R -- PLANNING FOR THE TRANSITION FROM FDA TO SAMHSA/CSAT ON REGULATORY OVESIGHT OF OPIOID TREATMENT PROGRAMS.

Notice Date

February 12, 2001

Contracting Office

DHHS, PSC, DAM, GAB, Room 5-101, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857

ZIP Code

20857

Point of Contact

Janet Miller, Supv. Contracting Officer, 301-443-2475 or Julia Savoy, Contract Specialist, 301-443-2475

E-Mail Address

Program Support Center (JMiller@psc.gov or JSavoy@psc.gov)

Description

The Agency Substance Abuse and Mental Health Services Administration, through the Program Support Center, General Acquisition Branch, plan to award a sole source simplified acquisition to The Mr. Ellsworth Dory, 6101 Marline Lane, Camp Spring, Maryland, 207048. Objective: The objective of this purchase order is to obtain expert consultation on CSAT's new regulatory authorities to ensure the smooth transfer of responsibility for oversight of OTPs from FDA to SAMHSA. We seek general assistance in facilitating implementation of the new rules concerning OTPs and specific assistance to address the steps and activities necessary for CSAT to adopt in order to ensure a successful transition, including, but not limited to the following: Development of an administrative policy and procedures manual including site visit protocols for routine and for cause inspections by CSAT/OPAT staff; Train Office of Pharmacologic and Alternative Therapies OPAT staff in all aspects of regulatory compliance including the conduct of inspections; Conduct on-site inspections of OTPs to ensure regulatory compliance; Train OPAT staff in the review of individual patient exceptions and OTP program wide exemptions as permitted by the regulations; Review staff documentation of exceptions and exemptions request and make recommendations for improvements in review procedures, as necessary; Provide technical assistance to new OPT applicants to enable them to understand the new certification requirements. THE PROPOSED SIMPLIFIED ACQUISITION ACTION IS FOR SUPPLIES AND SERVICES FOR WHICH THE GOVERNMENT INTENDS TO SOLICIT AND NEGOTIATE WITH ONLY ONE SOURCE UNDER AUTHORITY OF FAR 6.302. INTERESTED PERSONS MAY IDENTIFY THEIR INTEREST AND CAPABILITY TO RESPOND TO THE REQUIREMENT OR SUBMIT PROPOSALS WITHIN 7 DAYS AFTER THE DATE OF PUBLICATION OF THE NOTICE. A DETERMINATION BY THE GOVERNMENT NOT TO COMPETE THIS PROPOSED SIMPLIFIED ACQUISITIONS BASED UPON RESPONSES TO 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. FOR FURTHER INFORMATION, PLEASE CONTACT JULIA SAVOY IN RM 5-101, PARKLAWN BUILDING, 5600 FISHERS LANE, ROCKVILLE, MD 20857 OR 0N 301-443-2475.

Web Link

Program Support Center (Program Support Center)

Record

Loren Data Corp. 20010214/RSOL001.HTM (W-043 SN50D4H2)