RFP 3679125R0003_Questions and Answers_Posted 07MAY2025.pdf

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BATTERIES (HEARING AIDS AND OTHER ASSOCIATED DEVICES)
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36C79125R0003
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This document is a Questions and Answers (Q&A) file for a Department of Veterans Affairs (VA) solicitation for batteries used in hearing aids and other medical devices. The solicitation (36C79125R0003) seeks proposals for eight battery types, including alkaline and zinc-air batteries, with estimated quantities ranging from 140 to 175,750,000 units across a base year and four option years. The VA intends to make multiple firm-fixed price, indefinite delivery/indefinite quantity (IDIQ) contracts, utilizing full and open competition within Trade Agreements Act (TAA) requirements.

Key details include strict manufacturing origin restrictions, with only batteries from TAA-compliant countries acceptable. The solicitation targets three large battery manufacturers globally, with no small business manufacturers identified. Packaging must be six batteries per pack, driven by child-proof packaging regulations. The VA explicitly omitted certain battery sizes (like ZA675MF) due to statutory sourcing requirements. Proposals were due by 16 May 2025, with the government emphasizing the need to mitigate potential contract performance risks and ensure consistent battery supply for veterans' medical devices.

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BATTERIES (HEARING AIDS AND OTHER MEDICAL DEVICES)

SOLICITATION 36C79125R0003 (UNRESTRICTED COMPETITION)

Questions and Answers (Q and A): (4/17/2025 – 5/7/2025)

1. Question (4/17/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), is it safe to assume the product in your DLS warehouse is sufficient for the requirement to provide two (2) samples of each battery type offered?

Answer: Yes, as long as the incumbent contractor Offeror is proposing the same battery types for this RFP as is currently being delivered to the DLS, then the batteries from the Offeror that currently in the DLS inventory should be fine. Please make sure to annotate in your proposal which products (e.g., battery type(s)) you would like the DLS Team to verify for your proposal evaluation.

2. Question (4/17/2025 and 4/22/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), also noticing that battery size ZA675MF was omitted from the list of items. Was that intentional?

Answer: Yes, that is correct, battery size ZA675MF was intentional omitted from the list of items on this RFP. Pursuant to Federal Acquisitions Regulations (FAR) 6.302-(b)(2), 8.704(a), and the Veterans Affairs Acquisition Manual (VAAM) M808.002-70(a), the Government must pursue other statutorily mandated sourcing mechanisms for that battery type.

3. Question (4/21/2025): From an interested party - We are planning to participate in the above solicitation, as a leading supplier of hearing aid and other batteries in the U.S., one of our suppliers is a manufacturer of zinc air hearing aid batteries located in China. Is there anything to prevent their product from being considered for this solicitation based on the fact that it is manufactured in China?

Answer: The Trade Agreements Act (TAA) is applicable to this acquisition and any Chinese manufactured end products cannot be accepted. Please reference FAR 25.4 Trade Agreements for further information.

4. Follow-up Question from Question 3 (4/21/2025): Based on your response, I read FAR 25.4 and didn't see specific mention of China. Is the issue that the US doesn't have an active trade agreement with China and, therefore, cannot use China-sourced products as alternatives to buying American? Interestingly, no zinc air hearing aid batteries are manufactured in the US any longer, and none of the current manufacturing countries (i.e. China; Germany; and the UK) are listed in FAR 25.4.

Answer: As stated on pages 10 and 35 of the RFP, FAR Clause 52.225-5 applies to this acquisition and lists the “World Trade Organization Government Procurement Agreement (WTO GPA) Designated Countries” in which we are authorized to make purchases from. The clause in its full text can be referenced here: FAR 52.225-5. The Government understands there are only three countries that manufacture the zinc air batteries, and two of them (Germany and UK) are listed as WTO GPA Designated Countries in the FAR Clause 52.225-5. Additionally, any Offeror proposing a battery that is not manufactured in the United States is required to submit a Trade Agreements Certificate in accordance with FAR Provision 52.225-6.

5. Question (4/21/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), we don’t recognize all 8 of these battery types. Do you have the estimated quantities needed?

Answer: Solicitation 36C79125R0003 is a Request For Proposals (RFPs) for the Unrestricted Procurement or the portion of the Batteries 2025 Acquisition that is utilizing full and open completion to solicited cost proposals from industry for eight (8) of the twenty-five (25) battery types of the complete Batteries 2025 procurement. The Government’s estimated quantiles for the eight (8) CLINs are listed on page 11 of the SF 1449 posted on sam.gov under the Notice ID of 36C79125R0003 but are included below for your convenience.

CLIN Battery Type Base Option Yr 1 Option Yr 2 Option Yr 3 Option Yr 4 Est. Total QTY

X001 ALKAAAA 31,000 29,063 27,125 25,188 23,250 135,626

X002 NIMHBA151 32 30 28 26 24 140

X003 NIMHSERVOX 280 263 245 228 210 1,226

X004 NIMH13 2,195 2,058 1,920 1,783 1,646 9,603

X005 NIMH312 7,534 7,063 6,592 6,121 5,651 32,961

X006 ZA312MF 37,000,000 36,075,000 35,150,000 34,225,000 33,300,000 175,750,000

X007 ZA13MF 9,000,000 8,775,000 8,550,000 8,325,000 8,100,000 42,750,000

X008 ZA10MF 3,000,000 2,925,000 2,850,000 2,775,000 2,700,000 14,250,000

6. Follow-up Question from Question 3 (4/21/2025): There have been some significant changes in the zinc air hearing aid battery manufacturing landscape recently. Under exceptional circumstances, is it possible for an exemption to the FAR Clause 52.225-5 to be applied in order to ensure at least two suppliers submit competitive proposals/offers?

Answer: Pursuant to paragraph (c) in FAR Provision 52.225-6, the Government will evaluate offers of U.S.-made or end products from designated TAA compliant countries without regard to the restrictions of the Buy American – Supplies statute. The Government doesn’t intend to issue an exemption to the Trade Agreement Act (TAA) and doesn’t anticipate the future need to contemplate an exemption due to the receipt of no offers for such products or that the offer(s) received for those products are insufficient to fulfill the requirements of this solicitation. The Government’s robust market research for this requirement has given us high confidence in the receipt of more than one (1) competitive proposals from responsible Offerors proposing batteries that are end products from at least two (2) TAA compliant designated countries.

7. Question 2 was repeated on 4/22/2025 from another incumbent contractor (e.g., a current Batteries 2020 contract holder).

Answer to Question 2 was repeated.

8. Question 2 was repeated (4/22/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), Is it likely that a separate solicitation for ZA675MF will be issued for a 2025 start date?

Answer to Question 2 was revised: The VA’s Batteries 2025 Procurement Program consists of twenty-five (25) Battery types or Contract Line-Item Numbers (CLINs). RFP v2 36C79125R0003, which was originally posted to sam.gov on 4/17/2025 and was Amended today on sam.gov is the Unrestricted Competition portion of the Batteries 2025 procurement program (e.g., the portion of the procurement program utilizing full and open competition) and consists of eight (8) of the twenty-five (25) battery types or Contract Line-Item Numbers (CLINs) contained within the entire Batteries 2025 procurement program.

Pursuant to Federal Acquisitions Regulations (FAR) 6.302-(b)(2), FAR 8.704(a), and the Veterans Affairs Acquisition Manual (VAAM) M808.002-70(a), the Government must comply with statutorily mandated sourcing mechanisms for the remaining seventeen (17) of the twenty-five (25) battery types included in the Batteries 2025 procurement program. There will not be a second solicitation posted on sam.gov for the remaining seventeen (17) of the twenty-five (25) battery types included in the Batteries 2025 procurement program.

9. Question (4/22/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), Regarding “CLIN X006, which the Government anticipates making two (2) awards:” Do the estimated quantities for the ZA312MF battery in the pricing chart represent the amount for each supplier, or the full estimated quantity (to be split later by supplier in the award announcement)?

Answer: The Government intends to select two (2) successful offerors for CLIN X006 - ZA312 Mercury Free, Zinc-air, 2-terminal, 1.4-volt, button type, non-rechargeable, size 312. ANSI No. 7002ZD. The same product quantity shall be utilized by the Ordering Officers as the original potential delivery order regardless of whether a single delivery order or double delivery orders are issued for CLIN X006. In the event of two delivery orders being issued, the DLS will be placing a double order at the exact same quantity on each delivery order.

Note: The estimated quantities displayed for CLIN X006 are the same estimated quantities listed on both the RFP (P. 11) and on Attachment 0001 – Batteries Price Sheet and these estimated quantities should be used by all Offerors interested in offering the ZA312 Mercury Free, Zinc-air, 2-terminal, 1.4-volt, button type, non-rechargeable, size 312. ANSI No. 7002ZD to submit a cost proposal based on a firm-fixed price unit price at the estimated quantities stated in the Schedule of Items for each period of performance. The quantities listed are estimates, which are based on the prior Batteries 2020 procurement cycle and the prior batteries contracts’ historical ordering data from the DLS. Usage / Ordering trend analysis was utilized to project the base year period of performance and all four of the option year periods of performance quantity estimates. The estimated quantities listed in the Schedule of Items are estimated and are NOT Government ordering commitments to the successful offerors.

Estimated quantities listed for each CLIN are the estimates of the total annual requirement for the described product for proposal planning and proposal submission purposes. The Government may issue delivery orders at quantities greater than or less than the estimated total quantity as stated in the Schedule.

Additionally, there is no express or implied guarantee that the estimated quantities stated in the Schedule will be ordered regularly by the Government.

10. Question (4/30/2025): From an interested party, (1) Is there not a solicitation for size 675 hearing aid batteries? I didn't see any CLINs for that size which seemed odd since I recall always reviewing the full line when I worked for Company A. (2) I hadn't seen just one battery size be separated out before, is this solicitation on the normal 5 year cycle or was it started earlier than normal for some reason? (3) Can you advise how often purchase orders are typically placed for the zinc air batteries in the solicitation? (e.g. How many shipments per month are required to Denver?). (4) I'm planning to submit at least three CLINs for consideration that are manufactured in China by listing them in "Other End Products:" per page 68. This is in case "offers for such products are insufficient to fulfill requirements of the solicitation." I hope this isn't an inconvenience for you.

Answer (4/30/2025):

(1) That is correct, the 675’s were included in the overall program list of requirements for battery types and sizes during initial market research. However, during our acquisition strategy reviews and planning, we identified the statutory requirement for having to source with Nonprofit Agencies Employing People Who Are Blind or Severely Disabled in accordance with FAR subpart 8.704 and 41 U.S.C. chapter 85. Therefore, that specific item, along with others from the initial list has been omitted from the Unrestricted competition requirement currently listed in sam.gov.

(2) The current Contracting Team cannot speak for the previous Batteries Acquisition Teams that executed the previous battery program requirements, but it appears that the FAR and VAAR requirements for required sources was not utilized or not known. Therefore, it is not just one type or size of battery that is subject to that required sources requirement for our overall battery program, it is seventeen (17) CLINs in total that are affected. This is the reason why only eight

(8) CLINs are offered for Full and Open competition portion of the Batteries 2025 Procurement Program, because these eight (8) batteries are not available through AbilityOne’s non-profit agencies or listed as available on the AbilityOne’s Procurement List (PL). This Batteries 2025 procurement cycle is on the normal 5-year timeline for this requirement, yet we were able to solicit this requirement sooner because the acquisition team pursued earlier timelines to allow for appropriate internal reviews and any transition needed for the successful offerors receiving an award.

(3) The frequency of Delivery Orders issued against the Indefinite Delivery – Indefinite Quantity procurement vehicle by the Ordering Officers at the VA’s Denver Logistics Service (DLS) cannot not be predicted. The provided estimated annual quantities of batteries is based on the projected/predicted annual ordering trend analysis and historical ordering data. The DLS is the VA’s national warehouse and distribution center which ensures the availability and consistent supply for the as-needed distribution of the batteries. The frequency that the DLS issues Delivery Orders and the quantities of each battery type ordered typically fluctuates based on eligible Veterans’ need/demand. However, you could divide the estimated annual quantities amounts provided in the RFP by 12 to get a rough monthly average of the demand.

(4) The Government acknowledges your intent to include batteries that are end products from non-compliant TAA countries.

Pursuant to paragraph (c) in FAR Provision 52.225-6, the Government will only evaluate for award those responsive offers submitted by responsible offerors of U.S.-made end products or end products from the designated TAA compliant countries without regard to the restrictions of the Buy American – Supplies statute. The Government doesn’t intend to issue an exemption to the Trade Agreement Act (TAA) and doesn’t anticipate the future need to contemplate an exemption to the TAA due to the receipt of no offers for specific battery types or that the offer(s) received for specific battery types are insufficient to fulfill the requirements of this solicitation. The Government’s robust market research for this requirement has given us a degree of high confidence in the receipt of more than one (1) responsive proposal from more than one (1) responsible Offeror offering the Government batteries that are the end products from at least two (2) TAA compliant designated countries.

11. Question (4/30/2025): From an incumbent contractor (e.g., a current Batteries 2020 contract holder), Would we have the option to pursue a price change if there were an impactful increase in labor and material costs during the contract term under the Economic Price Adjustment (EPA)?

Answer (5/1/2025): The VA’s Battery Procurement Program has been providing batteries of various types and sizes for distribution to VA hospitals and clinics, eligible Veterans, and other Government agencies on an as-needed basis since at least 1999 successfully, and no previous acquisition cycle for the VA’s batteries requirements have included the Economic Price Adjustment (EPA) clause. The Contracting Officer has determined the inclusion of an EPA clause in solicitation 36C79125R0003, or any resultant contract awards is not in the best interests of the Government due to the absence of compelling market evidence to justify the inclusion of the EPA clause in a commercial supplies acquisition utilizing a firm-fixed price, indefinite delivery - indefinite quantity type contract vehicle for the procurement of commercial off-the-shelf batteries of various types and sizes.

12. Question (4/29/2025) - From an interested party: (1) I want to make you aware early in the process that the decision to use full and open for this solicitation based on commercial sources is limiting small business from bidding this solicitation. (2) After much research and time, we have discovered that one of the large business battery manufactures is now all the sudden not offering quotes to anyone in support of this solicitation. (3) With limited Commercial Battey Manufactures, the packaging requirements of CLIN’s X006, X007, X008 in standard packaging of 6 batteries per pack limits the commercial manufacturing sources for this RFP. As an example, Company A and Company B both package 8 batteries per blister, and Company B now owns Company A, it limits the commercial manufacturing sources for this RFP. (4) Is it the intent of the VA to limit the competition to a single manufacturing source?

(5) With the Tariffs now in place and unknown how they will impact battery pricing in the future, oversea suppliers like Company C are too risky for small businesses to use, and anyone using Company C will not be competitive against Company B. (6) We also noticed the Economic price adjustment FAR clause was left out of this solicitation, putting small business at risk. (7) CLINs X001 thru X004 could have easily been set aside for SDOVBs and limited quantities and sources would have opened to allow them to source these batteries under the SB non-Manufacturing Rule waiver. (8) I have no doubt that SDOVSB’s Businesses will be left out once again over a preference to have a single large contract. (9) The Battery manufacturing NAICS Code 335910 is on the Small Business Waiver list under the non-manufacturing rule, allowing Small Business to bid and not be the primary manufacture, this makes no sense. (10) Since my company did respond to your sources sought prior to the solicitation being released in a timely manner, I would like to know if any other SDOVB submitted an interest to your sources sought prior to your decision to go full and open. (11) Did the VA use the two-person rule for qualified suppliers?

Answer: (05/07/2025):

(1) Previous acquisition cycles of this requirement have dated back to at least 1999 with the majority of acquisition strategies offering an unrestricted procurement or utilizing full and open competition that has not prevented responsible small businesses from being able to submit competitive proposals in response to Requests for Proposals (RFPs). Of which, we have small businesses currently in the program as incumbent performing contractors that have been awarded multiple Contract Line Item Numbers (CLINs) in the previous and current procurement cycles.

(2) In terms of what a private organization within the battery industry chooses to do in terms of their participation, distribution, or authorized reseller strategies, the VA has no influence over the actions and business strategies of a private company.

(3) We have conducted robust market research and analysis, and the Government has a clear understand the cell type battery manufacturing industry, and who are the applicable companies producing products that meet the requirements of the Trade Agreements Act (TAA), as implemented by, in which we may consider for federal contracts. The VA has no control over the commercial manufacturing capacity for cell batteries globally or the common practices within the battery manufacturing industry.

However, previous battery procurement cycles and VA battery contracts performance history indicates that Standard Packaging was eight (8) batteries per blister pack until the requirement of child-proof packaging per Reese’s Law (P.L. 117-171) at which time several large business battery manufactures began utilizing a six (6) battery per blister pack, which is now a common industry practice.

(4) The Government intends to award multiple Firm Fixed Price (FFP) – Indefinite Delivery, Indefinite Quantity (IDIQ) type contracts as a result of this solicitation.

The Acquisition Strategy for this portion of the Battery 2025 Procurement Program is utilizing Full and Open competition within the requirements of the TAA to encourage the maximum participation of all interested parties within the battery manufacturing industry and the battery distributors and resellers industry.

Responsible large and small business are encouraged to submit a responsive proposal in response to this solicitation. The Government has already received interest from industry in response to this RFP from more than one (1) large business battery manufacturers, who produce batteries or end products from at least two countries that have a reciprocal trading agreements with the United States.

(5) The Government acknowledges the concern and understands that recent Tariffs may impact pricing of products produced from overseas and being shipped into the U.S., but the Government anticipates the use of FAR Clause 52.229-3 to address concerns related to tariffs. The Battery Procurement Program has been providing batteries of various types and sizes to VA hospitals and clinics, eligible Veterans, and other Government agencies since at least 1999 successfully following this proven battery procurement program. Batteries have been successful supplied by large business battery manufacturers who produce batteries from countries with reciprocal trade agreements with the U.S.

and by domestic small business and large business battery distributors and resellers, who source their batteries from the previously mentioned large business battery manufactures. Market research indicates that are no small business battery manufactures and that there are only three (3) large business battery manufactures, who produce batteries that are from designated countries under the TAA.

(6) The VA’s Battery Procurement Program has been providing batteries of various types and sizes for distribution to VA hospitals and clinics, eligible Veterans, and other Government agencies on an as-needed basis since at least 1999 successfully, and no previous acquisition cycles for the VA’s batteries requirements have included the Economic Price Adjustment (EPA) clause.

The Contracting Officer has determined the inclusion of an EPA clause in solicitation 36C79125R0003, or any resultant contract awards is not in the best interests of the Government due to the absence of compelling market evidence to justify the inclusion of the EPA clause in a commercial supplies acquisition utilizing a FFP IDIQ type contract vehicle for the procurement of commercial off-the-shelf batteries of various types and sizes.

(7) There is no Small Business Administration (SBA) Non-Manufacturing Rule Class Waiver in place for this battery requirement, which has the primary NAICS Code of 335910 – Battery Manufacturing. The Contracting Officer determined that requesting/applying for an individual non-manufacturer waiver is not in the best interests of the Government. The Government’s robust market research for this battery procurement indicated that there were no small business battery manufacturers who produce batteries that meet the requirements of the TAA.

Market research indicates that are only three (3) large business battery manufactures, who produce batteries that are from countries with reciprocal trade agreements.

(8) Small businesses are not left out of this solicitation, nor have small businesses been left out of the previous batteries acquisition cycles. Additionally, one (1) of the incumbent contractors, a currently performing contractor in the Batteries 2020 Procurement Program who was awarded multiple CLINs is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) concern.

(9) NAICS Code 335910 – Battery Manufacturing is not listed on the current SB NMR Class Waiver list.

(10) Seven (7) of the nineteen (19) respondents to the Batteries 2025 Sources Sought self-certified as being from the SDVOSB socio-economic subcategory. All SDVOSB respondents also self-certified that their companies/organizations were non-manufacturers of batteries, or that they were battery distributors and resellers who source their batteries from a battery manufacturer. The Government’s robust market research for this battery procurement indicated that there were no small business battery manufacturers who produce batteries that are from designated countries in accordance with the TAA. Therefore, the Veterans First Contracting Program is not applicable to this procurement. The VA must make every effort to mitigate the risk factors driving the threat of potential contract performance failure, which presents a seriously harm the Government’s ability to maintain battery distribution operations.

In view of the unacceptable risk to the Government of potential contract failure, this solicitation contains eight (8) battery types or CLINs utilizing full and open competition in order to encourage the maximum participation of all three (3) of the large business battery manufactures, who produce batteries that are end products from TAA-compliant designated countries and to encourage the maximum participation of any interested small or large business distributors and resellers who can secure distribution agreements with one (1) or more of the three (3) large business battery manufactures, who are the only producers of TAA-compliant batteries that meet the VA’s requirements.

(11) VA’s Rule of Two was considered during acquisition planning, however, no SDVOSB or VOSB battery manufacturers were identified for this requirement during market research under NAICS Code 335910 – Battery Manufacturers. All small businesses identified during market research self-certified as battery distributors and resellers. VA must make every effort to mitigate the risk factors driving the threat of potential contract performance failure, which presents a seriously harm the Government’s ability to maintain battery distribution operations. In view of the unacceptable risk to the Government of potential contract failure, this solicitation is utilizing full and open competition in order to encourage the maximum participation of all three (3) of the large business battery manufactures, who produce all the TAA compliant batteries globally and to encourage the maximum participation of any and all interested small or large business battery distributors and resellers who can secure distribution agreements/arrangements with one (1) or more of the three (3) large business battery manufacturers.

13.

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