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

“proposed sunscreen order” applies throughout its part

the term “proposed sunscreen order” means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing 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; (B) is not GRASE and is misbranded; or (C) is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise;

“sponsor” applies throughout its part

the term “sponsor” means the person that submitted— (A) a request under section 360fff–1 of this title ; (B) a pending request; or (C) any other application subject to this part;

“sunscreen” applies throughout its part

the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and;

“sunscreen active ingredient” applies throughout its part

the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

“genetically targeted drug” applies in that section

the term “genetically targeted drug” means a drug that— (A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title ) that is serious or life-threatening; (B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and (C) incorporates or utilizes a genetically targeted technology;

“genetically targeted technology” applies in that section

the term “genetically targeted technology” means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition, including a disease or condition due to other variants in the same gene; and;

“variant protein targeted drug” applies in that section

the term “variant protein targeted drug” means a drug that— (A) is the subject of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [ 42 U.S.C. 262(a) ] for the treatment of a rare disease or condition (as such term is defined in section 360bb of this title ) that is serious or life-threatening; (B) modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition; and (C) is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition.

“record” applies in that section

the term “record” means all notices and other matter published in the Federal Register with respect to the regulation or order reviewed, all information submitted to the Secretary with respect to such regulation or order, proceedings of any panel or advisory committee with respect to such regulation or order, any hearing held with respect to such regulation or order, and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

“commerce” applies throughout its part

the term “commerce” means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and;

“electronic product” applies throughout its part

the term “electronic product” means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;

“electronic product radiation” applies throughout its part

the term “electronic product radiation” means— (A) any ionizing or non-ionizing electromagnetic or particulate radiation, or (B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;

“manufacturer” applies throughout its part

the term “manufacturer” means any person engaged in the business of manufacturing, assembling, or importing of electronic products;

“State” applies throughout its part

the term “State” includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, and American Samoa.

“recall” applies in that section

the term “recall” means— (1) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title ; or (2) the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title .

“device user facility” applies in that section

The term “device user facility” means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician’s office. The Secretary may by regulation include an outpatient diagnostic facility which is not a physician’s office in such term.;

“serious illness” applies in that section

The terms “serious illness” and “serious injury” mean illness or injury, respectively, that— (i) is life threatening, (ii) results in permanent impairment of a body function or permanent damage to a body structure, or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

“serious injury” applies in that section

The terms “serious illness” and “serious injury” mean illness or injury, respectively, that— (i) is life threatening, (ii) results in permanent impairment of a body function or permanent damage to a body structure, or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

“annual distribution number” applies in that section

the term “annual distribution number” means the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption. (iii) Such person immediately notifies the Secretary if the number of such devices distributed during any calendar year exceeds the annual distribution number referred to in clause (ii). (iv) The request for such exemption is submitted on or before October 1, 2027 .

“applicable medical imaging device” applies in that section

the term “applicable medical imaging device” means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and;

“contrast agent” applies in that section

the term “contrast agent” means a drug that is approved under section 355 of this title or licensed under section 262 of title 42 , is intended for use in conjunction with an applicable medical imaging device, and— (i) is a diagnostic radiopharmaceutical, as defined in section 3 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or (ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid. (q) Regulation of over-the-counter hearing aids (1) Definition (A) In general In this subsection,

“over-the-counter hearing aid” applies in that section

the term “over-the-counter hearing aid” means a device that— (i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation); (ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment; (iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs; (iv) may— (I) use wireless technology; …

“pediatric patients” applies in that section

the term “pediatric patients” means patients who are 21 years of age or younger at the time of the diagnosis or treatment. (ii) In this subsection,

“pediatric subpopulation” applies in that section

the term “pediatric subpopulation” means 1 of the following populations: (I) Neonates. (II) Infants. (III) Children. (IV) Adolescents. (7) The Secretary shall refer any report of an adverse event regarding a device described in paragraph (6)(A)(i)(I) for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 393a 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 tropical 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 262 of title 42 after the date of approval of the tropical disease product application. (3) Tropical disease

“tropical disease” applies in that section

The term “tropical disease” means any of the following: (A) Tuberculosis. (B) Malaria. (C) Blinding trachoma. (D) Buruli Ulcer. (E) Cholera. (F) Dengue/dengue haemorrhagic fever. (G) Dracunculiasis (guinea-worm disease). (H) Fascioliasis. (I) Human African trypanosomiasis. (J) Leishmaniasis. (K) Leprosy. (L) Lymphatic filariasis. (M) Onchocerciasis. (N) Schistosomiasis. (O) Soil transmitted helmithiasis. (P) Yaws. (Q) Filovirus Diseases. (R) Zika Virus Disease. (S) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.

“tropical disease product application” applies in that section

The term “tropical disease product application” means an application that— (A) is a human drug application as defined in section 379g(1) of this title — (i) for prevention or treatment of a tropical disease; (ii) the Secretary deems eligible for priority review; (iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and (iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, …

“cyber device” applies in that section

the term “cyber device” means a device that— (1) includes software validated, installed, or authorized by the sponsor as a device or in a device; (2) has the ability to connect to the internet; and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats. (d) Exemption The Secretary may identify devices, or categories or types of devices, that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section.

“adverse event” applies throughout its subchapter

The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse. (2) Cosmetic product

“cosmetic product” applies throughout its subchapter

The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product. (3) Facility (A) In general .—

“facility” applies throughout its subchapter

The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. (B) Such term does not include any of the following: (i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location. (ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of title 26 ), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.

“responsible person” applies throughout its subchapter

The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 364e(a) of this title or section 1453(a) of title 15 . (5) Serious adverse event

“serious adverse event” applies throughout its subchapter

The term “serious adverse event” means an adverse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; (vi) an infection; or (vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

“authorized person” applies in that section

the term “authorized person” means an officer or employee of the Department of Health and Human Services who has— (i) appropriate credentials, as determined by the Secretary; and (ii) been duly designated by the Secretary to have access to the records required under this section.

“adequate substantiation of safety” applies in that section

The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe. (2) Safe

“safe” applies in that section

The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

“professional” applies in that section

the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics. (2) Professional use labeling A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that— (A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and (B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15 .

“United States” applies in that section

the term “United States” means the States and the District of Columbia. (b) Availability to owner of part of analysis samples Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.

“base amount” applies in that section

The term “base amount” means the inspection budget determined under subparagraph (B) for fiscal year 2002. (ii) The term “adjusted base amount”, in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent. (iii) The term “adjusted base amount”, with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted base amount applicable to the preceding year increased by 5 percent. (11) The authority provided by this subsection terminates on October 1, 2027 .

“adverse event” applies in that section

The term “adverse event” means any health-related event associated with the use of a nonprescription drug that is adverse, including— (A) an event occurring from an overdose of the drug, whether accidental or intentional; (B) an event occurring from abuse of the drug; (C) an event occurring from withdrawal from the drug; and (D) any failure of expected pharmacological action of the drug. (2) Nonprescription drug

“authorized person” applies in that section

the term “authorized person” means an officer or employee of the Department of Health and Human Services who has— (i) appropriate credentials, as determined by the Secretary; and (ii) been duly designated by the Secretary to have access to the records required under this section.

“nonprescription drug” applies in that section

The term “nonprescription drug” means a drug that is— (A) not subject to section 353(b) of this title ; and (B) not subject to approval in an application submitted under section 355 of this title . (3) Serious adverse event The term “serious adverse event” is an adverse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). (4) Serious adverse event report

“serious adverse event report” applies in that section

The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b). (b) Reporting requirement (1) In general The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title ) appears on the label of a nonprescription drug marketed in the United States (referred to in this section as the “responsible person”) shall submit to the Secretary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug.

“adverse event” applies in that section

The term “adverse event” means any health-related event associated with the use of a dietary supplement that is adverse. (2) Serious adverse event The term “serious adverse event” is an adverse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). (3) Serious adverse event report

“authorized person” applies in that section

the term “authorized person” means an officer or employee of the Department of Health and Human Services, who has— (i) appropriate credentials, as determined by the Secretary; and (ii) been duly designated by the Secretary to have access to the records required under this section.

“serious adverse event report” applies in that section

The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b). (b) Reporting requirement (1) In general The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 343(e)(1) of this title ) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the “responsible person”) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.

“advisory committee” applies in that section

The term “advisory committee” means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration. (2) Financial interest

“financial interest” applies in that section

The term “financial interest” means a financial interest under section 208(a) of title 18 . (b) Recruitment for advisory committees (1) In general The Secretary shall— (A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups; (B) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities; (C) at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including— (i) product developers, …

“article” applies in that section

the term “article” means a paper, poster, abstract, book, book chapter, or other published writing. (b) Policies The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.

“affiliate” applies in that section

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 power to control, both of the business entities.;

“final dosage form” applies throughout its subpart

The term “final dosage form” means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).;

“human drug application” applies throughout its subpart

The term “human drug application” means an application for— (A) approval of a new drug submitted under section 355(b) of this title , or (B) licensure of a biological product under subsection (a) of section 262 of title 42 .

“person” applies in that section

The term “person” includes an affiliate thereof. (10) The term “active”, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.;

“prescription drug establishment” applies throughout its subpart

The term “prescription drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term “manufactured” does not include packaging.;

“prescription drug product” applies throughout its subpart

The term “prescription drug product” means a specific strength or potency of a drug in final dosage form— (i) for which a human drug application has been approved, (ii) which may be dispensed only under prescription pursuant to section 353(b) of this title , and (iii) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).

“process for the review of human drug applications” applies in that section

The term “process for the review of human drug applications” means the following activities of the Secretary with respect to the review of human drug applications and supplements: (A) The activities necessary for the review of human drug applications and supplements. (B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval. (C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements.

“skin-test diagnostic product” applies in that section

The term “skin-test diagnostic product”— (A) means a product— (i) for prick, scratch, intradermal, or subcutaneous administration; (ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; (iii) not intended to be a preventive or therapeutic intervention; and (iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of— (I) an allergy to an antimicrobial agent; (II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022 ; or (III) infection with fungal or mycobacterial pathogens; and (B) includes …

“supplement” applies throughout its subpart

The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved. (3);

“small business” applies in that section

the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce. (B) Waiver of application fee The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review.

“advisory review” applies in that section

The term “advisory review” means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.;

“advisory review fee” applies in that section

The term “advisory review fee” has the meaning indicated for such term in subsection (a)(1)(D).;

“carry over submission” applies in that section

The term “carry over submission” means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.;

“direct-to-consumer television advertisement” applies in that section

The term “direct-to-consumer television advertisement” means an advertisement for a prescription drug product (as defined in section 379g(3) of this title ) intended to be displayed on any television channel for less than 3 minutes.;

“DTC advertisement” applies in that section

The term “DTC advertisement” has the meaning indicated for such term in subsection (a)(1)(A).;

“full-time equivalent review employees” applies in that section

the term “full-time equivalent review employees” means the total combined number of full-time equivalent employees in— (i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and (ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

“operating reserve fee” applies in that section

The term “operating reserve fee” has the meaning indicated for such term in subsection (a)(2)(A).;

“person” applies in that section

The term “person” includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.;

“process for the advisory review of prescription drug advertising” applies in that section

The term “process for the advisory review of prescription drug advertising” means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.;

“resubmission” applies in that section

The term “resubmission” means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary’s comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.;

“submission for advisory review” applies in that section

The term “submission for advisory review” means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.

“180-day supplement” applies throughout its subpart

The term “180-day supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.;

“30-day notice” applies throughout its subpart

The term “30-day notice” means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.;

“affiliate” applies throughout its subpart

The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) 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 power to control, both of the business entities.;

“de novo classification request” applies throughout its subpart

The term “de novo classification request” means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.;

“efficacy supplement” applies throughout its subpart

The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.;

“establishment subject to a registration fee” applies throughout its subpart

The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

“panel-track supplement” applies throughout its subpart

The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.;

“person” applies throughout its subpart

The term “person” includes an affiliate thereof.;

“premarket application” applies throughout its subpart

The term “premarket application” means— (A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42 ; or (B) a product development protocol described in section 360e(f) of this title . Such term does not include a supplement, a premarket report, or a premarket notification submission.;

“premarket notification submission” applies throughout its subpart

The term “premarket notification submission” means a report submitted under section 360(k) of this title . (4) (A) The term “supplement”, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which— (i) an application or report has been approved under section 360e(d) of this title , or an application has been approved under section 262 of title 42 ; or (ii) a notice of completion has become effective under section 360e(f) of this title .;

“premarket report” applies throughout its subpart

The term “premarket report” means a report submitted under section 360e(c)(2) of this title .;

“process for the review of device applications” applies throughout its subpart

The term “process for the review of device applications” means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests: (A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions. (B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.

“real-time supplement” applies throughout its subpart

The term “real-time supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.;

“request for classification information” applies throughout its subpart

The term “request for classification information” means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device. (7) The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.;

“small business” applies in that section

the term “small business” means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. (II) Waiver The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024 , if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.

“animal drug application” applies throughout its subpart

The term “animal drug application” means— (i) an application for approval of any new animal drug submitted under section 360b(b)(1) of this title ; or (ii) an application for conditional approval of a new animal drug submitted under section 360ccc of this title . (B) Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application.;

“animal drug establishment” applies throughout its subpart

The term “animal drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.;

“animal drug product” applies throughout its subpart

The term “animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.;

“animal drug sponsor” applies throughout its subpart

The term “animal drug sponsor” means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.;

“final dosage form” applies throughout its subpart

The term “final dosage form” means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.;

“investigational animal drug submission” applies throughout its subpart

The term “investigational animal drug submission” means— (A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application; or (B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.;

“person” applies throughout its subpart

The term “person” includes an affiliate thereof. (12) The term “affiliate” refers to the definition set forth in section 379g(11) of this title .

“process for the review of animal drug applications” applies throughout its subpart

The term “process for the review of animal drug applications” means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions: (A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

“supplemental animal drug application” applies throughout its subpart

The term “supplemental animal drug application” means— (A) a request to the Secretary to approve a change in an animal drug application which has been approved; or (B) a request to the Secretary to approve a change to an application approved under section 360b(c)(2) of this title for which data with respect to safety or effectiveness are required.;

“small business” applies in that section

the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates. (B) Waiver of application fee The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.

“abbreviated application” applies in that section

The terms “abbreviated application for a generic new animal drug” and “abbreviated application” mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title . Such term does not include a supplemental abbreviated application for a generic new animal drug. (2) Adjustment factor The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by— (A) for purposes of subsection (f)(1), such Index for October 2002; and (B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.

“abbreviated application for a generic new animal drug” applies in that section

The terms “abbreviated application for a generic new animal drug” and “abbreviated application” mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title . Such term does not include a supplemental abbreviated application for a generic new animal drug. (2) Adjustment factor The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by— (A) for purposes of subsection (f)(1), such Index for October 2002; and (B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.

“final dosage form” applies in that section

The term “final dosage form” means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds. (5) Generic new animal drug

“generic investigational new animal drug meeting request” applies in that section

The term “generic investigational new animal drug meeting request” means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug. (9) Investigational submission for a generic new animal drug

“generic new animal drug” applies in that section

The term “generic new animal drug” means a new animal drug that is the subject of an abbreviated application. (6) Generic new animal drug product

“generic new animal drug product” applies in that section

The term “generic new animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved. (7) Generic new animal drug sponsor

“generic new animal drug sponsor” applies in that section

The term “generic new animal drug sponsor” means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary. (8) Generic investigational new animal drug meeting request

“investigational submission” applies in that section

The terms “investigational submission for a generic new animal drug” and “investigational submission” mean— (A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or (B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug. (10) Person

“investigational submission for a generic new animal drug” applies in that section

The terms “investigational submission for a generic new animal drug” and “investigational submission” mean— (A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or (B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug. (10) Person

“person” applies in that section

The term “person” includes an affiliate thereof (as such term is defined in section 379g(11) of this title ). (11) Process for the review of abbreviated applications for generic new animal drugs

“process for the review of abbreviated applications for generic new animal drugs” applies in that section

The term “process for the review of abbreviated applications for generic new animal drugs” means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions: (A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

“request to establish a generic investigational new animal drug file” applies in that section

The term “request to establish a generic investigational new animal drug file” means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug. (13) Supplemental abbreviated application for generic new animal drug

“supplemental abbreviated application” applies in that section

The terms “supplemental abbreviated application for a generic new animal drug” and “supplemental abbreviated application” mean a request to the Secretary to approve a change in an approved abbreviated application.

“supplemental abbreviated application for a generic new animal drug” applies in that section

The terms “supplemental abbreviated application for a generic new animal drug” and “supplemental abbreviated application” mean a request to the Secretary to approve a change in an approved abbreviated application.

“reinspection” applies in that section

the term “reinspection” means— (i) with respect to domestic facilities (as defined in section 350d(b) 1 of this title), 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and (ii) with respect to importers, 1 or more examinations conducted under section 381 of this title subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, …

“reinspection-related costs” applies in that section

the term “reinspection-related costs” means all expenses, including administrative expenses, incurred in connection with— (i) arranging, conducting, and evaluating the results of reinspections; and (ii) assessing and collecting reinspection fees under this section; and;

“responsible party” applies in that section

the term “responsible party” has the meaning given such term in section 350f(a)(1) of this title . (b) Establishment of fees (1) In general Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.

“abbreviated new drug application” applies throughout its subpart

The term “abbreviated new drug application”— (A) means an application submitted under section 355(j) of this title , an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997 ), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and (B) does not include an application— (i) for a positron emission tomography drug; or (ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.;

“active pharmaceutical ingredient” applies throughout its subpart

The term “active pharmaceutical ingredient” means— (A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— (i) to be used as a component of a drug; and (ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or (B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).;

“adjustment factor” applies throughout its subpart

The term “adjustment factor” means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.;

“affiliate” applies throughout its subpart

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 power to control, both of the business entities.;

“contract manufacturing organization facility” applies throughout its subpart

The term “contract manufacturing organization facility” means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility. (6);

“facility” applies throughout its subpart

The term “facility”— (i) means a business or other entity— (I) under one management, either direct or indirect; and (II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and (ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

“finished dosage form” applies in that section

The term “finished dosage form” means— (A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application; (B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or (C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).;

“generic drug submission” applies in that section

The term “generic drug submission” means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.;

“human generic drug activities” applies in that section

The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs: (A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions. (B) The issuance of— (i) approval letters which approve abbreviated new drug applications or supplements to such applications; or (ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

“positron emission tomography drug” applies in that section

The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title , except that paragraph (1)(B) of such section shall not apply.;

“prior approval supplement” applies in that section

The term “prior approval supplement” means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.;

“resources allocated for human generic drug activities” applies in that section

The term “resources allocated for human generic drug activities” means the expenses for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees under subsection (a) and accounting for resources allocated for the …

“Type II active pharmaceutical ingredient drug master file” applies in that section

The term “Type II active pharmaceutical ingredient drug master file” means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

“affiliate” applies throughout its subpart

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 power to control, both of the business entities.;

“biosimilar biological product” applies throughout its subpart

The term “biosimilar biological product” means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved. (4) (A) Subject to subparagraph (B),

“biosimilar biological product application” applies throughout its subpart

the term “biosimilar biological product application” means an application for licensure of a biological product under section 262(k) of title 42 . (B) Such term does not include— (i) a supplement to such an application; (ii) an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992 , or a large volume parenteral drug product approved before such date; (iii) an application filed under section 262(k) of title 42 with respect to— (I) whole blood or a blood component for transfusion; (II) an in vitro diagnostic biological product; or (III) a biological product for further …

“biosimilar biological product development meeting” applies throughout its subpart

The term “biosimilar biological product development meeting” means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.;

“biosimilar biological product development program” applies throughout its subpart

The term “biosimilar biological product development program” means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development. (7);

“biosimilar biological product establishment” applies throughout its subpart

The term “biosimilar biological product establishment” means a foreign or domestic place of business— (i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and (ii) at which one or more biosimilar biological products are manufactured in final dosage form. (B) For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.;

“biosimilar initial advisory meeting” applies throughout its subpart

The term “biosimilar initial advisory meeting”— (A) means a meeting, if requested, that is limited to— (i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and (ii) if so, general advice on the expected content of the development program; and (B) does not include any meeting that involves substantive review of summary data or full study reports.;

“final dosage form” applies throughout its subpart

The term “final dosage form” means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).;

“financial hold” applies throughout its subpart

The term “financial hold”— (A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 379j–52(a)(1) of this title ; and (B) does not mean that any of the bases for a “clinical hold” under section 355(i)(3) of this title have been determined by the Secretary to exist concerning the investigation.;

“person” applies throughout its subpart

The term “person” includes an affiliate of such person.;

“process for the review of biosimilar biological product applications” applies throughout its subpart

The term “process for the review of biosimilar biological product applications” means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements: (A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

“supplement” applies throughout its subpart

The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42 .

“small business” applies in that section

the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title ) or a biosimilar biological product application (as defined in section 379j–51(4) of this title ) and introduced or delivered for introduction into interstate commerce.

“affiliate” applies throughout its subpart

The term “affiliate” has the meaning given such term in section 379g(11) of this title .;

“gross annual sales” applies throughout its subpart

The term “gross annual sales” means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.;

“outsourcing facility” applies throughout its subpart

The term “outsourcing facility” has the meaning given to such term in section 353b(d)(4) of this title .;

“reinspection” applies throughout its subpart

The term “reinspection” means, with respect to an outsourcing facility, 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction.

“affiliate” applies throughout its subpart

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 power to control, both of the business entities.;

“contract manufacturing organization facility” applies throughout its subpart

The term “contract manufacturing organization facility” means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.;

“costs of resources allocated for OTC monograph drug activities” applies throughout its subpart

The term “costs of resources allocated for OTC monograph drug activities” means the expenses in connection with OTC monograph drug activities for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) …

“OTC monograph drug” applies throughout its subpart

The term “OTC monograph drug” means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title .;

“OTC monograph drug activities” applies throughout its subpart

The term “OTC monograph drug activities” means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities: (A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including— (i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs; (ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use; (iii) all OTC monograph drug development and review activities, including intra-agency collaboration; …

“OTC monograph drug facility” applies throughout its subpart

The term “OTC monograph drug facility” means a foreign or domestic business or other entity that— (i) is— (I) under one management, either direct or indirect; and (II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug; (ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and (iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on …

“OTC monograph drug meeting” applies in that section

The term “OTC monograph drug meeting” means any meeting regarding the content of a proposed OTC monograph order request.;

“OTC monograph order request” applies throughout its subpart

The term “OTC monograph order request” means a request for an order submitted under section 355h(b)(5) of this title .;

“person” applies in that section

The term “person” includes an affiliate of a person.;