U.S. Food and Drug Administration Office of Acquisitions & Grants Services (OAGS)

Transcription

1 U.S. Food and Drug Administration Office of Acquisitions & Grants Services (OAGS) Montgomery County Chamber of Commerce OAGS OVERVIEW Who we are What we buy How we operate

2 OAGS Mission Our mission is to provide high quality support to the FDA programs by managing all contracts, and assistance agreements in a timely manner and at a reasonable cost. 2

3 OAGS - Services We Offer Contract Services Simplified Acquisition Services Interagency Agreement Services Grant/Cooperative Agreement Services Purchase Card Administration Services Strategic Business Advisors Acquisition policy, customer relations support, and responding to contract related FOIA requests. 3

4 OAGS is a.. Consolidated acquisition office Located throughout the country Aligned by commodity and service A cradle to grave operation Pre-solicitation Solicitation, Receipt and Evaluation Negotiation, Source Selection and Award Contract Administration and Closeout 4

5 OAGS Office Locations Chicago, IL Stoneham, MA Jamaica, NY Philadelphia, PA Rockville, MD Atlanta, GA Dallas, TX Jefferson, AR 5

6 Office of the Director Glenda Barfell Business Management Team Vacant Associate Director Associate Director Leonard Grant Priscella Sullivan Division of Acquisition Support And Grants Michelle Hawley Division of Acquisition Programs Ron Rouse Division of Acquisition Operations Ted Weitzman Division of Information Technology Acquisitions Sandra Bellinger Grants and Assistance Agreements Team Customer Relations Team Tina Beard State Contracts Team Lisa O Neill Acquisition Policy & Support Team Ron Loube Construction & Facilities Support Team Gina Jackson NCTR Contracts Vacant CTP Acquisition Team Vacant Contract Operations Team Kimbalynn Dieng Scientific Support Team Doreen Williams Service Contracts Team Patricia Pemberton IT Acquisitions Team Linda Alexander-Giles Systems Technology Acquisitions Team Jenn Fagan 6

7 OAGS Team Specialties Grants and Assistance Agreements Team Negotiate, award and monitor federal funds awarded through various grant mechanisms. Award and administer Inter-Agency Agreements (IAGs). State Contracts and Compliance Team Contracts to support the MQSA, Food, Tissue and Feed/BSE Programs. These contracts commission the states to conduct inspections to ensure the quality and safety of the nations food, animal feed and medical devices. Construction and Facilities Support Team Provides facility support, furniture, construction and renovation, architect/engineering services contracts and simplified acquisitions for all headquarter locations, Irvine, San Juan, and Dauphin Island. National Center for Toxicological Research (NCTR) Provides support for NCTR related work as well as lab supplies and lab equipment as designated. Acquisition Policy and Support Provides acquisition policy, oversight, compliance and manages purchase card program 7

8 OAGS Team Specialties Scientific Support Team Mission specific contracts and simplified acquisitions, including research and development requirements and lab supply and equipment requirements Contract Operations Team Service contracts and simplified acquisitions, including but not limited to, chemicals/drugs/reagents, animals, shredding, administrative support, building security, etc. Services Team Service contracts and simplified acquisitions, including but not limited to, Document control/records management, events management, guard services, moving, library support, custodial, etc. CTP Acquisition Team Contracts and simplified acquisitions to fulfill the mission of the Center for Tobacco Products. Information Technology Teams (IT Acquisitions & Systems Technology) All information technology related contracts and simplified acquisitions. Business Management Team (BMT) Facilitates collaboration between OAGS and the FDA Center/Offices to provide early acquisition support and multidisciplinary technical expertise in order to make the acquisition process more efficient. 8

9 Acquisition Principles Fairness - all interested parties receive the same information Transparency processes of acquisition are ethical, legal, regulatory and known Competition seek competition whenever possible Socioeconomic goals provide opportunities to designated small business groups small, disadvantaged, SDVOSB, womenowned, Hubzone Acquisition Process respecting and following process takes time, supports principles, prevents problems 9

10 Service Level Agreement Processing Time (1 of 2) Service Processing Time Data Needed from Customer New Competitive Contracts New Competitive Task/Delivery Orders New Non Competitive Contracts New Non Competitive Task/Delivery Orders Sealed Bid Contracts 8(a) Contracts Contract Administration (Modifications) 180 calendar days or within the established acquisition plan or processed within 60 calendar days or within the established acquisition plan 167 calendar days or within established acquisition plan 30 calendar days or within the established acquisition plan 100 calendar days or within the established acquisition plan 120 calendar days or within the established acquisition plan or processed within 120 calendar days 30 days for unilateral and 60 days for bilateral or within established acquisition plan Firm MON Package (iprocurement requisition, Statement of Work, IGCE and any other clearances required) Firm MON Package (iprocurement requisition, Statement of Work, IGCE and any other clearances required) Firm MON Package (iprocurement requisition, Statement of Work, IGCE, Justifications for Other than Full and Open Competition (JOFOC), other clearances) Firm MON Package (iprocurement requisition, Statement of Work, IGCE, Justifications for Other than Full and Open Competition (JOFOC), other clearances) Firm MON Package (iprocurement requisition, Statement of Work, IGCE, and any other clearances required) Firm MON Package (iprocurement requisition, Statement of Work, IGCE and any other clearances required) iprocurement requisition with all supporting documents is received in OAGS. 10

11 Service Level Agreement Processing Time (2 of 2) Service Processing Time Data needed from Customer Simplified Acquisitions: $0 to$10,000 $10,001 to $25,000 $25,001 to $100,000 GSA/GWAC (SOW) GSA/GWAC (equipment) GSA/GWAC (supplies) HHS Strategic Sourcing 15 calendar days 25 calendar days 60 calendar days 120 calendar days 30 calendar days 60 calendar days 30 calendar days iprocurement requisition all supporting documents is received in OAGS. IAGs 40 OAGS days Complete, accurate package received in OAGS Grants and Cooperative Agreements 45 calendar days from the date of the rank order memo Receipt of a Grant Applications in OAGS Purchase Card Administration applications for new cards 5 days Receipt of Cardholder s application in OAGS 11

12 2011 Acquisition Cut-Off Dates (1 of 2) OCTOBER 15, 2010 One third of all new requirement packages identified on the Center Acquisition Plan (CAP) (actions over $150,000) must be submitted to OAGS. MARCH 1, 2011 New contract awards valued over $150,000 (inclusive of the value of any options and exclusive of direct award 8(a) contracts) Competing grants APRIL 30, 2011 Non-competing/Earmark Grants MAY 1, 2011 Directed 8(a) contracts (i.e., those less than or equal to $3.5 million) BPA Actions under established BPAs, including HHS BPAs Multiple Award Task and Delivery Orders, including orders against FDA contracts and GSA Schedules Reimbursable IAGs JUNE 1, 2011 Task and Delivery Orders against FDA Single Award Contracts $25,001 to $150,000 Simplified Acquisitions, inclusive of options 12

13 2011 Acquisition Cut-Off Dates (2 of 2) JULY 31, 2011 $10,001 to $25,000 Simplified Actions, inclusive of options Unilateral Modifications (e.g., option exercises or other administrative type mods) Service IAGs AUGUST 15, 2011 $3,001 to $10,000 Simplified Actions AUGUST 31, 2011 Actions <$3,000 in which vendor DOES NOT accept Purchase Card* While there are exceptions, the vast majority of purchases under $3,000 should be made using the Purchase Card. Accordingly, any requisition received for items or services that are available using the Purchase Card will be returned to the sponsoring office. 13

14 Acquisition Goals and Statistics COMPETITION Team Total actions excluding micropurchases Total Available Actions excluding micropurchases Competed Not Not Available for Competed Competition Competition Percentage Total dollars excluding micropurchases Dollars Eligible for Competition Dollars Competed Dollars Not Competed Dollars Not Available for Competition Dollars Competed Precentage CBER % $41,426, $38,281, $35,593, $2,688, $3,144, % CDER % $83,389, $70,190, $68,235, $1,954, $13,199, % CDRH % $30,438, $27,080, $26,690, $389, $3,358, % CFSAN % $35,927, $29,719, $26,802, $2,916, $6,207, % CTP % $20,206, $10,730, $7,953, $2,776, $9,476, % CVM % $11,259, $11,031, $9,182, $1,849, $228, % NCTR % $41,368, $39,683, $38,877, $806, $1,684, % ORA % $92,552, $64,483, $56,792, $7,691, $28,068, % OC % $331,347, $271,596, $250,458, $21,138, $59,751, % Total FDA % $687,917, $562,798, $520,587, $42,210, $125,119, % October September 30, 2010 data pull ( Snapshot) FDA Goals (over the micropurchase threshold) Percent eligible Dollars awarded through competition 80% or more Green 55%-79% Yellow Less than 55% Red OR Percent eligible actions awarded through competition 65% or more Green 50%-64% Yellow Less than 50% Red 14

15 Acquisition Goals and Statistics SOCIOECONOMIC FY Goal FY 08 FY 09 FY 10 FY 11* Small Business Award Categories: Small Businesses 43/37% 49.9% 44.33% 37.20% 50.11% 8(a) Businesses 5.0% 16.1% 13.44% 10.12% 10.05% Small Disadvantaged Businesses 5.0% 20.7% 25.08% 20.85% 12.19% Women-Owned Small Businesses 5.0% 14.1% 15.61% 11.63% 8.25% HubZone Businesses 3.0% 2.1% 3.23% 4.18% 8.06% Service Disabled Veteran Owned 3.0% 6.7% 5.55% 1.96% 7.61% * As of 11/24/2010 Note: Met all Small Business Goals in FY07 15

16 Acquisition Goals and Statistics AWARDS Acquisition Summary Actions Dollars (in Millions) FY 06 3,361 $283 (excludes Grants & IAGs) FY 07 3,848 $462.5 (includes Grants &IAGs) FY 08 5,160 $617.7 (includes Grants & IAGs) FY 09 6,045 $831.1 (includes Grants & IAGs) FY10 5,700 $1,200.0 (includes Grants & IAGs) 16

17 Doing Business with the FDA FY 2011 Procurement Forecast at OSDBU s website: Know about the FDA and what we acquire Visit FedBizOpps Website at Single point of entry for business opportunities valued in excess of $25,000 Register to receive notifications whenever business opportunities relevant to your industry are posted. Awareness of FDA Small Business Goals Respond to Requests for Information (RFI) Submit detail sufficient to determine capabilities Reference successful prior performance with other Government agencies Meet with FDA SBS Kevin Pope (on detail from CMS) kevin.pope@fda.hhs.gov or (301)

18 FDA Priorities Advance Regulatory Science and Innovation Strengthen the Safety and Integrity of the Global Supply Chain Maintaining Food and Medical Product Safety Strengthen Compliance and Enforcement Activities to Support Public Health Manufacturing, Distribution, and Marketing Address the Unmet Public Health Needs of Special Populations 18

19 Commodities and Services Purchased Information Technology services, hardware and software. Office furniture, equipment, and supplies Animal feed Bedding and cages Laboratory glassware Chemicals and supplies Pharmaceuticals, drugs, and intravenous solutions Electronic components and supplies Plastic and metal rods, sheets, and tubing X-ray equipment Scientific equipment Laboratory furniture, equipment, and supplies Animals for research (including horses, calves, cats, dogs, guinea pigs, chicks, hens, etc.) Research studies 19

20 Commodities and Services Purchased Investigations, surveys Tests and analyses of a scientific or medical nature Examinations, surveys, inspections, and reviews Management evaluations/consulting Services Conference support Training Construction renovation Construction management projects Architect/engineering support Operation and maintenance of facilities Facility support (e.g. custodial, trash, guard services) 20

21 Potential Opportunities (Facilities) O&M requirement at NCTR This is currently on the street as a SB-Set Aside Base + 4 Option Periods There will be a Pre-proposal conference on 11/22/10, at NCTR in Jefferson, AR. The closing date for the solicitation is 12/13/10. O&M requirement for the Beltsville Research Facility on Muirkirk Road This should be released within the next six months. The format will follow the NCTR requirement. 21

22 Potential Opportunities (Services) Public Health Education Campaigns Support Services Contract for Center for Tobacco Products Multiple Award IDIQ The contract will include the following scope of services: 1. Developing and delivering major public health education campaigns for a wide range of audience sizes and types (i.e., from national to local levels, from the general population to specific target populations). 2. Conducting formative research-both qualitative and quantitative-to document program requirements, collect consumer-based data, segment audiences, and develop, test, and refine campaign messages for targeted CTP audiences. 3. Developing strategic campaign content, including writing, editing, and translation for diverse platforms and audiences in compliance with Federal standards for plain language, usability, and Section 508; graphic design; and developing print and broadcast advertisements for national and regional placement. 22

23 Potential Opportunities (Services) Public Health Education Campaigns Support Services Contract for Center for Tobacco Products (cont d) 4. Developing and applying rigorous quantitative measures to track and evaluate the effectiveness of campaign activities. 5. Developing, testing, implementing, and maintaining interactive, mobile, and new media strategies and channels, including new and social media tools, e-partnerships, and user centered Websites. 6. Supporting strategic partnership development and maintenance, including community, corporate, media outreach, entertainment industry outreach, and partnership database development and maintenance. 7. Working with FDA to write and publish journal articles associated with its public health education campaign activities Currently working on strategy with OSDBU. Will be published in FBO. Anticipated release date of solicitation is 2nd quarter FY 11 23

24 Potential Opportunities (Services) OIP International Logistics Competitive 8(a) IDIQ Contract with one base year plus four 1-year options. Office of International Programs (OIP) has a requirement for international program support, including administrative, logistical and other related services. General Scope: The contractor shall provide rapid response services to FDA requirements (e.g. provide ground transportation within 1 hour of notice) or arrange an escort, lodging and per diem within 3 hours of notice. The contractor shall provide the following under this contract: all necessary labor, materials and facilities for the arrangement of international and domestic travel, escorts, interpreters and/or translators, conference and hotel accommodations, as well as conference arrangements for selected participants in the health exchange programs between the U.S. and various foreign countries and with multilateral organizations, transportation and subsistence allowance. 24

25 Potential Opportunities (Services) AV Support - Audio Visual Conference Services 8(a) Competitive, FDA Wide IDIQ Task Order contract Anticipated RFP Release date February The contractor s primary duties shall include the following: 1. Operation of Conference Center AV/IT/Telephone Technology ensure appropriate level of support to the staff attending and conducting meetings at the Conference Center. Thorough and detailed knowledge of operating the AV systems, the FDA network and the video and telephone technology is required to provide support for routine operation of these various technology devices. 2. IT requirements may include periodic re-imaging of training computers and assisting presenters with access to local accounts and to network accounts. Technicians will need to closely coordinate with the Conference Center Manager monitoring the various scheduled events and the respective technical requirements. 3. Create and maintain user guides to assist users with operation of A/V equipment and/or give instruction for presenters and meeting facilitators that want to operate the AV equipment themselves. Occasionally perform presentations to instruct Center staff on the capabilities, functions, and operation of A/V equipment. Assist in web cast services as needed for events taking place in the auditorium or main conference rooms. 25

26 Potential Opportunities (Services) AV Support - Audio Visual Conference Services (cont d) 4. Create and maintain user guides to assist users with operation of A/V equipment and/or give instruction for presenters and meeting facilitators that want to operate the AV equipment themselves. Occasionally perform presentations to instruct Center staff on the capabilities, functions, and operation of A/V equipment. Assist in web cast services as needed for events taking place in the auditorium or main conference rooms. 5. Maintenance and Repair of Conference Center AV/IT/Telephone Technology Technicians will develop thorough knowledge of routine maintenance requirements for all technical equipment as specified by the manufacturer. 6. Keep equipment in good and professional working condition at all times. Coordinate necessary repairs and routine maintenance services with room usage. Assist with maintenance of technical equipment/documentation for the proper operation and functions of the equipment. Keep documentation, maintenance records, vendors call list, etc. up to date and readily available. 7. Assist in the design, content and general upkeep of web pages explaining procedures, functionality, and general information on the rooms for the FDA/White Oak CSU I Intranet. 26

27 Potential Opportunities (IT) Hyperion and OBIEE Operations and Maintenance: This objective of this requirement is to acquire services to support the Operations and Maintenance (O&M) of both Oracle Business Intelligence Enterprise Edition Plus (OBIEE) and Oracle Hyperion Planning (Hyperion) for the Office of Financial Management. The contractor shall provide all functional and technical services to maintain and support the OBIEE and Hyperion systems including the reporting components, helpdesk, and day to day operations; and carry out enhancements as needed. The acquisition strategy is a competitive 8(a) set-aside and the solicitation is expected to be released before the end of November. Unique Device Identification Database: The objective of this requirement is to develop and implement a system for identification of medical devices used in the United States by warehousing the required unique device identifier (UDI) information in one webaccessible database comprising standardized and structured data elements. The acquisition is in market research stage and an acquisition strategy has not been determined. 27

28 Potential Opportunities (IT) Offsite tape storage: The Contractor will maintain tape storage at its facility. The tapes provide backup in the event of a problem at an FDA data center. The Contractor will catalog and maintain a tracking system for the tapes. It is anticipated that there will be locality restrictions with limitations to the proximity to the FDA. The acquisition is in the market research stage and a strategy has not yet been finalized. 28

29 OAGS Contact Information Glenda Barfell, Director Priscella Sullivan, Associate Director Leonard Grant, Associate Director Sandy Bellinger, Director, Division of Information Technology Acquisitions Ronald Rouse, Director, Division of Acquisition Programs Michelle Hawley, Director, Division of Acquisition Support and Grants Ted Weitzman, Director, Division of Acquisition Operations

30 Questions