21 USC 391 - Separability clause

Collapse to view only § 391. Separability clause

§ 391. Separability clause
§ 392. Exemption of meats and meat food products
§ 393. Food and Drug Administration
§ 393a. Office of Pediatric Therapeutics
§ 394. Scientific review groups
§ 395. Loan repayment program
§ 396. Practice of medicine
§ 397. Contracts for expert review
§ 398. Notices to States regarding imported food
§ 399. Grants to enhance food safety
§ 399a. Office of the Chief Scientist
§ 399b. Office of Women’s Health
§ 399c. Improving the training of State, local, territorial, and tribal food safety officials
§ 399d. Employee protections
§ 399e. Nanotechnology
§ 399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
§ 399g. Food and Drug Administration Intercenter Institutes
§ 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
§ 399i. Food and Drug Administration Working Capital Fund

§ 391. Separability clause

If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.

(June 25, 1938, ch. 675, § 1001, formerly § 901, 52 Stat. 1059; renumbered § 1001, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 392. Exemption of meats and meat food products

(a) Law determinative of exemption

(b) Laws unaffected

(June 25, 1938, ch. 675, § 1002(b), (c), formerly § 902(b), (c), 52 Stat. 1059; Pub. L. 90–399, § 107, July 13, 1968, 82 Stat. 353; renumbered § 1002(b), (c), Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 393. Food and Drug Administration

(a) In general

(b) MissionThe Administration shall—

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that—

(A) foods are safe, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are safe and effective;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic product radiation;

(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

(d) Commissioner

(1) Appointment

(2) General powersThe Secretary, through the Commissioner, shall be responsible for executing this chapter and for—

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(e) Technical and scientific review groups

(f) Agency plan for statutory compliance

(1) In general

(2) Objectives of agency planThe plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—

(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this chapter;

(B) maximizing the availability and clarity of information for consumers and patients concerning new products;

(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this chapter for the review of all applications and submissions described in subparagraph (A) and submitted after November 21, 1997; and

(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

(g) Annual reportThe Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—

(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f);

(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and

(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.

(h) Annual report regarding foodNot later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—

(1) information about food facilities including—

(A) the appropriations used to inspect facilities registered pursuant to section 350d of this title in the previous fiscal year;

(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;

(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that the Secretary inspected in the previous fiscal year;

(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;

(E) the number of high-risk facilities identified pursuant to section 350j of this title that the Secretary inspected in the previous fiscal year; and

(F) the number of high-risk facilities identified pursuant to section 350j of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.

(2) information about food imports including—

(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;

(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and

(C) the average cost of physically inspecting or sampling a line of food subject to this chapter that is imported or offered for import into the United States; and

(3) information on the foreign offices of the Food and Drug Administration including—

(A) the number of foreign offices established; and

(B) the number of personnel permanently stationed in each foreign office.

(i) Public availability of annual food reports

(June 25, 1938, ch. 675, § 1003, formerly § 903, as added Pub. L. 100–607, title V, § 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100–690, title II, § 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105–115, title IV, §§ 406, 414, Nov. 21, 1997, 111 Stat. 2369, 2377; renumbered § 1003 and amended Pub. L. 111–31, div. A, title I, §§ 101(b)(2), 103(m), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 201(b), Jan. 4, 2011, 124 Stat. 3925.)

§ 393a. Office of Pediatric Therapeutics

(a) Establishment

(b) Duties

The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—

(1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pediatric population;

(2) subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 355a of this title or an assessment under section 355c of this title;

(3) one or more additional individuals with expertise in pediatric epidemiology; and

(4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b).

(d) Neonatology expertise

(Pub. L. 107–109, § 6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, § 306(a), Sept. 27, 2007, 121 Stat. 864; Pub. L. 112–144, title V, § 511, July 9, 2012, 126 Stat. 1050; Pub. L. 115–52, title V, § 505(d)(1), Aug. 18, 2017, 131 Stat. 1047.)

§ 394. Scientific review groups

Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(June 25, 1938, ch. 675, § 1004, formerly § 903, as added Pub. L. 101–635, title III, § 301, Nov. 28, 1990, 104 Stat. 4584; renumbered § 904, Pub. L. 103–43, title XX, § 2006(1), June 10, 1993, 107 Stat. 209; renumbered § 1004, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 395. Loan repayment program

(a) In general

(1) Authority for program

(2) Limitation

The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—

(A) has a substantial amount of educational loans relative to income; and

(B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years.

(b) Applicability of certain provisions

(June 25, 1938, ch. 675, § 1005, formerly § 905, as added Pub. L. 103–43, title XX, § 2006(2), June 10, 1993, 107 Stat. 210; renumbered § 1005, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 396. Practice of medicine

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

(June 25, 1938, ch. 675, § 1006, formerly § 906, as added Pub. L. 105–115, title II, § 214, Nov. 21, 1997, 111 Stat. 2348; renumbered § 1006, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 397. Contracts for expert review

(a) In general

(1) Authority

(2) Increased efficiency and expertise through contracts

(b) Review of expert review

(1) In general

(2) Limitation

(June 25, 1938, ch. 675, § 1007, formerly § 907, as added Pub. L. 105–115, title IV, § 415, Nov. 21, 1997, 111 Stat. 2377; renumbered § 1007, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 398. Notices to States regarding imported food

(a) In general

(b) Rule of construction

(June 25, 1938, ch. 675, § 1008, formerly § 908, as added Pub. L. 107–188, title III, § 310, June 12, 2002, 116 Stat. 673; renumbered § 1008, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 399. Grants to enhance food safety

(a) In generalThe Secretary is authorized to make grants to eligible entities to—

(1) undertake examinations, inspections, and investigations, and related food safety activities under section 372 of this title;

(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments;

(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases;

(4) build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application; and

(5) take appropriate action to protect the public health in response to—

(A) a notification under section 398 of this title, including planning and otherwise preparing to take such action; or

(B) a recall of food under this chapter.

(b) Eligible entities; application

(1) In generalIn this section, the term “eligible entity” means an entity—

(A) that is—

(i) a State;

(ii) a locality;

(iii) a territory;

(iv) an Indian tribe (as defined in section 5304(e) of title 25); or

(v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and

(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(2) ContentsEach application submitted under paragraph (1) shall include—

(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a);

(B) a description of the types of activities to be funded by the grant;

(D) a description of how grant activities will be monitored; and

(E) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section.

(d) Additional authorityThe Secretary may—

(1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and

(2) award a grant under this section in a fiscal year for which the requirement of subsection (c) has not been met only if such requirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating circumstances that the Secretary may determine appropriate.

(e) Duration of awards

(f) Progress and evaluation

(1) In general

(2) No duplication

(g) Supplement not supplant

(h) Authorization of appropriations

(June 25, 1938, ch. 675, § 1009, formerly § 909, as added Pub. L. 107–188, title III, § 311, June 12, 2002, 116 Stat. 673; renumbered § 1009 and amended Pub. L. 111–31, div. A, title I, §§ 101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 210(a), Jan. 4, 2011, 124 Stat. 3948.)

§ 399a. Office of the Chief Scientist

(a) Establishment; appointment

(b) Duties of the OfficeThe Office of the Chief Scientist shall—

(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3) develop and advocate for a budget to support intramural research;

(4) develop a peer review process by which intramural research can be evaluated;

(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—

(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

(June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.)

§ 399b. Office of Women’s Health

(a) Establishment

(b) Purpose

The Director of the Office shall—

(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the “Administration”) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;

(3) provide information to women and health care providers on those areas in which differences between men and women exist;

(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;

(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of title 42).

(June 25, 1938, ch. 675, § 1011, as added Pub. L. 111–148, title III, § 3509(g), Mar. 23, 2010, 124 Stat. 536.)

§ 399c. Improving the training of State, local, territorial, and tribal food safety officials

(a) Training

The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title;

(3) training to achieve advanced product or process specialization in such inspections;

(4) training that addresses best practices;

(5) training in administrative process and procedure and integrity issues;

(6) training in appropriate sampling and laboratory analysis methodology; and

(7) training in building enforcement actions following inspections, examinations, testing, and investigations.

(b) Partnerships with State and local officials

(1) In general

(2) Content

(3) Effect

(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program

(1) In general

In order to improve food safety and reduce the incidence of foodborne illness, the Secretary shall, not later than 180 days after January 4, 2011, enter into one or more memoranda of understanding, or enter into other cooperative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to—

(A) owners and operators of farms;

(B) small food processors; and

(2) Implementation

(e) Authorization of appropriations

(June 25, 1938, ch. 675, § 1012, formerly § 1011, as added Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945; renumbered § 1012, Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137.)

§ 399d. Employee protections

(a) In general

No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee’s initiative or in the ordinary course of the employee’s duties (or any person acting pursuant to a request of the employee)—

(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, standard, or ban under this chapter; 1

1 So in original.

(2) testified or is about to testify in a proceeding concerning such violation;

(3) assisted or participated or is about to assist or participate in such a proceeding; or

(4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.

(b) Process

(1) In general

(2) Investigation

(A) In general

(B) Reasonable cause found; preliminary order

(i) Standard for complainant

(ii) Standard for employer

(iii) Violation standard

(iv) Relief standard

(3) Final order

(A) In general

(B) Content of order

If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation—

(i) to take affirmative action to abate the violation;

(ii) to reinstate the complainant to his or her former position together with compensation (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and

(iii) to provide compensatory damages to the complainant.

(D) Bad faith claim

(4) Action in court

(A) In general

(B) Relief

The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including—

(i) reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;

(ii) the amount of back pay, with interest; and

(iii) compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.

(5) Review

(A) In general

(B) No judicial review

(6) Failure to comply with order

(7) Civil action to require compliance

(A) In general

(B) Award

(1) Other laws

(2) Rights of employees

(d) Enforcement

(e) Limitation

(June 25, 1938, ch. 675, § 1013, formerly § 1012, as added Pub. L. 111–353, title IV, § 402, Jan. 4, 2011,

§ 399e. Nanotechnology

(a) In general

(b) Activities

In conducting activities related to nanotechnology, the Secretary may—

(1) assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

(2) in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

(3) promote Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4) promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5) collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;

(6) build scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7) ensure ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8) encourage the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9) carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

(Pub. L. 112–144, title XI, § 1126, July 9, 2012, 126 Stat. 1116.)

§ 399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups

(a) Communication plan

(b) ContentThe communication plan described under subsection (a)—

(1) shall take into account—

(A) the goals and principles set forth in the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities issued by the Department of Health and Human Services;

(B) the nature of the medical product; and

(C) health and disease information available from other agencies within such Department, as well as any new means of communicating health and safety benefits and risks related to medical products;

(2) taking into account the nature of the medical product, shall address the best strategy for communicating safety alerts, labeled indications for the medical products, changes to the label or labeling of medical products (including black-box warnings, health advisories, health and safety benefits and risks), particular actions to be taken by health care professionals and patients, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication; and

(3) shall include a process for implementation of any improvements or other modifications determined to be necessary.

(1) Communication plan

(2) Posting of communication plan on the office of minority health web site

(Pub. L. 112–144, title XI, § 1138, July 9, 2012, 126 Stat. 1125.)

§ 399g. Food and Drug Administration Intercenter Institutes

(a) In general

The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an “Institute”) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the “Centers”). Such activities may include—

(1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute;

(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 355, 360(k), 360c(f)(2), and 360e of this title and section 262 of title 42, and other applicable authorities;

(3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute;

(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute;

(5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and

(6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.

(b) Public process

(d) Termination of Institutes

(June 25, 1938, ch. 675, § 1014, as added Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136.)

§ 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing

(a) In generalThe Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—

(1) may, to support the advancement, development, and implementation of advanced and continuous pharmaceutical manufacturing—

(A) solicit requests for designation as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a “National Center of Excellence”);

(B) beginning not later than one year after December 29, 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that—

(i) request such designation; and

(ii) meet the eligibility criteria specified in subsection (c); and

(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions.

(b) Request for designation

(c) Eligibility criteria for designationTo be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher education shall include in its request for designation a description of the institution’s or consortium’s—

(1) physical capacity and technical capabilities to conduct advanced research on, and to develop and implement, advanced and continuous pharmaceutical manufacturing;

(2) collaboration or partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities;

(3) proven capacity to design, develop, implement, and demonstrate new, highly effective technologies for use in advanced and continuous pharmaceutical manufacturing;

(4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing; and

(5)

(A) experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities to—

(i) support the implementation of advanced or continuous pharmaceutical manufacturing for companies manufacturing or seeking to manufacture in the United States;

(ii) support Federal agencies with technical assistance and workforce training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous pharmaceutical manufacturing;

(iii) organize and conduct advanced research and development activities, with respect to advanced or continuous pharmaceutical manufacturing, needed to develop new and more effective technology, and to develop and support technological leadership;

(iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing processes; and

(v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or

(B) a plan, to be implemented within 2 years, to establish partnerships described in subparagraph (A).

(d) Termination of designation

(e) Conditions for designationAs a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees—

(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);

(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);

(3) to develop, along with industry partners (which may include large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or consortium designated under this section, if any, a strategic plan for developing an advanced and continuous pharmaceutical manufacturing workforce;

(4) to develop, along with industry partners and other institutions or consortia of such institutions designated under this section, a strategic plan for strengthening existing, and developing new, partnerships with other institutions of higher education or consortia thereof, or nonprofit organizations; and

(5) to provide an annual report to the Food and Drug Administration regarding the designee’s activities under this section, including a description of how the designee continues to meet and make progress on the criteria specified in subsection (c).

(f) Funding

(1) In generalThe Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the purposes of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including—

(A) expanding capacity for advanced research on, and development of, advanced and continuous pharmaceutical manufacturing; and

(B) implementing advanced research capacity and capabilities in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to public health threats, mitigate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other circumstances with respect to which the Secretary may determine the rapid development of new products or new manufacturing processes may be appropriate.

(2) Consistency with FDA missionAs a condition on receipt of funding under this subsection, a National Center of Excellence shall consider any input from the Secretary regarding the use of funding related to—

(A) best practices to increase, and provide for the advancement of, advanced and continuous pharmaceutical manufacturing through the National Center of Excellence; and

(B) the extent to which activities conducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration.

(3) Rule of construction

(g) Annual review and reports

(1) Annual report to CongressBeginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—

(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section;

(B) include in such report an accounting of the Federal administrative expenses described in subsection (i)(2) over the reporting period; and

(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.

(2) Center of Excellence report

(3) Periodic review

(4) Additional report to CongressNot later than 1 year after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including—

(A) a national framework of principles related to the implementation of advanced and continuous pharmaceutical manufacturing;

(B) a plan for the development of Federal regulations and guidance to support and facilitate the incorporation of advanced or continuous manufacturing into the development of pharmaceuticals;

(C) a plan for development of Federal regulations or guidance related to the review of advanced and continuous pharmaceutical manufacturing, including how such manufacturing practices may be incorporated into the review of medical product applications; and

(D) a summary of relevant feedback related to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract manufacturers, and other relevant entities.

(h) DefinitionsIn this section:

(1) Advanced and continuous pharmaceutical manufacturingThe term “advanced and continuous pharmaceutical manufacturing” refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods—

(A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or

(B) for which the input materials are continuously fed into and transformed within the process, and the output materials are continuously removed from the system, utilizing an integrated manufacturing process that consists of a series of 2 or more simultaneous unit operations.

(2) Biological product

(3) Drug

(4) Institution of higher education

(5) Secretary

(i) Authorization of appropriations

(1) In general

(2) Federal administrative expenses

(Pub. L. 114–255, div. A, title III, § 3016, Dec. 13, 2016, 130 Stat. 1095; Pub. L. 117–328, div. FF, title III, § 3204(a), Dec. 29, 2022, 136 Stat. 5815.)

§ 399i. Food and Drug Administration Working Capital Fund

(a) In general

(b) Appropriations

(Pub. L. 115–141, div. A, title VII, § 722, Mar. 23, 2018, 132 Stat. 387.)