MODIFICATION
B -- Therapeutic Equivalence of Generic Iron Complex Product - Sources Sought
- Notice Date
- 4/19/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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-SS-1116099
- Archive Date
- 5/18/2013
- Point of Contact
- Natalie Mitchell, Phone: 3018279606
- E-Mail Address
-
natalie.mitchell@fda.hhs.gov
(natalie.mitchell@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Therapeutic Equivalence of Generic Iron Complex Product General Information: Document Type: Sources Sought - FDA-SS-1116099 Release Date: April 19, 2013 Response Date: May 3, 2013 at 4:00pm EST via email to Natalie.Mitchell@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Natalie Mitchell, Contract Specialist Description of Services/Supplies: Therapeutic Equivalence of Generic Iron Complex Product CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants Services (OAGS) DESCRIPTION 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 evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex Nulecit TM and its RLD Ferrlecit®. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirements. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the following: Background: Parenteral iron injection products are used to treat anemia, particularly in patients with chronic kidney disease (CKD). There are four types of parenteral iron complex products available in North America: iron sucrose, sodium ferric gluconate, iron dextran, and ferumoxytol. All parenteral iron products are colloids comprising a continuous aqueous medium and particles of carbohydrate protected iron oxyhydroxide. After intravenous administration, iron colloid particles are processed by phagocytes and iron ions are delivered to the lysosomes within the cell as part of the intracellular labile iron pool. The phagocyte uptake and biodistribution of iron complex particles depend upon their physicochemical properties. If iron is not needed immediately, it is stored in the form of ferritin or hemosiderin. When the iron is needed in the body, iron is released from the cell and transferrin binds iron ions and delivers them to their destination. If transferrin is oversaturated or if the iron complex product is so unstable that iron is spontaneously released at a rate that exceeds transferrin binding capacity, non-transferrin bound iron (NTBI) is formed in the plasma. NTBI can be toxic to cells as it acts as a catalyst in the formation of free radicals from reactive oxygen species. In March 2011, FDA approved the first generic sodium ferric gluconate iron complex Nulecit TM, an alternative to Ferrlecit®. It has been suggested (in a March 2011 EU guidance) that generic iron formulations could have higher levels of labile iron, leading to the formation of a greater amount of nontransferrin-bound iron (NTBI) in vivo than the RLD that would potentiate oxidative stress and inflammation, then resulting in direct cellular damage and possibly increasing the risk of atherosclerotic disease. FDA's approval of generic iron complex products was based on equivalence in product characteristics supported by equivalence in in vivo pharmacokinetic studies. Products that meet these approval standards should have no significant difference in NTBI. The March 2011 EU guidance reflects the fact that the EU equivalence approach recommends non-clinical studies, unlike the FDA approach, which sets strict standards for product characteristic equivalence. The Agency believes that a battery of physicochemical characterization tests including in-vitro labile iron determination would ensure comparable tissue distribution and no more in vivo labile iron leakage from generic formulations than that from RLD. Well controlled, prospective studies that investigate iron tissue distribution in preclinical species and compare NTBI levels between brand and generic in hemodialysis patients may confirm the agency's approval criteria and help address the public concerns. Statement of Work (SOW) or Objectives: The objectives of this requirement is to evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex Nulecit TM and its RLD Ferrlecit®. Specific aims are: 1) compare reticuloendothelial system (RES) uptake of RLD and generic; 2) compare biodistribution of the RLD and generic in animal models; 3) conduct in-vivo study to compare plasma NTBI levels and oxidative stress after i.v. administration of RLD and generic in healthy subjects or patients. This study is part of post-market surveillance that can help address potential concerns regarding the quality of generic iron complex products and support the Agency's review standards. Below are the detailed descriptions: 1) Conduct in-vitro phagocytosis assays to compare RES uptake of RLD and generic. Since a battery of in vitro characterization tests have proved physicochemical equivalence between Nulecit TM and its RLD Ferrlecit®, the rate and extent of phagocyte uptake of generic and RLD should be similar. 2) Determine the time-dependent iron content in the major target organ (e.g., plasma, RES, target tissues) and compare biodistribution of RLD and generic in appropriate animal models. Time points for sampling of target tissues should be selected to cover the main time-concentration profiles. 3) Conduct a prospective, randomized, 2-way crossover study to compare plasma NTBI levels in hemodialysis patients treated with generic and RLD (healthy control can be used). Utilize in vitro and in vivo biomarkers such as malondialdehyde, heme-oxygenase-1 (HO-1) RNA or others to evaluate the oxidative stress and toxicity caused by generic and RLD. Statistical analyses will be conducted to determine whether there are any significant differences between generic and RLD in the above tests. This is a 3-year project. Due to the sequential nature of in vivo pharmacokinetic studies, this project is non-severable. 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 deliver the specific equipment as required. Responses to this notice shall be limited to 5 pages, and must include: 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 541712 (size standard $ or number of 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 System for Award Management (SAM) to be considered as potential sources. 5. If applicable, 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 indicate the firm's status (see item #3, above). 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, Request for Proposals, Solicitation, 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. Responses to this notice must be received via email to Contract Specialist Natalie Mitchell at email address Natalie.Mitchell@fda.hhs.gov no later than 4:00 PM Eastern Standard time on Friday, May 3, 2013 for consideration. Responses to this announcement will not be returned, nor 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 the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1116099/listing.html)
- Place of Performance
- Address: Rockville, Maryland, United States
- Record
- SN03041387-W 20130421/130419234652-592788989854da145c8e7b6d103c898d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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