[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63221-63222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0343]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 14 on 
Bacterial Endotoxins Test General Chapter; 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 guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the International Conference on 
Harmonisation Regions; Annex 14: Bacterial Endotoxins Test General 
Chapter.'' The guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The guidance 
provides the results of the ICH Q4B evaluation of the Bacterial 
Endotoxins Test General Chapter harmonized text from each of the three 
pharmacopoeias (United States, European, and Japanese) represented by 
the Pharmacopoeial Discussion Group (PDG). The guidance conveys 
recognition of the three pharmacopoeial methods by the three ICH 
regulatory regions and provides specific information regarding the 
recognition. The guidance is intended to recognize the 
interchangeability between the local regional pharmacopoeias, thus 
avoiding

[[Page 63222]]

redundant testing in favor of a common testing strategy in each 
regulatory region. The guidance is in the form of an annex to the core 
guidance on the Q4B process entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core 
ICH Q4B 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 Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research (CDER), Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or 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-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Robert King, Sr., Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 4166, Silver Spring, MD 20993-0002, 301-
796-1242; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 3342, Silver Spring, MD 20993-0002, 301-796-8377.

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; 
and the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of July 19, 2010 (75 FR 41871), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts 
for Use in the International Conference on Harmonisation Regions; Annex 
14: Bacterial Endotoxins Test General Chapter.'' The notice gave 
interested persons an opportunity to submit comments by September 14, 
2010.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in October 2012.
    The guidance provides the specific evaluation results from the ICH 
Q4B process for the Bacterial Endotoxins Test General Chapter 
harmonized text originating from the three-party PDG. This guidance is 
in the form of an annex to the core ICH Q4B guidance (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073405.pdf ) made available in the Federal Register of 
February 21, 2008 (73 FR 9575). The annex will provide guidance to 
assist industry and regulators in the implementation of the specific 
topic evaluated by the ICH Q4B process.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency'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. 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.

III. Electronic Access

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

    Dated: October 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24784 Filed 10-22-13; 8:45 am]
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