Questions to 1071399.doc

Questions and Answers to FDA-SOL-1071399 Offeror question number 1:

In looking over the Statement of Work it sates that a Single Award IDIQ Contract will be awarded, my question is does this mean that only those labs that can provide the three areas (chemical analysis, third party validation and chemical standards synthesis ) will be in contention for the work or will the three areas be awarded separately?

FDA answer number 1:

Please note there is only one category now for Chemical Analysis, therefore, there should only be one proposal.

Offeror question number 2:

Is there still a preference for HUBZone companies?

FDA answer number 2:

No.

Offeror question number 3:

Can NELAC be substituted for ISO17025?

FDA answer number 3:

Yes Offeror question number 4:

If we do not currently have a method developed for a particular chemical analysis but have the capabilities is there a time frame that would be given to develop a method?

FDA answer number 4:

No

Offeror question number 5:

On page 7 of 26 footnote #6 has been omitted. In dealing with CLIN # 0022 have I overlooked footnote#6 somewhere else?

FDA answer number 5:

This is a typo. There is no footnote 6.

Offeror question number 6:

Will FDA approve the use of Canadian laboratories if the laboratory is part of a US network?

FDA answer number 6:

Yes

Offeror question number 7:

Which tests are required for specific matrices (i.e. food, supplements, botanical extracts, cosmetics, etc)?

FDA answer number 7:

The proposal should reflect the company’s capabilities based on the information provided. More specific matrices will be provided through the task orders.

Offeror question number 8:

Will the contract be awarded to a single company or divided among competing laboratories?

FDA answer number 8:

Yes

Offeror question number 9:

Will the contract bundle all testing requirements or will the award be split between laboratories that specialize in specific matrices?

FDA answer number 9:

All testing requirements will be bundled.

Offeror question number 10:

Can you provide specific test volumes per matrix?

FDA answer number 10:

This will vary from test to test. A typical analysis would require processing of serving size quantities of a particular food type, selection of gram quantity portions of those samples, and extraction and analysis of 10-100 milliliter extracts. As many as three subsamples sample would be required.

Offeror question number 11:

What is the expected detection limit for each test?

FDA answer number 11:

This will vary from test to test. For analysis of compounds such as acrylamide or bus-phenol A, low parts-per-billion (ppb) detection limits may be required. For melamine, detection limits necessary could range from low ppb to high ppb, depending on the question at hand.

Offeror question number 12:

What is the expected implementation date for the contract?

FDA answer number 12:

Expected contract Award date is September 30, 2010.

Offeror question number 13:

It is difficult to determine a collection cost without knowing how many products need to be collected. A large collection may require trips to multiple stores in a given city in order to collect all products. Is there a way to provide greater detail for this portion of the bid?

FDA answer number 13:

A typical assignment might entail the following:

400 total samples, some collected from designated geographic regions. The geographic regions would be represented by the major cities identified in the RFQ.

Food type 1: 20 national brands, collected from any location in the U.S. Two samples of each brand, each sample from a different lot. (40 samples total)

Food type 2: 10 national brands, 2 samples each from a city in each of 5 different geographic regions (northwest, southwest, Midwest, northeast and southeast) (100 samples total)

Food type 2: 10 regional brands. 2 samples each from 2 regional brands in each of 5 geographic regions (20 samples total)

Food type 3: Fast food item. 2 samples each from 10 retail chains in mid-Atlantic region, 2 samples each from 10 retail chains in different geographic region. (40 samples)

Food type 4: 20 national brands. 2 samples for each brand in 2 different geographic regions. (80 samples)

Food type 5: 20 national and regional brands. 2 samples each, with some regional brands collected out of a designated region. (40 samples)

Food type 6: 10 national brands: 2 samples each collected out of geographic region 1 and two samples each collected out of geographic region 2. (40 samples)

Food types 1-6: 40 samples submitted to vendor directly from CFSAN.

Offeror question number 14:

The solicitation is limited to a small business. We believe that a team approach would provide FDA with the most possible options. If the prime on the contract is a designated small business but there are subcontractors:

a. Would the subcontractors be required to be small business?

b. If not, is there a goal for the amount of overall work that must be performed by small business subcontractors?

FDA answer number 14:

This solicitation is not a small business set-aside, however, we do encourage teaming arrangements if at all possible.

Offeror question number15:

The pricing for the analytical services is fairly straightforward to us but we do have a couple of question that would help us price the data collection events:

c. For the data collection can we use labor plus materials only and not a fixed unit price?

d. If it is required to have a fixed unit price for each event is there an idea of the average number of collection locations and sample units for each survey so that we can use this information to help us produce a fixed unit cost?

FDA answer number 15:

We do require a fixed cost, below is a sample collection for your reference.

Food type 1: 20 national brands, collected from any location in the U.S. Two samples of each brand, each sample from a different lot. (40 samples total)

Food type 2: 10 national brands, 2 samples each from a city in each of 5 different geographic regions (northwest, southwest, Midwest, northeast and southeast) (100 samples total)

Food type 2: 10 regional brands. 2 samples each from 2 regional brands in each of 5 geographic regions (20 samples total)

Food type 3: Fast food item. 2 samples each from 10 retail chains in mid-Atlantic region, 2 samples each from 10 retail chains in different geographic region. (40 samples)

Food type 4: 20 national brands. 2 samples for each brand in 2 different geographic regions. (80 samples)

Food type 5: 20 national and regional brands. 2 samples each, with some regional brands collected out of a designated region. (40 samples)

Food type 6: 10 national brands: 2 samples each collected out of geographic region 1 and two samples each collected out of geographic region 2. (40 samples)

Food types 1-6: 40 samples submitted to vendor directly from CFSAN.

Offeror question number 16:

On page 7 of 26, under D. Accreditation, please advise if an equivalent to the ISO 17025 can be an FDA audit.

FDA answer number 16:

No, we do not want to audit the laboratory in lieu of accreditation.

Offeror question number 17:

On page 5 of 26, under Technical Requirements ,please clarify procedures for sample storage and disposal. Does the reference of 50 - 1000 samples refer to the collective lot over the life of the project or is it a different interpretation.

FDA answer number 17:

50-1000 samples refers to the number that could be specified under any given task, not over the lifetime. Samples would be required to be stored only until reports are delivered to the FDA and they would be disposed of according to standard procedures for that vendor. Results from analysis conducted under this contract will be for obtaining information. Samples analyzed under this contract will not be treated as regulatory samples, so there are no special long term storage requirements.

Offeror question number 18:

On page 5 of 26, under Technical Requirements, can Philadelphia be included and what is the minimal amount of cities needed to collect samples.

FDA answer number 18:

No, the collection cities will be only those listed on the solicitation.

Offeror question number 19:

In order to establish pricing and for set-up requirements, we would need to know the number of samples being provided for each testing.

FDA answer number 19:

Below is a sample collection for your reference.

Food type 1: 20 national brands, collected from any location in the U.S. Two samples of each brand, each sample from a different lot. (40 samples total)

Food type 2: 10 national brands, 2 samples each from a city in each of 5 different geographic regions (northwest, southwest, Midwest, northeast and southeast) (100 samples total)

Food type 2: 10 regional brands. 2 samples each from 2 regional brands in each of 5 geographic regions (20 samples total)

Food type 3: Fast food item. 2 samples each from 10 retail chains in mid-Atlantic region, 2 samples each from 10 retail chains in different geographic region. (40 samples)

Food type 4: 20 national brands. 2 samples for each brand in 2 different geographic regions. (80 samples)

Food type 5: 20 national and regional brands. 2 samples each, with some regional brands collected out of a designated region. (40 samples)

Food type 6: 10 national brands: 2 samples each collected out of geographic region 1 and two samples each collected out of geographic region 2. (40 samples)

Food types 1-6: 40 samples submitted to vendor directly from CFSAN.

Offeror question number 20:

Can subcontractor being utilized for certain testing requirements?

FDA answer number 20:

Companies are in their right to subcontract, however if you choose to subcontract you must include a subcontracting plan and specify what aspects of the project will be subcontracted out.

Offeror question number 21:

XXX is a GMP/GLP certified lab. Will this be equivalent to being ISO 17025 certified?

FDA answer number 21:

In answer to your question, a GMP/GLP certification is not equivalent to an ISO 17025 accreditation. Thank you.

Offeror question number 22:

Can you let us know what is an equivalent accreditation to an ISO 17025?

FDA answer number 22:

The Federal Government does not provide accreditation requirements. Thank you.