Law Library

Small Business Guide to FDA

TABLE OF CONTENTS

Introduction

The Federal Register - What It Is and How To Use It

Federal Register Reader Aids

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

How To Petition the FDA,
Petition Content and Format

How To Participate in Agency Decision-Making
Public Meetings, Industry Information/Education Meetings, Public Hearings, Public Advisory Committees and Panels

What To Do When
Marketing a New Product, Handling an FDA
Inspection, Recalling Violative Products

Who To Contact for Assistance

Small Business Representatives

FDA District Offices

FDA Center Small Business Contacts

How To Obtain Assistance for FDA's Procurement and Contract Activities

List of Frequently Called Numbers

Introduction

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.

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The Federal Register - What It Is and How To Use It

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 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 . Information about meetings of advisory committees is also available by calling (1-800) 741-8138.

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How to Comment on Proposed Regulations

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:

  • Give the title, date of publication, and docket number for the proposal.

  • State who you are and how the proposal affects you. (Economic costs and back-up data are more compelling than generalities.)

  • Give supporting statements for your position and present new data and scientific findings, if possible.

  • Whether you agree or disagree, you may suggest alternatives to the proposal or to requirements that are part of the proposal.

  • The more substantive your comments, the more weight they will carry. The same thing is true for petitions (see petition content and format). When FDA considers comments from the public, it's not a simple matter of counting up "for" or "against" options.

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.

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Federal Register Reader Aids

How to Comment On Proposed Regulations

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:

  • Give the title, date of publication, and docket number for the proposal.

  • State who you are and how the proposal affects you. (Economic costs and back-up data are more compelling than generalities.)

  • Give supporting statements for your position and present new data and scientific findings, if possible.

  • Whether you agree or disagree, you may suggest alternatives to the proposal or to requirements that are part of the proposal.

  • The more substantive your comments, the more weight they will carry. The same thing is true for petitions. When FDA considers comments from the public, it's not a simple matter of counting up "for" or "against" options.

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.

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Small Manufacturers Assistance (DSMA)

Need Help with Medical Device Regulations?

The Division of Small Manufacturers Assistance (DSMA) was mandated by the 1976 medical device legislation to provide technical assistance and regulatory guidance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices. DSMA is located in the Center for Devices and Radiological Health (CDRH) within FDA. Additional information is available from the Small Business Guide to FDA page.

For information relating to the Current Good Manufacturing Practice (CGMP) requirements and Quality Systems, including the regulation [docket 90N-0172] that published October 7, 1996 please refer to the Good Manufacturing Practice (GMP) Quality System Regulation Information page.

For information relating to Human Factors, including the guidance "Do It By Design" please refer to Human Factors Activities on the Human Factors Program page.

How may we assist you?

DSMA is a free source of information & advice on the following:

  • Establishment Registration (Form 2891)
  • Device Listing (Form 2892)
  • Device Classification, i.e., Class I, Class II, and Class III Medical Devices & Medical Device Exemptions
  • Premarket Notification [510(k)]
  • Premarket Approval (PMA)
  • Investigational Device Exemption (IDE)
  • Good Manufacturing Practices (GMP)
  • Standards, Policies, & Procedures
  • Regulations, Interpretations, & Petitions
  • Radiation-Emitting Devices
  • Post Marketing Requirements
  • Medical Device Reporting (MDR)
  • Third Party Review

DSMA services include:
  • Answering Requests for Information
  • Conducting/Participating; Workshops on Medical Device Regulations
  • Conducting/Participating; Workshops on GMP Requirements
  • Distributing FDA/CDRH Publications and Guidance Documents by;
    1. World Wide Web (Internet)
    2. CDRH Facts-On-Demand (Automated Fax System)
    3. Electronic Docket (Computer Bulletin Board)
    4. U.S. Mail
  • Acting as Spokesperson for Small Device Firms

Obtaining Information

Manufacturers and others who are interested in the regulatory requirements for marketing medical devices and radiation-emitting electronic products can quickly obtain the latest information on operating policies and procedures through the CDRH Home Page, CDRH Electronic Docket or from CDRH Facts-On-Demand.

Documents Previously Located on CDRH Electronic Docket
CDRH Facts-On-Demand

Questions?

If you have questions concerning the process of getting medical devices to market, Premarket Notification [510(k)], Investigational Device Exemption (IDE), Premarket Approval (PMA) Applications, Establishment Registration (Form 2891), Device Listing (Form 2892), Exporting Medical Devices, Importing Medical Devices, or Good Manufacturing Practices (GMP), send your questions to: DSMA Inquiries. Please include your Email address, telephone number and fax number in case we have difficulty responding by return Email.

Contacting DSMA

The DSMA office is open Monday through Friday from 8:00 AM to 5:00 PM Eastern Standard Time.

DSMA Mailing Address is:

CDRH/OHIP/DSMA (HFZ-220)
1350 Piccard Drive
Rockville, MD 20850-4307 USA

DSMA Fax Number: 301.443.8818

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How to Comment On Proposed Regulations

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:

  • Give the title, date of publication, and docket number for the proposal.

  • State who you are and how the proposal affects you. (Economic costs and back-up data are more compelling than generalities.)

  • Give supporting statements for your position and present new data and scientific findings, if possible.

  • Whether you agree or disagree, you may suggest alternatives to the proposal or to requirements that are part of the proposal.

  • The more substantive your comments, the more weight they will carry. The same thing is true for petitions. When FDA considers comments from the public, it's not a simple matter of counting up "for" or "against" options.

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.

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How to Obtain Agency Documents

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:

  • documents relating solely to internal personnel rules and practices

  • trade secrets and confidential commercial or financial information

  • certain interagency and intraagency memoranda containing opinions and recommendations prepared to assist in Agency decision-making

  • personnel, medical, and similar files, the disclosure of which would be a clearly unwarranted invasion of personal privacy

  • investigatory records compiled for enforcement purposes when disclosure would interfere with enforcement procedures

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) 443-63l0.

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:

  • Within 10 working days after receipt of an FOIA request, FDA must determine whether to comply with such a request. The Agency may grant itself a l0-day extension in "unusual circumstances." The Agency is required to give written notice of such an extension.

  • FDA charges uniform fees for searches and copying. By law, these fees may not exceed the actual costs. FDA may waive these fees if disclosure of the information will primarily serve the general public, and not benefit an individual or business. Your letter must specifically request such a waiver and say why you believe you are entitled to it.

  • If FDA denies your request for records (less than two percent of requests are denied), it must tell you the specific reason(s) for the denial and advise you of your right to appeal. Names and addresses of those respon- sible for the denial must be disclosed to you.

  • If you receive a denial letter, you may send a letter of appeal to the Assistant Secretary for Health, Department of Health and Human Services. File your appeal within 30 days after notification of the denial. Send the appeal letter by certified mail, return receipt requested, to have proof of the timeliness of your appeal.

  • The Assistant Secretary for Health has 20 working days after receipt to respond. If FDA did not take a 10-day extension the first time, the Department may do so now. Should your appeal be denied, you are entitled to judicial review.

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).

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How to Obtain FDA Statutes and Regulations

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:

  • Parts 1 to 99. General regulations for the enforcement of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Color additives.

  • Parts 100 to 169. Food standards, good manufacturing practice for foods, low-acid canned foods, acidified foods, and food labeling.

  • Parts 170 to 199. Food additives.

  • Parts 200 to 299. General regulations for drugs.

  • Parts 300 to 499. Drugs for human use.

  • Parts 500 to 599. Animal drugs, feeds, and related products.

  • Parts 600 to 799. Biologics and cosmetics.

  • Parts 800 to 1299. Medical devices and radiological health. Regulations under the Federal Import Milk Act, the Federal Tea Importation Act, the Federal Caustic Poison Act, and for control of communicable diseases and interstate conveyance sanitation.

  • Parts 1300 through end. Drug Enforcement Administration regulations and requirements.

"REQUIREMENTS OF LAWS AND REGULATIONS ENFORCED BY THE U.S. FOOD AND DRUG ADMINISTRATION"

"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.

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How to Petition the FDA

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:

  • Clearly state what problem you think the Agency needs to address.

  • Propose specifically what the Agency's action should be. Your proposal should be based on sound, supportable facts.

  • Submit the petition, an original and three copies, unless otherwise stipulated in the Federal Register announcement, to the Food and Drug Administration, Dockets Management Branch (HFA-305), Room 1-46 Park Building, 12420 Parklawn Drive, Rockville, MD 20857.

FDA carefully considers every petition and must respond within 180 days by either approving or denying it, or providing a tentative response indicating why FDA has been unable to reach a decision. If FDA approves the petition, it may be published in the Federal Register. Your petition could eventually be incorporated into Agency policy. An example showing how to prepare a citizen's petition follows:

Petition Content and Format

(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

  1. . If the petition requests the Commissioner to issue, amend or revoke a regulation, give the exact wording of the existing regulation (if any) and the proposed regulation or amendment requested.

  2. . If the petition requests the Commissioner to issue, amend or revoke an order, include a copy of the exact wording of the citation to the existing order (if any) and the exact wording requested for the proposed order.

  3. . If the petition requests the Commissioner to take or refrain from taking any other form of administrative action, state the specific action or relief requested.

B. STATEMENT OF GROUNDS
Include a well organized statement of the factual and legal grounds upon which the petition is based. Opposing views known to the petitioner should be presented.

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)

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How to Participate in Agency Decision-Making

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.

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What to do When . . .

Marketing a New Product

FDA must give the manufacturer, distributor or importer permission to market certain products before they can be sold in interstate commerce. For example:

  • New human and veterinary drugs and certain medical devices must be approved for safety and effectiveness, and their labeling reviewed for accuracy and thoroughness.

  • Substances added to food must meet the requirements of the food additive regulations that are based on FDA's review of scientific data of safety and utility that have been submitted to FDA.

  • Manufacturers of low-acid canned foods packaged in air- tight bottles, plastic bags, and cans and acidified foods must register with FDA and submit detailed information about heat-treatments to destroy bacteria (and acidification, if necessary to prevent growth of bacterial spores).

  • Specific premarket controls apply to biological products which have been required to be licensed under Federal law.

Marketing these kinds of products or conducting experimental investigations with them in human clinical trials, requires that one or more applications be filed with FDA and that certain procedures be followed.

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.

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.

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.

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Who to Contact for Assistance

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.

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Small Business Representatives (SBRs)

FDA, Northeast Region
Small Business Representative (HFR-NEl7) George R. Walden
850 Third Ave.
Brooklyn NY 11232
(718) 965-5300 ext. 5528
fax (718) 965-5759

FDA, Mid-Atlantic Region
Small Business Representative (HFR-MA17) Joseph X. Phillips
900 U.S. Customhouse
2nd & Chestnut St.
Philadelphia, PA 19106
(215) 597-0537
fax (215) 597-6649

FDA, Southeast Region
Small Business Representative (HFR-SE17) Barbara Ward-Groves
60 Eight St. NE
Atlanta, GA 30309
(404) 347-4001 Ext 5256
fax (404) 347-4349

FDA, Midwest Region
Small Business Representative, (HFR-MW17) Joe L. Petty
20 N. Michigan Ave., Rm 510
Chicago, IL 60602
(312) 353-9400 ext. 23
fax (312) 886-1682

FDA, Southwest Region
Small Business Representative, (HFR-SW17) Marie T. Falcone
7920 Elmbrook Dr., Suite 102
Dallas, TX 75247-4982
(214) 655-8100 ext. 128
fax (214) 655-8130

FDA, Pacific Region
Small Business Representative, (HFR-PA17) Mark S. Roh
Oakland Federal Building
1301 Clay Street, Suite 1180-N
Oakland, CA 94612-5217
(510) 637-3980
fax (510) 637-3977

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Regions and Districts
Food and Drug Administration

Northeast Region

New York Field Office: (Regional Office)

850 3rd Ave. VACANT
Brooklyn, NY 11232 Regional Director
Phone - (718) 965-5416
fax - (718) 965-5759


Boston District:

One Montvale Ave. James A. Rahto
Stoneham, MA 02180 District Director
Phone - (617) 279-1726
fax - (617) 279-1742

Buffalo District:
599 Delaware Ave. E. Pitt Smith
Buffalo, N.Y. 14202 District Director
Phone - (716) 846-4478
fax - (716) 846-4470

New York District Office:

850 3rd Ave. Edward T. Warner
Brooklyn, N.Y. 11232 District Director
Phone - (718) 965-5301
fax - (718) 965-5117

Mid-Atlantic Region

Philadelphia Field Office (Regional Office)

U.S. Customhouse Susan Setterberg
2nd and Chestnut Sts. Regional Director
Room 900
Philadelphia, PA 19106
Phone - (2l5) 597-8058
fax - (215) 597-6649
Baltimore District:
900 Madison Ave. Kenneth Shelin
Baltimore, MD 21201 District Director
Phone - (410) 962-4012
fax - (410) 962-0044

Cincinnati District:
1141 Central Pkwy. John R. Marzilli
Cincinnati, OH 45202-1097 District Director
Phone - (513) 684-3504
fax - (513) 684-2905

New Jersey District:
Waterview Corporate Center Matthew H. Lewis
10 Waterview Blvd., 3rd Floor District Director
Parsippany, NJ 07054
Phone - (201) 331-2900
fax - (201) 331-2969

Philadelphia District:
U.S. Customhouse Diana J. Koliatis
2nd and Chestnut Sts. District Director
Room 900
Philadelphia, PA 19106
Phone - (215) 597-3708
fax - (215) 597-6649

Southeast Region
Atlanta Field Office (Regional Office)

60 Eighth St. N.E. John Turner
Atlanta, GA 30309 Regional Director
Phone - (404) 347-4266
fax - (404) 347-4349

Atlanta District:
60 Eighth St. N.E.Ballard Graham
Atlanta, GA 30309District Office
Phone - (404) 347-4344
fax - (404) 347-1912

Nashville District:

297 Plus Park Blvd. Raymond K. Hedblad
Nashville, TN 37217 District Director
Phone - (615) 781-5392
fax - (615) 781-5383

New Orleans District:

4298 Elysian Fields Ave. James T. Gamet
New Orleans, LA 70122 District Director
Phone - (504) 589-2401
fax - (504) 589-6541

Florida District:

7200 Lake Ellenor Dr. Douglas Tolen
Suite 120 District Director
Orlando, FL 32809
Phone - (407) 648-6996
fax - (407) 648-6881

San Juan District:

466 Fernandez Juncos Ave. Samuel Jones
San Juan, PR 00901-3223 District Director
Phone - (809) 729-6842
fax - (809) 729-6809

Mid-West Region
Chicago Field Office (Regional Office)

20 North Michigan Ave. VACANT
Room 550 Regional Director
Chicago, IL 60602
Phone - (312) 353-9400
fax - (312) 886-1682

Chicago District:

300 S. Riverside Plaza, 5th Floor
Suite 550 South Raymond Mlecko
Chicago, IL 60606D istrict Director
Phone - (312) 353-7379
fax - (312) 886-3280

Detroit District:

1560 E. Jefferson Ave. Brenda Holman
Detroit, MI 48207District Director
Phone - (313) 226-6260
fax - (313) 226-3076

Minneapolis District:

240 Hennepin Ave.John Feldman
Minneapolis, MN 55401 District Director
Phone - (612) 334-4102
fax - (612) 334-4134


Southwest Region

Dallas Field Office (Regional Office)

7920 Elmbrook Rd.Edward Esparza
Dallas, TX 75247-4982 Acting Regional Director
Phone - (214) 655-8100
fax - (214) 655-8130


Dallas District:

3032 Bryan St. Linda M. Collins, Acting
Dallas, TX 75204District Director
Phone - (214) 655-5315
fax - (214) 655-5331


Denver District:

6th and Kipling Sts. Meredith Grahn, Acting
(P.O. Box 25087) District Director
Denver, CO 80225-0087
Phone - (303) 236-3017
fax - (303) 236-3099


Kansas District:

11630 West 80th St. Michael W. Rogers
Lenexa, KS 66214District Director
Phone - (913) 752-2144
fax - (913) 752-2136



St. Louis Branch:

808 North CollinsCharles Breen
Lacledes Landing Branch Director
St. Louis, MO 63102
Phone - (314) 425-4137
fax - (314) 425-5596


Pacific Region

Francisco Field Office (Regional Office)

Oakland Federal Building Ronald M. Johnson
1301 Clay St. Suite 1180-N Regional Director
Oakland, CA 94612-5217
Phone - (510) 637-3960
fax - (510) 637-3976

Angeles District:

19900 MacArthur Blvd. Elaine C. Messa
Irvine, CA 92715District Director
Phone - (714) 798-7600
fax - (714) 798-7715


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


Francisco District:

1431 Harbor Bay Parkway Patricia C. Ziobro
Alameda, CA 94502-7070 District Director
Phone - (510) 337-6730
fax - (510) 337-6701

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FDA Center Small Business Contacts

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:

Small Business Representatives for the Centers Food and Drug Administration

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
Margaret A. Tart, Director
Manufacturers Assistance & Communications Staff (HFM-42)
Suite 600 Rockwall I
1401 Rockville Pike
Rockville, MD 20850
Phone - (301) 827-3854
Voice Information System - (30l) 827-l800 (1-800-835-4709)
fax - (301) 827-3844 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
Ruth D. Reardon
Communication and Education Branch (HFV-l2)
Room N445 Metro Park North #2
7500 Standish Place
Rockville, MD 20855
Phone - (301) 594-5907
fax - (301) 594-1831

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.

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How to Obtain Assistance for FDA's Procurement and Contract Activities

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

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Frequently Called Numbers

OFFICE OF EXTERNAL AFFAIRS

CONSUMER INQUIRIES(301) 443-3170 INDUSTRY AND SMALL BUSINESS LIAISON TEAM (301) 827-3430

Fax on Demand under:

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

FLASH-FAX (Documents via fax) (locally) (301) 827-3844 or connect to the fax system toll free - l-800-835-4709

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) 594-1012
OR FAX (301) 594-3302 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) 599-7248
(For information about grants involving FDA
regulated products)

SMALL BUSINESS ADMINISTRATION


1441 L. Street N.W.
Washington, D.C. 20416
Small Business Answer Desk (1-800) 368-5855
OR Wash. D.C. area (202) 653-6533


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

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