[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Page 67736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23281]
[[Page 67736]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0019]
Guidance for Industry and Food and Drug Administration Staff:
Class II Special Controls Guidance Document: Automated Blood Cell
Separator Device Operating by Centrifugal or Filtration Separation
Principle; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry and FDA
Staff: Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation
Principle'' dated November 2007. The guidance document serves as the
special control for the automated blood cell separator device operating
on a centrifugal or filtration separation principle intended for the
routine collection of blood and blood components, and describes a means
by which the device may comply with the requirement of special controls
for class II devices. Elsewhere in this issue of the Federal Register,
FDA is publishing a final rule to reclassify the automated blood cell
separator device operating by centrifugal separation principle into
class II (special controls).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist the office
in processing your requests. The guidance may also be obtained by mail
by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to either
http://www.fda.gov/dockets/ecomments or http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry and FDA Staff: Class II Special Controls
Guidance Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle'' dated November 2007.
This special controls guidance identifies the relevant classification
regulation that provides a description of the applicable automated
blood cell separator device. In addition, other sections of this
special control guidance list the risks to health identified by FDA and
describe measures that, if followed by manufacturers and combined with
general controls, will ordinarily address the risks associated with
these automated blood cell separators.
In the Federal Register of March 10, 2005 (70 FR 11990), FDA
announced the availability of the draft guidance of the same title. FDA
received one comment on the proposed rule and draft guidance and that
comment was considered as the rule and guidance were finalized. The
guidance announced in this notice finalizes the draft guidance dated
January 2005.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0594.
III. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. 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 the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23281 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-01-S