r/title-21-FOOD-AND-DRUGS wiki — defined terms

“prescription drug” applies in that section

the term “prescription drug” means a drug subject to section 353(b)(1) of this title .

“qualified infectious disease product” applies in that section

The term “qualified infectious disease product” means a drug (including a biological product), including an antibacterial or antifungal drug, 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 under subsection (f).

“qualifying pathogen” applies in that section

the term “qualifying pathogen” means a pathogen identified and listed by the Secretary under paragraph (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 resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species; (C) multi-drug resistant tuberculosis; and (D) Clostridium difficile.

“real world evidence” applies in that section

the term “real world evidence” means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. (c) Program framework (1) In general Not later than 2 years after December 13, 2016 , the Secretary shall establish a draft framework for implementation of the program under this section.

“human data studies” applies in that section

The term “human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.;

“new human data studies” applies in that section

the term “new human data studies” means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which— (I) have not been relied on by the Secretary to support— (aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title ; or (bb) approval of a drug that was approved under section 355 of this title ; and (II) do not duplicate the results of another study that was relied on by the Secretary to support— (aa) a proposed or final determination that a drug described in subclause …

“non-human data” applies in that section

The term “non-human data” means data from testing other than with human subjects which provides information concerning safety or effectiveness. (C) Hearing procedures (i) Denial of request for hearing If the Secretary determines that information submitted in a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies.

“adverse drug experience” applies in that section

The term “adverse drug experience” means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including— (A) an adverse event occurring in the course of the use of the drug in professional practice; (B) an adverse event occurring from an overdose of the drug, whether accidental or intentional; (C) an adverse event occurring from abuse of the drug; (D) an adverse event occurring from withdrawal of the drug; and (E) any failure of expected pharmacological action of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in …

“covered application” applies in that section

The term “covered application” means an application referred to in section 355(p)(1)(A) of this title . (3) New safety information The term “new safety information”, with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study (including a study under section 355( o )(3) of this title), or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system under section 355(k) of this title ; or other scientific data deemed appropriate by the Secretary about— (A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be …

“different, comparable aspect of the elements to assure safe use” applies in that section

the term “different, comparable aspect of the elements to assure safe use” means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 355(j) of this title that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 355(j) of this title with the same such listed drug, but achieves the same level of safety as such strategy.

“responsible person” applies in that section

The term “responsible person” means the person submitting a covered application or the holder of the approved such application. (8) Unexpected serious risk

“serious risk” applies in that section

The term “serious risk” means a risk of a serious adverse drug experience. (6) Signal of a serious risk

“signal of a serious risk” applies in that section

The term “signal of a serious risk” means information related to a serious adverse drug experience associated with use of a drug and derived from— (A) a clinical trial; (B) adverse event reports; (C) a postapproval study, including a study under section 355( o )(3) of this title; (D) peer-reviewed biomedical literature; (E) data derived from the postmarket risk identification and analysis system under section 355(k)(4) of this title ; or (F) other scientific data deemed appropriate by the Secretary. (7) Responsible person

“unexpected serious risk” applies in that section

The term “unexpected serious risk” means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.

“antitrust laws” applies in that section

the term “antitrust laws”— (A) has the meaning given the term in subsection (a) of section 12 of title 15 ; and (B) includes section 45 of title 15 to the extent that such section applies to unfair methods of competition. (2) Antitrust laws Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.

“commercially reasonable, market-based terms” applies in that section

the term “commercially reasonable, market-based terms” means— (A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in section 1395w–3a(c)(6)(B) of title 42 ; (B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and (C) no additional conditions are imposed on the sale of the covered product;

“covered product” applies in that section

the term “covered product”— (A) means— (i) any drug approved under subsection (c) or (j) of section 355 of this title or biological product licensed under subsection (a) or (k) of section 262 of title 42 ; (ii) any combination of a drug or biological product described in clause (i); or (iii) when reasonably necessary to support approval of an application under section 355 of this title , or section 262 of title 42 , as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and (B) does not include any drug or biological product that appears on the …

“device” applies in that section

the term “device” has the meaning given the term in section 321 of this title ;

“eligible product developer” applies in that section

the term “eligible product developer” means a person that seeks to develop a product for approval pursuant to an application for approval under subsection (b)(2) or (j) of section 355 of this title or for licensing pursuant to an application under section 262(k) of title 42 ;

“license holder” applies in that section

the term “license holder” means the holder of an application approved under subsection (c) or (j) of section 355 of this title or the holder of a license under subsection (a) or (k) of section 262 of title 42 for a covered product;

“REMS” applies in that section

the term “REMS” means a risk evaluation and mitigation strategy under section 355–1 of this title ;

“REMS with ETASU” applies in that section

the term “REMS with ETASU” means a REMS that contains elements to assure safe use under section 355–1(f) of this title ;

“Secretary” applies in that section

the term “Secretary” means the Secretary of Health and Human Services;

“single, shared system of elements to assure safe use” applies in that section

the term “single, shared system of elements to assure safe use” means a single, shared system of elements to assure safe use under section 355–1(f) of this title ; and;

“sufficient quantities” applies in that section

the term “sufficient quantities” means an amount of a covered product that the eligible product developer determines allows it to— (A) conduct testing to support an application under— (i) subsection (b)(2) or (j) of section 355 of this title ; or (ii) section 262(k) of title 42 ; and (B) fulfill any regulatory requirements relating to approval of such an application.

“regenerative medicine therapy” applies in that section

the term “regenerative medicine therapy” includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act [ 42 U.S.C. 264 ] and part 1271 of title 21, Code of Federal Regulations.

“drug” applies in that section

the term “drug”— (A) means a drug (as defined in section 321(g) of this title ) that is intended for human use and that is subject to section 353(b)(1) of this title ; and (B) does not include biological products (as defined in section 262 of title 42 ), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i); (2) the term “drug shortage” or “shortage”, with respect to a drug, means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug; and;

“meaningful disruption” applies in that section

the term “meaningful disruption”— (A) means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; and (B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (i) Regulations (1) In general Not later than 18 months after July 9, 2012 , the Secretary shall adopt a final regulation implementing this section.

“drug shortage” applies in that section

the term “drug shortage” or “shortage” has the meaning given such term in section 356c of this title .

“shortage” applies in that section

the term “drug shortage” or “shortage” has the meaning given such term in section 356c of this title .

“health system” applies in that section

The term “health system” means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients. (3) Repackage For the purposes of this section only, the term “repackage”, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to— (A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under section 356e of this title ; and (B) facilitate access to the drug by hospitals within the same health system.

“generic drug” applies in that section

The term “generic drug” means a drug that is approved pursuant to section 355(j) of this title .;

“inadequate generic competition” applies in that section

The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs 1 on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is— (A) the reference listed drug; or (B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.;

“reference listed drug” applies in that section

The term “reference listed drug” means the listed drug (as such term is used in section 355(j) of this title ) for the drug involved.

“meaningful disruption” applies in that section

The term “meaningful disruption”— (A) means a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; (B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months; (C) does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the …

“designated platform technology” applies in that section

The term “designated platform technology” means a platform technology that is designated as a platform technology under subsection (d). (i) Rule of construction Nothing in this section shall be construed to— (1) alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act [ 21 U.S.C. 355 ] or license biological products pursuant to section 351 of the Public Health Service Act [ 42 U.S.C.

“platform technology” applies in that section

The term “platform technology” means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates— (A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biological product; (B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and (C) facilitates the manufacture or development of more than one drug or biological product …

“priority countermeasure” applies throughout this title

The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4) 1 of title 42.;

“priority drugs or biological products” applies throughout this title

The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

“biomarker” applies in that section

The term “biomarker”— (A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and (B) includes a surrogate endpoint. (2) Biomedical research consortia

“biomedical research consortia” applies in that section

The term “biomedical research consortia” means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 1001(a) of title 20 ), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals. (3) Clinical outcome assessment

“clinical outcome assessment” applies in that section

The term “clinical outcome assessment” means— (A) a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and (B) includes a patient-reported outcome. (4) Context of use

“context of use” applies in that section

The term “context of use” means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review. (5) Drug development tool

“drug development tool” applies in that section

The term “drug development tool” includes— (A) a biomarker; (B) a clinical outcome assessment; and (C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section. (6) Patient-reported outcome

“patient-reported outcome” applies in that section

The term “patient-reported outcome” means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person. (7) Qualification

“qualification” applies in that section

The terms “qualification” and “qualified” mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this chapter. (8) Requestor

“qualified” applies in that section

The terms “qualification” and “qualified” mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this chapter. (8) Requestor

“requestor” applies in that section

The term “requestor” means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section. (9) Surrogate endpoint

“surrogate endpoint” applies in that section

The term “surrogate endpoint” means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and— (A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or (B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title .

“manufacture, preparation, propagation, compounding, or processing” applies in that section

the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and;

“name” applies in that section

the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. (b) Annual registration (1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.

“region of interest” applies in that section

the term “region of interest” means a foreign geographic region or country, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate.

“wholesale distributor” applies in that section

the term “wholesale distributor” means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. (h) Inspections (1) In general Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 374 of this title .

“qualified infectious disease product” applies in that section

the term “qualified infectious disease product” has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355f(g) ], as added by section 801 of this Act.

“antimicrobial drug” applies in that section

The term “antimicrobial drug” means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that— (i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus; (ii) may include a qualified infectious disease product designated under section 355f(d) of this title ; and (iii) is subject to section 353(b)(1) of this title . (B) If provided by the Secretary through regulations, such term may include— (i) drugs other than systemic antibacterial and antifungal drugs; and (ii) biological products (as such term is defined in section 262 of title 42 ) to the extent such products exhibit antimicrobial activity.;

“antimicrobial susceptibility testing device” applies in that section

The term “antimicrobial susceptibility testing device” means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).;

“interpretive criteria standard” applies in that section

The term “interpretive criteria standard” means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).

“qualified infectious disease product” applies in that section

The term “qualified infectious disease product” means a qualified infectious disease product designated under section 355f(d) of this title .;

“susceptibility test interpretive criteria” applies in that section

The term “susceptibility test interpretive criteria” means— (A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and (B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate. (4);

“bioequivalence” applies in that section

The term “bioequivalence” means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a new animal drug and becomes available at the site of drug action. (ii) A new animal drug shall be considered to be bioequivalent to the approved new animal drug referred to in its application under subsection (n) if— (I) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses; (II) the extent of …

“date of approval” applies in that section

the term “date of approval” shall mean the later of— (A) the date an application under subsection (b) is approved under subsection (c); or (B) the date of issuance of the interim final rule controlling the drug.

“patent” applies in that section

the term “patent” means a patent issued by the United States Patent and Trademark Office. (p) Safety and effectiveness data (1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) or section 360ccc(a) of this title for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— (A) if no work is being or will be undertaken to have the application approved, (B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, (C) if approval of the application under subsection …

“substantial evidence” applies in that section

the term “substantial evidence” means evidence consisting of one or more adequate and well controlled investigations, such as— (A) a study in a target species; (B) a study in laboratory animals; (C) any field investigation that may be required under this section and that meets the requirements of subsection (b)(3) if a presubmission conference is requested by the applicant; (D) a bioequivalence study; or (E) an in vitro study; by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have …

“rare disease or condition” applies in that section

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.

“eligible investigational drug” applies in that section

the term “eligible investigational drug” means an investigational drug (as such term is used in section 360bbb of this title )— (A) for which a Phase 1 clinical trial has been completed; (B) that has not been approved or licensed for any use under section 355 of this title or section 351 of the Public Health Service Act [ 42 U.S.C. 262 ]; (C) (i) for which an application has been filed under section 355(b) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C.

“eligible patient” applies in that section

the term “eligible patient” means a patient— (A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); (B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— (i) is in good standing with the physician’s licensing organization or board; and (ii) will not be compensated directly by the manufacturer for so certifying; and (C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on …

“phase 1 trial” applies in that section

the term “phase 1 trial” means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). (b) Exemptions Eligible investigational drugs provided to eligible patients in compliance with this section are exempt from sections 352(f), 353(b)(4), 355(a), and 355(i) of this title, section 351(a) of the Public Health Service Act [ 42 U.S.C.

“biological product” applies in that section

The term “biological product” has the meaning given such term in section 351 of the Public Health Service Act [ 42 U.S.C. 262 ].;

“emergency use” applies in that section

The term “emergency use” has the meaning indicated for such term in paragraph (1).;

“product” applies in that section

The term “product” means a drug, device, or biological product.;

“unapproved product” applies in that section

The term “unapproved product” has the meaning indicated for such term in paragraph (2)(A).;

“unapproved use of an approved product” applies in that section

The term “unapproved use of an approved product” has the meaning indicated for such term in paragraph (2)(B). (b) Declaration of emergency or threat justifying emergency authorized use (1) In general The Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of— (A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (B) a determination by the Secretary of Defense that there is a military emergency, or a …

“eligible product” applies in that section

The term “eligible product” means a product that— (A) is approved or cleared under this subchapter, conditionally approved under section 360ccc of this title , or licensed under section 351 of the Public Health Service Act [ 42 U.S.C.

“expiration date” applies in that section

the term “expiration date” means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.

“product” applies in that section

The term “product” means a drug, device, or biological product. (b) Expiration dating (1) In general The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if— (A) the expiration date extension is intended to support the United States ability to protect— (i) the public health; or (ii) military preparedness and effectiveness; and (B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.

“medical product” applies in that section

the term “medical product” means a drug (as defined in section 321 of this title ), a device (as defined in such section 321 of this title ), or a biological product (as defined in section 262 of title 42 ).

“countermeasure” applies in that section

the term “countermeasure” means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;

“eligible countermeasure” applies in that section

the term “eligible countermeasure” means— (A) a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 247d–6b(c) of title 42 ; or (B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 247d–7e of title 42 for advanced research and development.

“qualified countermeasure” applies in that section

the term “qualified countermeasure” has the meaning given such term in section 247d–6a of title 42 ;

“qualified pandemic or epidemic product” applies in that section

the term “qualified pandemic or epidemic product” means a product that meets the definition given such term in section 247d–6d of title 42 and— (A) that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or (B) is included under this paragraph pursuant to a determination by the Secretary.

“security countermeasure” applies in that section

the term “security countermeasure” has the meaning given such term in section 247d–6b of title 42 ; and;

“human drug application” applies in that section

The term “human drug application” has the meaning given such term in section 379g(1) of this title . (2) Priority review The term “priority review”, with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act. (3) Priority review voucher

“material threat medical countermeasure application” applies in that section

The term “material threat medical countermeasure application” means an application that— (A) is a human drug application for a drug intended for use— (i) to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act [ 42 U.S.C.

“priority review voucher” applies in that section

The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] after the date of approval of the material threat medical countermeasure application. (4) Material threat medical countermeasure application

“master file holder” applies in that section

The term “master file holder” means a person who submits data and information to the Secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission, as described in subsection (a).;

“medical countermeasure submission” applies in that section

The term “medical countermeasure submission” means an investigational new drug application under section 355(i) of this title , a new drug application under section 355(b) of this title , or an abbreviated new drug application under section 355(j) of this title , a biological product license application under section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] or a biosimilar biological product license application under section 351(k) of the Public Health Service Act [ 42 U.S.C.

“qualified countermeasure” applies in that section

The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic product” have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [ 42 U.S.C. 247d–6a , 247d–6b, 247d–6d].

“qualified pandemic or epidemic product” applies in that section

The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic product” have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [ 42 U.S.C. 247d–6a , 247d–6b, 247d–6d].

“security countermeasure” applies in that section

The terms “qualified countermeasure”, “security countermeasure”, and “qualified pandemic or epidemic product” have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [ 42 U.S.C. 247d–6a , 247d–6b, 247d–6d].

“eligible entity” applies in that section

the term “eligible entity” means an entity that meets each of the following: (1) The entity is— (A) an institution of higher education (as such term is defined in section 1001 of title 20 ) or a consortium of such institutions; or (B) an organization described in section 501(c)(3) of title 26 and exempt from tax under section 501(a) of such title. (2) The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.

“medical product” applies in that section

the term “medical product” includes a drug, a biological product as defined in section 262 of title 42 , a device, and any combination of such products. (f) Authorization of appropriations To carry out this section, there is authorized to be appropriated $1,380,822 for the period beginning on October 1, 2022 and ending on December 23, 2022 . 1

“regulated person” applies in that section

the term “regulated person” means— (1) a person who is required to register under section 360 or 381(s) of this title; (2) a wholesale distributor of a drug product; or (3) any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.

“medical product” applies in that section

the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title , a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [ 42 U.S.C. 262(i) ]. (c) Savings clause Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [ 42 U.S.C. 201 et seq.].

“financial interest” applies in that section

the term “financial interest” means a financial interest under section 208(a) of title 18 . (b) Statement of patient experience (1) In general Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016 , the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application.

“patient experience data” applies in that section

the term “patient experience data” includes data that— (1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and (2) are intended to provide information about patients’ experiences with a disease or condition, including— (A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and (B) patient preferences with respect to treatment of such disease or condition.

“adequate expertise” applies in that section

the term “adequate expertise” means that the membership of the classification panel includes— (i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and (ii) at least one voting member who is knowledgeable about the technology of the device. (D) The Secretary shall provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.

“different technological characteristics” applies in that section

the term “different technological characteristics” means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device. (C) To facilitate reviews of reports submitted to the Secretary under section 360(k) of this title , the Secretary shall consider the extent to which reliance on postmarket controls may expedite the classification of devices under subsection (f)(1) of this section.

“necessary” applies in that section

the term “necessary” means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device. (iv) Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device. (v) The determination of the Secretary with respect to the specification of valid scientific evidence under clauses (i) and (ii) shall be binding upon the Secretary, unless such determination by the Secretary could be contrary to the public health.

“substantial equivalence” applies in that section

the term “substantially equivalent” or “substantial equivalence” means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device— (i) has the same technological characteristics as the predicate device, or (ii) (I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title , that demonstrates that the device is as safe …

“substantially equivalent” applies in that section

the term “substantially equivalent” or “substantial equivalence” means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device— (i) has the same technological characteristics as the predicate device, or (ii) (I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title , that demonstrates that the device is as safe …

“approved use or indication” applies in that section

the term “approved use or indication” means the use or indication approved under section 355 of this title or licensed under section 262 of title 42 for a drug designated under section 360bb of this title for a rare disease or condition.

“date of approval” applies in that section

the term “date of approval” shall mean the later of— (i) the date an application under subsection (a) is conditionally approved under subsection (b); or (ii) the date of issuance of the interim final rule controlling the drug. (e) Withdrawal of conditional approval (1) The Secretary shall issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that another person has received approval under section 360b of this title for the same drug in the same dosage form for the same intended use and that person is able to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended.

“transgenic animal” applies in that section

the term “transgenic animal” means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; Provided that the term “transgenic animal” does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding. (k) Sunset (1) The Secretary’s authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028 .

“manufacturing expenses” applies in that section

The term “manufacturing expenses” means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an application with respect to such new animal drug is submitted under section 360b or 360ccc of this title.

“qualified safety and effectiveness testing” applies in that section

The term “qualified safety and effectiveness testing” means testing— (i) which occurs after the date such new animal drug is designated under this section and before the date on which an application with respect to such drug is submitted under section 360b of this title ; and (ii) which is carried out under an investigational exemption under section 360b(j) of this title .;

“designated medical gas” applies throughout its part

The term “designated medical gas” means any of the following: (A) Oxygen that meets the standards set forth in an official compendium. (B) Nitrogen that meets the standards set forth in an official compendium. (C) Nitrous oxide that meets the standards set forth in an official compendium. (D) Carbon dioxide that meets the standards set forth in an official compendium. (E) Helium that meets the standards set forth in an official compendium. (F) Carbon monoxide that meets the standards set forth in an official compendium. (G) Medical air that meets the standards set forth in an official compendium.

“medical gas” applies throughout its part

The term “medical gas” means a drug that— (A) is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and (B) is administered as a gas.

“necessary” applies in that section

the term “necessary” means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device. (C) For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness. (D) Nothing in this paragraph alters the standards for premarket approval of a device.

“medical food” applies in that section

The term “medical food” means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. (c) Authorization of appropriations For grants and contracts under subsection (a), there is authorized to be appropriated $6,904,110 for the period beginning on October 1, 2022 and ending on December 23, 2022 . 1

“qualified testing” applies in that section

The term “qualified testing” means— (A) human clinical testing— (i) which is carried out under an exemption for a drug for a rare disease or condition under section 355(i) of this title (or regulations issued under such section); and (ii) which occurs before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 of title 42 ; (B) preclinical testing involving a drug for a rare disease or condition which occurs after the date such drug is designated under section 360bb of this title and before the date on which an application with respect to such drug is submitted under section 355(b) of this title or under section 262 …

“rare disease or condition” applies in that section

The term “rare disease or condition” means (1) in the case of a drug, 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, (2) in the case of a medical device, any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical device for such disease or condition will be developed without assistance under subsection (a), …

“affiliate” applies throughout its part

The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has the power to control, both of the business entities. (2) Authorized

“authorized” applies throughout its part

The term “authorized” means— (A) in the case of a manufacturer or repackager, having a valid registration in accordance with section 360 of this title ; (B) in the case of a wholesale distributor, having a valid license under State law or section 360eee–2 of this title , in accordance with section 360eee–1(a)(6) of this title , and complying with the licensure reporting requirements under section 353(e) of this title ; (C) in the case of a third-party logistics provider, having a valid license under State law or section 360eee–3(a)(1) of this title , in accordance with section 360eee–1(a)(7) of this title , and complying with the licensure reporting requirements under section 360eee–3(b) of …

“dispenser” applies throughout its part

The term “dispenser”— (A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and (B) does not include a person who dispenses only products to be used in animals in accordance with section 360b(a)(5) of this title .

“distribute” applies throughout its part

The term “distribute” or “distribution” means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title . (6) Exclusive distributor

“distribution” applies throughout its part

The term “distribute” or “distribution” means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title . (6) Exclusive distributor

“exclusive distributor” applies throughout its part

The term “exclusive distributor” means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s product to a subsequent repackager, wholesale distributor, or dispenser. (7) Homogeneous case

“homogeneous case” applies throughout its part

The term “homogeneous case” means a sealed case containing only product that has a single National Drug Code number belonging to a single lot. (8) Illegitimate product

“illegitimate product” applies throughout its part

The term “illegitimate product” means a product for which credible evidence shows that the product— (A) is counterfeit, diverted, or stolen; (B) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is the subject of a fraudulent transaction; or (D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans. (9) Licensed

“licensed” applies throughout its part

The term “licensed” means— (A) in the case of a wholesale distributor, having a valid license in accordance with section 353(e) of this title or section 360eee–1(a)(6) of this title , as applicable; (B) in the case of a third-party logistics provider, having a valid license in accordance with section 360eee–3(a) of this title or section 360eee–1(a)(7) of this title , as applicable; and (C) in the case of a dispenser, having a valid license under State law. (10) Manufacturer

“manufacturer” applies throughout its part

The term “manufacturer” means, with respect to a product— (A) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product; (B) a co-licensed partner of the person described in subparagraph (A) that obtains the product directly from a person described in this subparagraph or subparagraph (A) or (C); or (C) an affiliate of a person described in subparagraph (A) or (B) that receives the product directly from a person described in this subparagraph or subparagraph (A) or (B).

“package” applies throughout its part

The term “package” means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product. (B) Individual saleable unit For purposes of this paragraph, an “individual saleable unit” is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser. (12) Prescription drug

“prescription drug” applies in that section

The term “prescription drug” means a drug for human use subject to section 353(b)(1) of this title . (13) Product

“product” applies in that section

The term “product” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title , does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42 , imaging drugs, an intravenous product described in clause (xiv), (xv), or …

“product identifier” applies in that section

The term “product identifier” means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product. (15) Quarantine

“quarantine” applies in that section

The term “quarantine” means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures. (16) Repackager

“repackager” applies in that section

The term “repackager” means a person who owns or operates an establishment that repacks and relabels a product or package for— (A) further sale; or (B) distribution without a further transaction. (17) Return

“return” applies in that section

The term “return” means providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product. (18) Returns processor or reverse logistics provider

“returns processor” applies in that section

The term “returns processor” or “reverse logistics provider” means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution. (19) Specific patient need The term “specific patient need” refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient.

“reverse logistics provider” applies in that section

The term “returns processor” or “reverse logistics provider” means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution. (19) Specific patient need The term “specific patient need” refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient.

“standardized numerical identifier” applies in that section

The term “standardized numerical identifier” means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters. (21) Suspect product

“suspect product” applies in that section

The term “suspect product” means a product for which there is reason to believe that such product— (A) is potentially counterfeit, diverted, or stolen; (B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is potentially the subject of a fraudulent transaction; or (D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans. (22) Third-party logistics provider

“third-party logistics provider” applies in that section

The term “third-party logistics provider” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product. (23) Trading partner

“trading partner” applies in that section

The term “trading partner” means— (A) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or (B) a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product. (24) Transaction (A) In general

“transaction” applies in that section

The term “transaction” means the transfer of product between persons in which a change of ownership occurs. (B) Exemptions The term “transaction” does not include— (i) intracompany distribution of any product between members of an affiliate or within a manufacturer; (ii) the distribution of a product among hospitals or other health care entities that are under common control; (iii) the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section 247d of title 42 , except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason; (iv) the dispensing of a product pursuant to a …

“transaction history” applies in that section

The term “transaction history” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. (26) Transaction information

“transaction information” applies in that section

The term “transaction information” means— (A) the proprietary or established name or names of the product; (B) the strength and dosage form of the product; (C) the National Drug Code number of the product; (D) the container size; (E) the number of containers; (F) the lot number of the product; (G) the date of the transaction; (H) the date of the shipment, if more than 24 hours after the date of the transaction; (I) the business name and address of the person from whom ownership is being transferred; and (J) the business name and address of the person to whom ownership is being transferred.

“verification” applies in that section

The term “verification” or “verify” means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title . (29) Wholesale distributor

“verify” applies in that section

The term “verification” or “verify” means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title . (29) Wholesale distributor

“wholesale distributor” applies in that section

The term “wholesale distributor” means a person (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title ).

“pediatric subpopulation” applies in that section

the term “pediatric subpopulation” has the meaning given the term in section 360j(m)(6)(E)(ii) of this title .

“priority review voucher” applies in that section

The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] after the date of approval of the rare pediatric disease product application. (3) Rare pediatric disease

“rare pediatric disease” applies in that section

The term “rare pediatric disease” means a disease that meets each of the following criteria: (A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. (B) The disease is a rare disease or condition, within the meaning of section 360bb of this title . (4) Rare pediatric disease product application

“rare pediatric disease product application” applies in that section

The term “rare pediatric disease product application” means a human drug application, as defined in section 379g(1) of this title , that— (A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease; (B) (i) is for such a drug— (I) that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title ; and (II) that is the subject of an application submitted under section 355(b)(1) of this title ; or (ii) is for such a biological product— …

“Advisory Committee” applies throughout its part

the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

“final sunscreen order” applies throughout its part

the term “final sunscreen order” means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients— (A) is GRASE and is not misbranded if marketed in accordance with such order; or (B) is not GRASE and is misbranded;

“GRASE” applies throughout its part

the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title ;

“GRASE determination” applies throughout its part

the term “GRASE determination” means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE;

“nonprescription” applies throughout its part

the term “nonprescription” means not subject to section 353(b)(1) of this title ;

“pending request” applies throughout its part

the term “pending request” means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014 ) for consideration for inclusion in the over-the-counter drug monograph system— (A) that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014 ; and (B) for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014 ;