Organization Name:

Note: Representatives submitting on behalf of an organization must enter information below.

Requestor Representative:

Section 301 Investigation: China's Acts, Policies, and Practices Related to Technology 

Transfer, Intellectual Property, and Innovation - Form to Request Exclusion of Product

When submitting a product exclusion request using this form, enter the specified 

information in the following fields and explain the basis and rationale for your statements. 

By completing this form, you certify that the information provided is complete and 

correct to the best of your knowledge. 

1. Indicate whether the comment contains business confidential information (BCI), is a public

document, or is a public version of a BCI document.

3.

2. Please provide a complete and detailed description of the particular product of concern:

4.

*

10-digit HTSUS item number* for product you wish to address in this product exclusion request:

Use numerical characters only with no special characters (example: 1023456789). For help in finding

the HTSUS item number associated with your product, see https://hts.usitc.gov/

7.

5. Requestor's relationship to the product:

6. Does this submission in regulations.gov include additional attachments?

Please indicate whether any additional attachment contains business confidential information 

(BCI), is a public document, or is a public version of a BCI document.

Requestor Information

Requestor Name (Last, First):

VERSION 2 CONTINUED BELOW 1

PUBLIC VERSION
8. Is this product, or a comparable product, available from sources in the United States? (If you

9. Is this product, or a comparable product, available from sources in third countries? (If you

10. Please provide the value and quantity (with units) of the Chinese-origin product of concern

that you purchased for each calendar year specified. Limit this figure to the products

purchased by your firm (or by members of your trade association) alone. Please provide

estimates if precise figures are unavailable.

2017 Value:

2016 Value:

2015 Value:

2017 Quantity:

2016 Quantity:

2015 Quantity:

% of your total gross sales in 2017 that the Chinese-origin product accounted for.

% of the total cost of producing the final product(s) the Chinese-origin input 

accounts for.

% of your total gross sales in 2017 that sales of the final product(s) incorporating 

the input accounted for.

VERSION 2 CONTINUED BELOW 2

indicate "NO", you must provide support for your assertion in Box 12).

indicate "NO", you must provide support for your assertion in Box 12).

11. Is the Chinese-origin product of concern sold as a final product or an input used in

a) For imports sold as final products, please provide:

b) For imports of inputs used in the production of final products, please provide:

the production of a final product or products?

BUSINESS CONFIDENTIAL PUBLIC VERSION
12. Please provide information in support your request, taking account of the

VERSION 2 END 3

instructions provided in Section B of the Federal Register notice. If you

responded "NO" to Questions 8 or 9, you must provide support for your

assertion in the box below. (Note: text entered below can extend beyond the

apparent size of this box).

BUSINESS CONFIDENTIAL PUBLIC VERSION
DMSLIBRARY01\33147552.v1

 1700 Pennsylvania Avenue, NW

Washington, DC 20006-4706

Phone: 202/626-2390

Fax: 202/626-3737

www.kslaw.com

October 9, 2018

VIA REGULATIONS.GOV

The Honorable Robert E. Lighthizer

United States Trade Representative

Office of the U.S. Trade Representative 

600 17th Street, N.W.

Washington, DC 20508

Docket No. USTR–2018–00025

PUBLIC VERSION1

Re: Section 301 Investigation: China's Acts, Policies, and Practices Related to 

Technology Transfer, Intellectual Property, and Innovation – Exclusion 

Request of Drive DeVilbiss Healthcare 

Dear Ambassador Lighthizer:

On behalf of Drive DeVilbiss Healthcare (“Drive”) , one of the leading U.S. 

manufacturers and suppliers of home health products, we hereby request that the Office of the 

United States Trade Representative (“USTR”) exclude imports of double electric breast pumps 

(including carry bag and external battery pack) from the tariffs imposed on these imports 

under section 301 of the Trade Act of 1974. We are filing this exclusion request in accordance 

 1 Invacare requests business confidential treatment of certain information in this document. 

Disclosure of the information marked “Business Confidential” in this request would endanger trade 

secrets or profitability and the information would not customarily be released to the public.
The Honorable Robert E. Lighthizer 

October 9, 2018

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with the guidelines announced in the Federal Register notice that USTR published on July 11, 

2018.2 

Imposing a tariff of 25 percent under section 301 on Drive’s imports from China will 

adversely affect Drive’s ability to provide its home medical equipment and supplies to the health 

care consumers who need these products to maintain their health and physical well-being.3 

Moreover, it will have a serious adverse impact on Drive’s financial results, profitability and 

employment levels. Imposition of these duties will, in all likelihood, adversely affect Drive, its 

employees, and healthcare consumers throughout the United States. 

We discuss these issues in detail below.

I. Drive DeVilbiss Healthcare and the Home Medical Equipment Industry

a. Drive 

Drive is one of the leading manufacturer and providers of home medical equipment and 

supplies and other healthcare products in the United States. Headquartered in Port Washington, 

New York, Drive has corporate offices and production and distribution facilities in the United 

States, Europe, Asia and Australia. In the United States, Drive has offices and facilities in New 

York, California, Georgia, New Jersey, Indiana, Florida and Pennsylvania. As a company that 

 2 Procedures to Consider Requests for Exclusion of Particular Products from the Determination 

of Action Pursuant to Section 301: China’s Acts, Policies, and Practices Related to Technology Transfer, 

Intellectual Property, and Innovation, 83 Fed. Reg. 32181 (July 11, 2018).

3 Drive is filing ___ separate exclusion requests for products it is importing from China. These 

requests cover a number of products that Drive either uses in its own manufacturing process or sells to 

healthcare providers or consumers as part of its product offerings.
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had sales revenues of $[[ ]] in 2017, Drive has been, and remains, a significant and 

important contributor to the U.S. economy. 

Drive provides a range of health care products to consumers and healthcare providers in 

the United States. Among other things, Drive provides consumers and providers with mobility 

products, sleep and respiratory products, long term care beds, bariatric products, wheelchairs 

(including power-operated wheelchairs), sleep surfaces and pressure prevention products, selfassist products, rehabilitation products, resident room equipment, personal care products and 

electrotherapy devices. Moreover, Drive produces a number of these products in the United 

States. Specifically, Drive produces a range of oxygen therapy, suction, aerosol therapy and 

sleep therapy devices in the United States. In 2017, Drive sold more than $ [[ ]] worth of 

products that were produced in its U.S. facilities.

Finally, Drive employs a significant number of staff in the United States and other 

countries. In the United States, Drive has more than [[ ]] workers and staff, which 

includes a significant number who work in Drive’s manufacturing facilities. On a global basis, 

Drive employs more than [[ ]] workers and staff. Drive is an excellent example of a U.S.-

based manufacturing company that competes and succeeds in the very competitive global market 

for health care products.

b. The Home Medical Equipment Industry

Drive is one of the leading members of the home medical equipment industry in the 

United States. The home medical equipment industry furnishes a range of home medical 

products, supplies, and services to consumers for use in their homes. Members provide products 
The Honorable Robert E. Lighthizer 

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like (i) oxygen equipment and therapy, (ii) sleep therapy technologies, (iii) mobility assistive 

technologies (including wheelchairs), (iv) inhalation drug therapy, (v) home infusion devices and 

supplies, (vi) diabetes therapy and related supplies, and (vii) a variety of other medical 

equipment, therapies, services, and supplies used in the home setting. Within the industry, these 

devices and supplies are referred to as “home medical equipment” (“HME”) and supplies.

The HME industry annually sells more than $50 billion worth of medical equipment, 

supplies and services to healthcare consumers in the United States. The members of this industry 

work on a daily basis to ensure that high-quality health care products and services remain 

available to seniors, home-bound patients, chronically ill individuals, and persons with 

disabilities, so they can continue to use them in the comfort and security of their homes. 

Home medical equipment and supplies are typically critical components in the treatment 

of chronic medical conditions, which include diseases like chronic obstructive pulmonary 

disease, congestive heart failure, and neuromuscular diseases (such as cerebral palsy, multiple 

sclerosis, muscular dystrophy, and ALS). For example, individuals with chronic pulmonary 

disease may need to use oxygen concentrators to remain active and functioning. Similarly, 

individuals with spinal cord injuries or muscular dystrophy may need advanced power 

wheelchairs to remain mobile and active. On the whole, many seniors, chronically ill 

individuals, and persons with disabilities need to know that they have a reliable source of supply 

for their home medical equipment. Making it harder for these individuals to obtain the 

healthcare products they need is neither an effective way to promote the health of these 

Americans nor a desirable policy choice.
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Today, in the United States, more than 53 million Americans are disabled. Moreover, 

more than 51 million people are over the age of 65 and are eligible for Medicare, which provides 

reimbursement for home medical equipment and supplies. Every day, an additional 10,000 

individuals in the United States reach the age of 65 and become eligible for Medicare. Imposing 

an additional duty of 25 percent on HME products, including those imported by Drive, will only 

serve to limit the ability of these Americans to obtain critically necessary healthcare products.
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II. Information Required by USTR For This Exclusion Request

In its July 11, 2018 notice,4 USTR specified that certain information must be included in 

any request seeking an exclusion from the duties imposed by USTR under section 301. 

Consistent with these guidelines, Drive provides the following information:

a. Description of the Product Covered by this Exclusion Request, the 

Applicable 10 Digit Subheading of the HTSUS, and the Administrability of 

the Exclusion Request 

This exclusion request covers a double electric breast pump (including a carry bag 

and an external battery pack). The double breast pump covered by this request is a therapeutic 

medical device that assists new mothers in relieving the pain and discomfort resulting from 

engorged mammary glands when they cannot feed their infant. The following provides a 

detailed description of a double electric breast pump (including a carry bag and an external 

battery pack), as required by USTR’s exclusion request guidelines:

A double electric breast pump (including a carry bag and an external battery pack) 

consists of a pump mechanism and container. It includes a liquid crystal display 

providing the status of its programs and functions. The pump has 9 adjustable suction 

strengths ranging from 30 mm Hg – 270 mm Hg, using a single vacuum chamber and has 

stimulation and expression modes to imitate the natural breastfeeding experience. The 

pump has a closed-loop, anti-backflow system that guarantees no milk backup into the 

tubing or motor. 

The pump weighs approximately 0.82 lbs and its dimensions are 4” x 6.5” x 8”. The 

pump set includes AC/DC adapter or internal battery pack that can be powered by 4 AA 

Alkaline batteries (which are not included). The construction materials include plastic, 

silicone, and polypropylene. All parts that have direct contact with the milk and breast 

are bisphenol A (BPA) free. Product is latex free. The products includes a carry bag 

with zipper for transport of the unit and accessories which is made out of oxford fabric 

and polyurethane. 

 4 83 Fed. Reg. 32181 (July 11, 2018).
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Imports of this breast pump are covered by the ten-digit HTS number 8413.81.0040. Given the 

specificity of this product description, U.S. Customs and Border Protection will be able to 

readily administer this exclusion. 

b. Annual Quantity and Value of the Chinese-Origin Product That the 

Requestor Purchased in the Last Three Years

In Appendix A, Drive provides the annual quantity and value of its purchases of imports 

of double electric breast pumps (including a carry bag and an external battery pack) from China 

for the years 2015, 2016, 2017 and the first half of 2018. As requested by USTR’s on-line filing 

form, Drive also provides the percentage of its total gross U.S. sales that this product accounted 

for in 2017.

c. Rationale For Requested Exclusion

i. Drive Will Not Be Able to Obtain This Product from Non-Chinese 

Sources 

Drive sources its breast pumps from China because it cannot obtain a comparable 

product, with the same technical specifications and quality levels, from U.S. or other nonChinese sources. Over the years, Drive has worked closely with its Chinese suppliers to ensure 

that they supply products that meet Drive’s exacting technical and quality specifications. Drive 

also works carefully with its Chinese suppliers to ensure their products satisfy U.S. consumers’ 

demand for high-quality health care items. Drive maintains its relationships with these suppliers 

because they have demonstrated the ability to provide Drive with the quality products that the 

market demands. 

Drive could not easily replace these suppliers within the next one to two years. Two 

factors make it difficult for Drive to replace the Chinese supplier of this product with another, 
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non-Chinese supplier. First, based on Drive’s experience, the process of qualifying a new 

supplier to produce and supply its breast pumps would take between one to two years. 

Moreover, even after this qualification process, Drive would need to spend significant time 

working with the supplier to develop a product that meets Drive’s specifications and meets the 

needs of healthcare consumers in the U.S. market. Accordingly, it would not be an easy task for 

Drive to quickly change its suppliers of the breast pumps it imports from China. 

Moreover, Drive could not quickly replace its Chinese supplier because breast pumps are 

therapeutic medical devices that are subject to pre-market testing and approval by the Food and 

Drug Administration (“FDA”).5 As a result, if Drive wished to change the supplier of its breast 

products, Drive would need to undertake a lengthy verification and validation process to comply 

with FDA’s good manufacturing process regulations.6

 Moreover, the decision to change the 

supplier and product might be subject to review and approval by the FDA. Because this process 

is typically lengthy and can be difficult, Drive would not be able, as a practical matter, to change 

the sourcing for its breast pumps within the next year or two. 

In sum, Drive could not replace its suppliers of breast pumps from China to other sources 

quickly, which would have a significant impact on Drive and the consumers of its products. 

ii. Imposition of the Section 301 Duties on Drive’s Imports from China 

Will Cause Severe Economic Harm to Drive and its Customers

 5 See 21 C.F.R. § 884.5160.

6 See 21 C.F.R. Part 820. 
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Imposition of the section 301 duties on Drive’s imports from China is likely to have a 

severe economic impact on Drive and its customers. As an initial matter, it is important to 

remember that the Federal government has recognized that the medical devices industry, which 

includes the HME industry, is a strong component of and contributor to the U.S. manufacturing 

sector. In a 2016 study of the medical devices industry prepared by the Commerce Department, 

Commerce described the U.S. medical devices industry as “highly regarded globally for their 

innovations and high technology products.”7

 Commerce went on to note:

The United States medical device industry is known for producing high quality products 

using advanced technology resulting from significant investment in research and 

development. During the last decade, the United States medical device industry 

experienced an unprecedented advancement in innovative and developed technologies, 

leading to the birth of new therapies and growth in {the} overall healthcare industry.8

Like the rest of the medical devices industry, Drive continues to work to develop, produce and 

provide the respiratory, suction, aerosol and sleep therapy products that consumers in the U.S. 

market demand. 

Considering the importance of a financially strong HME industry for the U.S. economy 

and the importance these products have for healthcare consumers, it simply does not make sense 

to impose these duties on Drive’s imports from China. Imposition of these duties will have a 

severe impact on the company’s financial health. In this regard, the financial condition of HME 

manufacturers like Drive is dependent on reimbursements paid by Medicare, Medicaid and 

private insurers. Unfortunately, Medicare, Medicaid and private insurers pay only a fixed 

 7

 Department of Commerce, International Trade Administration, 2016 Top Markets 

Report: Medical Devices, at p. 2 (2016). See 

https://www.trade.gov/topmarkets/pdf/Medical_Devices_Executive_Summary.pdf.

8

 Id. 
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reimbursement amount to HME providers for certain home medical equipment, like the patient 

slings Drive imports from China. This fixed reimbursement level limits the sales revenues and 

operating income levels of HME providers, who are the firms to whom these insurers typically 

make reimbursement payments. 

As a result, this fixed payment also limits the sales revenues and operating results of 

companies like Drive because their sales revenues are, in effect, derived from the revenues of the 

downstream providers who furnish home medical equipment and supplies to home healthcare 

consumers. In other words, the fixed reimbursement levels paid by Medicare and other insurers 

for home medical equipment and supplies severely limit the sales revenues and profits of Drive 

and other HME manufacturers. 

Because of this unusual reimbursement structure in the HME industry, Drive cannot 

readily pass the duties imposed by USTR under section 301 on to the purchasers of its healthcare 

products. This means that Drive would need to fully absorb the additional duty of 25 percent 

imposed on these products. If Drive is forced to absorb these duties, it will result in an increase 

in the cost of goods sold for the company and a significant reduction in its overall operating 

income levels.9

 After analyzing the impact of the tariffs on its financial results in detail, Drive 

expects that its operating income level will be [[ ]] during the first year of the tariffs. 

 9 Furthermore, Medicare and Medicaid have adopted policies that result in unreasonably 

low fixed reimbursement levels for the HME industry, creating an unsustainable financial 

environment for HME manufacturers and providers. In these circumstances, placing an 

additional cost burden on Drive and other members of the HME industry – which already faces 

significant cost and revenue challenges -- will further limit their ability to provide its customers 

with the HME products they need.
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Drive believes that it is unreasonable to place such a significant cost burden on Drive, a 

leading member of an U.S. industry that remains “highly regarded globally for {its} innovations 

and high-technology products.”10 Drive is proud that it continues to make a significant 

investment in its U.S. manufacturing operations. In light of the fact that Drive maintains a 

significant manufacturing footprint in the United States, it cannot be said that Drive’s only 

interest lies in maintaining its access to imports of HME products from China. Drive has, 

however, filed this request because it needs to continue providing its products, both U.S. 

manufactured and imported, to the consumers in the U.S. market who need them. 

Drive’s financial results and profitability levels will also be affected by another factor. If 

Drive were forced to pass through an additional 25 percent cost to the purchasers of its breast 

pumps and related products, it is likely that this would cause a decline in Drive’s sales of these 

products. A significant percentage of nursing mothers have modest or minimal incomes. These 

individuals would not, therefore, be able to afford a significant increase in the price of Drive’s 

breast pumps and related products. Given this, it is highly likely that the new tariffs will cause 

nursing mothers not to purchase these products. This could have a serious effect on the financial 

results of Drive, especially when the impact of these duties on its sales of breast pumps and 

related products is considered together with the impacts the tariffs are likely to have on other 

products sold by Drive, such as its patient lifts. 

 10 Commerce, International Trade Administration, 2016 Top Markets Report: Medical 

Devices, at p. 2 

(https://www.trade.gov/topmarkets/pdf/Medical_Devices_Executive_Summary.pdf).
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In sum, we urge USTR to grant this request for an exclusion from the section 301 tariffs. 

Imposition of the duty on these products will have a disproportionately harmful effect on Drive, 

a leader in the U.S. home health care market.

iii. Technology Transfer Requirements and The “Made in China 2025” 

Program Are Not Applicable to This Product

Finally, we note that Drive’s imports of breast pumps are not subject to technology 

transfer or licensing requirements by China. They are also not covered by China’s “Made in 

China 2025” program.11 As a result, the concerns that caused USTR to impose duties on imports 

from China are not implicated by imports of this product from China by Drive.

III. Conclusion

In sum, imposition of tariffs of an additional 25 percent on Drive’s imports from China of 

double electric breast pumps (including a carry bag and external battery pack) will not have the 

desired effect of increasing employment in the United States or improving the sales and 

profitability of manufacturing interests in the United States. On the contrary, imposition of the 

tariffs on these imports will significantly increase the cost at which Drive obtains this product 

from China, which will have a direct and severe impact on Drive’s bottom line and its 

employment levels. Additionally, imposing a duty of 25 percent on these imports will seriously 

limit Drive’s ability to provide health care consumers with the health care products they need on 

a daily basis. 

In light of these considerations, Drive respectfully requests that USTR exclude double 

electric breast pumps (including a carry bag and external battery pack) from the scope of its 

 11 Breast pumps are not listed as an advanced medical device in the program.
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announced duties under section 301. Granting this request will help Drive continue to provide 

healthcare consumers with the products they need to maintain their health and well-being on a 

daily basis. Moreover, granting this exclusion request and the other requests filed by Drive 

today will avoid causing severe economic harm to Drive and its employees. Accordingly, Drive 

believes that excluding these imports from the scope of the section 301 tariffs is in the best 

interests of the United States and that it will not undermine the goals that the Administration 

hopes to achieve with these tariffs. 

We appreciate your consideration of this request. If you have any questions or require 

further information, please do not hesitate to call us. 

Respectfully,

/s/ Jeffrey M. Telep 

Jeffrey M. Telep

Neal J. Reynolds

Counsel for Drive DeVilbiss Healthcare
The Honorable Robert E. Lighthizer 

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Appendix A

Annual Quantity and Value of Chinese-Origin Product 

Drive Purchased in the Last Three Years

2015 2016 2017 2018 (YTD)

Quantity 

(Units)

[[ ]] [[ ]] [[ ]] [[ ]]

Value ($1,000) $ [[ ]] $ [[ ]] [[ ]] $ [[ ]]

Percentage of Drive’s total gross U.S. sales in 2017 

Represented by the Chinese Product: [[ ]]