FDA UDI Help Desk | FDA - U.S. Food and Drug Administration DEA Policy Questions should be sent in writing.DEA Diversion Control DivisionAttn: Liaison and Policy Section 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. For specific information about drugs or drug products please contact the following Division: Food and Drug Administration An invoice that has been returned as improper will have a cover letter explaining the reason for return. 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.). Regional Field Office VIFDA-RFO VI, 3rd Floor Gaisano City Capital, Luna St,. The payment period does not begin until the date the invoice is received by the FDA Vendor Payments Team. To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. Should rounding be completed on the invoices current billable lines and/or subtotals for services/goods? Complete description of the problem WO32 Second Floor Regional Field Office IV-B3/F Halcon Heights Bldg., Roxas Drive cor Dama de Noche, Brgy. GENERAL QUESTIONS: Help. (404) 347-4266 5901-B Ammendale Road Center for Drug Evaluation and Research Indiana Medicaid: Providers: Pharmacy Services 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. How to comment on proposed regulations or submit petitions. . Hillandale Building, 4th Floor Regional Field Office VIIFDA-RFO VII, North Road, Jagobiao, Mandaue City,Cebu(032) 262-0996, c. Regional Field Office VIIIPerpetual Help Credit Cooperative Inc. (800) 882-9539, Drug Enforcement AdministrationAttn: Office of Diversion Control . Tel. 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. Hours: 8 a.m. to 8 p.m. CT, Monday through Friday. How do I contact the eOPF Helpdesk? - OPM.gov 2. FDA Industry Systems Drug Enforcement Administration - DEA @DEAHQ. If you need additional help or wish to make a suggestion, please contact us using the email form below. (214) 655-8100 X111 Contacts at the European Medicines Agency DEA. Please be as specific as possible to help us in our efforts to support you. The Web Server number (found on the bottom left of the accept screen) 6. 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? Civic Drive Filinvest Corporate CityAlabang, Muntinlupa City In addition, DICE develops educational resources for the FDA website to help the medical device industry understand FDA regulations and policies. PDF CVS Caremark Payer Sheet Within each of these categories, there are approximately 30 services ranging from audio or video or . The Line Item Number is a one or two-digit number that is used to identify each supply/service item on the contract agreement. 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. Contact Us | disasterassistance.gov 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. Skip to main content; Skip to FDA Search . South Luzon ClusterFDA Building, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City(02)8 857-1900 local 8106, a. Contact information (phone and email) 4. Lapaz, Iloilo City(033) 500-5609, b. Provide recommendations and training strengthening compliance and accountability programs. Our stakeholders always have accurate, timely, targeted, and useful educational information about medical devices and radiation-emitting electronic products. The FDA's service catalog is comprised of seven parent categories including infrastructure services, personal and mobile computing, enterprise IT application services, professional services, training, governance and general and administrative. Contact Information. Frederick, MD 21701. Connect with UnitedHealthcare | AARP Medicare Plans Mindanao East Cluster#31 2/F, Lotrim Construction Inc. 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. HFR-NE1 If you need immediate assistance, Registrar Corp can help. Beltsville, MD 20705-1266, Mailing Address for Therapeutic Biologic License Applications (BLAs) ), price, quantity, discount, shipping and performance terms, Electronic funds transfer (EFT) remittance information, Company contact name, title and direct phone number, The term "invoice" can include receiving reports and delivery tickets when contractually designated as a requirement for payment completion. Phone: +1-757-224-0177. Technical Phone Support - Fresenius Medical Care GUDID Account Creation: Five Steps to Follow - Reed Tech CAQH ProView - Contact CAQH To report pharmaceutical drugs (i.e., oxycodone, hydrocodone, etc. Pharmacies are required to submit upper case values on B1/B2 transactions. 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 However, we are unable to provide assistance outside of the scope of ERIC and are unable to provide reference services. Springfield, VA 22152 An official website of the United States government, : HFR-PA1 Silver Spring, MD 20993, Mailing Address for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs) HFR-SW1 CBP Line Number. How can I get help using ERIC? 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 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 Call or Visit Us. DEA. 158-15 Liberty Avenue WebHelpDesk Medical Practitioners Please contact us! +31 (0)88 781 6000 (EMA switchboard) Tel. Before visiting the sites, become familiar with their privacy policies and usage rules. DEA. Beltsville, MD 20705-1266, Mailing Addresses for Return of Adverse Event Reports to CDER, For voluntary reports from healthcare professionals and consumers: 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). The Drug Enforcement Administration uses a variety of social media outlets to provide accurate, official information to the public. Registrar Corp assists businesses with U.S. FDA compliance. Beltsville, MD 20705-1266, Abbreviated New Drug Applications (ANDAs) The Office of Human Capital Managementstrives to be a valued business partner with our FDA counterparts. 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. Registration questions:DEA.Registration.Help@dea.gov, DEA POLICY QUESTIONS:Liaison and Policy Section Executive Resources: provides leadership, direction, coordination, and policy guidance on Agencywide executive resources and scientific programs or services. The Division of Industry and Consumer Education (DICE) answers questions (by phone and email) from the medical device industry and consumers of medical devices and radiation-emitting electronic products. | Note: For HHS OIG personnel inquiries, please proceed to https://oig.hhs.gov/ 10903 New Hampshire Ave FAX (312) 886-1682, Food and Drug Administration Each account identifies a separate Labeler Organization, typically the corporate headquarters. If the FDA Vendor Payments team is not included in the invoice submission, the invoice will be returned to the vendor. For more information, contact 866.807.ERIC (3742), also via e-mail at ERIC@FDA.GOV, An official website of the United States government, : 20 N. Michigan Ave, Rm 510 Dallas, Texas 75247-4982 For more information, see Quality defects and recalls. To report unlawful or suspicious activities on the Internet onlyUnlawful Internet Prescription Drug Sales or Suspicious Online Pharmacies Points of Contact for Drug Registration and Listing | FDA Import Trade Auxiliary Communications System - Food and Drug Administration Central Document Room (CDR) Website technical support. 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. Center for Drug Evaluation and Research no: +632 8 857-1900 For regulatory questions, contact the Division of Industry and Consumer Education (DICE) at dice@cdrh.fda.gov. Jamaica, New York 11433-1034 Regional Field Office X2nd Floor, Almie Rose Chan Yu Bldg., Zone 7, Bulua, Cagayan de Oro City(088) 882-2842, b. Also see: Medicare.gov or Call 1-800-MEDICARE (for people with Medicare) Our stakeholders include the medical device industry, consumers, patients, healthcare providers, FDA colleagues, and other Federal, State, and local government agencies. CDER Central Document Room: Point of Contact Contact Information; Department of Agriculture (USDA) . 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? MedWatch - Central Triage Unit Fax: (650) 225-4630. 5901-B Ammendale Rd. Contact Us | ORAPP - Food and Drug Administration Tel. What are the most common reasons that an invoice is returned? Contact Us | Frederick Health The team maintains close coordination with other pertinent FDA offices involved in IT development and provides input to Agency human resources information systems technology. 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). FAX (214) 655-8130, Food and Drug Administration Please be as specific as possible to help us in our efforts to support you. Contact Us - DEA Fax: +1-757-224-0179 [email protected] . Oakland, California 94612-5217 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. Oakland Federal Bldg 20 HHS Employee Directory - PSC arrow_drop_down Helpful Links : Import Trade Auxiliary Communications System v . The .gov means its official.Federal government websites often end in .gov or .mil. 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. For more details, see How to Report a Problem. To get started, at a minimum please enter an Entry Number. North Luzon Cluster3/f Primus Medicus Bldg., Mc Arthur Hiway, Brgy. Division of Payment Services The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Contact Us - National Institute of Allergy and Infectious Diseases 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. 2nd and Chestnut Streets Before sharing sensitive information, make sure you're on a federal government site. 5600 Fishers Lane FDA Line Number. 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. HFR-MW1 The Indiana Family and Social Services Administration (FSSA) is making resources for the management of opioid therapy easily available to the provider community. 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. See Contact FDA Centers and Offices below or search the employee directory. 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. Thank you for contacting the FDA UDI Help Desk. If the due date or discount date falls on a weekend or federal holiday, the FDA will issue payment by the following business day. 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. 3 June, 2018. Contact Us - Division of Industry and Consumer Education (DICE) | FDA FEMA Helpline General questions or comments about FEMA disaster assistance for individuals and families can be emailed to: AskIA@fema.dhs.gov The site is secure. If you are experiencing a life-threatening medical emergency. Phone: (888) 835-2555 Hours: 24 hrs/day, 7 days/week. PDF Agent and Broker Marketplace Help Desks and Call Centers ) or https:// means youve safely connected to the .gov website. Frederick Health. HFR-MA1 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). Before sharing sensitive information, make sure you're on a federal government site. It can be found on the award. Office of Human Capital Management, Recalls, Market Withdrawals and Safety Alerts. "Contact Us. 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. Contact Us For ORA DX Support, complete the form below or contact the ORA Applications Help Desk at 240-247-8803. Select the links below for access to these resources: Substance Use Disorder Treatment Overdose Prevention Therapy-Indiana (optIN) NextLevel Recovery Agency/Organization . Invoices are often returned due to a missing Line Item Number, missing vendor contract information and incorrect totals for good/services rendered.