2011-26088. Request for Information: Building A 21st Century Bioeconomy

ACTION:

Notice of Request for Information (RFI).

SUMMARY:

The purpose of this Request for Information (RFI) is to solicit input from all interested parties regarding recommendations for harnessing biological research innovations to meet national challenges in health, food, energy, and the environment while creating high-wage, high-skill jobs.

The public input provided through this Notice will inform the Office of Science and Technology Policy (OSTP) as it works with Federal agencies and other stakeholders to develop a National Bioeconomy Blueprint.

DATES:

October 7, 2011—December 6, 2011.

ADDRESSES:

[e-mail].

SUPPLEMENTARY INFORMATION:

Purpose

The purpose of this Request for Information (RFI) is to solicit input from all interested parties regarding recommendations for harnessing biological research innovations to meet national challenges in health, food, energy, and the environment while creating high-wage, high-skill jobs.

The public input provided through this Notice will inform the Office of Science and Technology Policy as it works with Federal agencies and other stakeholders to develop a National Bioeconomy Blueprint.

Background

On September 16, 2011, President Obama announced that his Administration will develop a National Bioeconomy Blueprint detailing Administration-wide steps to harness biological research innovations to address national challenges in health, food, energy, and the environment. Biological research underpins the foundation of a significant portion of our economy. By better leveraging our national investments in biological research and development, the Administration will grow the jobs of the future and improve the lives of all Americans.

Twenty-first century advances in biological research and technologies are poised to return tremendous public benefits. For example, advances in human genome-informed personalized medicine and data analytics could be combined to improve human health in novel ways. In bio-based industry, biological design can create new opportunities for biofuels, chemicals, materials, and energy-efficient manufacturing processes.

The National Bioeconomy Blueprint will identify strategies to meet grand challenges, promote commercialization and entrepreneurship, focus research and development investments in areas that will provide the foundation for the bioeconomy, expand workforce training to prepare the next generation of scientists and engineers for the bioeconomy jobs of the future, identify regulatory reforms that will reduce unnecessary burdens on innovators while protecting health and safety, and describe appropriate public-private partnerships to accelerate innovation in key areas.

OSTP seeks comment on the questions listed below to inform the development of the National Bioeconomy Blueprint:

Grand challenges: President Obama has identified “grand challenges” as an important element of his innovation strategy, such as “smart anti-cancer therapeutics that kill cancer cells and leave their normal neighbors untouched; early detection of dozens of diseases from a saliva sample; personalized medicine that enables the prescription of the right dose of the right drug for the right person; a universal vaccine for influenza that will protect against all future strains; and regenerative medicine that can end the agonizing wait for an organ transplant.”

(1) Identify one or more grand challenges for the bioeconomy in areas such as health, energy, the environment, and agriculture, and suggest concrete steps that would need to be taken by the Federal government, companies, non-profit organizations, foundations, and other stakeholders to achieve this goal.

Research and development: R&D investments, particularly in platform technologies, can support advances in health, energy, the environment, and agriculture, and accelerate the pace of discovery in fundamental life sciences research.

(2) Constrained Federal budgets require a focus on high-impact research and innovation opportunities. With this in mind, what should be the Federal funding priorities in research, technologies, and infrastructure to provide the foundation for the bioeconomy?

(3) What are the critical technical challenges that prevent high throughput approaches from accelerating bioeconomy-related research? What specific research priorities could address those challenges? Are there particular goals that the research community and industry could rally behind (e.g., NIH $1,000 genome initiative ^[1] )?

(4) The speed of DNA sequencing has outstripped advances in the ability to extract information from genomes given the large number of genes of unknown function in genomes; as many as 70% of genes in a genome have poorly or unknown functions. All areas of scientific inquiry that utilize genome information could benefit from advances in this area. What new multidisciplinary funding efforts could revolutionize predictions of protein function for genes?

Moving life sciences breakthroughs from lab to market: It is a challenge to commercialize advances in the life sciences because of the risk, expense, and need for many years of sustained investment. The Administration is interested in steps that it can take directly, but is also interested in encouraging experimentation with new private-sector-led models for funding commercialization of life sciences research.

(5) What are the barriers preventing biological research discoveries from moving from the lab to commercial markets? What specific steps can Federal agencies take to address these shortcomings? Please specify whether these changes apply to academic labs, government labs, or both.

(6) What specific changes to Federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs ^[2] would help accelerate commercialization of federally-funded bioeconomy-related research?

(7) What high-value data might the government release in the spirit of its open government agenda that could spur the development of new products and services in the bioeconomy?

(8) What are the challenges associated with existing private-sector models (e.g. venture funding) for financing entrepreneurial bioeconomy firms and what specific steps can agencies take to address those challenges?

Workforce development: Investment in education and training is essential to creating a technically-skilled 21st century American bioeconomy workforce.

(9) The majority of doctorate recipients will accept jobs outside of academia. What modifications should be made to professional training programs to better prepare scientists and engineers for private-sector bioeconomy jobs?

(10) What roles should community colleges play in training the bioeconomy workforce of the future?

(11) What role should the private sector play in training future bioeconomy scientists and engineers?

(12) What role might government, industry, and academia play in encouraging successful entrepreneurship by faculty, graduate students, and postdocs?

Reducing regulatory barriers to the bioeconomy: As President Obama has stated, our regulatory system must “identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends” and “protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.”

(13) What specific regulations are unnecessarily slowing or preventing bioinnovation? Please cite evidence that the identified regulation(s) are a) slowing innovation, and b) could be reformed or streamlined while protecting public health, safety, and the environment.

(14) What specific steps can Federal agencies take to improve the predictability and transparency of the regulatory system? (Please specify the relevant agency.)

(15) What specific improvements in the regulatory processes for drugs, diagnostics, medical devices, and agricultural biotechnology should federal agencies implement? What challenges do new or emerging technologies pose to the existing regulatory structure and what can agencies do to address those challenges?

Public-private partnerships: The Administration is interested in serving as a catalyst for public-private partnerships that build the bioeconomy and address important unmet needs in areas such as health, energy, agriculture, and environment.

(16) What are the highest impact opportunities for public-private partnerships related to the bioeconomy? What shared goals would these partnerships pursue, which stakeholders might participate, and what mutually reinforcing commitments might they make to support the partnership?

(17) What are the highest impact opportunities for pre-competitive collaboration in the life sciences, and what role should the government play in developing them? What can be learned from existing models for pre-competitive collaboration both inside and outside the life-sciences sector? What are the barriers to such collaborations and how might they be removed or overcome?

Response to this RFI is voluntary. Responders are free to address any or all the above items, as well as provide additional information that they think is relevant to the development of a National Bioeconomy Blueprint.

Please note that the Government will not pay for response preparation or for the use of any information contained in the response.

How To Submit a Response

All comments must be submitted electronically to: [e-mail].

Responses to this RFI will be accepted through December 6, 2011. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government's use of such information.

Responses received after the deadline will be considered during implementation of the activities of the National Bioeconomy Blueprint if not received before finalization of the National Bioeconomy Blueprint.

Responses to the RFI, including the names of the authors and their institutional affiliations, will be posted at http://www.whitehouse.gov/​ostp/​bioeconomy.

Inquiries

Specific questions about this RFI should be directed to the following e-mail address: [e-mail].

Form should include:

[Assigned ID #]

[Assigned Entry date]

Name/E-mail

Affiliation/Organization

City, State

Comment 1

Comment 2

Comment 3

Comment 4

Comment 5

Attachment

Ted Wackler,

Deputy Chief of Staff.

Footnotes

1.  http://www.genome.gov/​27541190

2.  http://www.sbir.gov/​