21 U.S.C. § 399e: Nanotechnology

Summary

The Secretary of Health and Human Services must increase and expand work to learn more about nanomaterials used or meant to be used in products the Food and Drug Administration regulates. The goal is to study safety, possible medical benefits, how these tiny materials affect the body, and how they interact with living systems. To do this, the Secretary may review scientific studies, build databases and models with other agencies, join research and standards efforts, improve ways to detect and measure nanomaterials, collect and share data, train and grow FDA expertise, monitor nanomaterials in domestic and imported products, and carry out other related activities.

Title 21, §399e

Food and Drugs, Source: USLM XML via OLRC

(a)In general

The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems.

(b)Activities

In conducting activities related to nanotechnology, the Secretary may—

(1)assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

(2)in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

(3)promote Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4)promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5)collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;

(6)build scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7)ensure ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8)encourage the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9)carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act

June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables. This Act, referred to in subsec. (b)(6), is Pub. L. 112–144,

July 9, 2012, 126 Stat. 993, known as the Food and Drug Administration Safety and Innovation Act. For complete classification of this Act to the Code, see Tables. Codification Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§399e Nanotechnology

Summary

Title 21, §399e

Notes & Related Subsidiaries

Editorial Notes

References in Text

Citations & Metadata