A-A-51755A
Unit.
For Size 1 – Package (PG). Shall be supplied 8.1 g in a commercially available container. Container shall be supplied together with an oral adapter equipped with a metered dose valve and protective cap. When container is used in conjunction with oral adapter, the assembled unit shall deliver at least 112 single oral inhalations. One package containing one container, together with an oral adapter equipped with a metered dose valve, as specified, constitutes one unit.
For Size 2 – Package (PG). Shall be supplied 14.2 g in a commercially available container. Container shall be supplied together with an oral adapter equipped with a metered dose valve and protective cap. When container is used in conjunction with oral adapter, the assembled unit shall deliver at least 200 single oral inhalations. One package containing one container, together with an oral adapter equipped with a metered dose valve, as specified, constitutes one unit.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.
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