Notices. Notice

7,916 words·~36 min read·/register/2007/06/28/07-3185·

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

BILLING CODE 4163-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0241] Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for institutional review boards (IRBs). DATES: Submit written or electronic comments on the collection of information by August 27, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Institutional Review Boards—21 CFR 56.115 (OMB Control Number 0910-0130)—Extension When reviewing clinical research studies regulated by FDA, IRBs are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. These records include: Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes and decisions made by the IRB, the number of votes on each decision for, against, and abstaining, the basis for requiring changes in or disapproving research; records of continuing review activities; copies of all correspondence between investigators and the IRB; statement of significant new findings provided to subjects of the research; and a list of IRB members by name, showing each member's earned degrees, representative capacity, and experience in sufficient detail to describe each member's contributions to the IRB's deliberations, and any employment relationship between each member and the IRB's institution. This information is used by FDA in conducting audit inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate protections to human subjects participating in clinical research. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 56.115 5,000 14.6 73,000 100 7,300,000 Total 7,300,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The recordkeeping requirement burden is based on the following: The burden for each of the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. FDA estimates that there are approximately 5,000 IRBs. The IRBs meet on an average of 14.6 times annually. The agency estimates that approximately 100 hours of person-time per meeting are required to meet the requirements of the regulation. Dated: June 21, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12496 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0430] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 2, 2007 (72 FR 5057), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0338. The approval expires on June 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 21, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12497 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0015] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adoption of Food and Drug Administration Food Code by Local, State and Tribal Governments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Adoption of FDA Food Code by Local, State and Tribal Governments” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of April 13, 2007 (72 FR 18659), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0448. The approval expires on June 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 21, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12499 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0231] Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for premarket approval of medical devices. DATES: Submit written or electronic comments on the collection of information by August 27, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Pre-market Approval of Medical Devices—21 CFR Part 814 / FDAMA Sections 201; 202; 205; 208; 209 (OMB Control Number 0910-0231)—Extension Section 515 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e) sets forth the requirements for pre-market approval of certain class III medical devices. Class III devices are either pre-amendments devices that have been classified into class III, or post-amendments devices which are not substantially equivalent to a pre-amendments device, or transitional devices. Class III devices are devices such as implants, life sustaining or life supporting devices, and /or devices which otherwise present a potentially unreasonable risk of illness or injury, and /or are of substantial importance in preventing impairment of human health. Most pre-market approval applications

(PMAs)are for post-amendments class III devices. Under section 515 of the act, an application must contain certain specific information, including full reports of all information concerning investigations showing whether the device is reasonably safe and effective. The application should also include a statement of components, ingredients, and properties of the principles of operation for such a device. In addition, the application should also include a full description of the methods used in, and the facilities and controls used for the manufacture and processing of the device and labeling specimens. The implementing regulations, contained in part 814 (21 CFR part 814), further specifies the contents of a PMA for a class III medical device and the criteria FDA sets forth in approving, denying, or withdrawing approval of a PMA as well as supplements to PMAs. The purpose of this regulation is to establish an efficient and thorough procedure for FDA's review of PMAs and supplements to PMAs for certain class III (pre-market approval) medical devices. The regulations under part 814 facilitate the approval of PMAs and supplements to PMAs for devices that have been shown to be reasonably safe and effective and otherwise meet the statutory criteria for approval. The regulations also ensure the disapproval of PMAs and supplements to PMAs for devices that have not been shown to be reasonably safe and effective and that do not otherwise meet the statutory criteria for approval. The Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 105-115) was enacted on November 21, 1997, to implement revisions to the act by streamlining the process of bringing safe and effective drugs, medical devices, and other therapies to the U.S. market. Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. This section provided that PMA supplements were required for all device changes that affect safety and effectiveness of a device unless such changes are modifications to manufacturing procedures or method of manufacture. This type of manufacturing change now requires a 30-day notice, or where FDA finds such notice inadequate, a 135-day PMA supplement. To make the PMA process more efficient, in the past several years FDA has done the following:

(1)Made changes to the PMA program based on comments received;

(2)complied with changes to the program mandated by FDAMA and Medical Device User Fee Modernization Act; and

(3)worked toward completion of its PMA reinvention efforts. Respondents to this information collection are persons filing a PMA application or a PMA supplement with FDA for approval of certain class III medical devices. Part 814 defines a person as any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. These respondents include entities meeting the definition of manufacturers such as manufacturers of commercial medical devices in distribution prior to May 28, 1976 (the enactment date of the Medical Device Amendments). In addition, hospitals that reuse single use devices

(SUDs)are also included in the definition of manufacturers. It is expected that FDA will receive four PMA applications from hospitals that remanufacture SUDs annually. This figure has been included in table 1 of this document, as part of the reporting burden in § 814.15. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Part 800/ Section/FDAMA No. of Respondents Annual Frequency per Response Total Annual Responses Hours Per Responses Total Hours 814.15(b) 10 1 10 2 20 814.20 48 1 48 668 32,064 814.37(a-c) and

(e)48 1 48 167 8,016 814.39(a) 460 1 460 60 27,600 814.39(d) 70 1 70 6 420 814.39(f) 254 1 254 16 4,064 814.82(a)(9) 34 1 34 135 4,590 814.84(b) 34 1 34 10 340 Section 201 (FDAMA) Agreement Meeting 3 1 3 50 150 Section 202 (FDAMA) Expedited Reviews 7 1 7 10 70 Section 205 (FDAMA) Determination Meeting 5 1 5 50 250 Section 208 (FDAMA) Classification Panel Meetings 19 1 19 30 570 Section 209 (FDAMA) 100 day meeting 36 1 36 10 360 Totals 1,028 13 1,028 1,214 78,514 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2—Estimated Annual Recordkeeping Burden** 1 21 CFR Part 800 No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 842

(5)&

(6)1,128 1 1,128 17 19,176 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The industry-wide burden estimate for PMAs is based on an FDA actual average fiscal year

(FY)annual rate of receipt of 48 PMA original applications, 530 PMA supplements, and 254 30-day notices using FY 2002 through 2006 data. The burden data for PMAs is based on data provided by manufacturers by device type and cost element in an earlier study. The specific burden elements for which FDA has data are as follows: • Clinical investigations—67 percent of total burden estimate; • Submission of additional data or information to FDA during a PMA review—12 percent; • Additional device development cost (e.g., testing)—10 percent; and • PMA and PMA supplement preparation and submissions, and development of manufacturing and controls data— 11 percent. Reporting Burden: The reporting burden can be broken out by certain sections of the PMA regulation as follows: § 814.15—Research Conducted Outside the United States Approximately 20 percent of the clinical studies submitted in support of a PMA application are conducted outside the United States. Each study should be performed in accordance with the “Declaration of Helsinki” or the laws and regulations of the country in which the study was conducted. If the study was conducted in accordance with the laws of the country, the PMA applicant is required to explain to FDA in detail the differences between the laws of the country and the “Declaration of Helsinki”. Based on the number of PMAs received that contained studies from overseas, FDA estimates that the burden estimate necessary to meet this requirement is 20 hours. § 814.20

(a)through

(c)and (e)—Application The majority of the 32,064 hourly burden estimate is due in part to this requirement. Included in this requirement are the conduct of laboratory and clinical trials as well as the analysis, review, and physical preparation of the PMA application. FDA estimates that 48 manufacturers, including hospital re-manufacturers of SUDs, will be affected by these requirements which are based on the actual average of FDA receipt of new PMA applications in FY 2002 through 2006. FDA's estimate of the hours per response

(668)was derived through FDA's experience and consultation with industry and trade associations. In addition, FDA also based its estimate on the results of an earlier study which accounts for the bulk of the hourly burden for this requirement, identified by manufacturers. § 814.37—PMA Amendments and Re-Submitted PMAs As part of the review process, FDA often requests PMA applicant to submit additional information regarding the device necessary for FDA to file the PMA or to complete its review and make a final decision. The PMA applicant may, also on their own initiative, submit additional information to FDA during the review process. These amendments contain information ranging from additional test results, re-analysis of the original data set to revised device labeling. Almost all PMAs received by the agency have amendments submitted during the review process. FDA estimates that 8,016 burden hours are necessary to satisfy this requirement. § 814.39 (a)—PMA Supplements FDA believes that the amendments mandated by FDAMA for § 814.39(f), permitting the submission of the 30-day notices in lieu of regular PMA supplements, will result in an approximate 20 percent reduction in the total number of hours as compared to regular PMA supplements. As a result, FDA estimates that 27,600 hours of burden are needed to complete the requirements for regular PMA supplements. § 814.39(d)—Special PMA Supplements—Changes Being Affected This type of supplements is intended to enhance the safety of the device or the safe use of the device. The number of PMA supplements received that fit this category averaged 70 per year based on the numbers received from FY 2002 through FY 2006. Because of the minimal data required to be included in this type of supplement, FDA estimates that the burden hours necessary to satisfy this requirement are 420 hours. § 814.39(f)—30-Day Notice Under section 515(d) of the act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement under paragraph

(a)of this section and are eligible to be the subject of a 30-day notice. A 30-day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of part 820 (21 CFR part 820). The manufacturer may distribute the device 30 days after the date on which FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice, that it is not adequate. FDA estimates the burden to satisfy this requirement is 4,064 hours. § 814.82 (a)(9)—Post-Approval Requirements Post-approval requirements concerns approved PMAs that were not reclassified and require a periodic report. After approval, all PMAs require a submission of an annual report. On average, approximately half of the submitted PMAs (34), require associated post-approval studies, i.e., follow-up of patients used in clinical trials to support the PMA or additional preclinical information, that is labor-intensive to compile and complete; the remaining PMAs require minimal information. Based on experience and consultation with industry, FDA has estimated that preparation of reports and information required by this section requires 4,590 hours. § 814.84(b)—Reports Post-approval requirements described in § 814.82 (a)(7) require submission of an annual report for each approved PMA. FDA estimates that respondents will average about 10 hours in preparing their reports to meet this requirement. This estimate is based on FDA's experience and consultation with industry. Thus, FDA estimates that the periodic reporting burden required by this section will take 340 hours. Statutory Reporting Burden Estimate (FDAMA) The total statutory reporting burden under the requirements of sections 201, 202, 205, 208, and 209 of FDAMA is estimated to be 1,400 hours. This burden estimate was based on actual real FDA data tracked from January 1, 1998, to the present, and an estimate was also derived to forecast future expectations with regard to this statutory data. § 814.82

(5)and (a)(6)—Recordkeeping The recordkeeping burden under this section requires the maintenance of records, used to trace patients and the organization and the indexing of records into identifiable files to ensure the device's continued safety and effectiveness. These records are required only of those manufacturers who have an approved PMA and who had original clinical research in support of that PMA. For a typical year's submissions, 70 percent of the PMAs are eventually approved with 75 percent of these having original clinical trial data. Therefore, approximately 34 PMAs a year (48 annual submissions x 70 percent), would be subject to these requirements. Also, because the requirements apply to all active PMAs, all holders of an active PMA application must maintain these records. PMAs have been required since 1976, and there are 1,128 active PMAs that could be subject to these requirements, based on actual FDA data. Each study has approximately 200 subjects, and at an average of 5 minutes per subject, there is a total burden per study of 1,000 minutes, or 17 hours. The aggregate burden for all 1,128 holders of approved original PMAs, therefore, is 19,176 hours (1,127 approved PMAs with clinical data x 17 hours per PMA). The applicant determines which records should be maintained during product development to document and/or substantiate the device's safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device's continuing safety and effectiveness. Dated: June 21, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-12502 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Allergenic Products Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Allergenic Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Allergenic Products Advisory Committee for the Center for Biologics Evaluation and Research

(CBER)notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating the interest to FDA by July 30, 2007, for vacancies listed in the notice. Concurrently, nomination material for prospective candidates should be sent to FDA by July 30, 2007. ADDRESSES: All letters of interest and nominations should be submitted in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT ). FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM-71), 1401 Rockville Pike, Rockville, MD 20892, 301-827-1289, *gail.dapolito@fda.hhs.gov* SUPPLEMENTARY INFORMATION: Section 120 of the FDA Modernization Act of 1997 (FDAMA) (21 U.S.C. 355) requires that newly formed FDA advisory committees include representatives from the biologic manufacturing industries. Although not required for existing committees, to keep within the spirit of FDAMA, the agency intends to add nonvoting industry representatives to its CBER advisory committee identified below. I. CBER Allergenic Products Advisory Committee The Committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA's research programs which provide the scientific support for regulating these agents. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see ADDRESSES ) within 30 days of publication of this document. Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the Allergenic Products Advisory Committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner of Food and Drugs will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person within the 30 days. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages, nominations for appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the allergenic product manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: June 21, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-12527 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0246] Menley & James Laboratories, Inc. et al.; Proposal to Withdraw Approval of Six New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of six new drug applications

(NDAs)from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. DATES: Submit written requests for a hearing by July 30, 2007; submit data and information in support of the hearing request by August 27, 2007. ADDRESSES: Requests for a hearing, supporting data, and other comments are to be identified with Docket No. 2007N-0246 and submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The holders of approved applications to market new drugs for human use are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 314.81 (21 CFR 314.81). The holders of the approved applications listed in the following table have failed to submit the required annual reports and have not responded to the agency's request by certified mail for submission of the reports. Application No. Drug Applicant NDA 6-410 Benzedrex (propylhexadrine) Nasal Spray Menley & James Laboratories, Inc., Commonwealth Corporate Center, 100 Tournament Drive, Horsham, PA 19044 NDA 7-518 Synthetic Vitamin A Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 NDA 8-837 Isoniazid Tablets Barnes Hind, 895 Kifer Rd., Sunnyvale, CA 94806 NDA 8-851 NDK Fluoride Dentrifice (sodium monofluorophosphate) NDK Co., c/o J.W. Emmer/Kenneth Emmer, 215 Genevieve Dr., Lafayette, LA 70503 NDA 9-395 Paskalium (potassium aminosalicylate) Glenwood, 111 Cedar Lane, Englewood, NJ 07631 NDA 19-518 Extra Strength Aim (sodium monofluorophosphate) Chesebrough-Ponds USA Co., 33 Benedict Pl., P.O. Box 6000, Greenwich, CT 06836-6000 Therefore, notice is given to the holders of the approved applications listed in the table and to all other interested persons that the Director of the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing approval of the applications and all amendments and supplements thereto on the ground that the applicants have failed to submit reports required under § 314.81. In accordance with section 505 of the act and 21 CFR part 314, the applicants are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these applications. An applicant who decides to seek a hearing shall file the following:

(1)A written notice of participation and request for a hearing (see DATES ), and

(2)the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing (see DATES ). Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and 21 CFR part 12. The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the applications and the drug products may not thereafter lawfully be marketed, and FDA will begin appropriate regulatory action to remove the products from the market. Any new drug product marketed without an approved NDA is subject to regulatory action at any time. A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. Reports submitted to remedy the deficiencies must be complete in all respects in accordance with § 314.81. If the submission is not complete or if a request for a hearing is not made in the required format or with the required reports, the Commissioner of Food and Drugs (the Commissioner) will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing. All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under section 301 of the act (21 U.S.C. 331(j)) or 18 U.S.C. 1905, the submissions may be seen in the Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday. This notice is issued under section 505 of the act and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner. Dated: June 11, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7-12494 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; 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 Committees* : Dermatologic and Ophthalmic 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 August 1, 2007, from 8 a.m. to 12:30 p.m. *Location* : Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. *Contact Person* : Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, fax: 301-827-6776, e-mail: *Sohail.Mosaddegh@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), codes 3014512534 or 3014512535. 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 committees will meet in joint session to be briefed on iPLEDGE, the risk management program for isotretinoin products. Presentations will provide updates on risk management activities for isotretinoin since the full implementation of iPLEDGE on March 1, 2006. 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 *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and 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 11, 2007. Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11:15 a.m. Those desiring to make 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 July 2, 2007. 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 July 3, 2007. 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 John Lauttman, 301-827-7001, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 21, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-12501 Filed 6-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Data Collection; Comment Request; National Physician Survey of Practices on Diet, Physical Activity, and Weight Control SUMMARY: In compliance with the provisions of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute

(NCI)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget

(OMB)for review and approval. *Proposed Collection: Title:* Physician Survey of Practices on Diet, Physical Activity, and Weight Control. *Type of Information Collection Request:* NEW. *Need and Use of Information Collection:* This study will obtain current, national data on primary care physicians' knowledge, attitudes, and practices related to diet, physical activity, and weight control. Obesity, poor diet, and lack of physical activity are becoming recognized as major public health problems in the United States, and have been linked to increased risk, adverse prognosis, and poor quality of life for cancer and many other chronic diseases. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer prevention knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Data from the survey will be used to profile existing physician practice, understand barriers to counseling and referral, and to inform methods for improving the utilization of these services for adults and children. Two questionnaires, one sent to physicians and one sent to their practice administrators, will be administered by mail or telephone to a randomly-selected national sample of 2,000 physicians belonging to primary care specialties. Study participants will be 2,000 practicing physicians who are family practitioners, general internists, pediatricians, and obstetrician/gynecologists and 2,000 practice administrators. The annual reporting burden is as follows: *Estimated Number of Respondents:* 4,000; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours Per Response:* .333; and *Estimated Total Annual Burden Hours Requested:* 1,332. The annualized cost to respondents is estimated at: $65,048. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondent Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours Physician 2000 1 0.333 666 Medical Practice Administrator 2000 1 0.333 666 Total 4000 1 1,332 *Hourly earnings data are taken from the National Compensation Survey: Occupational Wages in the United States, June 2005, U.S. Department of Labor, U.S. Bureau of Labor Statistics. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(a)Whether the proposed collection of information is necessary for the performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: Send comments to Ashley Wilder Smith, PhD, M.P.H., Health Sciences Specialist, National Cancer Institute, 6130 Executive Blvd., MSC 7344, Executive Plaza North, Room 4090, Bethesda, MD 20892-7344. Telephone: 301-451-1843; E-mail: *smithas@mail.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication should be received by August 27, 2007. Dated: June 20, 2007. Ashley Wilder Smith, National Cancer Institute Task Order Monitor, National Institutes of Health. [FR Doc. E7-12535 Filed 6-27-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Orally Active Derivatives of 1,3,5(10)-estratriene *Description of Technology:* The utility of estrogenic substances in the practice of medicine is well documented. Estrogens may be used for the replacement of the natural hormone estradiol in hypogonadism, and following the removal of the ovaries or cessation of ovarian activity during menopause. They are also widely employed as a component of oral contraceptives. However, orally-active synthetic estrogens are associated with a number of side effects, such as: Enhanced risk of endometrial carcinoma; induction of malignant carcinoma, especially in the cervix, breast, vagina and liver; promotion of gallbladder disease, thromboembolic and thrombotic diseases, myocardial infarction, hepatic adenoma, elevated blood pressure, and hypercalcemia; and reduced glucose tolerance. The NIH announces a new family of novel, active estrogens that are nitrate esters of estradiol. These nitrate esters possess enhanced estrogenic activity following oral administration and lack a 17-ethynyl alcohol, which has been implicated in many side effects attributed to other synthetic estrogens. It is anticipated that these esters could be used in all instances where estrogen is prescribed as a treatment. *Applications:* Hormone replacement therapies; Oral contraceptives. *Market:* The hormone replacement market exceeds one billion dollars per year, and the oral contraceptive market is more than three billion dollars per year. *Development Status:* Early stage. *Inventors:* Hyun K. Kim *et al.* (NICHD). *Patent Status:* U.S. Patent 5,554,603 issued 10 Sep 1996 (HHS Reference No. E-137-1993/0-US-01); Foreign counterparts in Australia, Canada, Japan, and Europe. *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Tara L. Kirby, PhD; 301/435-4426; *tarak@mail.nih.gov.* Methods of Inducing Immune Tolerance Using Immunotoxins *Description of Invention:* The invention concerns immunotoxins and methods of using the immunotoxins for the treatment of rejection response in a patient, including graft-versus-host disease and transplantation of organs, tissues and cells into a host. In a specific embodiment of the invention, the transplant involves pancreatic islet cells. The immunotoxins are targeted via an antibody that is specific to T cells. This allows the specific ablation of resting T cells, resulting in an accentuation of immune tolerizing responses and an increased tolerance to transplants and grafts. The toxin portion of the immunotoxin is genetically engineered to maintain bioactivity when recombinantly produced in *Pichia pastoris.* Data are available in transgenic animals expressing human CD3ε which supports the effects of the immunotoxin against T cells. *Applications:* Use of immunotoxins decreases T cell population, allowing greater host immune tolerance of transplants and grafts; Specific method for increasing immune tolerance to pancreatic islet transplants. *Advantages:* Specificity of the immunotoxin avoids the killing of other cells, reducing side-effects associated with other mechanisms of treatment (X-ray and cyclophosphamide) such as infection and induced malignancy; A GMP production process for the immunotoxin has already been successfully implemented. *Benefits:* New methods and compositions with limited side-effects have the potential to revolutionize treatment of transplant/graft recipients; provides an opportunity to capture a significant market share for the millions of people who require transplants/grafts. *Inventors:* David Neville *et al.* (NIMH). *Patent Status:* U.S. Patent No. 5,167,956 issued 01 Dec 1992 (HHS Reference No. E-012-1991/0-US-01); U.S. Patent No. 5,762,927 issued 09 Jun 1998 (HHS Reference No. E-012-1991/4-US-02); U.S. Patent No. 6,103,235 issued 15 Aug 2000 (HHS Reference No. E-012-1991/7-US-01); U.S. Patent No. 7,125,553 issued 24 Oct 2006 (HHS Reference No. E-012-1991/7-US-02); U.S. Patent Application No. 09/810,999 filed 16 Mar 2001, which published as U.S. 2001/0024645 on 27 Sep 2001, Allowed (HHS Reference No. E-059-1998/0-US-02); International Patent Application No. PCT/US00/10253 filed 14 Apr 2000, which published as WO 00/61132 on 19 Oct 2000 (HHS Reference E-168-1999/0-PCT-02); U.S. Patent No. 6,632,928 issued 14 Oct 2003 (HHS Reference No. E-044-1997/0-US-07); U.S. Patent Application No. 10/435,567 filed 09 May 2003, which published as 2003/0185825 on 02 Oct 2003 (HHS Reference No. E-044-1997/0-US-08); U.S. Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 2004/0127682 on 01 Jul 2004 (HHS Reference No. E-044-1997/1-US-06); Foreign rights are also available. *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* David A. Lambertson, PhD; 301/435-4632; *lambertsond@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of using the immunotoxins for the treatment of rejection response in a patient. Please contact David Neville at *davidn@mail.nih.gov* for more information. Dated: June 20, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-12534 Filed 6-27-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, August 2, 2007, 1:30 p.m. to August 2, 2007, 3:30 p.m., Marriott Bethesda North Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852 which was published in the **Federal Register** on April 24, 2007, 72 FR 20348. This meeting notice is amended to reflect the location change to the Embassy Suites Hotel at Chevy Chase Pavilion, 1400 Military Road, NW., Washington, DC 20015 and meeting time to 3 p.m. to 5 p.m. The meeting is closed to the public. Dated: June 21, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3185 Filed 6-27-07; 8:45 am]

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