Contracts: Opportunities and Procedures, CRG, NHLBI, NIH

Contract
award instrument establishing a binding legal agreement between NIH

National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.

and an award recipient for products or services. The Office of Acquisition

Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)

Management and Policy (OAMP) web site provides additional information

is another type of mechanism used by NHLBI

National Heart, Lung, Blood Institute (NHLBI)
a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.

to create animal models, develop and test devices and to conduct clinical research. A proposal

Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.

is written by an individual or non-federal organization to enter into a contract, usually in response to a request for proposal RFP

Requests for Proposals (RFP)
initiatives sponsored by an NIH institute for a contract to meet a specific need, such as the development of an animal model or circulatory assist devices or a specific multicenter clinical trial.

but which can also be investigator initiated. The proposal consists of a technical and a business proposal, including a description of the project and its costs, as well as the methods, personnel, and facilities to carry it out.

Contracts generally define very specific needs in the statement of work( SOW

Statement of Work (SOW)
a detailed description of work written in a proposal to be performed under a contract.

). They will identify the evaluation criteria and provide detailed instructions on the content for the proposal and submission date.

Contracts undergo a peer review process that is similar to grants with a team of reviewers who have expertise in the particular subject area. This is called the technical review. Proposals with scores in the competitive range will be considered for further negotiations. Much of the information in contracts is confidential, including the identity of offerors, and will not be disclosed. After the contract is awarded, all offeror

Offeror
a contracting term denoting an applicant responding to a request for proposals.

s will be informed of the number of proposals submitted, the identity of the successful offeror, the dollar value and period of performance.

A number of resources exist that can help you to become more knowledgeable about contracts or to help you begin the application process:

NIH Contracting Information and Resources gives general information on contracts.

“A Guide to the NIH Acquisition Process” provides assistance to potential contractors not familiar with the acquisition program. The handbook answers questions most frequently asked, e.g., how to learn about NIH plans to award

Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.

a contract, how to submit proposals, how proposals are evaluated, etc.

Data security issues are addressed in NHLBI Information Technology Security Policies, Forms and Procedures for Contracts.

The NHLBI Grants and Contracts site lists RFPs currently available as well as an archive of older RFPs.

Contacting the Office of Acquisitions:
Director, Office of Acquisitions
John C. Taylor
Phone: 301-435-0330

Deputy Director, Office of Acquisitions Chris Belt
Phone: 301-435-0330

Extramural Contracts Branch
Chief, Rick Phillips
Phone: 301-435-03405

COAC Services Branch
Chief, Joanna Magginas
Phone: 301-435-0355

Page Last Updated: November 29, 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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Home » Clinical Research Guide» Contacts: Opportunities and Procedures

CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	Contracts: Opportunities and Procedures A contract Contract award instrument establishing a binding legal agreement between NIH National Institutes of Health (NIH) the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. and an award recipient for products or services. The Office of Acquisition Office of Acquisition (OA) OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy) Management and Policy (OAMP) web site provides additional information is another type of mechanism used by NHLBI National Heart, Lung, Blood Institute (NHLBI) a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. to create animal models, develop and test devices and to conduct clinical research. A proposal Proposal a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out. is written by an individual or non-federal organization to enter into a contract, usually in response to a request for proposal RFP Requests for Proposals (RFP) initiatives sponsored by an NIH institute for a contract to meet a specific need, such as the development of an animal model or circulatory assist devices or a specific multicenter clinical trial. but which can also be investigator initiated. The proposal consists of a technical and a business proposal, including a description of the project and its costs, as well as the methods, personnel, and facilities to carry it out. Contracts generally define very specific needs in the statement of work( SOW Statement of Work (SOW) a detailed description of work written in a proposal to be performed under a contract. ). They will identify the evaluation criteria and provide detailed instructions on the content for the proposal and submission date. Contracts undergo a peer review process that is similar to grants with a team of reviewers who have expertise in the particular subject area. This is called the technical review. Proposals with scores in the competitive range will be considered for further negotiations. Much of the information in contracts is confidential, including the identity of offerors, and will not be disclosed. After the contract is awarded, all offeror Offeror a contracting term denoting an applicant responding to a request for proposals. s will be informed of the number of proposals submitted, the identity of the successful offeror, the dollar value and period of performance. A number of resources exist that can help you to become more knowledgeable about contracts or to help you begin the application process: NIH Contracting Information and Resources gives general information on contracts. “A Guide to the NIH Acquisition Process” provides assistance to potential contractors not familiar with the acquisition program. The handbook answers questions most frequently asked, e.g., how to learn about NIH plans to award Award provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity. a contract, how to submit proposals, how proposals are evaluated, etc. Data security issues are addressed in NHLBI Information Technology Security Policies, Forms and Procedures for Contracts. The NHLBI Grants and Contracts site lists RFPs currently available as well as an archive of older RFPs. Contacting the Office of Acquisitions: Director, Office of Acquisitions John C. Taylor Phone: 301-435-0330 Deputy Director, Office of Acquisitions Chris Belt Phone: 301-435-0330 Extramural Contracts Branch Chief, Rick Phillips Phone: 301-435-03405 COAC Services Branch Chief, Joanna Magginas Phone: 301-435-0355 Page Last Updated: November 29, 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov