E6-44. Statement of Organization, Functions, and Delegations of Authority

Part N, National Institutes of Health, of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS) (40 FR 22859, May 27, 1975, as amended most recently at 70 FR 61146, October 20, 2005, and redesignated from Part HN as Part N at 60 FR 56606, November 9, 1995), is amended as set forth below to reflect the reorganization of the NIH Ethics Office.

Section N-B, Organization and Functions, under the heading Office of the Director (NA, formerly HNA), is amended as follows:

Replace the current section NAT (formerly HNAT) with the following:

NIH Ethics Office (NAT, formerly HNAT). (1) Provides oversight and strategic direction of NIH activities relating to ethics policy, oversight, and operational activities; (2) develops and administers the NIH policies and procedures for implementing the Government-wide conflict of interest statutes and regulations, the HHS supplemental conflict of interest regulations, and HHS policies; (3) implements a program for trans-NIH ethics oversight that includes information technology (IT) support systems, periodic reviews, audits, delegations of authority, training, and records management; (4) determines real or potential conflicts of interest and assesses ethical considerations in scientific reporting, clinical trials, and scientific conferences and workshops; and (5) serves as the liaison and coordinates the NIH response to requests from Congress, the Inspector General, HHS, and the Office of Government Ethics, and performs appropriate liaison activities.

IC Operations and Liaison Branch (NAT2, formerly HNAT2). (1) Provides centralized operational services to ICs in the review and processing of: (a) Individual ethics actions and (b) ethics actions having IC-wide impact such as preapproval of awards, blanket approval of widely attended gatherings (WAGs), and handling ethics for OD committees; and (2) provides advisory services in the management of IC ethics reviews.

Policy and Management Review Branch (NAT3, formerly HNAT3). (1) Provides technical review of NIH and IC Ethics Programs and conducts risk assessment; (2) develops NIH-wide policies and procedures to ensure a rigorous NIH Ethics Program; (3) manages ethics delegations of authority; (4) develops and manages content for the NIH Ethics Web site; and (5) provides NIH-wide ethics training to staff.

Delegations of Authority

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

Dated: November 10, 2005.

Elias A. Zerhouni,

Director, National Institutes of Health.