MODIFICATION
B -- Augmenting an Intraocular Lens (IOL) Registry for Toxic Anterior Segment Surgery (TASS) surveillance
- Notice Date
- 7/11/2012
- Notice Type
- Modification/Amendment
- 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
- FDA-12-1101048
- Archive Date
- 8/4/2012
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@hhs.fda.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@hhs.fda.gov)
- Small Business Set-Aside
- N/A
- Description
- EXTEND RESPONSE DATE TO 7/20/12 AMENDMENT 2- QUESTIONS AND ANSWERS FOR FDA-12-1101048 QUESTION 1) Objectives-Known existing registries currently collect aggregate data on episodes of TASS at surgical centers but do not collect more granular data at the patient level nor follow-up on the adequacy of recommended interventions. Can you please list the registries that exist that are expected to be an input to, or in any other way providing data to the modified registry? ANSWER 1) It is expected that the offerors know what the exisiting registries are. QUESTION 2) By modifying an existing patient level IOL registry (owned by the contractor) to collect this additional data, the FDA will be able to determine the role of devices in the outbreak as well as inititate and early response to TASS. Since the statement says, "modifying an exisiting patient level IOL registry", can you provide the name of the exisiting registry, who owns it and whether or not access will be granted to the data in this registry to companies other than the one that owns it. Or, does this mean that the expectation is that a new registry is created to incorporate new data and analysis with an existing IOL registry, and if this is the case, what IOL registry is the existing registry, who ownsw it and will access be granted to the data? ANSWER 2) It is expected that the contractor modify a registry that they either own themselves or has developed partnerships with other IOL owners to simply add this component and then help to populate that registry. The offerors should have an exisiting IOL registry or have access to one. QUESTION 3) Is there an incumbent, and if so, who is it and what is the contract number for the exisiting contract? ANSWER 3) There is no incumbent.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-12-1101048/listing.html)
- Record
- SN02799799-W 20120713/120711235808-671c23026932637be8fd02bd78ee25ab (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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