4782
Federal Register
/Vol. 62, No. 21/Friday, January 31, 1997/Notices
participate in biomedical research.Increase the exposure of K–12 students,their teachers and the public to the lifesciences. Construct or renovatebiomedical research facilities.Biomedical research investigatorssupported by the NIH require a broadarray of technologies, tools andmaterials for their research. The NCRRplays a key role in addressing trans-NIHresearch issues, such as access to state-of-the-art instrumentation andtechnologies; containment of theescalating costs of highly sophisticatedresearch; development of appropriate,specialized research models; efforts toremedy the shortage of clinical andminority investigators; and efforts toimprove the research infrastructure.To ensure the continued relevance of its strategic plan, the NCRR seeks inputto the following questions in terms of the issues described above:(A) What are the most importantresearch trends that will drivebiomedical research?(B) What research resources andtechnologies will be critical inaddressing these trends and meetingbiomedical investigators’ needs?(C) What strategies will eliminatebarriers to progress and enhance accessto research resources and technologies?(D) Who would you recommend toserve as a panel member for NCRR’sstrategic planning process? Please listthe name, degree, position title,department, institution name andaddress, phone and fax numbers, andspecific area of expertise for each personrecommended.We have provided a user-friendlyresponse form at NCRR’s StrategicPlanning Survey Web site: <http:// www.ncrr.nih.gov/survey.htm>; or youmay mail your response to the Office of Science Policy, NCRR/NIH, OneRockledge Center, 6705 Rockledge DriveMSC 7965, Suite 5046, Bethesda, MD20892–7965; FAX 301–480–3654.
Dated: January 22, 1997.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 97–2482 Filed 1–30–97; 8:45 am]
BILLING CODE 4140–01–M
Recombinant DNA Research: ActionUnder the Guidelines
AGENCY
:
National Institutes of Health,PHS, DHHS.
ACTION
:
Notice of Action under the NIHGuidelines for Research InvolvingRecombinant DNA Molecules (59 FR34496, 59 FR 40170, 60 FR 20726, 61 FR1482, 61 FR 10004).
SUMMARY
:
This notice sets forth anaction taken by the Director, NationalInstitutes of Health (NIH), under theNIH Guidelines for Research InvolvingRecombinant DNA Molecules.
FOR FURTHER INFORMATION CONTACT
:
Additional information can be obtainedfrom Ms. Debra Knorr, Acting Director,Office of Recombinant DNA Activities(ORDA), Office of Science Policy,National Institutes of Health, MSC 7010,6000 Executive Boulevard, Suite 302,Bethesda, Maryland 20892–7010, (301)496–9838.
SUPPLEMENTARY INFORMATION
:
Today’saction is being promulgated under theNIH Guidelines for Research InvolvingRecombinant DNA Molecules. Theaction was proposed and published forcomment in the
Federal Register
of July8, 1996 (61 FR 35774), then revised andproposed for comment in the
FederalRegister
of November 22, 1996 (61 FR59726), and reviewed andrecommended for approval by the NIHRecombinant DNA Advisory Committee(RAC) at its meeting on December 9,1996.
I. Background Information andDecision on Action Under the NIHGuidelines
A. Amendments to Section IV–C–2 of the NIH Guidelines Regarding the Recombinant DNA Advisory Committee
On July 8, 1996, the Director, NIH,published a Notice of Intent to ProposeAmendments to the NIH Guidelines forResearch Involving Recombinant DNAMolecules (NIH Guidelines) RegardingEnhanced Mechanisms for NIHOversight of Recombinant DNAActivities in the
Federal Register
(61 FR35774). In the Notice of Intent, the NIHDirector requested public comment onproposed mechanisms to enhancescientific, ethical, and societal oversightof human gene transfer research underthe NIH Guidelines. Specifically, inpart, the termination of the RAC and theestablishment of the Office of Recombinant DNA Activities AdvisoryCommittee (OAC) consisting of 6–10members.Comments in support of terminationof the RAC reflected an interest inmaking substantive changes in the roleof the RAC. Most of these commentssupported the proposed restructuring of the functions of the RAC and did notspecifically endorse termination of RAC.Opposing comments focused on thehistorical importance of retaining theRAC as an internationally recognizedforum for public discussion of thescience, safety, and ethics of humangene therapy research. These authorsarticulated the critical role that the RACplays in maintaining public confidencein human gene therapy research.The importance of the continuation of the RAC,
per se,
was underscored bycomments which specifically addressedthe establishment of the OAC. Of the 53comments which addressed this issue,12 expressed support and 41 expressedopposition. The majority of commentssubmitted in opposition to the OACstated that the proposed functions of theOAC could be accomplished by theRAC, or by a restructured version of theRAC. Several authors emphasized that,absent the historic credibility of theRAC, the OAC might suffer from aninability to attract and motivate the typeof expertise and judgement needed forthis important public forum.On November 22, 1996, the NIHDirector published Notice of ProposedActions Under the NIH Guidelines forResearch Involving Recombinant DNAMolecules in the
Federal Register
(61FR 59726). In these Proposed Actions,in part, the NIH Director proposedretaining the RAC, while modifying itsroles and responsibilities relevant tohuman gene therapy research andreducing the membership from 25members to 15 members, and requestedcomments.During the December 9, 1996,meeting, the RAC, which had reviewedthe comments received, approved theoverall concepts in the ProposedActions. The RAC specifically approvedreducing the membership of the RACfrom 25 members to 15 members. Themotion passed by a vote of 12 in favor,0 opposed, and 2 abstentions.The action is detailed in Section II—Summary of Action. I accept thisrecommendation to reduce themembership of the RAC from 25members to 15 members, and the NIHGuidelines will be amendedaccordingly.
II. Summary of Action
A. Amendments to Section IV–C–2, Recombinant DNA Advisory Committee(RAC)
In Section IV–C–2, the first paragraphis amended to read:‘‘Section IV–C–2. Recombinant DNAAdvisory Committee (RAC)‘‘The RAC is responsible for carryingout specified functions cited below aswell as others assigned under its charteror by the DHHS Secretary and the NIHDirector. The RAC consists of 15members including the Chair, appointedby the DHHS Secretary or his/herdesignee, at least 8 of whom are selectedfrom authorities knowledgeable in thefields of molecular genetics, molecular
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National Institutes of Health: freg2496
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