Notices. Notice

4,439 words·~20 min read·/register/2007/06/07/07-2851

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007E-0010] Determination of Regulatory Review Period for Purposes of Patent Extension; CHANTIX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for CHANTIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product CHANTIX (varenicline tartrate). CHANTIX is indicated as an aid to smoking cessation treatment. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CHANTIX (U.S. Patent No. 6,410,550) from Pfizer, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 26, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CHANTIX represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for CHANTIX is 2,401 days. Of this time, 2,219 days occurred during the testing phase of the regulatory review period, while 182 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : October 15, 1999. The applicant claims September 15, 1999, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was October 15, 1999, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : November 10, 2005. FDA has verified the applicant's claim that the new drug application

(NDA)for CHANTIX (NDA 21-928) was initially submitted on November 10, 2005. 3. *The date the application was approved* : May 10, 2006. FDA has verified the applicant's claim that NDA 21-928 was approved on May 10, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 545 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by August 6, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 4, 2007. 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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 2, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-10915 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998D-1232] (formerly 98D-1232) Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance for industry and FDA staff entitled “Assayed and Unassayed Quality Control Material.” The guidance describes FDA's current practices concerning assayed an unassayed quality control material, including information to include in a 510(k) for assayed quality control material, as well as labeling recommendations. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Assayed and Unassayed Quality Control Material” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0396. SUPPLEMENTARY INFORMATION: I. Background This guidance document provides recommendations to manufacturers regarding preparation of premarket notifications and labeling for quality control

(QC)material. These materials are intended to monitor reliability of a test system and help minimize reporting of incorrect test results. They are often the best source of ongoing feedback that a laboratory has to monitor whether results reported to physicians are sufficiently reliable. QC materials may be marketed together with a specific test system, or alternatively, for more general use. Both assayed and unassayed QC materials are discussed in the guidance document. Both types of QC materials are subject to FDA's Quality System Regulation (part 820 (21 CFR part 820)) and labeling regulation (§ 809.10 (21 CFR 809.10)). However, most types of unassayed QC materials are exempt from premarket notification. (See “Classification and Identification of QC Material” of the guidance document for exceptions.) Although premarket notifications are number required for unassayed QC materials, some aspects of this guidance document concerning labeling, stability, and matrix effects are still relevant for these materials. The draft version of this guidance was issued February 3, 1999. FDA received one set of comments on the draft guidance document during the comment period. The document reflects FDA's consideration of the comments and has also been updated to provide clarification as needed. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on assayed and unassayed quality control material. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Assayed and Unassayed Quality Control Material; Availability,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number

(2231)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.htm* l. Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 610 have been approved under OMB control number 0910-0206; the collections of information in 21 CFR part 807 have been approved under OMB control number 0910-0120; the collections of information in § 809.10 have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 31, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-10996 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0212] Draft Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis.” This draft guidance addresses issues regarding the development of therapy for prophylaxis and treatment of malaria. Specific topics include recommendations for preclinical development, clinical trial study design, the use of microbiological testing during clinical trials, and statistical considerations. 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 written or electronic comments on the draft guidance by September 5, 2007. 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, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Leonard Sacks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6178, Silver Spring, MD 20993-0002, 301-796-1600. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis.” Malaria is a major global problem with the greatest burden of disease and mortality occurring in developing countries. Although cases of malaria are uncommon in the United States, antimalarial drugs have significant public health importance in the United States: Antimalarial prophylaxis is used extensively by U.S. travelers and by U.S. citizens residing in or deployed to endemic areas (e.g., military personnel). This guidance addresses the development of therapy for the prophylaxis and treatment of malaria. Overall aspects of a developmental program for antimalarial therapy are discussed. Specific topics include recommendations for preclinical development, clinical trial study design, the use of microbiological testing during clinical trials, and statistical considerations. 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 developing drug and nonvaccine biological products for the treatment and prophylaxis of malaria. 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 ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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 either *http://www.fda.gov/ohrms/dockets/default.htm* or *http://www.fda.gov/cder/guidance/index.htm* . Dated: May 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11001 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Food Quality Indicator Device AGENCY: Food and Drug Administration, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the Food and Drug Administration, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 7,014,816, issued March 21, 2006, entitled “Food Quality Indicator Device” [E-093-1997/0-US-03] and foreign counterparts; to Litmus, LLC, having a place of business in Little Rock, AR. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the manufacture, use, distribution and sale of the Food Quality Indicator Device as claimed in the licensed patent rights. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 6, 2007 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Adaku Nwachukwu, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone:

(301)435-5560; Facsimile:

(301)402-0220; E-mail: *madua@mail.nih.gov.* SUPPLEMENTARY INFORMATION: The technology relates to an effective way to monitor food quality and freshness in real time. The major factor for food spoilage is the release of volatile bases due to the action of enzymes contained within the food or produced by microorganisms, such as bacteria, yeasts and molds growing in the food. The rate of release of such bases depends on food's storage history. In this technology, a reactive dye locked in a water-repellent material reacts with the bases released during food decomposition, and changes color. Thus a rapid and informed decision can be made about quality of food and its shelf life under the storage conditions used. Since the detection is based on biological processes that are the root cause for food spoilage, these indicators are much more reliable. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless within sixty

(60)days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: May 21, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer,Office of Technology Transfer,National Institutes of Health. [FR Doc. E7-10963 Filed 6-6-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substances Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMSHA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMSHA Reports Clearance Officer on

(240)276-1243. Project: Community Mental Health Services Block Grant Application Guidance and Instruction, FY 2008-2010 (OMB No. 0930-0168)—Revisions Sections 1911 through 1920 of the Public Health Service Act (42 U.S.C. 300x through 300x-9) provide for annual allotments to assist States to establish or expand an organized, community-based system of care for adults with serious mental illnesses and children with serious emotional disturbances. Under these provision of the law, States may receive allotments only after an application is submitted and approved by the Secretary of the Department of Health and Human Services. For the FY 2008-2010 Community Mental Health Services Block Grant application cycle, SAMSHA will provide States guidance and instructions to guide development of comprehensive State applications/plans and implementation reports. Proposed revisions to the guidance include:

(1)The integration of mental health transformation as a guiding principle in the development of State mental health plans. State plans for FY 2008-2010 will describe State mental health transformation efforts and activities within the context of the five

(5)legislative criteria, identify mental health transformation activities funded by the MHBG and other State funding sources, identify activities of the State mental health planning council that contribute to and support State transformation efforts, include one State transformation performance indicator in the plan, and include a description of the services provided to older adults under criterion 4 of the State's plan.

(2)The introduction of the Web Block Grant Application System (WebBGAS). WebBGAS enables States to submit applications/plans, and implementation reports electronically thus reducing the burden of paperwork required for submission, revision, and reporting purposes. In FY 2008, all States and Territories will be encouraged to submit State plans using WebBGAS. Other advantages to using WebBGAS include: • Eliminating redundancy in data entry by pre-populating the States' previous year data in the current year's plans and implementation reports. • Standardizing Mental Health Block Grant data for reporting and quantitative analysis. • Allowing the States' mental health planning councils to have access to state plans and implementation reports throughout the FY as a means to enable councils to meet their Federal mandate of reviewing the plans and providing recommendations to the State. • Adhering to the Federal Government's e-governments and e-grants initiatives, where applicable.

(3)A requirement for States to report nine CMHS National Outcome Measures

(NOMS)for mental health. All nine measures are derived from tables in the Uniform Reporting System

(URS)which was developed in collaboration with the States. Four

(4)of the nine measures were established, in concert with OMB PART, to support the long-term goals of the Mental Health Block Grant program and SAMSHA's Government Results and Performance Act

(GPRA)measures. The nine CMHS measures are: • Increased access to services • Reduced utilization of psychiatric inpatient beds for 30 and 180 days • Number of evidenced-based practices and number of persons served in these programs • Client perception of care • Increased/retained employment or returned to/stayed in school • Decreased criminal justice involvement • Increased stability in housing • Increased social supports and social connectedness, and • Improved level of functioning. Two of the NOMS, Increased Social Supports and Social Connectedness, and Improved Functioning, are currently under development at SAMSHA. States that are unable to report data on these or other indicators will be required to describe their current reporting capacity and efforts underway to make collection of the data possible.

(4)Revisions to tables in the Uniform Reporting System (URS). Since FY 2001, States have reported annual data on the public mental health system to the MHBG Program through 21 tables in the URS. For the past three years, CMHS worked collaboratively with States, using the Data Infrastructure Grant

(DIG)process, to refine the data and make reporting more meaningful to both States and CMHS. This effort resulted in a list of revisions to the basic and development tables in the FY 2005-2007 MHBG guidance. The revisions to the URS tables are described below: Revisions to Tables in the Uniform Reporting System Table description Table No. Table name Change Proposed change Table 1 Profile of State Population by Diagnosis No Change Table 2 Total Unduplicated Served by Age, Gender & Race Minor Combine Age 0-3 with Age 4-12. Table 3 Total Served by Setting, by Age & Gender No Change Table 4 Employment Minor Add Optional Table 4a. Reporting of Employment Status by 5 Diagnostic Groupings. Table 5 Medicaid Status No Change Table 6 Profile of Client Flow and Turnover Minor Add Column for Length of Stay for clients in facility more than 1 year. Table 7 State MH Expenditures and Revenues No Change Table 8 Profile of Community MHBG Expenditures No Change Table 9 Public Mental Health Service System Inventory List (Deleted in 2005) Major New table added, “Social Connectedness and Improved Functioning” for SAMHSA's newest NOMS. Table 10 Profile of Agencies receiving MHBG Funds No Change Table 11 Consumer Evaluation of Care* Minor Add revisions to table and questions to clarify the survey instrument and methodology used to collect data for this domain if the recommended survey was not used. Table 12 State Mental Health Agency Profile No Change Table 13 Untreated Prevalence of Mental Illness No Change Continue as developmental until refined by DIG Workgroup. Table 14 Adults with SMI & SED served by Age, gender, Race, & Ethnicity Minor Combine Age 0-3 with Age 4-12. Table 15 Living Situation Profile No Change Table 16 EBPs Minor Add two questions at the end of each EBP:

(1)Did the State use the SAMHSA Toolkit to guide implementation?

(2)Has staff been specifically trained to implement the EBP? Table 17 EBPs Minor Add two questions at the end of each EBP:

(1)Did the State use the SAMHSA Toolkit to guide implementation?

(2)Has staff been specifically trained to implement the EBP? Table 18 Use of New Generation Atypical Antipsychotics No Change Table 19 Outcomes: Criminal Justice & School Attendance Minor Add new questions for two CMHS NOMS: Arrests, and School Attendance. Table 20 30 and 180 day state hospital readmissions Minor Combine Age 0-3 with Age 4-12. Table 21 30 and 180 day readmission to any psych bed Minor Combine Age 0-3 with Age 4-12. The future of the SAMHSA/CMHS State mental data reporting program continues to evolve with a related plan to implement a State Client level Initiative project with a few States to test the feasibility of implementing client level reporting in the States. Activities of this pilot in the next three years will include:

(1)Identifying and documenting the States' most promising approaches to the collection of client-level data;

(2)developing recommendations for expanding client-level data collection systems to incorporate the NOMs; and

(3)pilot testing the most promising approaches with other interested States to determine their feasibility. SAMHSA expects that the results of this effort will improve the ability of States to report unduplicated client-level outcomes comparing Time 2 to Time 1. These data are expected to support the CMHS Block Grant in future PART reviews. The following table summarizes the annual burden for the revised application. Application Number of respondents Responses/ respondent Burden response

(hrs)Total burden hours Plan: 1 year 44 1 180 7,920 2 year 6 1 150 900 3 year 9 1 110 990 Implementation Report 59 1 75 4,425 URS Tables 59 1 40 2,360 Total 59 16,595 Written comments and recommendations concerning the proposed information collection should be sent by July 9, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: June 1, 2007. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. 07-2851 Filed 6-6-07; 8:45 am]

Connectionstraces to 9

Traces to 9 documents

U.S. Code

CFR

6 references not yet in our index