§379j–71. Definitions — Inbound Citations
21 U.S.C. § 379j–71
Cited by 57 provisions in release 119-102.
Citations to 21 U.S.C. § 379j–71 as a whole
-
(C) The term “OTC monograph drug” has the meaning given such term in section 379j–71 of this title.
-
(aa) the subject of a Tier 2 OTC monograph order request (as defined in section 379j–71 of this title);
Citations to §379j–71(2)
-
(ii) The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.
-
(B) information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
-
(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and
-
(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
Citations to §379j–71(5)
-
(I) has ceased all activities related to OTC monograph drugs prior to—(aa) for purposes of fiscal year 2026, January 1, 2025;(bb) for purposes of fiscal year 2027, January 1, 2026; and(cc) for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and
-
(C) A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—(i) a contraindication, warning, or precaution;(ii) a statement about risk associated with misuse or abuse; or(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
-
(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
-
(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.
-
(vi) postmarket safety activities with respect to OTC monograph drugs, including—(I) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;(II) developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and(III) activities under section 379aa of this title;
-
(I) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
Citations to §379j–71(6)
-
(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and
-
(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington–Arlington–Alexandria–DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.
-
(A) For each fiscal year, for purposes of subsection (b)(1)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than 10 weeks.
-
(1) Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.
-
(B) The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).
-
(C) The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.
-
(h) This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.
-
(1) In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2030, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—(A) the Committee on Energy and Commerce of the House of Representatives;(B) the Committee on Health, Education, Labor, and Pensions of the Senate;(C) scientific and academic experts;(D) health care professionals;(E) representatives of patient and consumer advocacy groups; and(F) the regulated industry.
Citations to §379j–71(7)
-
(A) Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
-
(B) The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.
-
(C) A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—(i) a contraindication, warning, or precaution;(ii) a statement about risk associated with misuse or abuse; or(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
-
(F) An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.
-
(B) For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for a fiscal year shall be equal to the product of—(i) for fiscal year 2026—(I) the fee for fiscal year 2025 under subsection (a)(2); and(II) the inflation adjustment percentage under subparagraph (C); and(ii) for each of fiscal years 2027 through 2030—(I) the applicable fee under subsection (a)(2) for the preceding fiscal year; and(II) the inflation adjustment percentage under subparagraph (C).
-
(ii) OTC monograph order request fees under subsection (a)(2); and
-
(B) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
-
(2) An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.
-
(iii) the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
-
(iv) the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
-
(v) the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year; and
Citations to §379j–71(8)
-
(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and
-
(i) the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
Citations to §379j–71(9)(A)
-
(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
-
(D) If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.
-
(ii) the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
Citations to §379j–71(10)(A)
-
(i) Each person that owns a facility identified as an OTC monograph drug facility at any time during the applicable period specified in clause (ii) for a fiscal year shall be assessed an annual fee for each such facility as determined under subsection (c).
-
(i) A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—(I) has ceased all activities related to OTC monograph drugs prior to—(aa) for purposes of fiscal year 2026, January 1, 2025;(bb) for purposes of fiscal year 2027, January 1, 2026; and(cc) for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.
-
(ii) The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.
-
(II) the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the period of the preceding 3 fiscal years exceeds 1,625; and
-
(I) the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by
-
(i) OTC monograph drug facility fees under subsection (a)(1); and
-
(d) Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—(1) be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
-
(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
-
(B) information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
-
(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and
-
(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
Citations to §379j–71(11)
-
(3) A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.
Citations to §379j–71(12)
-
(i) Each person that owns a facility identified as an OTC monograph drug facility at any time during the applicable period specified in clause (ii) for a fiscal year shall be assessed an annual fee for each such facility as determined under subsection (c).
-
(A) Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).
-
(C) A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—(i) a contraindication, warning, or precaution;(ii) a statement about risk associated with misuse or abuse; or(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
-
(d) Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—(1) be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
-
(2) An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.
-
(3) A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.
Citations to §379j–71(13)
-
(C) A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—(i) a contraindication, warning, or precaution;(ii) a statement about risk associated with misuse or abuse; or(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.
-
(D) If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.