[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Pages 25869-25870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11008]



Food and Drug Administration

[Docket No. FDA-2010-N-0233]

The National Institutes of Health and the Food and Drug 
Administration Joint Leadership Council: Stakeholders Meeting; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting, in conjunction with the National Institutes of Health (NIH), 
to solicit comments from interested persons on how the agencies can 
more effectively collaborate to advance the translation of biomedical 
research discoveries into approved diagnostics and therapies as well as 
promote science to enhance the evaluation tools used for regulatory 
review. A newly formed NIH-FDA Joint Leadership Council will help 
ensure that regulatory considerations form an increasing component of 
biomedical research planning, and that the latest science is integrated 
into the regulatory review process.

DATES: The public meeting will be held on June 2, 2010, from 8:30 a.m. 
to 12:30 p.m. Persons interested in attending the meeting must register 
by Wednesday, May 26, 2010, at 5 p.m. e.s.t. (see section III of this 
document). Submit written or electronic comments by Wednesday, May 26, 
2010, at 5 p.m. e.s.t.

ADDRESSES: The public meeting will be held at FDA, 10903 New Hampshire 
Ave., Bldg. 31, rm. 1503C, Silver Spring, MD 20993-0002.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket 
number found in brackets at the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4283, Silver Spring, MD 20993-0002, 301-796-4769, FAX: 
301-847-8617, e-mail: [email protected].


I. Background

    With the dramatic breakthroughs occurring in biomedical research 
discovery, new public health challenges on the rise, an ever-changing 
economic landscape resulting from globalization, and the prospect for 
fundamental changes to healthcare delivery in the United States, there 
is a pressing need for greater collaboration between FDA and NIH. Both 
NIH and FDA have the goals of translating science discoveries into 
medical products and therapies, and both NIH and FDA have important 
roles and contributions to make towards these efforts. To address these 
important areas of common interest, NIH and FDA announced a new 
partnership effort that includes, among other initiatives, the 
regulatory science program and the NIH-FDA Joint Leadership Council.
    The NIH-FDA Joint Leadership Council provides a forum for the 
leadership of both agencies to: (1) Work together on strategic planning 
at a high level; (2) stimulate an enhanced culture of collaboration 
between the agencies at all levels; and (3) further coordinate and 
target efforts to promote promising new therapies using the latest 
technological advances, such as stem cell biology, biomarkers, and 
computational sciences. NIH and FDA plan to work jointly to address the 
gap between biomedical research discoveries and new medical products. 
They can create new programs to support development of innovative 
therapies and promote personalized medicine, utilizing new clinical 
trial design strategies and regulatory review processes incorporating 
the use of genetic or other biomarkers and information technologies. 
These activities will also support postmarketing and/or other 
population-based surveys for safety assessments. Overall, there are 
many new avenues for NIH and FDA to explore such that we can deliver 
safer and more effective treatments faster.

II. Scope of the Meeting

    FDA and NIH are interested in receiving comments from the public on 
the regulatory considerations that should be an integral part of the 
biomedical research program development and scientific tools or 
approaches that would enhance the ability to evaluate new medical 
products. The comments should focus on ways in which NIH and FDA can 
partner to promote interdisciplinary biomedical research through 
scientific exchange and new programs designed to advance innovation and 
development of new therapies incorporating many of the latest basic 
research discoveries. Suggestions about the ways FDA and NIH can work 
together to promote an integrated biomedical research agenda including 
regulatory review approaches and/or processes on areas of common 
interest and mission are being sought. Some areas for which we are 
specifically interested in input are the following:
    1. What steps should be taken to enhance the translation of 
biomedical research discoveries into new and approved preventatives, 
diagnostics, therapies, or devices for clinical use?
    2. What are the priority scientific issues that currently need to 
be addressed (e.g., clinical trial design, endpoint selection and 
qualification, bioinformatics needs) in order to inform regulatory 
assessments and analyses of new products?
    3. How could we enhance the exchange of scientific information 
across all sectors in order to better identify and prioritize 
scientific areas for emphasis in regulatory research?
    4. What mechanisms for the support of regulatory science research 
would be most effective and efficient in addressing pressing priority 
areas in the translational pipeline?

III. Registration To Attend and/or To Participate in the Meeting

    If you wish to attend the public meeting, you must register by e-
mailing Rakesh Raghuwanshi

[[Page 25870]]

([email protected]) by Wednesday, May 26, 2010, at 5 p.m. 
e.s.t. When registering, you must provide the following information: 
(1) Your name, (2) title, (3) company or organization (if applicable), 
(4) mailing address, (5) telephone number, and (6) e-mail address. If 
you wish to make a presentation, when you register, indicate the 
specific topic or issue to be addressed in your presentation. We will 
do our best to accommodate all persons who wish to make a presentation 
at the meeting. FDA and NIH encourage persons and groups having similar 
interests to consolidate their information for presentation through a 
single representative. After reviewing the requests to present, we will 
contact each participant prior to the meeting with the amount of time 
available and the approximate time the participant's presentation is 
scheduled to begin. Presenters must then send the final electronic 
copies of their presentations in Microsoft PowerPoint, Microsoft Word, 
or Adobe Portable Document to Format (PDF) to Rakesh Raghuwanshi 
([email protected]) by Monday, May 31, 2010, at 12 noon 
    There is no fee to register for the public meeting and registration 
will be on a first-come, first-served basis. Early registration is 
recommended because seating is limited. Registration on the day of the 
public meeting will be permitted on a space available basis beginning 
at 8 a.m.
    If you need special accommodations due to a disability, please 
inform the meeting contact (see FOR FURTHER INFORMATION CONTACT) by 
Wednesday, May 26, 2010, at 5 p.m. e.s.t.

IV. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Transcripts of the meeting will be available for review 
approximately 30 days after the meeting at http://www.regulations.gov 
and at the Division of Dockets Management (see ADDRESSES). A transcript 
will also be available in either hardcopy or on CD-ROM, after 
submission of a Freedom of Information request. Written requests are to 
be sent to Division of Freedom of Information (HFI-35), Office of 
Management Programs, Food and Drug Administration, 5600 Fishers Lane, 
rm. 6-30, Rockville, MD 20857.

    Dated: May 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11008 Filed 5-7-10; 8:45 am]