E9-8478. Notice of a Public Consultation Meeting on Proposed Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecule (NIH Guidelines)

There will be a public consultation meeting to solicit stakeholder input regarding the proposed revisions to the NIH Guidelines. The meeting will be held on Tuesday, June 23, 2009 at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, Virginia, 22202, from approximately 8 a.m. to 5 p.m.

Discussions will focus on the proposed revisions to the NIH Guidelines which include: (1) Broadening the scope of the NIH Guidelines, which currently cover laboratory and clinical research involving DNA molecules created via recombinant techniques (i.e., joining of DNA molecules), to apply to nucleic acids that are synthesized chemically or by other means without the use of recombinant technology; (2) Revising the criteria for determining when the introduction of a drug resistance trait into a microorganism must be reviewed by the Recombinant DNA Advisory Committee and approved by the NIH Director; and (3) Changing the level of review required for recombinant or synthetic experiments involving more than one-half but less than two-thirds of the genome of certain viruses in tissue culture as described in Section III-E-1 of the NIH Guidelines.

The Notice of Consideration of a Proposed Action under the NIH Guidelines was published in the Federal Register on March 4, 2009 (74 FR 9411) and may be located at the following link: http://oba.od.nih.gov/​rdna/​rdna.html.

For further information concerning this meeting contact Ms. Laurie Lewallen, Advisory Committee Coordinator, Office of Biotechnology Activities, Office of the Director, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892-7985, 301-496-9838, [e-mail].

The meeting will be open to the public, with attendance limited to the space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed above in advance of the meeting.

A draft agenda and additional information for the meeting will be posted on the OBA Web site: http://oba.od.nih.gov/​rdna/​rdna.html. Background and supplemental information may also be obtained by contacting NIH OBA by e-mail [e-mail].

Dated: April 8, 2009.

Jacqueline Corrigan-Curay,

Acting Director, Office of Biotechnology Activities, National Institutes of Health.