83 FR 24919 - Class Waiver of the Nonmanufacturer Rule

SMALL BUSINESS ADMINISTRATION

Federal Register Volume 83, Issue 105 (May 31, 2018)

The U.S. Small Business Administration (SBA) is granting a class waiver of the Nonmanufacturer Rule (NMR) for Positive Airway Pressure Devices and Supplies Manufacturing. This U.S. industry comprises establishments primarily engaged in manufacturing Continuous Positive Airway Pressure (CPAP) devices, Bi-level Positive Airway Pressure (BiPAP) devices, and other products intended to treat sleep apnea by keeping a person's airways open during sleep.

[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Rules and Regulations]
[Page 24919]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11658]


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SMALL BUSINESS ADMINISTRATION

13 CFR Part 121


Class Waiver of the Nonmanufacturer Rule

AGENCY: U.S. Small Business Administration.

ACTION: Notification of waiver of the Nonmanufacturer Rule for positive 
airway pressure devices.

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SUMMARY: The U.S. Small Business Administration (SBA) is granting a 
class waiver of the Nonmanufacturer Rule (NMR) for Positive Airway 
Pressure Devices and Supplies Manufacturing. This U.S. industry 
comprises establishments primarily engaged in manufacturing Continuous 
Positive Airway Pressure (CPAP) devices, Bi-level Positive Airway 
Pressure (BiPAP) devices, and other products intended to treat sleep 
apnea by keeping a person's airways open during sleep.

DATES: This action is effective July 2, 2018.

FOR FURTHER INFORMATION CONTACT: Carol J. Hulme, Program Analyst, by 
telephone at 202-205-6347; or by email at [email protected].

SUPPLEMENTARY INFORMATION: Section 8(a)(17) and 46 of the Small 
Business Act (Act), 15 U.S.C. 637(a)(17) and 657, and SBA's 
implementing regulations require that recipients of Federal supply 
contracts (except those valued between $10,000 and $250,000) set aside 
for small business, service-disabled veteran-owned small business 
(SDVOSB), women-owned small business (WOSB), economically disadvantaged 
women-owned small business (EDWOSB), historically underutilized 
business zones (HUBZones) or participants in the SBA's 8(a) Business 
Development (BD) program provide the product of a small business 
manufacturer or processor, if the recipient is other than the actual 
manufacturer or processor of the product. This requirement is commonly 
referred to as the Nonmanufacturer Rule (NMR). 13 CFR 121.406(b). 
Sections 8(a)(17)(B)(iv)(II) and 46(a)(4)(B) of the Act authorize SBA 
to waive the NMR for a ``class of products'' for which there are no 
small business manufacturers or processors available to participate in 
the Federal market.
    As implemented in SBA's regulations at 13 CFR 121.1202(c), in order 
to be considered available to participate in the Federal market for a 
class of products, a small business manufacturer must have submitted a 
proposal for a contract solicitation or been awarded a contract to 
supply the class of products within the last 24 months. The SBA defines 
``class of products'' based on a combination of (1) the six digit North 
American Industry Classification System (NAICS) code, (2) the four 
digit Product Service Code (PSC), and (3) a description of the class of 
products.
    On February 27, 2017, SBA received a request to waive the NMR for 
Positive Airway Pressure Devices and Supplies under NAICS codes 339112 
(surgical and medical instrument manufacturing) and 339113 (surgical 
appliance and supplies manufacturing), and PSC 6515 (medical and 
surgical instrument, equipment and supplies). According to that 
request, along with supporting documentation, there were no small 
business manufacturers or processors of CPAP devices in the Federal 
market.
    On September 18, 2017 (82 FR 43637), the U.S. Small Business 
Administration (SBA) issued a Notice of Intent to grant a class waiver 
for CPAP, BiPAP and other sleep apnea devices.
    As revealed by the two comments submitted in response to the 
document, there are no small business manufacturers or processors of 
this product in the Federal market. The first comment, dated October 
19, 2017, did not include domestic small business manufacturers capable 
of meeting the requirement. The second comment did not identify any 
manufacturers.
    Therefore, in the absence of a small business manufacturer of these 
products, a class waiver is necessary to allow otherwise qualified 
regular dealers to supply the product of any manufacturer on a Federal 
contract set aside for small business, service-disabled veteran-owned 
small business (SDVOSB), women-owned small business (WOSB), 
economically disadvantaged women-owned small business (EDWOSB), 
historically underutilized business zones (HUBZones) or participants in 
the SBA's 8(a) Business Development (BD) program.
    More information on the NMR and Class Waivers can be found at 
https://www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/non-manufacturer-waivers.

David Wm. Loines,
Acting Director, Office of Government Contracting.
[FR Doc. 2018-11658 Filed 5-30-18; 8:45 am]
 BILLING CODE 8025-01-P