Tips on doing business with FDA

Transcription

1 Tips on doing business with FDA Shaunta Johnson and Natasha Boyce Office of Small & Disadvantaged Business Utilization U.S. Department of Health and Human Services

2

3 VOS Sources Sought Strategic Partnering Industry Days Mentor- Protégé Rules & Regs Cape Statement Customer Needs Certification BEST PRACTICES Business Cards

4

5

6

7 FDA is responsible for: Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health * FDA s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

8 Acquisition Goals and Statistics FDA SOCIOECONOMIC GOALS Small Business Award Categories Small Businesses FY Goal* FY 10 FY 11 FY12 FY13 FY14 FY15 41% (35% until FY14) (45% in FY 14) 37.20% 47.46% 55.90% 48.93% 43.28% 78.89% 8(a) Businesses 5.0% 10.12% 19.53% Small Disadvantaged Businesses 5.0% 20.85% 28.24% 34.70% 30.69% 25.28% 55.23% Women-Owned Small Businesses 5.0% 11.63% 12.05% 16.55% 9.92% 13.63% 24.89% HubZone Businesses 3.0% 4.18% 2.96% 3.59% 2.59% 3.61% 1.90% Service Disabled Veteran Owned 3.0% 1.96% 3.99% 4.68% 2.14% 2.93% 13.07% 8

9 COMMERCIAL AND INSTITUTIONAL BUILDING CONSTRUCTION ANALYTICAL LABORATORY INSTRUMENT MANUFACTURING SURGICAL APPLIANCE AND SUPPLIES MANUFACTURING COMPUTER AND COMPUTER PERIPHERAL EQUIPMENT AND SOFTWARE MERCHANT WHOLESALERS COMPUTER AND SOFTWARE STORES SOFTWARE PUBLISHERS CUSTOM COMPUTER PROGRAMMING SERVICES COMPUTER SYSTEMS DESIGN SERVICES COMPUTER FACILITIES MANAGEMENT SERVICES ADMINISTRATIVE MANAGEMENT AND GENERAL MANAGEMENT CONSULTING SERVICES AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES FACILITIES SUPPORT SERVICES TEMPORARY HELP SERVICES COMPUTER AND OFFICE MACHINE REPAIR AND MAINTENANCE ADMINISTRATION OF PUBLIC HEALTH PROGRAMS

10

11 Food and Drug Administration The FY 2016 Budget includes $1.6 billion within the Food and Drug Administration (FDA) and CDC, an increase of $303 million over FY 2015, to support a broad range of food safety activities. These investments will further the Department s implementation of the Food Safety and Modernization Act by improving surveillance systems; enhancing response and detection; and establishing the framework for an integrated federal, state, and local system; and improving import safety to prevent foodborne illnesses from domestic and international foods and feed.

12 Search by: Operating Division NAICS Keyword

13

14 NIH Information and Technology Acquisition and Assessment Center (NITAAC) Chief Information Officer Solutions and Partners (CIOSP-3) $20 Billion set-aside for small businesses $20 Billion for small business to compete with other than small Streamlined ordering process for program officials GSA FSS and GWAC Contracts NASA SEWP

15 Currently, the PSC SSD competed and established HHS-wide Blanket Purchase Agreements (BPA) for the following commodities: Custodial Products Events Management Services Office Equipment Office Furniture Office Supplies Temporary Administrative and Professional Staffing Services Temporary Professional and Medical Staffing Services Domestic Mail Information Technology Peripherals and Hardware Laboratory Supplies

16 Pre-Award Catalog for Federal Domestic Assistance ( Other Agency Forecasting Tools such as: HHS Grants Forecast ( System for Award Management/Central Contracting Registry ( Grants.gov ( Post-Award USASpending.gov ( Other Agency Transparency systems such as: Tracking Accountability in Government Grants System (TAGGS) ( ALL ALLOW PROSPECTIVE GRANTEES AND INTERESTED MEMBERS OF THE PUBLIC TO SEARCH BY KEY WORD

17

18 One Page/PDF Tailored for Audience NAICS Core Competencies Past Performance Value Proposition Bullet Points Spell Check Remove Jargon Visually Interesting

19

20

21

22

23 TRADE ASSOCIATIONS VENDOR OUTREACH SESSIONS INDUSTRY DAYS MENTOR-PROTEGE

24

25 Statutory Law Small Business Act (Public Law , as amended)

26 Title 13 of the United States Code of Federal Regulations (13 CFR) Section 121 SB Size Regulations Section 124 8(a) BD/SDB Programs Section 125 Subcontracting Limitations on Subcontracting SDVOSB Program Section 126 HUBZone Program Section 127 WOSB Program Section 134 Appeal Procedures

27 Small Business Jobs Act of 2010 National Defense Authorization Act of 2013 National Defense Authorization Act of 2015

28 Know Organization s Points of Contact Understand FDA s Mission and Needs Know FDA s SB Goals and Top NAICS codes Research Research Research Budget and Brief Procurement Forecast FPDS and USA Spending Understand Strategic Sourcing, Internal IDIQs, GWACs

29 Pursue Grants Create Targeted Marketing Tools Respond to Sources Sought Notices Network VOS Industry Days Trade Associations Know the Rules

30

31 SMALL BUSINESSES ARE THE OF THE ECONOMY

32 OSDBU CONTACT 200 Independence Avenue, SW Room 537 Washington, DC Website: Phone:

33

34

35 @HHSOSDBU