MODIFICATION
R -- Multimedia Materials for the Center for Tobacco Products (CTP)
- Notice Date
- 8/18/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541890
— Other Services Related to Advertising
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1153430
- Archive Date
- 9/10/2015
- Point of Contact
- Eric Rabinovich, Phone: 2404027631, James G. Whitt, Phone: 2404027627
- E-Mail Address
-
eric.rabinovich@fda.hhs.gov, james.whitt@fda.hhs.gov
(eric.rabinovich@fda.hhs.gov, james.whitt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- PART 1 - DESCRIPTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1153430. This solicitation is issued as a Total Small Business Set-Aside. This solicitation documents and incorporates provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2005-83-2-2-08032015, dated August 5, 2015. The associated North American Industry Classification System (NAICS) Code is 541890 - Other Services Related to Advertising; Small Business Size Standard is $15 Million in average annual receipts. The US Food and Drug Administration (FDA) intends to issue a Commercial Item Firm-Fixed-Price purchase order that meets the following specifications below. 1.1 Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act or TCA) provides the U.S. Food and Drug Administration (FDA) with the authority to regulate the manufacture, distribution, and marketing of tobacco products to address public health issues, including use of tobacco by young people and dependence on tobacco. CTP's Office of Compliance and Enforcement (OCE) aims to ensure that regulated industry complies with the laws. OCE uses a three (3) pronged approach to help industry move towards this goal by: 1) developing and providing compliance training and education, 2) monitoring compliance with the law through surveillance, inspections, and investigations, and 3) taking advisory and enforcement actions such as issuing Warning Letters and Civil Money Penalties against noncompliant industry as appropriate. The Center for Tobacco Products has contracted with various parties to conduct inspections of tobacco retailers to ensure their compliance with the TCA. Since the inception of the Retail Compliance Check Inspection Program, CTP has provided guidance to manufacturers, distributers, and retailers. OCE intends to raise awareness among newly regulated retailers that will be impacted by Deeming as additional retailers will now be subject to FDA regulatory authority, including inspections. 1.2 Objectives The Contractor shall develop materials to make newly regulated entities aware of: a) FDA authority to regulate the tobacco industry; b) Regulatory requirements that apply to retailers; and c) FDA's authority to conduct inspections to ensure compliance with the TCA. PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS The Quoter shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Deliverable 3.1 - Retailer Factsheet 1 EA $ 0002 Deliverable 3.2 - Cigarette Props 1 EA $ 0003 Deliverable 3.3 - Graphics of Tobacco Products 1 EA $ Total Amount $ PART 3 - TECHNICAL REQUIREMENTS 3.1 The contractor shall develop and submit to FDA one (1) tri-fold fact sheet (8"x11.5"). The fact sheet must include relevant logos, CTP, FDA, and HHS provided by FDA, and the contractor shall provide graphics and text, and a draft tri-fold fact sheet, which notifies the newly regulated retail establishments that: 1) They are now subject to FDA jurisdiction; and 2) They must comply with these provisions: a. Age and ID requirements b. Registration and listing (if considered a manufacturer); and c. FDA conducts inspections to determine compliance. After receipt of the logos from FDA, the contractor shall provide a draft of the fact sheet to FDA within three (3) weeks. FDA will review the proposed draft fact sheet and provide feedback within three (3) weeks of receiving the draft. After FDA has provided feedback on the draft, the contractor then shall have three (3) weeks to provide a final version in an editable source. The contractor shall provide both drafts of the fact sheet in an editable source document via software compatible with Microsoft Word (97-2003) and Adobe Creative Suite 6 Design Standard. 3.2 The contractor shall provide electronic cigarette props packaged in individual blister packs suitable for display on a J-hook. The packaging must use the branded logos provided by FDA. The contractor shall provide a sketch of the prop to be manufactured for approval by FDA prior to the manufacturing. A total of twelve (12) electronic cigarette props shall be created. Each prop shall be between five (5) and six (6) inches long, not including the packaging and shall be similar to the top graphic located at the FDA website at http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm394674.jpg. The COR will not accept delivery of any prop that does not conform with the referenced picture. The contractor shall also provide twelve (12) electronic cigarette replacement cartridges (2-3 inches long) also packaged individually in blister packs using the branded logos provided by FDA. An initial sketch shall be created and approved by FDA prior to production. The prop shall resemble the bottom item pictured on the FDA website at http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm394674.jpg 3.3 The contractor shall create three (3) graphics with graphic resolution consisting of three hundred (300) dpi for the following types of tobacco products: dissolvable tobacco products, gel, waterpipe tobacco, electronic nicotine delivery systems (including e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes), cigars, cigarillos, and pipe tobacco. Each graphic shall be "generic" and not contain any recognizable brand or trade name. Each graphic shall be provided in the following formats:.png,.eps and.AI. The following deliverables and timelines shall apply: Deliverables Task Due Date Participate in a Kickoff Meeting. The contractor shall meet with The FDA/CTP either in person or via teleconference to discuss the project and any outstanding questions. Within 10 days of the award of contract. 3.1 Retailer factsheet Develop and create fact sheet for newly-regulated retailers 90 days after award. 3.2 Props Electronic cigarettes in blister packs 90 days after award. 3.3 Graphics Graphics of tobacco products 90 days after award. PART 4 - PACKING, MARKING AND SHIPPING All deliverables required under this purchase order shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the purchase order number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. PART 5 - INSPECTION AND ACCEPTANCE The Contracting Officer's Representative (COR) will perform inspection and acceptance of deliverables described within Part 3. For the purposes of this PART, (COR - to be determined upon purchase order award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at the locations identified in Part 6. Acceptance will be communicated in writing, unless otherwise indicated in writing by the Contracting Officer or COR, within 30 days of receipt. This purchase order incorporates the following clause, FAR 52.246-2, Inspection of Supplies-Fixed Price (Aug 1996), as well as FAR 52.246-4 Inspection of Services-Fixed Price (Aug 1996), by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make its full text available. PART 6 - DELIVERIES OR PERFORMANCE Satisfactory performance of this purchase order shall be deemed to occur upon completed delivery of each deliverable described in PART 3 and upon acceptance by the Contracting Officer, or the COR, of these products. Deliveries required by the Contractor shall be made within 90 days of purchase order award, to the addresses/addressees listed below: 6.1 Deliveries: U.S. Food and Drug Administration Center for Tobacco Products 10903 New Hampshire Ave Silver Spring, MD 20903 Building 75 POC: Brandon S. Bruce (240) 402-9226 brandon.bruce@fda.hhs.gov Supplies and Equipment shall be delivered Monday thru Friday, between 9:00am - 3:00pm Eastern Time. 6.2 Period of Performance: All deliverables shall be provided within 90 days of award. PART 7 - CONTRACT ADMINISTRATION DATA Contracting Officer Representative (COR) The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Purchase Order Award) The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. Contracting Officer (CO) The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The contact information for the Contracting Officer: James G. Whitt 5630 Fishers Lane Rockville, MD 20853 James.Whitt@fda.hhs.gov 240.402.7627 The contact information for the Contract Specialist: Eric Rabinovich 5630 Fishers Lane Rockville, MD 20853 Eric.Rabinovich@fda.hhs.gov 240.402.7631 PART 8 - FAR and HHSAR CLAUSES The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition, with the following addenda to the provision: Period for Acceptance of Offers: The quoter agrees to hold the prices firm through September 30, 2015. FAR 52.204-16 Commercial and Government Entity Code Reporting (Nov 2014) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certification (Dec 2012) The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The Contractor shall submit one (1) original copy of each invoice to the address specified below: ATTN: FDA Vender Payments Team Office of Financial Services Food and Drug Administration Building 32, Room 2162, Mail Hub 2145 Silver Spring MD 20993-0002 (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this purchase order must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above. FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (Apr 2014) FAR 52.204-18 Commercial and Government Entity Code Maintenance (Nov 2014) FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (May 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: • 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). • 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). • 52.219-6 Notice of Total Small Business Set-Aside (Nov 2011)(15 U.S.C. 644). • 52.219-8 Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)) • 52.219.14 Limitations on Subcontracting (Nov 2011)(15 U.S.C. 637(a)(14)) • 52.219-28 Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). • 52.22219 Child Labor-Cooperation with Authorities and Remedies (Jan 2014)(E.O. 13126). • 52.222-21 Prohibition of Segregated Facilities (Feb 1999) • 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) • 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) • 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) • 52.222-37 Employment Reports on Veterans (Jul 2014)(38 U.S.C. 4212) • 52.222-50 Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627) • 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) • 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury) • 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-8 Option to Extend Services (Nov 1999) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following Health and Human Services Acquisition Regulation (HHSAR) clauses apply to this acquisition and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html • 352.202-1 Definitions (Jan 2006) • 352.215-70 Late proposals and revisions (Jan 2006) • 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010) • 352.227-70 Publications and Publicity (Jan 2006) • 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) PART 9 - INSTRUCTIONS TO QUOTERS It is the quoter's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from award consideration. Quotation Preparation Instructions: All responsible sources may submit a quote, which, if timely received, will be considered. The quote must reference solicitation number FDA-SOL-1153430. The quotes are due in person, by postal mail or email to the point of contact listed below, by no later than August 26, 2015, by 4:30 PM, Eastern Time at the Food and Drug Administration, OO/OAGS, Attn: Eric Rabinovich, 5630 Fishers Lane, Room 2139, HFA-500, Rockville, Maryland 20857. Quoters must ensure the RFQ number is visible in the subject line of the email. Faxed quotes will not be accepted. Late submissions will be treated in accordance with the solicitation provision at FAR 52.212-1(f). For information regarding this solicitation, please contact Eric Rabinovich by phone on (240) 402-7631, or email: Eric.Rabinovich@fda.hhs.gov. Quoters may submit all questions regarding this RFQ to Eric Rabinovich, via email at Eric.Rabinovich@fda.hhs.gov. The FDA must receive the questions no later than 4:30 PM, Eastern Time, Wednesday, August 19, 2015. The subject line must read: Solicitation No. FDA-SOL-1153430. FDA will not answer questions received after this date and time, and will not answer questions submitted to individuals other than the named contact point (no phone calls, please). RFQ questions and FDA responses will be posted to the Federal Business Opportunities (FedBizOpps) web site. It is the vendor's responsibility to check the FedBizOpps web site for the questions and answers and any other amendments issued for this RFQ. A complete quote shall consist of a cover letter; Volume 1-Technical Quote; and Volume 2-Business/Price Quote. Incomplete quotes will be considered non-responsive and will not be further evaluated. Each volume shall be sent as a separate document. The Technical Quote (Volume 1) and Business/Price Quote (Volume 2) must be kept separate from each other. Kept separate is defined as not including any cost/price information in the Technical Quote (Volume 1). The Technical Quote must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. The signature of an official authorized to bind the Quoter shall be placed on each volume. Each volume shall be submitted as follows: Technical Volume: Text color shall be black. Color may be used in graphics or charts for greater clarity at the Quoter's option. Text in graphics and charts shall be no smaller than 9-point; text in tables shall be no smaller than 9-point Arial. The size and font of headers and footnotes are not dictated. No fonts may be condensed. The Technical Quote is limited to 15 pages. Quoters shall use only 8.5 inch by 11 inch (210mm by 297mm) double-sided paper, single-spaced pages, with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than 9 point. **FDA will not evaluate information submitted over the page limitation** Note: A page in the technical quote that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitation. The following items are not included in the overall 30-page limit: • Cover Page • Table of Contents • Dividers • Resumes (2 page limit) • Contractor Teaming Arrangement (if applicable) • Skill Matrix/Resumes All critical information from appendices must be summarized in the technical quote. Business/Price Volume: The price proposed shall be detailed and represent the quoter's response to the schedule of services above. Quoters are encouraged to include a commercial price list with their quote, as applicable. Every page of the pricing volume must be numbered. There is no page limit to the pricing volume. All total dollar amounts provided shall be rounded to the nearest cent. The Government is not responsible for locating or securing any information which is not identified in the quotation; however, the Government reserves the right to obtain information for use in the evaluation from any and all sources, including sources outside of the Government. Quoters should include their DUNS number with the quote. Any assumptions forming the basis of the submittal must be clearly identified in the cover letter submitted with the RFQ. Evaluation Criteria and Basis for Award: (a) The provision at FAR 52.212-2, Evaluation-Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a purchase order resulting from this solicitation to the responsible quoter whose offer demonstrates the technical capability to meet the technical requirements listed under Part 3 of this solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to the quoter whose offer is determined to be the Lowest Priced-Technically Acceptable quote. (b) This is an open-market combined synopsis/solicitation for services as defined herein. The Government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, ALL quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" The Quoter shall list the exception(s) and rationale for the exception(s). (d) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the offer shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Government reserves the right to make an award without communications.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1153430/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, Center for Tobacco Products, Building 75, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN03843165-W 20150820/150818235454-8e269bbe622fa1467cce33dce10cea26 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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