E9-27485. Office of the Director, National Institutes of Health; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.

The meeting will be open to the public, with attendance limited to 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 below in advance of the meeting.

Name of Committee: Recombinant DNA Advisory Committee.

Date: December 1-2, 2009.

Time: December 1, 2009, 9 a.m. to 5:30 p.m.; December 2, 2009, 8:30 a.m. to 4:15 p.m.

Agenda: The Recombinant DNA Advisory Committee will review and discuss selected human gene transfer protocols as well as related data management activities. Protocols to be reviewed include a protocol for Leber congenital amaurosis using an AAV vector, a protocol for adenosine deaminase severe combined immunodeficiency disease (ADA SCID) using a lentiviral vector and a protocol for alpha 1 antitrypsin deficiency using an AAV vector. Additional discussions include an update on a trial that used a lentiviral vector for beta-thalassemia and sickle cell disease and a discussion of proposed final changes to the NIH Guidelines for Research Involving Recombinant DNA to address synthetic nucleic acids. Finally, an experiment involving the introduction of tetracycline resistance into non-ocular strains of Chlamydia trachomatis will be discussed as required under Section III-A-1 of the NIH Guidelines for Research Involving Recombinant DNA Molecules. Further information on this research can be found in the October 28, 2009 Federal Register (74 FR 55568). An agenda for the meeting will be available on the OBA Web site (http://oba.od.nih.gov/​rdna_​rac/​rac_​meetings.html).

Place: National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892.

Contact Person: Laurie Lewallen, Advisory Committee Coordinator, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892-7985, 301-496-9839, [e-mail].

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

Information is also available on the Institute's/Center's home page: http://oba.od.nih.gov/​rdna/​rdna.html,, where an agenda and any additional information for the meeting will be posted when available.

OMB's “Mandatory Information Requirements for Federal Assistance Program Announcements” (45 FR 39592, June 11, 1980) requires a statement concerning the official government programs contained in the Catalog of Federal Domestic Assistance. Normally NIH lists in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which DNA recombinant molecule techniques could be used, it has been determined not to be cost effective or in the public interest to attempt to list these programs. Such a list would likely require several additional pages. In addition, NIH could not be certain that every Federal program would be included as many Federal agencies, as well as private organizations, both national and international, have elected to follow the NIH Guidelines. In lieu of the individual program listing, NIH invites readers to direct questions to the information address above about whether individual programs listed in the Catalog of Federal Domestic Assistance are affected.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS)

Dated: November 9, 2009.

Anna Snouffer,

Deputy Director, Office of Federal Advisory Committee Policy.