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COMPLIANCE ASSISTANCE SUMMARIES
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AGRICULTURE
Food Safety Inspection Service (FSIS)
FSIS offers compliance assistance to small meat, poultry, and egg product plants. The FSIS publishes supporting documentation and guidance materials for federally inspected establishments to use in designing and implementing sanitation standard operating procedures and hazard analysis and critical control point (HACCP) food safety systems. FSIS provides technical guidance on many subjects of regulation, including requirements for plant sanitation, the use of food ingredients and food irradiation sources, and the control of pathogens. Also, to help meet the challenges our Nation has faced since September 11, 2001, FSIS has published security guidelines for food producing establishments. Many FSIS publications are available in languages besides English. Web addresses for these publications are:

Besides its publications, FSIS offers a telephone service, FSIS HACCP Hotline (1-800-233-3935) to help establishments solve problems arising from HACCP plan development and implementation. Assistance on general matters involving meat, poultry, and egg products is available from the FSIS Technical Service Center (402-221-7400; Fax: 402-221-7438; e-mail Tech.Center@fsis.usda.gov.

FSIS also operates an extensive small establishment outreach program, featuring FSIS-sponsored workshops and programs, educational material development and distribution, HACCP and food-safety training and training sessions for FSIS consumer safety officers. (http://www.fsis.usda.gov/Science/small_very_small_plant_outreach/index.asp) FSIS consumer safety officers are a highly qualified corps of individuals with the special mission of helping small establishments resolve problems arising in their implementation of HACCP systems. FSIS operates a special food safety outreach program for Native American communities; it includes training for operators of small meat plants.

Through the FSIS network of State cooperators, seminars and training classes on HACCP and food safety are held around the country for operators of food producing establishments. The Outreach Program also distributes multi-media training materials in CD-ROM and video as well as printed formats.

Another useful information source on regulatory compliance is an e-mail service by the FSIS Washington office and directly accessible on the FSIS website. This service, FSIS Regulations (Regulations@fsis.usda.gov) gives information on laws, regulations, and policies governing FSIS inspection programs and affecting establishments regulated by FSIS.

Animal and Plant Health Inspection Service (APHIS)
APHIS has made compliance assistance resources available to small business entities in several formats. All work extremely well in that APHIS has not received complaints or negative comments regarding insufficient information or difficulty gaining access. The listing of resources we submitted included four web addresses:

  • www.aphis.usda.gov/lpa/pubs - At this site, small entities will find publications and other materials to help explain APHIS programs such as press releases, frequently asked question, publications, industry alerts, technical reports and stakeholder announcements.
  • www.aphis.usda.gov/lpa/video -This web page provides access to videos about several APHIS programs. With proper equipment, the videos can be viewed from a computer. There is also contact information to obtain copies.
  • On-Site Evaluations/Assistance - For on-site assistance, the telephone number for each Regional Office is listed to request inspections, assistance, etc.
  • www.aphis.usda.gov/ies - This is the web site of the SBREFA Contact. It contains program information and contact information. Comments, complaints, and/or suggestions can be sent by on line mail service to IES@aphis.usda.gov.
  • Toll Free Telephone - Comments, complaints, and/or suggestions can be made without charge by calling 1-866-5Call IES.

Grain Inspection, Packers and Stockyards Administration (GIPSA)
Publications - Regulation, Rules, Technical and Administrative, Directives, Annual Reports: The Grain Inspection, Packers and Stockyards Administration posts current FGIS directives on the GIPSA website at: http://www.usda.gov/gipsa/pubs/pubs.htm or http://www.usda.gov/gipsa/reference-library/directives.htm. The publications are in PDF format, so they may be printed directly from the web.

Seminars, classes - Technical Training (e.g., Grain Inspection): GIPSA's Technical Services Division (TSD) provides extensive training throughout the official inspection system to ensure uniform, accurate results are provided at all locations. TSD also offers customized industry education services to facilitate the commercial marketing of grain. Topics include the visual grading of any grain, rice, bean, pea, or lentil and objective, non-visual quality tests such as protein, oil, and mycotoxins. Contact Larry McDonald for more information at: larry.h.mcdonald@usda.gov.

Telephone service - information about GIPSA: Responding to customers’ needs is GIPSA's main priority. GIPSA designed its programs to concentrate on customers’ needs. If customers have comments on GIPSA Customer Service Standards or want information on any GIPSA programs, contact: USDA, GIPSA, STOP 3601, 1400 Independence Avenue, SW, Washington, DC 20250-3601 or telephone: (202) 720-0219.

CD ROM's/Videos/E-Learning Courses - Technical Information (e.g., Procedures for Inspection Grain): GIPSA offers various educational materials created for the U.S. grain industry. They include multimedia CD's and several brochures/handouts. Single copies of CDs are available free by mail and the brochures/handouts are available in PDF format for online viewing and/or download. All materials are public domain and may be freely duplicated and distributed in their original form. Contact Roger Friedrich for more information at: Roger.L.Friedrich@usda.gov or send a request to: request.gipsa@usda.gov.

Online/e-mail service - Wide range of information about GIPSA and its programs: Information regarding GIPSA's programs and services can be found in the GIPSA Strategic Plan and on the Agency's website at: http://www.usda.gov/gipsa.

Onsite Evaluations/Assistance - Process Verification Program for Grain Handlers: GIPSA is considering proposing a new process verification program to meet the market's rapidly evolving needs. In this program, GIPSA would apply internationally recognized quality management standards to verify the quality process used rather than testing actual grain itself. The process verification designation verifies the process, not the final product. The process verification program would give industry participants independent verification of their quality processes and standards, and a way to capture values not easily identified by traditional inspection and testing. For more information, contact John Sharpe at: John.R.Sharpe@usda.gov or telephone: (202) 720-0228.

Food and Nutrition Service (FNS)
The Food and Nutrition Service administers family feeding programs such as the School Lunch and Breakfast Programs, the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), the Farmers’ Market Nutrition Program (FMNP) and the Food Stamp Program (FSP). The Agency administers most of these programs through State agencies and, therefore, has very little direct interaction with small businesses. However, a few of our programs (or parts of them) do relate to small business in some way. This summary pertains only to those parts of FNS.

Small Business Compliance Assistance for Retailers in the Food Stamp Program
FNS is continuing to carry out its compliance assistance efforts to retailers in the Food Stamp Program. Staff have attended conferences, presented workshops and held face-to-face meetings with retailers to provide technical assistance and listen to their concerns. With regards to new initiatives, FNS has created a bi-annual publication (mailer) that is sent to all retailers that participate in the Program. The mailer provides updates on current policy and any changes to Program rules and offers tips for retailers on best practices. Secondly, FNS will begin using a simplified application for new retailers in Fall 2004. The simplified application is an improvement over the current application because we have eliminated unnecessary and duplicative questions, the questions are easier to understand and it takes less time for a storeowner to complete the form. You can find more information about our work with retailers and publications we offer on the FNS website at www.fns.usda.gov/fsp/retailers/. The Food Stamp regulations that relate to retailers can be found in the Code of Federal Regulations at 7 CFR Parts 278 and 279 (a link to an electronic version is also available on the general FSP website referenced above).

Small Business Compliance Assistance for Farmers’ Markets/Retailers in the WIC/FNMP Programs
Under the Child Nutrition Act provisions for the WIC and FMNP Programs, State agencies are responsible for the authorization, training, monitoring, and corrective action of small businesses such as retailers, farmers, and farmers’ markets. FNS has issued regulations establishing guidelines and parameters for State agency administration of these activities. Although some uniformity is imposed by these regulations, there are also considerable areas of State discretion, so that many of the rules will not be the same from one State to the next. For example, State agencies must accept applications from retailers for WIC authorization at least once every three years, but may do so much more frequently, and each State has its own application form. For another example, States are required to allow only certain types and amounts of food to be transacted for WIC food instruments, but the precise brand, package size, and maximum allowed price will vary from State to State. The FNS web site (http://www.fns.usda.gov/wic) includes the WIC/FMNP regulations (7 CFR Parts 246 and 248) and also a list of the WIC and FMNP State agency addresses, telephone numbers, and web sites.

Agricultural Marketing Service (AMS)
The Agricultural Marketing Service (AMS) has a number of compliance assistance programs to help small entities to comply with program regulations. They range from publications to seminars to e-mail assistance to CD-ROMs and videos. The issues they discuss include information on the Perishable Agricultural Commodities Act, marketing orders, the National Organic Program, grading programs, and science & technology programs, among others. All this assistance and contact information can be accessed by clicking the appropriate program's link on the AMS website http://www.ams.usda.gov.

Rural Utilities Service (RUS)
The Rural Utilities Service (RUS) is a financing agency, not a regulating authority. RUS does not have enforcement policies. Its policy on minimum compliance requirements as a condition for financing is to work with the individual applicant/borrower to ensure compliance. RUS does not impose penalties or engage in enforcement activities. Assistance with its programs can be obtained at our web site at http://www.usda.gov/rus/. This site contains information on all of our programs and complete contact information by subject matter and geographic location. If needed, a RUS field representative can come to your location to provide assistance.

Department of Agriculture Single Point of Contact:
Jacquelyn Chandler
Office of Budget and Program Analysis
U.S. Department of Agriculture
1400 Independence Avenue, SW, Rm. 147-E
Washington, DC 20250
Telephone: 202-720-1516
E-mail: jyc@obpa.usda.gov

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COMMERCE
The Department of Commerce understands that a vibrant small business sector is critical to creating new jobs in a dynamic and growing economy, and is mindful of its responsibilities under the Small Business Regulatory Enforcement Fairness Act (SBREFA) and the Small Business Paperwork Reduction Act (SBPRA). The Commerce Department provides substantial assistance through a variety of media to help small businesses comply with enforcement regulations and paperwork requirements.

National Oceanic and Atmospheric Administration
The National Oceanic and Atmospheric Administration (NOAA) regulates small businesses under several natural resource protection statutes that NOAA enforces, including the Marine Mammal Protection Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act. NOAA has a comprehensive program providing regulatory compliance guidance and assistance to the small businesses/entities, which comprise much of NOAA’s regulated community. It has long been NOAA’s practice to answer inquiries from small businesses, and it answers tens of thousands of such inquiries annually. Inquiries are received via telephone, mail, and electronic mail; during public hearings, town hall meetings and workshops held by NOAA throughout the year; and in day-to-day interactions small businesses have with NOAA. NOAA distributes compliance guides to all those to whom a rule will apply and to others who have expressed interest. It makes the guides available at sites where affected parties are likely to see them. The guides may take different forms to best serve the needs of the parties affected by a particular rule.

The NOAA National Marine Fisheries Service (NMFS) operates a forms portal at http://www.nmfs.noaa.gov/gpea_forms/forms.htm where small businesses can obtain electronic copies of forms and permits, streamlining their ability to comply with fisheries enforcement regulations. A continually increasing number of forms can be completed and permits applied for and renewed online through interactive web-based applications.

The NOAA Office of Law Enforcement provides several venues for obtaining regulatory enforcement information:

NOAA program offices often prepare “plain English” summaries of new regulations and distribute them by fax to the regulated communities and the press. For complex regulations, question/answer sheets of the most frequently asked questions are often published in the fishery trade journals that are most often read by the affected fishermen. Information about NOAA’s regulations and compliance guidance is often posted on NOAA Web pages and on electronic bulletin boards.

Additionally, small businesses and entities may contact specific program offices responsible for the regulations at issue. Program offices hold informational workshops to explain new regulations and answer questions from the industry concerning compliance. Fishermen, who make up much of the regulated community, often speak with NOAA’s individual fishery plan coordinators for guidance in response to specific factual situations described by the fishermen. In permitted fisheries, letters explaining regulatory changes and providing the name of a person to contact for additional information and guidance, may be sent to each permit holder. NMFS also has public affairs positions in its regional offices that specialize in community outreach

Bureau of Industry and Security
The Bureau of Industry and Security (BIS), formerly the Bureau of Export Administration (BXA), regulates small businesses under the Export Administration Regulations, which set the criteria for authorizing exports of dual-use items – commercial items with potential military or weapons proliferation applications. It provides exporters with a wide range of compliance assistance, including compliance guides in the form of instructional brochures, fact sheets, and information posted on the BIS Web site, and assists small businesses through seminars, meetings, workshops, and, when requested, one-on-one counseling. Resources available to small businesses include:

  • BIS Website: http://www.bis.doc.gov/index.htm
  • BIS Export Enforcement Hotline: 1-800-424-2980
  • Office of Export Enforcement Intelligence: (202) 482-1208
    Exporter Counseling Division: (202) 482-4811

The Office of Antiboycott Compliance (OAC) within BIS advises small businesses on compliance with the antiboycott regulations through its telephone advice line. Callers can seek compliance advice before engaging in transactions and obtain assistance in resolving boycott issues. The Antiboycott Advice phone number is (202) 482-2381.

Census Bureau
The Census Bureau serves as the leading source of quality data about the nation’s people and the economy. To assist small businesses in responding to economic surveys and other data collection requirements, the Census Bureau recently appointed Eli Serrano as its small business ombudsman. The office is in the process of identifying the information needs and expectations of small businesses and developing a business plan. Pending the establishment of a toll-free phone number, the ombudsman can be contacted at Eli.Samuel.Serrano@census.gov.

As part of its mission to collect and disseminate economic data about businesses of all sizes, the Census Bureau maintains the Foreign Trade Statistics Web site at http://www.census.gov/foreign-trade/aes/index.html. This site provides small businesses and other exporters with the Automated Export System (AES), a paperless way to file the Shipper’s Export Declaration (SED).

International Trade Administration
The International Trade Administration (ITA) is dedicated to opening markets for U.S. products and services and providing assistance and information to exporters. An important part of the ITA mission is to increase the participation of small and medium-sized enterprises (SMEs) in exporting. The Small Business Program/Office of Export Assistance and Business Outreach (OEABO) focuses on SMEs, including women- and minority-owned businesses. The Small Business Program advocates for the small business perspective in trade policy formulation and in multilateral fora, such as the World Trade Organization and the Organization for Economic Cooperation and Development. It also assists SME exporters, through outreach programs, to understand the benefits of trade and how trade policy affects their commercial success. Small and medium-sized businesses can access vital information about trade and exporting on ITA’s Web site at www.export.gov, which provides online trade resources and one-on-one assistance for companies interested in international business.

The collection of information from small and medium-sized businesses is vital to assisting them to enter and become successful in exporting to international markets. ITA continues to work toward reducing the information collection burden on the public by increasing the number of electronic public forms in use, simplifying and streamlining forms, eliminating collections no longer required, and using information technology to reduce the amount of time required to complete each request. These steps will help achieve the intended effect of reducing the burden on the public and enhance our service to the customer by producing public collections of information that are clearer and easier to use.

U.S. Patent & Trademark Office
The U.S. Patent and Trademark Office (USPTO) publishes inventor resources on the agency website. The “Inventor Resources” site is dedicated to serving the special needs and interests of the inventor and entrepreneur. It is at http://www.uspto.gov/web/offices/com/iip/index.htm.

The USPTO Office of Procurement awards and administers a wide variety of contracts and simplified purchases for the acquisition of goods and services required throughout the agency. The Office of Procurement continually strives to remain on the leading edge of procurement reform and current technology. It is our goal to identify and utilize new innovative techniques to develop a partnership with industry. A major goal is to promote and give consideration to small business concerns. Requirements over the micro purchase amount of $2,500 are identified early in the acquisition process to allow for consideration for small, small disadvantaged, woman-owned and minority-owned businesses. An Internet Purchasing Application and vendor information is available at http://www.uspto.gov/web/offices/ac/comp/proc/ipa/ipamain.htm. For additional information, contact the Small Business Liaison (Muriel.brown@uspto.gov).

For more information about paperwork requirements, please contact the Paperwork Reduction Act Officer (susan.brown@uspto.gov).

Department of Commerce Single Point of Contact:
Tom Pyke
Office of the Chief Information Officer
U.S. Department of Commerce
14th St. and Constitution Ave.
Washington, D.C. 20230
(202) 482-4797

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DEFENSE
Small Business Compliance Assistance Resources Summary (44 U.S.C. 3504(c)(6))
It is Department of Defense policy that a fair proportion of DoD total purchases, contracts, subcontracts, and other agreements for property and services be placed with small business concerns, service-disabled veteran-owned small business concerns, qualified historically underutilized business zone (HUBZone) small business concerns, small disadvantaged business concerns, women-owned small business concerns, and historically Black colleges and universities and minority institutions.

The Director of the Office of Small and Disadvantaged Business Utilization (SADBU) is the principal proponent within the Office of the Secretary of Defense for executing national and DoD policy as mandated by the Congress and the President. The Director acts as ombudsman and coordinator with the functional activity concerned in responding to complaints and resolving problems encountered by small business firms performing under DoD contracts.

Regulations that require the Government to look at small, disadvantaged, minority, or women-owned businesses when doing government procurement are located in the Federal Acquisition Regulation (FAR) Part 19 and the Defense FAR Supplement (DFARS) Part 219. These regulations are available on-line at http://www.arnet.gov/far/ and http://www.acq.osd.mil/dpap/dars/.

The Washington Headquarters Services, Directorate for Information Operations and Reports (WHS/DIOR), serves as the central repository for statistical information for the Department of Defense. General procurement data, including subcontract information, is located on the WHS/DIOR web site at http://www.dior.whs.mil/peidhome/peidhome.htm. Specifically, SADBU utilizes the standard tabulation (ST) 28 report, titled “Contract Awards by FSC and Purchasing Office,” as a key document to assist small business concerns in identifying contracting activities with contracting potential. The ST 28 matches the dollar obligations and contract actions under each specific Federal Supply Class or Service Codes and details the contracting activities that made awards by name, city, and state. The ST 28 can be found at http://www.dior.whs.mil/peidhome/procstat/procstat.htm.

The Defense Logistics Agency, on behalf of the Secretary of Defense, administers the DoD Procurement Technical Assistance Program (PTAP). PTAP Centers are a local resource that can provide assistance to business firms in marketing products and services to the Federal, state and local governments. A list of PTAP Centers can be found at http://www.dla.mil/db/procurem.htm.

The DoD Regional Councils for Small Business Education and Advocacy are a nationwide network of small business specialists organized to promote the National Small Business Programs of the United States. Council objectives include promoting the exchange of ideas and experiences, and general information among small business specialists and the contracting community; developing closer relationships and better communication among Government entities and the small business community; and staying abreast of statutes, policies, regulations, directives, trends, and technology affecting the Small Business Program. There are eight Regional Councils sponsored by the DoD Office of Small and Disadvantaged Business Utilization (SADBU) governed by individual by-laws. Further information can be found at http://www.acq.osd.mil/sadbu/programs/regional/index.html.

Information on DoD’s initiatives and programs is available on SADBU’s web site http://www.acq.osd.mil/sadbu/index.html. Contact information and links to DoD Component SADBU Offices can be found at http://www.acq.osd.mil/sadbu/links/dod_sadbu.htm.

Department of Defense Single Point of Contact:
Robert L. Cushing, Jr.
Department of Defense
Washington Headquarters Services
Executive Services and Communications Directorate
1225 South Clark Street, Suite 504
Arlington, VA 22202-4326
Telephone: 703-604-6269
E-mail: robert.cushing@whs.mil

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EDUCATION

  • Online information centers on grants and contracts, financial aid, education research and statistics, education policy (including legislation, regulations and guidance), and education programs: www.ed.gov.
  • Online subscriptions to Department of Education newsletters: www.ed.gov.
  • Department of Education programs and initiatives: 1-800-USA-LEARN (1-800-872-5327).
  • Student aid: 1-800-4FED-AID (1-800-433-3243).
  • Matters affecting small businesses: U.S. Department of Education, Office of Small and Disadvantaged Business Utilization, 400 Maryland Ave., SW, Washington, DC 20202; Telephone: 202-708-9820.
  • Student loan issues: www.ombudsman.ed.gov, U.S. Department of Education, FSA Ombudsman, 830 First St., NE, 4th Floor, Washington, DC 20202-5144; Telephone: 1-877-557-2575; Fax: 202-275-0549.

Education Department Single Point of Contact:
John Tressler
U.S. Department of Education
Office of the Chief Information Officer
400 Maryland Ave. SW
Washington, DC 20202.
Telephone: (202) 245-6589
E-mail: John.Tressler@ed.gov

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ENERGY
The Office of Small & Disadvantaged Business Utilization (OSDBU) and the Office of the Ombudsman handle small business compliance at the U.S. Department of Energy (DOE). And, each site facility and DOE contractor has a small business manager dedicated to small business compliance. (http://smallbusiness.doe.gov)

The OSDBU oversees small business programs department-wide, setting policies and procedures to ensure small business compliance in DOE contract awards. The OSDBU also maintains a website with a clearinghouse of small business information, as well as small business policies and regulations and information on resources available to small businesses both at DOE and at other agencies/departments. The OSDBU has an extensive outreach/marketing program, including advertising in various publications and participation in various small business conferences.

DOE maintains a number of partnerships with many federal agencies such as the Small Business Administration and the Office of Federal Contract Compliance to promote small business compliance. The OSDBU has a “Small Business Council” composed of representatives of major trade associations, small and minority business chambers, women and veteran groups to ensure information/feedback to/from the small business community relative to small business compliance.

The Office of the Ombudsman provides small business access to an impartial review of their issues in dealing with the DOE and its contractors. The Office gives small business guidance and referral services to the correct entity within DOE and serves as a voice for the small business within DOE.

Department of Energy Single Point of Contact:
Theresa Speake, Director
Office of Small & Disadvantaged
Business Utilization
U.S. Department of Energy
1000 Independence Ave., SW
Washington, DC 20585
Telephone: 202-586-8383
E-mail: Theresa.Speake@hq.doe.gov

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HEALTH & HUMAN SERVICES
Small Business Resources -
Office of Small and Disadvantaged Business Utilization

Located in HHS's Office of the Secretary, the Department's Office of Small and Disadvantaged Business Utilization (OSDBU) fosters the use of small and disadvantaged businesses as Federal contractors. To accomplish this task, the OSDBU develops and implements outreach programs aimed at heightening the awareness of small business community to the contracting opportunities available across the Department.

Outreach efforts include activities such as sponsoring small business fairs and procurement conferences as well as participating in trade group seminars, conventions, and other forums, which promote the utilization of small and disadvantaged businesses as contractors. The OSDBU web page, www.HHS.gov/osdbu, presents important resources to aid contractors in doing business with the Department. OSBDU's Director is Ms. Debbie Ridgeley. Ms. Ridgeley may be contacted by telephone at 202-690-7300, or by E-mail at: Debbie.ridgely@hhs.gov.

HHS Regulatory Agencies -
Food and Drug Administration (FDA)

FDA provides a wealth of written and electronic information to assist small business compliance with FDA regulatory requirements.

FDA has published hundreds of guidelines to assist regulated industry, including small business, in complying with the laws and regulations that FDA administers. These guidelines cover virtually all areas that FDA regulates, from new drug and medical device premarket review, to product import and export issues, to issues that relate to the manufacture of foods, drugs, devices, and biological products.

FDA has also published and made widely available guidelines that the agency has developed for its own enforcement and compliance staff. These guidelines describe the general standards for compliance action and set forth the procedures to be followed in conducting investigational and enforcement activities. Essentially all of these written materials are available through FDA's many web-sites. FDA has also prepared "plain language" versions of some of the more technical documents to assist small businesses and others in understanding FDA's expectations.

FDA has created a number of small business and industry assistance "homepages" on its web-sites that bring together an array of useful regulatory and compliance information. For example, the Center for Devices and Radiological Health has created a "Device Advice" webpage, a self-service interactive site for obtaining information about medical devices. The human pharmaceutical program has created a comparable webpage, A Small Business Assistance”.

FDA's Small Business Representatives (SBR’s) are a significant resource for the small business community. Each of FDA's five regional offices is assigned an SBR to provide small business educational outreach and training.

FDA regional offices represent another significant informational resource for the small business community. The regional offices answer thousands of questions, conduct scores of training programs, and organize many "grassroots" meetings to educate the regulated industry, especially small businesses, about emerging regulatory topics of interest.

In addition, FDA's public affairs specialists (PAS’s), who are assigned to many of the agency's field offices, are able to respond to questions about FDA's programs, policies, and procedures.

Finally, FDA has appointed ombudsmen in the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Center for Devices and Radiological Health. These officials not only provide compliance assistance, but also help regulated companies explore available options in resolving disputes with the agency.

Guidelines
Technical guides
FDA has issued hundreds of guides to assist manufacturers in meeting premarket approval and other regulatory requirements. Among these guidelines a number of guidelines expressly directed to the concerns and needs of small businesses.

Inspectional guides
FDA has made publicly available the agency's manuals and written procedures governing the conduct of inspectional and investigational activities.

Policy guides
FDA has issued many guidelines to help regulated industry understand the laws, policies, and regulations that FDA administers. Many of these documents are issued in "plain language" versions to assist small businesses and others in understanding FDA's expectations.

All of the above-cited guidance materials may be accessed through the following Web sites:

Web Assistance
The following small business and industry-assistance homepages also bring together an array of useful regulatory and compliance information:

  • Center for Drug Evaluation and Research (CDER) Small Business Assistance: http://www.fda.gov/cder/about/smallbiz/default.htm - This site provides a listing of various programs, laws, regulations, and organizations that pertain to the drug development and approval process. This site is specifically geared to small businesses; however, general information relating to both small and large businesses is also available here (i.e., guidance documents, CDER calendar, etc...)
  • Information on Devices: http://www.fda.gov/cdrh/devadvice/ - This is an interactive, self-service site. It contains information on "How to Market Your Device" as well as an overview of the regulations, guidance documents, consumer information, and more.
  • Veterinary Products: http://www.fda.gov/cvm/faqs/faqs.html - This site answers "Frequently Asked Questions" about veterinary products. It includes links to sites that provide information and requirements for topics such as "New Animal Drug Approval" and "Marketing a Pet Food Product," as well as others.
  • Center for Biologic Evaluation and Research (CBER): http://www.fda.gov/CBER/manufacturer.htm - This website from the Center for Biologic Evaluation and Research explains the manufacturers assistance program, which provides assistance and training to companies, both large and small, regarding CBER policies and procedures. This site also contains links to other sites that may be of values to the small business owner.
  • Office of Regulatory Affairs Information on Small Business: http://www.fda.gov/ora/fed_state/small_business/default.htm
  • Office of Regulatory Affairs Small Business Guide to FDA: http://www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm. This site is from the FDA's Office of Regulatory Affairs. It offers links to a number of useful sites such as "What to do when marketing a new product," "recalling a product," "undergoing an FDA inspection," etc... It also provides an introduction to the Federal Register, information on obtaining FDA documents, frequently call numbers, and much more information.
  • Center for Food Safety and Applied Nutrition Guide to Starting a Food Business: http://www.cfsan.fda.gov/~comm/foodbiz.html - Advice on "Starting A Food Business" which may be of interest for the (potential) small business owner. This site provides links to federal and state regulatory agencies, import & export information, as well as several other helpful sites.

Small Business and Industry Assistance Offices
Each major FDA component has its own industry assistance office. Staff in these offices provide program-specific information and compliance assistance, through the contact points indicated below:

CDER Small Business Assistance Drug Information Branch
301-827-4573, druginfo@cder.fda.gov
CBER Division of Manufacturers Assistance and Training
301-827-2000, or matt@cber.fda.gov
CDRH Division of Small Manufacturers, International and Consumer Assistance
dsma@cdrh.fda.gov Telephone: 1-800-638-2041
CVM Communications Staff jkla@cvm.fda.gov Telephone: 301-827-3806
CFSAN Industry Activities Staff giguina@cfsan.fda.gov Telephone: 301-436-1730

The Small Business Representatives identified below in each of FDA's five regional offices provide small businesses with personalized educational outreach and compliance assistance:

Northeast Region (CT, MA, ME, NH, NY, RI, VT)
Marilyn Corretto
158-15 Liberty Avenue
Jamaica, NY 11433-1034
Telephone: 718-662-5618
Fax: 718-662-5434
E-mail: oranersbr@ora.fda.gov

Central Region (DC, DE, IL, IN, KY, MD, MI, MN, ND, NJ, OH, PA, SD, VA, WI, WV)
Marie T. Falcone
U.S. Customhouse
2nd and Chestnut Sts., Room 900
Philadelphia, PA 19106
Telephone: (215) 597-2120 ext. 4003
Fax: (215) 597-5798
E-mail: mfalcone@ora.fda.gov

Southeast Region (AL, FL, GA, LA, MS, NC, PR, SC, TN, VI
Food and Drug Administration
60 Eighth St., N.E.
Atlanta, GA 30309
Telephone: (404) 253-1217
Fax: (404) 253-1207
E-mail: orasesbr@ora.fda.gov

Southwest Region (AR, CO, IA, KS, MO, NE, NM, OK, TX, UT, WY)
David Arvelo
40 N. Central Expy., Suite 900
Dallas, TX 75204
Telephone: (214) 253-4952
Assistant: Sue Thomason
Telephone: (214) 253-4951
Fax: (214) 253-4970
E-mail: oraswrsbr@ora.fda.gov

Pacific Region (AK, AZ, CA, HI, ID, MT, NV, OR, WA
Marcia Madrigal
Oakland Federal Building
1301 Clay Street, Suite 1180-N
Oakland, CA 94612-5217
Telephone: (510) 637-3980
Fax: (510) 637-3977
E-mail: mmadriga@ora.fda.gov

Ombudsman
FDA's Ombudsman Offices provide compliance assistance and assistance in informal dispute resolution. There are also ombudsmen offices in most of the program offices.

Office of the Commissioner
Laurie Lenkel
Office of the Ombudsman
Food and Drug Administration
5600 Fishers Lane
Room 4B-44, HF-7
Rockville, MD 20857
Telephone: (301) 827-3390
Fax: (301) 480-8039
E-mail: ombuds@oc.fda.gov

Center for Biologics Evaluation and Research
Sherry Lard Whiteford
CBER Ombudsman (HFM-4)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
Telephone: (301) 827-0379
E-mail: lard@cber.fda.gov

Center for Drug Evaluation and Research
Warren Rumble, CDER Ombudsman (HFD-1)
5515 Security Lane, Suite 500
Rockvillle, MD 20852
Telephone: (301) 594-5480 or (301) 827-4312 (fax)
E-mail: ombudsman@cder.fda.gov

Center for Devices and Radiological Health
Les Weinstein
CDRH Ombudsman
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
9200 Corporate Blvd. (HFZ-5)
Rockville, MD 20850
Telephone: (301) 827-7991
Fax: (301 ) 827-2565
E-mail: ombudsman@cdrh.fda.gov

Center for Veterinary Medicine
Marcia K. Larkins, D.V.M
FDA Center for Veterinary Medicine
Ombudsman
7519 Standish Place HFV-7
Rockville, MD 20855
Telephone: (301) 827-4535
Fax: (301) 827-3957
E-Mail: mlarkins@cvm.fda.gov

Center for Medicare and Medicaid Services (CMS)
CMS's Small Business Office
CMS has a full-time Small and Disadvantaged Business Utilization Specialist (SDBUS) located in its Acquisition and Grants Group. The SDBUS is the Agency's focal point for ensuring that all reasonable action is taken to increase awards to small, small disadvantaged, HUBZones, and women-owned businesses. This Office maintains company profiles and capability statements for all types of services. Inquiries should be directed to Sharon McKinney on (410) 786-5162 or e-mail may be sent to: smckinney@cms.hhs.gov.

Grant Opportunities
While CMS's Program Offices are concerned with the scientific, technical, and programmatic topics, the Acquisition and Grants Group/Research Contracts and Grants Division is primarily charged with the business management and policy aspects of CMS's discretionary grant and cooperative agreement activities.

Currently, CMS conducts a myriad of R&D programs including (but not limited to) the following: Real Choice Systems Change Grants, Medicaid Infrastructure Grants, State Health Insurance Assistance Program, Historically Black Colleges and Universities, and Hispanic Health Initiatives. For additional information, please contact Judy Norris on (410) 786-5130 or e-mail to: jnorris1@cms.hhs.gov.

Regulatory Burden
The CMS liaison with the Small Business Administration's Office of the National Ombudsman is the Office of Strategic Operations and Regulatory Affairs (OSORA).

OSORA is the Agency's focal point for assessing and reducing the burden of Federal paperwork on small businesses in accordance with the Small Business Paperwork Relief Act of 2002 (SBPRA).

OSORA is responsible for responding to small entity concerns on regulatory burden, coordinating the development of department-wide non-retaliation policy with the Department of Health and Human Services, and participating in Regulatory Enforcement Fairness hearings and meetings when issues relate to the CMS mission.

OSORA established the following resources as contacts for small businesses experiencing problems pertaining to the regulatory burden aspect of doing business.
Phone: (410) 786-1002
Email: sbaombudsman@cms.hhs.gov

Website
CMS provides on its all-purpose web site http://www.cms.hhs.gov extensive amounts of information about the agency's programs, organized in terms of the kind of health-service provider affected, e.g., hospitals, nursing homes, home health agencies, or durable medical equipment suppliers. In addition, CMS offers a list of compliance assistance resources available to small businesses through its SBA Ombudsman web site at http://www.cms.hhs.gov/regulations/sbaombudsman/. This web site deals only with issues pertaining to regulatory burden.

National Institutes of Health (NIH)
The NIH Small Business Office (SBO) serves as an advocate for small business through various program activities and outreach efforts. These efforts are intended to maximize prime and subcontract acquisition opportunities at the NIH for small businesses owned by the disadvantaged, women, veterans, service-disabled veterans, and Historically Underutilized Business Zone (HUBZone) concerns. Inquires should be sent to Diana Mukitarian, Chief, (301) 496-9639, sbmail@od.nih.gov

The Small Business Program is located in the NIH's Office of Acquisition Management and Policy, whose URL is: http://oa.od.nih.gov/oamp/index.html

Among other things, the Small Business Program at the NIH is responsible for:

  • Developing and maintaining acquisition review procedures and guidelines for requests for contracts, subcontracting plans and operations as contract activities. Such reviews result in recommendations to contracting officers regarding the method of acquisition to be pursued and the acceptability of proposed subcontracting plans and prime contractors' small business programs;
  • Conducting surveillance of contract, simplified acquisition and satellite small business program activity, and conducting studies of specific problem areas to ensure effective small business program performance and compliance with applicable laws and regulations;
  • Ensuring the development and presentation of management data to provide continuing visibility of program activity and to evaluate program accomplishments against agency socio-economic goals;
  • Representing the NIH at Federal, state, local government and congressional small business conferences and fairs. Serving as a guest and expert speaker at various Federal, state, local government and Congressional small business conferences and fairs;
  • Serving as a liaison between the NIH program and contract staff and the contractor community;
  • Delivering industry assistance by maintaining a program designed to locate capable small, disadvantaged, woman, veteran, service-disabled and HUBZone - owned small business concerns for current and future acquisitions;
  • Representing the NIH to industry by interfacing with CEOs and other principals of private companies, to include small and large firms, as well as nonprofits and universities;
  • Responding to inquiries and requests for advise from small, disadvantaged, woman, veteran, service-disabled and HUBZone - owned businesses; and assisting small business in their marketing and business development efforts and activities.

Department of Health and Human Services Single Point of Contact:
Debbie Ridgely, Director
Office of Small and Disadvantaged Business Utilization
Room 360-G Humphrey Building
Washington, DC 20201
Telephone: (202) 260-0040
E-mail: SB.PRA@HHS.gov

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Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) exists primarily to expand access to health care for medically underserved individuals and families across the nation through community-based networks of primary and preventive health care services. HRSA has become known as "The 'Access' Agency" for its services to Americans who lack health insurance; 62 million Americans in rural communities; 78 million racial and ethnic minorities; over 800,000 Americans with HIV/AIDS; and about 80,000 U.S. residents awaiting organ transplants.

HRSA Contracting Office and Small Business Representative
The HRSA contracting office, the Contracts Operations Branch, is currently part of the Division of Grants and Procurement Management. The current Small Business Representative, Ms. Debora Pitts, is available to assist small businesses in navigating the field of HRSA acquisitions. Ms. Pitts may be contacted at 301-443-3789.

Key Contact Persons in HRSA Contracts
HRSA "HCA" (Head of Contracting Activities) is Dr. Albert F. Marra, who may be reached at 301-443-1433. The HRSA Chief of the Contracts Operations Branch is Mr. Steve Zangwill, who may be contacted at 301-443-5097, or at szangwill@hrsa.gov. Mr. Zangwill is assisted by Mr. Frank Murphy, who leads the negotiated contract team, at 301-443-5165, and Ms. Bonnie Garcia, who heads the simplified acquisitions team at 301-443-5116. The main office number is 301-443-1433.

All contracting opportunities at HRSA are announced publicly via the world wide web using the government's new FedBizOpps program at the following web site: www.fedbizopps.gov.

Contractors and vendors are urged to visit that site, as well as the larger HRSA web site at www.hrsa.gov to keep abreast of contracting needs as well as programmatic changes and developments. Another vehicle open to interested potential contractors is to study the grants funding opportunities available to various agencies and organizations. These grants opportunities, which are also announced via the web, the Federal Register, FedBizOpps, and through "The HRSA Preview," give further indications of potential acquisitions needs. The HRSA Preview may be obtained through the HRSA web site or by calling 1-877-HRSA-123. Contractors may also find fertile opportunities for sub-contracting with HRSA grantees.

National Institutes of Health (NIH)
Small Business Office
The NIH Small Business Office (SBO) serves as an advocate for small business through various program activities and outreach efforts. These efforts are intended to maximize prime and subcontract acquisition opportunities at the NIH for small businesses owned by the disadvantaged, women, veterans, service-disabled veterans, and Historically Underutilized Business Zone (HUBZone) concerns

The Small Business Program is located in the NIH's Office of Acquisition Management and Policy, whose URL is: http://oa.od.nih.gov/oamp/index.html

Specific points of contact include:
NIH Small Business Office
Annette Owens-Scarboro
6100 Executive Boulevard, Room 6D05
Bethesda, MD 20892-7540
Phone: (301) 496-7669
Fax: (301) 480-2506
E-mail: ao31z@nih.gov

The National Cancer Institute
Joseph Bowe
Small Business Specialist
6120 Executive Boulevard, Room 608
Bethesda, MD 20892-7222
Phone: (301) 496-8628
Fax: (301) 480-0309
E-mail: jbl@nih.gov

The National Institute of Environmental Health Sciences
Mary B. Workman
Small Business Specialist
Acquisitions Management Branch
P.O. Box 12874, MD NH-02
Research Triangle Park, NC 27709
Phone: (919) 541-0377
Fax: (919) 541-5117
E-mail: workman@niehs.nih.gov

Among other things, the Small Business Program at the NIH is responsible for:

  • Developing and maintaining acquisition review procedures and guidelines for requests for contracts, subcontracting plans and operations as contract activities. Such reviews result in recommendations to contracting officers regarding the method of acquisition to be pursued and the acceptability of proposed subcontracting plans and prime contractors' small business programs;
  • Conducting surveillance of contract, simplified acquisition and satellite small business program activity, and conducting studies of specific problem areas to ensure effective small business program performance and compliance with applicable laws and regulations;
  • Ensuring the development and presentation of management data to provide continuing visibility of program activity and to evaluate program accomplishments against agency socio-economic goals;
  • Representing the NIH at Federal, state, local government and congressional small business conferences and fairs. Serving as a guest and expert speaker at various Federal, state, local government and Congressional small business conferences and fairs;
  • Serving as a liaison between the NIH program and contract staff and the contractor community;
  • Delivering industry assistance by maintaining a program designed to locate capable small, disadvantaged, woman, veteran, service-disabled and HUBZone - owned small business concerns for current and future acquisitions;
  • Representing the NIH to industry by interfacing with CEOs and other principals of private companies, to include small and large firms, as well as nonprofits and universities;
  • Responding to inquiries and requests for advise from small, disadvantaged, woman, veteran, service-disabled and HUBZone - owned businesses; and assisting small business in their marketing and business development efforts and activities.

Department of Health and Human Services Single Point of Contact:
Debbie Ridgely, Director
Office of Small and Disadvantaged Business Utilization
202-690-7300 call
email addresses
debbie.ridgely@hhs.gov
arthuretta.martin@hhs.gov

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HOMELAND SECURITY
The Department of Homeland Security's (DHS) Office of Small Business and Disadvantaged Business Utilization (OSDBU) assists, counsels, and advises small businesses of all types (small businesses, small disadvantaged business, women-owned small businesses, veteran owned small businesses, service disabled veteran owned small businesses, and small businesses located in historically underutilized business zones) on procedures for contracting with DHS.

Office of Small and Disadvantaged Business Utilization (OSDBU)
The Department of Homeland Security's (DHS) Office of Small Business and Disadvantaged Business Utilization (OSDBU) assists, counsels, and advises small businesses of all types (small businesses, small disadvantaged business, women-owned small businesses, veteran owned small businesses, service disabled veteran owned small businesses, and small businesses located in historically underutilized business zones) on procedures for contracting with DHS. The point of contact for this small business program is Kevin Boshears; he may be reached at (202) 772-9792 and kevin.boshears@dhs.gov.

Office of the Private Sector
The Office of the Private Sector has an e-mail address where small business inquiries could be made, namely private.sector@dhs.gov. The Office will, pursuant to the Homeland Security Act, have the capability to advise the Secretary regarding the impact on the private sector, including small business, of proposed regulations concerning homeland security. For now an individual and phone number that can be used as an entry point to the Office would be Ms. Elizabeth Callaway at (202) 282-8484 and elizabeth.callaway@dhs.gov.

Department of Homeland Security Single Point of Contact:
Yvonne Pollard
U.S. Department of Homeland Security
Washington, DC 20528
Telephone: (202) 692-4221
E-mail: yvonne.pollard@dhs.gov

Bureau of Citizenship & Immigration Services (INS)
The paperwork requirement imposed by the Bureau of Citizenship and
Immigration Services is the Form I-9. Completion of this one-page form
By employers helps to insure a legal workforce within the United States and does not present a significant burden for businesses. The Bureau has instituted electronic filing of some applications and provides application status on line. These improvements have been a boost to many businesses, providing a speedy mechanism for filling critical positions with foreign experts or semi-skilled workers with temporary and permanent foreign workers. Many employers make use of the Bureau's petitions and applications for approval to hire alien temporary workers.

Live voice assistance, Employer Hotline (800) 357-2099 is available for employers and Live voice assistance for general questions (800) 357-5283. Information for e-filing can be found at www.bcis.gov. Employer Assistance Resources can be found at www.bcis.gov under the title "Information for Employers", Office of Business Liaison. Requests for speakers and questions can be faxed to (202) 305-2523.

DHS Point of Contact for Small Business Compliance Assistance:
Felicia A. Colvin
Supervisory Information Specialist
Office of Business Liaison
Bureau of Citizenship and Immigration Services
Telephone: (202) 305-2461

Bureau of Customs and Border Protection (CBP)
The newly formed Bureau of Customs and Border Protection (CBP) has been working under the trade concept of “informed compliance” since the passage of the Customs Modernization Act (1993). This law mandated CBP to develop a proactive strategy to advise importers of their responsibilities under the law. To fulfill this mandate, CBP has implemented several measures for providing guidance on laws governing international trade for all importers and exporters, including small businesses. Small businesses can avail themselves of this information using the following means: CBP Web Site (downloadable); local and national trade meetings/seminars; weekly publications of the Customs Bulletin; binding rulings program; other informed compliance brochures and pamphlets; and direct contact with CBP personnel.

There are over 300 ports of entry where we enforce numerous laws for CBP and other government agencies while serving as America’s frontline for border security. As the agency’s primary responsibility, CBP has twin goals of improving security and facilitating legitimate trade and travel, which are not mutually exclusive. In its role to facilitate trade, CBP has always provided compliance assistance to the trade community about the laws and regulations that apply to importing and exporting. Customs officers at the ports of entry, the Strategic Trade Centers, field operations offices and at Headquarters daily receive and respond to requests for information from the public.

The CBP Web Site lists all ports of entry with their addresses and telephone numbers. CBP has incorporated a Customer Service Center that responds to inquiries via a toll free number (1-877-Customs). The Office of Trade Relations (OTR) is designated as the point of contact within CBP for small businesses and may be reached at (202) 927-1440 or via email at traderelations@dhs.gov. This office was revamped in 2002 to ensure effective, extensive communication between CBP and all facets of the trade community. Any small entity seeking general information about importing procedures or wanting to comment on their interaction with CBP may contact OTR for assistance.

Customs and Border Protection
Office of Trade Relations
1300 Pennsylvania Avenue NW, Room 4.2A
Washington, DC 20229
Telephone: 202-927-1440
Fax: 202-927-1696
E-mail: traderelations@dhs.gov

Coast Guard
Coast Guard single point of contact:
Steve Venckus
Chief, Office of Regulations and Administrative Law (G-LRA)
2100 2d Street SW (Room 1417)
Washington, DC 20593-0001
Phone: 202-267-1534
Fax: 202-267-6234
Email: svenckus@comdt.uscg.mil.

The Coast Guard encourages small entities to participate in the development of Coast Guard regulations. Our Web site offers help in understanding and complying with those regulations. Use the following links to access help in these areas:

The Coast Guard proudly maintains the following policy:
If you question or lodge a complaint regarding a Coast Guard policy or action, to us or to anyone else, or if you seek outside help in dealing with a Coast Guard policy or action, the Coast Guard will not retaliate against you in any fashion. The Coast Guard wants you to be able to comment, question, or lodge a complaint about our policies or actions without fear that we will retaliate or try to discourage future questions or complaints. If you think the Coast Guard has broken this promise, we will investigate, take appropriate action, and make sure that mistakes are not repeated. You may comment, ask questions, or file a complaint about Coast Guard policies or actions by contacting your local Coast Guard office, or you can also contact the Small Business Administration Office of the National Ombudsman at 888-REG-FAIR (734-3247), fax: 202-481-5719, email: ombudsman@sba.gov.

Small businesses generally are independently owned and operated and are not dominant in their field. If you need help determining whether or not your business qualifies as a "small business", contact the SBA's Office of the National Ombudsman using the information given in the preceding paragraph.

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HOUSING AND URBAN DEVELOPMENT
The Office of Small and Disadvantaged Business Utilization OSDBU has many tools available for small businesses. Through the establishment of the Information Technology (IT) training HUD has provided a learning tool for small businesses to understand all aspects of HUD’s IT opportunities. Introducing this training program has enabled HUD to form partnerships with small businesses and identify qualified companies to seek IT opportunities within the agency.

HUD sponsors Marketing and Outreach business fairs and focuses both on direct HUD contracting opportunities and contracting opportunities created by HUD assisted projects including Community Development Block Grant recipients and Public Housing authorities. HUD outreach sessions include HUD program offices and prime contractors who offer sub-contracting opportunities to small, small disadvantaged and women-owned businesses. HUD has attended approximately 50 outreach conferences including procurement fairs, trade shows, marketplace presentations throughout the country with a strong emphasis on the utilization of small businesses.

HUD’s contracting home page is linked to the OSDBU homepage in HUD’s website. The contracting home page contains notices of HUD procurement opportunities and allows interested parties to download a file containing solicitations. A special OSDBU page contains Small Business tips, the Forecast of Contracting Opportunities, a Small Business Resource Guide and notification of outreach activities.

The chart below identifies the Department’s compliance assistance resources for submission to OMB for the Internet.

HUD also has the HUD Procurement System (HPS), an integrated commercial and customized software program that automates procurement operations department-wide. This system includes a rapid query of contracting information that enables all companies to submit bids or proposals for upcoming contracting opportunities and the identification of HUBZones for participation in contracting and sub-contracting opportunities. Additionally, it provides HUD with a system to monitor and evaluate its actual achievements in regard to participation of small businesses in HUD activities.

HUD sponsors Marketing and Outreach business fairs and focuses both on direct HUD contracting opportunities and indirect contracting opportunities created by HUD assisted projects including, Community Development Block Grant recipients and public housing authorities. During these events, program offices and prime contractors who offer sub-contracting opportunities to small, small disadvantaged and women owned businesses are urged to attend. Last year, HUD attended approximately 50 outreach conferences including procurement fairs, trade shows and marketplace presentations throughout the country. The OSDBU Business Utilization Development Specials (BUDS), have regular one-on-one meetings with small businesses. The Director holds “Thursday Open House” sessions for all small, small disadvantaged and Women Owned Small Businesses (WOSBs). These meetings give small businesses the opportunity to meet personally with the Director and the specialized BUDS advocate within the OSDBU. The aforementioned efforts are in addition to the daily counseling and one-on-one meetings held with these businesses at the HUD headquarters and field offices.

The OSDBU has increased its staff to include a Contract Specialist, an Information Technology Specialist, a Small Business Policy Specialist and a Research Analyst. HUD has implemented innovative projects and tools utilizing the latest technologies that have and will continue to have a positive effect on the participation of WOSBs in departmental contracting activities. There are IT outreach sessions held regularly with IT small businesses to inform them of new procurement opportunities at HUD.

New Methodologies that challenge conventional procedures include the establishment of subcontracting policies that have resulted in an increase in contract dollars to small businesses. The HUD Procurement System (HPS) effectively tracks all contracting and subcontracting dollars awarded to small businesses. HUD has established a subcontracting goal of up to 40% of the total value of each contract and subsequent extensions, modifications and options. Contractors that are unable to meet the established goal must provide the rational for the proposed level of subcontracting. In accordance with the Federal Acquisition Regulation (FAR) at Part 19.702 and HUD's own federal acquisition regulation (HUDAR) at 2452.219-70, solicitations exceeding $500,000 that include HUDAR provision 2452.219-70, shall provide the maximum practicable subcontracting opportunities to small, small disadvantaged and women-owned businesses. Prior to award, each contract shall be evaluated on specific subcontracting goals and commitments to small businesses. These pioneering subcontracting policies also include subcontracting plans for General Services Administration schedule buys. There is a concentrated effort to conduct outreach with small businesses across the nation.

HUD OSDBU continuously performs at a level of professional excellence to serve our customers. HUD consistently formulates and implements written policies supporting small businesses and includes references to small businesses in standard operating procedures. HUD has designated a senior executive as the Director of the OSBDU who is responsible for implementing small business policy initiatives. Furthermore, HUD maintains an effective system to provide acknowledgement of procurement personnel that utilize 8(a) small businesses. HUD places a high priority on direct communications and outreach efforts; we utilize newsletters, facilitate trade show and marketplace presentations and conduct business assistance and training seminars. HUD is one of the most innovative governmental agencies and is constantly retrofitting its employment with the latest technologies to enhance service to small businesses. HUD constantly employs proactive strategies to increase opportunities for these businesses to serve as prime contractors and subcontractors. HUD has achieved phenomenal success in requiring prime contractors to establish measurable programs to increase subcontracting opportunities.

Publications:

Seminars and Classes:

WEB based compliance:

  • Brent Pick is HUD’s webmaster and updates all contract compliance issues on the web. (303) 672-5281 ext. 1821 Brent_Pick@hud.gov

Telephone Service:

  • (202) 708-1428, Office of Small and Disadvantaged Business Utilization HUD Headquarters, Room 3130

Future Activities:

  • CD-Roms/Video
  • Online/E-mail Service

On-Site Evaluation/Assistance:

  • Office of Small and Disadvantaged Business Utilization, A. Jo Baylor, Director: HUD – Headquarters 451 7th Street, SW, Room 3130, Washington, D.C. 20410; E-mail: a.jo_baylor@hud.gov

Housing and Urban Development Single Point of Contact:
A.Jo Baylor Director, Office of Small and Disadvantaged Business Utilization
HUD Headquarters 451 7th St, SW
Room 3130
Washington, DC 20410
Telephone: (202) 708-1428
E-mail: a.jo_baylor@hud.gov

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INTERIOR

Bureau of Land Management
Submit Permits and Reports Electronically https://www.wispermits.org/
How to File a Mining Claim http://www.blm.gov/nhp/pubs/brochures/minerals/index.htm#Q3
Minerals Management Service
"Dear Payor" Letters, Notices to Lessees, Small Refiner Program http://www.mrm.mms.gov/RIKweb/SmallRefiners.htm
Electronic Payment Information http://www.mrm.mms.gov/ReportingServices/PDFDocs/fedwire.pdf
Regulations governing collecting, accounting for and distributing revenues associated with mineral production from leased federal and Indian lands http://www.mrm.mms.gov/Laws_R_D/FRNotices/FRHome.htm
Regulations governing leasing and operations on the Federal offshore http://www.mms.gov/offshore/Regulations.htm
Workshops to explain more complex regulations Available at various locations around the country
Training on how to report royalty revenue and related information Available at various locations around the country
Bureau of Reclamation
Statute, regulations, Reclamation Reform Act (RRA) Fact Sheets, RRA forms & instructions, and Status of Irrigation Districts List http://www.usbr.gov/rra/
Explanations of the most common Reclamation Reform Act questions and issues in plain English www.usbr.gov/rra and at the Reclamation District offices in all irrigation districts
Fish and Wildlife Service
General Compliance Guidance http://pdm.fws.gov/sba/sbindex.html
Compliance Guidance for Wildlife Import and Export License Holders http://www.le.fws.gov/PublicBulletin.htm
Non-Retaliation Policy http://policy.fws.gov/do142.html
Outreach Presentations for the Import/Export Community http://www.le.fws.gov/inspectors.htm
Courses on Conservation, Grantwriting, Conservation Partnerships, Developing and Working with Friends Groups, and Other Topics http://training.fws.gov/
Assistance for Importers and Exporters, Taxidermists, Guides and Outfitters http://www.le.fws.gov/inspectors.htm
FWS Publications Online http://library.fws.gov/pubs3.html
Office of Surface Mining
Applicant Violator System http://www.avs.osmre.gov/
Small Operator Assistance Program http://www.osm.gov/soap.htm
Copies of OSM Forms http://www.osm.gov/forms.htm
Policies and Guidance http://www.osm.gov/policy.htm

Department of the Interior Single Point of Contact:
John Strylowski
U.S. Department of the Interior
MS 7229 MIB
Washington, DC 20240
Telephone: 202-208-3071
Fax: 202-219-2100
E-Mail: john_strylowski@ios.doi.gov

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JUSTICE
Office of Small and Disadvantaged Business Utilization (OSDBU)
The Office of Small and Disadvantaged Business Utilization (OSDBU) strives to improve and increase the Department's performance in utilizing small, small disadvantaged, small woman-owned and veteran-owned businesses as contractors and subcontractors. Our various bureaus spend approximately two billion dollars a year in the private sector. Currently, more than 42 percent of those dollars go to small businesses, with 10 to 15 percent going to minority-owned firms and 3 to 5 percent going to woman-owned companies.

The OSDBU Director and the Deputy Attorney General are committed to encouraging and assisting well-qualified and skillful small, minority, and woman-owned businesses seeking contracts with the Department of Justice. The acquisition function in the Justice Department has been assigned to each of our bureaus' contracting staffs, most of which are located in the metropolitan Washington, DC area. We have prepared several avenues to assist small and disadvantaged businesses in getting better acquainted with the requirements and procurement practices of the bureaus.

Information on DOJ's initiatives and activities is available on the DOJ Small Business Web Site:

http://www.usdoj.gov/jmd/osdbu

This site provides extensive small business assistance information including registration for the monthly vendors outreach sessions that provide the opportunity for one-on-one meetings with small business specialists and contracting officers:

http://www.usdoj.gov/jmd/osdbu/mcform.htm

OSDBU Contact:
David Sutton, Director
OSDBU
1331 Penn Ave. N.W.
National Place Bldg., Suite 1010
Washington, DC 20530
Telephone: 202-616-0523 or 1-800-345-3712
Fax: 202-616-1717
E-Mail: David.Sutton@usdoj.gov

Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)
Publications of benefit or interest to ATF industry members and the general public (i.e., firearms and explosives regulations, newsletters, rulings, press releases, statistics and State & local training courses, Federal law and regulations, State Laws and Published Ordinances, and Federal Register notices.)

  • Theft/losses of explosives materials: 1-888-ATF-2662
  • Toll free for reports of gun related crimes and after hours theft/losses: 1-800-ATF-GUNS
  • Toll free for theft/losses of firearms: 1-800-800-3855
  • ATF Firearms and Explosives Compliance Web Site: www.atf.gov

The ATF provides various publications to our industry members as well as the general public. Some of the publications available either on ATF web site or in hard copy, include manuals which provide ATF's regulatory requirements in a plain language format; informational brochures to help raise awareness of possible criminal activity (i.e., Reporting theft of Explosives and Firearms, Arson incidents); and industry newsletters for all businesses regulated by ATF. Publications, brochures and forms are produced in quantities of 115,000 each for firearms and 12,000 for explosives, for distribution to the licensees, permittees, and to trade and research organizations and the press.

ATF hosts/participates in national, international, as well as regional/local conferences and meetings. In addition, ATF personnel are often invited by associations to attend their national conferences to give presentations on topics of interest to association members, and/or set up an exhibit booth. The ATF exhibit booth provides yet another venue through which industry members that attend these meetings, may ask questions or concerns regarding ATF policy or regulations.

ATF personnel have also been asked by industry associations as well as regulatory associations/agencies to participate on various panels. Recent topics on which the ATF has provided our expertise include but are not limited to, Safe Explosives Act, Shot Show University, Annual Importers Conference.

There are a number of application forms and reports required by ATF, some of which are now available on ATF's web site www.atf.gov.

ATF Contact:
Mary Jo Hughes
Chief, FEA Services Division
Office of Firearms, Explosives and Arson
Bureau of Alcohol, Tobacco, Firearms and Explosives
650 Massachusetts Avenue, NW
Washington, DC 20226
Telephone: 202-927-8045
Fax: 202-927-7488

Civil Rights Division (CRT)
CRT - Disability Rights Section (DRS)

The home page provides information about the toll-free ADA Information Line, the Department's ADA enforcement activities, the ADA technical assistance program, certification of State and local building codes, proposed changes in ADA regulations and requirements, and the ADA mediation program. The home page also provides direct access to ADA regulations and technical assistance materials, Freedom of Information Act materials, links to the Department's press releases, and links to the other Federal agencies' Internet home pages that contain ADA information. ADA. The website received over one million visitors during FY 2003.

ADA Guide for Small Business
http://www.usdoj.gov/crt/ada/smbusgd.pdf

ADA Information Line
DRS operates a toll-free ADA Information Line to provide information to the public about the requirements of the ADA and to distribute technical assistance publications to the public. Automated service is available 24 hours a day, seven days a week. During business hours, members of the public can consult with Department staff for assistance in applying ADA requirements to their own specific situation. The ADA Information Line numbers are (800) 514-0301(voice); (800) 514-0383 (TTY). During FY 2003, the Information Line received 120,000 calls.

ADA Fax on Demand
The ADA Information Line Fax Delivery Service allows the public to obtain free ADA information by fax 24 hours a day, seven days a week. By calling the ADA Information Line, callers can select from among 32 different ADA technical assistance publications and receive the information, usually within minutes, directly on their fax machines or computer fax/modems.
ADA Information Line: 800-514-0301 (voice); 800-514-0383 (TTY)

ADA publications
DRS produces a range of technical assistance documents, including an ADA Guide for Small Businesses that has been published jointly with the Small Business Administration. ADA.During FY 2003, the Department developed 41 new technical assistance materials, including five publications on specific topics of interest to businesses that can be printed and distributed directly from the web addressing the issues of service animals, restriping parking lots, refueling assistance at gas pumps, communicating with people who are deaf or hard of hearing in hospital settings, and communicating with people who are deaf or hard of hearing in hotels, motels, and other places of transient lodging.

ADA training
DRS provides ADA training at meetings nationwide; and conducts outreach to broad and targeted audiences that have included mayors, local Chambers of Commerce, and millions of businesses. Requests for speakers and training should be placed through the ADA Information Line: 800-514-0301 (voice); 800-514-0383 (TTY). During 2003, the Department fulfilled 60 training, speaking, and exhibit engagements.

ADA Mediation Program
The Department's ADA Mediation Program facilitates compliance by entities, including small businesses, using a voluntary alternative dispute resolution approach. Carried out through a partnership between the Federal government and the private sector, more than 450 professional mediators are available nationwide to mediate ADA cases. In FY 2003, 188 complaints with businesses were resolved successfully through the ADA Mediation Program. To date in FY 2004, the Department has referred an additional 144 cases to the mediation program.

CRT - Office of Special Counsel for Unfair Immigration Related Employment Practices (OSC)
OSC's Internet site has helpful information specifically designed for businesses as well as workers. The site describes the legal obligations of employers to comply with the anti-discrimination provision of the Immigration and Nationality Act (INA) and provides other information to assist compliance (such as brochures, booklets, frequently asked questions, and legal references). In FY 2003, the OSC web site had more than 386,000 new and recurring page visitors. The site is at http://www.usdoj.gov/crt/osc. In April, OSC published a newsletter, “OSC Update,” which provides an update of OSC’s outreach and enforcement activities, and highlights OSC’s informal resolution program.

OSC Employer Hotline
OSC has a national toll-free telephone line solely for the use of employers who wish to consult with OSC staff members about their compliance concerns. The telephone line is staffed by OSC attorneys and Equal Opportunity Specialists who promptly address employers' questions, providing immediate guidance. OSC staff often advise employers on how to avoid discrimination in the workplace, minimizing any future liability. Voice: 1-800-255-8155; TDD: 1-800-362-2735

OSC Job Applicant or Employee Hotline
Based on information received from individuals calling this line, and OSC's prompt investigation of these cases, OSC often is able to bring early, efficient, cost-effective resolutions to employment disputes that might otherwise result in the filing of charges, the accumulation of potential back pay awards, or litigation expenses. These early interventions minimize the impact of statutory enforcement on small businesses.
Voice: 1-800-255-7688 or (202) 616-5525; TDD: 1-800-237-2515
The OSC processed over 18,580 calls to its employer and employee hotlines in FY 2003.

OSC Training Materials
OSC also provides employers, where necessary, with training materials for their staff, including booklets, posters and educational videotapes, on how to ensure that they do not engage in discriminatory behavior. The employer hotline number is distributed with all of OSC's outreach materials for employers.
Voice: 1-800-255-8155; TDD: 1-800-362-2735; E-mail Address: osccrt@usdoj.gov
Download Brochures and Booklets: http://www.usdoj.gov/crt/osc/htm/outreach.htm
Based on FY 2003 levels, the OSC expects to disseminate over 100,000 copies of its brochures and booklets free of charge during FY 2004.

Compliance Assistance Education
OSC takes part in numerous employer training sessions throughout the country, providing employers guidance on how they can comply with the antidiscrimination provisions of the immigration laws. OSC attorneys also conduct outreach seminars across the country that are organized by OSC grantees and specifically designed to address issues of concern to employers. OSC routinely provides compliance assistance training and other guidance to employers that OSC determined committed unlawful discrimination to ensure that such violations do not recur.
Voice: 1-800-255-8155; TDD: 1-800-362-2735; E-mail Address: osccrt@usdoj.gov.
In FY 2003, OSC officials conducted 83 such presentations.

OSC Grants
In addition to the direct outreach activities of its own staff, OSC provides grants to employer associations (such as chambers of commerce) and other entities to allow those organizations to conduct further compliance assistance among their members and constituents. In FY 2003, OSC’s grantees presented information about INA compliance at hundreds of events that were attended by thousands of employers and workers and distributed thousands of copies of OSC’s brochures and booklets. There are 11 OSC grantees operating across the country in FY 2004. Grants totaled almost $675,000. Press Statement: http://www.usdoj.gov/crt/osc/press/30814grantees.pdf

OSC Assistance to SBA's Small Business Development Centers
To improve its outreach and service to the small business community, OSC contacted the SBA’s Office of Small Business Development Centers (OSBDC) and the Association of Small Business Development Centers (ASBDC) and offered to provide training and information materials, assistance with training events, and technical guidance to the SBDC networks across the county. There are more than 1,000 SBDC centers and subcenters that provide low-cost counseling and training to small businesses. The SBDCs are generally receptive to providing INA compliance information to their small business clients, and OSC expects to cultivate this partnership in 2004 and future years. OSC will soon roll out a small business resource page on its website.

OSC address and phone numbers:

Office of Special Counsel
for Immigration Related
Unfair Employment Practices
Civil Rights Division
Department of Justice
Post Office Box 27728
Washington, DC 20038-7728
Telephone: 202-616-5594

OSC Employer Hotline:
Voice: 1-800-255-8155
TDD: 1-800-362-2735

Civil Rights Division - General Point of Contact
David K. Flynn *
Chief, Appellate Section
P.O. Box 66078
Washington, DC 20035-6078
Telephone: 202-514-2195
Fax: 202-524-8490
* (Please note that Mr. Flynn is not assigned either to the Disability Rights Section (DRS) or to the Office of Special Counsel (OSC). General small business inquiries for information or for assistance concerning compliance with matters within the areas of responsibility of DRS or OSC should be directed to the addresses and phone numbers in the respective sections.)

Drug Enforcement Administration
DEA's Office of Diversion Control (OD) is the internal office that has oversight over and works with small businesses. As such, OD and Diversion field personnel continuously review ways in which the DEA can ensure small businesses have access to SBREFA material as well as improve upon current outreach initiatives.

OD Web Site
Office of Diversion Control's Web Site (http://www.DEAdiversion.usdoj.gov). contains information specifically relating to DEA's Diversion Program. Between January 1 and October 31, 2003, DEA’s entire Diversion Control Program web site was visited 1,047,968 (an average of 4,463 visits per day). Below are some of the web pages that were visited and the number of times they were viewed

Publications
DEA provides various publications to its registrant population as well as the general public. Some of the publications available either on Diversion's web site or in a hard copy, include registrant manuals which provide DEA's regulatory requirements in a plain language format; the SBREFA Advisory Notice; informational brochures to help raise awareness of possible criminal activity (i.e., a Pharmacist's Guide to Prescription Fraud, Recognizing the Drug Abuser, Drug Addiction in Healthcare Professionals, and Stimulant Abuse by School Age Children); industry newsletters; press releases; and program reports.
www.DEAdiversion.usdoj.gov/pubs/index.html

For those small businesses that do not have access to the Internet, the DEA provides contact telephone numbers for Diversion Headquarters and field personnel as well as the SBA Ombudsman in the back of hard bound copies of the registrant manuals.

Requests for information or reports should be mailed to:

Drug Enforcement Administration
Office of Diversion Control / ATTN:
Washington, DC 20537

Small Business Regulatory Fairness Advisory: www.DEAdiversion.usdoj.gov/pubs/fair_adviz.htm
This notice advises DEA registrants to contact DEA Field Offices if they have any questions regarding DEA's regulations and policies. If they are a small business, they may contact the SBA's Office of the Ombudsman to comment on DEA's enforcement actions. This Advisory is also included in all revised and new manuals.

Seminars/Classes

Web-Based Compliance

Onsite Evaluation/ Assistance

Meetings/Conferences
DEA hosts national as well as regional/local conferences and meetings. In addition, Diversion personnel are often invited by associations to attend their national conferences to give presentations on topics of interest to association members, and/or set up an exhibit booth.
www.DEAdiversion.usdoj.gov/mtgs/dea_mtgs.html

Toll Free Telephone Numbers
Contact information for Diversion Control Program personnel located at DEA Headquarters and local field offices may be viewed at the following web address:
http://www.deadiversion.usdoj.gov/offices_n_dirs/index.html

SUMMARY OF JUSTICE DEPARTMENT CONTACT INFORMATION:

DRS address and phone number:
Disability Rights Section
Civil Rights Division
P.O. Box 66738
Washington, DC 20035-6738
Telephone: 202-307-0663
Fax: 202-307-1198

ADA Information Line
800-514-0301 (voice)
800-514-0383 (TTY)

Drug Enforcement Administration Contact (for regulatory and enforcement matters)
Patricia Good
Chief, Liaison and Policy Section
Office of Diversion Control
Drug Enforcement Administration
Washington, DC 20537
Telephone: 202-307-7297
Fax: 202-307-8570

Justice Department contacts for Department wide matters (such as the Ombudsman's Reports to Congress) and other issues of general agency concern:
Kevin R. Jones
Deputy Assistant Attorney General
Office of Legal Policy
Department of Justice
Main Building, Room 7238
950 Pennsylvania Avenue, NW
Washington, DC 20530
Telephone: 202-514-4604
Fax: 202-514-9112
E-mail: Kevin.r.jones@usdoj.gov

Robert Hinchman
Senior Counsel
Office of Legal Policy
Department of Justice
Main Building, Room 7236
950 Pennsylvania Avenue, NW
Washington, DC 20530
Telephone: 202-514-8059
Fax: 202-514-9112
E-mail: robert.hinchman@usdoj.gov

Justice Department contact for general public affairs inquiries:
Mark Corallo
Director
Office of Public Affairs
Main Building, Room 1248
950 Pennsylvania Avenue, NW
Washington, DC 20530
Telephone: 202-514-2007
Fax: 202-513-5331
E-mail: Mark.Corallo@usdoj.gov

Justice Department contact for small and disadvantaged business utilization
Ramona Johnson-Glover, Acting Director
OSDBU
1331 Penn Ave. N.W.
National Place Bld., Suite 1010
Washington, DC 20530
Telephone: 202-616-0521
Fax: 202-616-1717
E-mail: Ramona.M.JohnsonGlover@USDOJ.gov

Justice Department single point of contact for the Paperwork Reduction Act (PRA)
Brenda Dyer
Policy and Planning Staff
Justice Management Division
Patrick Henry Building, Room 1600
Washington, DC 20530
Telephone 202-616-1167
Fax: 202-514-1590
E-mail: brenda.e.dyer@usdoj.gov

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LABOR
The U.S. Department of Labor (DOL) recognizes its obligation to respond to the ever-increasing complexities of employment laws and the difficulties businesses face in understanding them. Secretary of Labor Elaine L. Chao launched the Compliance Assistance Initiative to help America’s employers and employees better understand how to comply with the federal employment laws and regulations it administers. DOL believes compliance assistance is the most effective way to protect the wages, health benefits, retirement security, safety, and health of America’s workforce by preventing employment law violations.

DOL has developed the following tools and resources to ensure that employers and workers have access to clear and accurate information and assistance – when and where they need it, and in the format that suits them best.

Department of Labor Web Site
The most widely used compliance assistance tool is the DOL Web site, which features centralized compliance assistance information at www.dol.gov/compliance. The public can use this site to access a wide range of information and resources about DOL’s rules and regulations any time, day or night. These Web pages are gateways to DOL agencies’ compliance assistance information.

elaws Advisors
The elaws Advisors (Employment Laws Assistance for Workers and Small Businesses) are interactive e-tools that provide information on DOL’s federal employment laws. Available at www.dol.gov/elaws, each elaws Advisor mimics the interaction an individual would have with a DOL employment law expert by generating answers based on the user’s responses to a set of questions. The FirstStep Employment Law Advisor – one of the newest elaws Advisors – helps employers simply and quickly determine which of DOL’s major employment laws apply to their bu