SOURCES SOUGHT
R -- CTP Office of Compliance Regulatory
- Notice Date
- 4/1/2015
- Notice Type
- Sources Sought
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-SS-1144645
- Archive Date
- 4/30/2015
- Point of Contact
- Narissa Charles, Phone: 2404027569
- E-Mail Address
-
narissa.charles@fda.hhs.gov
(narissa.charles@fda.hhs.gov)
- Small Business Set-Aside
- Competitive 8(a)
- Description
- In accordance with FAR Part 7, this Request for Information (RFI)/Sources Sought is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration (FDA) or its Centers. The purpose of this RFI is to help the FDA understand the industry and viable solutions capable of fulfilling FDA’s requirements which are currently available in the commercial marketplace as described in this notice. NOTICE TO SMALL BUSINESSES The purpose of this Sources Sought Notice is to seek declarations of technical capabilities and various information, data, and materials from qualified small disadvantaged business concerns certified as 8(a) firms by the Small Business Administration (SBA). The FDA intends to provide maximum practicable opportunities to firms meeting this criteria. The proposed North American Industry Classification System (NAICS) Code is 541611. The information obtained from respondents will be used to assist the Government in determining the best acquisition strategy for this procurement. FDA welcomes responses from all qualified interested parties. This RFI is for information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of FDA. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. The FDA does not intend to hold discussions concerning this RFI with any interested parties. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this RFI or the Government's use of such information as either part of the evaluation process or for the development of specifications of a subsequent requirement. FDA reserves the right to contact vendors if additional information is required. GENERAL INSTRUCTIONS & SUBMISSIONS Responses to the Sources Sought Notice should not exceed 10 pages in length with utilizing a font not less than Times New Roman 11 pt. Responses should be submitted via email to Narissa Charles at Narissa.Charles@fda.hhs.gov, by no later than 3:00 PM, Eastern Time on Wednesday, April 15, 2015. A complete response to the Sources Sought Notice should include answers to all of the requested information below. Please note that a respondent’s f ailure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide the services required. Responses should demonstrate capability, not merely affirm the respondent’s capability (e.g., the response must go beyond the statement that, “XYZ company can provide scan documents.”). BACKGROUND The FDA Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) is responsible for enforcing the Federal Food, Drug & Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act and its implementing regulations and does so through a variety of methods including inspections of manufacturers and retailers, reviewing product regulatory submissions and notifications, and finding and analyzing print and electronic advertising, labeling, and promotions. Through these activities, OCE generates a large volume of data regarding inspections, imports and recalls, industry submissions and notifications, registrations and applications, product and ingredient listings, and advertising, labeling, and consumer information. The high volume of submissions and notifications, inspections, and other compliance records create a need for additional programmatic and administrative support to assist with the timely review, compiling, and processing of information, and documents. TASK AREAS Task 1 - Receipt, Review, and Processing of Retailer Compliance Check Inspection Data The Government requires support to ship, receive, data entry, review, compile, and process documents associated with the Tobacco Retailer Compliance Check Inspection Program including inspection data. Review may include compiling information into templates based on FDA instruction, and research or verification of provided data via internet, mail, e-mail, or telephone. Each review consists of approximately 10 documents and requires information to be compiled into 3-4 templates. Task 2 - Processing Documents Processing documents may include data entry, uploading documents and creating cases in databases identified by the FDA. Documents associated with the Tobacco Retailer Compliance Check Inspection Program include, but are not limited to: inspection reports, administrative or enforcement notices and follow-ups, and details regarding tobacco retail establishments. These documents vary in length; however, the average range is from 1 page to 25 pages. The Contractor shall also support OCE in tasks dealing with communication between CTP and the Retailer, such as: receiving documents from Retailers, generating, scanning, uploading, or compiling documents, and tracking delivery of mailings. Task 3 - Analysis and Compilation of Data for Tobacco Product Review Program The Government requires support with data management of industry submissions and notifications. Management includes, receipt, analysis and tracking electronic and paper documents submitted from the tobacco industry. Documents will be managed in accordance with CTP workflows and established administrative processes to support the tobacco product review program. The Contractor will be responsible for sending, receiving, tracking, quality assurance, review and control, scanning of documents, and other aspects of data management associated with the review. Task 4 - Analysis and Compilation of Data for Promotion, Advertising, and Labeling The Government requires support for rec o r ding, reviewing, analyzing, a nd t r ac king in f o r m a tion contained in industry submissions and notifications. These activities require that information pertaining to labeling, advertising or other promotional material identified by FDA be routinely compiled, recorded, reviewed, analyzed, and tracked. Routine data searches to identify possible promotional events or activities where free samples of tobacco products may be distributed will be conducted. The Contractor will be responsible for preparing hard copy or electronic documents to properly document these activities. The Contractor is also responsible for sending, receiving, tracking, uploading, quality assurance review and control, scanning of documents, and other aspects of data management associated with the review program. Task 5 - Surveillance, Review, and Notification of Online and Print Sale and Promotional Activities The Government requires support with searching, compiling, recording, reviewing, analyzing, and track online and print information associated with this routine surveillance, information as identified, and/or information requested by FDA. The Contractor shall provide support for the sending, receipt, tracking, analysis, compilation, preparation, processing, and other aspects of management, of information, documents, and other materials associated with this activity. The Contractor shall draft notifications associated with this activity and provide associated support for the data entry, review, compilation, and processing of notifications. Task 6 - Surveillance of Sales to Minors The Government requires support in recruiting minors, as defined below, to conduct online purchases of regulated tobacco products in multiple states. The Contractor, or the designated person or entity, rather than FDA, has the oversight responsibility for minors involved in the program. T he Contractor shall ensure that the Minors are within the required age range (16 or 17 year olds) by obtaining a copy of their birth certificate and identification (if available) and an original parental/legal guardian consent form for each state where the purchases are attempted. Consistent with applicable law, the Contractor shall be responsible for recruiting minors to conduct such purchases and shall be responsible for managing and protecting such minors and their information. The Contractor shall facilitate, complete, and document such purchases including payment and shipment. It is estimated that the inspection services will be provided for 4-6 full days each month in which a minor will attempt to conduct online purchases of tobacco products. The Contractor shall secure a grant of immunity from the proper authorities prior to using Minors in any jurisdiction where it would be illegal to use Minors to conduct online undercover buy assignments or where a minor’s possession of tobacco products is illegal. The Contractor shall provide proof of such immunity upon request from FDA. The Contractor shall ensure that all Minors are insured against accidents or other injuries. REQUIRED SUBMISSION DATA Please provide the follow Business information on your cover sheet: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number, website and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, limited liability corporation, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); CAPABILITIES QUESTIONS 1. How would you suggest pricing this requirement? Considering operational costs in conjunction with successful project performance, is this work most suitable to be performed at a Government or Contractor facility? Should the facilities and equipment costs be included in the fully burdened labor rates? If not, how would they be priced (e.g. per square foot, per piece of equipment)? 2. Please provide your capabilities to perform high volume tasks on short deadlines as well as experience in this area. 3. Please provide capabilities gathering and securing sensitive data in a regulatory environment. 4. The IGCE for this requirement is not yet finalized; however, the Government is contemplating use of an Indefinite Delivery Indefinite Quantity (IDIQ) type contract with a ceiling as high as $60M. Please briefly - no more than two to three paragraphs - describe your capability to staff and execute a project of this magnitude and complexity in terms of project scope, IDIQ and task order management approach and access to capital. Also please describe any certifications (e.g. ISO or CMMI) which demonstrate proven management and quality outcomes. 5. Discuss your firm’s capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 6. Discuss vendor’s current Government Wide Acquisition contracts (GWAC) which may be appropriately used to solicit a requirement as defined in this Sources Sought notice 7. What equipment (e.g. scanners, IT equipment, furniture, phones, vehicles, mail totes, hand trucks, telecommunications, access control equipment etc.) would be needed in a facility (Government or Contractor) in order to complete work effort? 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SS-1144645/listing.html)
- Place of Performance
- Address: Primarily in the Washington, DC metro area., See task 6, United States
- Record
- SN03685587-W 20150403/150401234842-c6a2403d5eb0e61ffa81b5ac5fc1d810 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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