SUBCHAPTER X—MISCELLANEOUS
Editorial Notes
Codification
Former subchapter IX of this chapter was redesignated as this subchapter.
§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,
§392. Exemption of meats and meat food products
(a) Law determinative of exemption
Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [
(b) Laws unaffected
Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [
(June 25, 1938, ch. 675, §1002(b), (c), formerly §902(b), (c),
Editorial Notes
References in Text
The Meat Inspection Act, approved March 4, 1907, as amended, referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967,
Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4, 1913, ch. 145,
The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch. 337,
The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is act Mar. 4, 1923, ch. 262,
The Import Milk Act of February 15, 1927, referred to in subsec. (b), is act Feb. 15, 1927, ch. 155,
Codification
Subsecs. (a) and (b) of this section comprise respectively subsecs. (b) and (c) of section 1002 of act June 25, 1938. Subsecs. (a) and (d) of section 1002 of act June 25, 1938, which prescribed the effective date of this chapter and made appropriations available, are set out as notes under
Amendments
1968—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 1968 Amendment
Amendment by
Availability of Appropriations
Act June 25, 1938, ch. 675, §1002(d), formerly §902(d),
§393. Food and Drug Administration
(a) In general
There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the "Administration").
(b) Mission
The 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;
(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
(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.
(c) Interagency collaboration
The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.
(d) Commissioner
(1) Appointment
There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the "Commissioner") who shall be appointed by the President by and with the advice and consent of the Senate.
(2) General powers
The 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;
(C) research relating to foods, drugs, cosmetics, devices, and tobacco products in carrying out this chapter;
(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
The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of
(f) Agency plan for statutory compliance
(1) In general
Not later than 1 year after November 21, 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this chapter. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.
(2) Objectives of agency plan
The 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;
(C) implementing inspection and postmarket monitoring provisions of this chapter;
(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 report
The 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 food
Not 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
(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
(D) the number of domestic facilities and the number of foreign facilities registered pursuant to
(E) the number of high-risk facilities identified pursuant to
(F) the number of high-risk facilities identified pursuant to
(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
The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.
(June 25, 1938, ch. 675, §1003, formerly §903, as added
Editorial Notes
Amendments
2011—Subsecs. (h), (i).
2009—Subsec. (d)(2)(C).
1997—Subsec. (b).
Subsec. (c).
Subsecs. (d), (e).
Subsecs. (f), (g).
1988—Subsec. (b)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 1997 Amendment
Amendment by
Effective Date
"(1) Except as provided in paragraph (2), the amendments made by this title [enacting this section and amending
"(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) [now 1003(d)(1),
Improving FDA Guidance and Communication
"(a)
"(1) a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and
"(2) a plan for implementation of such best practices, including across other applicable agencies, which shall address—
"(A) streamlining development and review of guidance documents within centers and across the Food and Drug Administration;
"(B) streamlining processes for regulatory submissions to the Food and Drug Administration, including through the revision or issuance of guidance documents; and
"(C) implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the COVID–19 public health emergency, as appropriate.
"(b)
"(1) a review of the types and methods of public communication that the Food and Drug Administration uses to communicate and interact with medical product sponsors and other external stakeholders;
"(2) the identification of best practices for the efficient development, issuance, and use of such communications; and
"(3) a plan for implementation of best practices for communication with external stakeholders, which shall address—
"(A) advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regulatory clarity to product sponsors and other stakeholders, and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders, including the use of tools such as product submission templates, webinars, and frequently asked questions communications;
"(B) streamlining processes for regulatory submissions; and
"(C) implementing innovative communication development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as appropriate.
"(c)
"(d)
"(e)
"(1) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], publish a draft of the reports and plans required under this section; and
"(2) not later than 180 days after publication of the draft reports and plans under paragraph (1)—
"(A) publish a final report and plan; and
"(B) begin implementation of the best practices pursuant to such final plan."
Improving Information Technology Systems of the Food and Drug Administration
"(a)
"(1)
"(2)
"(A) agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission;
"(B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and priorities;
"(C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns;
"(D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks;
"(E) the ways in which the Food and Drug Administration will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and
"(F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.
"(3)
"(A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and
"(B) whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans."
Office of Minor Use and Minor Species Animal Drug Development
Regulations for Sunscreen Products
Construction of 2011 Amendment
Nothing in amendment by
Advancing Regulatory Science To Promote Public Health Innovation
"(a)
"(b)
"(1) identify a clear vision of the fundamental role of efficient, consistent, and predictable, science-based decisions throughout regulatory decisionmaking of the Food and Drug Administration with respect to medical products;
"(2) identify the regulatory science priorities of the Food and Drug Administration directly related to fulfilling the mission of the agency with respect to decisionmaking concerning medical products and allocation of resources toward such regulatory science priorities;
"(3) identify regulatory and scientific gaps that impede the timely development and review of, and regulatory certainty with respect to, the approval, licensure, or clearance of medical products, including with respect to companion products and new technologies, and facilitating the timely introduction and adoption of new technologies and methodologies in a safe and effective manner;
"(4) identify clear, measurable metrics by which progress on the priorities identified under paragraph (2) and gaps identified under paragraph (3) will be measured by the Food and Drug Administration, including metrics specific to the integration and adoption of advances in regulatory science described in paragraph (5) and improving medical product decisionmaking, in a predictable and science-based manner; and
"(5) set forth how the Food and Drug Administration will ensure that advances in regulatory science for medical products are adopted, as appropriate, on an ongoing basis and in an [sic] manner integrated across centers, divisions, and branches of the Food and Drug Administration, including by senior managers and reviewers, including through the—
"(A) development, updating, and consistent application of guidance documents that support medical product decisionmaking; and
"(B) adoption of the tools, methods, and processes under section 566 of the Federal Food, Drug, and Cosmetic Act (
"(c)
"(1) advancing the regulatory science priorities identified under paragraph (2) of subsection (b) and resolving the gaps identified under paragraph (3) of such subsection, including reporting on specific metrics identified under paragraph (4) of such subsection;
"(2) the integration and adoption of advances in regulatory science as set forth in paragraph (5) of such subsection; and
"(3) the progress made in advancing the regulatory science goals outlined in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on January 13, 2012, and the Medical Device User Fee Agreement transmitted by the Secretary to Congress on April 20, 2012.
"(d)
Information Technology
"(a)
"(1) report to Congress on—
"(A) the milestones and a completion date for developing and implementing a comprehensive information technology strategic plan to align the information technology systems modernization projects with the strategic goals of the Food and Drug Administration, including results-oriented goals, strategies, milestones, performance measures;
"(B) efforts to finalize and approve a comprehensive inventory of the information technology systems of the Food and Drug Administration that includes information describing each system, such as costs, system function or purpose, and status information, and incorporate use of the system portfolio into the information investment management process of the Food and Drug Administration;
"(C) the ways in which the Food and Drug Administration uses the plan described in subparagraph (A) to guide and coordinate the modernization projects and activities of the Food and Drug Administration, including the interdependencies among projects and activities; and
"(D) the extent to which the Food and Drug Administration has fulfilled or is implementing recommendations of the Government Accountability Office with respect to the Food and Drug Administration and information technology; and
"(2) develop—
"(A) a documented enterprise architecture program management plan that includes the tasks, activities, and timeframes associated with developing and using the architecture and addresses how the enterprise architecture program management will be performed in coordination with other management disciplines, such as organizational strategic planning, capital planning and investment control, and performance management; and
"(B) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.
"(b)
"(1) the development and implementation of a comprehensive information technology strategic plan, including the results-oriented goals, strategies, milestones, and performance measures identified in subsection (a)(1)(A);
"(2) the effectiveness of the comprehensive information technology strategic plan described in subsection (a)(1)(A), including the results-oriented goals and performance measures; and
"(3) the extent to which the Food and Drug Administration has fulfilled recommendations of the Government Accountability Office with respect to such agency and information technology."
FDA Study of Mercury Compounds in Drugs and Food
"(a)
"(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and
"(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 [Nov. 21, 1997] and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.
"(b)
"(c)
"(1)
"(A) the scope of mercury use as a drug or dietary supplement; and
"(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.
"(2)
Management Activities Study
Congressional Findings
"(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years;
"(2) the presence and importance of the Food and Drug Administration must be guaranteed; and
"(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health."
§393a. Office of Pediatric Therapeutics
(a) Establishment
The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
(b) Duties
The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.
(c) Staff
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
(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
At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
(
Editorial Notes
Codification
Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
Amendments
2017—Subsec. (d).
2012—Subsec. (c)(2) to (4).
Subsec. (d).
2007—Subsec. (b).
§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
(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
§395. Loan repayment program
(a) In general
(1) Authority for program
Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(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
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.
(June 25, 1938, ch. 675, §1005, formerly §905, as added
Editorial Notes
References in Text
The Public Health Service Act, referred to in subsec. (b), is act July 1, 1944, ch. 373,
§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
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
§397. Contracts for expert review
(a) In general
(1) Authority
The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (
(2) Increased efficiency and expertise through contracts
The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies.
(b) Review of expert review
(1) In general
Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter in a timely manner.
(2) Limitation
A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (
(June 25, 1938, ch. 675, §1007, formerly §907, as added
Editorial Notes
References in Text
The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373,
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
§398. Notices to States regarding imported food
(a) In general
If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.
(b) Rule of construction
Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.
(June 25, 1938, ch. 675, §1008, formerly §908, as added
§399. Grants to enhance food safety
(a) In general
The Secretary is authorized to make grants to eligible entities to—
(1) undertake examinations, inspections, and investigations, and related food safety activities under
(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
(B) a recall of food under this chapter.
(b) Eligible entities; application
(1) In general
In 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
(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) Contents
Each 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;
(C) an itemization of how grant funds received under this section will be expended;
(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.
(c) Limitations
The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
(d) Additional authority
The 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
The Secretary may award grants to an individual grant recipient under this section for periods of not more than 3 years. In the event the Secretary conducts a program evaluation, funding in the second year or third year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.
(f) Progress and evaluation
(1) In general
The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. A recipient of a grant described in the preceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when determining whether to continue funding for such recipient.
(2) No duplication
In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that require measurement and review of the activities of grant recipients under either this chapter or such Act.
(g) Supplement not supplant
Grant funds received under this section shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this section.
(h) Authorization of appropriations
For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015.
(June 25, 1938, ch. 675, §1009, formerly §909, as added
Editorial Notes
References in Text
The FDA Food Safety Modernization Act, referred to in subsec. (f), is
Amendments
2011—
2009—Subsec. (b).
Statutory Notes and Related Subsidiaries
Construction of 2011 Amendment
Nothing in amendment by
§399a. Office of the Chief Scientist
(a) Establishment; appointment
The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.
(b) Duties of the Office
The 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
§399b. Office of Women's Health
(a) Establishment
There is established within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the "Office"). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.
(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
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
(June 25, 1938, ch. 675, §1011, as added
Editorial Notes
Codification
Another section 1011 of act June 25, 1938, ch. 675, was enacted by
§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
(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
The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency.
(2) Content
A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency.
(3) Effect
Nothing in this subsection shall be construed to limit the authority of the Secretary under
(c) Extension service
The Secretary shall ensure coordination with the extension activities of the National Institute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices required as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act.
(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
(C) small fruit and vegetable merchant wholesalers.
(2) Implementation
The competitive grant program established under paragraph (1) shall be carried out in accordance with
(e) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal years 2011 through 2015.
(June 25, 1938, ch. 675, §1012, formerly §1011, as added
Editorial Notes
References in Text
The FDA Food Safety Modernization Act, referred to in subsec. (c), is
Prior Provisions
A prior section 1012 of act June 25, 1938, was renumbered section 1013 and is classified to
Statutory Notes and Related Subsidiaries
Construction
Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see
§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
(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
A person who believes that he or she has been discharged or otherwise discriminated against by any person in violation of subsection (a) may, not later than 180 days after the date on which such violation occurs, file (or have any person file on his or her behalf) a complaint with the Secretary of Labor (referred to in this section as the "Secretary") alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such a complaint, the Secretary shall notify, in writing, the person named in the complaint of the filing of the complaint, of the allegations contained in the complaint, of the substance of evidence supporting the complaint, and of the opportunities that will be afforded to such person under paragraph (2).
(2) Investigation
(A) In general
Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have committed a violation of subsection (a) of the Secretary's findings.
(B) Reasonable cause found; preliminary order
If the Secretary concludes that there is reasonable cause to believe that a violation of subsection (a) has occurred, the Secretary shall accompany the Secretary's findings with a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review.
(C) Dismissal of complaint
(i) Standard for complainant
The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.
(ii) Standard for employer
Notwithstanding a finding by the Secretary that the complainant has made the showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.
(iii) Violation standard
The Secretary may determine that a violation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.
(iv) Relief standard
Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior.
(3) Final order
(A) In general
Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.
(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.
(C) Penalty
If such an order is issued under this paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys' and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.
(D) Bad faith claim
If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorneys' fee, not exceeding $1,000, to be paid by the complainant.
(4) Action in court
(A) In general
If the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(C).
(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
Unless the complainant brings an action under paragraph (4), any person adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the date of such violation. The petition for review must be filed not later than 60 days after the date of the issuance of the final order of the Secretary. Review shall conform to
(B) No judicial review
An order of the Secretary with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding.
(6) Failure to comply with order
Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. In actions brought under this paragraph, the district courts shall have jurisdiction to grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages.
(7) Civil action to require compliance
(A) In general
A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The appropriate United States district court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such order.
(B) Award
The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys' and expert witness fees) to any party whenever the court determines such award is appropriate.
(c) Effect of section
(1) Other laws
Nothing in this section preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law.
(2) Rights of employees
Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.
(d) Enforcement
Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus proceeding brought under
(e) Limitation
Subsection (a) shall not apply with respect to an employee of an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or such entity's agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, rule, regulation, standard, or ban under this chapter.
(June 25, 1938, ch. 675, §1013, formerly §1012, as added
Statutory Notes and Related Subsidiaries
Construction
Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see
§399e. Nanotechnology
(a) In general
The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (
(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).
(
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675,
This Act, referred to in subsec. (b)(6), is
Codification
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
§399f. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
(a) Communication plan
The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall review and modify, as necessary, the Food and Drug Administration's communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.
(b) Content
The 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.
(c) Issuance and posting of communication plan
(1) Communication plan
Not later than 1 year after July 9, 2012, the Secretary, acting through the Commissioner of Food and Drugs, shall issue the communication plan described under this section.
(2) Posting of communication plan on the office of minority health web site
The Secretary, acting through the Commissioner of Food and Drugs, shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of the Food and Drug Administration, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan.
(
Editorial Notes
Codification
Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
§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
(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
The Secretary shall provide a period for public comment during the time that each Institute is being implemented.
(c) Timing
The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after December 13, 2016.
(d) Termination of Institutes
The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination.
(June 25, 1938, ch. 675, §1014, as added
§399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
(a) In general
The 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
(C) award grants to such institutions or consortia of institutions; and
(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions.
(b) Request for designation
A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(c) Eligibility criteria for designation
To 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
The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.
(e) Conditions for designation
As 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 general
The 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 mission
As 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
Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.
(g) Annual review and reports
(1) Annual report to Congress
Beginning 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
An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and annually thereafter for the duration of the grant period, submit to the Secretary a summary of programs and activities funded under the grant.
(3) Periodic review
The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.
(4) Additional report to Congress
Not 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) Definitions
In this section:
(1) Advanced and continuous pharmaceutical manufacturing
The 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
The term "biological product" has the meaning given such term in
(3) Drug
The term "drug" has the meaning given such term in
(4) Institution of higher education
The term "institution of higher education" has the meaning given such term in
(5) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(i) Authorization of appropriations
(1) In general
There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.
(2) Federal administrative expenses
Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.
(
Editorial Notes
References in Text
This Act, referred to in subsec. (f)(3), is
Codification
Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
Amendments
2022—
Statutory Notes and Related Subsidiaries
Transition Rule
§399i. Food and Drug Administration Working Capital Fund
(a) In general
There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to review by the Secretary of Health and Human Services, determines may be performed more advantageously as central services. The Fund shall be reimbursed from applicable discretionary resources, notwithstanding any otherwise applicable purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment, information technology, and other expenses. Charges for equipment and information technology shall include costs associated with maintenance, repair, and depreciation (including improvement and replacement).
(b) Appropriations
Of any discretionary resources appropriated in this Act for fiscal year 2018 for "Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses", not to exceed $5,000,000 of amounts available as of September 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable purpose limitations.
(c) Emergency funds excluded
No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.
(
Editorial Notes
References in Text
This Act, referred to in subsec. (b), is div. A of
The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in subsec. (c), is title II of
Codification
Section was enacted as part of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018, and also as part of the Consolidated Appropriations Act, 2018, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.