International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7(R2) on Dissolution Test General Chapter; Availability, 37129-37131 [2011-15814]

Download as PDF Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices applicant for extension acted with due diligence during the regulatory review period by December 21, 2011. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 2, 2011. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2011–15905 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0428] Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F– 18) Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 millicuries per milliliter (mCi/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SODIUM FLUORIDE F 18 injection, 10 to 200 mCi/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug Evaluation and Research, Food and srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993–0002, 301– 796–7577. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/ mL, is the subject of NDA 22–494, held by National Cancer Institute, National Institutes of Health, and initially approved on January 26, 2011. SODIUM FLUORIDE F 18 (sodium fluoride F–18) is indicated for diagnostic positron emission tomography imaging of bone to define areas of altered osteogenic activity. The NDA holder has never marketed SODIUM FLUORIDE F 18 (sodium PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 37129 fluoride F–18) injection, 10 to 200 mCi/ mL, and in a letter dated May 2, 2011, the NDA holder requested that FDA move the product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. In previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the Agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. FDA has reviewed its records and, under § 314.161, has determined that SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/ mL, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to SODIUM FLUORIDE F 18 (sodium fluoride F–18) injection, 10 to 200 mCi/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: June 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15815 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0012] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7(R2) on Dissolution Test General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the SUMMARY: E:\FR\FM\24JNN1.SGM 24JNN1 37130 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): Dissolution Test General Chapter’’ (Q4B Annex 7(R2)). 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 Q4B Annex 7(R2) is a revision of the previously published ICH guidance, ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter’’ (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions, updates the considerations for implementation, and updates the references used for the Q4B evaluation. 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). Submit either electronic or written comments on Agency guidances at any time. DATES: Submit written requests for single copies of the 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 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. srobinson on DSK4SPTVN1PROD with NOTICES ADDRESSES: FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 Regarding the Guidance Robert H. 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 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 (EU), 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 (MHLW); 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the Federal Register of April 5, 2010 (75 FR 17148), FDA published a notice announcing the availability of Q4B Annex 7. In September 2010, the April 2010 guidance was revised to add guidance on Health Canada consideration. This second revision, Q4B Annex 7(R2), specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions: The Basket Apparatus (Apparatus 1), the Paddle Apparatus (Apparatus 2), and the Flow-Through Cell. Q4B Annex 7(R2) also updates the considerations for implementation for FDA, EU, and MHLW. In addition, it updates the references used for the Q4B evaluation. Following changes made by the three pharmacopeias and after review of the changes by the ICH Q4B Expert Working Group, the ICH Steering Committee, with the endorsement of the three participating regulatory agencies, approved Q4B Annex 7(R2) in November 2010. The guidance provides specific evaluation outcomes from the ICH Q4B process for the Dissolution Test Chapter harmonization proposal originating from the three-party PDG. The 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). When implemented, the annex will provide guidance for industry and regulators on the use of the specific pharmacopoeial texts evaluated by the ICH Q4B process. FDA is issuing Q4B Annex 7(R2) as Level 2 guidance under FDA’s good guidance practices regulation (21 CFR 10.115). Consistent with FDA’s good guidance practices regulation, the Agency will accept comments on the guidance at any time. 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 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 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 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 20, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–15814 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. srobinson on DSK4SPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committees: Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 20, 2011, from 8 a.m. to 1 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research, Food 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: GIDAC@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 VerDate Mar<15>2010 19:06 Jun 23, 2011 Jkt 223001 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: The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long; from 9 a.m. to 1 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information. FDA generally makes background material available to the public no later than 2 business days before the meeting or follows other procedures to make such material available to the public. There is no background material that is publicly available for this meeting. Procedure: On July 20, 2011, from 8 a.m. to 9 a.m., the meeting is open to the public. 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 6, 2011. Oral presentations from the public will be scheduled between approximately 8 a.m. to 9 a.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 indication of the approximate time requested to make their presentation on or before June 27, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 28, 2011. Closed Committee Deliberations: On July 20, 2011, from 9 a.m. to 1 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational gastroenterology drug. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 37131 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristine T. Khuc at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Dated: June 21, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–15823 Filed 6–23–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0013] Statement of Organizations, Functions, and Delegations of Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER), Office of Compliance. This reorganization includes the organizations and substructure components as listed in this document. This document is announcing availability of the Staff Manual Guide that explains the details of this reorganization. SUMMARY: FOR FURTHER INFORMATION CONTACT: Karen Koenick, Center for Drug Evaluation and Research (HFD–063), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301–796–4422. I. Summary The Statement of Organization, Functions, and Delegations of Authority for CDER (35 FR 3685, February 25, 1970, 60 FR 56605, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37129-37131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15814]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0012]


International Conference on Harmonisation; Guidance on Q4B 
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 
International Conference on Harmonisation Regions; Annex 7(R2) on 
Dissolution Test General Chapter; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 37130]]

availability of a guidance entitled ``Q4B Evaluation and Recommendation 
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): 
Dissolution Test General Chapter'' (Q4B Annex 7(R2)). 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 Q4B Annex 7(R2) is a revision 
of the previously published ICH guidance, ``Q4B Evaluation and 
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; 
Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised 
guidance specifies additional dissolution apparatuses to which 
interchangeability applies in the three ICH regions, updates the 
considerations for implementation, and updates the references used for 
the Q4B evaluation. 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, 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 H. 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 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 (EU), 
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 
(MHLW); 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 the Federal Register of April 5, 2010 (75 FR 17148), FDA 
published a notice announcing the availability of Q4B Annex 7. In 
September 2010, the April 2010 guidance was revised to add guidance on 
Health Canada consideration. This second revision, Q4B Annex 7(R2), 
specifies additional dissolution apparatuses to which 
interchangeability applies in the three ICH regions: The Basket 
Apparatus (Apparatus 1), the Paddle Apparatus (Apparatus 2), and the 
Flow-Through Cell. Q4B Annex 7(R2) also updates the considerations for 
implementation for FDA, EU, and MHLW. In addition, it updates the 
references used for the Q4B evaluation.
    Following changes made by the three pharmacopeias and after review 
of the changes by the ICH Q4B Expert Working Group, the ICH Steering 
Committee, with the endorsement of the three participating regulatory 
agencies, approved Q4B Annex 7(R2) in November 2010.
    The guidance provides specific evaluation outcomes from the ICH Q4B 
process for the Dissolution Test Chapter harmonization proposal 
originating from the three-party PDG. The 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). When implemented, the annex 
will provide guidance for industry and regulators on the use of the 
specific pharmacopoeial texts evaluated by the ICH Q4B process.
    FDA is issuing Q4B Annex 7(R2) as Level 2 guidance under FDA's good 
guidance practices regulation (21 CFR 10.115). Consistent with FDA's 
good guidance practices regulation, the Agency will accept comments on 
the guidance at any time. 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 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

[[Page 37131]]

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 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15814 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P
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