SOURCES SOUGHT
R -- Consent Decree
- Notice Date
- 3/20/2012
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical 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
- 1098941
- Point of Contact
- Vida - Niles,
- E-Mail Address
-
vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Sources Sought Release Date: March 20, 2012 Response Date: April 3, 2012 at 10:00 am EST via e-mail to Contract Specialist: Vida Niles at Vida.Niles@fda.hhs.gov Description: Development of a Strategy for Consent Decree This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses). This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quote, or an indication the Government will contract for the items or services herein. This notice 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 notice. The Government does 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 source sought. Any response received will not be used as a proposal. NAICS CODES: 541690 and 541990 No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience in developing and implementing of a Consent Decree. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned. Project Title: Development of a Strategy, Goals, Recommendations and Providing Assistance in Managing FDA's Implementation of a Consent Decree, with a Focus on Application Integrity Policy (AIP) Background The FDA under the Federal Food, Drug, and Cosmetic Act (as amended, May 2001) has the authority to enforce judicial actions to ensure firm's compliance with the Current Good Manufacturing Practices (21 CFR 210 and 211) for drug manufacturing and distribution of products, after a company has failed to respond to advisory action, such as untitled and warning letters. One such judicial action is an injunction, a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur (11 U.S.C. 332; Rule 65, Rules of Civil Procedure). An injunction may be considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. Proceeding by injunction does not preclude institution of additional or concurrent action such as recall, publicity, seizures, embargo by cooperating officials, or criminal prosecution. In considering an injunction, the agency must evaluate the seriousness of the offense, the actual or potential impact of the offense on the public, whether other possible actions could be as effective or more effective, the need for prompt judicial action, and whether it will be able to demonstrate the likelihood of the continuance of the violation in the absence of a court order. Injunction will be the action of choice when: a. There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice; or b. There are significant amounts of violative products owned by the same person, voluntary recall by the firm was refused or is significantly inadequate to protect the public, and seizures are impractical or uneconomical; or c. There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches. With respect to a and b above, it is helpful, but not mandatory, to show that there has been a history of prior violations, and that previous attempts to correct them through alternative warnings or sanctions have not been effective. A showing of a violative history should be made whenever possible, but especially in those cases where an imminent danger to health cannot be alleged. The U.S. Food and Drug Administration has an option to file a consent decree of permanent injunction against a company. In drafting a consent decree, Office of Chief Counsel will seek center approval on matters germane to its original review, including reconditioning or reprocessing plans, CGMP requirements, recalls, cessation of product manufacturing or distribution operations, and measures that could affect availability of medically necessary products. OCC will seek the district's approval on matters requiring district follow-up activities, such as reinspection frequency and rates, reviews of defendant's corrective actions, and witnessing destruction and disposition of goods from distributing unapproved and misbranded drugs. The consent decree often provides a series of measures that, when satisfied, will permit a firm to resume the manufacture and distribution of products marketed by itself and its subsidiaries. Additionally, as part of the consent decree, a firm may agree not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA's current good manufacturing practices (CGMP) regulations. Finally, a drug manufacturing firm may also agree that it will not distribute certain products, until the products are approved by FDA's ANDA or NDA processes. The Agency may also include in the Consent Decree a provision that before resuming manufacturing, a firm will have an independent third party CGMP and/or AIP expert consultant undertake a review of firm's facilities and certify compliance with FDA's CGMP regulations and verify the reliability of data in drug application submissions. Following that certification, FDA would make a determination as to whether the firm's facilities are in compliance. Scope The Office of Compliance seeks to procure the services of a person(s) that has a proven experience, expertise, knowledge and abilities to provide guidance to the Office of Compliance staff, especially the Office of Manufacturing and Product Quality and the Division of Scientific Investigations to determine how best to manage the consent decree involving Application Integrity Policy (AIP). The AIP focuses on the integrity of data and information in applications submitted for Agency review and approval. On September 10, 1991, the Food and Drug Administration (FDA) published the Notice of this policy formally entitled, "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities; Final Policy" (Federal Register, 56 FR 46191). The AIP describes the Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. FDA published the Federal Register (FR) Notice and a companion document, "Points to Consider for Internal Reviews and Corrective Action Operating Plans," in Compliance Policy Guide (CPG) 7150.09 (see Sec. 120.100 of the Compliance Policy Guides publication). Qualifications and Skills The following skills and practical experience must be shown in your response: • Experience evaluating firms where AIP has been invoked; • Experience evaluating pharmaceutical manufacturing and testing firms; • Ability to understand government procedures and decision making as it relates to public health protection; • Ability to understand the AIP procedure and related FDA documents; • Knowledge of the abilities and limitations of third party auditors and pharmaceutical manufacturing and testing firms • Experience with non-AIP data integrity problems at pharmaceutical manufacturing and testing facilities • Experience evaluating pharmaceutical manufacturing and testing facilities • Knowledge of successful compliance strategies Responses must include capability statements and duns number be sent to this notice no later than 10:00 a.m. EST on April 3, 2012 submitted by email to vida.niles@fda.hhs.gov,Vida Niles, Contract Specialist for consideration. Responses to this announcement will not be returned, nor will there be 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 FDA may contact one or more respondents for clarifications and to enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. NO TELEPHONE CALLS ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1098941/listing.html)
- Record
- SN02701314-W 20120322/120321000115-e16111485df914e088f635f24f99df0a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |