on FDA’s website, v.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The u of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Background
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The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353) was signed into law on January 4, 2011. Section 101 of FSMA amends ction 414(a) and 704(a)(1)(B) of the FD&C Act (21 U.S.C. 350c(a) and 374(a)(1)(B)). Section 414 was originally added to the FD&C Act by the Public Health Security and Bioterrorism Preparedness and Respon Act of 2002 (the
1 This guidance has been prepared by the Office of Compliance in the Center for Food Safety and Applied Nutrition in cooperation with the Center for Veterinary Medicine at the U.S. Food and Drug Administration.
Bioterrorism Act) (Public Law 107-188). Prior to the passage of FSMA, ction 414(a) of the FD&C Act provided the Secretary (by delegation FDA) with access to records relating to food that was reasonably believed to be adulterated and prent a threat of rious adver health conquences or death to humans or animals. FSMA expands FDA’s access to records beyond records relating to the specific suspect article of food to records relating to any other article of food that the FDA reasonably believes is likely to be affected in a similar manner. In addition, FDA can now access records if FDA believes that there is a reasonable probability that the u of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cau rious adver health conquences or death to humans or animals. The Bioter
rorism Act also amended ction 704(a)(1)(B) of the FD&C Act to include a cross-reference to ction 414. Section 101 of FSMA amends this ction, which pertains to factory inspections, by updating the cross-reference to refer to the amended version of ction 414(a).
FDA’s access to records under ction 414 is parate from previously existing routine records access provided in commodity specific regulations, such as the Low-Acid Canned Food regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations (21 CFR part 106). The commodity specific record access regulations were not amended by FSMA.
III.Questions and Answers
1. Does FDA’s records access authority under ctions 414(a) and 704(a) of the FD&C Act apply to records relating to human food and/or animal food?
Yes. The term “food” means (1) articles ud for food or drink for man or other animals, (2) chewing gum, and (3) articles ud for components of any such article, as defined in ction
怎样腌制黄瓜201(f) of the FD&C Act (21 U.S.C. 321(f)).
2. Does FDA’s records access authority under ctions 414(a) and 704(a) apply to both domestic and foreign persons?
Yes. FDA’s records access authority under ctions 414(a) and 704(a) applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food when the circumstances in ction 414(a)(1) or (2) of the FD&C Act are met. A person’s refusal to permit FDA to access and copy any record as required by ction 414(a) or 704(a) is a prohibited act under ction 301(e) of the
FD&C Act (21 U.S.C. 331(e)). The term “person” has the same meaning as defined in ction 201(e) of the FD&C Act to include individual, partnership, corporation, and association.
FDA prefers that requested records relating to the manufacture, processing, packing, transportation, distribution, receipt, holding or importation of food that is intended for or enters the U.S. supply chain to be provided to the Agency in English.
3(a). Under what circumstances may FDA access and copy records under ction 414(a) of the FD&C Act?
FDA may access and copy records from domestic and foreign persons who manufacture, process, pack, transport, distribute, receive, hold, or import food (excluding farms and restaurants) if:
•(1) FDA has a reasonable belief that the food, and any other food that FDA reasonably believes is likely to be affected in a similar manner,
a)is adulterated, and
b)prents a threat of rious adver health conquences or death to humans or
助睡眠的食物animals.
•Or, (2) FDA believes that there is a reasonable probability that u of or exposure to the food, and any other food that the FDA reasonably believes is likely to be affected in a
similar manner, will cau rious adver health conquences or death to humans or
animals.
3(b). What records may FDA access and copy if the circumstances under ction 414(a) of the FD&C Act are met?
•If the circumstances in (1) are met, FDA may access and copy the records that are needed to assist FDA in determining whether the food is adulterated and prents a threat of
rious adver health conquences or death to humans or animals
•If the circumstances in (2) are met, FDA may access and copy the records that are needed to assist FDA in determining whether there is a reasonable probability that the u of or exposure to the food will cau rious adver health conquences or death to human or animals.
4. When is FDA likely to exerci its authority under ction 414(a) and 704(a) of the
FD&C Act to access and copy records?
FDA may request to access and copy records whenever the requirements of ction 414(a)(1) or (2) are satisfied, but requests are most likely to occur when FDA becomes aware of:
•Reportable food reports, as defined in ction 417(a)(2) of the FD&C Act [21 U.S.C.
350f(a)(2)]
•Foodborne outbreaks
•Epidemiological evidence which implicates food causing illness or death
•Product recalls
•Adver event reports
误会•Consumer complaints
