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Statement of Organization, Functions, and Delegations of Authority; National Institutes of Health

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Part N, National Institutes of Health, of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (40 FR 22859, May 27, 1975, as amended most recently at 66 FR 6617, January 22, 2001, and redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as set forth below to establish the Division of the National Toxicology Program (NTP) within the National Institute of Environmental Health Sciences (NIEHS).

Section N-V, Organization and Functions, is amended as follows:

Immediately after the paragraph headed “Office of Translational Research” (N V4, formerly HN V4), insert the following:

Division of the National Toxicology Program (N V5, formerly HN V5). (1) Provides toxicological evaluations on substances of public health concern; (2) develops and validates improved toxicology methods (more sensitive, specific, and rapid); (3) develops approaches and generates data to strengthen the science base for risk assessments; and (4) communicates results with all stakeholders. Program goals are achieved through a highly integrated, cooperative research and testing program carried out through in-house research, research and development contracts, cooperative agreements, and other support mechanisms.

Biomolecular Screening Branch (N V52, formerly HN V52). (1) Develops research and testing activities in high and medium throughput screening assays for rapid detection of biological activities of significance to toxicology and carcinogenesis, (2) carries out the NTP automated screening assays with C. elegans, (3) develops analysis tools and approaches to allow an integrated assessment of high throughput screening endpoints and associations with findings from traditional toxicology and cancer models, and (4) develops assays and approaches to understand the genetic and epigenetic bases for differences in susceptibility.

Cellular and Molecular Pathology Branch (N V53, formerly HN V53). Responsible for (1) managing, evaluating, reviewing, and reporting all pathology data generated through conduct of NTP toxicity and carcinogenicity studies; (2) establishing standards, terminology, and diagnostic criteria for rodent pathology; (3) providing laboratory animal medicine support for the NTP and Division of Intramural Research (DIR); (4) maintaining the NTP Archives; and (5) managing pathology, toxicology, and other contracts to support NTP and DIR investigators. Staff veterinary scientists provide collaborative pathology diagnostic support for DIR investigators and mentoring/training in toxicologic pathology and laboratory animal medicine.

Program Operations Branch (N V54, formerly HN V54). (1) Provides recommendations to the NTP for scientific, administrative, and fiscal procedures and requirements by which NTP goals may be accomplished through in-house and contract activities; (2) provides resources for analytical chemistry, toxicokinetics, and evaluations of bioavailability and biotransformation; (3) initiates the contract award process and participates with the NIEHS contracts office in the review and award of the contract; (5) manages toxicity and carcinogenicity studies performed under contract and monitors them for technical and fiscal performance; (6) manages the receipt, maintenance, tracking, and dissemination of NTP documents and data.

Toxicology Branch (N V55, formerly HN V55). (1) Responsible for the design, interpretation, review, and reporting of general toxicology and carcinogenicity studies, usually in rodent models, as well as studies to evaluate targeted effects on the immune system, reproduction, development, and interference with chromosomes and Start Printed Page 23818DNA for substances studied by the NTP; (2) integrates information derived from studies of absorption, metabolism, distribution, and excretion of test substances within the body and the development of mathematical models that utilize this information in the extrapolation and prediction of findings across different species and exposure conditions; (3) oversees analysis and development of models using information derived from studies of gene expression in different tissues; (4) incorporates systems biology approaches; (5) reports results from all these specialized toxicology studies; (6) develops new methodologies for toxicological assessments; and (7) provides guidance on the proper utilization of new types of toxicology information in hazard identification, hazard characterization, and regulatory decision-making.

NTP Laboratory (NTPL) (N V56, formerly, HN V56). Responsible for providing laboratory capabilities and support for the performance of agent-specific, targeted research directly related to specific substances nominated to the NTP, issues of central importance to programs of the NTP, or the development of new methods to advance the scientific programs of the NTP.

Delegations of Authority Statement: All delegations and redelegations of authority to officers and employees of NIH that were in effect immediately prior to the effective date of this reorganization and are consistent with this reorganization shall continue in effect, pending further redelegation.

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Dated: April 20, 2011.

Francis S. Collins,


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[FR Doc. 2011-10318 Filed 4-27-11; 8:45 am]