Page 123 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

90 SECTION | I General

VetBooks.ir FDA Organization product centers and their regulatory roles. The NCTR
conducts FDA mission-critical, peer-reviewed, critical
The FDA’s current organization consists of the Office
path research targeted to developing a scientifically
of the Commissioner and four major directorates overseeing
sound basis for regulatory decisions and reducing risks
the core functions of the agency: Medical Products and
associated with FDA-regulated products. Research is
Tobacco, Foods and Veterinary Medicine, Global
aimed at evaluating the biological effects of potentially
Regulatory Operations and Policy, and Operations. In addi-
toxic chemicals or microorganisms, defining the com-
tion, the FDA is organized geographically into Regional
plex mechanisms that govern their toxicity, understand-
Offices and component Districts, where field staff are
ing critical biological events in the expression of
assigned. The Office of the Commissioner provides central-
toxicity, and developing methods to improve assess-
ized agency-wide program direction and management
ment of human exposure, susceptibility, and risk.
services to support effective administration and the FDA’s
Customized assessment of chemicals of vital interest to
consumer protection efforts within its regulatory frame-
the FDA involves the coordination of expertise in the
work, and to put available resources to the most efficient
areas of biochemical and molecular markers of safety
use. The Office of Medical Products and Tobacco provides
and toxicity, neurotoxicology, microbiology, chemistry,
high-level coordination and leadership across the centers for
genetic or reproductive/developmental toxicology and
human drugs, biologics, medical devices, and tobacco
systems-biology assessments for characterizing biomar-
products. The office also oversees the agency’s special
kers. The NCTR has developed and is standardizing
medical programs. This Office consists of the Center for
technologies, such as genomics, proteomics, metabolo-
Drug Evaluation and Research (CDER), the Center for
mics, and nanotechnology to identify and characterize
Devices and Radiological Health (CDRH), the Center
early biomarkers of toxicity using quantitative risk
for Biologics Evaluation and Research (CBER), and the
assessment methods. The NCTR also represents the
Center for Tobacco Products (CTP). The Office of Foods
FDA on key committees of the National Toxicology
and Veterinary Medicine (OFVM) has a wide range of
Program (NTP), a program that evaluates the effects of
responsibilities related to protecting the safety and security
chemicals on health (FDA, 2016b).
of foods for humans and animals, regulating the safety and
Throughout this chapter, reference may be made to
effectiveness of animal drugs, and ensuring that food labels
the US Code (USC), the Code of Federal Regulations
contain useful and reliable information. Within OFVM, the
(CFR) and certain guidance documents. The USC
Center for Food Safety and Applied Nutrition (CFSAN),
contains all general and permanent US laws, including
the Center for Veterinary Medicine (CVM), and the Office
the FFDCA. FDA develops regulations based on the
of Regulatory Affairs (ORA) work together to carry out the
laws set forth in the FFDCA or other laws under which
FDA’s food safety, nutrition, and animal health activities.
FDA operates. The CFR is a codification of regulations
The Office of Global Regulatory Operations and Policy
in the Federal Register by the executive departments
(also known as GO) comprises the Office of Regulatory
and agencies of the federal government. Title 21 of the
Affairs and the Office of International Programs. The GO
CFR is reserved for rules of the FDA. Each title (or vol-
Office provides executive oversight, strategic leadership,
ume) of the CFR is revised once each calendar year. A
and policy direction to the FDA’s domestic and interna-
revised Title 21 is issued on approximately April 1 of
tional product quality and safety efforts, including global
each year and is usually available on the US
collaboration, global data sharing, development and harmo-
Government Publishing Office Electronic CFR website
nization of standards, field operations, compliance, and
(US GPO, 2017). Guidance documents represent the
enforcement activities. The Office of Operations is respon-
FDA’s current thinking on a particular subject. These
sible for various agency functions, including finance and
documents are prepared for FDA review staff and regu-
budget, facilities engineering, information management and
lated industry to provide guidelines for the processing,
technology, human resources, crisis management, and emer-
content, and evaluation or approval of applications and
gency operations (FDA, 2016a).
also for the design, production, manufacturing, and
The National Center for Toxicological Research
testing of regulated products. They also establish poli-
(NCTR), established by executive order in 1971, is an
cies intended to achieve consistency in the FDA’s regu-
important research component of the FDA that plays a
latory approach and establish inspection and
critical role in the FDA’s mission to promote and protect
enforcement procedures. Because guidance documents
public health. The NCTR, in partnership with researchers
are not regulations or laws, they are not enforceable,
from elsewhere in the FDA, other government agencies,
either through administrative actions or through the
academia and industry, provides innovative technology,
courts. An alternative approach may be used if such
methods development, vital scientific training, and unique
approach satisfies the requirements of the applicable
technical expertise which is critical in supporting FDA
statute, regulations, or both.