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Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:
(a) No greater than minimal risk to children is presented; and
(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in § 50.55.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 343 - Misbranded food
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 348 - Food additives
§ 350a - Infant formulas
§ 350b - New dietary ingredients
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 355 - New drugs
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
§ 360f - Banned devices
§ 360h - Notification and other remedies
§ 360i - Records and reports on devices
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 381 - Imports and exports
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 262 - Regulation of biological products
§ 263b - Certification of mammography facilities
Title 21 published on 10-May-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 50 after this date.
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.