2011-22207. 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: September 13-14, 2011.

Time: September 13, 2011, 10:30 a.m. to 5:30 p.m.

Agenda: The NIH Recombinant DNA Advisory Committee (RAC) will review and discuss selected human gene transfer protocols, including a protocol that will use a recombinant Saccharomyces cerevisiae that expresses the human Brachyury protein in adults with metastatic carcinoma. The RAC will also discuss proposed amendments to Section III-E-1 of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), experiments involving partial genomes of eukaryotic viruses in tissue culture, and Appendix B of the NIH Guidelines, Classification of Human Etiologic Agents by Risk Group. Please view the meeting agenda at http://oba.od.nih.gov/​rdna_​rac/​rac_​meetings.html for more information.

Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Time: September 14, 2011, 8:30 a.m. to 1:15 p.m.

Agenda: The NIH Recombinant DNA Advisory Committee (RAC) will discuss selected human gene transfer protocols, including a study using a modified Bifidobacterium longum for targeting of chemotherapy for advanced cancer. The RAC will also hear a presentation of the results of a Phase 1/2 trial using a modified AAV1 virus that expresses the sarcoplasmic reticulum Ca²⁺-ATPase in subjects with advanced heart failure. Please view the meeting agenda at http://oba.od.nih.gov/​rdna_​rac/​rac_​meetings.html for more information.

Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Chezelle George, Office of Biotechnology Activities, Office of Science Policy/OD, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892, 301-496-9838, [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.

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: August 22, 2011.

Jennifer S. Spaeth,

Director, Office of Federal Advisory Committee Policy.