Federal Register: June 28, 2004 (Volume 69, Number 123)
DOCID: FR Doc 04-14659
OFFICE OF MANAGEMENT AND BUDGET
Management and Budget Office
ACTION: Reports and guidance documents; availability, etc.:
DOCUMENT ACTION: Notice.
Compliance Assistance Resources and Points of Contact Available to Small Businesses
In accordance with the Small Business Paperwork Relief Act of 2002, the Office of Management and Budget (OMB) is publishing a ``list of the compliance assistance resources available to small businesses'' and a list of the points of contacts in agencies ``to act as a liaison between the agency and small business concerns'' with respect to the collection of information and the control of paperwork.
Small Business Paperwork Relief Act of 2002; implementation—; Compliance assistance resources and points of contact available to small businesses; list,
Authority: The Small Business Paperwork Relief Act (44 U.S.C. 3520).
The Small Business Paperwork Relief Act of 2002 (Pub. L. 107198) requires OMB to ``publish in the Federal Register and make available on the Internet (in consultation with the Small Business Administration) ``a list of the compliance assistance resources available to small businesses'' (44 U.S.C. 3504(c)(6)). In addition, under another provision of this Act, ``each agency shall, with respect to the collection of information and the control of paperwork, establish 1 point of contact in the agency to act as a liaison between the agency and small business concerns'' (44 U.S.C. 3506(I)(1)).
Working in cooperation with the Small Business and Agriculture Enforcement Ombudsman (SBA Ombudsman) in the Small Business Administration, OMB has, with the active assistance and support of the SBA Ombudsman, assembled a list of the compliance assistance resources available to small businesses. Because it may be helpful to the public to have the list of agency contacts together with the list of compliance assistance resources, OMB is publishing these lists together. These lists are also available today on OMB's Web site at http://www.whitehouse.gov/omb/inforeg/infocoll.html. The SBA Ombudsman has created a link to this information on the SBA Ombudsman's Web site at http://www.sba.gov/ombudsman. B. Legislative Initiatives
The publication of these lists is part of a more comprehensive effort to assist small businesses. The context for this initiative began several years ago with enactment of the ``Small Business Regulatory Enforcement Fairness Act of 1996'' (Pub. L. 104121, Title II) (SBREFA). Among other provisions, SBREFA calls on agencies to ``publish one or more guides to assist small entities in complying'' with certain regulations (Section 212), and ``to answer inquiries by small entities concerning information on, and advice about, compliance'' with regulatory statutes (Section 213). In other words, Federal regulatory agencies are to develop small entity compliance guides and to answer inquiries, and provide advice, about regulatory compliance issues.
In addition, SBREFA created within the Small Business Administration the office of the ``Small Business and Agriculture Enforcement Ombudsman'' (Section 222). The SBA Ombudsman's responsibilities involve working ``with each agency with regulatory authority over small businesses to ensure that small business concerns [involving the agency's implementation and enforcement of those regulatory authorities] are provided with a means to comment on the enforcement activity'' conducted by each agency. In other words, the SBA Ombudsman is to monitor, and report annually to Congress, on the enforcement practices of Federal regulatory agencies.
SBREFA was followed by the Small Business Paperwork Relief Act of 2002 (Pub. L. 107198) (SBPRA). As described above, this law requires OMB to publish ``a list of the compliance assistance resources available to small business.'' OMB is also publishing the points of contacts in agencies who are ``to act as a liaison between the agency and small business concerns'' with respect to the collection of information and the control of paperwork.
In addition, this statute directed the Director of OMB to convene and have a representative chair a Task Force ``to study the feasibility of streamlining requirements with respect to small business concerns regarding collection of information and strengthening dissemination of information'' (44 U.S.C. 3520). The Small Business Paperwork Relief Task Force has been developing recommendations to improve and more closely link the existing assistance resources through the use of information technology. More specifically, the Small Business Paperwork Relief Task Force is charged with examining five ways to reduce the information collection burden placed by government on small business concerns. They are:
1. Examine the feasibility and desirability of requiring the consolidation of information collection requirements within and across Federal agencies and programs, and identify ways of doing so.
2. Examine the feasibility and benefits to small businesses of
having OMB publish a list of data collections organized in a manner by which they can more easily identify requirements
with which they are expected to comply.
3. Examine the savings and develop recommendations for implementing electronic submissions of information to the Federal government with immediate feedback to the submitter.
4. Make recommendations to improve the electronic dissemination of information collected under Federal requirements.
5. Recommend a plan to develop an interactive Governmentwide Internet program to identify applicable collections and facilitate compliance.
SBPRA requires OMB to publish a report on the first three topics by
June 28, 2003. This report can be found on the OMB Web site at http://www.whitehouse.gov/omb/inforeg/infocoll.html. On May 5, 2004, OMB
published in the Federal Register its Draft Report of the Small Business Paperwork Relief Task Force. As required, this draft report discussed the final two topics listed above. The final Report of the Small Business Paperwork Relief Task Force is available on OMB's Web site at http://www.whitehouse.gov/omb/inforeg/infocoll.html.
SBREFA and SBPRA are closely related. SBREFA focuses on helping small businesses understand how to comply with Federal regulations. SBPRA focuses on helping small businesses understand how to comply with Federal collections of informationthat is, filling out forms, reporting information, and keeping certain records. These two types of requirements are related because, as the Task Force report noted, agencies generally collect information, or require those regulated to keep records, as part of regulatory provisions. The informationrelated provisions are designed to help the agency ensure compliance with the rule.
The close functional linkage between compliance with Federal
regulations and with Federal reporting and recordkeeping requirements
suggests it is important to coordinate these legislative initiatives
designed to assist small businesses. It is also the reason that the
development, in particular, of the list of compliance assistance
resources available to small businesses should be viewed in the context
of the recommendations being developed by the Small Business Paperwork
Relief Task Force. The list of compliance assistance resources
describes what is now available at the Federal agencies. The Task Force
has developed recommendations to improve and more closely link the
existing assistance resources through the use of information technology.
Donald R. Arbuckle,
Deputy Administrator, Office of Information and Regulatory Affairs. Compliance Assistance Summaries and Points of Contact
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 (18002333935), 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 (4022217400; Fax: 402221 7438; email Tech.Center@fsis.usda.gov.
FSIS also operates an extensive small establishment outreach program, featuring FSISsponsored workshops and programs, educational material development and distribution, HACCP and foodsafety 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 multimedia training materials in CDROM 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 Web site. 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:
number for each Regional Office is listed to request inspections, assistance, etc.
PublicationsRegulation, Rules, Technical and Administrative,
Directives, Annual Reports: The Grain Inspection, Packers and
Stockyards Administration posts current FGIS directives on the GIPSA
Web site at: http://www.usda.gov/gipsa/referencelibrary/directives.htm. The publications
are in PDF format, so they may be printed directly from the Web.
Seminars, classesTechnical 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, nonvisual quality tests such as protein, oil, and mycotoxins. Contact Larry McDonald for more information at: firstname.lastname@example.org.
Telephone serviceinformation 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 202503601 or telephone: (202) 7200219.
CD ROM's/Videos/ELearning CoursesTechnical 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: email@example.com.
Online/email serviceWide 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 Web site at: http://www.usda.gov/gipsa.
Onsite Evaluations/AssistanceProcess 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) 7200228.
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 facetoface meetings with retailers to provide technical assistance and listen to their concerns. With regards to new initiatives, FNS has created a biannual 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 Web site at http://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 Web site 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://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 email
assistance to CDROMs 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 Web site 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. 147E, Washington, DC 20250, Telephone: 2027201516, Email: firstname.lastname@example.org. Commerce
The Department of Commerce understands a vibrant small business sector is critical to creating new jobs in a dynamic and growing economy, so it is mindful of its responsibilities under the Small Business Regulatory Enforcement Fairness Act (SBREFA). The Commerce Department provides substantial regulatory enforcement compliance assistance through a variety of media.
Within the Commerce Department, two agencies regulate the activities of small businesses. The National Oceanic and Atmospheric Administration (NOAA) regulate 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. 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 dualuse items commercial items with potential military or weapons proliferation applications.
NOAA has a comprehensive program providing regulatory compliance
guidance and assistance to small entities, which comprise much of
NOAA's regulated community. It has long been NOAA's practice to answer
inquiries by small entities, when appropriate, in the interest of
administering statutes and regulations. NOAA answers tens of thousands
of inquiries from small entities 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 dayto
day interactions small entities 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 them 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.
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 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.
BIS similarly provides exporters a wide range of compliance
assistance. These include compliance guides in the forms of
instructional brochures, fact sheets and guidance posted on the BIS Web
site. BIS also educates small businesses through seminars, meetings, workshops and, when requested, oneonone counseling.
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. The OAC also offers counseling to small businesses to assist them in solving their boycott problems legally. Antiboycott Advice Line: (202) 4822381.
Patent & Trademark Office
U.S. Patent and Trademark Office (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. Our site includes helpful links such as current USPTO contracts, upcoming opportunities, office staff listing, helpful information for small businesses, information on our new Performance Based Organization (PBO) procedures and other related topics.
The USPTO 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 at the United States Patent & Trademark Office, Office of Procurement 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, womanowned and minorityowned businesses. http://www.uspto.gov/web/offices/ac/comp/proc/ipa/ipamain.htm .
The Office of Procurement continues to promote Electronic Commerce (EC) and utilize innovative technologies to streamline procurement processes. Our EC effort, known as the InternetBased Purchasing Application (IPA), has been in use for over a year now. The IPA continues to grow and is a successful tool in conducting simplified acquisitions over the Internet.
For more information please contact: Susan K. Brown, Records
Officer (PRA Clearance Desk), U.S. Patent and Trademark Office, Office
of the Chief Information Officer, Suite 310, 2231 Crystal Drive, Washington, DC 20231,
Telephone: (703) 3087400, EMail: email@example.com.
Muriel A. Brown, Small Business Liaison, U.S. Patent and Trademark Office Office of Procurement, Box 6, Washington, DC 20231, Telephone: (703) 3058370, Email: Muriel.firstname.lastname@example.org.
Department of Commerce Single Point of Contact: Tom Pyke, Office of the Chief Information Officer, U.S. Department of Commerce, 14th St. & Constitution Ave., NW., Washington, DC 20230. Telephone (202) 4824797. Defense
It is the Department of Defense (DOD) policy that a fair proportion of DOD total purchases, contracts, subcontracts, and other agreements for property and services be placed with small business concerns, servicedisabled veteranowned small business concerns, qualified historically underutilized business zone (HUBZone) small business concerns, small disadvantaged business concerns, womenowned 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.
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 bylaws. Further information can be found at http://www.acq.osd.mil/sadbu/programs/regional/index.htm .
Information on DOD's initiatives and programs is available on SADBU's Web site http://www.acq.osd.mil/sadbu/index.htm. Contact information and links to DOD Component SADBU Offices can be found at http://www.acq.osd.mil/sadbu/links/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 222024326. Telephone: (703) 6046269. Email:
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) 2456589. E mail: John.Tressler@ed.gov. 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 departmentwide, setting policies and procedures to ensure small business compliance in DOE contract awards. The OSDBU also maintains a Web site 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) 5868383. Email: Theresa.Speake@hq.doe.gov. Health and Human Services
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, http://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) 6907300, or by Email at: Debbie.email@example.com. Food and Drug Association (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'' Web page, a selfservice interactive site for obtaining information about medical devices. The human pharmaceutical program has created a comparable Web page, ``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'' meeting 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.
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 abovecited 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:
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. * * *)
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.
Biologic Evaluation and Research explains the manufacturer's 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.
SmallBusiness/sbguide/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.
Small Business and Industry Assistance Offices. Each major FDA
component has its own industry assistance office. Staff in these
offices provide programspecific information and compliance assistance, through the contact points indicated below:
CDER Small Business Assistance Drug Information Branch. Telephone (301) 8274573, firstname.lastname@example.org. CBER Division of Manufacturers Assistance and Training. Telephone (301) 8272000, or email@example.com. CDRH Division of Small Manufacturers, International and Consumer Assistance. Telephone: 18006382041, or firstname.lastname@example.org. CVM communications staff. Telephone: (301) 8273806, or
CFSAN industry activities staff. Telephone: (301) 4361730, or
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, 15815 Liberty Avenue, Jamaica, NY 114331034. Telephone: (718) 6625618. Fax: (718) 6625434. Email: email@example.com. 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) 5972120 ext. 4003. Fax: (215) 5975798. Email: firstname.lastname@example.org. Southeast Region (AL, FL, GA, LA, MS, NC, PR, SC, TN, VI): Food and Drug Administration, 60 Eighth St., NE., Atlanta, GA 30309. Telephone: (404) 2531217. Fax: (404) 2531207. Email: email@example.com. 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) 2534952. Assistant: Sue Thomason, telephone: (214) 2534951. Fax: (214) 2534970. Email: firstname.lastname@example.org. Pacific Region (AK, AZ, CA, HI, ID, MT, NV, OR, WA): Marcia Madrigal, Oakland Federal Building, 1301 Clay Street, Suite 1180N, Oakland, CA 946125217. Telephone: (510) 6373980. Fax: (510) 6373977. Email: email@example.com. 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. Contacts are as follows: Office of the Commissioner: Laurie Lenkel, Office of the Ombudsman, Food and Drug Administration, 5600 Fishers Lane, Room 4B44, HF7, Rockville, MD 2085. Telephone: (301) 8273390. Fax: (301) 4808039. E mail: firstname.lastname@example.org. Center for Biologics Evaluation and Research: Sherry Lard Whiteford,
CBER Ombudsman (HFM4), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, MD 208521448. Telephone: (301) 8270379. Email: email@example.com. Center for Drug Evaluation and Research: CDER Ombudsman (HFD1) 5600 Fishers Lane, Room 974, Rockvillle, MD 20857. Telephone: (301) 594 5443 or (301) 8274312. Email: firstname.lastname@example.org. 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. (HFZ5), Rockville, MD 20850. Telephone: (301) 8277991. Fax: (301) 8272565. Email: email@example.com. Center for Veterinary Medicine: Marcia K. Larkins, D.V.M, FDA Center for Veterinary Medicine, Ombudsman, 7519 Standish Place HFV7, Rockville, MD 20855. Telephone: (301) 8274535. Fax: (301) 8273957. E Mail: firstname.lastname@example.org. Center for Medicare and Medicaid Services (CMS)
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 womenowned businesses. This Office maintains company profiles and capability statements for all types of services. Inquiries should be directed to Sharon McKinney, on (410) 7865162, or email may be sent to: email@example.com.
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) 7865130 or email to: firstname.lastname@example.org.
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 departmentwide 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 has established the following resources as contacts for small
businesses experiencing problems pertaining to the regulatory burden aspect of doing business: Phone: (410) 7861002. Email:
Web site. In addition, CMS provides on its allpurpose Web site
http://www.cms.hhs.gov extensive amounts of information about the agency's
programs, organized in terms of the kind of healthservice provider
affected, e.g., hospitals, nursing homes home health agencies, or
durable medical equipment suppliers. This information is not currently
differentiated in terms of the size of these providers' business
entities, but CMS is planning to take steps in the near future to earmark the
information in terms of its applicability to small businesses. 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, servicedisabled veterans, and
Historically Underutilized Business Zone (HUBZone) concerns. Inquires should be sent to Diana Mukitarian, Chief, (301) 4969639,
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:
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;
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 communitybased 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) 4433789.
Key Contact Persons in HRSA Contracts. HRSA ``HCA'' (Head of Contracting Activities) is Dr. Albert F. Marra, who may be reached at (301) 4431433. The HRSA Chief of the Contracts Operations Branch is Mr. Steve Zangwill, who may be contacted at (301) 4435097. Mr. Zangwill is assisted by Mr. Frank Murphy, who leads the negotiated contract team, at (301) 4435165, and Ms. Bonnie Garcia, who heads the simplified acquisitions team at (301) 4435116. The main office number is (301) 4431433.
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: http://www.fedbizopps.gov.
Contractors and vendors are urged to visit that site, as well as the larger HRSA Web site at http://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 1877HRSA123. Contractors may also find fertile opportunities for subcontracting with HRSA grantees.
Department of Health and Human Services Single Point of Contact: Debbie Ridgely, Director, Office of Small and Disadvantaged Business Utilization, Room 360G Humphrey Building, Washington, DC 20201. Telephone: (202) 2600040. Email: SB.PRA@HHS.gov. Homeland Security
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, womenowned 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) 7729792 and email@example.com.
Office of the Private Sector. The Office of the Private Sector has
an email address where small business inquiries could be made, namely
firstname.lastname@example.org. 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) 2828484 and
Department of Homeland Security Single Point of Contact: Ms. Elizabeth Callaway, U.S. Department of Homeland Security, Attn: Private Sector Office, Washington, DC 20528. Telephone: (202) 2828484. Email: Elizabeth.email@example.com. Bureau of Citizenship & Immigration Services (INS)
The paperwork requirement imposed by the Bureau of Citizenship and Immigration Services is the Form I9.
Completion of this onepage 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) 3572099 is available for employers and Live voice assistance for general questions (800) 3575283. Information for efiling can be found at http://www.bcis.gov. Employer Assistance Resources can be found at http://www.bcis.gov under the title ``Information for Employers'', Office of Business Liaison. Requests for speakers and questions can be faxed to (202) 3052523.
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) 3052461.
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 s
FOR FURTHER INFORMATION CONTACT
Keith B. Belton, Office of Information and Regulatory Affairs, Office of Management and Budget, Email: firstname.lastname@example.org, Telephone: (202) 3954815. Inquiries may be submitted by facsimile to (202) 3957285.