National Mammography Quality Surveillance Act (MQSA) Non-Federal Inspection State Contracts Program

Notice ID:

75F40122R00005

Department/Ind. Agency:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub Command:

FDA OFFICE OF REGULATORY AFFAIRS

Office:

FDA OFFICE OF REGULATORY AFFAIRS

All Dates/Times are:

(utc-05:00) eastern standard time, new york, usa

Updated Published Date:

(utc-05:00) eastern standard time, new york, usa

Original Published Date:

0000-00-00 00:00:00

Original Response Date:

dec 06, 2021 10:00 am est

Inactive Policy:

15 days after response date

Original Inactive Date:

dec 21, 2021

Initiative:

• None***--***

Product Service Code:

h265 - equipment and materials testing- medical, dental, and veterinary equipment and supplies

NAICS Code:

923120 - administration of public health programs

Original Set Aside:

The Food and Drug Administration intends to award sole source contracts to State and/or local assistance in the inspection of certified non-Federal mammography facilities in order to document and report compliance with mammography quality standards issued under 21 CFR Part 900. The program meets the criteria set forth in 41 U.S.C. 253(c) (5). In accordance with the Mammography Quality Standards Act, the inspection services are restricted to state organizations possessing the authority necessary to conduct regulatory MQSA inspections. Contractors must meet the following special requirements: (1) possess legal authority under state law necessary to gain access to any regulated private commercial establishment for the unique purpose of conducting regulatory inspections and investigations to determine compliance with the Mammography Quality Standards Act at any geographical location within the state; (2) have trained personnel experienced with the inspectional procedures and evidence development techniques necessary to assess the conformance of an establishment with the federal law or comparable state requirements; (3) demonstrate experience with state regulatory procedures for correcting violative practices. Only governmental organizations have the unique qualification to perform this kind of activity. Competition within states does not exist for this program. Within any state, its legislature designates the governmental organizations which have the authority and resources to accomplish a program. The prospective contractors for this solicitation are those designated state organizations. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this pre-solicitation can be met, no later than 15 days from the date of this announcement. A determination by the Government not to compete the proposed contracts based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The solicitation will be available on or the Second Quarter of Fiscal Year 2022on the SAM.gov website at http://www.sam.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the SAM.gov website for the release of the solicitation and amendments. Hard copies will be provided to individuals eligible under the American with Disabilities Act and Rehabilitation Act upon request. Responses to this notice must be sent via email to: Michael.Gemmill@fda.hhs.gov. No phone calls will be accepted.

10903 New Hampshire Avenue

Silver Spring , MD 20993

USA

Primary Point of Contacts:

MICHAEL GEMMILL