---
kind: "section"
citation: "21 U.S.C. § 399f"
title: "21"
title_heading: "Food and Drugs"
number: "399f"
heading: "Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/399f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter X — Miscellaneous"
---

# §399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups

- (a) **Communication plan—** The [Secretary](/usc/21/321.md?p=d) of Health and Human Services (referred to in this section as the “[Secretary](/usc/21/321.md?p=d)”), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall review and modify, as necessary, the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration’s communication plan to inform and educate health care providers and patients on the benefits and risks of medical [products](/usc/21/360eee.md?p=13), with particular focus on underrepresented subpopulations, including racial subgroups.
- (b) **Content—** The communication plan described under [subsection (a)](#a)—
  - (1) shall take into account—
    - (A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the [Department](/usc/21/321.md?p=c) of Health and Human Services;
    - (B) the nature of the medical [product](/usc/21/360eee.md?p=13); and
    - (C) health and disease information available from other agencies within such [Department](/usc/21/321.md?p=c), as well as any new means of communicating health and safety benefits and risks related to medical [products](/usc/21/360eee.md?p=13);
  - (2) taking into account the nature of the medical [product](/usc/21/360eee.md?p=13), shall address the best strategy for communicating safety alerts, labeled indications for the medical [products](/usc/21/360eee.md?p=13), changes to the [label](/usc/21/321.md?p=k) or [labeling](/usc/21/321.md?p=m) of medical [products](/usc/21/360eee.md?p=13) (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and
  - (3) shall include a process for implementation of any improvements or other modifications determined to be necessary.
- (c) **Issuance and posting of communication plan—**
  - (1) **Communication plan—** Not later than 1 year after July 9, 2012, the [Secretary](/usc/21/321.md?p=d), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall issue the communication plan described under this section.
  - (2) **Posting of communication plan on the office of minority health web site—** The [Secretary](/usc/21/321.md?p=d), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.

## Source credit

(Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)

## Notes

### Editorial Notes

### 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.