BNJ_ANSI_Redacted.pdf

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Brand Name Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Office of Acquisition & Grant Services (OAGS) Food & Drug Administration (FDA) U.S. Department of Health & Human Services (HHS)

b. Sponsoring organization.

Center for Devices & Radiological Health (CDRH) Office of Strategic Partnerships & Technology Innovation (OST)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The nature and purpose of this document is to delineate in writing the justification and approval of a brand name acquisition for American National Standards Institute (ANSI) membership in accordance with Federal Acquisition Regulations (FAR) 13.501(a)(1)(ii). The FDA intends to solicit the requirement on SAM.Gov as a Brand Name.

b. Project background.

As an Agency, the Food and Drug Administration has a rich history in its use and support of standards for regulatory purposes. Several Centers and other entities in the Agency rely on standards to facilitate activities across the total product life cycles of the areas under their regulatory jurisdictions. Since,1997 and in accordance with Food and Drug Administration Medical Device Act (DFAMA) of 1997, the Food and Drug Administration (FDA) established a consensus standards program recognizing all relevant medical devices for the purpose of executing FDA’s regulatory responsibilities.

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3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

American National Standards Institute Membership - USNC US TAG IEC TC77. U.S. National Committee Technical Advisory Group for International Electrotechnical Commission Technical Committee 77. ISO TC 338 TAG Fee

b. Project Description.

Several Centers and other entities in the Agency rely on standards memberships to maintain their access and membership in standards committees across the total product life cycles of the areas under its regulatory jurisdictions. Since, 1997 and in accordance with FDAMA of 1997, the Food and Drug Administration (FDA) established a consensus standards program recognizing all relevant medical devices standards and acquiring memberships to Standards Developing Organizations to have access to medical device standards. This ANSI membership allows full access to documents for voting, commenting, and continual participation as a member to attend critical meetings.

This also includes membership in the U.S National Committee (USNC) of the International Electrotechnical Commission (IEC) which serves as the focal point for U.S parties who are interested in the development, promulgation, and use of globally relevant standards for the electrotechnical industry and covering Technical Advisory Group (TAG) memberships for SDO committees including the newly created International Organization for Standardization Technical Committee (TC) TC 338 on menstrual products and the International Electrotechnical Commission (IEC) TC 77 on electromagnetic compatibility; allowing contractor to perform administrative functions to the membership of these technical committees.

CDRH Memberships are critical to the Center’s mission of approving medical device premarket applications which cite standards from many Standards Developing Organizations (SDO).

Members will access ANSI website to obtain their specific committee and review standards cited in the premarket review submissions to ensure that conformity assessment is cited appropriately. The membership will provide upcoming meetings and documents expected to be reviewed. The members will participate in standards meetings to represent FDA views and defend FDA’s position.

Requirement type.

Other: Membership Service

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Type of action.

Follow-on - 75F40121P00052

Proposed contract/order type.

Firm-fixed-price

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

American National Standards Institute (ANSI) Incorporated

1899 L ST NW FL 11

Washing, District of Columbia 20036-3804, United States

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

American National Standards Institute (ANSI) is just one of five main standards-developing organizations (SDOs) with whom we participate. The other main SDOs are ASTM International (formerly the American Society for Testing and Materials), Clinical Standards Laboratory Institute (CLSI) and International Electrotechnical Electronic Engineering (IEEE). The particular ANSI standards are unique to CDRH because their business model develops national and international voluntary consensus medical device standards that coincide with the regulatory and public health needs associated with the products/processes they address. Other SDOs do not develop these specific types of standards because they too have their own unique standards

Last Modified: April 5, 2017 Page 4 of 6 for products/processes. Membership to ANSI allows our scientists and clinical experts to participate in the development process to help ensure these standards will be of use to the Agency to meet our public health and regulatory needs.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

This acquisition will be solicited as a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6. The acquisition will be listed under FAR authority 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items on SAM.gov with the intent to award to American National Standards Institute (ANSI).

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Specialist (CS) will, prior to award, obtain pricing information from the proposed contractor for the same or similar services as well as utilize pricing history from the previous PO and perform a price analysis to document and sufficiently determine that the cost to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Due to ANSI's exclusive designation as the U.S. National Standards Body, its unique role in international standards representation, and its position as the sole accrediting agency for U.S.-based standards organizations, no other organization can provide equivalent services. This sole source procurement is necessary to ensure FDA's continued participation in critical national and international standards activities that support the agency's regulatory mission.

• ANSI is the sole organization designated as the U.S. National Standards Body, providing FDA with essential access to international standards development processes that directly impact regulatory decision-making

• As the exclusive accrediting agency for U.S.-based standards organizations, ANSI maintains oversight and quality assurance for the entire national standards infrastructure

• No alternative organization can provide equivalent access to ISO and IEC standards development activities, which are critical for FDA's regulatory harmonization efforts

• ANSI membership provides exclusive access to standards policy development at the national level, enabling FDA participation in shaping standards that affect public health and safety

• The organization offers specialized conformity assessment programs and accreditation services that are not available through other standards development organizations (SDOs)

• ANSI's dual role in coordinating the U.S. voluntary standards system and accrediting standards organizations provides FDA with strategic oversight capabilities unavailable elsewhere