cfr_sections
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40 rows where part_number = 316 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:5.0.1.1.6.1.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | A | Subpart A—General Provisions | § 316.1 Scope of this part. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35132, June 12, 2013] | (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological products and antibiotics. This part sets forth the procedures and requirements for: (1) Submissions to FDA of: (i) Requests for recommendations for investigations of drugs for rare diseases or conditions; (ii) Requests for designation of a drug for a rare disease or condition; and (iii) Requests for gaining exclusive approval for a drug for a rare disease or condition. (2) Allowing a sponsor to provide an investigational drug under a treatment protocol to patients who need the drug for treatment of a rare disease or condition. (b) This part does not apply to food, medical devices, or drugs for veterinary use. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. | |||
| 21:21:5.0.1.1.6.1.1.2 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | A | Subpart A—General Provisions | § 316.2 Purpose. | FDA | The purpose of this part is to establish standards and procedures for determining eligibility for the benefits provided for in section 2 of the Orphan Drug Act, including written recommendations for investigations of orphan drugs, a 7-year period of exclusive marketing, and treatment use of investigational orphan drugs. This part is also intended to satisfy Congress' requirements that FDA promulgate procedures for the implementation of sections 525(a) and 526(a) of the act. | ||||
| 21:21:5.0.1.1.6.1.1.3 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | A | Subpart A—General Provisions | § 316.3 Definitions. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 64 FR 402, Jan. 5, 1999; 64 FR 56449, Oct. 20, 1999; 78 FR 35132, June 12, 2013] | (a) The definitions and interpretations contained in section 201 of the act apply to those terms when used in this part. (b) The following definitions of terms apply to this part: (1) Act means the Federal Food, Drug, and Cosmetic Act as amended by section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C. 360aa-360dd)). (2) Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance. (3) Clinically superior means that a drug is shown to provide a significant therapeutic advantage over and above that provided by an approved drug (that is otherwise the same drug) in one or more of the following ways: (i) Greater effectiveness than an approved drug (as assessed by effect on a clinically meaningful endpoint in adequate and well controlled clinical trials). Generally, this would represent the same kind of evidence needed to support a comparative effectiveness claim for two different drugs; in most cases, direct comparative clinical trials would be necessary; or (ii) Greater safety in a substantial portion of the target populations, for example, by the elimination of an ingredient or contaminant that is associated with relatively frequent adverse effects. In some cases, direct comparative clinical trials will be necessary; or (iii) In unusual cases, where neither greater safety nor greater effectiveness has been shown, a demonstration that the drug otherwise makes a major contribution to patient care. (4) Director means the Director of FDA's Office of Orphan Products Development. (5) FDA means the Food and Drug Administration. (6) Holder means the sponsor in whose name an orphan drug is designated and approved. (7) IND means an investigational new drug application under part 312 of this chapter… | |||
| 21:21:5.0.1.1.6.1.1.4 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | A | Subpart A—General Provisions | § 316.4 Address for submissions. | FDA | [78 FR 35133, June 12, 2013] | All correspondence and requests for FDA action under the provisions of this rule should be addressed as follows: Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993. | |||
| 21:21:5.0.1.1.6.2.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | B | Subpart B—Written Recommendations for Investigations of Orphan Drugs | § 316.10 Content and format of a request for written recommendations. | FDA | [57 FR 62085, Dec. 29, 1992; 58 FR 6167, Jan. 26, 1993] | (a) A sponsor's request for written recommendations from FDA concerning the nonclinical and clinical investigations necessary for approval of a marketing application shall be submitted in the form and contain the information required in this section. FDA may require the sponsor to submit information in addition to that specified in paragraph (b) of this section if FDA determines that the sponsor's initial request does not contain adequate information on which to base recommendations. (b) A sponsor shall submit two copies of a completed, dated, and signed request for written recommendations that contains the following: (1) The sponsor's name and address. (2) A statement that the sponsor is requesting written recommendations on orphan-drug development under section 525 of the act. (3) The name of the sponsor's primary contact person and/or resident agent, and the person's title, address, and telephone number. (4) The generic name and trade name, if any, of the drug and a list of the drug product's components or description of the drug product's formulation, and chemical and physical properties. (5) The proposed dosage form and route of administration. (6) A description of the disease or condition for which the drug is proposed to be investigated and the proposed indication or indications for use for such disease or condition. (7) Current regulatory and marketing status and history of the drug product, including: (i) Whether the product is the subject of an IND or a marketing application (if the product is the subject of an IND or a marketing application, the IND or marketing application numbers should be stated and the investigational or approved indication or indications for use specified); (ii) Known marketing experience or investigational status outside the United States; (iii) So far as is known or can be determined, all indications previously or currently under investigation anywhere; (iv) All adverse regulatory actions taken by the United States or foreign authorities. (8) The basis for concludin… | |||
| 21:21:5.0.1.1.6.2.1.2 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | B | Subpart B—Written Recommendations for Investigations of Orphan Drugs | § 316.12 Providing written recommendations. | FDA | (a) FDA will provide the sponsor with written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of a marketing application if none of the reasons described in § 316.14 for refusing to do so applies. (b) When a sponsor seeks written recommendations at a stage of drug development at which advice on any clinical investigations, or on particular investigations would be premature, FDA's response may be limited to written recommendations concerning only nonclinical laboratory studies, or only certain of the clinical studies (e.g., Phase 1 studies as described in § 312.21 of this chapter). Prior to providing written recommendations for the clinical investigations required to achieve marketing approval, FDA may require that the results of the nonclinical laboratory studies or completed early clinical studies be submitted to FDA for agency review. | ||||
| 21:21:5.0.1.1.6.2.1.3 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | B | Subpart B—Written Recommendations for Investigations of Orphan Drugs | § 316.14 Refusal to provide written recommendations. | FDA | (a) FDA may refuse to provide written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of a marketing application for any of the following reasons: (1) The information required to be submitted by § 316.10(b) has not been submitted, or the information submitted is incomplete. (2) There is insufficient information about: (i) The drug to identify the active moiety and its physical and chemical properties, if these characteristics can be determined; or (ii) The disease or condition to determine that the disease or condition is rare in the United States; or (iii) The reasons for believing that the drug may be useful for treating the rare disease or condition with that drug; or (iv) The regulatory and marketing history of the drug to determine the scope and type of investigations that have already been conducted on the drug for the rare disease or condition; or (v) The plan of study for establishing the safety and effectiveness of the drug for treatment of the rare disease or condition. (3) The specific questions for which the sponsor seeks the advice of the agency are unclear or are not sufficiently specific. (4) On the basis of the information submitted and on other information available to the agency, FDA determines that the disease or condition for which the drug is intended is not rare in the United States. (5) On the basis of the information submitted and on other information available to the agency, FDA determines that there is an inadequate basis for permitting investigational use of the drug under part 312 of this chapter for the rare disease or condition. (6) The request for information contains an untrue statement of material fact. (b) A refusal to provide written recommendations will be in writing and will include a statement of the reason for FDA's refusal. Where practicable, FDA will describe the information or material it requires or the conditions the sponsor must meet for FDA to provide recommendations. (c) Within 90 days afte… | ||||
| 21:21:5.0.1.1.6.3.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.20 Content and format of a request for orphan-drug designation. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35133, June 12, 2013] | (a) A sponsor that submits a request for orphan-drug designation of a drug for a specified rare disease or condition shall submit each request in the form and containing the information required in paragraph (b) of this section. A sponsor may request orphan-drug designation of a previously unapproved drug, or of a new use for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved drug may seek and obtain orphan-drug designation for the subsequent drug for the same rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug. More than one sponsor may receive orphan-drug designation of the same drug for the same rare disease or condition, but each sponsor seeking orphan-drug designation must file a complete request for designation as provided in paragraph (b) of this section. (b) A sponsor shall submit two copies of a completed, dated, and signed request for designation that contains the following: (1) A statement that the sponsor requests orphan-drug designation for a rare disease or condition, which shall be identified with specificity. (2) The name and address of the sponsor; the name of the sponsor's primary contact person and/or resident agent including title, address, telephone number, and email address; the generic and trade name, if any, of the drug, or, if neither is available, the chemical name or a meaningful descriptive name of the drug; and the name and address of the source of the drug if it is not manufactured by the sponsor. (3) A description of the rare disease or condition for which the drug is being or will be investigated, the proposed use of the drug, and the reasons why such therapy is needed. (4) A description of the drug, to include the identity of the active moiety if it is a drug composed of small molecules, or of the principal molecular structural features if it is composed of macromolecules; its physical and chemical properties, if these characteristics can be… | |||
| 21:21:5.0.1.1.6.3.1.10 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.29 Revocation of orphan-drug designation. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35134, June 12, 2013] | (a) FDA may revoke orphan-drug designation for any drug if the agency finds that: (1) The request for designation contained an untrue statement of material fact; or (2) The request for designation omitted material information required by this part; or (3) FDA subsequently finds that the drug in fact had not been eligible for orphan-drug designation at the time of submission of the request therefor. (b) For an approved drug, revocation of orphan-drug designation also suspends or withdraws the sponsor's exclusive marketing rights for the drug but not the approval of the drug's marketing application. (c) Where a drug has been designated as an orphan drug because the prevalence of a disease or condition (or, in the case of vaccines, diagnostic drugs, or preventive drugs, the target population) is under 200,000 in the United States at the time of designation, its designation will not be revoked on the ground that the prevalence of the disease or condition (or the target population) becomes more than 200,000 persons. (d) If FDA revokes orphan-drug designation, FDA will publicize that the drug is no longer designated in accordance with § 316.28(e). | |||
| 21:21:5.0.1.1.6.3.1.11 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.30 Annual reports of holder of orphan-drug designation. | FDA | Within 14 months after the date on which a drug was designated as an orphan drug and annually thereafter until marketing approval, the sponsor of a designated drug shall submit a brief progress report to the FDA Office of Orphan Products Development on the drug that includes: (a) A short account of the progress of drug development including a review of preclinical and clinical studies initiated, ongoing, and completed and a short summary of the status or results of such studies. (b) A description of the investigational plan for the coming year, as well as any anticipated difficulties in development, testing, and marketing; and (c) A brief discussion of any changes that may affect the orphan-drug status of the product. For example, for products nearing the end of the approval process, sponsors should discuss any disparity between the probable marketing indication and the designated indication as related to the need for an amendment to the orphan-drug designation pursuant to § 316.26. | ||||
| 21:21:5.0.1.1.6.3.1.2 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.21 Verification of orphan-drug status. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35133, June 12, 2013] | (a) So that FDA can determine whether a drug qualifies for orphan-drug designation under section 526(a) of the act, the sponsor shall include in its request to FDA for orphan-drug designation under § 316.20 either: (1) Documentation as described in paragraph (b) of this section that the number of people affected by the disease or condition for which the drug is to be developed is fewer than 200,000 persons; or (2) Documentation as described in paragraph (c) of this section that demonstrates that there is no reasonable expectation that the sales of the drug will be sufficient to offset the costs of developing the drug for the U.S. market and the costs of making the drug available in the United States. (b) For the purpose of documenting that the number of people affected by the disease or condition for which the drug is to be developed is less than 200,000 persons, “prevalence” is defined as the number of persons in the United States who have been diagnosed as having the disease or condition at the time of the submission of the request for orphan-drug designation. To document the number of persons in the United States who have the disease or condition for which the drug is to be developed, the sponsor shall submit to FDA evidence showing: (1) The estimated prevalence of the disease or condition for which the drug is being developed, together with a list of the sources (including dates of information provided and literature citations) for the estimate; (2) Upon request by FDA, the estimated prevalence of any other disease or condition for which the drug has already been approved or for which the drug is currently being developed, together with an explanation of the bases of these estimates; and (3) The estimated number of people to whom the drug will be administered annually if the drug is a vaccine or is a drug intended for diagnosis or prevention of a rare disease or condition, together with an explanation of the bases of these estimates (including dates of information provided and literature citations). (c… | |||
| 21:21:5.0.1.1.6.3.1.3 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.22 Permanent-resident agent for foreign sponsor. | FDA | [78 FR 35133, June 12, 2013] | Every foreign sponsor that seeks orphan-drug designation shall name a permanent resident of the United States as the sponsor's agent upon whom service of all processes, notices, orders, decisions, requirements, and other communications may be made on behalf of the sponsor. Notifications of changes in such agents or changes of address of agents should preferably be provided in advance, but not later than 60 days after the effective date of such changes. The permanent-resident agent may be an individual, firm, or domestic corporation and may represent any number of sponsors. The name of the permanent-resident agent, address, telephone number, and email address shall be provided to: Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993. | |||
| 21:21:5.0.1.1.6.3.1.4 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs. | FDA | [78 FR 35133, June 12, 2013] | (a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition. (b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition. | |||
| 21:21:5.0.1.1.6.3.1.5 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.24 Deficiency letters and granting orphan-drug designation. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35133, June 12, 2013] | (a) FDA will send a deficiency letter to the sponsor if the request for orphan-drug designation lacks information required under §§ 316.20 and 316.21, or contains inaccurate or incomplete information. FDA may consider a designation request voluntarily withdrawn if the sponsor fails to respond to the deficiency letter within 1 year of issuance of the deficiency letter, unless within that same timeframe the sponsor requests in writing an extension of time to respond. This request must include the reason(s) for the requested extension and the length of time of the requested extension. FDA will grant all reasonable requests for an extension. In the event FDA denies a request for an extension of time, FDA may consider the designation request voluntarily withdrawn. In the event FDA considers a designation request voluntarily withdrawn, FDA will so notify the sponsor in writing. (b) FDA will grant the request for orphan-drug designation if none of the reasons described in § 316.25 for requiring or permitting refusal to grant such a request applies. (c) When a request for orphan-drug designation is granted, FDA will notify the sponsor in writing and will publicize the orphan-drug designation in accordance with § 316.28. (d) A sponsor may voluntarily withdraw an orphan-drug designation request or an orphan-drug designation at any time after the request is submitted or granted, respectively, by submitting a written request for withdrawal to FDA. FDA will acknowledge such withdrawal in a letter to the sponsor. Any benefits attendant to designation (such as orphan-exclusive approval) will cease once designation is voluntarily withdrawn, from the date of FDA's acknowledgement letter. If a sponsor voluntarily withdraws designation, FDA will publicize such withdrawal in accordance with § 316.28. | |||
| 21:21:5.0.1.1.6.3.1.6 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.25 Refusal to grant orphan-drug designation. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35133, June 12, 2013] | (a) FDA will refuse to grant a request for orphan-drug designation if any of the following reasons apply: (1) The drug is not intended for a rare disease or condition because: (i) There is insufficient evidence to support the estimate that the drug is intended for treatment of a disease or condition in fewer than 200,000 people in the United States, or that the drug is intended for use in prevention or in diagnosis in fewer than 200,000 people annually in the United States; or (ii) Where the drug is intended for prevention, diagnosis, or treatment of a disease or condition affecting 200,000 or more people in the United States, the sponsor has failed to demonstrate that there is no reasonable expectation that development and production costs will be recovered from sales of the drug for such disease or condition in the United States. A sponsor's failure to comply with § 316.21 shall constitute a failure to make the demonstration required in this paragraph. (2) There is insufficient information about the drug, or the disease or condition for which it is intended, to establish a medically plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition. (3) The drug is otherwise the same drug as an already approved drug for the same rare disease or condition and the sponsor has not submitted a medically plausible hypothesis for the possible clinical superiority of the subsequent drug. (b) FDA may refuse to grant a request for orphan-drug designation if the request for designation contains an untrue statement of material fact or omits material information or if the request is otherwise ineligible under this part. | |||
| 21:21:5.0.1.1.6.3.1.7 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.26 Amendment to orphan-drug designation. | FDA | [78 FR 35134, June 12, 2013] | (a) At any time prior to approval of a marketing application for a designated orphan drug, the sponsor holding designation may apply for an amendment to the designated use if the proposed change is due to new and unexpected findings in research on the drug, information arising from FDA recommendations, or unforeseen developments in treatment or diagnosis of the disease or condition. (b) FDA will grant the amendment if it finds that the initial designation request was made in good faith and that the amendment is intended to conform the orphan-drug designation to the results of unanticipated research findings, to unforeseen developments in the treatment or diagnosis of the disease or condition, or to changes based on FDA recommendations, and that, as of the date of the submission of the amendment request, the amendment would not result in exceeding the prevalence or cost recovery thresholds in § 316.21(a)(1) or (a)(2) upon which the drug was originally designated. | |||
| 21:21:5.0.1.1.6.3.1.8 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.27 Change in ownership of orphan-drug designation. | FDA | [57 FR 62085, Dec. 29, 1992; 58 FR 6167, Jan. 26, 1993] | (a) A sponsor may transfer ownership of or any beneficial interest in the orphan-drug designation of a drug to a new sponsor. At the time of the transfer, the new and former owners are required to submit the following information to FDA: (1) The former owner or assignor of rights shall submit a letter or other document that states that all or some rights to the orphan-drug designation of the drug have been transferred to the new owner or assignee and that a complete copy of the request for orphan-drug designation, including any amendments to the request, supplements to the granted request, and correspondence relevant to the orphan-drug designation, has been provided to the new owner or assignee. (2) The new owner or assignee of rights shall submit a statement accepting orphan-drug designation and a letter or other document containing the following: (i) The date that the change in ownership or assignment of rights is effective; (ii) A statement that the new owner has a complete copy of the request for orphan-drug designation including any amendments to the request, supplements to the granted request, and correspondence relevant to the orphan-drug designation; and (iii) A specific description of the rights that have been assigned and those that have been reserved. This may be satisfied by the submission of either a list of rights assigned and reserved or copies of all relevant agreements between assignors and assignees; and (iv) The name and address of a new primary contact person or resident agent. (b) No sponsor may relieve itself of responsibilities under the Orphan Drug Act or under this part by assigning rights to another person without: (1) Assuring that the sponsor or the assignee will carry out such responsibilities; or (2) Obtaining prior permission from FDA. | |||
| 21:21:5.0.1.1.6.3.1.9 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | C | Subpart C—Designation of an Orphan Drug | § 316.28 Publication of orphan-drug designations. | FDA | [78 FR 35134, June 12, 2013] | Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information: (a) The name and address of the sponsor; (b) The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug; (c) The date of the granting of orphan-drug designation; (d) The designated use in the rare disease or condition; and (e) If the drug loses designation after August 12, 2013, the date of it no longer having designation. | |||
| 21:21:5.0.1.1.6.4.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | D | Subpart D—Orphan-drug Exclusive Approval | § 316.31 Scope of orphan-drug exclusive approval. | FDA | [57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35134, June 12, 2013] | (a) FDA may approve a sponsor's marketing application for a designated orphan drug for use in the rare disease or condition for which the drug was designated, or for select indication(s) or use(s) within the rare disease or condition for which the drug was designated. Unless FDA previously approved the same drug for the same use or indication, FDA will not approve another sponsor's marketing application for the same drug for the same use or indication before the expiration of 7 years from the date of such approval as stated in the approval letter from FDA, except that such a marketing application can be approved sooner if, and at such time as, any of the following occurs: (1) Withdrawal of exclusive approval or revocation of orphan-drug designation by FDA under any provision of this part; or (2) Withdrawal for any reason of the marketing application for the drug in question; or (3) Consent by the holder of exclusive approval to permit another marketing application to gain approval; or (4) Failure of the holder of exclusive approval to assure a sufficient quantity of the drug under section 527 of the act and § 316.36. (b) Orphan-drug exclusive approval protects only the approved indication or use of a designated drug. If such approval is limited to only particular indication(s) or uses(s) within the rare disease or condition for which the drug was designated, FDA may later approve the drug for additional indication(s) or uses(s) within the rare disease or condition not protected by the exclusive approval. If the sponsor who obtains approval for these new indication(s) or uses(s) has orphan-drug designation for the drug for the rare disease or condition, FDA will recognize a new orphan-drug exclusive approval for these new (not previously approved) indication(s) or use(s) from the date of approval of the drug for such new indication(s) or use(s). (c) If a sponsor's marketing application for a drug product is determined not to be approvable because approval is barred under section 527 of the Federal Food, Drug… | |||
| 21:21:5.0.1.1.6.4.1.2 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | D | Subpart D—Orphan-drug Exclusive Approval | § 316.34 FDA recognition of exclusive approval. | FDA | [78 FR 35135, June 12, 2013] | (a) FDA will send the sponsor (or, the permanent-resident agent, if applicable) timely written notice recognizing exclusive approval once the marketing application for a designated orphan-drug product has been approved, if the same drug has not already been approved for the same use or indication. The written notice will inform the sponsor of the requirements for maintaining orphan-drug exclusive approval for the full 7-year term of exclusive approval. (b) When a marketing application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for a designated orphan drug that qualifies for exclusive approval, FDA will publish in its publication entitled “Approved Drug Products With Therapeutic Equivalence Evaluations” information identifying the sponsor, the drug, and the date of termination of the orphan-drug exclusive approval. A subscription to this publication and its monthly cumulative supplements is available from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, and is also available online at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. (c) If a drug is otherwise the same drug as a previously approved drug for the same use or indication, FDA will not recognize orphan-drug exclusive approval if the sponsor fails to demonstrate upon approval that the drug is clinically superior to the previously approved drug. | |||
| 21:21:5.0.1.1.6.4.1.3 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | D | Subpart D—Orphan-drug Exclusive Approval | § 316.36 Insufficient quantities of orphan drugs. | FDA | (a) Under section 527 of the act, whenever the Director has reason to believe that the holder of exclusive approval cannot assure the availability of sufficient quantities of an orphan drug to meet the needs of patients with the disease or condition for which the drug was designated, the Director will so notify the holder of this possible insufficiency and will offer the holder one of the following options, which must be exercised by a time that the Director specifies: (1) Provide the Director in writing, or orally, or both, at the Director's discretion, views and data as to how the holder can assure the availability of sufficient quantities of the orphan drug within a reasonable time to meet the needs of patients with the disease or condition for which the drug was designated; or (2) Provide the Director in writing the holder's consent for the approval of other marketing applications for the same drug before the expiration of the 7-year period of exclusive approval. (b) If, within the time that the Director specifies, the holder fails to consent to the approval of other marketing applications and if the Director finds that the holder has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated, the Director will issue a written order withdrawing the drug product's exclusive approval. This order will embody the Director's findings and conclusions and will constitute final agency action. An order withdrawing the sponsor's exclusive marketing rights may issue whether or not there are other sponsors that can assure the availability of alternative sources of supply. Once withdrawn under this section, exclusive approval may not be reinstated for that drug. | ||||
| 21:21:5.0.1.1.6.5.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | E | Subpart E—Open Protocols for Investigations | § 316.40 Treatment use of a designated orphan drug. | FDA | [74 FR 40945, Aug. 13, 2009] | Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter. | |||
| 21:21:5.0.1.1.6.6.1.1 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | F | Subpart F—Availability of Information | § 316.50 Guidance documents. | FDA | [78 FR 35135, June 12, 2013] | FDA's Office of Orphan Products Development will maintain and make publicly available a list of guidance documents that apply to the regulations in this part. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993. | |||
| 21:21:5.0.1.1.6.6.1.2 | 21 | Food and Drugs | I | D | 316 | PART 316—ORPHAN DRUGS | F | Subpart F—Availability of Information | § 316.52 Availability for public disclosure of data and information in requests and applications. | FDA | (a) FDA will not publicly disclose the existence of a request for orphan-drug designation under section 526 of the act prior to final FDA action on the request unless the existence of the request has been previously publicly disclosed or acknowledged. (b) Whether or not the existence of a pending request for designation has been publicly disclosed or acknowledged, no data or information in the request are available for public disclosure prior to final FDA action on the request. (c) Upon final FDA action on a request for designation, FDA will determine the public availability of data and information in the request in accordance with part 20 and § 314.430 of this chapter and other applicable statutes and regulations. (d) In accordance with § 316.28, FDA will make a cumulative list of all orphan drug designations available to the public and update such list monthly. (e) FDA will not publicly disclose the existence of a pending marketing application for a designated orphan drug for the use for which the drug was designated unless the existence of the application has been previously publicly disclosed or acknowledged. (f) FDA will determine the public availability of data and information contained in pending and approved marketing applications for a designated orphan drug for the use for which the drug was designated in accordance with part 20 and § 314.430 of this chapter and other applicable statutes and regulations. | ||||
| 9:9:2.0.2.1.17.0.7.1 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.1 Authorization required to make devices bearing official marks. | FSIS | No brand manufacturer, printer or other person shall cast, print, lithograph, or otherwise make or cause to be made any device containing any official mark or simulation thereof without prior written authority therefor from the Administrator as provided for in part 317 of this subchapter. | ||||||
| 9:9:2.0.2.1.17.0.7.10 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.10 Marking of meat food products with official inspection legend and ingredient statement. | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 37 FR 16863, Aug. 22, 1972; 38 FR 4385, Feb. 14, 1973; 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, 1979] | (a) Inspected and passed sausages and other products in casings or in link form, of the ordinary “ring” variety or larger shall be marked with the official inspection legend and list of ingredients in accordance with part 317 of this subchapter. The official marks required by this section shall be branded near each end of the sausage or similar product prepared in casings when the product is of a size larger than that customarily sold at retail intact. (b) Inspected and passed sausage and other products, in casings or in link form, of the smaller varieties, shall bear one or more official inspection legends and one or more lists of ingredients in accordance with part 317 of this subchapter on each kilogram (2.205 lbs.) of product, except where such products leave the official establishment completely enclosed in properly labeled immediate containers having a capacity of 5 kilograms (11.025 lbs.) or less and containing a single kind of product: Provided, That such products in properly labeled closed containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to another official establishment for further processing or to a governmental agency, need only have the official inspection legend and list of ingredients shown twice throughout the contents of the container. When such products are shipped to another official establishment for further processing, the inspector in charge at the point of origin shall identify the shipment to the inspector in charge at destination by means of Form MP 408-1. (c) The list of ingredients may be applied by stamping, printing, using paper bands, tags, or tissue strips, or other means approved by the Administrator in specific cases. (d) All cured products shall be marked with the list of ingredients in accordance with part 317 of this subchapter. | |||||
| 9:9:2.0.2.1.17.0.7.11 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.11 Special markings for certain meat food products. | FSIS | (a) Meat food products prepared in casing or link form (whether or not thereafter subdivided), other than sausage, which possess the characteristics of or resemble sausage, shall bear on each link or piece the word “imitation” prominently displayed: Provided, That the following need not be so marked if they bear on each link or piece the name of the product in accordance with § 317.2 of this subchapter: Such products as coppa, capocollo, lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts of meat which are prepared without added substance other than curing materials or condiments; meat rolls, bockwurst, and similar products which do not contain cereal or vegetables; headcheese, souse, sulze, scrapple, blood pudding, and liver pudding; and other products such as loaves, chili con carne, and meat and cheese products when prepared with sufficient cheese to give definite characteristics to the finished products: And provided further, That imitation sausage packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact, need not bear the word “imitation” on each link or piece if no other marking or labeling is applied directly to the product. (b) When cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, or calcium reduced dried skim milk is added to sausage in casing or in link form within the limits prescribed in part 319 of this subchapter, the products shall be marked with the name of each added ingredient, as for example “cereal added,” “potato flour added,” “cereal and potato flour added,” “soy flour added,” “isolated soy protein added,” “nonfat dry milk added,” “calcium reduced dried skim milk added,” or “cereal and nonfat dry milk added,” as the case may be. (c)(1) When product is placed in a casing to which artificial coloring is thereafter applied, as permitted in part 318 of this subchapter, the product shall be legibly and conspicuously marked… | ||||||
| 9:9:2.0.2.1.17.0.7.12 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.12 Marking of equine carcasses and parts thereof. | FSIS | (a) All inspected and passed equine carcasses and parts thereof prepared at any establishment shall be conspicuously marked at the time of inspection with the official inspection legend as prescribed in § 312.3 of this subchapter and with other information prescribed for marking products in this part. (b) All equine carcasses and meat and other parts thereof shall be marked to show the kinds of animals from which they were derived, before the products are sold, transported, offered for sale or transportation, or received for transportation in commerce. | ||||||
| 9:9:2.0.2.1.17.0.7.13 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.13 Marking of outside containers. | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978] | (a) Except as otherwise provided in part 325 of this subchapter, when any inspected and passed product for domestic commerce is moved from an official establishment, the outside container shall bear an official inspection legend as prescribed in part 312 of this subchapter. (b) When any product prepared in an official establishment for domestic commerce has been inspected and passed and is enclosed in a cloth or other wrapping, such wrapping shall bear the official inspection legend and official establishment number applied by the approved 2 1/2 -inch rubber brand in the form prescribed in part 312 of this subchapter: Provided, That the rubber brand may be omitted if the official inspection legend and official establishment number on the product itself are clearly legible through the wrapping or the wrapping is labeled in accordance with part 317 of this subchapter: Provided further, That plain unprinted wrappings, such as stockinettes, cheesecloth, paper, and crinkled paper bags, for properly marked products, which are used solely to protect the product against soiling or excessive drying during transportation or storage, need not bear the official inspection legend. (c) The outside containers of products for export shall be marked in compliance with part 322 of this subchapter as well as this part. (d) Slack barrels used as outside containers of products shall have a cloth or paper top covering bearing the official inspection legend containing the official establishment number. At the time of removal of the covering, the official inspection legend shall be destroyed. (e) The outside containers of any product which has been inspected and passed for cooking, pork which has been refrigerated as provided in § 318.10(c) of this subchapter, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in § 325.7(b) of this subchapter. (f) The outside containers of glands and organs which are not used for human food purposes, such as those described in § 325.19 of … | |||||
| 9:9:2.0.2.1.17.0.7.14 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.14 Marking tank cars and tank trucks used in transportation of edible products. | FSIS | [53 FR 28634, July 29, 1988] | Each tank car and each tank truck carrying inspected and passed product from an official establishment shall bear a label containing the name of the product in accordance with § 317.2 of this subchapter, the official inspection legend containing the number of the official establishment and the words “date of loading,” followed by a suitable space in which the date the tank car or tank truck is loaded shall be inserted. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label. | |||||
| 9:9:2.0.2.1.17.0.7.15 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.15 Marking outside containers of inedible grease, etc. | FSIS | (a) Outside containers of inedible grease, inedible tallow, or other inedible animal fat, or mixture of any such articles, resulting from operations at any official establishment shall be marked conspicuously with the word “inedible” prior to removal from the point of filling. Containers, such as tierces, barrels, and half barrels shall have both ends painted white with durable paint, if necessary, to provide a contrasting background, and the word “inedible” shall be marked thereon in letters not less than 2 inches high, while on tank cars and tank trucks the letters shall be not less than 4 inches high. (b) Inspected rendered animal fat which is intended not to be used for human food may also be marked “inedible” if handled as provided in paragraph (a) of this section and part 314 of this subchapter. | ||||||
| 9:9:2.0.2.1.17.0.7.16 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.16 Custom prepared products to be marked “Not for Sale.” | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973] | Carcasses and parts therefrom that are prepared on a custom basis under § 303.1(a)(2) of this subchapter shall be marked at the time of preparation with the term “Not for Sale” in letters at least three-eighths inch in height, except that such products need not be so marked if in immediate containers properly labeled in accordance with the regulations in § 317.16 of this subchapter. Ink used for marking such products must comply with the requirements of § 316.5. | |||||
| 9:9:2.0.2.1.17.0.7.2 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.2 Approval required for official marks. | FSIS | No device containing any official mark shall be made or caused to be made for use on any product until it has been approved by the Administrator as provided for in part 317 of this subchapter. | ||||||
| 9:9:2.0.2.1.17.0.7.3 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.3 Use of official marks prohibited except under supervision of Program employee; removal of official marks, when required. | FSIS | (a) No person shall affix or place, or cause to be affixed or placed, the official inspection legend or any other official mark, or any abbreviation or simulation of any official mark, to or on any product, or container thereof, except under the supervision of a Program employee, or as authorized by part 317 of this subchapter in connection with the manufacture of containers. (b) No person shall fill, or cause to be filled, in whole or in part, with any product, any container bearing or intended to bear any official mark, or any abbreviation or simulation of any official mark, except under the supervision of a Program employee. (c) Product bearing any official mark shall not be canned, cooked, cured, smoked, salted, packed, rendered, or otherwise prepared by any person for commercial purposes unless: (1) Such preparation is performed at an official establishment; or (2) Such preparation is conducted under State or other governmental inspection and the prepared product is marked to show that fact; or (3) The official marks are removed, defaced, or otherwise destroyed before or during such preparation; or (4) The preparation of the product consists solely of cutting up operations at any establishment exempted from inspection under paragraph 301(c)(2) of the Act or equal provisions of a law of a State or organized Territory or at any establishment in an unorganized Territory exempted under paragraph 23(b) of the Act. | ||||||
| 9:9:2.0.2.1.17.0.7.4 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.4 Marking devices; to be furnished by official establishments; control of. | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971; 46 FR 38072, July 24, 1981] | (a) The operator of each official establishment or official import inspection establishment shall furnish such ink brands, burning brands, and any other device for marking products with official marks as the Administrator may determine is necessary for marking products at such establishment. The official inspection legend on such a device shall be as prescribed in part 312 of this subchapter. (b) All official devices for marking products with the official inspection legend, or other official inspection marks, including self-locking seals, shall be used only under supervision of a Program employee, and, when not in use for marking shall be kept locked in properly equipped locks or compartments, the keys of which shall not leave the possession of a Program employee, or the locker or compartment shall be sealed with an official seal of the Department as prescribed in part 312 of this subchapter. | |||||
| 9:9:2.0.2.1.17.0.7.5 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.5 Branding ink; to be furnished by official establishments; approval by Program; color. | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 38 FR 9088, Apr. 10, 1973] | (a) The operator of each official establishment shall furnish all ink for marking products with the official marks at such establishment. Such ink must be made with harmless ingredients that are approved for the purpose by the Administrator. Samples of inks shall be submitted to the Program laboratory from time to time as may be deemed necessary by the inspector in charge. (b) Only ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses of cattle, sheep, swine, or goats and fresh meat cuts derived therefrom. Any ink containing F.D. & C. Violet No. 1 shall not be considered an approved ink within the meaning of this paragraph. (c) Green ink shall not be used to apply marks to carcasses of cattle, sheep, swine, or goats or fresh meat cuts derived therefrom. (d) Except as provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose by the Administrator in specific cases, may be used to apply ink brands, bearing official marks, to processed meat cuts derived from cattle, sheep, swine, or goats. (e) Only green ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses and parts of carcasses and meat cuts derived from horses, mules, and other equines. (f) Ink used must assure legibility and permanence of the markings and the color of ink shall provide acceptable contrast with the color of the product to which it is applied. | |||||
| 9:9:2.0.2.1.17.0.7.6 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.6 Products not to be removed from official establishments unless marked in accordance with the regulations. | FSIS | No person shall remove or cause to be removed from an official establishment any products which the regulations in this subchapter require to be marked in any way unless they are clearly and legibly marked in compliance with such regulations. | ||||||
| 9:9:2.0.2.1.17.0.7.7 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.7 Marking devices not to be false or misleading; style and size of lettering; approval required. | FSIS | No brand or other marking device shall be false or misleading. The letters and figures thereon shall be of such style and type as will make a clear and legible impression. All markings to be applied to products in an official establishment shall be approved prior to use by the Administrator as provided for in § 317.3 of this subchapter, except that official markings prescribed by the Federal meat grading regulations (7 CFR 53.19) need not be submitted to the Administrator for approval. | ||||||
| 9:9:2.0.2.1.17.0.7.8 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.8 Unmarked inspected products; moved between official establishments; moved in commerce. | FSIS | (a) Unmarked products which have been inspected and passed but do not bear the official inspection legend may be transported in compliance with part 325 of this subchapter from one official establishment to another official establishment, for further processing, in a railroad car, truck, or other closed container, if the railroad car, truck, or container is sealed with an official seal of the Department (as prescribed in part 312 of this subchapter) bearing the official inspection legend. (b) Products which have been inspected and passed but do not bear the official inspection legend may be removed from an official establishment in closed containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: Provided, That upon removal from such closed container the product may not be further transported in commerce unless such removal is made under the supervision of a Program employee and such product is reinspected by a Program employee and packed under his supervision in containers bearing the official inspection legend and all other information required by this part and part 317 of this subchapter: And provided further, That unmarked product shall not be brought into an official establishment in an open container. | ||||||
| 9:9:2.0.2.1.17.0.7.9 | 9 | Animals and Animal Products | III | A | 316 | PART 316—MARKING PRODUCTS AND THEIR CONTAINERS | § 316.9 Products to be marked with official marks. | FSIS | [35 FR 15577, Oct. 3, 1970, as amended at 36 FR 23720, Dec. 14, 1971; 84 FR 9698, Mar. 18, 2019] | (a) Each carcass that has been inspected and passed in an official establishment must be marked at the time of inspection with the official inspection legend containing the number of the official establishment, if the carcass is to be shipped into commerce from the establishment without further processing. (b) A passed and inspected carcass that is to be further processed in the slaughtering establishment need not be marked with the official inspection legend at the time of inspection. (c) Except as provided otherwise in § 316.8, each primal part of a carcass and each liver, beef tongue, and beef heart which has been inspected and passed shall be marked with the official inspection legend containing the number of the official establishment before it leaves the establishment in which it is first inspected and passed, and each such inspected and passed product shall be marked with the official inspection legend containing the number of the official establishment where it was last prepared. Additional official marks of inspection may be applied to products as desired to meet local conditions. Primal parts are the wholesale cuts of carcasses as customarily distributed to retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank are primal parts of beef carcasses. Veal, mutton, and goat primal parts are the leg; flank, loin, rack, breast, and shoulder. The ham, belly, loin, shoulder, and jowl are pork primal parts. Equine primal parts are the round, flank, loin, rib, plate, brisket, chuck, and shank. (d) Beef livers shall be marked with the official inspection legend containing the number of the official establishment, at which the cattle involved were slaughtered, on the convex surface of the thickest portion of the organ. (e) Inspected and passed parts of carcasses which are not marked with the official inspection legend under this section shall not enter any official establishment or be sold, transported, or offered for sale or transportation, in commerce, except as provided in § 316.8. |
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