---
kind: "section"
citation: "21 U.S.C. § 355f"
title: "21"
title_heading: "Food and Drugs"
number: "355f"
heading: "Extension of exclusivity period for new qualified infectious disease products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/355f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355f. Extension of exclusivity period for new qualified infectious disease products

- (a) **Extension—** If the [Secretary](/usc/21/321.md?p=d) approves an application pursuant to [section 355 of this title](/usc/21/355.md) for a [drug](/usc/21/321.md?p=g-1) that has been designated as a qualified infectious disease [product](/usc/21/360eee.md?p=13) under [subsection (d)](#d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of [section 355 of this title](/usc/21/355.md), the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of [section 355 of this title](/usc/21/355.md), or the 7-year period described in [section 360cc of this title](/usc/21/360cc.md), as applicable, shall be extended by 5 years.
- (b) **Relation to pediatric exclusivity—** Any extension under [subsection (a)](#a) of a period shall be in addition to any extension of the period under [section 355a of this title](/usc/21/355a.md) with respect to the [drug](/usc/21/321.md?p=g-1).
- (c) **Limitations—** [Subsection (a)](#a) does not apply to the approval of—
  - (1) a supplement to an application under [section 355(b) of this title](/usc/21/355.md?p=b) for any qualified infectious disease [product](/usc/21/360eee.md?p=13) for which an extension described in [subsection (a)](#a) is in effect or has expired;
  - (2) a subsequent application filed with respect to a [product](/usc/21/360eee.md?p=13) approved under [section 355 of this title](/usc/21/355.md) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery [device](/usc/21/321.md?p=h-1), or strength;
  - (3) a [product](/usc/21/360eee.md?p=13) that does not meet the definition of a qualified infectious disease [product](/usc/21/360eee.md?p=13) under [subsection (g)](#g) based upon its approved uses; or
  - (4) an application pursuant to [section 262(a) of title 42](/usc/42/262.md?p=a).
- (d) **Designation—**
  - (1) **In general—** The [manufacturer](/usc/21/360hh.md?p=3) or [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1) may request the [Secretary](/usc/21/321.md?p=d) to designate a [drug](/usc/21/321.md?p=g-1) as a qualified infectious disease [product](/usc/21/360eee.md?p=13) at any time before the submission of an application under [section 355(b) of this title](/usc/21/355.md?p=b) or [section 262(a) of title 42](/usc/42/262.md?p=a) for such [drug](/usc/21/321.md?p=g-1). The [Secretary](/usc/21/321.md?p=d) shall, not later than 60 days after the submission of such a request, determine whether the [drug](/usc/21/321.md?p=g-1) is a qualified infectious disease [product](/usc/21/360eee.md?p=13).
  - (2) **Limitation—** Except as provided in [paragraph (3)](#d-3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under [subsection (f)(2)(C)](#f-2-C).
  - (3) **Revocation of designation—** The [Secretary](/usc/21/321.md?p=d) may revoke a designation of a [drug](/usc/21/321.md?p=g-1) as a qualified infectious disease [product](/usc/21/360eee.md?p=13) if the [Secretary](/usc/21/321.md?p=d) finds that the request for such designation contained an untrue statement of material fact.
- (e) **Regulations—**
  - (1) **In general—** Not later than 2 years after July 9, 2012, the [Secretary](/usc/21/321.md?p=d) shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in [subsection (f)](#f).
  - (2) **Procedure—** In promulgating a regulation implementing this section, the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) issue a notice of proposed rulemaking that includes the proposed regulation;
    - (B) provide a period of not less than 60 days for comments on the proposed regulation; and
    - (C) publish the final regulation not less than 30 days before the effective date of the regulation.
  - (3) **Restrictions—** Notwithstanding any other provision of law, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations implementing this section only as described in [paragraph (2)](#e-2), except that the [Secretary](/usc/21/321.md?p=d) may issue interim guidance for [sponsors](/usc/21/360fff.md?p=8) seeking designation under [subsection (d)](#d) prior to the promulgation of such regulations.
  - (4) **Designation prior to regulations—** The [Secretary](/usc/21/321.md?p=d) shall designate [drugs](/usc/21/321.md?p=g-1) as qualified infectious disease [products](/usc/21/360eee.md?p=13) under [subsection (d)](#d) prior to the promulgation of regulations under this subsection, if such [drugs](/usc/21/321.md?p=g-1) meet the definition of a qualified infectious disease [product](/usc/21/360eee.md?p=13) described in [subsection (g)](#g).
- (f) **Qualifying pathogen—**
  - (1) **Definition—** In this section, the term “qualifying pathogen” means a pathogen identified and listed by the [Secretary](/usc/21/321.md?p=d) under [paragraph (2)](#f-2) that has the potential to pose a serious threat to public health, such as—
    - (A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;
    - (B) multi-[drug](/usc/21/321.md?p=g-1) resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
    - (C) multi-[drug](/usc/21/321.md?p=g-1) resistant tuberculosis; and
    - (D) Clostridium difficile.
  - (2) **List of qualifying pathogens—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.
    - (B) **Considerations—** In establishing and maintaining the list of pathogens described under this section, the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) consider—
        - (I) the impact on the public health due to [drug](/usc/21/321.md?p=g-1)-resistant organisms in humans;
        - (II) the rate of growth of [drug](/usc/21/321.md?p=g-1)-resistant organisms in humans;
        - (III) the increase in resistance rates in humans; and
        - (IV) the morbidity and mortality in humans; and
      - (ii) consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, medical professionals, and the clinical research community.
    - (C) **Review—** Every 5 years, or more often as needed, the [Secretary](/usc/21/321.md?p=d) shall review, provide modifications to, and publish the list of qualifying pathogens under [subparagraph (A)](#f-2-A) and shall by regulation revise the list as necessary, in accordance with [subsection (e)](#e).
- (g) **Qualified infectious disease product—** The term “qualified infectious disease [product](/usc/21/360eee.md?p=13)” means a [drug](/usc/21/321.md?p=g-1) (including a biological [product](/usc/21/360eee.md?p=13)), including an antibacterial or antifungal [drug](/usc/21/321.md?p=g-1), for human use that—
  - (1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and
  - (2) is intended to treat a serious or life-threatening infection, including such an infection caused by—
    - (A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
    - (B) qualifying pathogens listed by the [Secretary](/usc/21/321.md?p=d) under [subsection (f)](#f).

## Source credit

(June 25, 1938, ch. 675, § 505E, as added Pub. L. 112–144, title VIII, § 801(a), July 9, 2012, 126 Stat. 1077; amended Pub. L. 117–328, div. FF, title III, § 3212(a), Dec. 29, 2022, 136 Stat. 5826.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (c)(4). Pub. L. 117–328, § 3212(a)(1), added par. (4).

Subsec. (d)(1). Pub. L. 117–328, § 3212(a)(2), inserted “or section 262(a) of title 42” after “section 355(b) of this title”.

Subsec. (g). Pub. L. 117–328, § 3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: “The term ‘qualified infectious disease product’ means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—

“(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

“(2) qualifying pathogens listed by the Secretary under subsection (f).”

### Statutory Notes and Related Subsidiaries

### Effective Date

Pub. L. 112–144, title VIII, § 801(b), July 9, 2012, 126 Stat. 1079, provided that: “Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012].”