FILE | 99 | Industry Best Practices - Drug Content Management - SOURCES SOUGHT. PLEASE REVIEW

FBO DAILY ISSUE OF JULY 02, 2008 FBO #2410
DOCUMENT

99 -- Industry Best Practices - Drug Content Management - SOURCES SOUGHT. PLEASE REVIEW

Notice Date: 6/30/2008
Notice Type: SOURCES SOUGHT. PLEASE REVIEW
NAICS: 511140 — Directory and Mailing List Publishers
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: FDA-SOL-08-00743
Archive Date: 7/8/2008
Point of Contact: Dominique H Malone, Phone: (301) 827-7227
E-Mail Address: dominique.malone@fda.hhs.gov
Small Business Set-Aside: N/A
Description: A FULL PDF COPY OF THIS SOURCES SOUGHT IS ATTACHED. A.General Information: In accordance with FAR 15.201(e), this request is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in the announcement. This is a Sources Sought regarding potential sources. This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide The Food and Drug Administration (FDA) with [Industry Best Practices] Drug Product Content Management B. Objective: Improvement of quality of FDA drug product data and creation of DESI-FR database. C. Statement of Work: Requirements: Requirements designated as (Primary) are to be developed First. TASK 1 (Primary) Manage the Rx Prug Product Content The purpose of this effort is to contract with a private drug database whose drug product listing(s) includes every drug product on the US market with FDA application products coded or otherwise identified. The contractor will compare FDA drug product content (accuracy) with that of the contractor’s private drug product database listings and apply quality control to drug product listing content as appropriate. While the FDA understands the importance of drug product data bases that include pricing and clinical information, it’s primary interest is in the universe of application and non-application drug products and those attributes under a. a The contractor shall utilize their proprietary searchable drug product data base to find drug product information, including: (1) NDC #, (2) name of drug tradename (if applic), (3) name of generic or generic tradename, (4) each active ingredient and it’s strength, inactive ingredient (optional), (5) dosage form, (6) # of units in container and (5) FDA NDA or ANDA # The product must be updated daily. The contractor database must also include Rx biological drug products. b. The contractor will grant FDA a license to use the contractor’s database under the terms of this contract and the licensing agreement. c. The contractor will compare each business day the drug product content of their database [minimum of 98% accuracy of all drug products on the market] with the drug products FDA has listed in its system and be able to determine (1) the portion of the universe of drug products on the marketplace that are listed with FDA to date, and (2) to determine the accuracy of the drug products listed in FDA’s listing system, (as determined by drug product data elements in Task 1 (a) and (3)) and be able to identify all drug products that have not been listed in FDA’s listing system by establishments and which drug products may be inactive or removed from the market and should be coded obsolete in FDA’s listing system (to indicate the product is no longer available on the market). Drug products are never removed from FDA drug product listing system having regulatory implications. They will be coded to reflect their status as active, inactive or no longer on the market. d. The contractor drug product database must include all Rx human drug products on the US market within 98% accuracy. An appropriate drug product surveillance and collection method must be in place that continually and consistently interacts with manufacturers and/or distributors of Rx drug products to insure their drug product database is complete, comprehensive, timely and correct. The contractor must have a system of coding that allows differentiation of which drugs are application drug products (NDAs, ANDAs) and which are not (no NDA, ANDA). e. FDA regulates all drug products in the US marketplace including OTC drug products. The contractor’s drug product database must capture at least 70% all OTC human drug products on the US market. An appropriate method must be in place to collect information on OTCs to meet this requirements. Also, requirements in (a) apply. f. The contractor’s drug product database must differentiate between Rx products and OTC human drug products as required in (a). In addition, the contractor’s database must be able to differentiate between a drug product and a non-drug product as defined by FDA. This is important because industry has been prolific in the assignment of NDC #s to drug and non-drug products. It is important to understand this because in the electronic drug product listing system, an establishment must choose a regulatory status for each drug product. Although the establishment may have assigned an NDC# to a non-drug, the establishment will be unable to list a non-drug and will be confronted with this the first time an attempt is made to list or relist the non-drug under the electronic system. There is no category in the FDA listing system for a non-drug (device, nutritional supplement, etc.). TASK 2 (Primary) Perform Quality Control and Other Reviews Drug product data that is entered into FDA electronic drug listing system by the listing establishment will be reviewed by the contractor and errors identified for subsequent correction. The contractor will review NDC#s - any irregular NDC # must be noted for subsequent correction. All changes will be brought to the attention of the listing establishment for reconciliation using the email address provided by the establishment for that location in FDA’s registration data base. The contractor will review each drug product’s label content and format, which must conform to FDA requirements, and finally, the contractor must insure that establishments assign each drug product a regulatory status (NDA, ANDA, medical gas, API, etc). If the establishment does not know the status, or the product’s status is not one on the primary list, the establishment will choose “Other.” When “Other” is selected, the reviewer will select a regulatory status code using the database described in Task 3 and code the status. The FDA will provide the necessary training and orientation for the processes under Task 2. In situations where an error or inconsistent is detected, the contractor cannot correct the error. The communication method to be used to notify an establishment of a listing or other error will be using the email address on record to send an email to the establishment. a.The contractor will check to insure that NDC #s are assigned to human drug products only. Food supplements and devices, if not in a combination kit with a drug, will not receive NDC #s. The FDA has the right to withhold any NDC# if the NDC # which the establishment previously assigned to its drug product is irregular, not a drug, or the establishment is not within compliance. b.The contractor shall review drug product data that is entered into the electronic system by the establishment and identify any errors or irregularities for subsequent correction. The contractor will use their proprietary drug database to assist in locating listing errors by comparing with listed drug information entered by the establishment. Over a period of time in which data review may have noted a pattern of data entry errors in certain fields, it may be possible to limit the review to those certain fields. c.The contractor shall notify the establishment by email of each discrepancy found.and will request that more information be provided if necessary. d.Establishments must justify each drug product for being on the market. Validation categories include but are not limited to: NDA, ANDA, Medical Gas, IND, API, etc. When an establishment checks “Other” as a drug product regulatory category, the contractor must review the drug product, and find the correct compliance code to manually enter. To facilitate the review of drug products in “Other,” Task 3 of this RFP requires the contractor to develop a database so that FDA can cross-index NDC#s to Product Names to Compliance Codes and Federal Register # and dates. Compliance codes are used to designate a drug product’s regulatory status (justification for being on the market), although in the future these drug products could become the target of an Unapproved Drug CPG (June 19, 2006). No drug product will be listed unless a category is assigned showing a reason for the product being on the market. FDA will provide the necessary training for validation review. e.The contractor will review validation categories selected by the establishment for a drug product in FDA’s drug product listing system, and will manually assign validation codes when the establishment has selected “Other,” as in (d) f.The contractor will be able to connect by telephone or email with an FDA expert on regulatory status and compliance codes. This person will serve in an advisory role to the contractor on validation and other issues. In addition, the specifications for building a database that will facilitate compliance code assignments when “Other” is selected by the establishment for a drug product are included in Task 3. Scope of Work: Drug Listing Content Management The FDA Describes the following primary and secondary Tasks to be delivered by the contractor. Primary tasks have the highest primary and will be funded first. a. TASK 1 (Primary) Manage the Rx drug product content of FDA’s drug listing system Note: Current system is DRLS (Drug registration and Listing System); An electronic registration and listing platform will replace/supplement DRLS by early 2009: •Map vendor Rx drug product File to FDA Rx drug File to identify and reconcile discrepancies for Rx drug products in the vendor files but not in the FDA files •Map vendor Rx drug product File to FDA Rx drug File to identify and reconcile discrepancies for Rx drug products in FDA files but not in vendor files (or in vendor files and coded inactive or obsolete) •Add active Rx drug products that are not in FDA Rx drug product files and code as “other” •Code FDA Rx drug products as “inactive” or “obsolete” •Then update weekly a.Provide documentation of products coded Note: FDA will suggest codes to be used to identify Rx drug products which are inactive, or obsolete, or the vendor’s coding system may be used. b.Identify OTCs, non-drugs (devices, etc), and nutritional supplements that may be in FDA Drug files for removal Note: Only Rx drug products will be supported in FDA drug files. b. TASK 2 (primary) After appropriate training provided by FDA, perform perfunctory reviews on data that establishment enter upon listing their drug products in the FDA registration and listing platform (or in batch mode after the product(s) is listed (will be determined)). Note: This is to be performed for establishments listing drugs following the implementation of the electronic drug registration and listing platform and will occur for every drug product listed, when it is first listed, and then upon establishment confirmation that the drug Note: Current system is DRLS (Drug registration and Listing System); An electronic registration and listing platform will replace/supplement DRLS in 2008: Following training, and using Standard Guidances, grids, and checklist •Review drug product label for content/compliance to FDA statutes •Review and validate drug product “justification for being on the market.” •Review other drug product related fields: >for NDC # authenticity >for inappropriately enter drug products other than Rx > Note: Other primary interest areas are unapproved drugs, actions by the FDA, DESI/NOOH, DESI designation, combination products, marketing status of drug products, Note: Only Rx drug products will be supported in FDA drug files. TASK 3 (Primary) DESI Related Federal Register Notices Database Requirement 1: Database must comply with all 508 requirements. Requirement 2: Identify all DESI related Federal Register notices from 1938 to present. All notices pertaining to unapproved marketed human drugs must be found. If notice is only available in paper format, a high quality legible and searchable 508 compliant PDF document must be created. All electronic notices must also be converted to high quality searchable 508 compliant PDF documents. Quality control will be undertaken to assure that all DESI related Federal Registers notices are: -found -correctly identified in the database -are readable -correctly indexed with reference to key fields Requirement 3: Document personnel should be capable of reading, understanding, and indexing Federal Register notices in order to identify all key elements found on these notices. See Attachment A for examples of highlighted areas on Federal Register that need to be indexed. Index each document with key fields (if present in Federal Register) to support search and retrieval. Key fields are: - NDA# - drug name - active ingredients - DESI# - Federal Register: - date, volume, number, page, CFR number (ex. 40 CFR Parts 30) Requirement 4: Develop a Web application consisting of a standalone Oracle database that is consistent with the version of Oracle presently used by CDER. Designated FDA staff must be able to access the Web database by entering the appropriate IP address into their browser. The user interface should consist of but not be limited to: - an introductory screen with buttons linking to the data entry screen, the search screen, the reports screen - a data entry screen, - a screen that allows the user to search the database on all key fields, more than one field at a time, use wild card searches, and “and” “or” searches - an output screen that displays the results of the search - reports sorted by all key fields - output screen and report that shows a drug name and all related DESI FR notices - output screen and report that shows all drug products with related DESI FR notices associated with a particular NDC# - support search on more than one drug name or active ingredient - support search on FR notice that brings up all drugs listed on that notice - support search on an active ingredient that brings up all DESI FR notices associated with that active ingredient - output results that come out of a search should be put in a temporary table that can easily be exported into an Excel spreadsheet - the output screen will contain a link to the FR notice that will allow viewing of said notices and also printing of these notices Fields to be included in database: - drug name - drug NDA# - drug product NDC# - strength - all active ingredients for each drug product – each in a separate field - DESI status - Compliance codes - Federal Register: - date, volume, number, page - CFR number (ex. 40 CFR Parts 30) - searchable PDF image of Federal Register Requirement 5: Initially populate database with all DESI reviewed and unapproved marketed drugs (trade name, generic name, strength, active ingredients, NDC#, NDA#). Enter data for each drug that will result in each drug being related in the database to its appropriate Federal Register notice PDF file, FR date, FR volume, FR number, FR page, FR CFR number, DESI #, NDA#(if applicable), NDC#, strength, and all active ingredients of that drug, and compliance codes. Requirement 6: Provide a prototype of the database containing 5 drugs and their related DESI Federal Register notices appropriately indexed with all search capabilities working within one month of start date. Changes to the requirements of the database can occur based on the functionality of the prototype. TASK 4 (Secondary) Perform help desk activities after appropriate training by FDA. Limited to receiving and responding to email messages from establishments regarding their Rx drug products. Phone calls will not normally be accepted. Note: The nature of these help desk issues will relate to drug product listing. Vendor will not be asked to be involved in replying to questions regarding registration. Following training, and using Standards Guidances, Checklists and grids: a.Answer by email any issue regarding drug listing received by email within 24 hours (except WE and holidays) b.Forward any email that requires the attention of a more experienced FDA staff member c.Create an email coordinated response system for emails in the que that remain unanswered for longer the 24 hours because of the need for further research, etc. d.An FDA advisory/consultant will be available to be contacted by email or phone TASK 5 (Secondary) Handling of Forms 2657; Data Entry of Data from Form 2657 Although paper products will officially no longer be accepted for drug registration and listing after electronic registration and listing system is made available to industry, companies can request a waiver to continue using the forms. FDA anticipates the number of companies requesting this waiver will be very few. However, if and when paper forms arrive at FDA’s White Oak Center, they may be forwarded to the contractor for manual entry into the electronic drug product listing platform. If and when this task is activated, proper instruction will be provided to the contractor. The contractor shall open mail, enter data, and file forms 2657 if it becomes necessary to respond to a waiver request for continued use of the paper forms. Perform data entry of data into Listing platform from data received from establishments on Form 2657, Drug Listing. Forms will be received at FDA White Oak and sent by carrier to vendor operating address. Note: FDA is developing electronic registration and listing platforms in order to eliminate the above paper forms and therefore eliminate data entry requirements. There may be a residual amount of forms that continue to be received but we anticipate the use of forms to dwindle precipitously over the next 6 months to 1 year. >Following training, and using Standards Guidances, Checklists and grids: >Listing Processing >Receipt of, date stamping, opening and sorting of all incoming drug listing forms 2657 >Filing of and retrieving listing forms upon completion of processing >Data entry from 30 possible data entry fields, depending on submission type >Data entry from new form submissions >Data entry from uddate form submissions >Identifying and addressing form deficiencies >Mailing our and following up on deficiency letters to/from firms >An FDA advisory/consultant will be available to be contacted by email or phone C. Project Background: Background – Drug Product Content Management The FDA needs drug data content management support because it has neither the expertise or the skills to maintain content at the optimal accuracy, comprehensiveness, and timeliness to support its needs. The FDA currently does not have access to thousands of unlisted products on the market, so it cannot confront establishments regarding the drugs they do not list. Thousands of commercial [drug content] manager clients and customers, including government drug programs, have access to complete drug product content. However, FDA’s current drug registration and listing system, DRLS, is incomplete and inaccurate. The FDA will soon replace DRLS, which requires establishments to submit paper forms 2656 and 2657 to register and list (R&L). A system that will allow establishments to R&L directly by electronic transaction should be in place soon. Final details on system platform and industry access are still being worked out. This contract will primarily be a service contract supporting FDA’s electronic drug listing. We can only provide limited information on what support may be necessary as we transition from dependence on the paper forms to an electronic R&L platform. An update will be provided once more is known. With certainty, a quality review of drug product listed data in order to insure it is accurate and up-to-date, will be a primary function of this contract. Familiarity with drugs and drug products will be required, with very minimum data entry involved. A review of labeling and assignment of a compliance code that justifies a drug product being on the market, will be required for all non-application drugs. The contract also requires technical services that involves developing a DESI-Federal Register Database. The FDA will use the universe of drug products in the vendor’s drug data file to code each Rx non-application drug initially, then only as new non-application drugs are added as the vendor drug data files are updated. FDA will enter these coded drug products into the DESI-Federal Register Database along with the Federal Register # and Date that authorizes them. Using this database, vendor reviewers can easily assign codes to each non-application drug listed in the FDA’s electronic listing platform. More detail can be found within the content of this Statement of Work. The Food and Drug Administration (FDA) requires establishments to register and list their drugs (21 CFR 207). The Drug Registration and Listing System (DRLS) serves as the repository of registered drug establishments and their listed drug products. 21 CFR 207 instructs industry to use Forms 2656 and 2657 to register and list, and considers unlisted drugs to be “misbranded.” Non-compliant firms may be subject to criminal or regulatory action. But years of industry non-compliance have taken their toll. The Health and Human Services Office of the Inspector General found numerous discrepancies in DRLS content as compared to that of a private industry drug product database. Over 36% of DRLS’ drug product listings were no longer on the market. Many drug products on the market were not listed in DRLS. OIG concluded that FDA should routinely compare their drug product list with a commercial database to identify drugs that have not been listed and drugs which have been taken off the market. Today, leadership among this group of private drug product databases boast quality [accuracy and completeness] at the six sigma level1. These are industry’s best practices group. Early next year (2009), the FDA proposes to phase out the paper Forms 2656 and 2657. Establishments must use an electronic interface to register and list their drugs. Establishment must register under the new electronic system and relist all of their drug products. But as the IG suggested, FDA neither has the expertise or the staff to manage accurate drug product content. We seek to contract this and other services to a private drug database firm to insure FDA knows which drug products on the market have not been listed, and to provide its expertise, experience and professional resources to provide quality control for drug product content, labeling review, and other services to monitor compliance with FDA requirements. Drug Registration and Listing is critical for an number of FDA and other Government Programs: alocations for foreign & domestic establishments and ingredient information on all drugs b.information for initial establishment inspections (Sec 704) c.products affiliated with sites used in Risk Models guiding selection of GMP and ADE inspections d.information on drug products identical, related, or similar to DESI and NDA/ANDA drugs e.information that may be useful in identifying counterfeit, stolen, or diverted drugs. f.a searchable data base to accomplish establish and drug research. g.a means by which to code unlisted drug products identified through external sources DRLS is also used for/by: hImports – In daily use at the Port authority, officials use the DRLS to verify drug listings. i.Imports – In daily use at the Port Authority, officials use the DRLS database “Import Query” portal to determine if the foreign-made product is listed and has a [legitimate] NDC number (21 CFR 207.40 (b). Includes finished dose products, API’s, investigational drugs, homeopathics, OTCs, and veterinarian products. j Centers for Medicaid/Medicare Services (CMS) – These government drug programs refer to DRLS and are the most adversely affected by inaccurate content and on an almost daily base and through the expertise/consultation of DRLS data base management services as an advisory, acquire information essential to enforcing their drug reimbursement policies. The Office of Compliance and other FDA activities depend on the DRLS database for high profile programs that depend on data base extractions and reports are the Risk Management Survey Samples, DQRS, ADE inspections, and the Unapproved Universe Problem Solving Working Group. k DEA – Refers to the DRLS as an adjunct to other policy guidance to determine which drugs are controlled substances and how they are classified (schedule assignment) Note: With no professional oversight for label review at DRLS, we rely on the manufacturer’s determination regarding controlled substances designation. l. NIH – Utilizes DRLS for research purpose. Have recently requested additional information on all drug history including OTCs and homeopathic m.VA and DoD Tricare Drug Programs – Recent focus on unapproved drugs has resulted in interest from other government agencies with formulary programs who will refer to the DRLS in the future to assist in determining candidate drug products that qualify for formulary inclusion. n.Commercial drug database vendors frequently update their own databases by down- loading FDA approved drugs from the NDC Directory. o.Standard-Making Organizations – National Provider Organizations (NPOs) such as NCPDP download from the NDC Directory to gather data to support national standard initiatives (HIPAA, Drug Protocols for Reimbursement) p.Pharmaceutical Manufacturers, Distributors (Wholesalers, etc), pharmacies and pharmacy chains download NDC Directory data for various purposes to verify drug listing info and to gain advantage in the marketplace. q.Import Agents and Mediators – access DRLS data base to verify drug listing data Background - DESI Related Federal Register Notices Database This contractor must satisfy this database requirement first in order to accomplish Task 2, particularly the validation of listed non-application drug products that will be checked “Other” under the Drug Product Category entry. To more efficiently enforce FDA regulations concerning unapproved drugs, staff need access to an electronic database that supports linkage between marketed drug products and any DESI related Federal Register notice, NDA#, NDC#, and active ingredients associated with such products. The Federal Food and Drugs Act of June 30, 1906, first brought drug regulation under federal law. It prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by the FDA. The Food, Drug and Cosmetic Act (Act) of 1938 required the review and approval of new drugs for safety before marketing. Between 1938 and 1962, if a drug obtained approval, the FDA considered drugs that were identical, related, or similar (IRS) to the approved drug to be covered by that approval, and allowed those IRS drugs to be marketed without independent approval. In 1962 amendments to the Act added efficacy to the safety requirement. As part of the 1962 Act, Congress mandated that the FDA conduct a retrospective efficacy evaluation of drug products that the FDA had approved as safe between 1938 and 1962. This process was called the Drug Efficacy Study Implementation (DESI) review. All initial DESI determinations are published in the Federal Register (FR). If the FDA’s final determination classifies a drug as being ineffective, the product and all products IRS to it are no longer permitted to be marketed and are subject to enforcement action. Even if the FDA’s final determination classifies the drug as effective for its labeled indications, the FDA still requires approved applications for the continued marketing of the drug and all drugs IRS to it. It is the Agency’s longstanding policy that products subject to an ongoing DESI proceeding may remain on the market during the pendency of the proceeding. With all the new and changing products on the market, as well as the increasingly global marketplace, it has become increasingly difficult for the FDA to identify and act on all the unapproved products presently marketed. The Center for Drug Evaluation and Research’s (CDER) Office of Compliance (OC) needs a system that brings together all the elements needed to easily identify the DESI status of drugs, their approval status, and supporting documentation relevant to these drugs in DESI related Federal Register notices. D. Contract performance The majority of work under this contract is expected to be conducted at the contractor's site. E. Procurement/Contract Strategy: It is anticipated that a contract with 1 base year with 2 option years will be awarded. This is a new requirement. The NAICS Code is 511140, with a small business size standard of 500 employees. F. Capability Statement Requirements: Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 (“Limitations on Subcontracting”). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Respondents must address their capability, experience and knowledge directly correlated to the Statement of Work. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. DEADLINE FOR QUESTIONS IS JULY 2, 2008. SUBMISSIONS ARE DUE no later than 5:00pm, Eastern Time, Monday July 7, 2008. The capabilities response shall be e-mailed to: Dominique.Malone@fda.hhs.gov. Responses to the notice will not be returned. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. G. Additional Requirements/ Instructions for Submitting SOURCES SOUGHT Responses to FDA: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS 511140 (500 employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to in Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. a.Responses to this notice must be received by the Contract Specialist, Dominique.Malone@fda.hhs.gov on or before July 7, 2008 by 5:00 PM (noon) eastern standard time. DEADLINE FOR QUESTIONS IS JULY 2, 2008. b.Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. c.All transmitted information marked proprietary shall be treated as such. Therefore, businesses should identify any proprietary information in their SOURCES SOUGHT response. Proprietary materials will neither be distributed, nor discussed with, any other organization. Information submitted in response to this SOURCES SOUGHT will be used at the discretion of the Government. Further, the information submitted will remain confidential insofar as permitted by law, including the Freedom of Information and Privacy Acts. H. Other Information: The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Any responses received will not be used as a proposal. FDA does reserve the right to utilize any non-proprietary technical information in the anticipated SOW or solicitation. Information received will be considered solely to make informed decisions regarding a potential procurement. Responses to the SOURCES SOUGHT will not be returned and will not be accepted after the due date. All communications shall be by email. Respondents will not be notified of the results of the review of the responses. On behalf of the Food and Drug Administration, thank you for your interest.
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=fd51780cda0932bfa938609b0cbd5cf9&tab=core&_cview=1)
Document(s): SOURCES SOUGHT. PLEASE REVIEW; File Name: Sources Sought Notice (Drug Content Management.pdf); Link: https://www.fbo.gov//utils/view?id=1783069a68f9cd4434d17ce908b4cf9e; Bytes: 521.27 Kb; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: WO51 RM4262 HFD-330, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN01604093-W 20080702/080630220218-fd51780cda0932bfa938609b0cbd5cf9 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

99 -- Industry Best Practices - Drug Content Management - SOURCES SOUGHT. PLEASE REVIEW