[Federal Register: January 4, 2008 (Volume 73, Number 3)]
[Notices]
[Page 869-870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja08-33]
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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