Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 37129
applicant for extension acted with due Drug Administration, 10903 New fluoride F–18) injection, 10 to 200 mCi/
diligence during the regulatory review Hampshire Ave., Bldg. 51, rm. 6238, mL, and in a letter dated May 2, 2011,
period by December 21, 2011. To meet Silver Spring, MD 20993–0002, 301– the NDA holder requested that FDA
its burden, the petition must contain 796–7577. move the product to the ‘‘Discontinued
sufficient facts to merit an FDA SUPPLEMENTARY INFORMATION: In 1984, Drug Product List’’ section of the Orange
investigation. (See H. Rept. 857, part 1, Congress enacted the Drug Price Book. In previous instances (see, e.g., 72
98th Cong., 2d sess., pp. 41–42, 1984.) Competition and Patent Term FR 9763, March 5, 2007; 61 FR 25497,
Petitions should be in the format Restoration Act of 1984 (Pub. L. 98–417) May 21, 1996), the Agency has
specified in 21 CFR 10.30. (the 1984 amendments), which determined that, for purposes of
Interested persons may submit to the authorized the approval of duplicate §§ 314.161 and 314.162, never
Division of Dockets Management (see versions of drug products under an marketing an approved drug product is
ADDRESSES) electronic or written ANDA procedure. ANDA applicants equivalent to withdrawing the drug
comments and written petitions. It is must, with certain exceptions, show that from sale.
only necessary to send one set of the drug for which they are seeking FDA has reviewed its records and,
comments. It is no longer necessary to approval contains the same active under § 314.161, has determined that
send three copies of mailed comments. ingredient in the same strength and SODIUM FLUORIDE F 18 (sodium
However, if you submit a written dosage form as the ‘‘listed drug,’’ which fluoride F–18) injection, 10 to 200 mCi/
petition, you must submit three copies is a version of the drug that was mL, was not withdrawn from sale for
of the petition. Identify comments with previously approved. ANDA applicants reasons of safety or effectiveness.
the docket number found in brackets in do not have to repeat the extensive Accordingly, the Agency will continue
the heading of this document. clinical testing otherwise necessary to to list SODIUM FLUORIDE F 18
Comments and petitions that have not gain approval of a new drug application (sodium fluoride F–18) injection, 10 to
been made publicly available on (NDA). The only clinical data required 200 mCi/mL, in the ‘‘Discontinued Drug
http://www.regulations.gov may be in an ANDA are data to show that the Product List’’ section of the Orange
viewed in the Division of Dockets drug that is the subject of the ANDA is Book. The ‘‘Discontinued Drug Product
Management between 9 a.m. and 4 p.m., bioequivalent to the listed drug. List’’ delineates, among other items,
Monday through Friday. The 1984 amendments include what drug products that have been
is now section 505(j)(7) of the Federal discontinued from marketing for reasons
Dated: June 2, 2011.
Food, Drug, and Cosmetic Act (21 U.S.C. other than safety or effectiveness.
Jane A. Axelrad, 355(j)(7)), which requires FDA to ANDAs that refer to SODIUM
Associate Director for Policy, Center for Drug publish a list of all approved drugs.
Evaluation and Research.
FLUORIDE F 18 (sodium fluoride F–18)
FDA publishes this list as part of the injection, 10 to 200 mCi/mL, may be
[FR Doc. 2011–15905 Filed 6–23–11; 8:45 am] ‘‘Approved Drug Products With approved by the Agency as long as they
BILLING CODE 4160–01–P Therapeutic Equivalence Evaluations,’’ meet all other legal and regulatory
which is known generally as the requirements for the approval of
‘‘Orange Book.’’ Under FDA regulations, ANDAs. If FDA determines that labeling
DEPARTMENT OF HEALTH AND drugs are removed from the list if the
HUMAN SERVICES for this drug product should be revised
Agency withdraws or suspends to meet current standards, the Agency
approval of the drug’s NDA or ANDA will advise ANDA applicants to submit
Food and Drug Administration for reasons of safety or effectiveness or such labeling.
[Docket No. FDA–2011–N–0428] if FDA determines that the listed drug
was withdrawn from sale for reasons of Dated: June 20, 2011.
Determination That SODIUM safety or effectiveness (§ 314.162 (21 Leslie Kux,
FLUORIDE F 18 (Sodium Fluoride F– CFR 314.162)). Acting Assistant Commissioner for Policy.
18) Injection, 10 to 200 Millicuries per A person may petition the Agency to [FR Doc. 2011–15815 Filed 6–23–11; 8:45 am]
Milliliter, Was Not Withdrawn From determine, or the Agency may BILLING CODE 4160–01–P
Sale for Reasons of Safety or determine on its own initiative, whether
Effectiveness a listed drug was withdrawn from sale
for reasons of safety or effectiveness. DEPARTMENT OF HEALTH AND
AGENCY: Food and Drug Administration, This determination may be made at any HUMAN SERVICES
HHS. time after the drug has been withdrawn
ACTION: Notice. from sale but must be made prior to Food and Drug Administration
approving an ANDA that refers to the [Docket No. FDA–2009–D–0012]
SUMMARY: The Food and Drug
listed drug (21 CFR 314.161). FDA may
Administration (FDA) has determined not approve an ANDA that does not
that SODIUM FLUORIDE F 18 (sodium International Conference on
refer to a listed drug. Harmonisation; Guidance on Q4B
fluoride F–18) injection, 10 to 200 SODIUM FLUORIDE F 18 (sodium
millicuries per milliliter (mCi/mL), was Evaluation and Recommendation of
fluoride F–18) injection, 10 to 200 mCi/ Pharmacopoeial Texts for Use in the
not withdrawn from sale for reasons of mL, is the subject of NDA 22–494, held
safety or effectiveness. This International Conference on
by National Cancer Institute, National Harmonisation Regions; Annex 7(R2)
determination will allow FDA to Institutes of Health, and initially
approve abbreviated new drug on Dissolution Test General Chapter;
srobinson on DSK4SPTVN1PROD with NOTICES
approved on January 26, 2011. SODIUM Availability
applications (ANDAs) for SODIUM FLUORIDE F 18 (sodium fluoride F–18)
FLUORIDE F 18 injection, 10 to 200 is indicated for diagnostic positron AGENCY: Food and Drug Administration,
mCi/mL, if all other legal and regulatory emission tomography imaging of bone to HHS.
requirements are met. define areas of altered osteogenic ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: activity.
Reena Raman, Center for Drug The NDA holder has never marketed SUMMARY: The Food and Drug
Evaluation and Research, Food and SODIUM FLUORIDE F 18 (sodium Administration (FDA) is announcing the
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37130 Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
availability of a guidance entitled ‘‘Q4B Regarding the Guidance observers from the World Health
Evaluation and Recommendation of Robert H. King, Sr., Center for Drug Organization, Health Canada, and the
Pharmacopoeial Texts for Use in the Evaluation and Research, Food and European Free Trade Area.
ICH Regions; Annex 7(R2): Dissolution Drug Administration, 10903 New In the Federal Register of April 5,
Test General Chapter’’ (Q4B Annex Hampshire Ave., Bldg. 51, rm. 4150, 2010 (75 FR 17148), FDA published a
7(R2)). The guidance was prepared notice announcing the availability of
Silver Spring, MD 20993–0002, 301–
under the auspices of the International Q4B Annex 7. In September 2010, the
796–1242, or Christopher Joneckis,
Conference on Harmonisation of April 2010 guidance was revised to add
Center for Biologics Evaluation and
Technical Requirements for Registration guidance on Health Canada
Research (HFM–25), Food and Drug
of Pharmaceuticals for Human Use consideration. This second revision,
Administration, 1401 Rockville Pike,
(ICH). The Q4B Annex 7(R2) is a Q4B Annex 7(R2), specifies additional
suite 200N, Rockville, MD 20852–1448,
revision of the previously published dissolution apparatuses to which
ICH guidance, ‘‘Q4B Evaluation and interchangeability applies in the three
Recommendation of Pharmacopoeial Regarding the ICH ICH regions: The Basket Apparatus
Texts for Use in the ICH Regions; Annex Michelle Limoli, Office of (Apparatus 1), the Paddle Apparatus
7: Dissolution Test General Chapter’’ International Programs (HFG–1), Food (Apparatus 2), and the Flow-Through
(Q4B Annex 7). The revised guidance and Drug Administration, 5600 Fishers Cell. Q4B Annex 7(R2) also updates the
specifies additional dissolution Lane, Rockville, MD 20857, 301–827– considerations for implementation for
apparatuses to which interchangeability 4480. FDA, EU, and MHLW. In addition, it
applies in the three ICH regions, updates the references used for the Q4B
SUPPLEMENTARY INFORMATION: evaluation.
updates the considerations for
implementation, and updates the I. Background Following changes made by the three
references used for the Q4B evaluation. pharmacopeias and after review of the
In recent years, many important changes by the ICH Q4B Expert Working
The guidance is intended to recognize initiatives have been undertaken by
the interchangeability between the local Group, the ICH Steering Committee,
regulatory authorities and industry with the endorsement of the three
regional pharmacopoeias, thus avoiding associations to promote international
redundant testing in favor of a common participating regulatory agencies,
harmonization of regulatory approved Q4B Annex 7(R2) in
testing strategy in each regulatory requirements. FDA has participated in
region. The guidance is in the form of November 2010.
many meetings designed to enhance The guidance provides specific
an annex to the core guidance on the harmonization and is committed to evaluation outcomes from the ICH Q4B
Q4B process entitled ‘‘Q4B Evaluation seeking scientifically based harmonized process for the Dissolution Test Chapter
and Recommendation of technical procedures for pharmaceutical harmonization proposal originating
Pharmacopoeial Texts for Use in the development. One of the goals of from the three-party PDG. The guidance
ICH Regions’’ (core ICH Q4B guidance). harmonization is to identify and then is in the form of an annex to the core
DATES: Submit either electronic or reduce differences in technical ICH Q4B guidance made available in the
written comments on Agency guidances requirements for drug development Federal Register of February 21, 2008
at any time. among regulatory agencies. (73 FR 9575). When implemented, the
ADDRESSES: Submit written requests for ICH was organized to provide an annex will provide guidance for
single copies of the guidance to the opportunity for tripartite harmonization industry and regulators on the use of the
Division of Drug Information (HFD– initiatives to be developed with input specific pharmacopoeial texts evaluated
240), Center for Drug Evaluation and from both regulatory and industry by the ICH Q4B process.
Research, Food and Drug representatives. FDA also seeks input FDA is issuing Q4B Annex 7(R2) as
Administration, 10903 New Hampshire from consumer representatives and Level 2 guidance under FDA’s good
Ave., Bldg. 51, rm. 2201, Silver Spring, others. ICH is concerned with guidance practices regulation (21 CFR
MD 20993–0002, or the Office of harmonization of technical 10.115). Consistent with FDA’s good
Communication, Outreach and requirements for the registration of guidance practices regulation, the
Development (HFM–40), Center for pharmaceutical products among three Agency will accept comments on the
Biologics Evaluation and Research regions: The European Union (EU), guidance at any time. The guidance
(CBER), Food and Drug Administration, Japan, and the United States. The six represents the Agency’s current thinking
1401 Rockville Pike, suite 200N, ICH sponsors are the European on this topic. It does not create or confer
Rockville, MD 20852–1448. Send one Commission; the European Federation any rights for or on any person and does
self-addressed adhesive label to assist of Pharmaceutical Industries not operate to bind FDA or the public.
the office in processing your requests. Associations; the Japanese Ministry of An alternative approach may be used if
The guidance may also be obtained by Health, Labour and Welfare (MHLW); such approach satisfies the
mail by calling CBER at 1–800–835– the Japanese Pharmaceutical requirements of the applicable statutes
4709 or 301–827–1800. See the Manufacturers Association; the Centers and regulations.
SUPPLEMENTARY INFORMATION section for
for Drug Evaluation and Research and
Biologics Evaluation and Research, II. Comments
electronic access to the guidance
FDA; and the Pharmaceutical Research Interested persons may submit to the
and Manufacturers of America. The ICH Division of Dockets Management (see
Submit electronic comments on the Secretariat, which coordinates the ADDRESSES) either electronic or written
srobinson on DSK4SPTVN1PROD with NOTICES
guidance to http://www.regulations.gov. preparation of documentation, is comments regarding this document. It is
Submit written comments to the provided by the International only necessary to send one set of
Division of Dockets Management (HFA– Federation of Pharmaceutical comments. It is no longer necessary to
305), Food and Drug Administration, Manufacturers Associations (IFPMA). send two copies of mailed comments.
5630 Fishers Lane, rm. 1061, Rockville, The ICH Steering Committee includes Identify comments with the docket
MD 20852. representatives from each of the ICH number found in brackets in the
FOR FURTHER INFORMATION CONTACT: sponsors and the IFPMA, as well as heading of this document. Received
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Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices 37131
comments may be seen in the Division area. Please call the Information Line for Persons attending FDA’s advisory
of Dockets Management between 9 a.m. up-to-date information on this meeting. committee meetings are advised that the
and 4 p.m., Monday through Friday. A notice in the Federal Register about agency is not responsible for providing
last minute modifications that impact a access to electrical outlets.
III. Electronic Access
previously announced advisory FDA welcomes the attendance of the
Persons with access to the Internet committee meeting cannot always be public at its advisory committee
may obtain the document at http:// published quickly enough to provide meetings and will make every effort to
www.regulations.gov, http:// timely notice. Therefore, you should accommodate persons with physical
www.fda.gov/Drugs/Guidance always check the Agency’s Web site and disabilities or special needs. If you
ComplianceRegulatoryInformation/ call the appropriate advisory committee require special accommodations due to
Guidances/default.htm, or http:// hot line/phone line to learn about a disability, please contact Kristine T.
www.fda.gov/BiologicsBloodVaccines/ possible modifications before coming to Khuc at least 7 days in advance of the
GuidanceComplianceRegulatory the meeting. meeting.
Information/Guidances/default.htm. Agenda: The meeting will be open to FDA is committed to the orderly
Dated: June 20, 2011. the public from 8 a.m. to 9 a.m., unless conduct of its advisory committee
Leslie Kux, public participation does not last that meetings. Please visit our Web site at
Acting Assistant Commissioner for Policy. long; from 9 a.m. to 1 p.m., the meeting http://www.fda.gov/
[FR Doc. 2011–15814 Filed 6–23–11; 8:45 am] will be closed to permit discussion and AdvisoryCommittees/
review of trade secret and/or AboutAdvisoryCommittees/
BILLING CODE 4160–01–P
confidential commercial information. ucm111462.htm for procedures on
FDA generally makes background public conduct during advisory
DEPARTMENT OF HEALTH AND material available to the public no later committee meetings.
HUMAN SERVICES than 2 business days before the meeting Dated: June 21, 2011.
or follows other procedures to make Jill Hartzler Warner,
Food and Drug Administration such material available to the public. Acting Associate Commissioner for Special
[Docket No. FDA–2011–N–0002]
There is no background material that is Medical Programs.
publicly available for this meeting. [FR Doc. 2011–15823 Filed 6–23–11; 8:45 am]
Joint Meeting of the Gastrointestinal Procedure: On July 20, 2011, from BILLING CODE 4160–01–P
Drugs Advisory Committee and the 8 a.m. to 9 a.m., the meeting is open to
Drug Safety and Risk Management the public. Interested persons may
Advisory Committee; Notice of Meeting present data, information, or views, DEPARTMENT OF HEALTH AND
orally or in writing, on issues pending HUMAN SERVICES
AGENCY: Food and Drug Administration, before the committee. Written
HHS. submissions may be made to the contact Food and Drug Administration
ACTION: Notice. person on or before July 6, 2011. Oral
[Docket No. FDA–2011–N–0013]
presentations from the public will be
This notice announces a forthcoming
scheduled between approximately Statement of Organizations, Functions,
meeting of a public advisory committee
8 a.m. to 9 a.m. Those individuals and Delegations of Authority
of the Food and Drug Administration
interested in making formal oral
(FDA). At least one portion of the AGENCY: Food and Drug Administration,
presentations should notify the contact
meeting will be closed to the public. HHS.
Name of Committees: Gastrointestinal person and submit a brief statement of
Drugs Advisory Committee and the Drug the general nature of the evidence or ACTION: Notice.
Safety and Risk Management Advisory arguments they wish to present, the
names and addresses of proposed SUMMARY: The Food and Drug
Committee. Administration (FDA) is announcing
General Function of the Committees: participants, and an indication of the
approximate time requested to make that it has reorganized the Center for
To provide advice and
their presentation on or before June 27, Drug Evaluation and Research (CDER),
recommendations to the Agency on
2011. Time allotted for each Office of Compliance. This
FDA’s regulatory issues.
Date and Time: The meeting will be presentation may be limited. If the reorganization includes the
held on July 20, 2011, from 8 a.m. to number of registrants requesting to organizations and substructure
1 p.m. speak is greater than can be reasonably components as listed in this document.
Location: Hilton Washington DC/ accommodated during the scheduled This document is announcing
Silver Spring, The Ballrooms, 8727 open public hearing session, FDA may availability of the Staff Manual Guide
Colesville Rd., Silver Spring, MD. The conduct a lottery to determine the that explains the details of this
hotel telephone number is 301–589– speakers for the scheduled open public reorganization.
5200. hearing session. The contact person will FOR FURTHER INFORMATION CONTACT:
Contact Person: Kristine T. Khuc, notify interested persons regarding their Karen Koenick, Center for Drug
Center for Drug Evaluation and request to speak by June 28, 2011. Evaluation and Research (HFD–063),
Research, Food and Drug Closed Committee Deliberations: On Food and Drug Administration, 11919
Administration, 10903 New Hampshire July 20, 2011, from 9 a.m. to 1 p.m., the Rockville Pike, Rockville, MD 20852,
Ave., Bldg. 31, rm. 2417, Silver Spring, meeting will be closed to permit
srobinson on DSK4SPTVN1PROD with NOTICES
MD 20993–0002, 301–796–9001, Fax: discussion and review of trade secret
301–847–8533, e-mail: and/or confidential commercial I. Summary
GIDAC@fda.hhs.gov, or FDA Advisory information (5 U.S.C. 552b(c)(4)). The Statement of Organization,
Committee Information Line, 1–800– During this session, the committees will Functions, and Delegations of Authority
741–8138 (301–443–0572 in the discuss the drug development program for CDER (35 FR 3685, February 25,
Washington, DC area), and follow the of an investigational gastroenterology 1970, 60 FR 56605, November 9, 1995,
prompts to the desired center or product drug. 64 FR 36361, July 6, 1999, 72 FR 50112,
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