Form 4 - Contract Clearances - Fillable.pdf

FORM 4: CONTRACT CLEARANCE

Please check the box(es) below to assist CDC in determining clearance requirements for the proposed research.

(check all that apply):

The proposed research includes activities involving the use of hazardous materials or select agents.

The proposed research includes activities involving the use of live vertebrate animals.

The proposed research involves the collection or creation of data; purchase of data, information or samples; development of IT (including mobile apps) or IT solutions; and/or equipment that directly interface with IT or collects data.

COMMON CLEARANCES: The most common required clearance for procurement of services and supplies, as set forth in the Federal Acquisitions Regulations (FAR), Code of Federal Regulations (CFR) and Department of Health and Human Services (HHS) policies, are listed below.

1. Human Subjects: This clearance is required all service contracts and contracts for the procurement of data, information or samples (Reference HHSAR 370.301 and 45 CFR 46.103).

The purpose of this clearance is to make sure that Center for Disease Control and Prevention is in compliance with the Department of Health and Human Services (HHS) policy. The policy is that the contracting officer shall not award a contract involving human subjects until the prospective contractor provides assurance that the activity will undergo initial and continuing review by an appropriate Institutional Review Board (IRB) in accordance with HHS regulations at 45 CFR

46.103. The contracting officer shall require a Federal-wide assurance (FWA), approved by the HHS Office for Human Research Protections (OHRP), of each contractor, subcontractor, or institution engaged in human subjects research in performance of a contract. OHRP administers the assurance covering all HHS-supported or HHS-conducted activities involving human subjects.

2. Regulatory Compliance for proposals involving vertebrate animals: Animal use conducted under this contract shall be in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the current edition of the “Guide for the Care and Use of Laboratory Animals (the Guide), the Animal Welfare Act and Regulations (Title 9 Code of Federal Regulations part 1), and all applicable local, state, or other federal regulations.

The Offeror and any subcontractors shall have an approved, current Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW), at the time of contract award.

Accreditation of the Offeror and any subcontractors by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is preferred.

If animal species regulated by the United States Department of Agriculture (USDA) are involved in a contract, the Offeror and any subcontractors shall be registered with the Secretary of Agriculture of the United States in accordance with the following Federal regulations 7 U.S.C 2136 and 9 CFR sections 2.25-2.28 respectively.

The Offeror and/or subcontractors must address the following items in their submitted proposal as required by the Public Health Service Policy on Humane Care and Use of Laboratory Animals (section IV.D.1.):

a. identification of the species and approximate number of animals to be used;

b. rationale for involving animals, and for the appropriateness of the species and numbers used;

c. a complete description of the proposed use of the animals;

d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and

e. a description of any euthanasia method to be used.

3. Paperwork Reduction: This clearance is required for all service contracts and contracts for the procurement of data, information or samples (Reference HHSAR 352.211-3 and 5 CFR 1320).

The purpose of this clearance is to ensure that the Center for Disease Control and Prevention (CDC) is in compliance with the Paperwork Reduction Act of 1995. In addition, it helps determines the applicability for proposedprojects.

4. Section 508: This clearance is required for all information, communication and technology (ICT) contracts. (Reference HHSAR 339.2) In compliance with the Department of Health and Human Services (HHS) policy. (a) Electronic and information technology (EIT) supplies and services must comply with Section 508 of the Rehabilitation Act (the Act) of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board (Access Board) Electronic and Information Accessibility Standards (36 CFR part 1194).

Requiring activities must consult with their Section 508 Official or designee to determine if the contractor should be responsible for compliance with EIT accessibility standards which apply to website content and communications material.

(1) When conducting a procurement and employing the best value continuum, the solicitation shall include a separate technical evaluation factor developed by the contracting officer, requiring activity, and the Operating Division (OPDIV) Section 508 Official or designee.

(2) At a minimum, solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template (See http://www.hhs.gov/web/508 for the template). Solicitations for services shall include any other pertinent information that the contracting officer deems necessary to evaluate the offeror's ability to meet the applicable Section 508 accessibility standards.

5. Information Security and Privacy: This clearance is required for all contracts (Reference FAR 39.101(d)) The purpose of this clearance is to determine if the acquisition requires information security, involves personal identifiable information, and is subject to the privacy act.

6. Safety and Health: This clearance is required for all contracts that involve hazardous materials or hazardous operations, including services or products; research, development or test projects; transportation of hazardous materials; and construction. (Reference FAR 36.513 and 52.236-13) http://www.hhs.gov/web/508