• Embed Doc
  • Copy Link
  • Readcast
  • Collections
  • CommentGo Back
Download
 
20726
Federal Register
 /Vol. 60, No. 81/Thursday, April 27, 1995/Notices
Drive, Room 4132, Bethesda, MD 20892,(301) 594–7241.
 Name of SEP:
Microbiological andImmunological Sciences.
 Date:
June 23, 1995.
Time:
8 a.m.
Place:
Holiday Inn, Bethesda, MD.
Contact Person:
Dr. Jean Hickman,Scientific Review Administrator, 6701Rockledge Drive, Room 4178, Bethesda, MD20892, (301) 594–7078.
 Name of SEP:
Behavioral andNeurosciences.
 Date:
June 28, 1995.
Time:
1 p.m.
Place:
NIH, Rockledge II, Room 5198,Telephone Conference.
Contact Person:
Dr. Peggy McCardle,Scientific Review Admin., 6701 RockledgeDrive, Room 5198, Bethesda, MD 20892,(301) 435–1258.
 Name of SEP:
Behavioral andNeurosciences.
 Date:
July 6, 1995.
Time:
12 noon.
Place:
NIH, Rockledge II, Room 5198,Telephone Conference.
Contact Person:
Dr. Peggy McCardle,Scientific Review Admin., 6701 RockledgeDrive, Room 5198, Bethesda, MD 20892,(301) 435–1258.
Purpose/Agenda:
To review SmallBusiness Innovation Research Program grantapplications.
 Name of SEP:
Behavioral andNeurosciences.
 Date:
July 10, 1995.
Time:
8:30 a.m.
Place:
Holiday Inn, Chevy Chase, MD.
Contact Person:
Dr. Peggy McCardle,Scientific Review Admin., 6701 RockledgeDrive, Room 5198, Bethesda, MD 20892,(301) 435–1258.The meetings will be closed in accordancewith the provisions set forth in secs.552b(c)(4) and 552b(c)(6), Title 5, U.S.C.Applications and/or proposals and thediscussions could reveal confidential tradesecrets or commercial property such aspatentable material and personal informationconcerning individuals associated with theapplications and/or proposals, the disclosureof which would constitute a clearlyunwarranted invasion of personal privacy.This notice is being published less than 15days prior to the meeting due to the urgentneed to meet timing limitations imposed bythe grant review cycle.(Catalog of Federal Domestic AssistanceProgram Nos. 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878,93.892, 93.893, National Institutes of Health,HHS)Dated: April 21, 1995.
Susan K. Feldman,
Committee Management Officer, NIH.
[FR Doc. 95–10377 Filed 4–26–95; 8:45 am]
BILLING CODE 4140–01–M
National Institute on Drug Abuse;Notice of Meeting
Pursuant to Pub. L. 92–463, notice ishereby given of the meeting of theNational Advisory Council on DrugAbuse, National Institute on Drug Abuseon May 16–17, 1995.On May 16, from 9 a.m. to 5 p.m., themeeting will be held at the NationalInstitutes of Health, Building 1, WilsonHall, 9000 Rockville Pike, Bethesda,Maryland 20892. This portion of themeeting will be open to the public forannouncements and reports of administrative, legislative, and programdevelopments in the drug abuse field.Attendance by the public will be limitedto space available.On May 17, from 9 a.m. to 1 p.m., themeeting will be held at the ParklawnBuilding, Conference Room E, 5600Fishers Lane, Rockville, MD 20857. Inaccordance with provisions set forth insec. 552b(c)(4) and 552b(c)(6), Title 5,U.S.C. and sec. 10(d) of Pub. L. 92–463,this portion of the meeting will beclosed to the public for the review,discussion, and evaluation of grantapplications. These applications and thediscussions could reveal confidentialtrade secrets or commercial propertysuch as patentable material andpersonal information concerningindividuals associated with theapplications, disclosure of which wouldconstitute a clearly unwarrantedinvasion of personal privacy.A summary of the meeting and aroster of committee members may beobtained from Ms. Camilla L. Holland,NIDA Committee Management Officer,National Institutes of Health, ParklawnBuilding, Room 10–42, 5600 FishersLane, Rockville, Maryland 20857 (301/ 443–2755).Substantive program information maybe obtained from Ms. Eleanor C.Friedenberg, Room 10–42, ParklawnBuilding, 5600 Fishers Lane, Rockville,Maryland 20857, (301/443–2755).Individuals who plan to attend andneed special assistance, such as signlanguage interpretation or otherreasonable accommodations, shouldcontact the contact person named abovein advance of the meeting.
(Catalog of Federal Domestic AssistanceProgram Numbers: 93.277, Drug AbuseResearch Scientist Development andResearch Scientist Awards; 93.278, DrugAbuse National Research Service Awards forResearch Training; 93.279, Drug AbuseResearch Programs.)Dated: April 24, 1995.
Susan K. Feldman,
Committee Management Officer, NIH.
[FR Doc. 95–10378 Filed 4–26–95; 8:45 am]
BILLING CODE 4140–01–M
National Library of Medicine; Notice ofMeeting of the Biomedical LibraryReview Committee
Pursuant to Pub. L. 92–463, notice ishereby given of the meeting of theBiomedical Library Review Committeeon June 14–15, 1995, convening at 8:30a.m. in the Board Room of the NationalLibrary of Medicine, Building 38, 8600Rockville Pike, Bethesda, Maryland.The meeting on June 14 will be opento the public from 8:30 a.m. toapproximately 11 a.m. for thediscussion of administrative reports andprogram developments. Attendance bythe public will be limited to spaceavailable. Individuals who plan toattend and need special assistance, suchas sign language interpretation or otherreasonable accommodations, shouldcontact Dr. Roger W. Dahlen at 301–496–4221 two weeks before the meeting.In accordance with provisions setforth in secs. 552b(c)(4) and 552b(c)(6),Title 5, U.S.C., and sec. 10(d) of Pub. L.92–463, the meeting on June 14 will beclosed to the public for the review,discussion, and evaluation of individualgrant applications from 11 a.m. toapproximately 5 p.m., and on June 15from 8:30 a.m. to adjournment. Theseapplications and the discussion couldreveal confidential trade secrets orcommercial property, such as patentablematerial, and personal informationconcerning individuals associated withthe applications, disclosure of whichwould constitute a clearly unwarrantedinvasion of personal privacy.Dr. Roger W. Dahlen, ScientificReview Administrator, and Chief,Biomedical Information SupportBranch, Extramural Programs, NationalLibrary of Medicine, 8600 RockvillePike, Bethesda, Maryland 20894,telephone number: 301–496–4221, willprovide summaries of the meeting,rosters of the committee members, andother information pertaining to themeeting.
(Catalog of Federal Domestic AssistanceProgram No. 93.879—Medical LibraryAssistance, National Institutes of Health.)Dated: April 21, 1995.
Susan K. Feldman,
Committee Management Officer, NIH.
[FR Doc. 95–10379 Filed 4–26–95; 8:45 am]
BILLING CODE 4140–01–M
Recombinant DNA Research: ActionsUnder the Guidelines
AGENCY
:
National Institutes of Health,PHS, DHHS.
ACTION
:
Notice of Actions under the NIHGuidelines for Research Involving
 
20727
Federal Register
 /Vol. 60, No. 81/Thursday, April 27, 1995/Notices
Recombinant DNA Molecules (59 FR34496 and 59 FR 40170).
SUMMARY
:
This notice sets forth anaction to be taken by the Director,National Institutes of Health (NIH),under the NIH Guidelines for ResearchInvolving Recombinant DNA Molecules(59 FR 34496 and 59 FR 40170).
FOR FURTHER INFORMATION CONTACT
:
Additional information can be obtainedfrom Dr. Nelson A. Wivel, Director,Office of Recombinant DNA Activities(ORDA), Office of Science Policy andTechnology Transfer, National Institutesof Health, Suite 323, 6006 ExecutiveBoulevard, MSC 7052, Bethesda,Maryland 20892–7052, (301) 496–9838.
SUPPLEMENTARY INFORMATION
:
Today’saction is being promulgated under theNIH Guidelines for Research InvolvingRecombinant DNA Molecules. Thisproposed action was published forcomment in the
Federal Register
of February 8, 1995 (60 FR 7630), andreviewed and recommended forapproval by the NIH Recombinant DNAAdvisory Committee (RAC) at itsmeeting on March 6–7, 1995.
I. Background Information andDecisions on Actions Under the NIHGuidelines
 A. Amendments to Sections I, III, IV, V,and Appendices C, F, G, I, and M of the NIH Guidelines Regarding Consolidated  Review of Human Gene Transfer Protocols
On July 18–19, 1994, the NationalTask Force on AIDS Drug Developmentheld an open meeting for the purpose of identifying barriers to AIDS DrugDiscovery that included a proposal tostreamline the dual review process forhuman gene transfer experiments.Members of the Task Forcerecommended a consolidated reviewprocess to enhance interactions betweenthe NIH and the Food and DrugAdministration (FDA). As a result of theTask Force’s deliberations,recommendations were adopted in orderto eliminate any unnecessary overlapbetween the NIH and FDA review of human gene transfer proposals. BothDrs. Varmus and Kessler noted that theirrespective agencies would cooperatefully to effect the changes necessary toimplement these recommendations.The NIH and FDA proposed that theRAC become advisory to both the NIHDirector and the FDA Commissionerwith regard to the review of human genetransfer protocols. In the interest of maximizing the resources of bothagencies and simplifying the methodand period of review for researchprotocols involving human genetransfer, the NIH and FDA shouldinstitute an interagency consolidatedreview process that incorporates thefollowing principal elements:(1) All human gene transfer protocolsshall be submitted directly to the FDA.Submission will be in the formatrequired by the FDA and the sameformat will be used by the RAC whenpublic review is deemed necessary.(2) Upon receipt, FDA review willproceed. The NIH/ORDA staff willsimultaneously evaluate the protocol forpossible RAC review.(3) Factors which may contribute tothe need for RAC review include: (a)New vectors/new gene delivery systems,(b) new diseases, (c) unique applicationsof gene transfer, and (d) other issues thatrequire further public review.(4) If either the NIH/ORDA or FDAdecides that a proposal should bereviewed by the RAC, the proposal willbe forwarded to the RAC primaryreviewers immediately. Wheneverpossible, Principal Investigators will benotified within 15 working daysfollowing receipt of the submissionwhether RAC review will be required.(RAC reviewed applications will bedistributed to RAC membersapproximately four weeks prior to thenext quarterly RAC meeting.)(5) Semiannual data reportingprocedures will remain theresponsibility of NIH (ORDA).Semiannual data reports will bereviewed by the RAC in a public forum.In a letter dated August 2, 1994, Dr.Nelson A. Wivel, Director, ORDA, NIH,provided the RAC with backgroundinformation regarding the National Task Force on AIDS Drug Developmentmeeting, and proposed amendments toSections I, III, IV, V, and Appendices C,F, G, I, and M of the NIH Guidelines, toreflect the proposed consolidatedreview process. The revised reviewprocess was proposed as follows:(1) Investigators will be required tosubmit all human gene transferproposals directly to the FDA in theformat required by the FDA; therefore,investigators will no longer be requiredto provide a separate submission toNIH/ORDA for RAC review. The FDADivision of Cellular and Gene Therapieswill forward a copy of each submissionto NIH/ORDA. Both the FDA Division of Cellular and Gene Therapies and NIH/ ORDA will simultaneously evaluateeach proposal for the necessity for RACreview. Whenever possible, theinvestigators will be notified within 15working days following receipt of thesubmission regarding the necessity forRAC review.(2) If either the NIH/ORDA or FDAdecides that a proposal should undergoRAC review, the proposal will beforwarded to the RAC primary reviewersimmediately. Any protocol submittedless than 8 weeks before a RAC meetingwill be reviewed at the followingquarterly RAC meeting.(3) The RAC will makerecommendations regarding approval/ disapproval of protocols, including anyrelevant stipulations, to the NIHDirector. The NIH Director will review,approve, and transmit the RAC’srecommendations/stipulations to theFDA Commissioner.(4) The FDA will consider suchrecommendations/stipulations and willbe responsible for completion of review.The RAC and NIH/ORDA will no longerhave the responsibility for reviewingmaterial submitted for AcceleratedReview or for the review of minormodifications to human gene transferprotocols.These proposed actions werediscussed during the September 12–13,1994, RAC meeting (published forpublic comments in the
FederalRegister
, August 23, 1994 (59 FR43426)). Dr. Philip Noguchi, Director,Division of Cellular and GeneTherapies, Center for BiologicsEvaluation and Research, FDA,provided additional suggestionsregarding the proposed review processincluding FDA adoption of theAppendix M, Points to Consider in theDesign and Submission of Protocols forthe Transfer of Recombinant DNAMolecules into the Genome of One orMore Human Subjects (Points toConsider), of the NIH Guidelines. TheFDA will require investigators to submitthe Points to Consider with theirproposed experiments. A lengthydiscussion ensued involving RACmembers’ concerns and suggestionsregarding the consolidated reviewprocess.Dr. Noguchi submitted the followingcompromise proposal regarding theNIH/FDA consolidated review of humangene transfer experiments:(1) Appendix M, Points to Consider,will not be deleted from the NIHGuidelines. The NIH Guidelines will bemodified to provide for submission of Appendix M, Points to Consider,directly to the FDA prior to INDsubmission. The FDA will update theirguidance documents in a similarmanner. When necessary, the RAC willcontinue to be responsible for modifyingAppendix M, Points to Consider.(2) The RAC, NIH/ORDA, and FDAwill decide on the necessity for full RACreview. The submitted Appendix M,Points to Consider, will be publiclyavailable for all human gene transfer
 
20728
Federal Register
 /Vol. 60, No. 81/Thursday, April 27, 1995/Notices
submissions even if RAC review is notrequired.(3) The RAC and FDA will broadentheir scope of review for human genetransfer proposals to jointly andprospectively address global issues on aregular basis, e.g., ethical considerationin the implementation of gene therapypatient registry, access for ‘‘orphan’’genetic disease patients to therapies,criteria for prenatal gene therapy, andtransgenic technology forxenotransplantation.(4) The RAC, NIH/ORDA, and FDAwill establish a working group toenhance data monitoring efforts.(5) A RAC, NIH/ORDA, and FDAworking group will be established topropose long-term consolidation. Theworking group will have input frompublic, academic, and corporatesources.The RAC approved a motion to (1)accept the FDA proposal submitted byDr. Noguchi; (2) adopt the Categories forAccelerated Review that were approvedby the RAC at its March 3–4, 1994,meeting as guidelines for proposals thatwill not require RAC review; (3)establish a working group to examinethe review process for human genetransfer protocols (in response to Dr.Varmus’ request to establish such agroup); (4) the RAC prefers that anystipulation requirements should besatisfactorily met prior to forwarding itsrecommendation for approval to theNIH Director; and (5) accept theproposed amendments to the NIHGuidelines to reflect this revisedconsolidated review process (includingacceptance of a revised Appendix Mand incorporation of minor editorialchanges). The motion was approved bya vote of 15 in favor, 0 opposed, and 1abstention.On October 26, 1994, NIH/ORDAforwarded the revised actions to the NIHDirector for approval and the FDACommissioner for concurrence. FDAlegal counsel expressed concern thatimplementation of these actions wouldrequire amendment to the FDAInvestigational New Drug ApplicationRegulations (21 CFR Part 312) toaccommodate the release of proprietaryinformation. To resolve this concern, awaiver for release of information fromthe FDA to the NIH was proposed.While the NIH Guidelines could requiresuch a waiver for NIH-fundedinvestigators, it would be voluntary forothers submitting proposed human genetransfer experiments to the FDA. TheNIH expressed concern that failure tocomply with voluntary waiverprocedures may result in the loss of critical information necessary tomaintain: (1) The human gene therapydatabase, (2) ‘‘real-time’’ reporting of serious adverse events, and (3)comprehensive overview (by category)by the RAC in a public forum. Publicreview and access to submission,review, and follow-up information iscritical to the safe and focusedadvancement of human gene therapyresearch. As a result of these concerns,the NIH and FDA agreed on acompromise proposal that wouldaccommodate the single submissionformat proposed at the July 18–19, 1994,meeting of the National Task Force onAIDS Drug Development, yet maintainpublic access to critical information and‘‘real-time’’ reporting of adverse events.The compromise proposal involvessimultaneous submission of humangene transfer protocols to both NIH andthe FDA in a single submission format.This format includes (but is not limitedto) the documentation described inAppendices M-I through M-V, of theNIH Guidelines. NIH/ORDA and theFDA will simultaneously evaluate theproposal regarding the necessity forRAC review.These revisions to the consolidatedreview process were discussed duringthe March 6–7, 1995, RAC meeting(published for public comments in the
Federal Register
, February 8, 1995 (60FR 7630)). The following motions weremade in response to the February 24,1995, comments submitted by Ms.Sheryl Osborne of Viagene, Inc., SanDiego, California: (1) A motion to retainthe current requirement for obtainingInstitutional Review Board (IRB)approval prior to RAC submission. Afriendly amendment was made andaccepted that ORDA should notify theDirector of the Office for Protection fromResearch Risks regarding the necessityfor IRB adherence to the detailedquestions contained in Appendices M-IIthrough M-V of the NIH Guidelines(Informed Consent issues). Theamended motion was approved by avote of 17 in favor, 0 opposed, and 1abstention. (2) A motion was made thatthe RAC should continue to review andapprove Phase I follow-up studies, i.e.,Phase II and Phase III trials. Suchstudies may be submitted through theAccelerated Review process; however,the RAC retains the option to requirefull RAC review. The motion passed bya vote of 18 in favor, 0 opposed, and noabstentions.The RAC approved a motion toapprove the proposed amendments toSections I, III, IV, V, and Appendices C,F, G, I, and M of the NIH Guidelinesregarding NIH and FDA consolidatedreview of human gene transferprotocols, by a vote of 18 in favor, 0opposed, and no abstentions.The actions are detailed in SectionII—Summary of Actions. I accept theserecommendations, and the NIHGuidelines will be amendedaccordingly.
II. Summary of Actions
 A. Amendments to Section I, Scope of the NIH Guidelines
The amended version of Section I–A,Purpose, reads:Section I–A. PurposeThe purpose of the NIH Guidelines isto specify practices for constructing andhandling: (i) Recombinantdeoxyribonucleic acid (DNA) molecules,and (ii) organisms and virusescontaining recombinant DNAmolecules.Section I–A–1. Any recombinant DNAexperiment, which according to the NIHGuidelines requires approval by theNIH, must be submitted to the NIH orto another Federal agency that has jurisdiction for review and approval.Once approvals, or other applicableclearances, have been obtained from aFederal agency other than the NIH(whether the experiment is referred tothat agency by the NIH or sent directlythere by the submitter), the experimentmay proceed without the necessity forNIH review or approval (see exceptionin Section I–A–1–a).Section I–A–1–a. In the interest of maximizing the resources of both theNIH and the Food and DrugAdministration (FDA) and simplifyingthe method and period for review,research proposals involving thedeliberate transfer of recombinant DNAor DNA or RNA derived fromrecombinant DNA into human subjects(human gene transfer) will beconsidered through a consolidatedreview process involving both the NIHand the FDA. Submission of humangene transfer proposals will be in theformat described in Appendices M–Ithrough M–V of the Points to Consider.Investigators must simultaneouslysubmit their human gene transferproposal to both the NIH and the FDAin a single submission format. Thisformat includes (but is not limited to)the documentation described inAppendices M–I through M–V, of thePoints to Consider. NIH/ORDA and theFDA will simultaneously evaluate theproposal regarding the necessity forRAC review.
 B. Amendments to Section III, Experiments Covered by the NIH Guidelines
The amended version of Section IIIbeginning paragraphs reads:
of 00

Leave a Comment

You must be to leave a comment.
Submit
Characters: ...
You must be to leave a comment.
Submit
Characters: ...