The Federal Register - What It Is and How To Use It
Small Manufacturers Assistance(DSMA)
(Center for Devices and Radiological Health)
How To Comment on Proposed Regulations
How To Obtain Agency Documents
How To Obtain FDA Statutes and Regulations
Small Business Representatives
FDA Center Small Business Contacts
How To Obtain Assistance for FDA's Procurement and Contract Activities
List of Frequently Called Numbers
The Food and Drug Administration (FDA) recognizes that dealing with a large organization can frequently be a time consuming, frustrating experience. Although there is no acceptable panacea, FDA has instituted a number of activities aimed at easing this problem for regulated small businesses. These include the establishment of the Division of Small Manufacturers Assistance (DSMA) in the Center for Devices and Radiological Health, Small Business Assistance Programs in the six FDA field offices, and the creation of special units in each of the Centers. These units provide technical assistance to small companies, hold exchange meetings to hear the views and perspectives of small businesses, conduct educational workshops, develop informational materials, and provide an accessible, efficient channel through which small businesses can acquire information from the FDA.
The primary purpose of these activities is to increase our communication with the small business community. This, in turn, opens the door for improved understanding and a better working relationship.
Because FDA regulates a wide range of products - from aspirin to x-ray equipment - we could not tailor this booklet to exactly fit everyone's operation. Instead, we have compiled some basic yet important information about FDA, that, when put to use, will facilitate your interactions with the Agency.
If you want to know about FDA's organization, procedures, policies, and regulations, we suggest that you keep this booklet handy. It contains a lot of good information for firms like yours.
The Federal Register is one of the most important sources for information on what FDA -- or for that matter, what any government agency is doing. Published daily, Monday through Friday, the Federal Register carries all proposed and finalized regulations and many significant legal notices issued by the various agencies, as well as presidential proclamations and executive orders.
Subscriptions to the Federal Register can be purchased from the Superintendent of Documents. For price and order information, call (202) 512-1806 or (202) 512-1530 for online subscriptions. As an alternative, copies can usually be found in local libraries, county courthouses, or federal buildings.
The following are examples of how the Federal Register can be used to keep informed of FDA issues and activities:
ADVANCE NOTICE - Often, FDA will publish "Notices of Intent" in the Federal Register to give you the earliest possible opportunity to participate in its decisions. These notices inform you that FDA is considering an issue and that your views are welcome before a formal proposal is made.
PROPOSED REGULATIONS - When a formal proposal is developed, FDA publishes a "Notice of Proposed Rulemaking" in the Federal Register. The notice also informs you how much time you have to submit written comments about the proposed action. If you do not feel you have enough time to study the proposal and comment on it, you can request, in writing, that Agency officials extend the comment period. If FDA extends the period, a notice of the extension will be published in the Federal Register. Occasionally, a second or third proposal is published in the Federal Register because of the nature of the comments received. Each time a proposal is substantively revised or amended, a notice is published in the Federal Register.
FINAL REGULATIONS - Ultimately, a "Final Rule" is published, and the rule specifies the date when the new regulatory requirements or regulations become effective.
REGULATORY AGENDA - Twice a year -- in April and October - FDA, along with the entire Department of Health and Human Services, publishes an agenda in the Federal Register that summarizes policy-significant regulations, regulations that are likely to have a significant economic impact on small entities, and other actions under development. This agenda will help you identify actions of interest early to plan your participation. Each item listed includes the name, address and telephone number of an Agency official to contact if you need more information.
MEETINGS AND HEARINGS - Notices are published in the Federal Register announcing all meetings of the Agency's advisory committees (see public hearings) and all public meetings that provide an information exchange between FDA and industry, health professionals, consumers, and the scientific and medical communities. The notice contains the date, time and place of the meeting, as well as its agenda. The Federal Register also announces administrative hearings before the Agency and public hearings to gain citizen input into Agency activities (see citizen petition). Information about meetings of advisory committees is also available by calling (1-800) 741-8138.
Before you comment on regulations proposed by FDA, you may obtain more information about a proposal by contacting the person designated in the Federal Register statement. Whether you agree or disagree with the proposed regulations, you will want to communicate your comments in the most effective way possible. The following points will help you do this:
Comments on proposed regulations should always be forwarded to the Dockets Management Branch (HFA-306), Food and Drug Administration, Room l-46 Park Building, 12420 Parklawn Drive, Rockville, MD 20857.
Comments on proposed regulations should always be forwardedto the Dockets Management Branch (HFA-306), Food and DrugAdministration, Room l-46 Park Building, 12420 Parklawn Drive,Rockville, MD 20857.
FDA's policy is to make the fullest possible disclosure of records to the public, provided that disclosure is consistent with the rights of individuals to privacy and property (e.g., trade secret and confidential commercial information). When releasing records, the Agency must also consider the need to pursue internal policy deliberations and regulatory activities without disruption.
Under the Freedom of Information Act (FOIA), FDA is required to make available to the public all documents in its possession, with the possible exception of the following:
FDA regulations specifically exempt from disclosure the following categories of information: most safety and efficacy data; manufacturing methods; production, sales or distribution data; quantitative or semiquantitative formulas; and data on design or construction of products.
Address all requests for FDA records to the following:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
Room 12A-16
5600 Fishers Lane
Rockville, MD 20857
Phone: (30l) 827-6500.
Or send requests via facsimile to:
(30l) 443-l726, facsimile operator (30l) 443-2706.
In your request, describe the information needed as accurately and fully as possible, so that it can be easily located. You need not explain why you are requesting the information.
When requesting information from FDA, keep in mind these points:
The Freedom of Information Act pertains only to existing records. It is not a research service to compile information that cannot be readily identified. A request for specific information that is releasable to the public can be processed much more expeditiously than a request for "all information" on a particular subject. This is because "all information" may include information exempt from public disclosure, such as trade secrets, commercial or confidential information, that is not releasable and would, therefore, be subject to a denial. A full discussion of FDA's FOIA policies and procedures can be found in 21 CFR, Part 20.1 - 20.119.
There are a wide variety of documents that would be very helpful to you, such as FDA's Regulatory Procedures Manual or Compliance Policy Guides. If you would like a list of the available documents, write to the FOI staff.
There are many FDA pamphlets and informational materials that are available without going through an FOIA request. They may be obtained by contacting an FDA Small Business Representative (SBR) or a Center small business contact person (see who to contact for assistance).
Among the statutes enforced by FDA are: the Federal Food, Drug, and Cosmetic Act, as Amended; sections of the Public Health Service Act pertaining to biological products; the Radiation Control for Health and Education Act; the Safe Medical Devices Act; the Mammography Quality Standards Act; the Fair Packaging and Labeling Act; the Infant Formula Act; the Nutrition Labeling and Education Act; and the Dietary Supplement Health and Education Act. These are compiled in one booklet, "Federal Food, Drug, and Cosmetic Act as Amended and Related Laws," which is available from the Superintendent of Documents.
The regulations over which FDA has jurisdiction are codified under Title 21, Code of Federal Regulations (CFR). These are updated on April 1 of each year and are available for sale approximately four months later. Nine volumes are applicable to FDA and may be purchased singly or as a set from the Superintendent of Documents. The contents of each volume are listed below:
"Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration" is an easy-to-read booklet summarizing FDA requirements. Single copies are available at no charge by writing to: Office of Consumer Affairs (HFE-88), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Anyone may request or petition FDA to change or create an Agency policy or regulation under 21 CFR Part 10.30. If you believe this type of action is necessary, direct your request to FDA's Dockets Management Branch. When submitting a petition, keep these points in mind:
(Date) _______________________________________
Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, Room 1-46 Park Building, 12420 Parklawn Drive, Rockville, MD 20857.
CITIZEN PETITION
The undersigned submits this petition under _______________________ (relevant statutory sections, if known) of the ____________________ Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs (under 21 CFR, Part 5.10) to request the Commissioner of Food and Drugs to __________________(issue, amend, or revoke a regulation or order to take or refrain from taking any other form of administrative action).
A. ACTION REQUESTED
C. ENVIRONMENTAL IMPACT STATEMENT
Give an environmental impact analysis report in the form specified in 21 CFR,
Part 25.1(g), except for the types of actions specified in 21 CFR, Part 25.1(d).
D. ECONOMIC IMPACT STATEMENT
The following information is to be submitted only when requested by the Commissioner
following review of the petition: a statement of the effect of the requested
action on 1) cost (and price) increases to industry, government, and consumers;
2) productivity of wage earners, businesses, or government; 3) competition;
4) supplies of important materials, products, or services; 5) employment; and
6) energy supply or demand.
The undersigned certifies that, to the best of his/her knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
___________________________ ________________________________
(Signature) Name of Petitioner_______________________________
(Mailing Address)_______________________________
(Phone)
In addition to commenting on Federal Register documents and petitioning the Agency, there are a number of ways that can interact with FDA to make your viewpoint known. Here are a few examples:
Public Meetings or Conferences
FDA uses public meetings and conferences to discuss significant issues with the public. The Agency may schedule public meetings, sometimes referred to as "exchange meetings," before developing a proposal, or after proposing a program change. The meetings offer a chance for you and FDA managers to discuss issues informally before the rulemaking process begins. FDA announces meetings in the Federal Register and trade publications.
Industry Information/Education Meetings
Many meetings and workshops are conducted in which key representatives from industry, government, academia, and professional, consumer, ethnic, and patient groups discuss subjects of vital concern to industry and the FDA.
Public Hearings
A hearing is an opportunity for you to take part in a rule-making proceeding. FDA always announces hearings in the Federal Register and usually in other publications (e.g., industry newsletters) related to the topic of the hearing. Depending on the subject of the hearing, you can testify on specific issues that are included in an Agency proposal, or you can present your views about general issues on Agency programs. At all hearings, your testimony, whether it is presented orally or in writing, will become part of an official record of evidence which will help the Agency make policy decisions.
Public Advisory Committees and Panels
FDA routinely looks for qualified people to serve on a variety of public advisory committees and panels. Many of the Agency's committees and panels include two non-voting members representing consumer and industry interests. FDA requests nominations for these members through announcements in the Federal Register. The committees generally study current scientific work and make recommendations to the Agency on product approvals, regulations, and other actions. Membership on most committees requires a scientific background. A free copy of "FDA Public Advisory Groups," or further information about FDA advisory committees, can be obtained by contacting the Office of Committee Management (HFA-306), Food and Drug Administration, Room 3l0 Park Building, 12420 Parklawn Drive, Rockville, MD 20857; (301)443-2765 or fax (301) 443-8811. For current information or information updates on FDA advisory committee meetings, call the hotline by dialing (1-800) 741-8138 or (301) 443-0572, and the five digit number assigned to each advisory committee. This number will appear in each notice of meeting.
FDA must give the manufacturer, distributor or importer permission to market certain products before they can be sold in interstate commerce. For example:
In addition, although some products, such as cosmetics and some radiation-emitting items, do not need premarket approval from FDA, there are regulatory standards and regulations applicable to their manufacture and labeling that fall under FDA's jurisdiction. Therefore, to avoid unnecessary delay in bringing new products to market, it would be helpful to talk with an FDA product specialist early in your planning. (See Contacts for the most appropriate contact.)
Handling an FDA Inspection
FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present his/her credentials and "Notice of Inspection" upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions.
Usually, he/she will examine your production process, look at certain records and collect samples. At the conclusion of the inspection, the investigator will discuss with your firm's management his/her findings and concerns; however, he/she will not usually recommend specific corrective measures. He/she will leave with your management a written report of any conditions or practices which, in his/her judgment, indicate objectionable conditions or practices. This list of "Inspectional Observations," also called an FDA-483, can be used by your firm's management as a guide for corrective action. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.
If, for any reason, you do not agree with the findings of the FDA investigator, or are confused about what actions should be taken, you should contact the Director of Investigations Branch in the nearest FDA field office to resolve your concerns. If FDA takes regulatory action against your firm, the FDA Small Business Representatives are not available for guidance, since their activities are nonregulatory in nature. You can, however, contact a Compliance Officer for advice (see regions).
Recalling Violative Products
A recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which FDA would initiate legal action; e.g., seizure.
During a recall, a firm can expect to work more closely with FDA than under almost any other circumstance. In fact, the first step, when a product must be recalled, is for the manufacturer or distributor to call the nearest FDA field office and talk with the recall coordinator.
FDA's main concerns during a recall are that the firm has determined the location of the product and organized the prompt removal from commerce of any suspect lots. FDA will then work with the firm to identify the cause of the problem and the corrections needed to prevent a recurrence.
Essentially, the procedures for a product recall are determined by the individual company; however, a proper recall system will include provisions for record-keeping, handling product returns, liaison with FDA, and public information. The efficiency of tracking and removing a product depends on how well records have been maintained throughout the production and distribution process.
Knowing who to contact is the first step in obtaining information you need. It may be helpful to keep in mind that FDA has five centers and 21 district offices. Reaching the right office and, more importantly, the right person who has the information you need, can sometimes be frustrating. This list of contacts should help guide you in the right direction.
Whether you need information related to getting your product approved and on the market, or just need copies of FDA regulations, there are a number of sources to which you can go for general assistance:
Small Business Representatives (SBRs) - FDA has Small Business Representatives who exclusively help small businesses whose products are regulated by FDA. They are located in six regions of the country: New York, Philadelphia, Atlanta, Chicago, Dallas, and Oakland. These individuals are expressly available to deal with the special concerns of small firms. They provide information that clarifies how Agency laws and regulations apply to specific circumstances and suggest methods of meeting these requirements. The SBRs can respond to your inquiries, conduct or participate in workshops and conferences, or visit your plant, at your request, to offer assistance.
Small Business Representative (HFR-NEl7) Herman Janiger FDA, Northeast Region (CT, MA, ME, NH, NY, RI, VT) 158-15 Liberty Avenue Jamaica, NY 11433-1034 (718) 662-5618 fax (718) 662-5434 Email:hjaniger@ora.fda.gov Small Business Representative (HFR-MA17) Marie T. Falcone FDA, Mid-Atlantic Region (DC, DE, IL, IN, KY, MD, MI, MN, ND, NJ, OH, PA, SD, VA, WI, WV) U.S. Customhouse 2nd and Chestnut Sts., Room 900 Philadelphia, PA 19106 (215) 597-2120, ext. 4003 fax (215) 597-5798 Email:mfalcone@ora.fda.gov Small Business Representative (HFR-SE17) Vacant FDA, Southeast Region (AL, FL, GA, LA, MS, NC, PR, SC, TN, VI) 60 Eighth St. NE Atlanta, GA 30309 (404) 253-2238 fax (404) 253-1207 Email:orasesbr@ora.fda.gov Small Business Representative, (HFR-SW17) David Arvelo FDA, Southwest Region (AR, CO, IA, KS, MO, NE, NM, OK, TX, UT, WY) 7920 Elmbrook Dr., Suite 102 Dallas, TX 75247 (214) 655-8100 ext. 133 fax (214) 655-8114 Email:oraswrsbr@ora.fda.gov Small Business Representative, (HFR-PA17) Marcia Madrigal FDA, Pacific Region (AK, AZ, CA, HI, ID, MT, NV, OR, WA) Oakland Federal Building 1301 Clay Street, Suite 1180N Oakland, CA 94612 (510) 637-3980 fax (510) 637-3977 Email:mmadriga@ora.fda.gov
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Northeast Region
New York Field Office: (Regional Office)
850 3rd Ave. Diana J. Kolaitis
Brooklyn, NY 11232 Regional Director
Phone - (718) 340-7000
Ext. 54l6
fax - (718) 340-7037
New England District:
One Montvale Ave. John R. Marzilli
Stoneham, MA 02180 District Director
Phone - (78l) 279-l675
Ext. l55
fax - (78l) 279-l742
Buffalo District:
300 Pearl Street, Suite l00 Brenda J. Holman
Buffalo, N.Y. 14202 District Director
Phone - (716) 55l-446l
Ext. 3l03
fax - (716) 55l-4470
New York District Office:
850 3rd Ave. Brenda J. Holman
Brooklyn, N.Y. 11232 District Director
Phone - (7l8) 340 -7000
Ext. 530l
fax - (718) 340-7057
Central Region
Philadelphia Field Office (Regional Office)
U.S. Customhouse Susan M. Setterberg
2nd and Chestnut Sts. Regional Director
Room 900
Philadelphia, PA 19106
Phone - (2l5) 597-8058
fax - (215) 597-5798
Baltimore District:
Elaine K. Cole
900 Madison Ave. District Director
Baltimore, MD 21201
Phone - (410) 962-4012
fax - (410) 962-0044
Cincinnati District:
1141 Central Pkwy. Henry Fielden
Cincinnati, OH 45202-1097 Acting District Director
Phone - (513) 684-3504
fax - (513) 684-2905
New Jersey District:
Waterview Corporate Center Douglas I. Ellsworth
10 Waterview Blvd., 3rd Floor District Director
Parsippany, NJ 07054
Phone - (973) 33l-290l
fax - (973) 331-2969
Philadelphia District:
U.S. Customhouse Charlie Thorne
2nd and Chestnut Sts. Acting District Director
Room 900
Philadelphia, PA 19106
Phone - (215) 597-4390
Ext. 4200
fax - (215) 597-6649
Central Region
Chicago Field Office (Regional Office)
20 North Michigan Ave. Susan M. Setterberg
Room 550 Regional Director
Chicago, IL 60602
Phone - (312) 353-9400
Ext. 20
fax - (312) 886-1682
Chicago District:
300 S. Riverside Plaza, 5th Floor
Suite 550 South Raymond V. Mlecko
Chicago, IL 60606 District Director
Phone - (312) 353-7379
Ext. 189
fax - (312) 886-3280
Detroit District:
1560 E. Jefferson Ave. Raymond V. Mlecko
Detroit, MI 48207-3l79 Acting District Director
Phone - (313) 226-6260
Ext. l0l
fax - (313) 226-3076
Minneapolis District:
240 Hennepin Ave. James A. Rahto
Minneapolis, MN 55401-l9l2 District Director
Phone - (612) 334-4100
Ext. l2l
fax - (612) 334-4134
Southeast Region
Atlanta Field Office (Regional Office)
60 Eighth St. N.E. John H. Turner
Atlanta, GA 30309 Regional Director
Phone - (404) 347-4266
fax - (404) 347-4349
Nashville District:
297 Plus Park Blvd. Raymond K. Hedblad
Nashville, TN 37217 District Director
Phone - (615) 781-5392
Ext. 128
fax - (615) 781-5383
New Orleans District:
4298 Elysian Fields Ave. James D. Gamet
New Orleans, LA 70122 District Director
Phone - (504) 589-2401
fax - (504) 589-6360
Florida District:
555 Winderly Place. Douglas D. Tolen
Suite 200 District Director
Maitland, FL 3275l
Phone - (407) 475-470l
fax - (407) 475-4769
San Juan District:
466 Fernandez Juncos Ave. Samuel Jones
San Juan, PR 00901-3223 District Director
Phone - (787) 729-6842
fax - (787) 729-6809
Southwest Region
Dallas Field Office (Regional Office)
7920 Elmbrook Rd. Edward R. Esparza
Suite l02 Regional Director
Dallas, TX 75247-4982
Phone - (214) 655-8100
Ext. ll4
fax - (214) 655-8130
Dallas District:
33l0 Live Oak . Joseph R. Baca
Dallas, TX 75204 District Director
Phone - (214) 655-5315
fax - (214) 655-5331
Denver District:
6th and Kipling Sts. Gary C. Dean
Bldg. 20, Entrance W-l0 District Director
Denver Federal Center
(P.O. Box 25087)
Denver, CO 80225-0087
Phone - (303) 236-3017
fax - (303) 236-3099
Kansas District:
11630 West 80th St. Michael W. Rogers
Lenexa, KS 66214-3338 District Director
Phone - (913) 752-2144
fax - (913) 752-2136
St. Louis Branch:
l2 Sunnen Drive Charles Breen
Suite l22 Branch Director
St. Louis, Mo. 63l43-3800
Phone - (314) 645-ll67
Fax - (3l4) 645-2969
Pacific Region
San Francisco Field Office (Regional Office)
Oakland Federal Building Richard A. Baldwin
13301 Clay St. Suite 1180 Regional Director
Oakland, CA 94512-5217
Phone - (510) 637-3960
Ext. l8
fax - (510) 637-3976
Los Angeles District:
l43l Harbor Bay Parkway Elaine C. Messa
Alameda, CA 94502-7070 District Director
Phone - (5l0) 337-6730
fax - (5l0) 337-6859
Seattle District:
22201 23rd Dr. S.E. Roger L. Lowell
(P.O. Box 3012) District Director
Bothell, WA 98041-3012
Phone - (206) 483-4950
fax - (206) 483-4996
San Francisco District:
1431 Harbor Bay Parkway Patricia C. Ziobro
Alameda, CA 94502-7070 District Director
Phone - (510) 337-6730
fax - (510) 337-6859
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Center Small Business Contact Person - When you have an inquiry that requires highly specialized assistance, such as information to be submitted in a new drug application, or if you are requesting a meeting with someone in headquarters, you may save time by directly calling the small business contact person in the appropriate center. These people listed below can also send you a wide variety of informational materials or audiovisuals:
Center for Drug Evaluation and Research
Human Prescriptions and Over-the-Counter Drugs
Office of Training and Communication (HFD-008)
Metro Park North I
7520 Standish Place-Room 151
Rockville, MD 20855
Phone - (301) 594-1012
fax - (301) 594-3302
fax-on-demand - (1-800) 342-2722 or (301) 827-0577
Center for Biologics Evaluation and Research
Lorrie Harrison, Team Leader
Manufacturers Assistance and Technical Training (HFM-42)
Suite 200N
1401 Rockville Pike
Rockville, MD 20852-1448
Phone - (301) 827-2000
Voice Information System - (30l) 827-l800 (1-800-835-4709)
Office fax - (30l) 827-3843
Center for Food Safety and Applied Nutrition
John M. Tisler, Director
Industry Activities Staff (HFS-565)
Room 5425 FOB-8
200 C St., S.W.
Washington, DC 20204
Phone - (202) 205-5251
fax - (202) 205-4450
Center for Devices and Radiological Health
John F. Stigi, Director
Division of Small Manufacturers Assistance (HFZ-220)
Room 130C
1350 Piccard Dr.
Rockville, MD 20850
Phone - (1-800) 638-2041
fax - (301) 443-8818
Center for Veterinary Medicine
Joanne M. Kla
Communication and Education Branch (HFV-l2)
Room N428 Metro Park North #2
7500 Standish Place
Rockville, MD 20855
Phone - (301) 827-6507
fax - (301) 594-4512
In addition, the Division of Small Manufacturers Assistance (DSMA), established in the Center for Devices and Radiological Health, provides technical and other non-financial assistance to small medical device manufacturers. While located in headquarters, DSMA personnel routinely provide field assistance to firms by conducting workshops and, at the request of the manufacturer, by making onsite visits.
FDA has a special program that helps small companies participate in the Agency's procurement and contract activities. The program's goal is to seek out and encourage small companies to provide the Agency with needed supplies and services.
Procurement activities include the purchase of scientific and laboratory equipment such as chemicals, glassware, furniture, electronic components, various species of laboratory animals, animal feed, bedding, holding cages, and other related supplies.
The Agency also solicits proposals and awards contracts for research, surveys and studies in the areas of management, construction/renovation, science, and medicine.
The Agency has a Small and Disadvantaged Business Utilization Specialist who is available to assist and counsel small companies in capturing the Agency's procurement and contract dollars. Small companies that are interested in obtaining more information about the Agency's procurement and contract activities may direct their inquiries to:
Small and Disadvantaged Business Utilization Specialist
Food and Drug Administration
Division of Contracts and Grants Management
Policy and Evaluation Branch (HFA-505)
12420 Parklawn Drive
Rockville, MD 20857
(301) 443-2525
OFFICE OF EXTERNAL AFFAIRS
CONSUMER INQUIRIES (301) 443-3170 INDUSTRY AND SMALL BUSINESS LIAISON TEAM (301) 827-3430Fax-on-Demand under:
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
Fax-on-Demand (Documents via fax) (locally) (301) 827-3844 or connect to the fax system toll free - l-888-223-7329
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DIVISION OF SMALL MANUFACTURERS ASSISTANCE (301) 443-6597 OR TOLLFREE (1-800) 638-2041 CDRH FACTS-ON-DEMAND (Documents via fax) (1-800) 899-0381 ELECTRONIC DOCKET (Documents via computer (1-800) 252-1366 modem)
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRAINING AND COMMUNICATION (301) 827-4573 OR FAX (301) 827-4577 FAX-ON-DEMAND (Documents via fax) (1-800) 342-2722 OR (301) 827-0577
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
SEAFOOD HOTLINE (l-800) FDA-4010 OR LOCAL (202) 205-43l4
NATIONAL INSTITUTES OF HEALTH
SMALL BUSINESS INSTITUTES PROGRAM (301) 435-0715 (For information about grants involving FDA regulated products)
SMALL BUSINESS ADMINISTRATION
409 3rd Street S.W. Washington, D.C. 20416 Small Business Answer Desk (1-800) 827-5722 OR Wash. D.C. area (202) 606-4000
SUPERINTENDENT OF DOCUMENTS
Mail to: New Orders Superintendent of Documents P.O. Box 37l954 Pittsburgh, PA l5250-7954 (202) 512-1806 for on-line subscriptions (202) 512-1530
World Wide Web (WWW) FDA Home Page can be reached at the Uniform Resource Locator: http://www.fda.gov/ (with hypertext links to information about various FDA responsibilities: foods, human drugs, animal drugs, biologics, cosmetics, medical devices and radiological health, toxicology, and FDA news). FDA is placing the documents that the public most frequently requests on the WWW site to give users more immediate access.
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Web page updated by jch 2001-OCT-30