Docket Nos. FDA–2013–N–0683, FDA– 2013–N–0684, And
Pfizer Inc100 Route 206 NorthPeapack, NJ 00807August 8, 2013---Submitted Electronically--Food & Drug Administration5600 Fishers LaneRockville, MD 20852Subject: Docket Nos. FDA–2013–N–0683, FDA– 2013–N–0684, and FDA–2013–N–0685Food and Drug Administration Safety and Innovation Act Title VIIDrug Supply Chain; Standards for Admission of Imported Drugs, Registration ofCommercial Importers and Good Importer PracticesDear Madam/Sir:Pfizer appreciates the opportunity to submit comments in response to the important questionsraised in Sections 713-715 of the Food Drug Administration Safety and Innovation Act(FDASIA). Pfizer strongly supports the mission of the FDA to ensure patients receive thehighest quality medicines, as well as its role protecting them from unsafe imported drugs.Pfizer's mission is to be the premier, innovative biopharmaceutical company. We strive to setthe standard for quality, safety and value in the discovery, development and manufacturing ofmedicines for our patients. We believe firms have a responsibility to protect the integrity of theirsupply chains. Pfizer applauds FDA’s efforts to promulgate effective supply chain regulationspursuant to FDASIA and looks forward to partnering in the development of associated guidanceand regulations.Pfizer would like to set forth, as general principles that: 1) we encourage the Agency, inpromulgating the regulations required by Sec. 713, to incorporate the concept allowed underSection 801(r)(4)(B)(i), establishing that importers and types of imports may be differentiated onthe basis of risk; 2) importers willing to demonstrate strong internal controls to protect the supplychain from incursion should be “may proceeded”, at the time of entry, upon submission ofminimal incremental information; 3) FDA should coordinate with Customs & Border Protection(CBP) to implement a process enabling one channel of data to accomplish all steps necessaryto complete the import process for both agencies; 4) trusted importers should receive the benefitof “account management” whereby transactional review, when necessary, is conducted by acentralized dedicated team comprised of FDA and CBP officials familiar with the importer and itsbusiness operations.Pfizer has provided below responses to questions raised in the Federal Register notice. Weacknowledge that many of these matters require more extensive discussion and study. Thus,we believe thoughtful dialog with stakeholders from government, trade, and other stakeholderswithin a Federal Advisory Committee (FAC), in collaboration with the Customs & BorderProtection Advisory Committee on Commercial Operations of Customs and Border Protection(COAC), would yield the best solutions for effective border management of evolving risks, suchas those arising from illicit traffic in short supply drugs and excipients. Pfizer would be pleasedto participate in such a panel. If establishment of a FAC is not possible, within the rule makingtime frame, we suggest FDA set up workshop-style meetings before the publication of proposedrule, or during the comment period of the proposed rule, to facilitate such a dialog.
Page 2A. Section 713: Standards for Admission of Imported Drugs1.How should the regulations implementing section 801(r) of the FD&C Act (21 U.S.C.381(r)), as amended by section 713 of FDASIA, define ‘‘importer’’ as that term isused in 801(r)(l)?Pfizer recommends that the regulations define “importer” as defined in Title VII of theFood, Drug & Cosmetic Act, Section 805, referencing supplier verification wherein”importer" is defined as “A) the United States owner or consignee, other than logisticsservice providers, [of the article of food] at the time of entry of such article into the UnitedStates; or (B) in the case when there is no United States owner or consignee as describedin subparagraph (A), the United States agent or representative of a foreign owner [orconsignee of the article of food] at the time of entry of such article into the United States”.2.What information should FDA require importers to submit at the time of entry thatwould demonstrate a drug’s compliance with applicable requirements of the FD&CAct as a condition of granting admission of the drug into the United States?Pfizer believes that importers should be categorized according to risk: a) trusted importers;b) low risk; and c) unknown risk. Trusted Importers should be those that demonstrate internal controls that exceedminimal quality and supply chain integrity standards, and apply for and are approvedby the FDA to participate as a certified- trusted importer. We believe that trustedimporters should only be required to file, at the time of entry, a certified-trustedimporter affirmation of compliance code (AOC) conveying they have been approved forentry without further documentation. In addition, the following minimal data should berequired for risk targeting.o Unique manufacturing facility identifiero CBP advanced security data Low risk importers are those with an acceptable history of compliance that have notapplied for certified importer status. For this category, the following data should beprovided and validated by FDA.o Appropriate application number (NDA, ANDA, IND)o Unique manufacturing facility identifiero Product descriptiono Drug listing numbero FDA product codeo Quantityo Additional AOC codes defining the import scenario (eg samples, non-human use)o CBP entry data The “Unknown” category of importer represents the highest risk. It represents thatpopulation of importers with a negative or no compliance history. This category shouldtrigger both document and physical exams with particular emphasis on the ability todemonstrate the inbound logistics of the consignment.Low risk importers should be required to file, at the time of entry, data now required forPredictive Risk Risk-based Evaluation for Dynamic Import Compliance Targeting(PREDICT) processing.
Page 3Unknown importers should also be required to file PREDICT data, in addition to otherproofs of product integrity, such as: recent current good manufacturing processes (cGMP)or facility inspection certificates covering the production date of the imported lot; bills oflading evidencing the place and port of loading and shipper to the United States as well asconveyance security proofs demonstrating the product has not been tampered with duringtransport.3.What information could an importer submit to FDA at the time of entry todemonstrate compliance with applicable requirements of the FD&C Act relating to:a) homeopathic drugs intended for human use,No commentb. articles intended for human drug compounding,No commentc. articles intended for animal drug compounding, andNo commentd. drugs intended for research?Pfizer recommends that imports of materials intended for research conducted under aninvestigational new drug application (IND) should be exempt from FDA border processesthrough an Affirmation of Compliance Code for Research (ACCR) established for thepurpose. INDs include “manufacturing and control information describing the composition,manufacture, and control of the drug substance and the drug product.” In each phase ofthe investigation information “is required to be submitted to assure the properidentification, quality, purity, and strength of the investigational drug”. These controls areavailable as a function of the development processes and are dynamically sufficient tosatisfy FDA’s cGMP concerns such that further evidence at time of time of import would beredundant. In addition, human pharmaceutical drugs imported for non-human use (i.e.,CFR 201.125) should also be exempt from FDA border processes through an ACCR.4.What facility information should FDA request from importers at the time of entry tohelp assess whether a drug complies with applicable requirements of the FD&CAct?See our response to question #2. Beyond the AOC code, a unique manufacturing facilityidentifier would be appropriate for all categories of importer.5.What information could importers submit at the time of entry to demonstratecompliance with country of export regulations in accordance with section801(r)(2)(C) of the FD&C Act?Section 801(r)(2)(C) provides that the information to be submitted as a condition ofgranting admission into the U.S., “may” include information relating to compliance withcountry of export regulations. Where the United States has entered into a mutualrecognition agreement with another country, information relating to the US approvedstatus of the product and thereby the manufacturing site within the other country would be
Page 4part of the drug filing and be known in advance of arrival into the United States. Furtherinformation at the time of entry would be redundant.6.What information could importers submit at the time of entry to demonstrate that adrug offered for import complies with U.S. CGMP requirements?Pfizer believes that time of entry is the least efficient time to seek informationdemonstrating manufacturing compliance or supply chain security. Our proposal for theestablishment of a certified-trusted importer program will establish the importer’scompliance and product integrity before consignments ever reach the United Statesborder. Importers that have not been admitted to a certification program should berequired to present the evidence noted under Question #2.7.What information could importers submit at the time of entry that would serve asevidence of satisfactory inspection, such as by a foreign government or an agencyof a foreign government?We do not believe evidence of satisfactory inspection should be required at the time ofentry. We also support FDA’s efforts at improving information collection and leveraging ofinternational regulatory counterparts.8.Should FDA require that importers submit certificates of analysis (COAs) to theAgency as a condition of admission under section 801(r) of the FD&C Act?Requiring any documentation for admissibility determination contradicts the PREDICTsystem effort and the basic premises we have recommended.If so, how could an importer demonstrate a COA’s authenticity?We do not believe COA’s at the time of import should be used for importation purposes.9.Section 801(r)(4)(B)(i) of the FD&C Act permits FDA, as appropriate, to considerdifferences among imports and types of drugs and ‘‘based on the level of riskposed by the imported drug, provide for expedited clearance for those importersthat volunteer to participate in partnership programs for highly compliantcompanies and pass a review of internal controls, including sourcing of foreignmanufacturing inputs, and plant inspections.’’a. What criteria should FDA use to evaluate potential participants in ‘‘voluntarypartnership programs for highly compliant companies’’?There are two aspects that should be considered in evaluating companies for participationin trusted importer programs: 1) the company’s compliance history and ability tomanufacture quality, safe, and effective medicines, and 2) the company’s history ofdelivering products safely through secure supply chains. In general, with regard to productsafety and quality, we believe that demonstration of cGMP’s and compliance history overtime is the appropriate basis for assuring compliance with product quality regulations.Adherence to good distribution practices (GDP’s) to assure the quality of product ismaintained during transport and security standards to assure the integrity of the supplychain should also be considered in evaluating applicants for certified-trusted trader status.In that respect, we believe that participation in the Customs & Border Protection (CBP)and Transportation Security Administration (TSA) supply chain security programs arerelevant and important factors in differentiating traders on a risk basis. Specifically, goodstanding in the CBP’s Customs & Trade Partnership Against Terrorism (CTPAT) at or
Page 5above Tier II, and participation in TSA’s Certified Cargo Screening Program (CCSP), andprograms such as Canada’s Partners In Protection (PIP) are reliable demonstrations of thetrader’s investment in the integrity of its physical supply chain. Having a supply chainsecurity program that strategically and holistically looks at prevention, detection, andresponse to supply chain security threats such as product diversion, cargo theft,intentional adulteration, and counterfeit goods demonstrates further commitment toensuring supply chain integrity. Thus, we believe it would be appropriate to review theapplicant’s broad trade compliance commitment as well, by considering, for example,participation in CBP’s “Importer Self Assessment” program, which is a voluntary federalprogram that results in an exemption from compliance audits based on the firm’s internalcontrols. Companies willing to discuss and explain these internal control programs shouldbe recognized as posing the least risk and be admitted to the voluntary trusted importerprogram. Demonstrated investment in product safety and integrity should avail the trustedimporter the benefit of “green lane” passage through FDA and CBP border processes.b.How could FDA take into account differences among importers and types of drugsto allow for expedited entry as part of a voluntary partnership program?We believe a review of internal manufacturing, quality and supply integrity programs wouldreflect the level of risk the importer represents. Internal importer practices and proceduresshould demonstrate attention to the level and type of risk between importers and the typesof drugs they import. This can only be ascertained by the kind of review of internaloperations recommended above in 9(a). Importers not able to pass the predeterminedcriteria should be considered higher risk importers. In relation to product category risks, webelieve details such as dosage form (e.g., parenteral vs. topical), end use of material (e.g.,human vs. non-human use), product safety profile, drug shortage status, and orphan drugstatus are key primary criteria for consideration. Secondary criteria could include detailssuch as perishability and whether it is a life-saving drug.c.What risk factors should FDA consider when determining drug admissibility under avoluntary partnership program?We have enumerated criteria to be considered under Question 9(a).10.What benefits and burdens may be created by requiring drug importers toelectronically submit information demonstrating that a drug complies withapplicable requirements of the FD&C Act as a condition of admission? How couldwe minimize any possible burdens? How do we strike a reasonable balancebetween rigor and efficiency in requiring information that is both reliable and yetcan be submitted and reviewed efficiently?As indicated in response to previous questions, we believe admissibility decisions shouldbe made, on the basis of application to a certified-trusted importer program, beforeshipments ever reach the United States. In those cases in which a trusted importer AOChas not been obtained, the ability of importers to provide appropriate information to keygovernment agencies electronically, at or prior to entry, would be of benefit to facilitateverification of the admissibility of the material.The data listed in response to question 2 above should provide enough information tosupport a release decision. When FDA Entry Reviewers do not have visibility of currentapproved NDA information, including changes that were previously filed in an AnnualReport or Supplement, especially related to changes in the names of legal entities,however, delays occur, placing an undue burden on both importers and the FDA. Afocused effort resulting in improved visibility to, and sharing of current registration details
Page 6would help to alleviate much of this burden and provide a more efficient entry reviewprocess. Furthermore, manual FDA review of supportive, hard copy import data could bereduced by the establishment of additional Affirmation of Compliance codes that wouldstandardize, and allow the electronic submission of supplemental import data, includingnon-human use samples imported for laboratory testing purposes, PLAIR, US GoodsReturned and chemical intermediates exempt from drug listing/regulatory filingrequirements. Another beneficial change would be the establishment of a centralized FDAreview team responsible for pharmaceutical imports (similar to the Customs Center ofExcellence). This would not only provide efficiencies resulting from specialized expertsserving as reviewers, but also drive consistent regulation enforcement and eliminate theport-specific review practices currently in place. Additional alignment between FDA andCustoms practices, specifically surrounding use of temporary import bonds for import forexport (IFE) materials (e.g. material imported solely for packaging/labeling operations)would also be helpful, as well as a standardized process across ports associated withrefused entry materials.B.Section 714: Registration of Commercial Importers of Drugs1.How should the regulations implementing section 714 of FDASIA (section 801(s) ofthe FD&C Act) define ‘‘commercial importer’’ to ensure that the appropriate entitiesare required to register with FDA and meet requirements regarding good importerpractices (GIP)? Should these ‘‘commercial importers’’ be the same entities as the‘‘importers’’ required to comply with the standards for admission to be adoptedunder section 801(r) of the FD&C Act?The commercial importer should be subject to the same standards for admission as themanufacturer importer - required to comply with the import standards of the FD&C Act.One company importing the materials of another for the sole purpose of sale or distributionshould be held to the same requirements as a company importing its own approvedproduct for further manufacturing or distribution.2.Under section 801(s)(1) of the FD&C Act, the registration regulations will apply tocommercial importers of ‘‘drugs.’’ A ‘‘drug’’ is defined in section 201(g)(1) of theFD&C Act (21 U.S.C. 321(g)(1)) and includes, but is not limited to, finished dosageform drug products, drugs for further processing, active pharmaceuticalingredients, and other drug components, including inactive ingredients. Shouldcommercial importers of certain types of drugs, such as inactive ingredients, beexempt from the commercial importer registration requirements? Should theimportation of drugs for certain purposes (e.g., research use) be exempt fromregistration?We believe finished dosage form, drugs for further processing, and active pharmaceuticalingredients should require registration.Inactive ingredients, which are not subject to new drug applications (NDAs) as individualcompounds, should not require registration. There are thousands of such ingredients,many of which have multiple uses including non pharmaceutical manufacturing,. Inconsidering the applicant for certified importer status, however, internal controls coveringinactive ingredients should be considered. Where the importer is also the excipient-user,the entity is already subject to FDA registration requirements as a drug productmanufacturer. The imposition of an additional registration requirement would be redundantas there are already mechanisms and controls in place for these drug ingredients beforethey are used in the finished drug product.
Page 7Research compounds and samples for forensic or other analyses that are not for humanor animal use and not for sale and do not otherwise require special license (e.g,,pathogens) should be exempt from the FDA registration and border processes generallythrough filing of a new affirmation of compliance code submitted at the time of entry.3.What information should commercial importers be required to submit as part oftheir registration?Unique manufacturing facility identity and the data currently required of commercialimporters at the time of entry for targeting in PREDICT should continue to be required,supported, when needed,
Food & Drug Administration 5600 Fishers Lane Rockville, MD 20852 Subject: Docket Nos. FDA–2013–N–0683, FDA– 2013–N–0684, and FDA–2013–N–0685 Food and Drug Administration Safetyand Innovation Act Title VII Drug SupplyChain; Standards for Admission of Imported Drugs, Regist
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29 July 2013 . Docket Management Branch (HFA-305) Food and Drug Administration . 5630 Fishers Lane, Rm. 1061 . Rockville, MD 20852 . Submission of comments on: Docket No. FDA-2013-D-0558; Guidance for Industry on Contract
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