[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18353-18354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0069; (Formerly FDA-2007D-0393)]


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 document entitled ``Guidance for Industry: Blood 
Establishment Computer System Validation in the User's Facility'' dated 
April 2013. The 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. The guidance announced in this document finalizes the draft 
guidance of the same title dated October 2007.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-

[[Page 18354]]

305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Reisman, 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: Blood Establishment Computer System Validation 
in the User's Facility '' dated April 2013. The 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. The guidance document 
describes the requirements in Title 21 Code of Federal Regulations that 
apply to blood establishment validation of systems, and FDA's 
recommendations for the validation of systems. While the guidance may 
provide manufacturers of blood establishment computer software (BECS) 
with information about validation of computer systems in the user's 
facility, the guidance does not address the software manufacturer's 
validation responsibilities or the submission of a 510(k) premarket 
notification for BECS.
    In the Federal Register of October 29, 2007 (72 FR 61171), FDA 
announced the availability of the draft guidance of the same title 
dated October 2007. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated October 
2007.
    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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This 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. The collections of 
information in 21 CFR 211.68 and 211.100 have been approved under OMB 
control number 0910-0139.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06865 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P