Document ID: FDA-1999-D-3528-0006
Agency: fda
Document Type: Notice
Title: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further
Manufacture; Guidance for Industry; Availability
Posted Date: 2014-11-21T05:00Z

[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69496-69497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27521]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 1999-D-3528 (Formerly Docket No. 1999D-5046)]

Changes to an Approved Application: Biological Products: Human 
Blood and Blood Components Intended for Transfusion or for Further 
Manufacture; Guidance for Industry; 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 ``Changes to an Approved 
Application: Biological Products: Human Blood and Blood Components 
Intended for Transfusion or for Further Manufacture; Guidance for 
Industry'' dated December 2014. The guidance document provides 
manufacturers of licensed whole blood and blood components intended for 
transfusion or for further manufacture, including source plasma, with 
recommendations concerning submission of changes to an approved 
biologics license application (BLA). The guidance document also 
provides manufacturers of licensed whole blood and blood components 
recommendations in connection with the applicability and content of 
comparability protocols and labeling changes. The guidance applies to 
the manufacture and distribution of licensed products. The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated June 2013 and supersedes the document of the same title dated 
July 2001 (July 2001 guidance).

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, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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 240-402-7800. 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-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Changes 
to an Approved Application: Biological Products: Human Blood and Blood 
Components Intended for Transfusion or for Further Manufacture; 
Guidance for Industry'' dated December 2014. The guidance document 
provides manufacturers of licensed whole blood and blood components 
intended for transfusion or for further manufacture, including source 
plasma, with recommendations concerning submission of changes to an 
approved BLA in accordance with the requirements under Title 21 of the 
Code of Federal Regulations 601.12 (21 CFR 601.12). The guidance 
document also provides manufacturers of licensed whole blood and blood 
components with recommendations in connection with the applicability 
and content of comparability protocols under Sec.  601.12(e) and 
labeling changes under Sec.  601.12(f). Frequently, a manufacturer of a 
licensed product determines that it is appropriate to make a change in 
its product, production process, quality controls, equipment, 
facilities, responsible personnel, or labeling as documented in its 
approved BLA(s). Section 601.12 states the requirements to report such 
changes for licensed biological products to FDA.
    The recommendations contained in the guidance document reflect 
current FDA and industry experience with reporting changes to an 
approved application, including reporting the implementation of new 
technologies. The recommendations have been revised for reporting 
categories for certain changes to an approved application that were in 
the July 2001 guidance based on the experience gained over the last 
decade.
    In the Federal Register of May 31, 2013 (78 FR 32668), FDA 
announced the availability of the draft guidance of the same title 
dated June 2013. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. In 
response to comments, the guidance includes the addition of numerous 
appendices with tables to highlight the appropriate reporting 
categories related to certain manufacturing changes. The guidance 
announced in this notice finalizes the draft guidance dated June 2013.
    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

    The 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

[[Page 69497]]

Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in 21 CFR 601.12 and Form FDA 356h have been approved under 
OMB control number 0910-0338; the collections of information in 21 CFR 
607.26 and Form FDA 2830 have been approved under OMB control number 
0910-0052; the collections of information in 21 CFR 606.121, 606.170, 
and 610.40 have been approved under OMB control number 0910-0116; and 
the collections of information in 21 CFR 600.14 have been approved 
under OMB control number 0910-0458.

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: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27521 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P