77428 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

[Docket No. 201124–0316] 

RIN 0694–XC068 

Notice of Request for Public 

Comments on Condition of the Public 

Health Industrial Base and 

Recommend Policies and Actions To 

Strengthen the Public Health Industrial 

Base To Ensure Essential Medicines, 

Medical Countermeasures, and Critical 

Inputs Are Made in the United States 

AGENCY: Bureau of Industry and 

Security, Office of Technology 

Evaluation, U.S. Department of 

Commerce. 

ACTION: Notice of request for public 

comments. 

SUMMARY: On August 6, 2020, President 

Trump issued an Executive order, 

Combating Public Health Emergencies 

and Strengthening National Security by 

Ensuring Essential Medicines, Medical 

Countermeasures, and Critical Inputs 

Are Made in the United States. Among 

other directives, the E.O. directed that, 

by February 2, 2021, the Secretary of 

Commerce shall submit a report to the 

Director of the Office of Management 

and Budget, the Assistant to the 

President for National Security Affairs, 

the Director of the National Economic 

Council, and the Director of the Office 

of Trade and Manufacturing Policy, 

describing any change in the status of 

the Public Health Industrial Base (PHIB) 

and recommending initiatives to 

strengthen the PHIB. This notice 

requests comments from the public to 

assist the Department of Commerce 

(referred to henceforth as ‘‘Commerce’’) 

in preparing this report on the condition 

of the PHIB and recommending policies 

and actions to strengthen the PHIB. 

DATES: The due date for filing comments 

is December 23, 2020. 

ADDRESSES: Submissions: All written 

comments on the notice must be 

addressed to PHIB Study and filed 

through the Federal eRulemaking Portal: 

http://www.regulations.gov. To submit 

comments via http://

www.regulations.gov, enter docket 

number BIS–2020–0034 on the home 

page and click ‘‘search.’’ The site will 

provide a search results page listing all 

documents associated with this docket. 

Find a reference to this notice and click 

on the link entitled ‘‘Comment Now!’’ 

(For further information on using http:// 

www.regulations.gov, please consult the 

resources provided on the website by 

clicking on ‘‘How to Use This Site.’’) 

FOR FURTHER INFORMATION CONTACT: 

Jason Bolton at 202–482–5936 or via 

email Jason.Bolton@bis.doc.gov; 

PHIBstudy@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On August 6, 2020, President Trump 

issued Executive Order 13944, 

Combating Public Health Emergencies 

and Strengthening National Security by 

Ensuring Essential Medicines, Medical 

Countermeasures, and Critical Inputs 

Are Made in the United States (E.O. 

13944). Section 1 of E.O. 13944 stated 

that the United States must protect U.S. 

citizens, critical infrastructure, military 

forces, and the economy against 

outbreaks of emerging infectious 

diseases as well as chemical, biological, 

radiological, and nuclear (CBRN) 

threats. To achieve this, the United 

States must have a strong Public Health 

Industrial Base (PHIB) with resilient 

domestic supply chains for the Essential 

Medicines, Medical Countermeasures, 

and Critical Inputs deemed necessary 

for the United States. As defined in E.O. 

13944, ‘‘Essential Medicines’’ are those 

Essential Medicines deemed necessary 

for the United States pursuant to section 

3(c) of E.O. 13944; ‘‘Medical 

Countermeasures’’ means items that 

meet the definition of ‘‘qualified 

countermeasure’’ in section 247d– 

6a(a)(2)(A) of title 42, United States 

Code; ‘‘qualified pandemic or epidemic 

product’’ in section 247d–6d(i)(7) of 

title 42, United States Code; ‘‘security 

countermeasure’’ in section 247d– 

6b(c)(1)(B) of title 42, United States 

Code; or personal protective equipment 

described in part 1910 of title 29, Code 

of Federal Regulations. Section 7 of E.O. 

13944 contains the definitions of other 

terms that are applicable to this notice 

(e.g., ‘‘Active Pharmaceutical 

Ingredient,’’ ‘‘Advanced 

Manufacturing,’’ ‘‘API Starting 

Material,’’ ‘‘Critical Inputs,’’ ‘‘Finished 

Device,’’ ‘‘Finished Drug Product,’’ 

‘‘Healthcare and Public Health Sector,’’ 

and ‘‘Qualifying Countries’’). The 

definition of ‘‘produced in the United 

States’’ used in this notice is consistent 

with the definition of ‘‘produced in the 

United States’’ as used in Section 25.1 

of the Federal Acquisition Regulation 

(FAR) Buy American Act-Supplies and 

in the FAR Clause 52.225–1. 

Section 1 of E.O. 13944 directs that 

domestic supply chains must be capable 

of meeting national security 

requirements for responding to threats 

arising from CBRN threats and public 

health emergencies, including emerging 

infectious diseases such as COVID–19. 

The E.O. further states that it is critical 

that the United States reduce its 

dependence on foreign manufacturers 

for Essential Medicines, Medical 

Countermeasures, and Critical Inputs to 

ensure sufficient and reliable long-term 

domestic production of these products, 

minimize potential shortages, and 

mobilize our Nation’s PHIB to respond 

to these threats. The E.O. directed that 

the policy of the United States is to 

accelerate the development of costeffective and efficient domestic 

production of Essential Medicines and 

Medical Countermeasures and to have 

adequate redundancy built into the 

domestic supply chain; ensure longterm demand for these items, and 

critical inputs that are produced in the 

United States; create, maintain, and 

maximize domestic production 

capabilities for these items that are 

essential to protect public safety and 

human health and to provide for the 

national defense; and combat the 

trafficking of these items, and critical 

inputs over e-commerce platforms and 

from third party online sellers involved 

in the government procurement process. 

In E.O. 13994, the President directed 

the heads of Executive Branch agencies, 

including the Secretary of Commerce, to 

fulfill the stated policy objectives of the 

order. Under section 6, paragraph (b) 

(Reporting) of the E.O., the Secretary is 

directed, by February 2, 2021 (within 

180 days of the date of the August 6 

order), to submit a report to the Director 

of the Office of Management and Budget 

(OMB), the Assistant to the President for 

National Security Affairs, the Director of 

the National Economic Council, and the 

Director of the Office of Trade and 

Manufacturing Policy, describing any 

change in the status of the Public Health 

Industrial Base and recommending 

initiatives to strengthen the Public 

Health Industrial Base. 

This notice requests comments from 

the public to assist Commerce in 

preparing this report on the condition of 

the PHIB (‘‘change in the status’’) and 

recommending policies and actions 

(‘‘initiatives’’) to strengthen the PHIB. 

As stated in section 6, paragraph (c) 

of E.O. 13944, to the maximum extent 

permitted by law, and with the 

redaction of any information protected 

by law from disclosure, Commerce’s 

report shall be published in the Federal 

Register and on the agency’s official 

website. 

Definition of Public Health Industrial 

Base (PHIB) 

As defined in E.O. 13944, ‘‘PHIB’’ 

means the facilities and associated 

workforces within the United States, 

including research and development 

facilities, which help produce Essential 

Medicines, Medical Countermeasures, 

and Critical Inputs for the Healthcare 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 77429 

and Public Health Sector. The PHIB 

includes all entities domestically 

manufacturing or producing medical 

products, including medical devices, 

medical equipment, medical 

countermeasures, and medications, 

pharmaceutical products, and other 

products designed to improve patient 

outcomes. This includes the 

manufacturing of components and 

materials that are essential to create 

end-item medical products, as well as 

ancillary supplies and disposable 

consumable products. 

For medical devices and medical 

equipment, the PHIB includes all 

components that, if replaced by an 

equivalent alternative component, 

would require an amendment to the 

final product’s 510(k) certification. For 

medications and pharmaceutical 

products, it includes drug finishing (i.e., 

fill-finish, tableting, or capsule 

formulation), as well as the active 

pharmaceutical ingredients (API) and 

the key starting materials that are used 

to make the API. For blood products and 

medical products derived from animals 

(such as porcine and bovine heparin), 

the PHIB includes all aspects of the 

extraction, processing and formulation 

supply chain. For vaccines and 

biologics, it includes research and 

development, as well as the production 

of all components of the end product 

without which the end product would 

be ineffective for its intended purpose. 

The PHIB also includes the labor force 

necessary to conduct the manufacturing 

and supply chain operations described 

above. It does not include the ability of 

distributors to source medical products 

from foreign sources to distribute within 

the U.S. healthcare system. 

Written Comments 

Interested parties are invited to 

submit written comments, data, 

analyses, or information pertinent to the 

task of preparing this Commerce report 

pursuant to E.O. 13994 to the 

Department’s Office of Technology 

Evaluation no later than December 23, 

2020. 

The Department is particularly 

interested in comments and information 

directed to the policy objectives listed 

in E.O. 13944 as they affect the U.S. 

PHIB including, but not limited to, the 

following: 

(i) What is the condition of the 

current U.S. PHIB? Commenters in 

responding to this question are 

encouraged to reference their position in 

the PHIB (e.g., research and 

development facility, manufacturer, 

distributor, or consumer). 

(ii) What policies and actions should 

the U.S. Government take to strengthen 

the PHIB in the United States? 

(iii) What aspects or parts of the PHIB 

are most vulnerable during outbreaks of 

emerging infectious diseases? 

a. How likely might such an event be, 

how much of an impact might it have 

in manufacturing operations, and what 

mitigation measures might be most 

effective in offsetting these impacts? 

b. In responding to this question, 

commenters are encouraged to include 

any lessons learned from responding to 

COVID–19 or other historic pandemics, 

and the ramping up of U.S. capacity in 

various areas that did or did not occur 

to meet these challenges. 

(iv) What aspects or parts of the PHIB 

are most vulnerable to chemical, 

biological, radiological, and nuclear 

(CBRN) events? 

a. How likely might such an event be; 

how much might it impact 

manufacturing operations; and what 

mitigation measures might be most 

effective in offsetting these impacts. 

b. In responding to this question, 

commenters are encouraged to include 

any lessons learned from responding to 

previous CBRN threats and the ramping 

up of U.S. capacity in various areas that 

did or did not occur to meet these 

challenges. 

(v) For the Essential Medicines, 

Medical Countermeasures, and Critical 

Inputs with which your organization is 

involved under the PHIB, for what 

percentage of these items are you 

dependent on foreign suppliers? In 

responding to this question, please 

address: 

a. Whether or not there are foreign 

dependencies in any part of your supply 

chain for critical inputs (e.g., active 

pharmaceutical ingredients (APIs)) or 

for finished products? 

b. whether it would be possible to 

source these critical inputs and/or 

finished products from the United 

States, as well as how long you 

anticipate it would take to source these 

items from U.S. suppliers if your foreign 

supplier(s) was no longer available? 

(vi) Are there any costs, regulatory or 

other factors that make it difficult or 

impossible to produce or source 

Essential Medicines, Medical 

Countermeasures, and/or Critical Inputs 

in the United States? In addressing this 

question, please also address: 

a. Any concerns that you may have 

regarding sourcing or producing these 

items in the United States, in contrast to 

sourcing or producing them outside the 

United States. 

b. does your organization have 

mechanisms to determine whether 

Essential Medicines, Medical 

Countermeasures, and Critical Inputs 

are produced in the United States? 

What, if any, are the limitations to those 

mechanisms? Commenters are 

encouraged to be as specific as possible 

in their comments regarding the 

particular issues that may exist. For 

example, an example of a regulatory 

provision accompanied by a specific 

example of how the provision hinders 

domestic production is more helpful to 

Commerce than a statement that the 

regulatory environment in the United 

States discourages domestic production. 

c. how significant of a concern is 

‘‘pricing’’ in being able to achieve 

maximum domestic production? 

(vii) What is the U.S. Government 

doing or could do to foster private and 

public sector investment and innovation 

in the U.S. PHIB, including, for 

example, investments in upgrades to 

equipment, or the adoption of emerging 

technologies, and/or automation that 

would increase productivity and 

competitiveness. Should the U.S. 

Government do more to foster U.S. PHIB 

investment, particularly in automation 

and emerging technologies? If so, what 

policy actions should it undertake? 

(viii) With respect to the U.S. PHIB, 

what are the challenges to investing in 

automation and other productivityenhancing technologies in the United 

States as compared to moving 

operations abroad to lower-cost labor 

countries? Would increased investment 

in, or higher use of, more efficient and 

cost-effective automation and 

productivity enhancing technologies 

affect your decisions to source all or 

some of your Essential Medicines, 

Medical Countermeasures, and Critical 

Inputs in the United States? 

(ix) Briefly assess whether the amount 

of federal funds spent on U.S. PHIB 

research and development (R&D) is 

adequate; if not, specify why spending 

should be increased or decreased. 

Which types of R&D projects, if 

adequately funded, would have the 

most impact on the competitiveness of 

the U.S. PHIB supply chain? 

(x) Briefly assess U.S. Federal 

procurement policy with respect to the 

U.S. PHIB and how it encourages or 

discourages investment in the PHIB. 

How should U.S. Federal procurement 

policy to make the PHIB more 

productive and more internationally 

competitive, as well as to encourage 

investment in automation and other 

emerging technologies? 

(xi) What are the workforce challenges 

to strengthening the U.S. PHIB, and 

what are best practices or suggestions 

for how U.S. industry can overcome 

these challenges? What have you done 

to address these challenges? How might 

77430 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

emerging technologies in the PHIB 

create new workforce training needs? 

Which skillsets will the job market most 

demand in the future? 

(xii) How can the U.S. Government or 

the private sector help to accelerate the 

development of cost-effective and 

efficient domestic production of 

Essential Medicines and Medical 

Countermeasures and to have adequate 

redundancy built into the domestic 

supply chain for Essential Medicines, 

Medical Countermeasures, and Critical 

Inputs? 

(xiii) What are the three most 

important things that can be done by the 

U.S. Government or the private sector to 

ensure long-term demand for the 

Essential Medicines, Medical 

Countermeasures, and Critical Inputs 

that are produced in the United States? 

(xiv) What are the three most 

important things that can be done by the 

U.S. Government or the private sector to 

create, maintain, and maximize 

domestic production capabilities for the 

Critical Inputs, Finished Drug Products, 

and Finished Devices that are essential 

to protect public safety and human 

health and to provide for the national 

defense? 

(xv) How significant of a problem is 

trafficking of counterfeit Essential 

Medicines, Medical Countermeasures, 

and Critical Inputs over e-commerce 

platforms and from third party online 

vendors also involved in the U.S. 

Government procurement process? In 

responding to this question, 

commenters are encouraged to provide 

specific examples of how these practices 

may have undermined production in the 

United States, endangered U.S. citizens, 

or undermined the reliability of the U.S. 

supply chain. 

(xvi) How great of a threat is 

cybercrime or malicious cyber activity 

to your organization and other 

organizations that you depend on as 

part of your supply chain for Essential 

Medicines, Medical Countermeasures, 

and Critical Inputs? In addressing this 

question, commenters are encouraged to 

provide specific examples of how cyber 

threats (e.g., ransomware, distributed 

denial of service attacks (DDoS) and 

malware) have undermined production 

in the United States and the reliability 

of the U.S. supply chain for Essential 

Medicines, Medical Countermeasures, 

and Critical Inputs. How can the U.S. 

Government or the private sector 

strengthen the PHIB sector’s ability to 

prevent, detect, and recover from 

malicious cyber activity? To what 

extent, if any, does dependence on 

foreign suppliers increase your 

organization’s exposure to cybercrime or 

create additional burdens because of the 

complexities involved in dealing with 

different countries’ laws on cyber 

issues? 

(xvii) From your organization’s 

perspective, how dependent is the U.S. 

supply chain on foreign suppliers for 

items for use in Personal Protective 

Equipment (PPE)? In addressing this 

question, please address whether there 

are specific factors that undermine U.S. 

competitiveness in this area and provide 

any recommendations that your 

organization may have for reducing 

foreign dependency and increasing U.S. 

competitiveness. In addressing this 

question, specify whether your 

organization produces, sells or uses 

PPE. 

Requirements for Written Comments 

The http://www.regulations.gov 

website allows users to provide 

comments by filling in a ‘‘Type 

Comment’’ field, or by attaching a 

document using an ‘‘Upload File’’ field. 

The Department prefers that comments 

be provided in an attached document. 

The Department prefers submissions in 

Microsoft Word (.doc files) or Adobe 

Acrobat (.pdf files). If the submission is 

in an application format other than 

Microsoft Word or Adobe Acrobat, 

please indicate the name of the 

application in the ‘‘Type Comment’’ 

field. Please do not attach separate cover 

letters to electronic submissions; rather, 

include any information that might 

appear in a cover letter within the 

comments. Similarly, to the extent 

possible, please include any exhibits, 

annexes, or other attachments in the 

same file, so that the submission 

consists of one file instead of multiple 

files. Comments will be placed in the 

docket and open to public inspection, 

unless a statement is filed justifying 

nondisclosure and referring to the 

specific legal authority claimed, and a 

non-confidential version of the 

submission is provided. Anyone 

submitting business confidential 

information should clearly identify the 

business confidential portion at the time 

of submission, file a statement justifying 

nondisclosure and referring to the 

specific legal authority claimed, and 

provide a non-confidential version of 

the submission. Comments may be 

viewed on http://www.regulations.gov 

by entering docket number BIS–2020– 

0034 in the search field on the home 

page. 

All filers should name their files 

using the name of the person or entity 

submitting the comments. 

Communications from agencies of the 

United States Government will not be 

made available for public inspection. 

Anyone submitting business 

confidential information should clearly 

identify the business confidential 

portion at the time of submission, file a 

statement justifying nondisclosure and 

referring to the specific legal authority 

claimed, and provide a non-confidential 

version of the submission. Guidance on 

submitting business confidential 

information is as follows: Anyone 

submitting business confidential 

information should clearly identify the 

business confidential portion at the time 

of submission, include a statement 

justifying nondisclosure and referring to 

the specific legal authority claimed with 

the submission, and provide a nonconfidential version of the submission 

which will be placed in the public file 

on http://www.regulations.gov. For 

comments submitted electronically 

containing business confidential 

information, the file name of the 

business confidential version should 

begin with the characters ‘‘BC’’. Any 

page containing business confidential 

information must be clearly marked 

‘‘BUSINESS CONFIDENTIAL’’ on the 

top of that page. The non-confidential 

version must be clearly marked 

‘‘PUBLIC’’. The file name of the nonconfidential version should begin with 

the character ‘‘P’’. The ‘‘BC’’ and ‘‘P’’ 

should be followed by the name of the 

person or entity submitting the 

comments or rebuttal comments. If a 

public hearing is held in support of this 

investigation, a separate Federal 

Register notice will be published 

providing the date and information 

about the hearing. 

The Bureau of Industry and Security 

does not maintain a separate public 

inspection facility. Requesters should 

first view the Bureau’s web page, which 

can be found at https://

efoia.bis.doc.gov/ (see ‘‘Electronic 

FOIA’’ heading). If requesters cannot 

access the website, they may call 202– 

482–0795 for assistance. The records 

related to this assessment are made 

accessible in accordance with the 

regulations published in part 4 of title 

15 of the Code of Federal Regulations 

(15 CFR 4.1 through 4.11). 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2020–26609 Filed 11–30–20; 4:15 pm] 

BILLING CODE 3510–33–P