FILE | D | Drug Registration and Listing System - SOURCES SOUGHT ANNOUCEMENT IN PDF

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

D -- Drug Registration and Listing System - SOURCES SOUGHT ANNOUCEMENT IN PDF

Notice Date: 6/30/2008
Notice Type: SOURCES SOUGHT ANNOUCEMENT IN PDF
NAICS: 518210 — Data Processing, Hosting, and Related Services
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-08-00744
Archive Date: 7/8/2008
Point of Contact: Dominique H Malone, Phone: (301) 827-7227, Patricia M Pemberton,, Phone: 301-827-1022
E-Mail Address: dominique.malone@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
Small Business Set-Aside: N/A
Description: A COPY OF THIS IS ATTACHED IN PDF FORMAT 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 Drug Registration and Listing System. B. Objective: Continue data entry and other functions associated with DRLS. C. Statement of Work: FUTURE OF DRLS: The future of DRLS is with electronic registration and drug listing which will require industry to register and list their products electronically via a FDA website. The electronic registration system is Drug Facility Registration Module (DFRM); and drug product listing, eLIST. The systems are at different stages of development DFRM piloting was completed in December 2007 and is expected to be available industry-wide on a volunteer basis in mid-February 2008. eLIST is currently under alpha-beta testing and is not expected to be piloted until March or April 2008. Availability of eLIST to industry on a volunteer basis is expected late fall 2008. As outlined in the 2008 FDA appropriation language, FDA may make the systems mandatory even before 21 CFR 207 becomes law, although that may be risky without the ancillary CFR provisions kicking in. However, Critical Path is attempting to call for mandatory DFRM use by December 31, 2008 and eLIST by late spring, 2009, thus affecting, then reducing dramatically, the use of forms over 2009 (depends on when we refuse to receive them). We remain supportive, but at the same time practical and reasonable in our planning. SCHEDULE AND TRANSITION IMPACTS: Parallel with the transition to the electronic systems as described above, the FDA seeks the support of a best practices commercial drug product vendor to help transform DRLS from a fragmented to a complete and reliable product. Stakeholders increasingly desire information that represents the entire universe of drug products. DRLS either in its present or electronic versions, must depend on industry to register and list its drug products, and recertify annually. Industry often shrugs off that responsibility even though mandated by law because of lack of enforcement prerogative. DRLS and its public counterpart, the NDC Directory, will remain fragmented and unreliable as a complete data source in the foreseeable future. It is our desire to compete this requirement among the best practice community in order to obtain a contractor to manage, and thus dramatically improve, the DRLS data base of the future. To plan for and accommodate the transition to the electronic systems, DRLS will require uninterrupted contractual support to accomplish data entry and other functions as stated in the attached SOW. However, the need for that support will ramp down over time as the work shifts to industry as described above. That kind of flexibility in the contract is necessary due to the fact that the rate at which the work transitions cannot be fully estimated at this time. The support required is expected to be quite different in July 2009 than in August 2008. However, some minimal support even after the electronic systems are fully implemented, will be required. TASK 1 of 2 1.Registration Processing (Form FDA 2656, Registration of Drug Establishment/Labeler Code Assignment or alternate method. – Requires data entry of information from 1 to 30 possible data entry fields, depending upon submission type as listed below :) •Data Entry from new form submissions, Domestic and Foreign. •Data Entry from update form submissions, Domestic and Foreign. •Data Entry from annual registration submissions, Domestic and Foreign. •Data Entry and Filing of correspondence designating foreign firm’s U.S. Agent. •Data Entry from other correspondence received from firms, Domestic and Foreign. •Data Entry from other correspondence received from within FDA. •Identifying and addressing form deficiencies (this may include handling/processing of calls to/from firms; handling/processing e-mails to/from forms. •Mailing out, and following up on Deficiency Letters to/from firms. •Current number of annual registration form submissions approximate 10,000. This volume will decrease as establishments voluntarily and then mandatorily enter their own data. •Continue the transition to DFRM registration with eventually goal of voluntary self- registration by establishments. 2.Drug Product Listing Processing Prescription Drug Products – •(Forms FDA 2657), Drug Product Listing, and FDA 2658, Registered Establishment’s Report of Private Label Distributor or alternate method. •Requires data entry of information from 1 to 35 possible data fields depending upon submission type, as listed below: •Data Entry from new drug form submissions, Domestic and Foreign. •Data Entry from updated drug form submissions, Domestic and Foreign. • Data Entry from “other” sources reporting drug product information, Domestic and Foreign. Over the Counter Drug Products – •(Forms FDA 2657), Drug Product Listing, and FDA 2658, Registered Establishment’s Report of Private Label Distributor or alternate method. •Requires data entry of information from 1 to 35 possible data fields depending upon submission type, as listed below: •Only Foreign forms for Over the Counter Drugs products will be processed. 3.Administrative Support for DRLS •Receipt of, date stamping, opening and sorting of mail containing incoming drug registration and listing forms and other correspondence (approximately 60,000 annually) is required. This volume will decrease as establishments voluntarily and then mandatorily enter their own data. •Filing of and retrieving DRLS forms upon completion of processing. •Minimal telephone coverage to receive and place calls to firms in the database as necessary. A government-implemented automated phone system will provide information to callers or direct them to an appropriate source of information. This should significantly reduce the demands placed on the staff to handle repetitive and redundant information. •Phones will be checked & messages retrieved at least 3 times daily and responded to within 48 hours. Electronic registration (Drug Facility Registration Module) is expected to replace the paper form by the end of 2008. •Mail must be opened daily and disseminated. 4. Quality monitoring •The government will have in place a “system” to monitor quality and ensure accuracy of the data entry and data management process, to the extent possible. •The contractor shall monitor the workload of the contractor staff to insure timely accomplishment of tasks. •Four commercial drug data bases (ie, MediSpan, First Data Bank, Gold Standard, Micronetics Redbook) will serve as the primary means of data entry validation, quality control, and benchmarking (See HHS IG Report, May 2006) 5. Materials •The Government will provide on-site Government workspace for DRLS contractor operations. •The Government will provide those materials and supplies that are necessary for the performance of the DRLS contract (ie, printer, copier, paper, pens, pencils) 6. Staffing •Due to the transition to electronic registration and listing and the impact that is expected to have on the workload over time, staff requirements will be adjusted accordingly. For purposes of illustration, to support a scenario that envisions ramping down over time: Beginning August 1, 2008 – 8 FTEs (no change from previous year) December 31, 2008 - 6 FTEs July 1, 2009 - 5 FTEs 7.Personnel Qualifications and Requirements General Staff Qualifications • Relational database experience. • Ability to follow instructions from the Project Officer and designated on-site government representative. • Ability to enter data, into DRLS database records, from various drug registration and listing from submissions. • Ability to follow all SOPs including: ability to apply DRLS and Center standards when entering information into the DRLS data base. • Ability to review existing firm data base records, ensuring that new information does not conflict with such existing information. • Ability to identify form deficiencies, and flag such deficiencies using data base tracking codes (for further review and follow up). • Ability to receive and review other (non-form) documents submitted from industry, regarding their firm registration and drug products. • Ability to extract necessary information and enter it into firm data base records. • Listing will be accomplished within 60 working days; imports 7 days after receiving forms TASK 2 of 2 To be activated when and if funds become available. The Contractor shall perform: When industry begins using the electronic systems, FDA must have a plan in place to systematically verify on a record to record or randomly selected basis, the integrity of the data being entered. Not only is this crucial in order to gain insight as to the ease of industry adaptation to the new business plan, but sound approaches to identifying real or potential compliance, technical, or security issues say a lot about how supportive the electronic systems will be in helping to foment a partnership between FDA and industry in advancing the public health. 1. Verification of Industry-entered Drug Product Listing Data Using an electronic batch-review process, examine industry-entered data in order to: •Establish reasonable credibility of firm and drug products entered •Review correctness, currency, and completeness of data entered •Examine compliance to published guidance •Overview reliability and effectiveness of system and system format •Test search and query capabilities of system and perform quality reviews as necessary •Identify trends or patterns (1 record or among several or all records) •Access free text and comments 2.Staffing •Same as under Task 1. •Number and quality of staff required will be based on level of acuity of tasking and specific guidance provided 3.Personnel Qualifications and Requirements General Staff Qualifications •Same as under Task 1. D.Project Background: The data in DRLS is used in the FDA regulation of domestic and foreign drug product manufacturers and handlers. 21 CFR 207 requires every drug product manufacturer and handler to register and list their drug products by submitting forms. This data must then be entered into the DRLS database. The number of registration and drug products listings accomplished by the contractor staff approached 60,000 in 2007. Other work that must be accomplished includes retrieving and sorting the mail, retrieving phone messages and copying and filing forms. E. Contract performance The majority of work under this contract is expected to be conducted at the contractor's site. F. Procurement/Contract Strategy: It is anticipated that a contract with 1 base year. This is a new requirement. The NAICS Code is 518210, with a small business size standard of $23 mil 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 518210 (size is $23 mil) 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=a6adedbcbd4adf72fdb00c2c0742e184&tab=core&_cview=1)
Document(s): SOURCES SOUGHT ANNOUCEMENT IN PDF; File Name: Sources Sought (Sources Sought DRLS.pdf); Link: https://www.fbo.gov//utils/view?id=675f94102a2e505ff77451c57b8936a1; Bytes: 280.68 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: SN01603911-W 20080702/080630215808-a6adedbcbd4adf72fdb00c2c0742e184 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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D -- Drug Registration and Listing System - SOURCES SOUGHT ANNOUCEMENT IN PDF