[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69496-69497]
From the Federal Register Online via the Government Publishing 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announced in this notice finalizes the draft guidance of the same title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