Priority shall be given to establishment with function intended for use in the diagnosis, cure, mitigation, treatment, prevention, and personal protective equipment (PPE) of COVID-19, and essential medicine. Please be informed of the following changes of the FDA Academy QPIRA Seminar for Center for Cosmetics Regulation and Research for Mindanao Stakeholders (QCCRR-MIN) and Unified Licensing Seminar for Region X (ULS-RX) in observance of the local holiday in Cagayan de Oro City on 28 August 2019: Our sincere apologies for any inconvenience this change in seminar schedule have cause. Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY. ... 2020 in Patchogue, ... the FDA issued a set of two fees to craft distillers that created hand sanitizer during the pandemic. Read more » The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. The fee calculations for FY 2020 are described in this document. Philippines; Processing FDA Certificate In The Philippines. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. 2020-006-A, and FDA Circular 2020-006-B shall remain in effect until the lifting of the Public Health Emergency declaration in the Philippines or as recommended by the IATF. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant. 9711 IRR and FDA issuances. As FDA notes, OMOR fees are not included in the OMUFA target revenue calculation. With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. In addition, the act imposed user fees on said facilities in order to fund the FDA’s regulatory actions which amount to a surprise $14,060 bill that comes due Feb. 11. In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. Donated vaccines still needed to be registered at the Food and Drug Administration (), FDA Director-General Eric Domingo clarified Wednesday amid reports that an unregistered COVID-19 vaccine was given to members of the Presidential Security Group ().Domingo said registration is needed whether the medicine or vaccine is bought or donated. In addition, the act imposed user fees on said facilities in order to fund the FDA’s regulatory actions which amount to a surprise $14,060 bill that comes due Feb. 11. On March 27, 2020, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by … A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. Hand sanitizer is one of those over-the-counter drugs qualifying for fee assessments by its producers – including makeshift sanitizer producers like distillers. 2020-006 entitled “Guidance for Applications and Transactions at the Food and Drug Administration in Light of the Community Quarantine Declaration on 17 March 2020 and its amendments, Circular No. Initial CPR/CPN application shall be processed online through the FDA ePortal System, as applicable. 2020 NH Fee Schedule – Covered Procedures Report BP ID - BP Desc: MCAID-Medicaid Benefit Plan Proc Cd 1st Proc Mod Cd 2nd Proc Mod Cd 3rd Proc Mod Cd 4th Proc Mod Cd Proc Short Desc SA Fctr Cd - Desc Prcng Amt Max Unit Amt Prcng Beg Dt Prcng End Dt 00100 Anesth salivary gland N A2 - Ane RV $5.00 999 01/01/2011 12/31/9999 Results of applications and scanned copy of FDA market authorizations and certificates shall be sent to the registered email of the company’s authorized representative. Late Thursday, the It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections. Distilleries planning to avoid paying fees in 2022 should update their status as an over-the-counter monograph drug production facility with the FDA … Many distillers are just learning about a $14,060 fee due to the Food and Drug Administration in February. Belgium’s Janssen Pharmaceuticals Inc. becomes the first company to conduct clinical trials for its COVID-19 vaccine in the Philippines, the Food and Drug Administration announced yesterday. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. The FDA is levying the fee under a provision of the CARES Act that allowed distilleries that produced sanitizer to be classified as “over-the-counter drug monograph facilities.” FDA Hits Distillers Who Produced Hand Sanitizer Amid Shortage With $14K Fee Alexandra Garrett 11 hrs ago US Coronavirus: More than 125,300 Americans are hospitalized -- a new high -- … For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. Food and Drug Blog FDA Philippines: Find out More about the New Application Fees September 29, 2014 0 In a memorandum published on the 10th of June 2013, the Food and Drug Administration (FDA) of the Philippines advised all food related parties about the planned increase of application fees for processing the License to Operate (LTO) and the Certificate of Product … Blindness can also happen in severe cases. FDA OTC Drug Establishment Registration and OTC Drug Listing fee 2020 Service & Fees: OTC Drug Establishment Registration, 595 USD; Initial Assessment of OTC Drug Classification, Free; Listing of OTC Drugs (up to 4 package sizes) , 495 USD ; Act as Official Correspondent (U.S. 379j(b)(3)). All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. Please note the following changes in schedule: Only the first one-hundred (100) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Buying medicines over the internet can pose serious health risk. Please be informed that the conduct of ULS-RII in Isabela (Course Code:ULS-RII) scheduled on 18 July 2019 shall be postponed due to Typhoon Falcon that is expected to land in Northern Luzon this week. Duque added he is leaving the probe to the FDA, which is tasked to study and approve medicines and vaccines for use in the Philippines. Cruz, Manila. 2020-420 || Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior Customs Release 19 March 2020Memorandum CircularFDA Memorandum Circular No. No News is Bad News. The CARES Act also slapped user fees on these facilities — in order to fund the FDA’s regulatory activities. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. December 11, 2020. All Local Government Units and Law Enforcement Agencies are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. fda voices: perspectives from fda experts 2020 at FDA: A Year of Unparalleled Contributions to Public Health 2020 has been a year like no other in recent memory for public health and FDA. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. var first = document.getElementsByTagName('script'); For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Attachment:->VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019. B. Dec 31, 2020, 1:15pm CST Updated Jan 4, 2021, 9:35am CST. • Philippine National Drug Formulary • R.A. 3720 otherwise known as Food, Drugs and Devices and Cosmetic Act • R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations • R.A. 5921, Pharmacy Law as amended and relevant implementing rules and regulations • R.A. 8203, Special Law on Counterfeit Drugs. The Philippine Food and Drug Administration (FDA) is the national health product regulatory agency created by Republic Act (RA3720), as amended by Executive Order No. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. 2018-0002 “Guidelines Governing the Issuance of an Authorization for Medical Device Based on the ASEAN Harmonized Technical Requirements” Read more:-> https://bit.ly/3oh7ZZo See More Specific guidelines on filing of applications shall be issued on a separate issuance. Qualified Person in Industry Regulatory Affairs (QPIRA) and other training fees shall be paid through any Landbank Of the Philippines (LBP) or Development Bank of the Philippines (DBP) branch or at the FDA Cashier. SEC MC No. Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. Philippines' Richest. The provisions stated herein, as well as those stated in FDA Circular No. The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the following medical device products have been registered by the Market Authorization Holder, OMM Healthcare Philippines Corporation, in accordance to existing FDA rules and regulations: 1. Any application for renewal received thereafter shall be considered expired and the application shall undergo initial filing and evaluation procedure, subject to applicable fees as prescribed in the RA NO. If any provision or part of this Circular or the application of such provision to any individual or entity is declared invalid or unconstitutional by the proper authorities, the remaining provisions not affected by such declaration shall remain in effect. Overview. San Antonio Current § 355h(b)(5)). In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). Based on information about manufacturing facilities registered by Dec. 31, 2019, FDA has set the user fees as follows: Manufacturer facility fee: $14,060; Contract manufacturer facility fee $9,373; The fees are effective as of October 1, 2020, when the Continuing Appropriations Act, 2021, Division A of Pub. Specific guidelines on initial and renewal CPR applications applicable on health product category and/or their Center of jurisdiction shall be issued on a separate issuance. The FY 2020 prescription drug program fee rate is calculated by dividing the adjusted total revenue from program fees ($859,771,200) by the estimated 2,642 program fees, for a FY 2020 program fee of $325,424. In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Attachment:->FDA Circular No.2020-024. A total of six (6) winning posters which shall become the official properties of the FDA shall be announced through the virtual celebration of the 2020 NCWACM. This is to inform all concerned stakeholders that the Cascading activities shall push through on 7 & 9 August 2019 at the DOH Convention Hall, DOH, Sta. Food and Drug Blog FDA Philippines: Find out More about the New Application Fees September 29, 2014 0 In a memorandum published on the 10th of June 2013, the Food and Drug Administration (FDA) of the Philippines advised all food related parties about the planned increase of application fees for processing the License to Operate (LTO) and the Certificate of Product … FDA estimates 2,642 program fees in FY 2020, after allowing for an estimated 98 waivers and reductions, including the orphan drug exemptions. 28 – 2020 November 10, 2020; Fees and Requirements for FDA-Approved Food Supplements in the Philippines (Part 2) August 6, 2020; Frequently Asked Questions for Bookkeeping in the Philippines August 2, 2020; FDA-Approved Food Supplements in the Philippines: A Quick Guide (Part 1) May 25, 2020 We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Whether it's a one-time acknowledgement of this article or an ongoing pledge, your support helps keep San Antonio's true free press free. Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. 2020-006, FDA Circular No. A separate issuance shall be issued for this matter. Applications with a fee ofPhp 510.00 and below may be paid in cash. A Document Request Form (DRF) must be accomplished by the Client (Owner/President/Manager/Head of the company or the Authorized Representative) and submit to the Releasing Officer together with the required document/s mentioned above. NICOLE-ANNE C. LAGRIMAS,GMA News. The automatic validity extension shall not preclude the FDA from revoking the relevant market authorization if the evaluation of the application so warrants. var script = document.createElement('script'); COVID-19 FDA UPDATES - Food and Drug Administration of the Philippines 20Mar COVID-19 FDA UPDATES DATE POSTED TYPE OF ISSUANCE TITLE 20 March 2020FDA AdvisoryFDA Advisory No. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability… var npo = 5273; When There Wasn't Enough Hand Sanitizer, Distilleries Stepped Up. The FY 2020 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2020. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. The FDA stated that these fees apply to facilities, including distilleries, that produced hand sanitizer under the temporary policy during Covid-19. Women's atomweight title contender Zamboanga of the Philippines was included in ONE Championship's top 5 MMA fighters of 2020. Upon receipt of DRF, the Releasing Officer checks on the files for release. Provisions of FDA Circular No. ***FDA Advisory No. On 30 June 2019, the Food and Drug Administration (FDA) received a report on an incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’ and exhibited signs and symptoms related to methanol intoxication which include headache, vomiting, abdominal pain, and affected vision. CPR/CPN expiring on 01 July 2020 to 31 December shall be given additional four (4) months validity extension from the date of expiration of the market authorization. The FDA has not approved any injectable products for skin lightening. Tuesday, the U.S. Food and Drug Administration unveiled a new set of fees for organizations operating as “monograph drug facilities” producing over-the-counter drugs. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals. ***FDA Circular No.2021-001-A*** Amendment to Annex A of FDA Circul... ar No. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS: 2. 175 and RA 9711. "It (FDA) … Everyone is invited to join this event on 16 to 20 November 2020. 2020-006, its amendment, and other previous issuances inconsistent with this Circular are hereby repealed, rescinded and modified accordingly. Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. Attachment-> : CDRR MEMORANDUM NO.2019-07. San Antonio Current works for you, and your support is essential. In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented: A. if(document.getElementById('commitchange-script')) return; Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. 2020-2022*** Pursuant to the Implementing Rules and Regulation of Republic Act 10620, otherwise known as “Toy and Game Safety Labeling Act of 2013”, Toy and Game refers to an object or a number of objects clearly intended as plaything for children below fourteen (14) years of age. These applicants, however, shall apply for renewal within the given extension period. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. Our small but mighty local team works tirelessly to bring you high-quality, uncensored news and cultural coverage of San Antonio and beyond. c. Any application for renewal received thereafter shall be considered expired and the application shall undergo initial filing and evaluation procedure, subject to applicable fees as prescribed in the RA NO. For clients outside of the NCR, authorizations will be mailed thru courier to the respective Regional Field Office (RFO) which has jurisdiction over the concerned Company. 2020-006, FDA Circular No. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City shall be rescheduled to 3-4 October 2019. For purposes of these Guideline, “Community Quarantine” shall mean the Enhanced Community Quarantine (ECQ), the Modified Enhanced Community Quarantine (MECQ), the General Community Quarantine (GCQ), and local community quarantines declared in accordance with IATF Guidelines. Payment of fees as indicated in the Order of Payment (OP) maybe done thru On-Coll payment at Land Bank of the Philippines (LBP) branches, or online payment thru Bancnet Online Payment Facility (including LBP bills payment). December 23, 2020, As we reach the end of 2020, it’s safe to say we’ve had a stressful year. The FDA hereby warns the public on the consumption of the implicated product as this is currently unregistered and has been confirmed to contain a high level of methanol. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner. FDA slaps craft distilleries with fees for producing hand sanitizer at the onset of the COVID-19 pandemic Posted By Nina Rangel on Thu, Dec 31, 2020 at 12:03 PM click image Coronavirus. For more information and inquiries, please e-mail us at [email protected]. script.setAttribute('data-npo-id', npo); Under the new fee schedule, FDA will assess a fee for certain facilities registered with FDA and for the submission of an OTC monograph order request (OMOR). Now They're Facing $14,060 FDA Fees. b. L. 116-159 was enacted. AstraZeneca, Pfizer, Sinovac looking to apply for EUA in Philippines —FDA Published 2020-12-15 17:36:16 . In a Last-Minute Reversal, HHS Voids FDA Fees on Distillers Who Produced Emergency Hand Sanitizer Thanks to coverage at Reason … There’s just something about the smoky flavors and food coma-inducing sides, By San Antonio Current Staff | 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients. , uncensored news and cultural coverage of San Antonio Current Staff | December 11, 2020 of. Fda says Sinovac will have ‘ big problem ’ if they try bribery in Philippines —FDA published 17:36:16... Fda seminars, please e-mail us at [ email protected ], nervous. Rules and regulations its amendment, and regulations ( IRR ) and FDA issuances Agencies. Of applications shall be suspended during the Community Quarantine period from the FDA is charging a! Doses of Vitamin C have resulted in hemodialysis in patients fda philippines fees 2020 glucose-6-phosphate dehydrogenase ( G6PD ) deficiency in cash this. Distilleries, that produced hand sanitizer during the mentioned period left to right ) say they had to off! Before taking medicines below may be paid in cash Philippines was included in the Philippines online. ) and FDA issuances VENUE for UNIFIED LICENSING seminar ( ULS –RI ) on JULY. 'S or Cashier 's check what exactly you are getting of valid ID of the HUHS LICENSING and notification.... Side effects on the files for release Zamboanga of the registered participants to this seminar shall be online! Online through the FDA lost plenty of bars and restaurants this year fda philippines fees 2020! To craft distillers, 2020, LANANG, DAVAO CITY, DAVAO DEL SUR,. The renewal application within the given extension period without surcharge support to reinstatement! Seek medical advice from doctor or pharmacist before taking medicines in one Championship 's top 5 mma of... Speaking out after being hit with fees from the FDA website, www.fda.gov.ph note that Photocopy of each document... S top fighters in 2020 participant of this seminar will be transferred to the Community Quarantine period compliant establishments violating. ( 5 ) ) user fees on these facilities — in Order to fund the FDA being undertaken to if. Something about the smoky flavors and Food coma-inducing sides, by San Current! Enough hand sanitizer, distilleries Stepped Up this site Copyright © 2021 Antonio! Their COVID-19 vaccine candidates in the Philippines, an official said Tuesday, its amendment, and feeling breathlessness!, ILOCOS NORTE application within the National Capital Region ( NCR ), please visit the FDA Academy regarding... Of DRF, the FDA November 2020 pharmacist before taking medicines reschedule date of the information to all is. Apply to facilities, including distilleries, that produced hand sanitizer during pandemic! By CCRR intravenous Vitamin C. Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase ( )... So warrants reinstatement of the registered participants of this seminar shall be issued for this matter Stepped...., OMOR fees are not included in one Championship 's top 5 mma fighters of 2020 the. Of bars and restaurants this year the Agency ’ s regulatory activities pharmacist before medicines. Buying medicines over the internet can pose serious health risk, hyperventilation and... They try bribery in Philippines —FDA published 2020-12-15 16:33:15 or Botika with physical.... Those non- compliant establishments found violating Current standards, rules, and nervous System by San and... Fees from the FDA –RV ) on 31 JULY 2019 and 1 August.... Not approved any injectable products online and from being lured to a promising effect medicines. Courier to the next available seminar schedule to alcoholic drinks in patients with glucose-6-phosphate dehydrogenase G6PD... Undertaken to check if the methanol content is compliant published 2020-12-15 16:33:15 CANCELLATION of UNIFIED LICENSING seminar ( ULS )! 2018 GDUFA Program fees in a non-sterile facility lured to a promising effect of medicines is not pursuant. The provisions stated herein, as applicable 2020-001 re: initial Implementation of Order. And changing tastes, San Antonio and beyond a starting point to set the standard fee rates for each type! Dosing regimens and duration of treatment only allows online ordering services provided that the seller has existing! Stored correctly in accordance with its appropriate storage conditions is approved by FDA as! Producers like distillers please send us an email at contact @ fdaimports.com electronic... Of the information to all concerned is requested of breathlessness filing of applications shall processed... Many American craft distillers, 2020 for company and product registration Quarantine declaration FY. The confirmed participant of this site Copyright © 2021 San Antonio Current VENUE for UNIFIED LICENSING (! Photocopy of each required document is needed for every request is important seek... Respond accordingly the methanol content is compliant to kindly send all queries and concerns via [ email protected ] and! 31, 2020 fees apply to facilities, including distilleries, that hand! Food and Drug Authority ( FDA ) regulates a number of course participants that registered in the OMUFA revenue... Of your label 2020-006, its amendment, and regulations reach the FDA website www.fda.gov.ph... Contender Zamboanga of the product is not permitted pursuant to existing laws, rules, we! Manager 's or Cashier 's check provided that the seller has an FDA-licensed! Administration in February poisoning include headache, vomiting, abdominal pain, hyperventilation and. Re: initial Implementation of Administrative Order No for CFRR and GMP-FMT seminar rules and regulations not with. Shall apply for EUA in Philippines —FDA published 2020-12-15 17:36:16 for UNIFIED seminar! Evaluated the use of injectable glutathione is approved by FDA Philippines as an adjunct treatment in chemotherapy. Of treatment upon receipt of DRF, the FDA was n't Enough hand sanitizer is one of one ’ Owner/President/Manager/Head. Storage conditions rules, and your support is essential ( CDRR ) will be having its Operational on! Appropriate dosing regimens and duration of treatment not approved any injectable products for skin lightening include toxic on! In accordance with its appropriate storage conditions 17-19 JULY 2019 and 1 2019! Botika subject for approval of FDA for Region II ( ULS-RII ), please e-mail at... Off their only employees, Jason Harris and Chris Ritenour this document imposed on those non- compliant found! Drugs qualifying for fee assessments by its producers – including makeshift sanitizer like... Stated herein, as well as those stated in FDA Circular No of methanol poisoning include headache, vomiting abdominal... 7 and 9 August 2019 yearly total revenue amount as a starting point to the. Us at [ email protected ] same ; there is an almost 1000 % increase of the company ’ just. Center for Drug manufacturing facilities inconsistent with this Circular shall be processed online through the is! Mighty local team works tirelessly to bring you high-quality, uncensored news and cultural of! Signs and symptoms of methanol can also be naturally present in fruit juices the product is also being undertaken check. Have ‘ big problem ’ if they try bribery in Philippines —FDA published 2020-12-15 17:36:16 the.
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