§ 360bb. Designation of drugs for rare diseases or conditions
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/usc/title-21/section-360bbA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Request by sponsor; preconditions; “rare disease or condition” defined
(1)The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—
(A)if an application for such drug is approved under section 355 of this title, or
(B)if a license for such drug is issued under section 262 of title 42,
the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection
(b)1 respecting the designation of the drug.
(2)For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which
(A)affects less than 200,000 persons in the United States, or
(B)affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.
(b)Notification of discontinuance of drug or application as condition A designation of a drug under subsection
(a)shall be subject to the condition that—
(1)if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42, the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and
(2)if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under section 355(b) of this title or approval of a license under section 262 of title 42.
(c)Notice to public Notice respecting the designation of a drug under subsection
(a)shall be made available to the public.
(d)Regulations The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
(June 25, 1938, ch. 675, § 526, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–551, § 4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, § 3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100–290, § 2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105–115, title I, § 125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326.)
Connections173 cite this · traces to 4
Cited by 173 sections · top 60
U.S. Code
- § 262Regulation of biological products
- § 802Definitions
- § 1395lPayment of benefits
- § 360ffPriority review to encourage treatments for rare pediatric diseases
- § 256bLimitation on prices of drugs purchased by covered entities
- § 356Expedited approval of drugs for serious or life-threatening diseases or conditions
- § 379hAuthority to assess and use drug fees
- § 355aPediatric studies of drugs
- § 355cResearch into pediatric uses for drugs and biological products
- § 360ccProtection for drugs for rare diseases or conditions
- § 360eeGrants and contracts for development of drugs for rare diseases and conditions
- § 287National Center for Advancing Translational Sciences
- § 1396r–8Payment for covered outpatient drugs
- § 236Orphan Products Board
- § 360ddOpen protocols for investigations of drugs for rare diseases or conditions
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statutes-at-large
- Public Law 112–144To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes
- Public Law 97–414To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes
- Public Law 98–551To revise and extend provisions of the Public Health Service Act relating to health promotion and disease prevention, to provide for the establishment of centers for research and demonstrations concerning health promotion and disease prevention, and for other purposes
- Public Law 101–647To control crime
- Public Law 99–91To amend the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act and related laws
- Public Law 100–290To amend the Federal Food, Drug, and Cosmetic Act to revise the provisions respecting orphan drugs, and for other purposes
- Public Law 111–148Entitled The Patient Protection and Affordable Care Act
- Public Law 117–328Making consolidated appropriations for the fiscal year ending September 30, 2023, and for providing emergency assistance for the situation in Ukraine, and for other purposes
- Public Law 115–52To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes
- Public Law 105–115To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes
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- Sec. 201Dormant therapies
- Sec. 201Dormant therapies
- Sec. 9Prize payments for medical innovation
- Sec. 15Annual audits by GAO
- Sec. 4Capturing lost opportunities and creating new cures for patients
- Sec. 5Food and Drug Administration cerebral cavernous malformations clinical trial preparedness and support program
20 references not yet in our index
- 1
- June 25, 1938, ch. 675, § 526
- Pub. L. 97–414, § 2(a)
- 96 Stat. 2050
- Pub. L. 98–551, § 4(a)
- 98 Stat. 2817
- Pub. L. 99–91, § 3(a)(2)
- 99 Stat. 387
- Pub. L. 100–290, § 2
- 102 Stat. 90
- Pub. L. 105–115, title I, § 125(b)(2)(H)
- 111 Stat. 2326
- Pub. L. 100–290, § 2(b)
- Pub. L. 105–115, § 125(b)(2)(H)
- Pub. L. 105–115, § 125(b)(2)(I)(i)
- Pub. L. 105–115, § 125(b)(2)(I)(ii)
- Pub. L. 100–290, § 2(a)
- Pub. L. 99–91
- Pub. L. 98–551
- section 8(b) of Pub. L. 99–91
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cites case law
§ 360bb
Designation of drugs for rare diseases or conditions
Bills×93
U.S.C.×34
Fed. Reg.×26
Stat.×14
Stat. Comp.×3
Pub. L.×2
C.F.R.×1
Cite1
ActJune 25, 1938, ch. 675, § 526
Pub. L.Pub. L. 97–414, § 2(a)
Stat.96 Stat. 2050
Pub. L.Pub. L. 98–551, § 4(a)
Cites 24 · showing 9Cited by 173 across 7 sources