Source: https://www.law.cornell.edu/cfr/text/21/1004.6
Timestamp: 2015-12-01 10:49:51
Document Index: 470409369

Matched Legal Cases: ['art 1004', '§ 1004', 'art 16', '§ 1004', '§ 1004', 'art 16', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§\u202f601', '§ 360', '§ 360']

21 CFR 1004.6 - Approval of plans. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter J › Part 1004 › Section 1004.6 21 CFR 1004.6 - Approval of plans.
If, after review of any plan submitted pursuant to this subchapter, the Secretary determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 1004.1 in a manner designed to encourage the public to respond to the proposal, the Secretary will send written notice of his approval of such plan to the manufacturer. Such approval may be conditioned upon such additional terms as the Secretary deems necessary to protect the public health and safety. Any person who contests denial of a plan shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
§ 1004.6 Approval of plans.
If, after review of any plan submitted pursuant to this subchapter, the Secretary determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 1004.1 in a manner designed to encourage the public to respond to the proposal, the Secretary will send written notice of his approval of such plan to the manufacturer. Such approval may be conditioned upon such additional terms as the Secretary deems necessary to protect the public health and safety. Any person who contests denial of a plan shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter. [38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 FR 15676, Mar. 22, 1977] 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.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 360hh - Definitions§ 360ii - Program of control§ 360jj - Studies by Secretary§ 360kk - Performance standards for electronic products§ 360ll - Notification of defects in and repair or replacement of electronic products§ 360mm - Imports§ 360nn - Inspection, records, and reports§ 360oo - Prohibited acts§ 360pp - Enforcement§ 360qq - Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285§ 360rr - Federal-State cooperation§ 360ss - State standards