[Federal Register: October 29, 2007 (Volume 72, Number 208)]
[Notices]
[Page 61171-61172]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc07-68]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0393]
Draft Guidance for Industry: Blood Establishment Computer System
Validation in the User's Facility; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Blood Establishment Computer System Validation in the User's Facility''
dated October 2007. The draft guidance document provides assistance to
blood establishments in developing a blood establishment computer
system validation program, consistent with recognized principles of
software validation, quality assurance, and current good software
engineering practices. In the Federal Register of March 9, 2005 (70 FR
11679), FDA withdrew the guidance document entitled ``Draft Guideline
for the Validation of Blood Establishment Computer Systems,'' issued on
September 28, 1993, and is issuing this guidance to reflect our current
considerations on this topic.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by January 28, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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: Brenda R. Friend, 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 draft document entitled
``Guidance for Industry: Guidance for Industry: Blood Establishment
Computer System Validation in the User's Facility'' dated October 2007.
This draft guidance provides blood establishments with assistance in
developing a blood establishment computer system validation program,
consistent with recognized principles of software validation, quality
assurance, and current good software engineering practices. This draft
guidance addresses blood establishment computer system validation
rather than blood establishment computer software (BECS) validation. In
the Federal Register of March 9, 2005, FDA withdrew the guidance
document entitled ``Draft Guideline for the Validation of Blood
Establishment Computer Systems,'' issued on September 28, 1993, and is
issuing this guidance to reflect our current considerations on this
topic.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in 21 CFR 606.100(b) and 606.160 have been
approved under OMB control number 0910-0116; those in 21 CFR 211.68
have been approved under OMB control number 0910-0139.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft 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 draft 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 draft guidance
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default
.htm.
[[Page 61172]]
Dated: October 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21268 Filed 10-26-07; 8:45 am]
BILLING CODE 4160-01-S