BIS Public Health Industrial Base Survey (PHIB)

OMB Control No. 0690-0030

Expiration Date: 07/31/2023

Survey Questions:

1. What do you believe is the condition of the current U.S. PHIB? Commenters in responding to this question are encouraged to reference their position in the PHIB.

2. What policies and actions would you recommend to strengthen the PHIB in the United States?

3. What aspects or parts of the PHIB do you see as being most vulnerable when involving outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats? In responding to this, commenters are encouraged to include their lessons learned from confronting COVID-19 or other historic pandemics and the needed ramping up of U.S. capacity in various areas to meet these challenges.

4. For the Essential Medicines, Medical Countermeasures, and Critical Inputs that your organization is involved with under the PHIB what percentage of these items are you dependent on from foreign suppliers? In responding to this question, also address if there are foreign dependencies in parts of your supply chain for critical inputs (e.g., active pharmaceutical ingredients (APIs)) as well as finished products? In responding to this question, also address whether it would be possible to source those same items from the U.S. and how long you anticipate it would take to source these items from U.S. suppliers if your foreign supply was no longer available?

5. Are there any cost, regulatory, or other factors that make it more difficult or impossible to produce in or source from the United States for Essential Medicines, Medical Countermeasures, and Critical Inputs? In addressing this question, include any suggestions that you may have for how these concerns regarding sourcing or producing these items in the United States compared to sourcing or producing them outside the United States? In addressing this question, does your organization have mechanisms to determine whether Essential Medicines, Medical Countermeasures, and Critical Inputs are produced in the United States, and any limitations to those mechanisms? Commenters are discouraged from including general statements here and are encouraged to be as specific as they can in their comments regarding what particular issues may exist. For example, saying the regulatory environment in the U.S. discourages U.S. production is not as helpful to Commerce compared to a specific example of a regulatory provision where the commenter provides a specific example of how that deters U.S. production in their example.

6. Briefly describe your assessment of what the U.S. government is doing or could do to foster private and public sector investment and innovation in the United States in this U.S. PHIB, including investments in upgrades to equipment, or to adopt new, 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 other emerging technologies? If so, what policy actions should it undertake? 

7. With respect to the U.S. PHIB, what are the challenges to investing in automation and other productivity enhancing technologies in the United States compared to moving operations abroad to lower-cost labor countries? How would 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 supply chain in the United States?

8. Briefly describe your assessment of whether the amount of federal funds spent on U.S. PHIB 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 PHIB supply chain? 

9. Briefly describe your assessment of U.S. Federal procurement policy with respect to the U.S. PHIB and how it encourages and/or discourages investment in PHIB. What, if any, changes would you recommend to U.S. Federal procurement policy to make the PHIB more productive and internationally competitive and to encourage investment in automation and other emerging technologies?

10. What are the workforce challenges to strengthening the U.S. PHIB, and what are best practices or suggestions for how U.S. industry could overcome these challenges? What have you done to address these challenges? How might emerging technologies in the PHIB create new workforce training needs and which skillsets will the job market most demand?

11. 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 have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs?

12. In your opinion, 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 Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States?

13. In your opinion, 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 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?

14. How great of a problem do you believe is trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e-commerce platforms and from third party online sellers involved in the government procurement process? In responding to this question, commenters are encouraged to provide specific examples of how this may have undermined production in the U.S., endangered U.S. citizens, or undermined the reliability of the U.S. supply chain.

15. How great of a threat is cybercrime or malicious cyber activity to your organization and other organizations that you depend on for 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 such as ransomware, distributed denial of service attacks (DDoS), or malware have undermined production in the U.S. and the reliability of 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? In addressing this question, to what extent, if any, does dependence on foreign suppliers increase your organization’s exposure to cybercrime or create any additional burdens because of the complexities involved with dealing with different countries’ laws on cyber issues.

16. How dependent is the U.S. sewn products supply chain for use in Personal Protective Equipment (PPE) on foreign suppliers from your organization’s perspective? In addressing this question, are there specific factors that undermine U.S. competitiveness in this area of the supply chain and what recommendations does your organization have for reducing foreign dependency and increasing U.S. competitiveness? In addressing this question, specify whether your organization produces, sells or uses this type of PPE.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The control number assigned to this collection is OMB 0690-0030. Public reporting for this collection is estimated to be 120 minutes per response, including the time to review the instructions, complete, and submit the collection of information, but not including time to review and implement the requirements of the program. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the BIS Information Collection Officer, Bureaus of Industry and Security, Room 6883, Department of Commerce, 14th and Constitution Avenue, N.W., Washington, D.C. 20230