[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32668-32669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-3528 (Formerly Docket No. 99D-5046)]


Draft Guidance for Industry: Changes to an Approved Application: 
Biological Products: Human Blood and Blood Components Intended for 
Transfusion or for Further Manufacture; 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: 
Changes to an Approved Application: Biological Products: Human Blood 
and Blood Components Intended for Transfusion or for Further 
Manufacture'' dated June 2013. The draft guidance document provides 
manufacturers of licensed Whole Blood and blood components intended for 
transfusion or for further manufacture, including Source Plasma, with 
recommendations intended to assist with determining which reporting 
mechanism is appropriate for submission of changes to an approved 
biologics license application. 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 The draft guidance, when 
finalized, is intended to supersede the document of the same title 
dated July 2001 (July 2001 guidance).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by 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 electronic comments on the draft 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 R. McKnight, 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: Changes to an Approved Application: Biological 
Products: Human Blood and Blood Components Intended for Transfusion or 
for Further Manufacture'' dated June 2013. The document provides 
manufacturers of licensed Whole Blood and blood components intended for 
transfusion or for further manufacture, including Source Plasma, with 
recommendations intended to assist with determining which reporting 
mechanism is appropriate for submission of changes to an approved 
biologics license application in accordance with the requirements under 
Title 21 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 21 CFR 
601.12(e) and labeling changes under 21 CFR 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 biologics license application(s). Section 601.12 (21 
CFR 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 is in 
the July 2001 guidance based on the experience gained over the last 
decade. The draft guidance, when finalized, is intended to supersede 
the document of the same title dated July 2001, published in the 
Federal Register of August 7, 2001 (66 FR 41247).
    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

    The 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 601.12, Form FDA 2567, and Form 
FDA 356h have been approved under OMB control number 0910-0338; the 
collections of information in 21 CFR 607.21, 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 has been approved under OMB control number 
0910-0458.

[[Page 32669]]

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 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12923 Filed 5-30-13; 8:45 am]
BILLING CODE 4160-01-P