. sun/veg,? uner o? a 40 0" W410 DEPARTMENT or HEALTH HUMAN SERVICES Food and Drug Administration Rockv?le MD 2057 NOV 29 2005 The Honorable Tom Price House of Representatives Washington, DC. 20515-1006 Dear Mr. Price: Thank you for the letter of August 30, 2005, concerning your request that the Food and Drug Administration (FDA orthe Agency) proceed expeditiously with apprOVal of (4) processed decellularized human tissues, namely, - . As you probably know, FDA is prohibited by law from con?rming or denying the existence of an application unless the sponsor or the manufacturer of the product publicly acknowledges the application or provides the Agency with written or disclose: 1 information contained in its application. As (4) gave us this authorization on October 4, 2005, we have enclosed a letter from FDA dated (4) I '5 that mayaddress ISOrn'e of your concerns. If you have further questions after reviewing this letter, please contact us. The enclosed letter contains trade secret, commercial con?dential, or other privileged information protected from disclosure to the pUblic under the Freedom of InfOrmation Act (Title 5, United States Code section Trade S'ec?r'etsuA'ct (Title 18, section 1905), and FDA regulations. Please ?do nOt publish or'otherwi'Se make public any i such information. We would be glad to further diScuss the protected status of the information. Thank you again for contacting us concerning this matter. If you have ?irther questions, please let us know. Sincerely, 3W MA Patrick Ronan Associate Commissioner for Legislation Enclosure -. .- - COMMITTEE ON FINANCIAL SERVICES SUBCOMMITTEES: OVERSIGHT FINANCIAL lusmu?rIONs AND INTERNATIONAL Poucv TOM PRICE. M.D. 01" DIsmct, Geonou WASHINGTON, DC OFFICE: 506 CANNON House OFFICE BUILDING WASHINGTON. DC 20515 (202) 225-4501 FAX: (202)225?4656 COMMHTEE 0N EDUCATION AND THE won a Congress at the ?ttmteh ?utes MARIETTA, GA 30062 WORKFORCE PROTECTION 21ST CENTURY COMPETITIVENESS ASSISTANT DEPUTYWHIP August 30, 2005 Lester M. Crawford, DVM, Commissioner US. Food and Drug Administration 9.3. 5600 Fishers Lane {a . Rockville, MD 20851-0001 7 -- - -. mm135??: Dear Dr. Crawford, .17} i? . . . 31> The purpose of this letter is to convey to you my sincere concern about-the potential disruption 111" i the availability of the tissue used to replace missing cardiac valves in infants.) and children. As a physician and surgeon for over 25 years this issue is of great importance to me. It is my understanding that the Food and Drug Administration is continuing its review of several regulatory ?lings regarding (4) Irocessed decellularized human tissues, namely, (4) I As you lmow, these tissues undergo a process designed to remove the cellular components of the tissue without damaging their structure. The decellularization is not a substantial change from the current process and has the added signi?cant bene?t of decreasing the rejection rate. These products have been shown to offer a marked clinical bene?t and can truly be life-saving to children undergoing open-heart surgery for congenital cardiac defects' The lack of availability of this option severely impairs the ability to'treat' children with complex heart diseases or defects. After hearing the frustration from numerous cardiothoracic surgeons, around the country, I strongly believe there is' a?serious need for this improved clinical technology. I look forward to these products being available in the surgical armamentarimn in the United States as soon as practical. It is my understanding that the FDA has repeatedly granted approval, in previous decisions, for other decellulan'zed tissue products with similar technology. Iwould anticipatethat the agency would act with consistency in this instance. With respect, I request that you proceed with and Complete FDA to investigation of this matter expeditiously. Thank you for your time and sincere consideration of this matter. I lock 'forWard to your response. - Yours Trul Pr' M.D. w/ 2 .- 7 4 PRINTED ON RECYCLED PAPER [Vl' 5? gnu" 3~l DEPARTMENT or HEALTH HUMAN SERVICES Food and Drug Administration Rockville MD 20857 ?l?he Honorable Tom Price, M.D. House of Representatives OCT 0 9 2009 Washington, DC. 20515-1006 Dear Dr. Price: Thank you for your letter of July 21, 2009, on behalf of your constituent, Ms. Constance W. Sturgeon, President of Fertility Technology Resources, Inc. in Marietta, Georgia. In your letter, you requested that the Food and Drug Administration (FDA or the Agency) ensure that correct standards and procedures are being applied to the review of Ms. Sturgeon?s 510(k) application for the (4) FDA is prohibited by law from con?rming or denying the existence of an application unless the sponsor or the manufacturer of the product publicly acknowledges the application or provides the Agency with written authorization to release or disclose information contained in its application. On September 17, 2009, Ms. Sturgeon provided written authorization to FDA to release information contained in her application. The Agency has advised Ms. Sturgeon that the device in question?v 3 a, Center for Devices and Radiological Health (CDRH). In accordance with the Least Burdensome approach, data from a clinical trial is not required for purposes of clearing a 510(k) medical device in most cases. Per 21 CFR 807 Subpart E, the sponsor, however, will need to demonstrate the device in question is substantially equivalent to a legally marketed predicate device. At present, DIHD is still engaging in an open dialogue with Ms. Sturgeon regarding the necessary data to support the clearance of the (4) The speci?c issues in question are discussed in detail in the e-mail enclosed in your letter. Any medical device sponsor who believes that the FDA review process is unreasonable or unfair, may follow the appeal procedure outlined in 21 CFR 10.75. Alternatively, the sponsor may pursue one of the other dispute resolution/appeal processes, such as a Citizen Petition under 21 CFR 10.30, or by contacting the CDRH Ombudsman at 301- Page 2 The Honorable Tom Price, M.D. 796-5699 or A formal appeal request is ordinarily required to be in writing. The request should clearly identify the action being sought, and provide an explanation of the reason(s) for the request. The sponsor should provide the name, address, phone number, and e-mail address of a contact person from whom additional information can be obtained if necessary. Thank you for contacting us about this matter. If we can be of further assistance, please let us know Sincerely, 7x. a Stephen R. Mason Acting Assistant Commissioner for Legislation 1 69 ?an MODE MEMORY TRANSMISSION 02:03 02:04 FILE SEN COMM. STATION EMAIL TELEPHONE NO. PAGES DURATION 001 OK 5917705557570 003 00:00:34 OFFICE OF LEGISLATION- TELEEAX TRANSMITTAL SHEET FOOD AND DRUG ADMINISTRATION Of?ce of Legislation, 5600 Fishers Lane ParklaWn Bldg. IRoom l5-55 Rookvillo, MD 20857 TEL: (301) 827-3 793 FAX: (301) 827-1960; 827-1955; 8274614 DATE: 7570 Emik/ Groom: I . COMMENTS: NUMBER OF PAGES. INCLUDING COVER: I . If you do not mceive the number of pagcg indimed above, please ?ll immediately This document is intended only for the us: of the party to whom it is addressed and may contain information that is I privileged. con?dential, and protected from disoloswe under applicable law. If you are not the addressee. or a person authorized to deliver the document to the addressee, you are hereby noti?ed that any review, disclosure, dissemination. copying, or Other action based on the content. of this communication is not authorized. if you have received this document in error, please immediately notify us by telephone and return it to us at the above address by mail. Thank you. .- . .MIDI I I. I .. 0mm. 11' I I FINANCIAL lumen: . . . 3 ., 'Ovmstek'r woman-tenuous wammn?ocmce .. .. t. . . Q4cMmunsaOrh?ewtum(202)225-4501 ?lmb FAX: mans-4353?tummy at the vaults}! amiss; ..: - :gg. . .t Ei??Lgmgu-r. Lam'mo Reasons Iv .. . a - Mr. Stephen R. MasOn . Assistant ComrniSSioner 'fb'r Lsgislatibh' ded andDrugAdministr?tion? . US Department of?H?alth Services . . 153-31P3Ik1awnBuilding . 1' .- i . 5600 Fishers 1 .. .. Dear Mr. Mason: I am writing on behalf of T??hn?1?gY RGSOuIc?s?in'Mari?tt?; cpmpany . - fertility specialists around the bb'? are h?a?v'ih' dist?butiono Cunently, sh?ihas; encountgz'r?d pro' '16 Mt ?the?F?d?H =i?s2tf?tim?1? (FDA) ?Wing ?"535 . ., - ofthe community for over'ZO y?a'i?s??d'has?l?v?ysjb?cn l??eii?g'FDKf" standards. . . . _s . .Shas ., V. The deIOiVi?g?pfbj'ride'sa'b?? 7. . .. . . unh'ey. - ?guy-v0? - - . -.-. .- - - . - - . . y?w reductto b63914?180 needs to be ei?mbt?d from?Please review her case with?th'? ?hijds'tfeaf?'a??f' 'l?i?eih'zitmt??fwfrectfs? 32m A .and . procedures are being t6 this uhiQue? situationMr. Tom Kraus Associate Commissioner for Legislation U.S. Food and Drug Administration 10903 New Hampshire Avenue WO32-2346 Silver Spring, Maryland 20993-0002 Fax 301-847-8602 Mr. Kraus, Please accept this letter as acknowledgement that Magellan Services, LLC has a relationship with Congressman Tom Price MD’s office with regards to FDA’s classification of a product Magellan Services, LLC is associated with and any potential 510K filings required of this said product. Congressman Price and/or his office staff has our permission to view any filings, emails or communications between Magellan Services, LLC and the Agency. Additionally, any responses and/or determinations made by FDA concerning regulation of the said product can be communicated with Congressman Price’s office. If you have any questions as it relates to our desires stated herein, please do not hesitate to contact me at (404) 987-1575. Sincere regards, William Gavlak William Gavlak President Magellan Services, LLC 2065 Peachtree Industrial Court, Chamblee, GA 30341 Phone: (888) 433-3130 5?6 DEPARTMENT OF HEALTH HUMAN SERVICES I I Food and Drug Administration Silver Spring, MD 20993 The Honorable Tom Price, MD. House of Representatives 0 7 205 Washington, DC. 20515-1006 Dear Dr. Price: Thank you for your letter of March 19, 2015, on behalf of your constituent, William Gavlak, President of Magellan Services, LLC iMaiellani, reiardinF On June 30, 201 S, the Food and Drug Administration (FDA) received written authorization from Mr. William Gavlak to disclose, in this response, certain information that we would normally be prevented by federal law from disclosing concerning Magellan?s 510(k) pre-submission. Page 2 - The Honorable Tom Price, MD. Thank you, again, for contacting us concerning this matter. If we may be of ?mher assistance, please let us know. Sincerely, @247 L4, Dayle Lewis Cristinzio Acting Supervisory Congressional Affairs Specialist TOM PRICE, MD. I. COMMITTEE on THE BUDGET 6m DISTRICT, Gsoncm COMMITTEE ON WAYS AND MEANS I DEPUTYWHIP (203225?4658 ?Congress of the Bliniteh 5mm FDA twat Roowstt. GA 30075 1901152 of Representatihes WASHING ION. DC OFFICE. 100 CANNON House on rm; Burton?; Was-?motori. DC 20515 1.202) 225?4501 MAR 2 5 2015 A . March 2015 Elizabeth Claverie-Williams Branch Chief Infection Control Devices Branch Document Mail Center W066-6609 10903 New Hampshire Avenue Silver Springs, MD 20993-0002 RE: eellan 51 mm? (m (am Dear Ms. Claverie-Williams: I am writing on behalf of Magellan Services, LLC regarding their(b) (4) (4) We recognize the need for your due diligence, yet we would appreciate any assistance you could lend Magellan Services in ef?ciently addressing their concerns. Thank you in advance for your time and consideration. We appreciate your utmost attention to this matter. If additional information is needed, please do not hesitate to contact me at 202-225-4501. Yours uly, Ans-w? Tom Price, M.D. (GA-06 2 n53 1215.2 mm ?aw :35 Wang: 9i.? ?i?ggrrazmiaiihg? 325546; 20515?1006 OHICIN. Busmr?ss Ekftx?oebk Ef??'lemg 509mm); Mal-A Center Wobbwerooq \oqog New mama, SAW Sty??35, Mb 9.06% 000.; ?li' From: To: Subject: Date: Attachments: Importance: Grinder, Sharde Grinder, Sharde 2015-2619: Privacy Release attached Tuesday, June 30, 2015 3:54:22 PM Letter to FDA Granting Permission To Communicate.pdf High   From: McIntosh, Tina [mailto:Tina.McIntosh2@mail.house.gov] Sent: Monday, June 29, 2015 2:27 PM To: Jordan, Lillian T (b) (4) Subject: FW: Request for Help: Magellan Services (b) (4) Lillian  Please find attached the letter that I think will suffice for FDA to speak to our office.  Please forward to appropriate office for reply. Thank you again for your time & assistance in this matter.     Have a Blessed day- Tina Tina McIntosh Director of Constituent Services/Office Manager Office of Congressman Tom Price, M.D. 85-C Mill Street, Suite 300 Roswell, GA  30075 770-998-0049 770-998-0050 fax Confidential Notice:  This e-mail message, including any attachments, is for the sole use of the intended recipient (s) and may contain confidential and privileged information.  Any unauthorized review; use, disclosure or distribution is prohibited.  If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.         From: Bill@GreenManifolds [mailto:bill@greenmanifolds.com] Sent: Monday, June 29, 2015 2:24 PM To: McIntosh, Tina; rgrambergs@hotmail.com; duval@duvalFDAlaw.com Cc: DiBlasio, Carla Subject: RE: Request for Help: Magellan Services (b) (4) Tina,   Please find the attached letter that was sent to the FDA today providing Congressman Price’s office the required permission to view our dealings with the Agency over the last 18 months. We are extremely frustrated with the speed of progress (or, lack thereof.) Regards, Bill PRIVACY RELEASE FORM Congressman Tom Price, M.D. Sixth Congressional District of Georgia Date: /,72 - 52 (2 W) (6) Street Address City/State/Llp - 337168) phone Work/Cell Phone Social Security #1 /or All, etc. . (6) I (6) AGENCY Invo ve l0) Spouse/ Other Contact Please provide a brief explanation of your situation with the above agency and specify how our of?ce may be of assistance. Continue on another sheet if necessarymyme . It is im ortant for ou to retain the ori inals for our?les. I E/l/ . 8 few? zip L5 if F?/l ?an/NM Sc?xo?zi/?/zfl (767/??1070/ 5? J72: ?764th {"767 *Z?r?w?e?d If? 1/177 1715/? Am ?rm/1w? (?7k 7% so 7/4727; (war or ?nk/M ?ip x127 r. 41/4 #7 77w [?r/17 far/MC. 7/4/2/ Ft? 2/ Ufa/J 4' /1 rang/V61 77(42/1 ?zz/L? Wig]? ?zz/747; 72/141. (H Privacy Act Release I hereby authorize Congressman Tom Price and those acting in his behalf, in order to attempt to be of assistance to me, ?ining speci?cally to this matter. SIGN Once 85-C Mill Street, Suite 300 Roswell, GA 30075 770-998-0050 Fax 3' DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service xx ?Huma- Food and Drug Administration ?View,? l0903 New Hampshire Avenue Document Control Center Silver Spring, MD 20993-0002 October 9. 2015 SonaCare Medical, LLC Dawn Burleson, RN, MBA, CCRA Vice President of Clinical Affairs 10130 Perimeter Parkway, Suite 250 Charlotte, NC 28216 Re: Sonablate?g? 450 Evaluation of Automatic Class Designation De Novo Request Regulation Number: 21 CFR 876.4340 Regulation Name: High intensity ultrasound system for prostate tissue ablation Regulatory Classi?cation: Class 11 Product Code: PLP Dated: March 23, 2015 Received: March 24, 2015 Dear Dawn Burleson: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your de novo request for classi?cation of the Sonablate? 450. a prescription device under 21 CF Part 801.109 that is indicatedfor transrectal high intensity focused ultrasound (HIFU) ablation ofprostaiic tissue. FDA concludes that this device should be classi?ed into class II. This order, therefore, classi?es the Sonablate? 450, and substantially equivalent devices of this generic type, into class 11 under the generic name, high intensity ultrasound system for prostate tissue ablation. FDA identi?es this generic type of device as: High intensity ultrasound system for prostate tissue ablation. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound (HITU) energy into the prostate to thermally ablate a de?ned, targeted volume of tissue, performed under imaging guidance. This classi?cation does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non?prostatic tissues/organs. Section 513(t)(2) of the Food, Drug and Cosmetic Act (the Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This new law provides two options for de novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classi?ed under the Act may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classi?cation of the device under section 513(a)(1) 2:34:40 PM One World Inc. 4043711774 175 .- ldmc. FAX To: T0111 Price From: Keith Watts 79-- Fax: C9 5 0 Pages: 5 (Including cover) Phene: Date: 4726/2016 Re: CC: Urgent For Review Please Comment Please Reply Please Recycle Comments: 4920 N0rth Royal Atlanta Drive Tucker, GA 30084 Main 404071-1745 - 404-371-1774 Fax Aprl26/2016 2:34:40 PM One World Inc. 4043711774 2/5 PRIVACY RELEASE FORM Congressman Tom Price, M.D. Sixth Congressional District of Georgia Date: 4-25-2016 Name: (Mr./Mrs./Ms.} Keith Watts Street Address City/State/Zip l, 404 219-1281 Home phone Work/Cell Phone Social Security (6) and/or etc. Data of Birth (6) AGENCY Involved and Drug Admini stration Spouse] Other Contact Please provide a brief explanation of your situation with the above agency and specify how our of?ce may be of assistance. Continue on another sheet if necessary. Send photocopies only of any documents you may have to support your claim. It Is Important for you to retain the originals for your ?les. We, KG Pharmaceuticals, need help to find out when the FDA PCAC is 0 inc capsa1c1n pa m1 a e, ecause regulatory compliant compounding pharmacists cannot use the substance until it is on list 1. Subsequently, KG Pharmaceuticals cannot plan the_production of our product, cannot hire people, and cannot conduct our business in any material way if we cannot get answers from the FDA EGAC Please see attached for more detailed information. Privacy Act Release I hereby authorize Congressman Tom Price and those acting in his behalf, in order to attempt to be of assistance to me, to obtain in accor . nce with applicable laws and regulations, information pertaining speci?cally to this matter. Once compase return it to: DATE 4-25-2016 Office of Congressman Tom Price, M.D. as-c Mill Street, Suite 300 GA 30075 370998?0050 Fax 6 2:34:40 PM One World Inc. 4043711774 375 How i Can Assist You in Dealing with a Federal Agency Thank you for contacting my office for assistance. The provisions of the Privacy Act of 1974 require me to obtain a signed Privacy Act Release Form in order to proceed with your case. This form must be completed in its entirety before an Inquiry can be made on your behalf. Things You Should Know - Your Guide to Congressional Assistance: Once my office has your completed, signed privacy form, the federal agency with Jurisdiction over your situation will be contacted on your behalf. A response should be received from the agency within 45 60 days. This Is a standard guideline and may vary for each individual case. When the agency?s response is received, you will receive notification from my office. if you have an ongoing claim, further updates will be requested from the agency on your behalf. According to the US House of Representatives Committee on Standards of Official Conduct and due to the separation of the legislative and judicial branches of government, members of Congress cannot intervene in matters which are involved in criminal and civil legal cases. Examples of these types are listed below: in Legal Issues I Child custody issues I C3565 Additionally, certain cases which involve Georgia state agencies are not under my direct jurisdictional authority to Intervene as a member of the federal goVernrnent. However, I will forward your concerns to the appropriate state official and request that they reply to you directly. Examples of these types or cases are: - State Revenue taxes in Child support services 0 Private Insurance claims While i will alWays do my best to assist you, please remember that federal agencies have total discretion concerning decisions on individual cases. Also, in an effort to continually improve upon the constituent services provided by my Congressional office, I have created a survey where you can provide feedback on the seches you received. Your comments will be sent directly to my District Director and kept in the strictest confidence. The survey can be found on our website at Office of Congressman Tom Price, NLD. 354: Mill Street, Suite 300 Roswell, GA 30075 770-998-0049 Phone 770-998-0050 Fax 2:34:40 PM One World Inc. 4043711774 4I5 Pharmaceuticals, LLC 4/25/2016 Keith Watts, KG Pharmaceuticals, LLC Congressman Tom Price, MD 403 Cannon House Office Building Washington DC 20515 Dr. Price Our company needs your help receive some definitive cmnmunication from the FDA Pharmacy Compounding Advisory Committee (PCAC). In 2013, Congress passed the Compounding Quality Act. PCAC was formed, part, to review, "Built Drug Substances" that are not a subject of a USP monograph, have not been approved as a prescription drug, and are not an approved OTC product. PCAC asked for nominations of bulk drug substances to be reviewed to make a list of substances that would be recommended to the FDA for compounding. This over-reach by the FDA to control this industry segment resulted in over 200 substances being nominated resulting in overwhelming the PCAC and virtually stalling business for small, ethical, and regulatory compliant companies. PCAC members have no authority and are able to review an average of only 6 substances per meeting. The meets no more than three (3) times a year! The math is not in favor of our business, the patients in need of a non-opioid alternative to pain management, and future prospective employees of the company. PCAC will update the list to include capsaicin palmitate, because regulatory compliant compounding pharmacists cannot use the substance until it is on list 1. Subsequently, KG Pharmaceuticals cannot plan the production of our product, cannot hire people, and cannot conduct our business in any material way if we cannot get answers from the FDA PCAC In October 2015 the PCAC issued an interim guidance that stated the following: does not intend to take action against a state-licensed pharmacy, federal facility, or licensed physician compounding a drug product using a bulk drug substance that is not a component of an FDAsapproved drug product and that is not the subject of an applicable USP or NF menograph, provided that the following conditions are met: 1. The bulk drug substance appears on the 503A List 1 on FDA's website at .n'f'fmnuaiun The substance may be eligible for inclusion on the 503A bulks list, was nominated with suf?cient supporting information for FDA to evaluate it, and has not been identi?ed by FDA as a substance that appears to present safety concerns. 2. The built drug substance: a. Was originally manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)) of the Act; and b. Is accompanied by a valid CDA from the original manufacturer. 2:34:40 PM One World Inc. 4043711774 5:!5 c. "Original manufacturer" means the entity that originally produced the built drug substance and not a subsequent packer, repacker, labeler, or distributor. 3. The drug product compounded using the bulk drug substance is compounded in compliance with all other conditions of section 503A. of the Act." The PCAC also opened up the nomination process for any other built drug substances and we, KG Pharmaceuticals, nominated Capsaicin Palmitate. The FDA PCAC stated in the interim guidance the following: seeks to avoid unnecessary disruption to patient treatment while the Agency considers the bulk drug substances that were nominated with suf?cient support to permit FDA to evaluate them and promulgates the regulations required under section 503A. Therefore, as described further below, FDA is issuing this interim guidance stating that it does not intend to take action for compounding of drug products under section 503A using a built drug substance if an applicable USP or NF monograph for the substance does not exist, and the substance is not a component of an FDA-approved product if, among other conditions, FDA has determined that the nomination for the built drug substance included adequate information for FDA to evaluate the substance and at this time, the substance does not appear to present safety concerns." We submitted all the information that is requested by the PCAC on iljegulaticuslgoy as instructed. The submission was accepted and we received con?rmation on DeCember 16, 2015. We are now waiting for the FDA PCAC to decide if the submission is complete so it can be placed on 503A List 1. KG Pharma?s bulk drug substance, Capsaicin Palmitate, was the only substance nominated when the PCAC opened the nomination period in October of 20 5 and we have asked the FDA, PCAC when will we be placed on list 1 and no one will answer. We are told that there are lots of questions being submitted and the FDA will get to it when they can. We need help to out when the FDA PCAC will update the list to include capsaicin palmitate because compounding pharmacist cannot use the substance until it is on list 1 and we cannot plan the produotion of our product, we cannot hire people, we cannot have keep our business if we cannot get answers from the FDA PCAC. Our product is needed in the healthcare market place because it ?lls an unmet medical need of nomopioid, non-habit forming, pain relief in a topical lineage ferm. We need your help and we do not want special treatment, we only what to placed on 503A List 1 because we meet the criteria of the guidance as a complete submission so the PCAC can do a committee review. We understand that our nominated substance may not come up for committee review until the end of the other nominated substances because we made our nomination late in October of 20 1 5. Best regards, . eith Watts President, KG Pharmaceuticals, LLC From: To: Subject: Date: Skube, Jonathan Brown, Akeisha FW: 2016-2612 Keith Watts, KG Pharmaceuticals Thursday, August 25, 2016 10:36:31 AM Akeisha,   Please add to AIMS # 2016-2612.   Thanks,   Jonathan   From: Horowitz, Sarah Sent: Wednesday, August 17, 2016 4:23 PM To: McIntosh, Tina Cc: Jordan, Lillian T; Lexer, Susan; Skube, Jonathan; Meister, Karen G Subject: RE: Keith Watts, KG Pharmaceuticals   Hi Tina,   This email acknowledges receipt of Mr. Keith Watts’ letter of April 25, 2016, addressed to your office, concerning the U.S. Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee review of nominations of bulk drug substances for compounding. Your constituent’s letter  has been referred to the Office of Unapproved Drugs and Labeling Compliance within the FDA Center for Drug Evaluation and Research for response.    We thank you for contacting the FDA with your constituent’s concerns. We are reviewing the information that you provided, and we will notify you if we have any questions while we formulate our response.                                                                                                                                                                                            Sincerely, Sarah Horowitz   ________________________________________________ Sarah Horowitz Congressional Affairs Specialist Office of Legislation U.S. Food and Drug Administration 10903 New Hampshire Avenue WO 32, Room 2379 Silver Spring, MD 20903 P: (301) 796-4250       From: McIntosh, Tina [mailto:Tina.McIntosh2@mail.house.gov] Sent: Monday, August 08, 2016 7:28 AM To: Lexer, Susan Cc: Jordan, Lillian T; Horowitz, Sarah Subject: RE: Keith Watts, KG Pharmaceuticals Importance: High   Please let us know what we can do to receive a final reply NLT Wednesday, August 10.  This inquiry is almost 3 ½ months old.    Thank you for your assistance.     Have a Blessed day- Tina Tina McIntosh Director of Constituent Services/Office Manager Office of Congressman Tom Price, M.D. 85-C Mill Street, Suite 300 Roswell, GA  30075 770-998-0049 770-998-0050 fax Confidential Notice:  This e-mail message, including any attachments, is for the sole use of the intended recipient (s) and may contain confidential and privileged information.  Any unauthorized review; use, disclosure or distribution is prohibited.  If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.       From: Lexer, Susan [mailto:Susan.LexerSmith@fda.hhs.gov] Sent: Friday, July 01, 2016 9:11 AM To: McIntosh, Tina Cc: Jordan, Lillian T; Horowitz, Sarah Subject: RE: Keith Watts, KG Pharmaceuticals   Hi Tina, we hope to have a response soon.  Thank you for your continued patience.   Susan     -------------------------------------Susan Lexer Congressional Affairs Specialist Office of Legislation U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD  20993   Direct: 301.796.8915 BB: 240.672-5921 Susan.Lexer@fda.hhs.gov         From: McIntosh, Tina [mailto:Tina.McIntosh2@mail.house.gov] Sent: Thursday, June 30, 2016 11:38 AM To: Lexer, Susan Cc: Jordan, Lillian T; Horowitz, Sarah Subject: RE: Keith Watts, KG Pharmaceuticals Importance: High   Susan –   We’re trying to close this one out.  Could we get an update on the above referenced petition/claim.  Thank you in advance for any information/assistance you can provide.     Tina McIntosh Constituent Services Director Office of Congressman Tom Price, M.D. - GA06 85-C Mill St., Ste 300 Roswell, GA 30075 770-998-0049 770-998-0050 fax Confidential Notice:  This e-mail message, including any attachments, is for the sole use of the intended recipient (s) and may contain confidential and privileged information.  Any unauthorized review; use, disclosure or distribution is prohibited.  If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.       From: Horowitz, Sarah [mailto:Sarah.Horowitz@fda.hhs.gov] Sent: Friday, June 24, 2016 9:49 AM To: McIntosh, Tina Cc: Jordan, Lillian T; Lexer, Susan Subject: RE: Keith Watts, KG Pharmaceuticals   Hi Tina,   My colleague Susan Lexer is handling this inquiry.  She is out of the office today but will get back to you with a status update next week.  Please let me know if you have any other questions in the interim.   Thanks, Sarah     Sarah Horowitz, J.D. Congressional Affairs Specialist Office of Legislation Food and Drug Administration Tel:  (301) 796-4250 Fax: (301) 847-8602       From: McIntosh, Tina [mailto:Tina.McIntosh2@mail.house.gov] Sent: Friday, June 24, 2016 9:13 AM To: Horowitz, Sarah Cc: Jordan, Lillian T Subject: FW: Keith Watts, KG Pharmaceuticals Importance: High   Friends –   Happy Friday.  We were told we should have a reply in a few days on this one -  that was a couple of weeks ago.   Just requesting an update on the above referenced petition/claim.  Thank you in advance for any information/assistance you can provide.     Tina McIntosh Constituent Services Director Office of Congressman Tom Price, M.D. - GA06 85-C Mill St., Ste 300 Roswell, GA 30075 770-998-0049 770-998-0050 fax Confidential Notice:  This e-mail message, including any attachments, is for the sole use of the intended recipient (s) and may contain confidential and privileged information.  Any unauthorized review; use, disclosure or distribution is prohibited.  If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.       From: GA06, Tom Sent: Monday, June 13, 2016 10:06 AM To: 'kwatts@kgpharmaceuticals.com' Subject: FW: Keith Watts, KG Pharmaceuticals Importance: High   Keith –   Please find reply below to our follow-up with the FDA last week.  As soon as we have more concrete information, I’ll forward to you.     Have a Blessed day- Tina Tina McIntosh Director of Constituent Services/Office Manager Office of Congressman Tom Price, M.D. 85-C Mill Street, Suite 300 Roswell, GA  30075 770-998-0049 770-998-0050 fax Confidential Notice:  This e-mail message, including any attachments, is for the sole use of the intended recipient (s) and may contain confidential and privileged information.  Any unauthorized review; use, disclosure or distribution is prohibited.  If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.       From: FDA Sent: Friday, June 10, 2016 2:28 PM To: McIntosh, Tina Subject: FW: Keith Watts, KG Pharmaceuticals Importance: High   Hi Tina, we have received your constituent’s inquiry and hope to have a response soon.   Best, Susan     -------------------------------------Congressional Affairs Specialist FDA/Office of Legislation