[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23817-23818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10318]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

    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

[[Page 23818]]

DNA 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.

    Dated: April 20, 2011.
Francis S. Collins,
Director.
[FR Doc. 2011-10318 Filed 4-27-11; 8:45 am]
BILLING CODE 4140-01-P