attn_2_SOW_Analysis_Tobacco_Products.pdf

Attachment 2

Indefinite Delivery Indefinite Quantity (IDIQ) Statement of Work (SOW)

Background

Tobacco use is the leading cause of preventable illness in the United States and is responsible for more than 443,000 deaths annually. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act added sections

904(a)(1), 904(a)(3), and 915 to the Federal Food, Drug, & Cosmetic Act (FD&C Act), that requires each tobacco product manufacturer or importer, or an agent, to test and report constituents, ingredients, and additives to FDA. This testing and reporting may require method development and validation. Given the diversity of tobacco products, it is imperative that FDA be able to conduct various tobacco-related research projects to effectively regulate all tobacco products as defined in the FD&C Act. These projects will vary in scope and specific aims/objectives depending on the needs of the FDA in fulfilling its regulatory requirements.

Section 906 of the Tobacco Control Act provides FDA with the authority to enter into contracts for research, testing, and demonstrations of tobacco products and to obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking the services of a contactor capable of providing laboratories tests that at a minimum, shall include analysis of chemical and physical properties of tobacco products and tobacco smoke; method validation studies; and other projects that FDA identifies, in order to, effectively regulate tobacco products. The contractor shall be capable of providing laboratory services for any tobacco products that FDA has the authority to regulate under the FD&C Act.

For this IDIQ, the contractor shall analyze the specified tobacco products for specified Harmful and

Potentially Harmful Constituents (HPHCs). The list of possible HPHCs is included in Appendix A.

Under this IDIQ, the contractor shall analyze the following classes of tobacco products:

1. Electronic Nicotine Delivery System (ENDS) liquids and devices

2. Cigars, Cigarillos, and Little Cigars

3. Waterpipes

4. Smokeless Tobacco (portioned and unportioned)

5. Cigarettes, Roll You Own Tobacco (RYO), and Pipes

For physical measurements, the contractor shall analyze the following:

1. Cigarettes, RYO, Cigars: draw resistance/pressure drop, length, mass, diameter, puff count

(machine smoking)

2. Smokeless unportioned, Waterpipe, tobacco filler: particle size (sieve), moisture (OV),

3. Smokeless portioned: particle size (sieve), moisture, paper porosity (air permeability)

4. ENDS liquids: density (mass and volume)

5. ENDS device: coil temperature, draw resistance, airflow velocity, aerosol particle size, aerosol temperature

6. ENDS Battery: functional tests (voltage and current operating ranges, resistance), battery temperature, electrical load

7. Microbial plate counts (bacteria, yeast, and mold) and water activity.

For ingredient/additive measurement, the contractor shall analyze the following:

Menthol

Diacetyl

PG

Glycerol

Diethylene Glycol

Ethylene Glycol

2,3-pentanedione

Nicotine

Note: The contractor may need to participate in collaborative studies under this IDIQ. Proficiency testing should not be required, except as needed to maintain ISO 17025 certification.

PART 5– DELIVERABLES–

5.1 Sample Analysis

5.1.0 All reports shall consist of one paper copy, one electronic copy and one copy on CDROM, in a format specified by FDA.

5.1.1 The Contractor shall provide a report on the recovery studies and analysis of reference materials described under Part 4.1.4.

5.1.2 The Contractor shall provide interim reports at specific time periods as determined by FDA as reflected in the separate individual task order.

5.1.3 The Contractor shall also contact FDA immediately when quality control measures indicate that data generated by the Contractor may not be accurate.

5.1.4 The Contractor shall provide a final report that includes the raw data and tabulated results of all analyses for tobacco products specifically identified by FDA and for quality control samples; full descriptions of the methods used; descriptions of any laboratory issues encountered along with their solutions; and any other issues relevant to the study.

5.1.5 The Contractor shall ship all unused samples to FDA at the end of the study using an FDA

FedEx or UPS account, at no additional cost to the Contractor.

5.1.6 The contractor must sign a confidentiality agreement.

Appendix A: List of HPHCs to Be Tested Under This IDIQ

Acetaldehyde

Acetamide

Acetone

Acrolein

Acrylamide

Acrylonitrile

Aflatoxin B1

4-Aminobiphenyl

1-Aminonaphthalene

2-Aminonaphthalene

Ammonia

Anabasine o-Anisidine

Arsenic

A-a-C (2-Amino-9H-pyrido[2,3-b]indole)

Benz[a]anthracene

Benz[j]aceanthrylene

Benzene

Benzo[b]fluoranthene

Benzo[k]fluoranthene

Benzo[b]furan

Benzo[a]pyrene

Benzo[c]phenanthrene

Beryllium

1,3-Butadiene

Cadmium

Caffeic acid

Carbon monoxide

Catechol

Chlorinated dioxins/furans

Chromium

Chrysene

Cobalt

Coumarin

Cresols (o-, m-, and p-cresol)

Crotonaldehyde

Cyclopenta[c,d]pyrene

Dibenz[a,h]anthracene

Dibenzo[a,e]pyrene

Dibenzo[a,h]pyrene

Dibenzo[a,i]pyrene

Dibenzo[a,l]pyrene

2,6-Dimethylaniline

Ethyl carbamate (urethane)

Ethylbenzene

Ethylene oxide

Formaldehyde

Furan

Glu-P-1 (2-Amino-6-methyldipyrido[1,2-a:3’,2’-d]imidazole)

Glu-P-2 (2-Aminodipyrido[1,2-a:3’,2’-d]imidazole)

Hydrazine

Hydrogen cyanide

Indeno[1,2,3-cd]pyrene

IQ (2-Amino-3-methylimidazo[4,5-f]quinoline)

Isoprene

Lead

MeA-a-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole)

Mercury

Methyl ethyl ketone

5-Methylchrysene

4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)

Naphthalene

Nickel

Nicotine

Nitrobenzene

Nitromethane

2-Nitropropane

N-Nitrosodiethanolamine (NDELA)

N-Nitrosodiethylamine

N-Nitrosodimethylamine (NDMA)

N-Nitrosomethylethylamine

N-Nitrosomorpholine (NMOR)

N-Nitrosonornicotine (NNN)

N-Nitrosopiperidine (NPIP)

N-Nitrosopyrrolidine (NPYR)

N-Nitrososarcosine (NSAR)

Nornicotine

Phenol

PhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine)

Polonium-210

Propionaldehyde

Propylene oxide

Quinoline

Selenium

Styrene o-Toluidine

Toluene

Trp-P-1 (3-Amino-1,4-dimethyl-5H-pyrido[4,3-b]indole)

Trp-P-2 (1-Methyl-3-amino-5H-pyrido[4,3-b]indole )

Uranium-235

Uranium-238

Vinyl acetate

Vinyl chloride