International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins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, 41871-41872 [2010-17485]

Download as PDF Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices proposed project or to obtain a copy of the data collection reports and instrument, contact Kathy Kranzfelder, Director, NIDDK Office of Communications and Public Liaison, Building 31, Room 9A06, MSC2560, Bethesda, MD 20852 or e-mail your request, including your address to: KranzfelderK@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: July 6, 2010. Lynell Nelson, NIDDK, Project Clearance Liaison, National Institutes of Health. [FR Doc. 2010–17581 Filed 7–16–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0343] International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins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. jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 14: Bacterial Endotoxins Test General Chapter.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United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 The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding VerDate Mar<15>2010 16:24 Jul 16, 2010 Jkt 220001 redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the 14th annex to the core guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmaceutical Texts for Use in the ICH Regions’’ (the core ICH Q4B 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 September 14, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, 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 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 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 H. King, Sr., Center for Drug Evaluation and Research (HFD– 003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993–0002, 301–796–1242; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301– 827–0373. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4480. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 41871 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; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, 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 June 2010, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 14: Bacterial Endotoxins Test General Chapter’’ should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group. The draft guidance provides the specific evaluation results from the ICH Q4B process for the Bacterial Endotoxins Test General Chapter harmonization proposal originating from the three-party PDG. This draft E:\FR\FM\19JYN1.SGM 19JYN1 41872 Federal Register / Vol. 75, No. 137 / Monday, July 19, 2010 / Notices guidance is in the form of an annex to the core ICH Q4B guidance made available in the Federal Register of February 21, 2008 (73 FR 9575). Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https://www.fda. gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm. Dated: July 9, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–17485 Filed 7–16–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES jlentini on DSKJ8SOYB1PROD with NOTICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Child Health and Human Development Special Emphasis Panel, July 16, 2010, VerDate Mar<15>2010 16:24 Jul 16, 2010 Jkt 220001 10 a.m. to July 16, 2010, 12 p.m., National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on June 28, 2010, 75 FR 36662. The date of the meeting has been changed from July 16, 2010 to August 9, 2010. The meeting is closed to the public. Dated: July 12, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–17567 Filed 7–16–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus With Onset in Childhood and Adolescence, RFA DP 10–001, Initial Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 1 p.m.–2:30 p.m., August 3, 2010 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of ‘‘Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus with Onset in Childhood and Adolescence, RFA DP 10–001.’’ Contact Person for More Information: Donald Blackman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, Office of the Director, Extramural Research Program Office, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone: (770) 488–3023, E-mail: DBY7@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Dated: July 13, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–17562 Filed 7–16–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting SUMMARY: In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), as amended, the Department of Health and Human Services is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) will hold a special meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public. Date and Time: The ACCV will meet on Thursday, July 29 from 1 p.m. to 2 p.m. (ET). The public can join the meeting via audio conference call by dialing 1–888–606–5950 on July 29 at 1 pm and providing the following information: Leader’s Name: Dr. Geoffrey Evans. Password: ACCV. Agenda: This is a special meeting of the ACCV. Discussions will surround the draft interim influenza vaccine information materials developed by the Centers for Disease Control and Prevention (CDC) for distribution during the 2010–2011 season by health care providers in the United States to all seasonal influenza vaccine recipients (or to parents or legal representatives in certain cases). For this special meeting, members of the public are invited to attend by teleconference via a toll-free call-in phone number. SUPPLEMENTARY INFORMATION: Section 2126 of the Public Health Service Act, as amended, codified at 42 U.S.C. 300aa–26, requires the Secretary of Health and Human Services to develop and disseminate vaccine information materials for distribution by all health care providers in the United States to any person (or to parents or legal representatives in certain cases) receiving vaccines covered under the VICP. Development and revision of vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the CDC. Section 2126 requires that the E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41871-41872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17485]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


International Conference on Harmonisation; Draft 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 draft guidance entitled ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 14: Bacterial Endotoxins Test General Chapter.'' The draft 
guidance was prepared under the auspices of the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The draft 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 draft guidance conveys 
recognition of the three pharmacopoeial methods by the three ICH 
regulatory regions and provides specific information regarding the 
recognition. The draft 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. This draft guidance is the 14th annex to the 
core guidance on the Q4B process entitled ``Q4B Evaluation and 
Recommendation of Pharmaceutical Texts for Use in the ICH Regions'' 
(the core ICH Q4B 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 September 14, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, 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 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 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 H. King, Sr., Center for Drug 
Evaluation and Research (HFD-003), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 4150, Silver Spring, MD 20993-0002, 
301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation 
and Research (HFM-25), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0373.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

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; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, 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 June 2010, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial 
Texts for Use in the ICH Regions; Annex 14: Bacterial Endotoxins Test 
General Chapter'' should be made available for public comment. The 
draft guidance is the product of the Q4B Expert Working Group of the 
ICH. Comments about this draft will be considered by FDA and the Q4B 
Expert Working Group.
    The draft guidance provides the specific evaluation results from 
the ICH Q4B process for the Bacterial Endotoxins Test General Chapter 
harmonization proposal originating from the three-party PDG. This draft

[[Page 41872]]

guidance is in the form of an annex to the core ICH Q4B guidance made 
available in the Federal Register of February 21, 2008 (73 FR 9575). 
Once finalized, the annex will provide guidance to assist industry and 
regulators in the implementation of the specific topic evaluated by the 
ICH Q4B process.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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/default.htm.

    Dated: July 9, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-17485 Filed 7-16-10; 8:45 am]
BILLING CODE 4160-01-S
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