[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17426-17427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9335]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[CRADA 98-001]
Cooperative Research and Development Agreement
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), National
Center for Infectious Diseases, announces the opportunity for potential
collaborator(s) to enter into a Cooperative Research and Development
Agreement (CRADA) for the development of a worldwide sentinel
surveillance system to isolate, characterize, and monitor for the
emergence of new retroviruses and divergent HIV variants of public
health importance. The reagents generated from this project will be
used to validate the sensitivity and specificity of the current HIV
screening tests. This research effort is designed to further the
development of diagnostics to test for new HIV variants to ensure
protection of the blood supply.
Because CRADAs are designed to facilitate the development of
scientific and technological knowledge into useful, marketable
products, a great deal of freedom is given to Federal agencies in
implementing collaborative research. The CDC may accept staff,
facilities, equipment, supplies, and money from the other participants
in a CRADA; CDC may provide staff, facilities, equipment, and supplies
to the project. There is a single restriction in this exchange: CDC MAY
NOT PROVIDE FUNDS to the other participants in a CRADA. This
opportunity is available until May 11, 1998. Respondents may be
provided a longer period of time to furnish additional information if
CDC finds this necessary.
FOR FURTHER INFORMATION CONTACT:
Technical: Thomas M. Folks, Ph.D., Chief, HIV/Retrovirus Diseases
Branch, Division of AIDS, STD and TB Laboratory Research, National
Center for Infectious Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Rd. NE., Mailstop G-19, Atlanta, GA
30333, telephone (404) 639-1010.
Business: Lisa Blake-DiSpigna, Technology Transfer Representative,
National Center for Infectious Diseases, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA
30333, telephone (404) 639-3227, (E-Mail: [email protected]).
SUPPLEMENTARY INFORMATION: Efforts will be made to sample various
regions and risk groups in geographically dispersed countries. Where
possible, the optimal sample size will be sufficient to have a high
probability of detecting HIV variants present in these populations even
if their prevalence is low (<1%). samples="" will="" be="" tested="" for="" antibodies="" to="" hiv-1="" and="" hiv-2;="" sero-reactive="" specimens="" will="" be="" further="" processed="" for="" sera,="" plasma,="" and="" cells.="" attempts="" will="" be="" made="" to="" target="" populations="" attending="" std="" clinics,="" counseling="" and="" testing="" centers,="" antenatal="" clinics,="" and="" tb="" treatment="" centers.="" asymtomatic="" individuals="" reporting="" high="" risk="" behaviors="" and="" seronegative="" persons="" with="" elevated="" reactivity="" in="" screening="" assays="" will="" be="" further="" investigated.="" in="" addition,="" samples="" will="" be="" obtained="" whenever="" possible="" from="" sero-="" discordant="" couples="" and="" symptomatic="" individuals="" who="" have="" remained="" seronegative.="" such="" samples="" will="" be="" evaluated="" using="" generic="" retroviral="" testing="" to="" identify="" new="" or="" highly="" divergent="" viruses="" which="" lack="" common="" epitopes="" with="" prototypic="" hiv="" strains.="" specimen="" collection="" will="" be="" in="" accordance="" with="" cdc="" institutional="" review="" board="" (irb)="" approved="" protocols.="" an="" initial="" site="" assessment="" will="" be="" done="" to="" determine="" the="" prevalence="" of="" hiv="" infection="" and="" the="" feasibility="" of="" collecting="" and="" processing="" the="" requisite="" number="" of="" specimens.="" goals:="" the="" primary="" goal="" of="" this="" project="" is="" to="" collect="" isolates="" of="" representative="" emerging="" retroviruses="" and="" divergent="" hiv="" strains="" from="" persons="" with="" various="" transmission="" risk="" factors,="" representing="" different="" regions="" worldwide="" to="" help="" in="" understanding="" the="" degree="" of="" genetic="" diversity="" among="" emerging="" variants="" and="" what="" hiv="" strains="" predominate="" in="" these="" populations.="" special="" emphasis="" will="" be="" given="" to="" monitoring="" for="" the="" presence="" of="" divergent="" hiv="" variants="" that="" are="" distinct="" from="" already="" characterized="" hiv-\1/2\="" [[page="" 17427]]="" subtypes="" and="" to="" define="" the="" extent="" of="" variability="" within="" recognized="" subtypes.="" the="" secondary="" goal="" is="" to="" collect="" specimens="" representing="" these="" variants="" and="" recognized="" subtypes="" (a-i)="" to="" prepare="" a="" panel="" of="" sera="" collected="" from="" people="" whose="" infecting="" virus="" has="" been="" sequenced.="" the="" panel="" will="" be="" used="" to="" evaluate="" the="" sensitivity="" and="" specificity="" of="" existing="" and="" newly="" developed="" hiv="" antibody="" tests="" with="" regard="" to="" these="" strains="" and="" to="" assist,="" if="" necessary,="" in="" modifying="" these="" tests="" to="" broaden="" their="" sensitivity.="" specimens="" will="" primarily="" be="" blood,="" but="" may="" include="" urine="" or="" oral="" fluids="" to="" evaluate="" diagnostic="" tests="" using="" these="" specimens.="" the="" research="" efforts="" in="" support="" of="" this="" crada="" are="" focused="" on="" the="" combined="" use="" of="" molecular="" and="" epidemiologic="" data="" to="" examine="" the="" question="" of="" whether="" certain="" hiv="" strains="" have="" distinctive="" patterns="" of="" transmission="" and="" disease="" progression="" in="" infected="" individuals.="" the="" crada="" partner="" will="" be="" expected="" to="" provide="" both="" financial="" as="" well="" as="" scientific="" resources.="" substantial="" involvement="" in="" specimen="" testing="" including="" molecular="" and="" biochemical="" analysis="" of="" viruses="" and="" viral="" components="" would="" be="" anticipated="" from="" the="" crada="" partner.="" respondents="" should="" provide="" evidence="" of="" expertise="" in="" the="" development="" and="" marketing="" of="" clinical="" diagnostics="" (prior="" experience="" with="" hiv="" preferred)="" and="" supporting="" data="" (e.g.,="" publications,="" proficiency="" testing,="" certifications,="" resumes,="" etc.)="" of="" qualifications="" for="" the="" laboratory="" director="" and="" laboratory="" personnel="" who="" would="" be="" involved="" in="" the="" crada.="" the="" respondent="" will="" develop="" the="" final="" research="" plan="" in="" collaboration="" with="" cdc="" but="" should="" provide="" an="" outline="" of="" a="" research="" plan="" for="" review="" by="" cdc="" in="" judging="" applications.="" applicant="" submissions="" will="" be="" judged="" according="" to="" the="" following="" criteria:="" 1.="" knowledge="" of="" molecular="" diagnostics="" including:="" epitope="" specific="" and="" recombinant="" based="" immunoassays,="" rapid="" tests,="" and="" nucleic="" acid="" based="" detection="" assays.="" 2.="" working="" knowledge="" of="" nucleic="" acid="" sequencing,="" pcr,="" eukaryotic="" expression="" of="" recombinant="" antigens,="" and="" the="" large="" scale="" production="" of="" said="" products.="" 3.="" operational="" experience="" in="" an="" international="" setting.="" 4.="" procedural="" understanding="" of="" and="" experience="" in="" the="" development="" and="" marketing="" of="" hiv="" diagnostics="" in="" the="" united="" states.="" this="" crada="" is="" proposed="" and="" implemented="" under="" the="" 1986="" federal="" technology="" transfer="" act:="" public="" law="" 99-502,="" as="" amended.="" the="" responses="" must="" be="" made="" to:="" lisa="" blake-dispigna,="" program="" analyst,="" national="" center="" for="" infectious="" diseases,="" centers="" for="" disease="" control="" and="" prevention="" (cdc),="" 1600="" clifton="" road,="" ne.,="" mailstop="" c-19,="" atlanta,="" ga="" 30333.="" dated:="" april="" 3,="" 1998.="" joseph="" r.="" carter="" acting="" associate="" director="" for="" management="" and="" operations,="" centers="" for="" disease="" control="" and="" prevention="" (cdc).="" [fr="" doc.="" 98-9335="" filed="" 4-8-98;="" 8:45="" am]="" billing="" code="" 4160-18-p="">