Amendment to examination and investigation sample requirements--FDA. Direct final rule.
Fed Regist. 1998 Sep 25; 63(186):51297-9.FR

Abstract

The Food and Drug Administration (FDA) is amending its regulations regarding the collection of twice the quantity of food, drug, or cosmetic estimated to be sufficient for analysis. This action increases the dollar amount that FDA will consider to determine whether to routinely collect a reserve sample of a food, drug, or cosmetic product in addition to the quantity sufficient for analysis. Experience has demonstrated that the current dollar amount does not adequately cover the cost of most quantities sufficient for analysis plus reserve samples. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on food, drugs, and cosmetics without diminishing the protection of the public health. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule.

MeSH

Drug ApprovalUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10185810

Citation

"Amendment to Examination and Investigation Sample requirements--FDA. Direct Final Rule." Federal Register, vol. 63, no. 186, 1998, pp. 51297-9.

Amendment to examination and investigation sample requirements--FDA. Direct final rule. Fed Regist. 1998;63(186):51297-9.

(1998). Amendment to examination and investigation sample requirements--FDA. Direct final rule. Federal Register, 63(186), 51297-9.

Amendment to Examination and Investigation Sample requirements--FDA. Direct Final Rule. Fed Regist. 1998 Sep 25;63(186):51297-9. PubMed PMID: 10185810.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Amendment to examination and investigation sample requirements--FDA. Direct final rule. PY - 1998/8/29/pubmed PY - 1998/8/29/medline PY - 1998/8/29/entrez SP - 51297 EP - 9 JF - Federal register JO - Fed Regist VL - 63 IS - 186 N2 - The Food and Drug Administration (FDA) is amending its regulations regarding the collection of twice the quantity of food, drug, or cosmetic estimated to be sufficient for analysis. This action increases the dollar amount that FDA will consider to determine whether to routinely collect a reserve sample of a food, drug, or cosmetic product in addition to the quantity sufficient for analysis. Experience has demonstrated that the current dollar amount does not adequately cover the cost of most quantities sufficient for analysis plus reserve samples. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on food, drugs, and cosmetics without diminishing the protection of the public health. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10185810/Amendment_to_examination_and_investigation_sample_requirements__FDA__Direct_final_rule_ DB - PRIME DP - Unbound Medicine ER -

Tags