SOURCES SOUGHT
B -- Evaluations and Studies of New Drug Review Programs under PDUFA IV
- Notice Date
- 7/25/2008
- Notice Type
- Sources Sought
- NAICS
- 541614
— Process, Physical Distribution, and Logistics Consulting 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
- 1044785
- Response Due
- 8/1/2008 2:00:00 PM
- Archive Date
- 8/16/2008
- Point of Contact
- Mary Rose A. Nicol,, Phone: 301-827-7183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZ one firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitue an Invitation for Bids, a Request for Proposals, Soliciation, Request for Quotes, or an indication the Government will contract for the items contained herein. this notice is not to be construred as a committment 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 notice. The Government does not reimburse respondents for any cost associated with submissin of the information being reuesged or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience that can provide evaluation and studies of new drug review programs under PDUFA IV in accordance with the folllowing statement of work. This is a potential Indefinite Delivery Indefinte Quantity (IDIQ), Task Order oriented, fFirm-Fixed Price Contract with a base period and four option years. OBJECTIVE: FDA must engage independent expert consultants for these performance management studies and evaluations and therefore will use contractors for this purpose. The objective of this multi-year task order contract is to help meet FDA’s obligations as required in PDUFA IV to conduct studies and evaluations to improve performance management of the new drug review process in CDER and CBER. STATEMENT OF WORK: This contract could be used for one or more PDUFA IV performance management studies and evaluations. The scope of this contract will cover all aspects of FDA’s new drug review process in CDER and CBER and any other CDER, CBER, and FDA processes and activities that support the new drug review process in CDER and CBER including postmarket safety and inspection processes and activities. The scope of this contract will include all new drug review and support business processes and will include the medical and scientific bases for new drug review. This contract could also be used for studies and evaluations of other similar non-PDUFA product review processes in FDA but these would have to be funded with resources other than PDUFA user fees. Postmarket safety activities are those as defined in Title I, Section 102 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Postmarket safety activities with respect to drugs approved under human drug applications or supplements, include the following activities: 1.Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. 2.Developing and using improved adverse event data-collection systems, including information technology systems. 3.Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. 4.Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies). 5.Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities). The scope of this contract includes the following services by the contractor: 1.Strategies, tools, and assistance for implementing recommendations made by the contractor and accepted by FDA. 2.Training of FDA staff and development of training materials for implementation of recommendations. This includes online, updatable and modular training that is compliant with Section 508 of the Rehabilitation Act and compatible with current FDA and HHS online training systems. 3.Preparation of an html version of any final report that is compliant with Section 508 of the Rehabilitation Act for posting on FDA’s website. The studies under the performance management initiative are intended to foster: 1. Development of programs to improve access to internal and external expertise 2. Reviewer development programs, particularly as they relate to drug review processes 3. Advancing science and use of information management tools 4. Improving both inter- and intra-Center consistency, efficiency, and effectiveness 5. Improved reporting of management objectives 6. Increased accountability for use of user fee revenues 7. Focused investments on improvements in the process of drug review 8. Improved communication between the FDA and industry The contractor shall specify the methods it will employ in accomplishing the key tasks of each task order. The contractor shall demonstrate the ability to do the following: 1.Develop an evaluation study design and plan, including retrospective and prospective analyses and comparisons of performance as appropriate for each task. 2.Develop a data collection plan that includes the kinds, and availability of, data necessary to complete the evaluations. 3.Analyze program parameters as appropriate (e.g., time to first action, time to approval, review time) using FDA data systems. 4.Evaluate the effectiveness of any training program using metrics for behavioral and program outcomes. 5.Evaluate the system impact of changes in the new drug review process, including the value of changes to FDA and applicants. Value can include a better understanding of the review process that can lead to targeted improvements in the process. Anticipated Areas of Analyses for which Task Orders May be Issued to the Contractor The following list illustrates the kind of evaluation tasks that may be requested. Actual task orders will reflect agency priorities at the time of initiation. The contractor shall demonstrate the ability to conduct evaluations over several years. •Assessment of GRMPs Implementation. (See Attachment 1 for sample statement of work.) oAssessment of the progress toward full implementation of Good Review Management Principles (GRMPs), focusing on both FDA reviewer practices and industry sponsor practices affecting successful implementation. •Assessment of the electronic submission and review environment. oAssessment of the impact of the electronic submission and review environment on the efficiency and effectiveness of the overall process for the review of human drugs. •Other FDA Product Review Process Evaluations and Studies. oOther evaluations and studies of FDA’s product review processes as needed. 6.Relationship of Requirement to Other Contracts/Grants: There is an existing task order contract with Booz Allen Hamilton. 7.Type of Contract: This contract will be a cost reimbursement plus fee, task order contract. 8.Period of Performance: The period of performance for this contract will be one base year plus 4 option years. 9.Reporting Requirements and Deliverable Items: These requirements will vary by task. Work shall be performed at the Contractor's normal place of business, or a specified in the individual task order. Companies are encouraged to respond if they have the capability and capacity to provide the identified services with little or not disruption of services to the current users at the FDA. 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 respondent's 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 o allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 9"Limitations on Subcontracting"). Failure to definitively address each of these factors will result in finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone 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 54614 with size limitation standards of $6.5 million of average annual receipts and status, if qualified as 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZ one firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Business (must be listed in the VETBiz Vendor Information Pages). 4. DUNS number, Cage Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc.). companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of the firm’s GSA Schedule contracts(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 shall be provided for each entity expected to be teammates of the respondent for performance of this work. To maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 2:00 Pm, Eastern Time, August 15, 2008. The capabilities response shall be emailed to maryrose.nicol@fda.hhs.gov. All information received in response to notice that is marked Proprietary wil1 be handled accordingly. Responses to this notice will be returned, nor there any ensuring discussions or debriefings of any responses. Information provided in response to this notice wil1 is used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way bind the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA’s understanding of the notice submission. This announcement is Government Market Research, and may result in revision in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this it a notice for planning information purposes only and is not be construed as a commitment by the Government to enter into a contractual agreement, nor will the Government pay for information solicited.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=e2bc8f909954cf54066f8402360befea&tab=core&_cview=1)
- Place of Performance
- Address: PKLN RM14101 HFP-1, 5600 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01623905-W 20080727/080725225058-e2bc8f909954cf54066f8402360befea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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