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FBO DAILY ISSUE OF DECEMBER 25, 2002 FBO #0388
SOLICITATION NOTICE

R -- Legal consultant for development of regualtions and procedures

Notice Date

12/23/2002
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
 

ZIP Code

20857
 

Solicitation Number

Reference-Number-N10035
 

Archive Date

1/25/2003
 

Point of Contact

Dee Gibson, Contract Specialist, Phone (301) 827-7177, Fax (301) 827-7103, - Dee Gibson, Contract Specialist, Phone (301) 827-7177, Fax (301) 827-7103,
 

E-Mail Address

dgibson@oc.fda.gov, dgibson@oc.fda.gov
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis/solicitation for service prepared in accordance with the format in FAR subpart 12.6 Streamlined Procedures for evaluation and solicitation for commercial service as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a Request for Quotation (RFQ) number N10035. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 01-10. The associated North American Industrial Classification System (NAICS) Code for this procurement is 541199. The Standard Industrial Classification (SIC) Code is 7389. The Food and Drug Administration (FDA) is issuing a RFQ on a sole source basis to Christopher B. McHenry of Arlington Virginia for updating FDA Import Regulatory Operations. The most recent amendments to the Federal Food Drug and Cosmetic Act has tasked the agency to develop and implement new regulations and procedures to control the import of regulated products into the United States using new authorities granted to the agency. This procurement will provide support for the agency in the development of the regulations and procedures needed to implement the new authorities granted to the agency. This will be accomplished by having an attorney with unique experience in Food and Drug law to advice the Division of Import Operations, Office Regional Operations (DIOP), in the updating and development of policies and procedures. Specifications of Work Statement. 1. The contractor will provide regulatory guidance and advise to DIOP to ensure procedures and regulatory policies are in conformance with the Administrative Procedures Act, FADAMA (GGP) and provisions of the FDA&C ACT. 2. Provide guidance and advice to DIOP for documents and correspondence having impact on agency regulatory policy or stating such policy; 3. Review all regulatory records requiring DIOP clearance; 4. Assist in the development and implementation of procedures including those for appeal, mitigation, and petitions for relief from agency administrative actions; 5. Coordinate activities with OCC, Center compliance branches, and general counsel from other government agencies including Customs and USDA; 6. Draft responses to inquiries from outside counsel on import related matters; 7. Assist in the development of compliance policy guides and related guidance documents; 8. Participate in FDA/Customs liaison activities; 9. Provide regulatory training to DIOP staff; and perform other regulatory duties as determined necessary between DIOP management and the contractor. Deliverables: The contractor will provide services as requested by the Division of Import Operations management in a expeditious manner and provide a monthly accounting of the tasks worked on and hours performed. Ad hoc reports, policy documents and training will be determined by the government and contractor at a later date. Period of performance one year from the day the contract is awarded. Mr. McHenry is the only known source for this requirement because he has unique experience in developing regulations and procedures for the Food and Drug Administration. He has also served on the staff of the chief counsel as a litigation attorney and advisor to the agency and agency centers. This experience provides him with the unique knowledge of agency policies, and philosophies and a thorough understanding of the FDA organization. All responsible sources that can provide and meet the above requirements will submit written quotations by the due date referenced above. Simplified Acquisition Procedures will be used for this requirement. Evaluation/Award will be based on the acceptable quote that offers the best value to the government. Offerors will include resumes which state accomplishments in this area. The following provision & clauses apply to this acquisition: 52.212-1, Instructions to Offerors-Commercial Items; and 52.212-3 Offeror Representations and Certifications-Commercial Items. The following clauses apply to this acquisition: 52.212-4, Contract Terms and Conditions-Commercial Items. All offerors must submit the following: 1) Two (2) copies of a quotation; 2) Resume; and 3) Two (2) copies of the most recent fee schedule. Submission must be received by 3:00p.m. local time on January 10, 2003. No questions will be accepted after 5:00 pm December 31, 2002. Fax and e-mail quotes will be accepted. FAR clauses and provision can be accessed at www.arnet.gov/far.
 

Place of Performance

Address: Food and Drug Administratin, 15800 Crabbs Branch Way, Rockville, Maryland

Zip Code: 10855

Country: US
 

Record

SN00229165-W 20021225/021223213240 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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