Sources Sought Notice.pdf

Reference No. FDA-21-SSN-1236379

This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of potential qualified sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran- Owned, and Small Disadvantaged Business, other than small business) relative to the North American Industry Classification System (NAICS) code. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources and acquisition strategy.

Project Title: Tobacco Analysis and engineering Laboratory Services

Project Description: The purpose of this project is to conduct Tobacco Analysis and engineering Laboratory Services within the Food and Drug Administration (FDA), Center for Tobacco Products (CTP), to analyze and identify the 93 Harmful and Potentially Harmful Constituents (HPHCs) identified by the FDA specific to tobacco products and listed below (i.e., ENDS liquids and devices, cigars, cigarillos, waterpipes, smokeless tobacco, cigarettes, RYOs, and pipes) that are currently marketed in the US using validated analytical testing methods.

The Contractor shall supply services with the capability of providing laboratories tests that at a minimum, shall include analysis of chemical and physical properties of tobacco products and tobacco smoke, analysis of the engineering of e-cigarettes, the composition of e-liquids and e-cigarette aerosols, 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.

The objective is to acquire Contractor services to analyze the specified tobacco products for specified Harmful and Potentially Harmful Constituents (HPHCs). The list of possible HPHCs is included in Appendix A on pages 4-6 of this announcement. 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

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

For engineering measurements, the contractor shall use instruments but are not limited to the following:

• infrared temperature sensors

• thermocouples

• DAQ readers

• aerosol size distribution measurement equipment (e.g. scanning mobility particle sizers

(SMPS) for cigars or waterpipe measurements, electrical, low pressure impactors (ELPI) butanol-based condensation particle counters)

• airflow meters

• pressure gauges

• viscometers

• puff topography recorders

• the laboratory inductively coupled plasma-mass spectrometry (ICP-MS)

• gas chromatography-mass spectrometry (GC-MS)

• high pressure liquid chromatography-mass spectrometry (HPLC-MS)

• high pressure liquid chromatography-diode array detector (HPLC-DAD)

• aerosol-generating machine adapted for testing e-cigarettes and other deemed tobacco products

• scanning electron microscopy (SEM)

• energy dispersive X-ray spectroscopy (EDS)

• atomic absorption spectrometer

FDA will provide all samples for testing, specify storage conditions, and set specific timeless for the samples to be analyzed at the task order level. The laboratory shall be ISO 17025-accredited and have advanced, modern day techniques to modify and analyze chemical and engineering characteristics. Note: The contractor may need to participate in collaborative studies.

Proficiency testing should not be required, except as needed to maintain ISO 17025 certification.

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance is 5 years from date of award. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published on Beta.Sam.

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Describe your present work volume capacity to provide the types of services required under the project description to the best of your abilities with a brief statement addressing current staffing and laboratory equipment and resources, clearly addressing the limiting factor of pre-existing demands place upon you from existing customers.

*Please include a very brief synopsis of existing contracts/projects awarded – to include complexity and value, along with customer contact information.

2. Describe your proven capability to provide the services described herein.

3. Describe your experience providing services described herein, with an emphasis on the magnitude and complexity of the contracts/projects for same/similar services.

4. Is your business a small business under the NAICS code?

5. Does your firm qualify as a small disadvantaged business?

6. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small

Business Act?

7. Are you considered a certified HUBZone firm?

8. Are you considered woman-owned or operated business?

9. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business?

This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice shall be emailed to: Telisha Wilson at Telisha.wilson@fda.hhs.gov. Responses must be received via email, no later than 03/26/2021 1:00 PM EST. Please include Reference No. FDA-21-SSN-1236379 in the subject line when responding to this notice.

No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Reference No. FDA-21-SSN-1236379.

mailto:Telisha.wilson@fda.hhs.gov mailto:Telisha.wilson@fda.hhs.gov

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

1. Acetaldehyde

2. Acetamide

3. Acetone

4. Acrolein

5. Acrylamide

6. Acrylonitrile

7. Aflatoxin B1

8. 4-Aminobiphenyl

9. 1-Aminonaphthalene

10. 2-Aminonaphthalene

11. Ammonia

12. Anabasine

13. o-Anisidine

14. Arsenic

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

16. Benz[a]anthracene

17. Benz[j]aceanthrylene

18. Benzene

19. Benzo[b]fluoranthene

20. Benzo[k]fluoranthene

21. Benzo[b]furan

22. Benzo[a]pyrene

23. Benzo[c]phenanthrene

24. Beryllium

25. 1,3-Butadiene

26. Cadmium

27. Caffeic acid

28. Carbon monoxide

29. Catechol

30. Chlorinated dioxins/furans

31. Chromium

32. Chrysene

33. Cobalt

34. Coumarin

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

36. Crotonaldehyde

37. Cyclopenta[c,d]pyrene

38. Dibenz[a,h]anthracene

39. Dibenzo[a,e]pyrene

40. Dibenzo[a,h]pyrene

41. Dibenzo[a,i]pyrene

42. Dibenzo[a,l]pyrene

43. 2,6-Dimethylaniline

44. Ethyl carbamate (urethane)

45. Ethylbenzene

46. Ethylene oxide

47. Formaldehyde

48. Furan

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

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

51. Hydrazine

52. Hydrogen cyanide

53. Indeno[1,2,3-cd]pyrene

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

55. Isoprene

56. Lead

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

58. Mercury

59. Methyl ethyl ketone

60. 5-Methylchrysene

61. 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)

62. Naphthalene

63. Nickel

64. Nicotine

65. Nitrobenzene

66. Nitromethane

67. 2-Nitropropane

68. N-Nitrosodiethanolamine (NDELA)

69. N-Nitrosodiethylamine

70. N-Nitrosodimethylamine (NDMA)

71. N-Nitrosomethylethylamine

72. N-Nitrosomorpholine (NMOR)

73. N-Nitrosonornicotine (NNN)

74. N-Nitrosopiperidine (NPIP)

75. N-Nitrosopyrrolidine (NPYR)

76. N-Nitrososarcosine (NSAR)

77. Nornicotine

78. Phenol

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

80. Polonium-210

81. Propionaldehyde

82. Propylene oxide

83. Quinoline

84. Selenium

85. Styrene

86. o-Toluidine

87. Toluene

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

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

90. Uranium-235

91. Uranium-238

92. Vinyl acetate

93. Vinyl chloride