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Carpenter Hill, Koronadal City, South Cotabato (083)877-8803, FDA Advisory No.2023-0739 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0738 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0684 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0628 || Public Health Warning Against the Purchase, U.S Food and Drug Administration (U.S FDA), Department of Information and Communications Technology (DICT), Department of Science and Technology (DOST). Central Document Room (CDR) Regional Field Office II3/f Diwa Building, College Avenue, Tuguegarao City, Cagayan(078)377-0821, c. Regional Field Office III3/f Primus Medicus Bldg., Mc Arthur Highway, Brgy. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Silver Spring, MD 20993, AIDS Clinical Trials Information (800) 422-6237, Application Integrity Policy (301) 796-3191, Breast Implant Consumer Inquiries (CDRH) (301) 594-0485, CDER Therapeutic Biologics (301) 796-2390, Congressional Affairs (FDA/Office of Legislative Affairs) (301) 443-3793, Consumer Product Safety Commission (800) 638-2772, Division of Communications Management (CDER) (301) 827-1651, Electronic Submissions (CDER) (301) 594-5411, Environmental Officer (CDER) (301) 594-5629, Environmental Protection Agency (EPA) (800) 962-6215, ERIC (Employee Research & Information Center) (301) 827-ERIC, FDA Directory/Locator Information (301) 443-1544, Good Manufacturing Practices (GMP's) (301) 827-8907, Health Resources and Services Administration (301) 443-6593 IND/NDA, Industry Questions (General) (301) 827-4573, Meat and Poultry Hotline (USDA) (800) 535-4555, National Cancer Institute (NCI) (301) 496-5583, National Clearinghouse for Drug Abuse (800) 729-6686, National Institute on Drug Abuse (NIDA) (301) 443-6480, Patent and Trademark Office (703) 305-8341, Postmarketing Surveillance (CDER) (Drug Quality/Data Processing) (301) 770-9299, (Compliance) (301) 827-8928 Press Office (FDA)(Print only) (301) 827-6242, Press Office (FDA)Broadcast only) (301) 827-3434, Public Health Service (PHS) Employee Locator (301) 443-2414, Substance Abuse and Mental Health Services (800) 729-6686, Administration Veterinary Medicine (CVM) (301) 827-7975, Videoteleconferencing/Speaker Tracking (CDER) (301) 827-1243, Regional Food and Drug Contact Information, Food and Drug Administration Silver Spring, MD 20993-0002. . 8701 Morrissette Drive 1. HFR-MA1 Before sharing sensitive information, make sure you're on a federal government site. Welcome to Import Trade Auxiliary Communications System . | Note: For HHS OIG personnel inquiries, please proceed to https://oig.hhs.gov/ Contact AskCVM@fda.hhs.gov or call 240-276-9300 with questions Contact reglist@cdrh.fda.gov with questions about device registration or listing Regulatory questions or request for general. You may find answers to your questions on the UDI Basics web page, including: If you have specific questions related to UDI and GUDID, complete the following information to submit your question to the FDA UDI Help Desk. 2nd and Chestnut Streets Atlanta, Georgia 30309 The Reference Guide lists CDER's main offices and phone numbers. GENERAL QUESTIONS: This system is provided for Government-authorized use only. Secure .gov websites use HTTPSA lock ( HFR-PA1 check Submit close Reset . An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Call the FDA Consumer Complaint Coordinator for your state or region, Subscribe to podcasts and news feeds (RSS), View FDAs proposed regulations and submit comments online. The .gov means its official.Federal government websites often end in .gov or .mil. The Agency URL impacted (the link to the website) 5. Lock Our staff is available to assist you 24/7 by calling our toll-free number at 1-800-227-2572. This guide is designed to assist commercial vendors who conduct business with Food and Drug Administration (FDA). If you have a question about a medical device topic, we may be able to help you. Provide regular updates, training and briefing regarding HR policies and programs to HR professionals, FDA supervisors, managers and employees. Please be as specific as possible to help us in our efforts to support you. A locked padlock Mail Hub 2145 Thank you for contacting the FDA UDI Help Desk. Select the links below for access to these resources: Substance Use Disorder Treatment Overdose Prevention Therapy-Indiana (optIN) NextLevel Recovery Attn: Vendor Payments "Contact Us. Serves as the Agencys expert on the interpretation of legal and regulatory requirements for all matters related to executive resources and scientific programs to include recruitment/staffing and pay compensation. ); doctors and pharmaciesIllegal Prescription Drug Sales/Distribution (RX Abuse Online Reporting), MEDIA/PRESS INQUIRIES: (404) 347-4266 Center for Drug Evaluation and Research | CDER, Recalls, Market Withdrawals and Safety Alerts, Center for Drug Evaluation and Research | CDER. Center for Drug Evaluation and Research Decide how many GUDID accounts are needed. Submit invoices to the FDA Vendor Payments Team Mailbox via email, FDAVendorPaymentsTeam@fda.gov, with the COR or designated receiver copied on the email. Regional Field Office X2nd Floor, Almie Rose Chan Yu Bldg., Zone 7, Bulua, Cagayan de Oro City(088) 882-2842, b. Report a Product Complaint FAX (510) 637-3976, An official website of the United States government, : If you need additional help or wish to make a suggestion, please contact us using the email form below. 1-800-638-2041 For more information, see Quality defects and recalls. ERIC - Contact Us Contact Us Answers to many of our most frequently asked questions can be found at http://eric.ed.gov/?faq. For full reporting instructions, see Reporting a quality defect to EMA. Caution: Federal (US) law restricts these devices to sale . Visayas ClusterFDA-RFO VII, North Road, Jagobiao, Mandaue City, Cebu(032) 564-2565, a. Jamaica, New York 11433-1034 Contact your Contracting Officer Representative (COR) or the FDA ERIC Help Desk via phone 1-866-807-ERIC (3742), TTY 301-480-0434, or email ERIC@fda.hhs.gov. For electronically submitted invoices, the FDA VendorPayments Team will use the readable transmission date received to determine the invoice received date. If you have any questions or concerns, please contact the Agent/Broker Email Help Desk at FFMProducer-AssisterHelpDesk@cms.hhs.gov Updated: October 2021 1 Agent and Broker Marketplace Help Desks and Call Centers The table below provides information on the Help Desks available to agents and brokers who assist consumers +31 (0)88 781 6000 (EMA switchboard) Tel. Accountability Program: responsible for monitoring, evaluating, and reporting on the effectiveness, efficiency and compliance with law, rule and regulation, veterans preference, merit system principles and prohibited personnel practices as it relates to human resource management at FDA. 900 US Customhouse Regional Field Office IX3rd Floor Prime Arcade Building, Tiguma Highway, Pagdian City, Zamboanga del Sur(062)947-2658, b. These social media sites are commercial sites and not required to follow government standards. Contact Number 1-888-INFO-FDA (1-888-463-6332) 20 N. Michigan Ave, Rm 510 Contact information (phone and email) 4. For questions about enrollment, eligibility, health spending accounts, direct billing, benefit deductions or dependent verification, call the Benefits Service Center at 888-860-6178 Monday through Friday, 8 a.m. to 5 p.m. CT. You can also chat or send a secure email by logging into the Benefits Service Center. FAX (214) 655-8130, Food and Drug Administration The payment period does not begin until the date the invoice is received by the FDA Vendor Payments Team. Regional Field Office XI3rd Floor Biosite Medical Instrument Building, 553 Mangga St., Juna Subdivision, Matina, Davao CityContact Nos. Call or Visit Us. Conferences, Publications, Communications, Customer Service Plan DEA Headquarters:571-776-2840, Report Unlawful Activities:1-877-792-2873 FAX (404) 347-4349, Food and Drug Administration Phone: (888) 835-2555 Hours: 24 hrs/day, 7 days/week. Division of Payment Services Website Food and Drug Administration (FDA) Contact Contact the Food and Drug Administration Report a Problem with a Product Toll-free number 1-888-INFO-FDA (1-888-463-6332) Main address 10903 New Hampshire Ave. Silver Spring, MD 20993 SHARE THIS PAGE: Do you have a question? 5600 Fishers Lane Email: Kimberly.Pendleton@fda.hhs.gov Phone: (240) 402-7610: Department of Health and Human Services (HHS) - National Institutes of Health (NIH) Stephanie Fertig . Contact your Contracting Officer Representative (COR) or the FDA ERIC Help Desk via phone 1-866-807-ERIC (3742), TTY 301-480-0434, or email ERIC@fda.hhs.gov. Falsified medicines. If you have a specific question, email us at ERICRequests@ed.gov. 400 West 7th Street. Please contact us! Before sharing sensitive information, make sure you're on a federal government site. Beltsville, MD 20705-1266, An official website of the United States government, : What are the most common reasons that an invoice is returned? Tel. Phone: 1-800-721-0627 / TTY 711. CDER Central Document Room: Services include recruitment, competitive (Delegated Examining) staffing, merit promotion, position classification and management, processing all personnel, pay, benefits, and retirement actions. DEA works hard to ensure that its employees serve the public with honesty, integrity, and professionalism. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. Official websites use .govA .gov website belongs to an official government organization in the United States. Potential misconduct includes corruption involving bribery, embezzlement, espionage, smuggling, or other crimes; civil rights abuses involving custodial deaths, denial of rights, improper profiling or bias, or excessive use of force; and/or criminal or non-criminal misconduct involving abuse or violence; unauthorized use of DEA systems, equipment, or authority; suspicious activity; governmental ethics violations; or prohibited personnel practices. What is a performance. The Web Server number (found on the bottom left of the accept screen) 6. Frederick Health. No. You need to provide the following: 1. Initiates and recommends demonstration and/or pilot projects. Central Document Room Our stakeholders always have accurate, timely, targeted, and useful educational information about medical devices and radiation-emitting electronic products. HFR-NE1 Before sharing sensitive information, make sure you're on a federal government site. This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes all devices/storage media attached to this system. 10001 New HampshireAve Tel. III, San Fernando City, La Union(072)682-0708, b. See Contact FDA Centers and Offices below or search the employee directory. Office of Generic Drugs (HFD-600) DEA. Springfield, VA 22152, Contact the Diversion Control Division Real Sagkahan, Calanipawan Road, Tacloban City(053) 888-1806 / 09532203817, IV. To report unlawful or suspicious activities on the Internet onlyUnlawful Internet Prescription Drug Sales or Suspicious Online Pharmacies Before sharing sensitive information, make sure you're on a federal government site. Pharmacies are required to submit upper case values on B1/B2 transactions. FAX (312) 886-1682, Food and Drug Administration 5901B Ammendale Road Contact Us For ORA DX Support, complete the form below or contact the ORA Applications Help Desk at 240-247-8803. Technical support is available for the following Fresenius Medical Care manufactured and distributed products: For Novalung Clinical Support and Technical Service, please call 1-800-405-1321. For more details, see How to Report a Problem. 10001 New Hampshire Avenue 1301 Clay Street, Suite 1180-N The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 5901-B Ammendale Road Food and Drug Administration Full Name . 7920 Elmbrook Drive, Suite 102 CMS IT Service Desk 410-786-2580 1-800-562-1963 FDA Employee Resource & Information Center (ERIC) 301.827.ERIC (3742) 866.807.ERIC (3742) TTY 301.480.0434 IHS OITHelp@ihs.gov 888-830-7280 NIH& HRSA NIH IT Service Desk http://itservicedesk.nih.gov/ 301-496-HELP (4357) (local) 866-319-4357 (toll free) 301-496-8294 (TTY) OIG Doing Business With FDA, Recalls, Market Withdrawals and Safety Alerts, Enterprise System Life Cycle Management Support (ELMS), FDA Small Business and Disadvantaged Opportunities, Frequently Asked Questions - Vendor Payments, Vendor Name as shown on the Award Document, Description including line item number (Item No. Drug Enforcement Agency on DEA website. Device Advice: Comprehensive Regulatory Assistance, Recalls, Market Withdrawals and Safety Alerts, Contact Us Division of Industry and Consumer Education (DICE), Device Advice: Comprehensive Regulatory Assistance, Contacts for Medical Devices During the COVID-19 Pandemic, FDAs Role: Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions, Coronavirus Disease (COVID-19) Emergency Use Authorization (EUA) Information, Coronavirus Disease (COVID-2019) updates from FDA. 10903 New Hampshire Ave Provide recommendations and training strengthening compliance and accountability programs. Phone: (800) 551-2231 Hours: Monday - Friday, 6am - 5pm PT Additional information here. For technical questions, contact cdrhesub@fda.hhs.gov . Registrar Corp assists businesses with U.S. FDA compliance. Contact information Email * Verify Email * Phone Number * (will only be used if required for follow-up to this communication) Address 1000 of 1000 characters available Address 2 City State/Province Zip Code/Postal Code Country or Region * Message Subject Questions/Comments * 1000 of 1000 characters available Indicate the web address (URL) where you encountered the problem and the type of issue (such as a broken link, problem downloading a document, etc.). Civic Drive Filinvest Corporate CityAlabang, Muntinlupa City 3 June, 2018. UnitedHealthcare Customer Service advocates are available to assist you with password resets, enhancement requests and technical issues with the website. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993 DICE@fda.hhs.gov (800) 638-2041 (301) 796-7100 Office of Communication and Education For Updates on Twitter follow. Chicago, Illinois 60602 866-250-2005 / TTY 711 customerservice@elixirinsurance.com Elixir Insurance Member Portal Pay your premium online Mail Order Specialty Pharmacy Retail Pharmacy Please visit the pharmacy resources section on our provider page for more information about joining our network, billing, audits and more. Medical Practitioners Silver Spring, MD 20993, Mailing Address for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs) +31 (0)88 781 7676 (for use only as stated in the instructions) Urgent phone number for use outside of EMA business hours: Tel. HFR-MW1 Policy and Program Development: develop and coordinate the implementation of human resources policies and procedures for Agency activities involving employment, recruitment, classification, compensation and benefits, employee and labor management relations, training, career development, quality of work life issues, and executive resources. If you would like to narrow your entry search, please provide a Line Number. Before sharing sensitive information, make sure you're on a federal government site. HFR-SE1 * Category * First Name * Last Name * Email Address Phone Number. FDA Advisory No.2023-0739 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0738 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0684 || Public Health Warning Against the Purchase, FDA Advisory No.2023-0628 || Public Health Warning Against the Purchase, U.S Food and Drug Administration (U.S FDA), Department of Information and Communications Technology (DICT), Department of Science and Technology (DOST). Always include the Contracting Officer Representative (COR) or designated receiver as Cc on the email. The FDA ESG serves as a component of acommunications system, collecting information (regulatory submissions) from multiple sources, suchas pharmaceutical companies and device manufacturers, then forwarding that information to a fileserver where the appropriate FDA system can retrieve the information. In addition, DICE develops educational resources for the FDA website to help the medical device industry understand FDA regulations and policies. If you are experiencing a life-threatening medical emergency. To educate our stakeholders with understandable and accessible science-based regulatory information about medical devices and radiation-emitting electronic products. Responsible for implementing and consulting on the interpretation of legal and regulatory requirements for all matters relating to HR issues and transactions within the scope of the services provided. If you need immediate assistance, Registrar Corp can help. Regional Field Office IV-AUnit D, Milan Prestige Bldg., National Highway, Brgy, Halang, Calamba City, Laguna(049) 566-7834 / 09206481832, b. The site is secure. 20 South Luzon ClusterFDA Building, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City(02)8 857-1900 local 8106, a. +31 (0)65 008 9457. For interpretation and guidance on DEA policies and regulations. . Center for Drug Evaluation and Research Philadelphia, Pennsylvania 19106 Hours: 8 a.m. to 8 p.m. CT, Monday through Friday. Understanding the UDI format Developing a UDI. *Help Desk phone number serving Puerto Rico Providers is available by calling toll-free 1-8-842-7331. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. (202) 307-7936community.outreach@dea.gov, REGISTRATION AND MEDICAL PRACTITIONERS: (510) 637-3960X18 Within each of these categories, there are approximately 30 services ranging from audio or video or . 1-877-699-5710. The Indiana Family and Social Services Administration (FSSA) is making resources for the management of opioid therapy easily available to the provider community. 3 June, 2018. The .gov means its official.Federal government websites often end in .gov or .mil. (82) 295-2904, 0951-3771165 or 0995-2522582, c. Regional Field Office XIIINimfa Tiu Bldg., Acosta Subdivision, Libertad, Butuan City(085) 817-3485, a. Invoices are often returned due to a missing Line Item Number, missing vendor contract information and incorrect totals for good/services rendered. Central Document Room (CDR) Share sensitive information only on official, secure websites. Central Document Room (CDR) Handles all request to HHS and OPM regarding personnel variances, veterans pass-over requests, direct hire authority, and request for exceptions to policy, rule or regulation. CAQH Provider Help Desk: Chat: https://proview.caqh.org/PR Chat Hours: Monday - Friday: 8:30 AM to 6:30 PM (EST) Phone: 1-888-599-1771 Phone Hours (eff. 158-15 Liberty Avenue (214) 655-8100 X111 Lapaz, Iloilo City(033) 500-5609, b. Oakland Federal Bldg Help. Develop FDAs Guiding Principles and other internal guidance to ensure compliance with overall HHS policy, hiring authorities and pay administration and compensation. The site is secure. If the due date or discount date falls on a weekend or federal holiday, the FDA will issue payment by the following business day. Hillandale Building, 4th Floor Handles all request to HHS and OPM regarding personnel variances, veterans pass-over requests, direct hire authority, and request for exceptions to policy, rule or regulation. FAX (215) 597-5798, Food and Drug Administration Silver Spring, MD 20993-0002. What happens if FDA determines that an invoice is improper? Please be as specific as possible to help us in our efforts to support you. CDER Central Document Room: Beltsville, MD 20705-1266, Mailing Address for Therapeutic Biologic License Applications (BLAs) To our valued clients and stakeholders, to further improve our service and cater to more clients, we have now a total of (8) numbers: Other active communication: Email: fdac@fda.gov.ph Operating hours from 9:00am to 4:00pm Rest assured that our team will respond to your concerns as soon as we can. Will the payment due date change if I resubmit my invoices? Should rounding be completed on the invoices current billable lines and/or subtotals for services/goods? If you believe that a DEA employee or Task Force Officer has committed misconduct, please report it to misconduct@dea.gov . Bldg., cor. All rights reserved. Will the FDA accept a physical copy of an invoice? Beltsville, MD 20705-1266, Abbreviated New Drug Applications (ANDAs) Before sharing sensitive information, make sure you're on a federal government site. We will respond to your question within 3-4 days (excluding weekends and holidays). Systems and Data Management: responsible for all major human resources technology systems, internal IT support, helpdesk and file room operations. Regional Field Office VIFDA-RFO VI, 3rd Floor Gaisano City Capital, Luna St,. Frederick, MD 21701. 8701 Morrissette Drive Center for Food Safety and Applied Nutrition (CFSAN, includes Cosmetics), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), National Center for Toxicological Research (NCTR). Bldg., Quimpo Blvd., Ecoland, Davao City(082) 322-6201, a. Through conducting benchmarking and environmental scans of other HR programs, develops and coordinates implementation of new human resources/human capital programs that will help FDA meet organizational and programmatic needs. Thank you for contacting the FDA UDI Help Desk. DICE correspondence constitutes an informal communication that represents the best judgment at the time of the communication, but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. Website technical support. Office of CommunicationsDivision of Drug Information 240-566-3300. FDA UDI Help Desk | FDA FDA UDI Help Desk You may find answers to your questions on the UDI Basics web page, including: Am I a device labeler? The site is secure. At LMG, we provide a full range of consulting services to domestic and foreign establishments in FDA regulations. An official website of the United States government, : Invoice amounts should be entered exactly to the cent with no rounding. If the FDA Vendor Payments team is not included in the invoice submission, the invoice will be returned to the vendor. HFR-SW1 MedWatch - Central Triage Unit Executive Resources: provides leadership, direction, coordination, and policy guidance on Agencywide executive resources and scientific programs or services. (800) 882-9539, Drug Enforcement AdministrationAttn: Office of Diversion Control Complete description of the problem 3. To make corrections, see the HHS directory contact list. DEA employees are held to the highest standards of conduct. When does the payment period begin if an invoice is not sent directly to the FDA Vendor Payments Team? Mail: Genentech US Drug Safety 1 DNA Way Mailstop 258A South San Francisco, CA 94080. Division of Drug Information no: +632 8 857-1900 info@fda.gov.ph FDAC Hotlines Landline: (02) 8857-1900 local 1000 (02) 8842-5635 Email: fdac@fda.gov.ph Chat with Us on Facebook Chat with us Email: ask@fda.gov.ph File a Report Report Unregistered Products and Establishments Email: ereport@fda.gov.ph Center for Drug Regulation and Research (CDRR) File a Report Contact helpdesk by email at eopfhelpdesk@opm.gov . To achieve our mission, we stay current on regulatory issues and new scientific advances, anticipate our stakeholder needs and ensure that the information we disseminate is accurate, timely, and appropriately targeted for each audience.

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