Small Business Guide to FDA

TABLE OF CONTENTS

## Introduction

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

### How To Comment on Proposed Regulations

How To Obtain Agency Documents

#### How To Obtain FDA Statutes and Regulations 

::: Definition-Term
How To Petition the FDA,
:::

::: Definition-Term
How To Participate in Agency Decision-Making
:::

::: Definition-Term
What To Do When
:::

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

::: Definition-Term
Access Information From The Internet
:::

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, International and Consumer Assistance (DSMICA) in the
Center for Devices and Radiological Health, Small Business Assistance
Programs in the five FDA regional offices, and the creation of small
business assistance offices 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 - 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 (888)
293-6498 or (202) 512-1530 for online subscriptions. As an alternative,
copies can usually be found in local libraries, county courthouses,
federal buildings or on the Internet at
http://www.gpoaccess.gov/fr/index.html. 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 gives the timeframe in which 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 submit a written
request that Agency officials extend the comment period. If FDA extends
the period, a notice of the extension is 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.

**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. A Comprehensive list of proposed regulations
open for comment from all federal agencies may be viewed at
http://www.regulations.gov. At this website you may enter and directly
send your comments on any proposed regulation. 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.

Send your comments on proposed regulations to Dockets Management Branch,
Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857; (301) 827-6860.

HOW TO OBTAIN AGENCY DOCUMENTS

**A Handbook for Requesting Information and Records from FDA (BG 97-6)**

(http://www.fda.gov/opacom/backgrounders/foiahand.html)

Obtaining Public Information

Certain documents that are prepared for public distribution\--such as
press releases, consumer publications, speeches, and congressional
testimony\--are available from FDA without having to file a Freedom of
Information Act (FOIA) request. Many of these documents are available on
FDA\'s Internet site (www.fda.gov). We encourage you to browse the site
for documents you want to look at. Public information may also be
obtained by contacting the appropriate FDA information officer.

Obtaining Information Through FOIA

FOIA allows anyone to request copies of records not normally prepared
for public distribution. FOIA pertains to existing records only and does
not require agencies to create new records to comply with a request. It
also does not require agencies to collect information they do not have
or to do research or analyze data for a requestor. In addition, FOIA
requests must be specific enough to permit an FDA employee who is
familiar with the subject matter to locate records in a reasonable
period of time. Under FOIA, certain records may be withheld in whole or
in part from the requestor if they fall within FOIA exemptions.

HOW TO OBTAIN FDA STATUTES AND REGULATIONS

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 are
among the statues enforced by the FDA. They 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. These regulations are accessible on the
Internet at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
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.

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-   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.

# **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 http://www.fda.gov/ohrms/dockets/. 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 (3) copies, unless
    otherwise stipulated in the Federal Register announcement, to:

> Food and Drug Administration
>
> Dockets Management Branch
>
> Room 1-23
>
> 12420 Parklawn Drive
>
> Rockville, MD 20857
>
> \(301\) 827-6860

FDA carefully considers every petition and must respond within 180 days
by either approving or denying it (in whole or in part), or providing a
tentative response indicating why FDA has been unable to reach a
decision. All petitions will be subject to public examination and
copying as governed by the rules in 21 CFR 10.20(j). 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 1-23, 12420 Parklawn Dr., 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.

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1.  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.

2.  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\
A full statement, in a well organized format, of the factual and legal
grounds on which the petitioner relies, including all relevant
information and views on which the petitioner relies, as well as
representative information known to the petitioner which is unfavorable
to the petitioner\'s position.

C. ENVIRONMENTAL IMPACT STATEMENT\
Give an environmental impact analysis report in the manner specified in
21 CFR 25.42. (Claim for categorical exclusion under 21 CFR 25.30,
25.31, 25.32, 25.33, or 25.34 or an environmental assessment under Sec.
25.40 of this chapter.)

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.

E. CERTIFICATION

The undersigned certifies that, to the best knowledge and belief of the
undersigned, 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)

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 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 4B-17, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857; (301) 827-5496 or FAX (301) 827-5891. For current
information or information updates on FDA advisory committee meetings,
call the Advisory Committee Information Line 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.

**How Regulated Industry Can Communicate with FDA**

Main FDA Address and Phone Number (for general inquiries):

U.S. Food and Drug Administration\
5600 Fishers Lane (HF-40)\
Rockville, MD 20857\
Phone: (301) 827-4450)

\(888\) INFO-FDA (1-888-463-6332)\
FAX: (301) 443-1863

WHAT TO DO WHEN

**Marketing a New Product**

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

-   New human and veterinary drugs \[\"New\" drugs = those with new
    intended uses or new chemical entities\] and certain medical devices
    \[examples = stair-climbing wheelchair, contact lens, heart
    pacemaker\] 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.

-   All domestic and foreign facilities that manufacture/process, pack,
    or hold food (and dietary supplements) for human or animal
    consumption in the United States must register with the FDA. For
    more information on starting a food business see
    http://www.cfsan.fda.gov/\~comm/foodbiz.html.

-   In addition, 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 that are
    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. (See Who to Contact for Assistance for the most appropriate
contact).

**PRODUCTS THAT REQUIRE REGISTRATION, LISTING, FILING OF A COOKING
PROCESS, OR LICENSING PRIOR TO MARKETING:**

-   All domestic and foreign facilities that manufacture/process, pack,
    or hold food (and dietary supplements) for human or animal
    consumption in the United States must register with the FDA to
    satisfy the Bioterrorism Act of 2002. The agency highly recommends
    on line registration at http://www.
    http://www.cfsan.fda.gov/\~dms/fsbtact.html. You must register using
    Form 3537. If you do not have reasonable access to the Internet, you
    may obtain a copy of this form by writing to the U.S. Food and Drug
    Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or
    by requesting the form by phone at 800-216-7331 or 301-575-0156.

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-   Low Acid Canned Foods \[LACF\]\* such as traditional vegetables, or
    any other food requiring aseptic processing to control the growth of
    pathogens must register all manufacturing establishments and file
    all scheduled processes. \[To order forms 2541, 2541c: via phone
    202-205-5282 or via Internet at
    http://forms.psc.gov/forms/FDA/FDA-2541.pdf,
    http://forms.psc.gov/forms/FDA/FDA-2541c.pdf\]

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-   Acidified Foods\*\* such as salsas, hot sauces, certain salad
    dressings, relishes, barbecue sauces, or any other food that use
    acidification \[addition of vinegar, lemon juice, etc.\] to control
    the growth of pathogens must register all manufacturing
    establishments and file all scheduled processes. \[To order forms
    2541 or 2541a: Via phone: 202-205-5282 or via Internet at
    http://forms.psc.gov/forms/FDA/FDA-2541.pdf,
    http://forms.psc.gov/forms/FDA/FDA-2541a.pdf\]

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-   Drugs including medical gases, human and veterinary prescription
    drugs, over-the-counter \[OTC\] drugs, and certain biologics must
    register all establishments and list all drug products. \[To order
    forms 2656, 2657, or 2658: Via phone at 301-594-1086 or via Internet
    at http://forms.psc.gov/forms/FDA/FDA-2656.pdf,
    http://forms.psc.gov/forms/FDA/FDA-2657.pdf,
    http://forms.psc.gov/forms/FDA/FDA-2658.pdf\]

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-   **In addition,** many drugs require an Investigational New Drug
    \[IND\] application, New Drug Application \[NDA\]**,** an
    Abbreviated New Drug Application \[ANDA\]**,** New Animal Drug
    Application \[NADA\]**,** or an Abbreviated New Animal Drug
    Application \[ANADA\]. \[To order forms: Via phone at 301-827-3937
    or via Internet http://forms.psc.gov/forms/FDA/FDA-1571es.pdf,
    http://forms.psc.gov/forms/FDA/FDA-1572.pdf\] \*

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-   Devices **-** human and animal devices must register all
    establishments and list all drug products. \[To order forms 2891 or
    2892: Via FAX: 301-443-8818 or via Internet (2891 only)
    http://www.fda.gov/cdrh/comp/fda2891.pdf\]

-   **In addition,** many devices require Premarket Notification
    \[510(k)\] or Premarket Approval \[PMA\]

-   Biologics and Blood Banks **-** human biologics may also be
    considered a drug or device and subject to the requirements of a
    drug or device. \[Phone for forms: 301-827-3546\]\* USDA regulates
    biologics for animals. Many biologics establishments require
    licensing as well.

\*Some forms only available by mail from \[NO phone/FAX orders\]:

::: Definition-Term
> Consolidated Forms and Publications Distribution Center \[CFPDC\]
:::

::: Definition-Term
> Beltsville Service Center
:::

::: Definition-Term
> 6351 Ammendale Road
:::

::: Definition-Term
> Beltsville, MD 20705
:::

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, the investigator 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
any significant findings and concerns; and leave with your management a
written report of any conditions or practices, which, in the
investigator's 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, since the FDA representative will not usually
recommend specific corrective measures. 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 you do not agree with the actions being taken by the FDA or if you
have a question about the jurisdiction of the agency in a particular
matter, you can contact the FDA\'s Office of the Ombudsman to seek a
resolution.

-   Office of the Ombudsman\
    Food and Drug Administration\
    5600 Fishers Lane\
    Room 14B03, HF-7\
    Rockville, MD 20857

> Telephone: 301-827-3390
>
> FAX: 301-480-8039
>
> E-mail: ombudsma@oc.fda.gov *\[Sending confidential information by
> electronic mail is not recommended.\]*

See the FDA Center Small Business Contacts for the Ombudsman in the
various FDA Centers.

*If FDA takes regulatory action against your firm, the Small Business
Representatives are not available for guidance, since their activities
are nonregulatory in nature.* You should contact a district Compliance
Officer for advice (see FDA District Offices) under those circumstances.

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 a regulatory action such as seizure of
the product. 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. See list of FDA District Offices.

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.

FDA is also concerned about the final disposition of the recalled
product. Final disposition may be in the form of destruction, with
appropriate regard for local laws concerning waste removal or
incineration. Other possible conclusions to recalls include
reconditioning (relabeling, repacking, reworking, etc.) or exportation,
if permitted. Any method used must first be discussed with the FDA
District Office, as FDA may wish to witness the effort, and the firm
must maintain proper documentation.

Also with device recalls, the firm must report to the FDA District
Office any Corrections or Removals in accordance with 21 CFR 806.10 as
soon as the firm becomes aware of the problem.

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 the completeness of the records maintained throughout
the production and distribution process.

Information on Recalls of FDA Regulated Products:
http://www.fda.gov/ora/compliance_ref/recalls/recallpg.html

Professional Demeanor of FDA Employee:

If you are concerned about the professional demeanor of any FDA employee
during an inspection or during their performance of other official
duties, you should contact the District Director in the nearest FDA
field office to resolve your concerns. See LIST OF DISTRICT DIRECTORS.

WHO TO CONTACT FOR ASSISTANCE

Knowing whom to contact is the first step in obtaining information you
need. It may be helpful to keep in mind that FDA has five Centers, five
Regions, and 21 District Offices within those regions. 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, wanting an FDA speaker for your industry meeting, 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 help small businesses whose products are regulated
by FDA. They are located in four regions of the country: New York,
Philadelphia, Atlanta, and Dallas.

\
**OTHER LINKS WITH INFORMATION OR ASSISTANCE FOR INDUSTRY:**

**DRUGS** - \[CDER[\]]{.underline} -
http://www.fda.gov/cder/about/smallbiz/default.htm\
**FOODS, DIETARY SUPPLEMENTS, COSMETICS** - \[CFSAN\] -
http://www.cfsan.fda.gov/\~dms/industry.html\
**DEVICES** - \[DSMICA in CDRH\] -
http://www.fda.gov/cdrh/industry-asst.html or

\"DEVICE ADVICE\" - http://www.fda.gov/cdrh/devadvice\
**BIOLOGICS** - \[CBER\] - http://www.fda.gov/cber/manufacturer.htm\
**ANIMAL PRODUCTS** - \[CVM\] -
http://www.fda.gov/cvm/contactcvm/contactCVM.html

These sites are available to deal with the special concerns and/or
provide helpful information to small firms and new businesses. They
provide information that clarifies how Agency laws and regulations apply
to various products or 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.

All FDA speaker requests must be submitted through:

Food and Drug Administration\
Office of Public Affairs\
Program and Speaker Coordination Staff\
5600 Fishers Lane, Room 15A-08\
Rockville, MD 20857\
FAX 301-827-2823

**SMALL BUSINESS REPRESENTATIVES (SBRs)**

**\
****Northeast Region**

(CT, MA, ME, NH, NY, RI, VT)

**Marilyn Rodriguez-Bohorquez**

Small Business Representative (HFR-NE17)\
Food and Drug Administration

158-15 Liberty Avenue\
Jamaica, NY 11433-1034\
Phone (718) 662-5618\
FAX (718) 662-5434\
Email: [oranersbr@fda.hhs.gov](mailto:oranersbr@fda.hhs.gov )

**Central Region**

(DC, DE, IL, IN, KY, MD, MI, MN, ND, NJ, OH, PA, SD, VA, WI, WV)\
**Marie T. Falcone**

Small Business Representative (HFR-CE5)\
Food and Drug Administration, U.S. Customhouse\
200 Chestnut St., Room 900\
Philadelphia, PA 19106\
Phone (215) 717-3703\
FAX (215) 597-5798\
Email: <oracersbr@fda.hhs.gov>

**Southeast Region**

(AL, FL, GA, LA, MS, NC, PR, SC, TN, VI)

Small Business Representative (HFR-SE17)\
Food and Drug Administration\
60 Eighth St., N.E.\
Atlanta, GA 30309\
Phone (404) 253-1171\
FAX (404) 253-1207\
Email: [orasesbr@fda.hhs.gov](mailto:orasesbr@fda.hhs.gov )

**Southwest Region**

(AR, CO, IA, KS, MO, NE, NM, OK, TX, UT, WY, US-Mexico Border Imports)\
**David Arvelo**

Small Business Representative, (HFR-SW2)\
Food and Drug Administration

4040 N. Central Expressway, Suite 900\
Dallas, TX 75204\
Phone (214) 253-4952\
FAX (214) 253-4970\
Email: <oraswrsbr@fda.hhs.gov>

**Pacific Region**

(AK, AZ, CA, HI, ID, MT, NV, OR, WA)

**Please contact your local district office.\
**

**Seattle District FDA**

(WA, ID, OR, MT, AK)

Compliance Office

22201 23^rd^ Dr SE

Bothell, WA 98021

Phone (425) 483-4966

FAX (425) 483-4760

**Los Angeles District FDA**

(AZ, Southern Counties of California:  Los Angeles, Orange, San Diego,
Imperial, Ventura, Santa Barbara, San Luis Obispo, Riverside, San
Bernardino)

19701 Fairchild\
Irvine, CA 92612

949-608-4413

**San Diego District FDA**

(HI, NV, Pacific rim territories, Northern California including Fresno,
Sacramento, San Jose and Stockton.)

Food and Drug Administration

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

510-377-6769

::: Definition-Term
**REGIONS AND DISTRICTS\
FOOD AND DRUG ADMINISTRATION**
:::

  ------------------------------ ----------------- ----------------------
  **REGION and DISTRICT**        **STATES SERVED** **DIRECTOR**

                                                   

  NORTHEAST REGION:\             CT, MA, ME, NH,   DIANA J. KOLAITIS\
  [New York Regional             NY, RI, VT        REGIONAL DIRECTOR
  Office]{.underline}\                             
  158-15 Liberty Avenue\                           
  Jamaica, NY 11433-1034\                          
  Phone - (718) 662-5416\                          
  FAX - (718) 662-5434                             

  [New York District             NY                Jerome G. Woyshner\
  Office]{.underline}\                             District Director
  158-15 Liberty Avenue\                           
  Jamaica, N.Y. 11433-1034\                        
  Phone - (7l8) 662-5447\                          
  FAX - (718) 662-5665                             

  [New England District          CT, MA, ME, NH,   Gail T. Costello\
  Office]{.underline}\           RI, VT            District Director
  One Montvale Ave.\                               
  Stoneham, MA 02180\                              
  Phone - (78l) 596-7717\                          
  FAX - (78l) 596-7896                             

                                                   

  CENTRAL REGION:\               DC, DE, IL, IN,   SUSAN M. SETTERBERG\
  [Philadelphia Regional         KY, MD, MI, MN,   REGIONAL DIRECTOR
  Office]{.underline}\           ND, NJ, OH, PA,   
  U.S. Customhouse\              SD, VA, WI, WV    
  200 Chestnut St., Room 900\                      
  Philadelphia, PA 19106\                          
  Phone - (2l5) 597-4390\                          
  FAX - (215) 597-5798                             

  [Philadelphia District         DE, PA            Thomas Gardine\
  Office]{.underline}\                             District Director
  U.S. Customhouse\                                
  2nd and Chestnut Sts., Room                      
  900\                                             
  Philadelphia, PA 19106\                          
  Phone - (215) 597-4390\                          
  FAX - (215) 597-4660                             

  [Central Region Office -       DC, DE, IL, IN,   Andrew Bonanno\
  Chicago]{.underline}\          KY, MD, MI, MN,   Deputy Regional
  20 North Michigan Ave. Suite   ND, NJ, OH, PA,   Director
  510\                           SD, VA, WI, WV    
  Chicago, IL 60602\                               
  Phone - (312) 353-9400 ext.                      
  120\                                             
  FAX - (312) 886-1682                             
  ------------------------------ ----------------- ----------------------

+-----------------------------+----------------+----------------------+
| **REGION and DISTRICT**     | **STATES       | **DIRECTOR**         |
|                             | SERVED**       |                      |
+-----------------------------+----------------+----------------------+
|                             |                |                      |
+-----------------------------+----------------+----------------------+
| [Chicago District           | IL             | Vacant               |
| Office]{.underline}\        |                |                      |
| 550 W. Jackson Blvd.\       |                | District Director    |
| Suite 1500 South\           |                |                      |
| Chicago, IL 60661\          |                |                      |
| Phone - (312) 353-5863\     |                |                      |
| FAX - (312) 596-4187        |                |                      |
+-----------------------------+----------------+----------------------+
| [Baltimore District         | DC, MD, VA, WV | Lee Bowers\          |
| Office]{.underline}\        |                | District Director    |
| 6000 Metro Dr. Suite 101\   |                |                      |
| Baltimore, MD 21215\        |                |                      |
| Phone - (410) 779-5454\     |                |                      |
| FAX - (410) 779-5707        |                |                      |
+-----------------------------+----------------+----------------------+
| [Cincinnati District        | KY, OH         | Carol A. Heppe\      |
| Office]{.underline}\        |                | District Director    |
| 6751 Steger Drive\          |                |                      |
| Cincinnati, OH 45237-3097\  |                |                      |
| Phone - (513) 679-2700\     |                |                      |
| FAX - (513) 679-2771        |                |                      |
+-----------------------------+----------------+----------------------+
| [New Jersey District        | NJ             | Douglas I.           |
| Office]{.underline}\        |                | Ellsworth\           |
| Waterview Corporate Center\ |                | District Director    |
| 10 Waterview Blvd., 3rd     |                |                      |
| Floor\                      |                |                      |
| Parsippany, NJ 07054\       |                |                      |
| Phone - (973) 526-6000\     |                |                      |
| FAX - (973) 526-6069        |                |                      |
+-----------------------------+----------------+----------------------+
| [Detroit District           | IN, MI         | Joann M. Givens\     |
| Office]{.underline}\        |                | District Director    |
| 300 River Place Drive       |                |                      |
|                             |                |                      |
| Suite 5900\                 |                |                      |
| Detroit, MI 48207-4457\     |                |                      |
| Phone - (313) 393-8100\     |                |                      |
| FAX - (313) 393-8105        |                |                      |
+-----------------------------+----------------+----------------------+
| [Minneapolis District       | MN, ND, SD, WI | W. Charles Becoat\   |
| Office]{.underline}\        |                | District Director    |
| 212 3rd Ave., South\        |                |                      |
| Minneapolis, MN 55401-2532\ |                |                      |
| Phone - (612) 334-4100\     |                |                      |
| FAX - (612) 334-4134        |                |                      |
+-----------------------------+----------------+----------------------+
|                             |                |                      |
+-----------------------------+----------------+----------------------+
| SOUTHEAST REGION:\          | AL, FL, GA,    | GARY J. DYKSTRA\     |
| [Atlanta Regional           | LA, MS, NC,    | REGIONAL DIRECTOR    |
| Office]{.underline}\        | PR, SC, TN, VI |                      |
| 60 Eighth St. N.E.\         |                |                      |
| Atlanta, GA 30309\          |                |                      |
| Phone - (404) 253-1171\     |                |                      |
| FAX - (404) 253-1207        |                |                      |
+-----------------------------+----------------+----------------------+

  ------------------------------ ----------------- ----------------------
  **REGION and DISTRICT**        **STATES SERVED** **DIRECTOR**

                                                   

  [Atlanta District              GA, NC, SC        Mary H. Woleske\
  Office]{.underline}\                             District Director
  60 Eighth St. N.E.\                              
  Atlanta, GA 30309\                               
  Phone - (404) 253-1161\                          
  FAX - (404) 253-1202                             

  [New Orleans District          AL, LA, MS, TN    Carl Draper\
  Office]{.underline}\                             District Director
  6600 Plaza Drive Suite 400\                      
  New Orleans, LA 70127\                           
  Phone - (504) 240-2401\                          
  FAX - (504) 240-6360                             

  [Florida District              FL                Emma R. Singleton\
  Office]{.underline}\                             District Director
  555 Winderly Place. Suite 200\                   
  Maitland, FL 3275l\                              
  Phone - (407) 253-1161\                          
  FAX - (407) 253-1202                             

  [San Juan District             PR, VI            Donald J. Voeller\
  Office]{.underline}\                             District Director
  466 Fernandez Juncos Avenue\                     
  San Juan, PR 00901-3223\                         
  Phone - (787) 474-9500\                          
  FAX - (787) 729-6851                             

                                                   

  SOUTHWEST REGION:\             AR, CO, IA, KS,   DENNIS BAKER\
  [Dallas Regional               MO, NE, NM, OK,   REGIONAL DIRECTOR
  Office]{.underline}\           TX, UT, WY,       
  4040 N. Central Expressway,    US-Mexico Border  
  Suite 900\                     Imports           
  Dallas, TX 75204\                                
  Phone - (214) 253-4901\                          
  FAX - (214) 253-4960                             

  [Dallas District               AR, OK, TX        Michael A. Chappell\
  Office]{.underline}\                             District Director
  4040 N. Central Expressway,                      
  Suite 300\                                       
  Dallas, TX 75204\                                
  Phone - (214) 253-5200\                          
  FAX - (214) 253-5313                             

  [Southwest Import              AR, AZ, CA, CO,   Robert Deininger\
  District]{.underline}\         IA, KS, MO, NE,   District Director
  4040 N. Central Expressway,    NM, OK, TX, UT,   
  Suite 300\                     WY, US-Mexico     
  Dallas, TX 75204\              Border Imports    
  Phone -- (214) 253-5330\                         
  Toll-free -- (800) 991-4881\                     
  FAX -- (214) 253-5316                            
  ------------------------------ ----------------- ----------------------

  ------------------------------ ----------------- ----------------------
  **REGION and DISTRICT**        **STATES SERVED** **DIRECTOR**

                                                   

  [Denver District               CO, NM, UT, WY    Belinda Collins\
  Office]{.underline}\                             District Director
  6th & Kipling Sts., Denver                       
  Federal Ctr\                                     
  Bldg. 20, Entrance W-l0\                         
  Denver, CO 80225-0087\                           
  Phone - (303) 236-3000\                          
  FAX - (303) 236-3099\                            
  (Mailing Address:\                               
  P.O. Box 25087\                                  
  Denver, CO 80225-0087)                           

  [Kansas City District          IA, KS, MO, NE    Charles W. Sedgwick\
  Office]{.underline}\                             District Director
  11510 West 80th St.\                             
  Lenexa, KS 66214\                                
  Phone - (913) 752-2144\                          
  FAX - (913) 752-2136\                            
  (Mailing Address:\                               
  P.O. Box 15905\                                  
  Lenexa, KS 66285-5905)                           

                                                   

  PACIFIC REGION:\               AK, AZ, CA, HI,   BRENDA HOLMAN\
  [Oakland Regional              ID, MT, NV, OR,   REGIONAL DIRECTOR
  Office]{.underline}\           WA                
  Oakland Federal Building\                        
  1301 Clay St. Suite 1180 - N\                    
  Oakland, CA 94612-5217\                          
  Phone - (510) 637-3960\                          
  FAX - (510) 637-3976                             

  [Los Angeles District          AZ ,CA            Alonza E. Cruse\
  Office]{.underline}\                             District Director
  19701 Fairchild\                                 
  Irvine, CA 92612-2506\                           
  Phone - (949) 608-2900\                          
  FAX - (949) 608-4498                             

  [Seattle District              AK, ID, MT, OR,   Charles Breen\
  Office]{.underline}\           WA                District Director
  22201 23rd Dr. S.E.\                             
  Bothell, WA 98021\                               
  Phone - (425) 486-8788\                          
  FAX - (425) 483-4996                             

  [San Francisco District        CA, HI, NV        Vacant\
  Office]{.underline}\                             District Director
  1431 Harbor Bay Parkway\                         
  Alameda, CA 94502-7096\                          
  Phone - (510) 337-6700\                          
  FAX - (510) 337-6859                             
  ------------------------------ ----------------- ----------------------

FDA CENTERS\' 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. The people
listed below can also send you a wide variety of informational materials
or audiovisuals:

Center for Drug Evaluation and Research

Office of Training and Communication (HFD-210)

Ron Wilson, Director\
Small Business Assistance

E-mail wilsonr@cder.fda.gov

5600 Fishers Lane, Room 12B45

Rockville, MD 20852

Phone - (301) 827-1694

FAX -- (301) 827-3056

> CDER Ombudsman
>
> Warren Rumble (Acting)
>
> Phone - 301-594-5490
>
> FAX - 301-827-4312
>
> E-mail - ombudsman@cder.fda.gov

Small Business Assistance for drug firms can be accessed from the Center
for Drug Evaluation and Research at
http://www.fda.gov/cder/about/smallbiz/default.htm or by calling the
Division of Drug Information, listed above.

Center for Biologics Evaluation and Research

Division of Manufacturers Assistance and Training (HFM-42),
matt@cber.fda.gov

1401 Rockville Pike, Suite 200N

Rockville, MD 20857-1448

Phone - (301) 827-2000

FAX 301-827-3079

Voice Information System - (30l) 827-l800 (1-800-835-4709)

Office FAX - (30l) 827-3843

> CBER Ombudsman
>
> Sheryl Lard Whiteford
>
> Phone - 301-827-0373
>
> FAX - 301-827-0440
>
> E-mail - LARD@CBER.FDA.GOV

Center for Food Safety and Applied Nutrition

Graciela Iguina, giguina@cfsan.fda.gov

Industry Activities Staff (HFS-565)

5100 Paint Branch Parkway

College Park, MD 20740-3835

Phone - (301) 436-1730

FAX - (301) 436-2621

Center for Devices and Radiological Health

John F. Stigi, Director, dsmica@cdrh.fda.gov

Division of Small Manufacturers, International and Consumer Assistance
(HFZ-220), www.fda.gov/cdrh/devadvice/

Room 130C

1350 Piccard Dr.

Rockville, MD 20850

Phone - (1-800) 638-2041

FAX - (301) 443-8818

> CDRH Ombudsman
>
> Les Weinstein
>
> Phone - 301-827-7991
>
> FAX - 301-827-2565
>
> Email - OMBUDSMAN@CDRH.FDA.GOV

Center for Veterinary Medicine

Joanne M. Kla, jkla@cvm.fda.gov

Consumer Safety Officer

Communication Staff (HFV-l2)

Room N428 Metro Park North #2

7519 Standish Place

Rockville, MD 20855-2773

Phone - (301) 827-3806

FAX - (301) 594-4512

> CVM Ombudsman
>
> Marcia K. Larkins
>
> Phone - 301-827-4535
>
> FAX - 301-827-3957
>
> E-mail - mlarkins@cvm.fda.gov

In addition, the Division of Small Manufacturers, International and
Consumer Assistance (DSMICA), established in the Center for Devices and
Radiological Health, provides technical and other non-financial
assistance to small medical device manufacturers. Although DSMICA
personnel are located in headquarters, they routinely provide field
assistance to firms by conducting workshops and, at the request of the
manufacturer, making onsite visits.

**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. For more information see the FDA Small Business
Program website at <http://www.fda.gov/oc/ofacs/fdasbo/default.html> or
contact

*FDA Small Business Program Office Points of Contact:\
Mendel D. Hill, Small Business Program Manager\
Office of Facilities, Acquisitions  and Central Services\
Room 2074, HFA230\
5600 Fishers Lane, Rockville, MD 20857\
PHONE: (301) 827-7211\
FAX: (301) 827-7228\
e-mail: [MHILL1@oc.fda.gov](mailto:mhill1@oc.fda.gov)*

 

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:

::: Definition-Term
Small and Disadvantaged Business Utilization Specialist\
Food and Drug Administration\
Office of Facilities, Acquisitions and Central Services, HFA-505\
5630 Fishers Lane, Room 2038\
Rockville, MD 20857\
301-827-6890
:::

**FREQUENTLY CALLED NUMBERS & WEB SITE INDEX**

TOLL-FREE 888-INFO-FDA (888-463-6332)

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CBER contact information at <http://www.fda.gov/cber/pubinquire.htm> or
call **Voice Information System** - Direct access to Consumer Safety
Officer or Public Affairs Specialist

> 800-835-4709 or 301-827-1800

::: Definition-Term
**CENTER FOR DEVICES AND RADIOLOGICAL HEALTH**
:::

DIVISION OF SMALL MANUFACTURERS, INTERNATIONAL AND CONSUMER ASSISTANCE
(DSMICA)

TOLL-FREE 1-800-638-2041 or 301-443-6597

CDRH FAX-ON-DEMAND (Documents via FAX)

TOLL-FREE 1-800-899-0381 or 301-827-0111

CENTER FOR DRUG EVALUATION AND RESEARCH

DRUG INFORMATION LINE 301-827-4573

Or see CDER small business assistance web site at
<http://www.fda.gov/cder/about/smallbiz/default.htm>

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

#### OUTREACH AND INFORMATION CENTER 1-888-723-3366 

#### 5100 Paint Branch Parkway (HFS-555) College Park, MD 20740

Toll-Free Information Line:

#### 1-888-SAFEFOOD (1-888-723-3366)

NATIONAL INSTITUTES OF HEALTH GRANTS INFORMATION LINE

(For information about grants involving FDA regulated products)
301-435-0714

::: Definition-Term
**SMALL BUSINESS ADMINISTRATION**
:::

Small Business Answer Desk

1-800-827-5722

409 3rd Street S.W.\
Washington, DC 20416

202-606-4000

::: Definition-Term
**SUPERINTENDENT OF DOCUMENTS**
:::

New Orders 202-512-1806\
Superintendent of Documents\
P.O. Box 37l954\
Pittsburgh, PA l5250-7954

for ordering government publications online 202-512-1530

::: Definition-Term
**ACCESS INFORMATION FROM THE INTERNET**
:::

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. Web sites Referenced in this document and FDA-related
web sites:

  ---------------- ---------------------------------------------------------------- -----------------------
  CBER - Biologics http://www.fda.gov/cber/regsopp/8403.htm                         license forms,
  Standard                                                                          instructions, guidance
  Operating Policy                                                                  
  and Procedures                                                                    

  CBER - Center    http://www.fda.gov/cber/index.html                               blood, biologic
  for Biologics                                                                     products, tissue,
  Evaluation and                                                                    in-vitro diagnostics
  Research                                                                          

  CBER - Site Map  http://www.fda.gov/cber/sitemap.htm                              links to blood, tissue,
                                                                                    and biologics
                                                                                    information

  CDER - ANDA      http://www.fda.gov/cder/regulatory/applications/ANDA.htm         forms for generic drug
  Application                                                                       submissions,
  Process                                                                           instructions, guidance

  CDER - Center    http://www.fda.gov/cder/                                         prescription human
  for Drug                                                                          drugs, over-the-counter
  Evaluation &                                                                      drugs, medical gases
  Research                                                                          

  CDER -- Drug     http://www.fda.gov/cder/drls/default.htm                         facility registration
  Registration /                                                                    and drug listing forms,
  Listing                                                                           instructions, guidance

  CDER -- IND      http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm   investigational drug
  Application                                                                       forms, instructions,
  Process                                                                           guidance

  CDER -- NDA      http://www.fda.gov/cder/regulatory/applications/NDA.htm          forms for new drug
  Application                                                                       submissions,
  Process                                                                           instructions, guidance

  CDER -- Small    http://www.fda.gov/cder/about/smallbiz/default.htm               assistance for new and
  Business                                                                          small drug businesses
  Assistance                                                                        

  CDRH -- Center   http://www.fda.gov/cdrh/index.html                               human and animal
  for Devices &                                                                     devices, in-vitro
  Radiological                                                                      diagnostics,
  Health                                                                            radiologicals, lasers

  CDRH -- Device   http://www.fda.gov/cdrh/devadvice/                               device advice, search
  Advice                                                                            device databases; 510k
                                                                                    / PMA help

  CDRH -- Device   http://www.fda.gov/cdrh/devadvice/341.html                       forms for facility
  Registration /                                                                    registration and device
  Listing                                                                           listings, instructions,
                                                                                    guidance

  CDRH / Industry  http://www.fda.gov/cdrh/industry-asst.html                       assistance for small
  Assistance                                                                        device businesses

  CFSAN -- Center  http://vm.cfsan.fda.gov/list.html                                food \[except red meat
  for Food Safety                                                                   and poultry\], dietary
  & Applied                                                                         supplements, food
  Nutrition                                                                         additives, cosmetics,
                                                                                    dinnerware

  CFSAN -- LACF /  http://www.cfsan.fda.gov/\~comm/lacf-s1.html                     forms for facility
  Acidified Food                                                                    registration and filing
  Registration /                                                                    a cooking process
  Process Filing                                                                    \[acidified and low
                                                                                    acid canned foods
                                                                                    only\], instructions,
                                                                                    and guidance

  CFSAN --         http://www.cfsan.fda.gov/\~comm/foodbiz.html                     information, assistance
  Starting a Food                                                                   for new food businesses
  Business                                                                          

  Compilation of   http://www.fda.gov/opacom/laws/                                  access all FDA
  Laws Enforced by                                                                  regulations
  Food & Drug                                                                       
  Administration                                                                    
  ---------------- ---------------------------------------------------------------- -----------------------

  ---------------- ------------------------------------------------------------------- -----------------------
  CVM - Center for http://www.fda.gov/cvm/default.html                                 animal drugs, animal
  Veterinary                                                                           feed, pet products
  Medicine                                                                             

  CVM - FAQ\'s     http://www.fda.gov/cvm/faqs/faqs.html                               Frequently Asked
                                                                                       Questions \[and
                                                                                       Answers\] about
                                                                                       veterinary regulations

  CVM - NADA /     http://www.fda.gov/cvm/index/other/nadaappr.htm                     forms for new animal
  ANADA                                                                                drug submissions,
  Application                                                                          instructions, guidance
  Process                                                                              

  FDA - Citizen    http://www.fda.gov/opacom/morechoices/smallbusiness/citizpet.html   petition requests to
  Petitions                                                                            add, remove, or change
                                                                                       agency regulations

  FDA - Ombudsman  http://www.fda.gov/oc/ombudsman/homepage.htm                        mediation, resolution
                                                                                       of disputes with FDA
                                                                                       and help for industry

  FDA - Public     http://www.fda.gov/ohrms/dockets/                                   comment on proposed
  Docket of                                                                            regulations, view
  Proposed                                                                             pending regulations
  Regulations                                                                          

  FDA - Public     http://www.fda.gov/opacom/morechoices/smallbusiness/pubhear.html    how to participate in
  Hearings                                                                             FDA\'s rulemaking
                                                                                       process

  FDA - Recalls    http://www.fda.gov/ora/compliance_ref/recalls/recallpg.html         product recall
                                                                                       information,
                                                                                       regulations, procedures

  FDA FOI -        http://www.fda.gov/opacom/backgrounders/foiahand.html               how to submit requests
  Handbook for                                                                         under the Freedom of
  Requesting                                                                           Information Act
  Information and                                                                      
  Records                                                                              

  FDA Home Page    http://www.fda.gov/                                                 starting point for all
                                                                                       FDA web sites

  FDA              http://www.fda.gov/opacom/7modact.html                              changes to FDA
  Modernization                                                                        regulations since 1997
  Act                                                                                  

  Information for  http://www.fda.gov/oc/industry/default.htm                          FDA-regulated industry
  FDA-Regulated                                                                        web sites
  Industry                                                                             

  State Health     http://www.fda.gov/oca/sthealth.htm                                 links to state agencies
  Agencies                                                                             

  US Government -  http://www.fda.gov/opacom/morechoices/smallbusiness/supdoc.html     access to all
  Superintendent                                                                       government publications
  of Documents                                                                         

  US Government    http://www.access.gpo.gov/nara/cfr/cfr-table-search.html            access to all
  CFR\'s Online                                                                        government regulations
                                                                                       that are online

  USDA - Home Web  http://www.usda.gov/                                                red meat, poultry
  site                                                                                 regulations,
                                                                                       information
  ---------------- ------------------------------------------------------------------- -----------------------