Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability, 61171-61172 [E7-21268]

Download as PDF 61171 Federal Register / Vol. 72, No. 208 / Monday, October 29, 2007 / Notices ESTIMATED ANNUALIZED BURDEN Number of respondents Respondents Developmental work—Household screener .............................................................. Developmental work—Household screener & survey ............................................... Main implementation—Household screener .............................................................. Main implementation—Household screener & survey .............................................. Dated: October 17, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer Centers for Disease Control and Prevention. [FR Doc. E7–21208 Filed 10–26–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0393] Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility; Availability AGENCY: Food and Drug Administration, HHS.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. rfrederick on PROD1PC67 with NOTICES VerDate Aug<31>2005 15:25 Oct 26, 2007 14,535 6,151 515,027 59,635 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 The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 https:// www.fda.gov/dockets/ecomments or https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: 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 The draft guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized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 SUMMARY: Jkt 214001 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) 1 1 1 1 3/60 28/60 3/60 26/60 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 https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. E:\FR\FM\29OCN1.SGM 29OCN1 61172 Federal Register / Vol. 72, No. 208 / Monday, October 29, 2007 / Notices 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 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0047] Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications’’ dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ‘‘Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications’’ dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005. DATES: Submit written or electronic comments on agency guidances at any time. 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 https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., Center for rfrederick on PROD1PC67 with NOTICES ADDRESSES: VerDate Aug<31>2005 15:25 Oct 26, 2007 Jkt 214001 FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications,’’ dated November 2007. The guidance is intended to assist manufacturers and sponsors in the development of DNA vaccines to prevent infectious diseases. The document describes the manufacturing information that should be submitted to CBER for a new vaccine product for clinical study under an investigational new drug application (IND). Plasmid DNA products intended for noninfectious therapeutic indications are not addressed in the guidance. This guidance supersedes the guidance document entitled ‘‘Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications’’ dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance dated February 2005. In the Federal Register of February 18, 2005 (70 FR 8378), FDA announced the availability of the draft guidance of the same title dated February 2005. 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 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 collection of information mentioned in the guidance regarding the submission of manufacturer’s information in an IND was approved under OMB control number 0910–0014. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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 https:// www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: October 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21266 Filed 10–26–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [CIS No. 2416–07; DHS Docket No. USCIS– 2007–0052] RIN–1615–ZA54 Termination of the Designation of Burundi for Temporary Protected Status; Automatic Extension of Employment Authorization Documentation for Burundi TPS Beneficiaries U.S. Citizenship and Immigration Services, Department of Homeland Security (DHS). ACTION: Notice. AGENCY: SUMMARY: Following a review of country conditions and consultations with the Secretary of State and other appropriate Government agencies, the Secretary of Homeland Security has determined that the temporary protected status (TPS) designation for Burundi should be terminated. This termination will not take effect until May 2, 2009, to provide for an orderly transition. This Notice informs the public of the termination of the TPS designation for Burundi and sets forth procedures for nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

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


-----------------------------------------------------------------------

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 https://www.fda.gov/dockets/ecomments or https://
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 https://www.fda.gov/cber/guidelines.htm or https://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

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