[Federal Register Volume 72, Number 208 (Monday, October 29, 2007)]
[Notices]
[Pages 61171-61172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21268]


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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Draft Guidance for Industry: Blood Establishment Computer System 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.

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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 The draft guidance document provides assistance to 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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