---
kind: "section"
citation: "21 U.S.C. § 360bbb–8"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–8"
heading: "Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-8"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments

- (a) **In general—** For the purpose of promoting the efficiency of and informing the review by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration of [new drugs](/usc/21/321.md?p=p) and biological [products](/usc/21/360eee.md?p=13) for rare diseases and [drugs](/usc/21/321.md?p=g-1) and biological [products](/usc/21/360eee.md?p=13) that are genetically targeted, the following shall apply:
  - (1) **Consultation with stakeholders—** Consistent with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017, as referenced in the letters described in [section 101(b)](/usc/21/101.md) of the [Prescription Drug](/usc/21/360eee.md?p=12) User Fee Amendments of 2012, the [Secretary](/usc/21/321.md?p=d) shall ensure that opportunities exist, at a time the [Secretary](/usc/21/321.md?p=d) determines appropriate, for consultations with stakeholders on the topics described in [subsection (b)](#b).
  - (2) **Consultation with external experts—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall develop and maintain a list of external experts who, because of their special expertise, are qualified to provide advice on rare disease issues, including topics described in [subsection (b)](#b). The [Secretary](/usc/21/321.md?p=d) may, when appropriate to address a specific regulatory question, consult such external experts on issues related to the review of [new drugs](/usc/21/321.md?p=p) and biological [products](/usc/21/360eee.md?p=13) for rare diseases and [drugs](/usc/21/321.md?p=g-1) and biological [products](/usc/21/360eee.md?p=13) that are genetically targeted, including the topics described in [subsection (b)](#b), when such consultation is necessary because the [Secretary](/usc/21/321.md?p=d) lacks the specific scientific, medical, or technical expertise necessary for the performance of the [Secretary](/usc/21/321.md?p=d)’s regulatory responsibilities and the necessary expertise can be provided by the external experts.
    - (B) **External experts—** For purposes of [subparagraph (A)](#a-2-A), external experts are individuals who possess scientific or medical training that the [Secretary](/usc/21/321.md?p=d) lacks with respect to one or more rare diseases.
- (b) **Topics for consultation—** Topics for consultation pursuant to this section may include—
  - (1) rare diseases;
  - (2) the severity of rare diseases;
  - (3) the unmet medical need associated with rare diseases;
  - (4) the willingness and ability of individuals with a rare disease to participate in clinical trials;
  - (5) an assessment of the benefits and risks of therapies to treat rare diseases;
  - (6) the general design of clinical trials for rare disease populations and subpopulations;
  - (7) the demographics and the clinical description of patient populations; and
  - (8) the science of small population studies.
- (c) **Classification as special government employees—** The external experts who are consulted under this section may be considered special government employees, as defined under [section 202 of title 18](/usc/18/202.md).
- (d) **Protection of confidential information and trade secrets—**
  - (1) **Rule of construction—** Nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to [section 552(b) of title 5](/usc/5/552.md?p=b) as such provisions would be applied to consultation with individuals and organizations prior to July 9, 2012.
  - (2) **Consent required for disclosure—** The [Secretary](/usc/21/321.md?p=d) shall not disclose confidential commercial or trade secret information to an expert consulted under this section without the written consent of the [sponsor](/usc/21/360fff.md?p=8) unless the expert is a special government employee (as defined under [section 202 of title 18](/usc/18/202.md)) or the disclosure is otherwise [authorized](/usc/21/360eee.md?p=2) by law.
- (e) **Other consultation—** Nothing in this section shall be construed to limit the ability of the [Secretary](/usc/21/321.md?p=d) to consult with individuals and organizations as [authorized](/usc/21/360eee.md?p=2) prior to July 9, 2012.
- (f) **No right or obligation—**
  - (1) **No right to consultation—** Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the [Secretary](/usc/21/321.md?p=d) to meet with any particular expert or stakeholder.
  - (2) **No altering of goals—** Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in [section 101(b)](/usc/21/101.md) of the [Prescription Drug](/usc/21/360eee.md?p=12) User Fee Amendments of 2012.
  - (3) **No change to number of review cycles—** Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012.
- (g) **No delay in product review—**
  - (1) **In general—** Prior to a consultation with an external expert, as described in this section, relating to an investigational [new drug](/usc/21/321.md?p=p) application under [section 355(i) of this title](/usc/21/355.md?p=i), a [new drug](/usc/21/321.md?p=p) application under [section 355(b) of this title](/usc/21/355.md?p=b), or a biologics license application under [section 262 of title 42](/usc/42/262.md), the Director of the Center for [Drug](/usc/21/321.md?p=g-1) Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or appropriate Division Director), as appropriate, shall determine that—
    - (A) such consultation will—
      - (i) facilitate the [Secretary](/usc/21/321.md?p=d)’s ability to complete the [Secretary](/usc/21/321.md?p=d)’s review; and
      - (ii) address outstanding deficiencies in the application; or
    - (B) the [sponsor](/usc/21/360fff.md?p=8) [authorized](/usc/21/360eee.md?p=2) such consultation.
  - (2) **Limitation—** The requirements of this subsection shall apply only in instances where the consultation is undertaken solely under the authority of this section. The requirements of this subsection shall not apply to any consultation initiated under any other authority.

## Source credit

(June 25, 1938, ch. 675, § 569, as added Pub. L. 112–144, title IX, § 903, July 9, 2012, 126 Stat. 1088; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(O), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, § 3202(e), Dec. 29, 2022, 136 Stat. 5812.)

## Notes

### Editorial Notes

### References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsecs. (a)(1) and (f)(2), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

### Amendments

2022—Subsec. (b)(8). Pub. L. 117–328 added par. (8).

2016—Subsec. (a)(2)(A). Pub. L. 114–255 substituted “subsection (b)” for “subsection (c)” before period in first sentence.