International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability, 38187-38188 [2011-16255]

Download as PDF Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices information. No comments were received. 38187 FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Type of respondent Total annual responses Pretests .............................................................................. Screener ............................................................................. Telephone survey .............................................................. Internet panel survey ......................................................... 30 6,700 1,500 1,500 1 1 1 1 30 6,700 1,500 1,500 Total ............................................................................ ........................ ........................ ........................ 1 There [FR Doc. 2011–16251 Filed 6–28–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0436] International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability AGENCY: Food and Drug Administration, HHS. ACTION: 0.25 0.10 0.25 0.25 Total hours (15 min.) (6 min.) (15 min.) (15 min.) 8 670 375 375 .......................... 1,428 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 23, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Q11 Development and Manufacture of Drug Substances.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. 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 SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Average burden per response VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 1, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, 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 John Smith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 2619, Silver Spring, MD 20993–0002, 301– 796–1757; 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, Food and Drug PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3506, Silver Spring, MD 20993–0002, 301–796–4600. 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 E:\FR\FM\29JNN1.SGM 29JNN1 38188 Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES observers from the World Health Organization, Health Canada, and the European Free Trade Area. In May 2011, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q11 Development and Manufacture of Drug Substances’’ should be made available for public comment. The draft guidance is the product of the Q11 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q11 Expert Working Group. The draft guidance describes approaches to developing process and drug substance understanding, and provides guidance on what information should be provided in sections 3.2.S.2.2 through 3.2.S.2.6 of the CTD. The draft guidance provides further clarification on the principles and concepts described in ICH guidances ‘‘Q8 Pharmaceutical Development,’’ ‘‘Q9 Quality Risk Management,’’ and ‘‘Q10 Pharmaceutical Quality Systems’’ as they pertain to the development and manufacture of drug substance. The guidance is applicable to drug substances as defined in the ‘‘Scope’’ sections of ICH guidances ‘‘Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances’’ and ‘‘Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.’’ The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process (CTD sections 3.2.S.2.2. through 3.2.S.2.6) of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. 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. VerDate Mar<15>2010 17:48 Jun 28, 2011 Jkt 223001 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: June 23, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–16255 Filed 6–28–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; 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 (FDA). The meeting will be open to the public. Name of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 27, 2011, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You’’, click on ‘‘Public Meetings at the FDA White Oak Campus’’. Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, e-mail: ACPS–CP@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On July 27, 2011, the committee will discuss current strategies for FDA’s Office of Pharmaceutical Science implementation of quality by design principles within its review offices, incorporating an update on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Activities. The committee will also receive awareness presentations on FDA’s current partnering with the United States Pharmacopeia, principally to discuss the Monograph Modernization Program. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 20, 2011. Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:15 a.m. and 3:30 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38187-38188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16255]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0436]

International Conference on Harmonisation; Draft Guidance on Q11
Development and Manufacture of Drug Substances; 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 ``Q11 Development and
Manufacture of Drug Substances.'' 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 describes approaches to developing
process and drug substance understanding and provides guidance on what
information should be provided in certain sections of the Common
Technical Document (CTD). The draft guidance is intended to harmonize
the scientific and technical principles relating to the description and
justification of the development and manufacturing process of drug
substances (both chemical entities and biotechnological/biological
entities) to enable a consistent approach for providing and evaluating
this information across the three regions.

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 1, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, 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

John Smith, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 2619, Silver
Spring, MD 20993-0002, 301-796-1757; 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, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3506, Silver
Spring, MD 20993-0002, 301-796-4600.

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

[[Page 38188]]

observers from the World Health Organization, Health Canada, and the
European Free Trade Area.
In May 2011, the ICH Steering Committee agreed that a draft
guidance entitled ``Q11 Development and Manufacture of Drug
Substances'' should be made available for public comment. The draft
guidance is the product of the Q11 Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q11 Expert
Working Group.
The draft guidance describes approaches to developing process and
drug substance understanding, and provides guidance on what information
should be provided in sections 3.2.S.2.2 through 3.2.S.2.6 of the CTD.
The draft guidance provides further clarification on the principles and
concepts described in ICH guidances ``Q8 Pharmaceutical Development,''
``Q9 Quality Risk Management,'' and ``Q10 Pharmaceutical Quality
Systems'' as they pertain to the development and manufacture of drug
substance. The guidance is applicable to drug substances as defined in
the ``Scope'' sections of ICH guidances ``Q6A Specifications: Test
Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products: Chemical Substances'' and ``Q6B Specifications: Test
Procedures and Acceptance Criteria for Biotechnological/Biological
Products.'' The draft guidance is intended to harmonize the scientific
and technical principles relating to the description and justification
of the development and manufacturing process (CTD sections 3.2.S.2.2.
through 3.2.S.2.6) of drug substances (both chemical entities and
biotechnological/biological entities) to enable a consistent approach
for providing and evaluating this information across the three regions.
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/Guidances/default.htm.

Dated: June 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16255 Filed 6-28-11; 8:45 am]
BILLING CODE 4160-01-P

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