Instructions for calling the FDA's new BBS: Set modem for 7,e,1 (7 data bits, even parity, one stop bit) and dial 1-800-222-0185 ** Use lower-case to logon with the word 'bbs' at the login prompt.. you'll then be given opportunity to register *********************** Manual for interacting with the FDA BBS ****** FDA ELECTRONIC BULLETIN BOARD SYSTEM (BBS) USERS GUIDE (Revision B) WHAT IS THE FDA ELECTRONIC BBS? The FDA electronic BBS is an electronic newsletter provided free-of-charge by the U.S. Food and Drug Administration's Office of Public Affairs to professionals interested in FDA issues. All information is added to the BBS as soon as it is released. This free service replaces the commercially-provided FDA BBS service from British Telecom/Dialcom. This new FDA BBS allows you to access the same FDA information, with the same options and the same results provided by Dialcom. In addition, it offers a simplified user y interface and enhanced features not available from Dialcom. The features, functions and benefits of this new FDA BBS are described in Attachment A to this Users Guide. This new service provides specific access to the FDA BBS only and does not duplicate the generalized Dialcom Electronic Mail, Electronic News Service or other "for fee" Dialcom services. To continue those services, please make separate arrangements with Dialcom or other providers. The BBS currently has available: o New releases o Enforcement Report (weekly recall list) o Drug and Device Product Approvals List o Medical Devices and Radiological Health news o FDA Medical Bulletin o Special section on AIDS information o FDA Consumer magazine, index and selected articles o FDA Federal Register summaries (available by subject or date) o Answers arising from questions in news stories o Congressional testimony by FDA officials o Speeches by FDA officials o Veterinary Medicine news o Upcoming FDA meetings o Import alerts o On-line User Guide The BBS operates on a multi-user computer in the FDA Parklawn Computer Center (PCC) at Rockville, MD and is accessible 24 hours a day, 7 days a week. For more information about the FDA Electronic BBS, contact the FDA Press Office at (301) 443-3285. If technical support is needed, contact PCC at (301) 443-7318 during the hours of 7:00 A.M. to 7:00 P.M. Monday thru Friday. HOW DO I ACCESS THE BBS FROM MY COMPUTER? You can access the BBS from a communicating word processor or any type of computer or terminal with a 300, 1200, 2400 or 9600 Bps asynchronous modem. Set your modem to 7 bits, Even parity and 1 stop bit, and dial one of the toll-free 800 numbers listed in Attachment B. Once the modems have connected, you will receive the prompt: (Examples show your expected response enclosed in {}. Follow all entries you make with Enter or carriage return, line feed): Login: {"bbs"} (Note: Enter "bbs" in lower case or the system will insert slash bars ("/") in place of spaces in all text.) When connected, the BBS will welcome you and prompt you through the following dialog Please enter your name (first and last) ==> {Your Name} Hello {Your Name} Is this your correct name? (Y/N): {Y or N} The first time you access the BBS, it will prompt you as follows: Welcome. Our records indicate that you are a new user. Please register at this time. Please enter the Password you want: {4 to 12 non-blank alphanumeric characters} Retype to verify: {Re-enter the same password} Thank you. Your password is: {As entered above} Enter Company or Organization: {Your company or organization name} Enter Location or Dept: {Your location or department} Enter City: {Your city} Enter State (2 Character Code): {Your State} Thank you. You are now a registered user. The BBS will then present you with a menu of topics that you may access. The next time you access the BBS after you have registered, it will ask you for your password as follows: Please enter your password ==> {Your password} If you enter your password incorrectly, the BBS will display: Sorry. Your password is incorrect. Please try again. It will then re-prompt you to enter your password. If you enter your password incorrectly three times, the BBS will disconnect your modem and you will need to re-dial the BBS. Otherwise it will display the following menu of available topics: TOPIC CODE TOPIC * NEWS News releases * ENFORCE Enforcement Report * APPROVALS Drug and Device Product Approvals list * CDRH Centers for Devices and Radiological Health Bulletins * BULLETIN Text from Drug Bulletin * AIDS Current Information on AIDS * CONSUMER FDA Consumer magazine index and selected articles * SUBJ-REG FDA Federal Register Summaries by Subject * ANSWERS Answers arising from questions in news stories * INDEX Index of News Releases and Answers * DATE-REG FDA Federal Register Summaries by Publication Date * CONGRESS Text of Testimony at FDA Congressional Hearings * SPEECH Speeches Given by FDA Commissioner and Deputy * VETNEWS Veterinary Medicine News * MEETINGS Upcoming FDA Meetings * IMPORT Import Alerts * MANUAL On-line User Guide In addition to this main menu, the AIDS, IMPORT and SUBJ-REG topics also have the following sub-menus: AIDS Sub-menu: TOPIC CODE TOPIC * AIDS-PR AIDS Press Releases * AIDS-PO AIDS Policy * AIDS-AR AIDS Articles * AIDS-FR AIDS Fraud * AIDS-SP AIDS Speeches * AIDS-ME AIDS Meetings IMPORT Sub-menu: TOPIC CODE TOPIC * IMP-FO Import Food Articles * IMP-ME Import Medical Devices * IMP-BI Import Biological Articles * IMP-CO Import Cosmetic Articles * IMP-RA Import Radiological Health * IMP-VE Import Veterinary Medicine SUBJ-REG Sub-menu: TOPIC CODE TOPIC * SUB-FO Subj-Reg Foods * SUB-HU Subj-Reg Human Drugs * SUB-ME Subj-Reg Medical Devices * SUB-BI Subj-Reg Biologics * SUB-VE Subj-Reg Veterinary Drugs * SUB-CO Subj-Reg Cosmetics * SUB-RA Subj-Reg Radiological Health * SUB-AM Subj-Reg All Meetings * SUB-GA Subj-Reg General Agency HOW DO I USE THE BBS? You may scan, read, search or get additional details about the information in each topic. After displaying the topics above, the BBS will ask you to: ENTER A TOPIC CODE ==> {topic code, such as NEWS, ENFORCE etc.} If you enter AIDS, IMPORT or SUBJ-REG; the BBS will display either the AIDS, IMPORT or SUBJ-REG sub-menu and once again display: "ENTER A TOPIC CODE ==>." At this point, enter one of the sub-menu topic codes (such as AIDS-SP, IMP-CO, SUB-AM etc.). If you already know the sub-menu topic code, you may enter it directly without first entering AIDS, IMPORT or SUBJ-REG. Once you have entered a topic code, the BBS will then display the topic you selected and ask you to enter a command as follows: CURRENT TOPIC: (topic code, such as NEWS, ENFORCE etc.) ENTER BBS COMMAND ==> At this point, you may enter: Read Read displays the full text of all of the documents within your selected topic. Unless disabled by the "Page" command (which you may enter in response to: "ENTER BBS COMMAND ==>"), the BBS will stop periodically to ask you: More? (yes or no) ==> If you type "yes" or "y" or carriage return, it will continue on, periodically stopping to ask "More? (Yes or No)." If you type "no" or "n" it will stop and display: CURRENT TOPIC: (topic code, such as NEWS, ENFORCE etc.) ENTER BBS COMMAND ==> At this point, the Read command is terminated and you may enter any BBS command. Page Page enables or disables the "More? (yes or no)" prompt at the end of each page displayed by a Read or Scan command. If the prompt is enabled, entering "Page" disables it and vice versa. When the prompt is disabled, the BBS will display an entire document, or all documents in your selected topic, before stopping. If you do not use this command, "More? (yes or no)" will always be enabled. Scan Scan displays the topic, title and publication date of each document within your selected topic. It also displays a document number which you may subsequently use to select documents to Read. When the Scan completes displaying all document indexes, the BBS will display: CURRENT TOPIC: (topic code, such as NEWS, ENFORCE etc.) ENTER BBS COMMAND ==> You may now enter Read and a document number to get the full text of the selected document. If you decide you are not interested in any of the documents, you may enter other BBS commands. Otherwise, upon completion, the BBS will again display: CURRENT TOPIC: (topic code, such as NEWS, ENFORCE etc.) ENTER BBS COMMAND ==> Continue as described above to read more documents. To avoid having to Scan again, you may want to note the numbers of the documents you wish to Read when the BBS first displays the list. The Page command affects Scan in the same way as Read. Search Search finds documents within your selected topic that contain the keyword(s) you specify. This enables you to find documents that interest you without having to Read or Scan an entire topic. In the following examples, "Keyword" represents a word you wish the BBS to search for in each of the documents within your selected topic. After you enter "Search" the BBS will display: ENTER KEYWORD(S) ==> {keyword1 and/or keyword2 and/or keywordn .} You may enter a single keyword or several keywords separated by "and" or "or." When using "and" all of the words must be in the document. For example: Search ENTER KEYWORD(S) ==> Food and Drug will cause the BBS to look for documents containing both "Food" and "Drug." When using "or" the BBS will search for each word separately. For example: Search ENTER KEYWORD(S) ==>Food or Drug will cause the BBS to look for documents containing either "Food" or "Drug." You may also search using compound arguments containing both "and" and "or." For example: Search ENTER KEYWORD(S) ==> Food and Drug or FDA will find all documents containing either both "Food" and "Drug" or "FDA." Thus, if "FDA" appears in a document, the document will be selected regardless of whether "Food" and "Drug" also appear. You may type an asterisk, at the beginning or end of a word as a "wildcard". For example: Search ENTER KEYWORD(S) ==> drug* will find documents containing any word beginning with "drug" such as: "drug", "druggist", "drugs", or "drugged." (Please note that some older terminals cannot transmit an asterisk as a recognizable character to the BBS, so they cannot use the wildcard feature.) Documents on the BBS are entered and maintained using standard capitalization conventions. The first letter of each sentence and of proper nouns and adjectives are also capitalized. Acronyms are capitalized and typically are not separated by periods (for example, AIDS, FDA etc.). The BBS does not distinguish between upper and lower case letters of a word. Consequently, "Drug","drug" and "DRUG" are equivalent. Likewise, "aids", "Aids", and "AIDS" are also equivalent. "A. I. D. S." however is different because the letters are separated by periods. Therefore, if you suspect alternate uses of periods, or other punctuation, in an acronym or abbreviation, enter all likely keywords separated by "or." For example: Search ENTER KEYWORD(S) ==> HIV2 or HIV-2 or HIV-II will improve your chances of finding all relevant documents. The BBS does not impose a limit on the number of keywords (separated by "or" or "and") that you may enter. Once you enter a carriage return however, the BBS assumes you have finished entering keywords and begins the search with the keywords you entered to that point. If your number of keywords exceeds one line, continue entering keywords without striking the carriage return. After you enter a carriage return, the BBS will respond: Searching - - This could take up to 2 Minutes. Please Wait... After a few moments, the BBS will respond with either: None Found. CURRENT TOPIC: (topic code, such as NEWS, ENFORCE etc.) ENTER BBS COMMAND ==> Or: n Occurrences... ENTER BBS COMMAND ==> Enter Read to display the full text of the n documents in which your keyword(s) were found. Enter Scan to display only the titles and publication dates of the n documents that contain your keyword(s). Info and Info all Info displays more details about the topic you have currently selected, including telephone contacts for further information. Info all displays the above information for each of the topics. (The actual text that the BBS displays is contained in ATTACHMENT C.) Quit Quit logs you off the BBS and discontinues communications. After this, you may terminate the communications session from your PC or terminal. Topics Topics displays the main topics menu and any sub-menus. It reminds you of topic categories and allows you to change topics. After displaying the menu, the BBS will ask you to: ENTER A TOPIC CODE ==> {topic code, such as NEWS, ENFORCE etc.} The topic you enter at this point becomes the current topic, and the BBS will respond with: CURRENT TOPIC: (topic code you just selected) ENTER BBS COMMAND ==> The command you enter now will operate on the topic you just selected. Help Help displays the following list of BBS commands: COMMAND DESCRIPTION * Topics Displays Topics menu * Info Displays details on the current Topic. * Info all Displays above details on all Topics. * Help Lists BBS commands permitted. * Quit Logs off the BBS and disconnects the computer. * Read Displays full text of documents. * Scan Lists documents in a selected Topic. * Search Finds documents with the keyword(s) you specify * Page Enables or disables page prompt NOTE: If the BBS is slow to respond to any command, DO NOT carriage return several times. Every command you enter must be followed by a carriage return, but several impatient carriage returns may have you reading a topic which does not interest you. Attachment A Features, Functions and Benefits of New FDA BBS NEW BBS FEATURE FUNCTION USER BENEFIT Free access to BBS Toll-free 800 Avoids toll, subscription numbers; plus no and usage fees for Dialcom BBS service fees. FDA BBS service. Compatible with Read, scan and Easy user migration to New Dialcom FDA BBS search commands BBS. give same retrieval options and results. Simplified Help, Info, Topics and Quit commands provide remaining Dialcom functions. Enhanced BBS user Simplified command Easier and quicker user interface and menu processing access to BBS information. eliminates need for Back, Break, Stop and Off commands. On-line user BBS automatically Easy to add new users. registration prompts new users Avoids cost, inefficiency through and delay of manual registration registration. during first login. On-line User Guide Entering the topic Easy access to BBS code "manual" operational information. displays the text of this Users Guide. Attachment B Dial-in Access Numbers to FDA Electronic BBS To call Toll-Free, dial: 1-800-222-0185 If you are at a local location, (area code 301) dial any of the following numbers: Group 1 227-6849 227-6850 227-6851 227-6852 227-6853 227-6854 227-6855 227-6856 Group 2 227-6857 227-6858 227-6859 227-6860 227-6861 227-6862 227-6863 227-6864 To use an FTS number, dial any of the following numbers: Group 1 394-6849 394-6850 394-6851 394-6852 394-6853 394-6854 394-6855 394-6856 Group 2 394-6857 394-6858 394-6859 394-6860 394-6861 394-6862 394-6863 394-6864 Attachment C Additional Topic Information Displayed by Info or Info all Commands NEWS contains FDA news releases. News releases are issued on important matters of public health, safety and interest, including any recalls which have been designated by FDA as appropriate for widespread public attention. All releases are added to the BBS as soon as they are issued and held indefinitely. ENFORCE contains the weekly FDA Enforcement Report, a list of FDA-regulated products under recall. All items are classified into three categories: Class I (an item that causes serious health consequences or death), Class II (an item that may cause temporary adverse health consequences but not death), and Class III (an item that is not likely to cause adverse health consequences). Also listed are seizure items, prosecution actions, and injunction actions filed. A new Enforcement Report appears every Tuesday. The document is also available in printed form by subscription. For single printed copies contact the FDA Press Office at (301) 443-3285. APPROVALS contains the complete text of the Drug and Device Product Approvals list, published monthly. Available are human drug approvals, medical device approvals, biological licenses issued and veterinary drug approvals. APPROVALS is held for one month and covers material for previous month. Contact the FDA Press Office for additional information. CDRH contains the Centers for Devices and Radiological Health (CDRH) Bulletins. The Medical Device Bulletin and Radiological Health Bulletin (two separate bulletins) are issued monthly and contain information on recent CDRH developments and meetings. The topic will be updated monthly when new CDRH Bulletins are released. BULLETIN contains the current Drug Bulletin, a newsletter containing information of importance to physicians and other health professionals. BULLETIN is updated when a new Drug Bulletin is issued. AIDS contains current AIDS press releases, and notes to correspondents. It also includes FDA policies on AIDS, AIDS articles from FDA and other agencies, information on AIDS fraud, FDA Commissioner's speeches on AIDS as well as upcoming meetings on AIDS. Because of the diversity of these topics, they are separately grouped under an AIDS sub-menu. CONSUMER contains the table of contents and selected articles from the current issue of FDA Consumer, FDA's official monthly magazine. In addition to articles, the magazine also carries topical updates, a short notebook on regulatory matters, and reports on actions by FDA investigators. Articles from the magazine are often reprinted in quantities for use by consumers, industry and health professionals. The table of contents and stories from CONSUMER are held indefinitely. SUBJ_REG contains summaries of all Federal Register announcements arranged by subject. SUBJ_REG documents appear on the BBS as soon as they go on public display at the FDA Hearing Clerk and are held on the BBS for one week. The publication date for a particular document may not always be available at time of display; it will be added to the topic as soon as it is known. Included in the topic is a short summary of the article, the name of a person to contact for further information, and in the case of public meetings, articles that appear in SUBJ-REG contact the main Federal Register office at (202) 523-5240 and give the title of the article and its publication date. Hard copy of a document is not available until it has been published in the Federal Register. DATE-REG contains summaries of all FDA Federal Register announcements arranged by publication date. Included in the topic is a short summary of the article, the name of a person to contact for further information, and in the case of public meetings, information on where and when they will be held. Documents for DATE-REG will appear on the BBS the day before the material is published in the Federal Register, and are held on the BBS for one week. For the full text of articles that appear in DATE-REG, contact the main Federal Register office at (202) 523-5240 and give the title of the article and its publication date. Hard copy of a document is not available until it has been published in the Federal Register. ANSWERS contains to current questions arising as a result of news stories. New material is added as soon as it is released and held on the BBS indefinitely. INDEX contains the indexes of news releases and answers issued from the FDA Press Office from January 1984 to date. Only items issued within the last 30 days are available on the BBS; all others are available in hard copy from the FDA Press Office (301) 443-3285 or (202) 245-1144. CONGRESS contains the full text of prepared statements delivered by FDA officials at Congressional oversight hearings. Statements are added the BBS the same day as the Congressional hearing and are held for one month. For copies of a document older than one month, contact the Legislative Affairs Staff at (301) 443-3793. SPEECH contains the full text of prepared speeches delivered by the FDA Commissioner and Deputy Commissioner at various meetings. Speeches are added to the BBS as soon as possible and are held for one month. For copies of a speech older than one month, contact the FDA Executive Secretariat at (301) 443-5004. VETNEWS contains CVM Updates. CVM Updates are news items issued by FDA's Center for Veterinary Medicine about veterinary medicine. All CVM Updates are added to the BBS as soon as they are issued and held for one month. For copies of a issue older than one month, contact the Center for Veterinary medicine office of Information and Education at (301) 443-4557. IMPORT contains representative Import Detention Summaries, reports of imported items that have been detained because of a violation of the law. Each detention summary includes the product, quantity, shipper, country of origin, port of entry, date and reason for detention. IMPORT is published approximately twice a month and held until a new topic is added. For copies of any back issues, contact Import Operations at (301) 443-6360. MANUAL contains the text of this Users Guide. This enables users to easily access instructions on BBS operation while on-line. For additional information or recommended changes to this Users Guide, contact the FDA Press Office at (301) 443-3285 or Parklawn Computer Center (PCC) at (301) 443-7318. CURRENT TOPIC: MANUAL ENTER BBS COMMAND ==> CURRENT TOPIC: MANUAL ENTER BBS COMMAND ==>