Phone: (888) 835-2555 Hours: 24 hrs/day, 7 days/week. The CDER Reference Guide | FDA Phone Numbers: Main FDA for general inquiries: 1-888-INFO-FDA ( 1-888-463-6332 ) Drug Information: 301-796-3400 (8:00 a.m. - 4:30 p.m. Eastern Time) To submit a report about an Adverse. 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). 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. If you need immediate assistance, Registrar Corp can help. Import Trade Auxiliary Communications System - Food and Drug Administration Will the payment due date change if I resubmit my invoices? Falsified medicines. Pharmacies are required to submit upper case values on B1/B2 transactions. MedWatch - Central Triage Unit Toll Free Call Center: 1-877-696-6775 Visiting the SW Complex Note: Please be aware that mail sent to our Washington D.C. area offices takes an additional 3-4 days to process due to security precautions. HFR-SW1 10903 New Hampshire Ave WO32 Second Floor Oversees all facets of organizing campaigns and elections of unions seeking recognition; participates with HHS on negotiating contracts with recognized union; represents the Agency in unfair labor practice, mediation, impasses and arbitration proceedings before appropriate adjudicating authorities and provides advice and assistance to FDA managers and employees regarding the full scope of labor management relations activities. Telephone Numbers Frequently Requested of the FDA Advertising, Rx Drugs (301) 796-1200 Advisory Committees (800) 741-8138 AIDS Clinical Trials Information (800) 422-6237 American Cancer Society. Air Force SBIR/STTR One Help Desk: CBP Line Number. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. For full reporting instructions, see Reporting a quality defect to EMA. What are the most common reasons that an invoice is returned? (718) 662-5416 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? check Submit close Reset . Contact Number 1-888-INFO-FDA (1-888-463-6332) FAX (404) 347-4349, Food and Drug Administration *Help Desk phone number serving Puerto Rico Providers is available by calling toll-free 1-8-842-7331. Initiates and recommends demonstration and/or pilot projects. Submit invoices to the FDA Vendor Payments Team Mailbox via email, FDAVendorPaymentsTeam@fda.gov, with the COR or designated receiver copied on the email. 1301 Clay Street, Suite 1180-N Contact Us | Frederick Health Phone: (800) 551-2231 Hours: Monday - Friday, 6am - 5pm PT Additional information here. Contact Us | HHS.gov What constitutes a complete and proper invoice? To provide outstanding HR service to the FDA workforce. HFR-SE1 South Luzon ClusterFDA Building, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City(02)8 857-1900 local 8106, a. Contact helpdesk by email at eopfhelpdesk@opm.gov . 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. For specific information about drugs or drug products please contact the following Division: Food and Drug Administration Technical Phone Support - Fresenius Medical Care Registrar Corp assists businesses with U.S. FDA compliance. Contact Us - National Institute of Allergy and Infectious Diseases Share sensitive information only on official, secure websites. For more information, see Quality defects and recalls. 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 The ERIC help desk would be happy to provide general search assistance, tips for using the ERIC website, and to answer any questions that users have about ERIC. Contact Us - Elixir-Home Regional Field Office VIIFDA-RFO VII, North Road, Jagobiao, Mandaue City,Cebu(032) 262-0996, c. Regional Field Office VIIIPerpetual Help Credit Cooperative Inc. How to comment on proposed regulations or submit petitions. Welcome to Import Trade Auxiliary Communications System . Bldg., Quimpo Blvd., Ecoland, Davao City(082) 322-6201, a. Fax: (650) 225-4630. Regional Field Office IX3rd Floor Prime Arcade Building, Tiguma Highway, Pagdian City, Zamboanga del Sur(062)947-2658, b. WebHelpDesk. Should rounding be completed on the invoices current billable lines and/or subtotals for services/goods? 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. FAX (312) 886-1682, Food and Drug Administration Center for Drug Evaluation and Research April 1, 2022): Monday - Friday: 8 AM - 8 PM (EST) Terms of Service Privacy CAQH.ORG 20230410.81(.21) 2023 CAQH. Regional Field Office XIIPrime Regional Office, Brgy. Food and Drug Administration An official website of the United States government, : Springfield, VA 22152 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. What should I do if my invoice is returned as improper? The site is secure. In addition, DICE develops educational resources for the FDA website to help the medical device industry understand FDA regulations and policies. Decide how many GUDID accounts are needed. Indiana Medicaid: Providers: Pharmacy Services 5901B Ammendale Road San Isidro, City of San Fernando, Pampanga(045)649-4341, d. Regional Field Office CAR3/f Jovelyn D. Quilacio Realty Services, Purok 1, Padre Zamora, Baguio City(074)665-3975, II. To make corrections, see the HHS directory contact list. PDF CVS Caremark Payer Sheet Before sharing sensitive information, make sure you're on a federal government site. Yes. Invoice amounts should be entered exactly to the cent with no rounding. 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.). We are dedicated to the support of the goals and challenges of this world-class institution by providing services which promote collaboration and a work environment that is characterized by diversity, fairness, open communication, personal accountability, trust and mutual respect. To report unlawful or suspicious activities on the Internet onlyUnlawful Internet Prescription Drug Sales or Suspicious Online Pharmacies The site is secure. Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics. Central Document Room (CDR) If you have a question about a medical device topic, we may be able to help you. Call or Visit Us. Division of Industry and Consumer Education, An official website of the United States government, : Mail Hub 2145 Will the FDA accept a physical copy of an invoice? Domestic Cannabis Suppression / Eradication Program, Red Ribbon Toolkit - Resources For Your Community, DEA National Prescription Drug Take Back Day, Intelligence Research Specialist Job Announcements, Schedule A Hiring Authority: Intelligence Research Specialist, Privacy Impact Assessment and Management Information Systems, Victim Witness Assistance Program Resources, Unlawful Internet Prescription Drug Sales or Suspicious Online Pharmacies, Illegal Prescription Drug Sales/Distribution (RX Abuse Online Reporting), Visiting Official Department of Justice Pages on Third-Party Websites. For more details, see How to Report a Problem. What if the payment due date falls on a weekend or holiday, when will the FDA issue payment? Phone: +1-757-224-0177. Visayas ClusterFDA-RFO VII, North Road, Jagobiao, Mandaue City, Cebu(032) 564-2565, a. Services include recruitment, competitive (Delegated Examining) staffing, merit promotion, position classification and management, processing all personnel, pay, benefits, and retirement actions. FEMA Helpline General questions or comments about FEMA disaster assistance for individuals and families can be emailed to: AskIA@fema.dhs.gov Contact Us - Ohio Department of Job and Family Services 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. Central Document Room (CDR) Support For Product Questions, Issues, And Returns. ) or https:// means youve safely connected to the .gov website. This guide is designed to assist commercial vendors who conduct business with Food and Drug Administration (FDA). DEA. 900 US Customhouse Before sharing sensitive information, make sure you're on a federal government site. The ERIC help desk is happy to provide general search assistance, tips for using the ERIC website, and to answer any questions that you may have about ERIC. Contact Us For ORA DX Support, complete the form below or contact the ORA Applications Help Desk at 240-247-8803. 5901-B Ammendale Road Food and Drug Administration | USAGov At LMG, we provide a full range of consulting services to domestic and foreign establishments in FDA regulations. Report a problem with FDA-regulated products By phone:. If you need additional help or wish to make a suggestion, please contact us using the email form below. Center for Drug Evaluation and Research | CDER, Recalls, Market Withdrawals and Safety Alerts, Center for Drug Evaluation and Research | CDER. 2nd and Chestnut Streets Payment terms stated in the associated purchase order The latter of these two (2) dates: Date when the FDA Vendor Payments Team received the complete and proper invoice (invoice received date); or, Date when the FDA received the goods/services from the vendor and acceptance of the goods/services has occurred. The .gov means its official.Federal government websites often end in .gov or .mil. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Report a Product Complaint Office of Human Capital Management, Recalls, Market Withdrawals and Safety Alerts. +31 (0)65 008 9457. Where do I submit a physical copy of an invoice? Beltsville, MD 20705-1266, Mailing Address for Therapeutic Biologic License Applications (BLAs) 1-800-638-2041 Rockville, MD 20852-9787, For mandatory reports from regulated industry and IND reporters: To get started, at a minimum please enter an Entry Number. Point of Contact Contact Information; Department of Agriculture (USDA) . The Line Item Number is a one or two-digit number that is used to identify each supply/service item on the contract agreement. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. Our stakeholders include the medical device industry, consumers, patients, healthcare providers, FDA colleagues, and other Federal, State, and local government agencies. 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. Beltsville, MD 20705-1266, An official website of the United States government, : 10903 New Hampshire Ave Before sharing sensitive information, make sure you're on a federal government site. DEA. However, we are unable to provide assistance outside of the scope of ERIC and are unable to provide reference services. Please be as specific as possible to help us in our efforts to support you. The payment period does not begin until the date the invoice is received by the FDA Vendor Payments Team. Contact Us - DEA Also see: Medicare.gov or Call 1-800-MEDICARE (for people with Medicare) DEA employees are held to the highest standards of conduct. ERIC - Contact Us Contact Us Answers to many of our most frequently asked questions can be found at http://eric.ed.gov/?faq. 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. Provide regular updates, training and briefing regarding HR policies and programs to HR professionals, FDA supervisors, managers and employees. (800) 882-9539, Drug Enforcement AdministrationAttn: Office of Diversion Control Drug Enforcement Administration - DEA @DEAHQ. DEA works hard to ensure that its employees serve the public with honesty, integrity, and professionalism. Regional Field Office X2nd Floor, Almie Rose Chan Yu Bldg., Zone 7, Bulua, Cagayan de Oro City(088) 882-2842, b. (510) 637-3960X18 Tel. How can I get help using ERIC? To educate our stakeholders with understandable and accessible science-based regulatory information about medical devices and radiation-emitting electronic products. 1-844-684-6333 If you use a video relay service, captioned phone, or other communication service, give FEMA the number for that service. Center for Drug Evaluation and Research (82) 295-2904, 0951-3771165 or 0995-2522582, c. Regional Field Office XIIINimfa Tiu Bldg., Acosta Subdivision, Libertad, Butuan City(085) 817-3485, a. Registration questions:DEA.Registration.Help@dea.gov, DEA POLICY QUESTIONS:Liaison and Policy Section CDER Central Document Room: Updated Customer Mobile Hotlines of The Food and Drug Action Center FDA Registration - FDA Certificate - FDA Agent Central Document Room (CDR) FAX (215) 597-5798, Food and Drug Administration PDF US Department of Health and Human Services - HHS.gov Oakland, California 94612-5217 To our valued clients and stakeholders, to further improve our service and cater to more clients, we have now a total of (8) numbers: Rest assured that our team will respond to your concerns as soon as we can. Unique Device Identification System (UDI System), Recalls, Market Withdrawals and Safety Alerts, Unique Device Identification System (UDI System), Legacy Identification Number (NDC/NHRIC): Frequently Asked Questions, UPC Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions, UDI Compliance Policies and UDI Rule Compliance Dates, UDI Rule, Guidances, Training, and Other Resources, Global Unique Device Identification Database (GUDID), Device Advice: Comprehensive Regulatory Assistance, Developing a UDI using an FDA-accredited issuing agency's system, Meeting compliance dates and requirements, Understanding exceptions, alternatives, and time extensions, Submitting information to the GUDID database. Retrieved from https://www.dea.gov/who-we-are/contact-us on 1 May, 2023. CDER Contact Information | FDA - U.S. Food and Drug Administration Tel. The site is secure. Connect with UnitedHealthcare | AARP Medicare Plans The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Phone (614) 466-4815 Fax (614) 466-1767 Family Assistance Customer Inquiry Call Center: Phone (866) 244-0071 Child Care Help Desk: Phone (877) 302-2347 Out-of-State Inquiries: Fax (614) 466-1767 Email: out_of_state_inquiries@jfs.ohio.gov back to top Fiscal and Monitoring Services 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. Our staff is available to assist you 24/7 by calling our toll-free number at 1-800-227-2572. 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 site is secure. HFR-MA1 Each account identifies a separate Labeler Organization, typically the corporate headquarters. 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. When an invoice is determined improper in accordance with the Prompt Payment Act, the agency will identify all defects that prevent payment and the FDA will return the invoices to the point of contact listed on the invoice within 7 calendar days of receipt of the invoice by the FDA Vendor Payments Team. IT Services at the FDA - CIOReview 240-566-3300. Select the links below for access to these resources: Substance Use Disorder Treatment Overdose Prevention Therapy-Indiana (optIN) NextLevel Recovery FDA UDI Help Desk: Thank You | FDA - U.S. Food and Drug Administration 1. No. Mail: Genentech US Drug Safety 1 DNA Way Mailstop 258A South San Francisco, CA 94080. Food and Drug Administration If you need additional help or wish to make a suggestion, please contact us using the email form below. A locked padlock Help. An invoice that has been returned as improper will have a cover letter explaining the reason for return. CDER Contact Information, Recalls, Market Withdrawals and Safety Alerts, Center for Drug Evaluation and Research | CDER, Telephone Numbers Frequently Requested of the FDA, Main FDA for general inquiries: 1-888-INFO-FDA (1-888-463-6332), Drug Information: 301-796-3400 (8:00 a.m. - 4:30 p.m. Eastern Time). For electronically submitted invoices, the FDA VendorPayments Team will use the readable transmission date received to determine the invoice received date. Contact directory and links - my.aa.com The site is secure. +31 (0)88 781 7676 (for use only as stated in the instructions) Urgent phone number for use outside of EMA business hours: Tel. Attn: Vendor Payments Food and Drug Administration Division of Payment Services For mailed invoices, the received date will be the date stamped on the invoice by the FDA Vendor Payments Team. Yes - The date the agency receives a "proper" invoice, as defined by the Prompt Payment Act, determines the invoice received date for the purpose of calculating the payment due date. How do I contact the eOPF Helpdesk? - OPM.gov An official website of the United States government, : Contact Us - Division of Industry and Consumer Education (DICE) | FDA We will respond to your question within 3-4 days (excluding weekends and holidays). FAX (718) 662-5434, Food and Drug Administration All rights reserved. Drug Registrant Information: Invoices are often returned due to a missing Line Item Number, missing vendor contract information and incorrect totals for good/services rendered. For regulatory questions, contact the Division of Industry and Consumer Education (DICE) at dice@cdrh.fda.gov. Accessed 1 May, 2023. 10001 New Hampshire Avenue (202) 307-7936 community.outreach@dea.gov REGISTRATION AND MEDICAL PRACTITIONERS: Medical Practitioners Drug Registrant Information: (800) 882-9539 Drug Enforcement Administration Attn: Office of Diversion Control 8701 Morrissette Drive Springfield, VA 22152 Registration questions: DEA.Registration.Help@dea.gov DEA POLICY QUESTIONS: arrow_drop_down Helpful Links : Import Trade Auxiliary Communications System v . The site is secure. Oakland Federal Bldg WebHelpDesk GENERAL QUESTIONS: 5901-B Ammendale Rd. The .gov means its official.Federal government websites often end in .gov or .mil. 2. The .gov means its official.Federal government websites often end in .gov or .mil. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. The invoice must contain the following information: Complete and proper invoices are paid by the payment due date which is calculated based on the following factors: Will the FDA accept invoices that are submitted electronically? III, San Fernando City, La Union(072)682-0708, b. Executive Resources: provides leadership, direction, coordination, and policy guidance on Agencywide executive resources and scientific programs or services. Contact Us - Genentech San Isidro, City of San Fernando, Pampanga(045)649-4341, a. 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. Mindanao East Cluster#31 2/F, Lotrim Construction Inc. For more information, contact 866.807.ERIC (3742), also via e-mail at ERIC@FDA.GOV, An official website of the United States government, : Thank you for contacting the FDA UDI Help Desk. Lock Always include the Contracting Officer Representative (COR) or designated receiver as Cc on the email. Hillandale Building, 4th Floor HFR-NE1 These social media sites are commercial sites and not required to follow government standards. FDA Industry Systems / FDA Unified Registration and Listing Systems (FURLS) / Technical Help. Secure .gov websites use HTTPSA lock ( Fax: +1-757-224-0179 [email protected] . 5600 Fishers Lane Before sharing sensitive information, make sure you're on a federal government site. Coordinates and provides data information requests from internal and external clients to include coordinating demographics and workforce data for various HR reports (e.g., Staffing Reports, FOIA Request, Ad Hoc Data Request).
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