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, 63221-63222 [2013-24784]

Download as PDF Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices will be posted to the docket at https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary Medicine (HFV–241), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9048. margarita.brown@fda.hhs.gov. SUPPLEMENTARY INFORMATION: IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: October 8, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–24787 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0241] Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #188 entitled ‘‘Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.’’ The purpose of this guidance is to assist sponsors or nonapplicants with filling out Form FDA 1932, ‘‘Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,’’ in both paper and electronic format, as required by FDA regulations. SUMMARY: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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. emcdonald on DSK67QTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 I. Background In the Federal Register of May 25, 2010 (75 FR 29352), FDA published the notice of availability for a draft guidance #188 entitled ‘‘Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine,’’ giving interested persons until August 9, 2010, to comment on the draft guidance. FDA made changes to the draft document in response to these comments, to clarify the information that we expect to receive, to reflect ongoing International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) activities in which FDA is participating, and to provide direction for voluntary use of CVM internal terms for medication errors. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated May 24, 2010. II. Significance of Guidance This level 1 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 the 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. III. Paperwork Reduction Act of 1995 This 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 section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)) have been approved under 0910–0645. IV. Comments Interested persons may submit either electronic comments regarding this document to https://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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 63221 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 https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: October 18, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–24803 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P 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. 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 SUMMARY: E:\FR\FM\23OCN1.SGM 23OCN1 63222 Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 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 https://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 VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 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 (https:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 https://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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: October 2, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–24784 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration E:\FR\FM\23OCN1.SGM 23OCN1

Agencies

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

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 (https://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 https://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 https://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://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]
BILLING CODE 4160-01-P

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