Pre-Sol_RFP_75N94022R00003-_issued_11-15-22_2.pdf

Title: NICHD International and Domestic Pediatric and Maternal HIV Studies and Other High Priority Infectious Diseases Data Coordinating Center

Notice Number: 75N94022R00003

Announcement Type: Pre-Solicitation

Agency/Office: National Institutes of Health

Location: Eunice Kennedy Shriver National Institute of Child Health and Human Development

(NICHD)

Pre-Solicitation Notice

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. An RFP will be issued via sam.gov on or about November 30, 2022. The anticipated due date for submission of proposals in response to the RFP is on or about January 31, 2023.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Maternal and Pediatric Infectious Disease Branch is planning to issue an RFP for a single source award Indefinite Delivery, Indefinite Quantity (IDIQ) type contract for an ordering period of seven

(7) years for the NICHD International and Domestic Pediatric and Maternal HIV Studies and Other High Priority Infectious Diseases Data Coordinating Center.

It is anticipated that approximately 4 new clinical trial protocols will be issued each year by task order. The Contractor will conduct and monitor these new clinical trials and also provide the supporting services for these new clinical trials.

The Contractor shall conduct clinical trials on IMPAACT HIV and AIDS Related protocols through a multi-site network of domestic and international clinical centers to conduct the research on treatment, prevention, diagnosis, and epidemiology of HIV infection and other related IMPAACT infectious diseases in pediatric, adolescent, and maternal patient populations.

The NICHD requires the Contractor to conduct, support and maintain the new HIV AIDS clinical trial protocols through a multi-site network of domestic and international clinical centers to conduct research on treatment, prevention, diagnosis and epidemiology of HIV infection and other related IMPAACT infectious diseases in pediatric, adolescent, and maternal patient populations, as well as other high priority infectious diseases affecting children and pregnant women. The NICHD Network has been funded through the NICHD Data Coordinating Center contract since 1987. The NICHD Network consists of domestic and international clinical sites that enroll study subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women, as well as selected clinical trials of gender- specific manifestations of HIV infection in non-pregnant women. Primarily, the NICHD Network enrolls patients into trials conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network. Trials may also be conducted in the Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), and the NICHD-funded Adolescent HIV Medicine Trials Network (ATN). The Network also has collaborated on clinical trials in the past and may collaborate in the future with the Centers for Disease Controls and Prevention (CDC) and the Pediatric European Network for Treatment of AIDS (PENTA). Currently, the Network consists of 24 clinical centers. Under the IMPAACT Network, NICHD has 14 U.S. sites, located in 13 cities and 9 states/territories (including Puerto Rico). Internationally, there are 10 sites: 5 in different areas of Brazil, 3 in Africa, and 2 in Thailand.

The proposed acquisition will require performance of the following activities:

1. The Contractor shall provide support services, which include, but are not limited to, the following for the new HIV AIDS clinical trials issued by task order under this IDIQ. These services include clinical site monitoring of NICHD network sites participating in protocols of the IMPAACT network and selected investigator-initiated grant awards (R01, etc.), subcontract management and invoicing, protocol management of NICHD protocols, oversight of data management and data analysis, study agent procurement, team meetings, regulatory compliance assurance, site activation and protocol registration, safety monitoring, committee management, data management services, oversight of central and site laboratories and pharmacies, protocol team support, FISMA compliance and IT security, State Department Clearance requests, translation services, laboratory equipment support (mainly at foreign sites), and training of site personnel, to support the HIV clinical study protocols.

Work under this task order will be primarily under the IMPAACT Network. Some work may take place within the AIDS Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), Adolescent Trials Network (ATN, or similar NIH networks.

2. The Contractor shall provide the support services for the implementation of the protocols at the clinical sites as new studies arise. This includes the establishment of new subcontract agreements for the clinical sites and laboratories as well as data management and other operations and functions.

As previously existing protocols close, the Contractor will assume responsibility for any new protocols at the clinical sites.

3. The Contractor shall provide administrative subcontract management for the clinical trial sites.

More specifically, the Contractor shall draft, negotiate, execute, administer, monitor, renew and/or modify as necessary the subcontracts with domestic and international clinical research sites.

4. The Contractor shall provide laboratory expertise to advise and guide the clinical sites to ensure that they use laboratory facilities with the capability to perform virologic, immunologic, pharmacologic, and other laboratory assays, specimen processing, and specimen storage as specified by IMPAACT or other Network protocols in which NICHD clinical centers participate. The Contractor shall track the methodology for the specialized laboratory testing. The Contractor shall determine if samples need to be shipped from other Network sites or to a central repository and arrange for the shipping. Selected NICHD Network site(s) may participate in conducting specialized laboratory assays for samples from participating IMPAACT or other Network sites for specific protocols; the Contractor shall negotiate into the clinical site subcontract the required staff and equipment needed by the site to conduct such activities. Selected virologic, immunologic, and pharmacologic assays will require performance by laboratories with approved performance in the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) quality assurance programs (such testing may be done at laboratories that are NICHD Network sites or non-NICHD Network sites). (NICHD has an Interagency Agreement with NIAID for laboratory services, including quality control, but these laboratory services are not a part of the contract).

5. The Contractor shall provide centralized repository services to store biospecimens for the clinical sites. One repository is required for storage of domestic specimens. Currently in the Network, repositories are required in Brazil and South Africa. Additional repositories shall be added, if the need arises.

a. Ensure that sites have (through lease or direct provision, if required) electronic information systems compliant with the Federal Information Security Modernization Act (FISMA), necessary specialized equipment (including hardware and software) for sites to electronically communicate with the Contractor, NICHD and relevant components of the IMPAACT Network and other Networks as required, for processing and storage of biospecimens (e.g., ultralow temperature freezer, specialized shipping materials and training for shipment of biohazardous materials and dangerous goods, and for receipt, storage, monitoring, and dispensing of investigational drugs.

b. Obtain access for research protocol review and approval to a standing Institutional Review Board (IRB) and ensure that each institution conducting clinical trials has a current, approved Federal-Wide Assurance Number on file with the Office for Human Research Protection (OHRP).

c. Ensure that all the staff at each site participating in the design or conduct of trials involving human subjects, complete and maintain education on human research protections, as described at NIH Guide Notice OD-00-039 - REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS, release date June 5, 2000 (Revised August 25, 2000).

d. Develop and conduct NICHD Network Investigator meetings at selected IMPAACT meetings or other forums after obtaining approval from the COR.

e. Ensure that clinical sites have a community advisory board (CAB) constituted with members of the local community that can provide community perspective, advice, and advocacy for research in the community where that clinical research site is located and that provides community input through IMPAACT-wide teleconferences and meetings.

6. The Contractor shall provide services to ensure regulatory compliance for research activities, including subcontractor site performance. More specifically:

a. Provide oversight to ensure site access to a communications system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Event Reports (AERs) by NICHD Network clinical centers to the Contractor for transmission as required to the COR, AER Office of the IMPAACT Network or other Networks, and study sponsor, and establish and maintain same for selected international clinical trials as designated by the COR. Monitor the accuracy of adverse experience reporting through regular summary reports for submission to the COR. Draft safety reports as required by the FDA for selected studies for COR Submission.

b. Develop, implement, and monitor plans for acquisition, distribution, dispensing, handling, administration, and accountability of study drugs, in compliance with applicable Federal, state, and local regulations.

c. Provide site monitoring for quality assurance of research conducted at all subcontracted clinical and laboratory sites of the NICHD Network participating in the IMPAACT Network and for selected NICHD sponsored international clinical trials as needed. Monitoring schedules shall be approved by, and results reported to the COR with a copy to the CO and shall include assurance of compliance with FDA record keeping and reporting requirements (21 CFR 50 and 56; 21 CFR 312.50, Subpart D), accuracy and completeness of case report forms, source documentation, and other research records, and periodic record auditing and documentation by the staff of the subcontracted centers. Each site shall be visited a minimum of 2-3 times annually.

d. Provide staff with laboratory expertise and assist in monitoring clinical trials site laboratory quality with the COR and NIAID Quality Assurance (QA) programs.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

e. Meet with the COR a minimum of three times yearly to review annual site performance/monitoring reports for NICHD Network sites, and sites participating in other selected studies as designated by the COR and CO.

7. The Contractor shall provide clinical and statistical analysis. More specifically:

a. Provide scientific, technical, and administrative support for the development, implementation, and analysis of the specified research, including considerations of experimental design, sample size calculation, and interim and final primary and secondary analyses specified by study protocols, as requested by the COR.

b. Establish data elements to be recorded by the protocol research records, as requested by the COR and in conjunction with the protocol development team for each specific research project. Develop study forms for the standardized collection of data items. Develop documentation and coding for the computerization of data for retrieval, analysis, and reporting.

c. Provide for timely and accurate data collection, data entry, data quality assurance, retrieval of source documentation, and generation of data and safety monitoring reports.

d. Provide training for staff of subcontracted NICHD clinical and laboratory centers in data management procedures.

e. Provide for data input, editing, electronic data storage, database management, data retrieval, and statistical analysis using well-documented database management and statistical computer software programs.

f. Develop methodology, perform analyses, and provide results from meta-analyses of selected data sets derived from clinical trials or relevant collaborating epidemiologic studies that focus on specific issues related to HIV infection and disease and its related infectious and non-infectious complications and other high priority infectious diseases (e.g., tuberculosis) in women, infants, children, and adolescents that have relevance to development and conduct of clinical trials.

g. Provide data analysis and results. More specifically:

i. Perform statistical analyses of study data to test study hypotheses and evaluate potential confounding variables and/or covariates, as requested by the COR. Data analytic techniques needed include approaches to analyzing of multiple measurements of biologic variables over time within patients and between patient groups, with consideration for normal changes in these variables with age.

ii. Provide for biweekly to monthly communication, as needed, of analytic progress and results through routine meetings with COR or designees and periodic generation of reports. The Project Manager shall attend all meetings. The Epidemiologist, Statistician, and Senior Systems Analyst shall attend these meetings on an as needed basis.

iii. Provide programming and statistical support for timely generation of additional analyses requested by the COR and approved by the CO.

h. Provide for electronic data transmission between the Contractor, subcontracted clinical and laboratory centers, and the IMPAACT Statistical and Data Analysis Center databases using currently specified communications software and equipment.

i. Provide for electronic mail transmission between Contractor, subcontracted clinical and laboratory centers, and NICHD using commercially available communications software and equipment.

j. Maintain a web site to allow communication about Network activities, clinical trials, and information transfer (e.g., orders for study materials) between Contractor and subcontracted clinical and laboratory centers.

8. The Contractor shall provide services for implementation and monitoring of multiple clinical trials in support of the IMPAACT or other Networks. More specifically:

a. Develop, initiate, and coordinate the implementation and oversight of protocols at all participating NICHD Network clinical and laboratory centers within the IMPAACT or other Networks. Ensure compliance by sites with all requirements for protocol implementation, including IRB review and approval prior to protocol initiation, patient consent and confidentiality requirements, Federal bioresearch regulations and requirements for security and confidentiality of research records, and that each relevant clinical site staff member completes and maintains human research protection and Good Clinical Practice training.

b. Draft, negotiate, execute, administer, monitor, renew and/or modify as necessary with approval by CO a site-specific, protocol-specific budget for each protocol to be conducted by participating NICHD clinical and laboratory centers, based on anticipated number of patients to be enrolled.

c. Provide training for staff of subcontracted clinical and laboratory centers in procedures for implementation and conduct of specific protocols. Retraining may be required to be performed as necessary.

d. Provide training in and ensure the fulfillment and maintenance of standards for Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) across network clinical research sites and staff.

e. Ensure timely development and execution of material transfer agreements (MTAs) and data transfer agreements (DTAs) between sponsor(s) and participating domestic and international institutions.

9. The Contractor shall provide services for the support, review, and implementation in NICHD sites of IMPAACT research protocols and other research activities. More specifically:

a. For specific protocol topics identified by the COR, identify a protocol development team consisting of Contractor staff, NIH staff, subcontractors, and/or consultants. Provide support for the planning and conduct of protocol development team meetings. Submit within 30 days following the initial meeting a protocol development plan for COR review and approval, addressing regulatory issues, data collection forms development, drug distribution plan, protocol timeline, and participating sites. Develop a protocol document including background, objectives and endpoints, design, patient numbers, source, management, and selection, study agents or other interventions, clinical and laboratory monitoring, laboratory services, toxicity management, adverse experience reporting, evaluation of response, statistical considerations, data collection and monitoring, human subject considerations, biohazard containment, and data and safety reviews. Review, edit, and rewrite draft protocols based on COR’s review. Prepare and maintain the necessary documentation for application submissions in compliance with FDA requirements. The Contractor shall implement protocols at participating centers.

b. At the request of the COR and approval of the CO, provide support for the planning and conduct of meetings of protocol committees and subcommittees, data and safety monitoring boards, and investigators.

c. Provide administrative, technical, and logistical support at the request of the COR and with approval of the CO as needed for interaction and collaboration of the NICHD clinical and laboratory centers network with other institutes, agencies, and organizations conducting activities relevant to the areas of research.

10. The Contractor shall provide consultants with specialized expertise related to clinical trial efforts, as requested by COR, and approved by the CO. It should also plan for a yearly meeting of approximately 15 experts outside and within the protocols as requested by the COR and approved by the CO. This meeting will be an important venue to discuss important and complex scientific issues related to protocols and new developing and critical scientific issues still not included in the protocols.

It is anticipated that an IDIQ contract will be awarded for an ordering period of 7 years, beginning approximately in May of 2023 and, that it will allow the issuance of cost- reimbursement type task orders. The RFP is anticipated to be posted on or about November 30, 2022, and may be accessed through the sam.gov website at https://sam.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about January 31, 2023. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition is a full and open competition under the North American Industry Classification System (NAICS) code 541715. Any questions concerning this announcement must be submitted by email to the following two Contracting Officers: Elizabeth Osinski, eo43m@nih.gov and Alice Pagán, alice.pagan@nih.gov. Emails must reference the announcement number in the subject line. The reference number to be used for this announcement is 75N94022R00003. This is not an RFP, and this announcement does not commit the Government to award a contract.

https://sam.gov/content/home mailto:eo43m@nih.gov mailto:alice.pagan@nih.gov

Pre-Solicitation Notice