Department of Health and Human Services August 29, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Pharmacogenomic Data SubmissionsCompanion Guidance.'' The guidance is intended as a companion to the guidance of the same name, which was issued in 2005 (70 FR 14698; March 23, 2005). It reflects experience gained since the issuance of that guidance with voluntary genomic data submissions as well as with review by FDA of numerous protocols and data submitted under investigational new drug (IND) applications, new drug applications (NDAs), and biologics license applications (BLAs). The recommendations are intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PINs referenced above. After review and consideration of all comments received, the PINs may be amended to incorporate recommendations from the public. Once the PINs are finalized, they will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' The ``Response to Public Comments'' will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PINs. Where comments do not result in a revision to the PINs, explanations will be provided. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. The purpose of the recently published draft PINs is to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project, including requests to include new specialty services and/or a new target population within the scope of the Federal project.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.