[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Notices]
[Pages 869-870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0489]


Request for Comments on the Science and Technology Report; 
Establishment of Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: On March 31, 2006, the Food and Drug Administration (FDA) 
charged the Science Board to evaluate FDA's science-based capacities to 
meet current and future public health challenges. The Science Board 
established a subcommittee on science and technology to perform the 
review and draft a report of findings and preliminary recommendations. 
The subcommittee report was presented and discussed at the December 3, 
2007, Science Board Advisory Committee meeting, at which time the 
Science Board decided to obtain comments from the public on the 
subcommittee report. FDA is soliciting public comment on the 
subcommittee report on behalf of the Science Board.

DATES: To be considered, written or electronic comments on the 
subcommittee report must be received on or before February 4, 2008. All 
comments received while the docket is open will be forwarded to the 
Science Board for their review.

ADDRESSES: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select Docket No. 2007N-0489, ``FDA 
Report on Science and Technology'' and follow prompts to submit your 
statement. Written comments should be submitted to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, by close of

[[Page 870]]

business on (see DATES). All comments should 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. All comments received 
will be posted without change, including any personal information 
provided. All comments received while the docket is open will be 
forwarded to the Science Board for their review. All comments will also 
be discussed at the next Science Board Advisory Committee meeting. A 
notice of the next Science Board Advisory Committee meeting will be 
published at a later date. See SUPPLEMENTARY INFORMATION section for 
elctronic access.

FOR FURTHER INFORMATION CONTACT: Carlos Pe[ntilde]a, Office of the 
Commissioner, Food and Drug Administration (HF-33), 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6687, FAX: 301-827-3340, e-mail: 
carlos.Pe[ntilde]a,@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 31, 2006, FDA charged the Science Board to conduct a broad 
review of FDA scientific capacities, processes, and infrastructure 
which support FDA's core regulatory functions including the following: 
(1) Premarket review and consultation during the development of new 
FDA-regulated products; (2) oversight of marketed product quality; and 
(3) postmarket product safety surveillance and risk management. The 
following is the Commissioner of Food and Drugs' charge to the Science 
Board: ``Review and report the broad categories of scientific and 
technologic capacities that FDA needs to fully support its core 
regulatory functions and decisionmaking throughout the product life-
cycle, today and over the next decade.'' Specifically:
    (1) Are there any important gaps in current scientific capacities 
in which FDA should substantially increase efforts, to ensure that it 
can address current or expected scientific demands of FDA's regulatory 
mission? In what areas should the agency maintain or strengthen its 
current level of work and capacity?
    (2) Are there areas of science in which the agency should consider 
refocusing its efforts in order to better address current or 
anticipated future scientific demands of FDA's regulatory mission?
    (3) What opportunities exist to enhance the overall effectiveness 
of FDA's scientific and technologic capacity through coordination of 
scientific activities and priority setting across FDA components?
    (4) What opportunities exist to better leverage FDA's scientific 
capacity through collaboration with other public agencies and private 
organizations? Are there other approaches to resource leveraging that 
FDA could pursue to better support needed scientific capacities?
    The review was initiated to obtain advice regarding current 
science-based capacities and the degree to which they can prepare FDA 
for anticipated changes in science, technology and population health 
needs.
    To respond to this request from the agency, the Science Board 
established a subcommittee on science and technology to perform the 
review. The subcommittee was supported by 30 outside experts, who were 
drawn from government, academia, and industry. Their efforts culminated 
in a subcommittee report of findings and preliminary recommendations. 
The subcommittee report was presented and discussed at the December 3, 
2007, Science Board Advisory Committee meeting, at which time the 
Science Board decided to obtain comments from the public on the 
subcommittee report (an electronic copy of the subcommittee report is 
available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html).

II. Request for Comments

    In accordance with 21 CFR 14.35, FDA is soliciting public comment 
on the subcommittee report, on behalf of the Science Board. Comments 
received while the docket is open will be forwarded to the Science 
Board for their review. Comments will also be discussed at the next 
Science Board Advisory Committee meeting. A notice of the next Science 
Board Advisory Committee meeting will be published in the Federal 
Register at a later date.

III. Submission of Comments

    To help facilitate the public comment process upon the subcommittee 
report, FDA has established a public docket, on behalf of the Science 
Board. All comments submitted to the public docket are public 
information and may be posted to the FDA's Web site at: http://www.fda.gov for public viewing. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Comments received may be reviewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.


    Dated: December 28, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-25607 Filed 1-3-08; 8:45 am]
BILLING CODE 4160-01-S