News Column

Combine Solicitation - Pharmaprojects Drug Intelligence Database

August 4, 2014



Notice Type: Combine Solicitation

Posted Date: 01-AUG-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001

Subject: Pharmaprojects Drug Intelligence Database

Classification Code: D - Information technology services, including telecommunications services

Solicitation Number: FDA-SOL-13-1135672

Contact: Trevor R. Edwards, Phone 240-402-7529, Email trevor.edwards@fda.hhs.gov

Setaside: N/AN/A

Place of Performance (address): Food and Drug AdministrationLibrary WO2 Room 3051 10903 New Hampshire Ave Silver Spring, MD

Place of Performance (zipcode): 20993

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This synopsis is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Request for Proposal number is FDA-SOL-13-1135672. Provisions and clauses in effect through Federal Acquisition Circular 05-76 are incorporated into this request. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The provisions and clauses may be accessed in full text at www.acquisition.gov/far. The NAICS code is 511120, Periodical Publishers. There is no set-aside for this acquisition. All qualified vendors are encouraged to respond. The purpose of this procurement is to establish a Contract for 24/7 web access to the Pharmaprojects DrugIntelligence database (brand name or equal to product) for one, 12 month base period and two, 12 month optional periods. Product shall support the FDA BioSciences Library and researchers assigned to all sites within the Agency. This requirement will allow for unlimited IP access for the online application. The FDA requests proposal responses from qualified sources capable of providing 24 hours a day, 7 days a week web access to the Pharmaprojects DrugIntelligence database or equal to product. Base Period CLIN 0001 - Web access - Pharmaprojects DrugIntelligence database (brand name or equal to), Period of Performance: 12 months.

Option Period One CLIN 0002 - Web access - Pharmaprojects DrugIntelligence database (brand name or equal to), Period of Performance: 12 months.

Option Period Two CLIN 0003 - Web access - Pharmaprojects Drug Intelligence database (brand name or equal to), Period of Performance: 12 months.

If offeror is not proposing the brand name solution specified above, the proposed product shall meet the following salient, functional characteristics in order to be considered for award:

1. Resource shall include reports on the progress of new pharmaceutical products, both new chemical entities and biotechnological entities at all stages of development from early pharmaceutical studies to final launch in all major international markets and cover discontinuation.

2. Product shall be completely web based and be updated in real time as well as provide a development timeline on each drug and data including diseases, therapy, mechanism, delivery routes, biological targets, molecular structure, chemical data, licensing information, and company data.

3. Product shall have two search platforms and provide at least 46,000 online drug profiles and have the capability to be searched by a minimum of 75 different criteria such as: target family, new chemical entity, company pipeline, trends, therapy pipeline, therapeutic class, drug registration by country, first launch date, delivery mode, and chemical substructure within a therapy, pharmacology or indication. 4. Resource shall provide key data on drug profiles: therapies and indications by phase, originator and licenses, pharmacokinetic data, clinical trials data, and country information. 5. Products search capabilities shall include: Trend Analysis, Company, Therapy Profile, chemical structure search. 6. Resource shall allow for the reviewing of incidences, prevalence, and market data for at least 218 drug therapeutic areas as well as provide customizable reports and graphs that can be exported in a variety of formats. 7. Resource shall provide linking to SCRIP articles and PubMed citation and have the capability for users to create watch lists on drugs and drug development milestones. 8. Contractor shall provide users with the ability to submit an unlimited number of research requests to expert analysts and receive responses within 48 hours. 9. Contractor shall provide an unlimited number of training sessions on the use of the database as well as provide online tutorials or web based training. 10. Contractor shall provide technical assistance related to website/software issues via phone or email. This support shall be available during normal operational hours (8:30a - 5:00p Eastern Time, Monday - Friday, excluding Government holidays). Support will not be necessary during any other hours. 11. Contractor shall provide usage statistics on a monthly basis. The format of the usage statistics shall be provided via email or Contractor provided login. Reports shall include session count. 12. This requirement is subject to Section 508 compliance. Vendor proposals shall address how the proposed solution will comply with Section 508. Specifically the following 508 Standards are applicable: 1194.22 Web-based intranet and internet information and applications 1194.41 Information, documentation, and support Evaluation Factors for Award:

The Government shall award a contract resulting from this solicitation to the responsible offeror whose offer is the lowest price technically acceptable offer, which shall represent best value to the Government. Award will be made on the basis of the lowest evaluated price (inclusive of options) meeting or exceeding the non-cost factor (technical conformance to the requirements of the solicitation). The Government intends to evaluate offers and award a contract without discussions. The offeror's initial offer should contain the offeror's best terms from a price standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the best interest of the Government; accept other than the lowest offer; and waive informalities and minor irregularities in offers received. The following factors shall be used to evaluate offers:

1. Technical Features Meeting/Exceeding Salient Requirements (Brand Name or Equal)

2. Total Price (all CLINs shall be priced)

Proposal Instructions to Offerors:

Offerors are required to submit their proposals in two separate volumes as follows:

Volume I - Technical

Volume II - Pricing Proposal

The completion and submission of the above items will constitute an offer (proposal) and will indicate the offeror's unconditional assent to the terms and conditions of this RFP and any attachments hereto. Alternate proposals are not authorized. Objections to any terms and conditions of the RFP will constitute deficiency, which may render the offer unacceptable.

Volume I - Technical:

This portion of the proposal to include all data and information required for technical evaluation of brand name or equal product, and exclude any reference to the pricing aspects of each offer. If an equal product is proposed, offeror shall demonstrate how that product is equal to the brand name product. Offerors shall demonstrate in sufficient detail that the proposed solution will successfully meet the requirements of the salient characteristics. For purposes of clarification, offerors are encouraged to provide trial access to their products to demonstrate how the requirements of the salient characteristics will be met.

Volume II - Pricing:

This volume shall include the complete pricing. Offerors shall propose pricing for a twelve (12) month base period and two (2) additional 12 month optional periods. Offerors shall price each CLIN and clearly state an overall cost to the Government (inclusive of options). FAR Provisions and Clauses 52.211-6 Brand Name or Equal (AUG 1999) 52.212-1 -- Instructions to Offerors -- Commercial Items (APR 2014) 52.212-4 -- Contract Terms and Conditions -- Commercial Items (MAY 2014) Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jul 2014) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). ____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: _X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). ___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). ___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _X__ (8) 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). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). _X__ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). ___ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). _X__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (iii) Alternate II (Mar 2004) of 52.219-7. _X__ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (July 2010) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). ___ (ii) Alternate I (June 2003) of 52.219-23. ___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). _X__ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). __X_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X__ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _X__ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). __X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X__ (32) 52.222-35, Equal Opportunity for Veteran (Jul 2014) (38 U.S.C. 4212). _X__ (33) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). _X__ (34) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). ___ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X__ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) ___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (38) (i) 52.223-13, Acquisition of EPEAT(R) -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (39) (i) 52.223-14, Acquisition of EPEAT(R) -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (41) (i) 52.223-16, Acquisition of EPEAT(R) -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. __X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011). ___ (43) 52.225-1, Buy American'upplies (May 2014) (41 U.S.C. chapter 83). _X__ (44) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). ___ (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X__ (46) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (47) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2303 Note). ___ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). ___ (52) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (53) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). _X__ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (56) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ___ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items: ___ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). _X__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). ___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (vii) 52.222-17, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (viii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (ix) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (x) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (xi) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiv) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xvi) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) 52.213-2 Invoices (APR 1984) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor anytime within the current period of performance (b) If the Government exercises this option, the extended contract shall be considered to include this option clause (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36 months. (End of Clause) The contractor is requested to hold price quotations for a minimum of 45 days. Other Administrative Instructions: System for Award Management (SAM). In accordance with FAR 52.212-4, Offerors shall be registered in the SAM database to be considered for award. Registration is free and can be completed on-line at https://www.sam.gov/; provide DUNS number; Cage Code and TIN.

Proposals shall be submitted by email only as a MS Word or Adobe PDF attachment to Trevor R. Edwards at trevor.edwards@fda.hhs.gov. Proposals are due by 12:00 pm Eastern Time on August 11, 2014. Any questions must be addressed to Trevor R. Edwards, trevor.edwards@fda.hhs.gov.

Link/URL: https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-13-1135672/listing.html


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