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U.S. Department of Health and Human Services

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SMG 1231.181

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF APPLIED RESEARCH AND SAFETY ASSESSMENT
DIVISION OF MOLECULAR BIOLOGY


Effective Date: October 1, 2012

[PDF Version]

1.  DIVISION OF MOLECULAR BIOLOGY (DJJHIA).

A.  Conducts research to investigate the evolution of foodborne pathogens including the roles and nature of mutation and their emergence in the environment.
 

B. Develops improved extraction and detection methods for enteric viruses from food matrices including improved cell culture methods for their enrichment.
 

C. Provides expertise, advice, and research assessment in areas of new and emerging molecular biotechnologies and disciplines such as genomics, transcriptomics, and proteomics with an applied forward thinking vision.
 

D. Develops and applies bioinformatic methods to identify DNA biomarker sequences for the identification and subtyping of foodborne pathogens and viruses to aid epidemiological source tracking.
 

E. Explores and develops new molecular approaches to support rapid, high-throughput in vitro methods to identify new toxicants and profile complex mixtures and extracts.
 

F. Explores and develops new molecular metagenomic approaches to harness the gastrointestinal microbial community as a new measurable human health endpoint.
 

G. Investigates functional genomics of foodborne pathogenic bacteria including underlying phenotypes of observed mutations and adaptation by gene regulation in response to external environmental signals and during stages of infection.
 

H. Reviews regulatory actions for adequacy of analytical evidence in support of programmatic offices such as OFAS (BNFs for GMOs) and ONLDS/DDSP (NDI notifications for live microbials).
 

I. Serves as general molecular biology expertise for the Center in the support, development, and transfer of technologies to other intracenter research organizations and field components.

2.  AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Secretary of Health and Human Services on October 1, 2012.

 

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