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64052

Federal Register

/Vol. 66, No. 238/Tuesday, December 11, 2001/Notices

criteria specific for E. coli provideduseful guidance in response to thespecific request from the University of Florida. The RAC recommendedacceptance of the proposed criteria fordesignation of E. coli as a risk group 1agent by a vote of 7 in favor, 0 opposed,and 1 abstention.The NIH concurs with the RAC thatrisk assessment is enhanced by theestablishment of these criteria fordesignating strains of E. coli as riskgroup 1 agents. As noted in theproposed action, these criteria are notintended to eliminate the need for case- by-case consideration of the potentialeffects of a biological agent on thosewho may be exposed to it (Section II

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2 of the NIH Guidelines) and aresubject to reevaluation and change if itis shown that a strain meeting thecriteria is associated with disease inhealthy human adults.After the September RAC meeting, anadditional comment on the proposedcriteria was received. This comment,from the American Biological SafetyAssociation (ABSA), suggested that thephrase

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rough colony morphology

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wasnot very informative; colonymorphology is influenced byenvironmental factors and is not solelydependent upon genotype. We concurwith that comment; thus, mention of

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rough

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colony morphology has beendeleted from the criteria. ABSA alsosuggested that the second criterionshould be expanded upon to state thatthe bacteria do not carry

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***anyfunctional or complete genes encodingthese factors

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as opposed to

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***anygenes encoding these factors.

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We didnot concur with this comment due tothe fact that the strains of E. coli thathave been studied demonstrate thepresence or entire absence of factor-encoding genes. Strains carrying genesthat have been rendered non-functional by laboratory manipulations (e.g.,partial deletions or missense mutations)should not automatically be designatedas risk group 1 agents.Accordingly, the only change in thisfinal action from the proposed action isdeletion of the reference to

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roughcolony morphology.

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Amendments to the NIH Guidelines

Appendix B

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I. Risk Group (RG1)Agents of the NIH Guidelines isamended to read:RG1 agents are not associated withdisease in healthy adult humans.Examples of RG1 agents includeasporogenic Bacillus subtilis or Bacilluslicheniformis (see Appendix C

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A,Bacillus subtilis or Bacilluslicheniformis Host-Vector Systems,Exceptions); adeno-associated virus(AAV) types 1 through 4; andrecombinant AAV constructs, in whichthe transgene does not encode either apotentially tumorigenic gene product ora toxin molecule and are produced inthe absence of a helper virus. A strainof Escherichia coli (see Appendix C

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A, Escherichia coli K

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12 Host VectorSystems, Exceptions) is an RG1 agent if it (1) does not possess a completelipopolysaccharide (i.e., lacks the Oantigen); and (2) does not carry anyactive virulence factor (e.g., toxins) orcolonization factors and does not carryany genes encoding these factors.Those agents not listed in Risk Groups(RGs) 2, 3 and 4 are not automaticallyor implicitly classified in RG1; a riskassessment must be conducted based onthe known and potential properties of the agents and their relationship toagents that are listed.OMB

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Mandatory InformationRequirements for Federal AssistanceProgram Announcements

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(45 FR39592) requires a statement concerningthe official government programscontained in the Catalog of FederalDomestic Assistance. Normally, NIHlists in its announcements the numberand title of affected individual programsfor the guidance of the public. Becausethe guidance in this notice coversvirtually every NIH and Federalresearch program in which recombinantDNA techniques could be used, it has been determined not to be cost effectiveor in the public interest to attempt to listthese programs. Such a list would likelyrequire several additional pages. Inaddition, NIH could not be certain thatevery Federal program would beincluded as many Federal agencies, aswell as private organizations, bothnational and international, have electedto follow the NIH Guidelines. In lieu of the individual program listing, NIHinvites readers to direct questions to theinformation address above aboutwhether individual programs listed inthe Catalog of Federal DomesticAssistance are affected.

Dated: November 21, 2001.

Ruth L. Kirschstein,

Acting Director, National Institutes of Health.

[FR Doc. 01

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30513 Filed 12

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01; 8:45 am]

BILLING CODE 4140

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DEPARTMENT OF HEALTH ANDHUMAN SERVICESNational Institutes of HealthOffice of Biotechnology Activities;Recombinant DNA Research:Proposed Actions Under the NIHGuidelines

AGENCY

National Institutes of Health(NIH), PHS, DHHS.

ACTION

Notice of final action under theNIH Guidelines for Research InvolvingRecombinant DNA Molecules (NIHGuidelines).

SUMMARY

The NIH is amending theprovisions of the NIH Guidelinesrelating to the Recombinant DNAAdvisory Committee (RAC) byauthorizing a minimum of 15 votingmembers and establishing the charter of the committee as the controllingdocument for the membership andprocedures of the RAC.

DATES

This Final Action is effective asof January 10, 2002.

FOR FURTHER INFORMATION

Documentation and additionalinformation can be obtained from theOffice of Biotechnology Activities,National Institutes of Health, MSC 7985,6705 Rockledge Drive, Suite 750,Bethesda, Maryland 20892, Phone 301

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496

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9838, FAX 301

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496

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9839. The NIHOBA Web site is located at

http:// www4.od.nih.gov/oba/.

SUPPLEMENTARY INFORMATION

Background

The RAC serves a unique role inpromoting awareness andunderstanding of the scientific, medical,safety, and ethical issues associatedwith human gene transfer research. Thisoccurs through review and publicdiscussion of protocols, as well asthrough specific recommendations forimproving trials that are conveyed toinvestigators and their institutions. Tofulfill these functions and address alldimensions of human gene transferresearch as fully as possible, the RAChas historically been constituted in amanner that allows for diverseperspectives and necessary expertise inrelevant disciplines.Section IV

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2 of the NIH Guidelineshas provided that the RAC consist of 15voting members including the Chair,appointed by the DHHS Secretary ordesignee, at least 8 of whom must beauthorities knowledgeable in the fieldsof molecular genetics, molecular biology, recombinant DNA research, orother scientific fields. At least 4members of RAC, according to thissection, shall be persons knowledgeable

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64053

Federal Register

/Vol. 66, No. 238/Tuesday, December 11, 2001/Notices

in applicable law, standards of professional conduct and practice,public attitudes, the environment,public health, occupational health, orrelated fields. Representatives fromdesignated Federal agencies serve asnon-voting members.In recent years, not only has thenumber of gene transfer trialsdramatically increased, but these trialsnow encompass a much more expansivearray of clinical applications than waspreviously possible. Current trialsaddress, for example, cancer, inbornerrors of metabolism, cardiovasculardiseases, autoimmune disorders, andneurologic diseases. In addition, trialsemploy a growing variety of viralvectors, including vaccinia, fowl pox,canary pox, herpes simplex virus,adeno-associated virus, adenovirus, andretroviruses. Thus, an increasingly broad range of expertise is needed onthe RAC to adequately assess the issuesraised by the progressively more diversegene transfer trials being proposed andsubmitted to the NIH. Given thedynamism of the field, flexibility in howthis expertise is achieved is key to theeffective and efficient functioning of theRAC.In recognition of the rapidly evolvingfield of human gene transfer, the NIH isnow amending Section IV

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2 of theNIH Guidelines to authorize a

minimum

of 15 voting members with no maximumnumber of voting members specified.The maximum number of votingmembers will be established through thecharter for the RAC, which will now bethe controlling document for themembership and procedures of theCommittee in the event of any conflictwith the NIH Guidelines. This willenable NIH to respond promptly to theneed for additional expertise on theRAC through appropriate amendmentsto the charter. The present requirementthat at least 8 of the voting members beknowledgeable in the fields of molecular genetics, molecular biology,recombinant DNA research or otherscientific fields, is changed to

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at leasta majority of the voting members,

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andclinical gene transfer research is addedas an example of a relevant scientificfield. Finally, the listing of specifictypes of knowledge for members otherthan those knowledgeable in relevantscientific fields is broadened by addinglaboratory safety and protection of human subjects and by changing

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applicable law

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law,

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and

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standards of professional conduct andpractice

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ethics.

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Public Comments

These changes were published as aproposal in the August 24, 2001,

Federal Register

(66 FR 44638) with a30-day period for comment public. Twosets of comments were received inresponse, one from a biosafety officer ata large academic institution, the otherfrom private company engaged in genetransfer research. Both commentersexpressed the view that it wasunnecessary to allow for more than 15voting members, suggesting instead thatadditional expertise could be obtainedthrough the use of ad hoc experts.Neither commenter addressed theproposal to make the RAC charter thecontrolling document for themembership and procedures of the RAC.

Response to Public Commentary

Ad hoc members are onlyintermittently involved in the RACprocess, and while they do serve animportant function, they do not benefitfrom the longitudinal perspective thatofficially appointed RAC members bringto the review and discussion of humangene transfer protocols by virtue of theirongoing participation. Furthermore, because ad hoc experts do not vote, theNIH believes that they do not have asdirect a voice in the finalrecommendations concerning theseprotocols as do voting members. Theability to vote ensures that theperspectives of RAC members are fullyreflected in the outcome of RACdiscussions. For these reasons, the useof ad hoc members is not an optimalmeans of durably enhancing the range of expertise and intellectual continuity onthe RAC.Thus, no changes are being made inthe proposed amendments in responseto these two sets of comments. Twochanges have been made in theproposed amendments in order toclarify their intent, however. Thestatement that the charter of the RACwould establish the expertise of votingmembers has been deleted. Thatstatement implied incorrectly that theRAC charter would be more specificthan the NIH Guidelines in specifyingthe expertise of RAC members. Thecharter will repeat the provisions of theNIH Guidelines on the expertise of RACmembers. The reference to a

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majorityof the voting members

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in the thirdsentence of the second paragraph of Section IV

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2 has been changed to

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Atleast a majority of the voting members***

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Consistent with the currentprovision, this change clarifies thatmore than a majority may beknowledgeable in scientific fields, solong as at least four members areknowledgeable in the other fields listed.On November 1, the RAC met byteleconference and voted unanimouslyto recommend implementation of theproposal.

Amendments to the NIH Guidelines

Section IV

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2 of the NIH Guidelinesis amended to state:

Section IV

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2. Recombinant DNAAdvisory Committee (RAC)

The RAC is responsible for carryingout the functions specified in the NIHGuidelines, as well as others specifiedin its charter or assigned by theSecretary of Health and Human Servicesor the NIH Director. The RACmembership and procedures, inaddition to those set forth in the NIHGuidelines, are specified in the charterfor the RAC which is filed as providedin the General Services AdministrationFederal Advisory CommitteeManagement regulations, 41 CFR part101

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6, and is available on the OBA website,

http://www4.od.nih.gov/oba/rac/ RACCharter.htm.

In the event of aconflict between the NIH Guidelinesand the charter, the charter shallcontrol.The RAC will consist of not less than15 voting members, including the Chair,appointed under the procedures of theNIH and the Department of Health andHuman Services. The maximum numberof voting members will be established inthe charter of the RAC. At least amajority of the voting members must beknowledgeable in relevant scientificfields, e.g., molecular genetics,molecular biology, recombinant DNAresearch, including clinical genetransfer research. At least 4 members of the RAC must be knowledgeable infields such as public health, laboratorysafety, occupational health, protectionof human subjects of research, theenvironment, ethics, law, publicattitudes or related fields.Representatives of the Federal agencieslisted in the charter shall serve as non-voting members. Nominations for RACmembers may be submitted to the Officeof Biotechnology Activities, NationalInstitutes of Health, 6705 RockledgeDrive, Suite 750, MSC 7985, Bethesda,MD 20892

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7985 (20817 for non-USPSmail), 301

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496

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9838, 301

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496

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9838(fax).All meetings of the RAC shall beannounced in the

Federal Register

,including tentative agenda items, 15days before the meeting. Final agendas,if modified, shall be available at least 72hours before the meeting. No itemdefined as a Major Action under SectionIV

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(1) may be added to anagenda following

Federal Register

publication.OMB

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Mandatory InformationRequirement for Federal Assistance

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