Source: http://uscode.house.gov/view.xhtml?req=(title:21%20section:379i%20edition:prelim)
Timestamp: 2017-05-23 10:49:59
Document Index: 85415055

Matched Legal Cases: ['art 3', '§ 379', 'art 3', '§737', '§102', '§2', '§211', '§202', '§3051', '§202', '§211', '§2', '§102', '§206', 'art 3', '§216', '§211', 'art 3', '§217', '§207', '§207', '§106', '§107', '§207', '§207', '§205', 'art 3', '§214', '§211', 'art 3', '§201', 'art 3', '§201', 'art 3', '§101', '§103', '§2', '§104', '§105']

[USC10] 21 USC 379i: Definitions
TITLE 21 / CHAPTER 9 / SUBCHAPTER VII / Part C / subpart 3 / § 379i
21 USC 379i: Definitions
From Title 21-FOOD AND DRUGSCHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII-GENERAL AUTHORITYPart C-Feessubpart 3-fees relating to devices
(1) The term "premarket application" means-
(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-
(8) 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, and premarket notification submissions:
(9) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device applications for-
(10) 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 such Index for October 2011.
(12) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly-
(13) 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.
(June 25, 1938, ch. 675, §737, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1589
; amended Pub. L. 108–214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572
, 577; Pub. L. 110–85, title II, §211, Sept. 27, 2007, 121 Stat. 843
; Pub. L. 112–144, title II, §202, July 9, 2012, 126 Stat. 1002
; Pub. L. 114–255, div. A, title III, §3051(c)(2), Dec. 13, 2016, 130 Stat. 1124.)
2016-Par. (5). Pub. L. 114–255 substituted "360e(d)(5)" for "360e(d)(6)".
2012-Par. (9). Pub. L. 112–144, §202(1), struck out "incurred" after "expenses" in introductory provisions.
2007-Pub. L. 110–85, §211(1), substituted "For purposes of this subpart" for "For purposes of this part" in introductory provisions.
2004-Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.
Pub. L. 112–144, title II, §206, July 9, 2012, 126 Stat. 1007
, provided that: "The amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2012, regardless of the date of the enactment of this Act."
Pub. L. 110–85, title II, §216, Sept. 27, 2007, 121 Stat. 852
, provided that: "The amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act."
Pub. L. 110–85, title II, §217, Sept. 27, 2007, 121 Stat. 852
, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective Oct. 1, 2012, and that section 379j–1 of this title would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title II, §207(b)(1), July 9, 2012, 126 Stat. 1007
Pub. L. 112–144, title II, §207(a), July 9, 2012, 126 Stat. 1007
, provided that: "Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i [379i]; 739j [379j]) shall cease to be effective October 1, 2017. Section 738A (21 U.S.C. 739j–1 [379j–1]) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2018."
Pub. L. 107–250, title I, §106, Oct. 26, 2002, 116 Stat. 1602
, provided that: "The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [Oct. 26, 2002], except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notification submissions received on or after October 1, 2002, regardless of the date of enactment."
Pub. L. 107–250, title I, §107, Oct. 26, 2002, 116 Stat. 1602
, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective Oct. 1, 2007, except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective Jan. 31, 2008, was repealed by Pub. L. 112–144, title II, §207(c)(1), July 9, 2012, 126 Stat. 1007
Pub. L. 112–144, title II, §207(c), July 9, 2012, 126 Stat. 1007
, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective Sept. 30, 2007.]
Pub. L. 112–144, title II, §205, July 9, 2012, 126 Stat. 1007
, provided that: "Notwithstanding the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."
Pub. L. 110–85, title II, §214, Sept. 27, 2007, 121 Stat. 852
, provided that: "Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [Sept. 27, 2007], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."
Pub. L. 112–144, title II, §201(b), July 9, 2012, 126 Stat. 1002
, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."
Pub. L. 110–85, title II, §201(c), Sept. 27, 2007, 121 Stat. 842
, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."
Pub. L. 107–250, title I, §101, Oct. 26, 2002, 116 Stat. 1589
Pub. L. 107–250, title I, §103, Oct. 26, 2002, 116 Stat. 1600
, as amended by Pub. L. 109–43, §2(b), Aug. 1, 2005, 119 Stat. 441
"(a) In General.-Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning-
"(b) Additional Information.-For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include-
Pub. L. 107–250, title I, §104(b), Oct. 26, 2002, 116 Stat. 1601
, directed the Secretary of Health and Human Services to conduct a study for the purpose of making certain determinations regarding the medical device user-fee program established under the amendment made by section 102 of Pub. L. 107–250 and to submit a report to Congress by Jan. 10, 2007.
Pub. L. 107–250, title I, §105, Oct. 26, 2002, 116 Stat. 1601
"(a) In General.-In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.
"(b) Recommendations.-The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations."