[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31944-31945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0347]
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 13 on Bulk
Density and Tapped Density of Powders General Chapter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 13: Bulk Density and Tapped Density of
Powders 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 Bulk
Density and Tapped Density of Powders 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 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. 4150, Silver
Spring, MD 20993-0002, 301-796-1242; or Stephen Ripley, Center for
Biologics
[[Page 31945]]
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, International Programs, 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 14, 2010 (75 FR 40843), 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
13: Bulk Density and Tapped Density of Powders General Chapter.'' The
notice gave interested persons an opportunity to submit comments by
September 13, 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 June 2012.
The guidance provides the specific evaluation results from the ICH
Q4B process for the Bulk Density and Tapped Density of Powders 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: May 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12538 Filed 5-24-13; 8:45 am]
BILLING CODE 4160-01-P