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Code · REGISTER · 2007-04-09 · Federal Trade Commission · Notices

Notices. Proposed Consent Agreement

14,718 words·~67 min read·/register/2007/04/09/07-1730

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

BILLING CODE 6715-01-M FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843).
Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 3, 2007. **A. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1.
Fox River Financial Corporation, Burlington, Wisconsin;* to become a bank holding company by acquiring 100 percent of the voting shares of Fox River State Bank, Burlington, Wisconsin. Board of Governors of the Federal Reserve System, April 4, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-6603 Filed 4-6-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION [File No. 062 3112] Darden Restaurants, Inc., GMRI, Inc., and Darden GC Corp.; Analysis of Proposed Consent Order To Aid Public Comment AGENCY:
Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis To Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations. DATES: Comments must be received on or before May 2, 2007.
ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Darden, Inc., File No. 062 3112,” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Comments containing confidential material must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005). 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.
Comments that do not contain any nonpublic information may instead be filed in electronic form as part of or as an attachment to email messages directed to the following e-mail box: *consentagreement@ftc.gov.* 1 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission's General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c).
The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at *http://www.ftc.gov.* As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website.
More information, including routine uses permitted by the Privacy Act, may be found in the FTC's privacy policy, at *http://www.ftc.gov/ftc/privacy.htm.* FOR FURTHER INFORMATION CONTACT: Lucy Morris or Jonathan Kraden, Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC 20580,
(202)326-3224. SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty
(30)days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for April 3, 2007), on the World Wide Web, at *http://www.ftc.gov/os/2007/04/index.htm.* A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling
(202)326-2222. Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section. Analysis of Agreement Containing Consent Order To Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from Darden Restaurants, Inc., GMRI, Inc., and Darden GC Corp. (collectively, “respondents” or “Darden”). The proposed consent order has been placed on the public record for thirty
(30)days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty
(30)days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order. Respondents, through subsidiaries, own and operate several restaurant chains, including Olive Garden Restaurant, Red Lobster Restaurant, Smokey Bones Restaurant, and Bahama Breeze Restaurant. Respondents advertise, sell, and distribute Darden Gift Cards through their restaurants and Web sites, and third parties. Darden Gift Cards are plastic, stored-value cards, similar in size and shape to credit or debit cards, often branded with one or more of Darden's restaurant logos. Darden Gift Cards typically can be used to purchase goods or services at any of Darden's restaurant locations. This matter concerns the respondents' alleged failure to disclose, or failure to disclose adequately, material terms and conditions of Darden Gift Cards. The Commission's complaint alleges that, in the advertising and sale of Darden Gift Cards, respondents have represented, expressly or by implication, that a consumer can redeem a Darden Gift Card for goods or services of an equal value to the monetary amount placed on the card. Respondents have failed to disclose, or failed to disclose adequately, that, after a specified number of consecutive months of non-use ( *i.e.* , 15 or 24 months), respondents deduct a $1.50 fee per month from the value of the Darden Gift Card until it is used again. The proposed complaint alleges that the failure to disclose adequately this material fact is a deceptive practice. The proposed consent order contains provisions designed to prevent respondents from engaging in similar acts and practices in the future. Part I.A. of the proposed order prohibits respondents from advertising or selling Darden Gift Cards without disclosing, clearly and prominently:
(a)The existence of any expiration date or automatic fees, in all advertising, and
(b)all material terms and conditions of any expiration date or automatic fee, at the point of sale and prior to purchase. The effect of this provision is to require respondents to alert consumers to potential fees and expiration dates during advertising, and to fully disclose all relevant details at the point of sale, before consumers purchase the gift cards. Part I.B. of the proposed order prohibits respondents from advertising or selling Darden Gift Cards without disclosing, clearly and prominently the existence of any automatic fee or expiration date on the front of the gift card. Part II of the proposed order prohibits respondents from making any misrepresentation about any material term or condition associated with the Darden Gift Card. Part III.A. of the proposed order prohibits respondents from collecting or attempting to collect any dormancy fee on any Darden Gift Card activated prior to the date of issuance of the proposed order. Part III.B. of the proposed order requires respondents, upon issuance of the order, to cause the amount of any fees assessed on a Darden Gift Card prior to the date of issuance of the order to be restored to the card. Part III.C. of the proposed order requires respondents to provide notice to consumers of the automatic restoration of fees required by Section III.B. This notice must be clearly and prominently disclosed on respondents' websites, including *http://www.darden.com, http://www.dardenrestaurants.com, http://www.redlobster.com, http://www.olivegarden.com, http://www.smokeybones.com,* and *http://www.bahamabreeze.com.* Part IV of the proposed order contains a document retention requirement, the purpose of which is to ensure compliance with the proposed order. It requires that respondents maintain accounting and sales records for Darden Gift Cards, copies of ads and promotional material that contain representations covered by the proposed order, complaints and refund requests relating to the Darden Gift Cards, and other materials that were relied upon by respondents in complying with the proposed order. Part V of the proposed order requires respondents to distribute copies of the order to various principals, officers, directors, and managers of respondents as well as to the officers, directors, and managers of any third-party vendor who engages in conduct related to the proposed order. Part VI of the proposed order requires respondents to notify the Commission of any changes in corporate structure that might affect compliance with the order. Part VII of the proposed order requires respondents to file with the Commission one or more reports detailing compliance with the order. Part VIII of the proposed order is a “sunset” provision, dictating the conditions under which the order will terminate twenty years from the date it is issued or twenty years after a complaint is filed in Federal court, by either the United States or the FTC, alleging any violation of the order. The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify in any way its terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E7-6610 Filed 4-6-07; 8:45 am] BILLING CODE 6750-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-06AX] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Risk Perception, Worry, and Use of Ovarian Cancer Screening Among Women At High, Elevated, and Average Risk of Ovarian Cancer—NEW—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Accounting for an estimated 22,220 cases and 16,210 deaths in 2005, ovarian cancer is the most frequent cause of death from gynecologic malignancy in the United States. In over 80 percent of patients, ovarian cancer presents at a late clinical stage, affording a five-year survival rate of only 28 percent. For cases where ovarian cancer is identified in Stage I, however, the five-year survival rate exceeds 90 percent. Identifying a woman's risk of ovarian cancer plays a large role in determining the appropriateness of having her undergo screening. It is only for women with a strong family history of ovarian and/or breast cancer or women with a hereditary genetic risk for ovarian cancer that the currently available screening modalities of CA 125 and transvaginal ultrasound are recommended. Statements from the scientific and medical community regarding recommendations for ovarian cancer screening play only a partial role in a woman's decision to undergo screening exams. Numerous psychological and sociological factors can affect this decision as well, including a woman's knowledge, attitudes, beliefs, and experiences. For instance, a woman's experience of cancer within her family or experience with a friend who has had cancer may influence a woman's screening decisions. The literature also notes that women with a family history of ovarian cancer report increased worry and high levels of perceived risk. A positive association has also been shown between screening behavior and family history. Recent studies indicate, however, that screening is not occurring in proportion to women's levels of risk. These findings underscore the need for a better understanding of how perceived risk of ovarian cancer may influence worry about cancer and ultimately screening behavior. To address these issues, the Division of Cancer Prevention and Control (DCPC), at the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, is conducting a study to examine the effects of family history of cancer, knowledge about ovarian cancer, worry and/or anxiety, and perceived risk of cancer on the likelihood of a woman undergoing screening for ovarian cancer. By also examining other psycho-social factors such as a woman's closeness to a relative or friend with cancer, coping style, cancer worry, use of other cancer screening tests, social support, and provider's recommendations, the study will elucidate the causal pathway leading from actual risk (as measured by family history) through perceived risk to intent to undergo screening and actual screening behavior. The proposed study will consist of two tasks. In Task 1, a baseline survey will be administered through a computer-assisted telephone interview
(CATI)program. Initially, an estimated 32,000 women will be screened to determine eligibility, and then approximately 2000 women will be asked a series of questions over a 35-minute time period. Questions will cover key variables related to ovarian cancer screening including coping, anxiety, perceived risk, worry, personal cancer history, family cancer history, closeness with family or friends who have had cancer, screening behavior, and knowledge of ovarian cancer. In Task 2, a follow-up questionnaire will be administered, also using a CATI program, to approximately 1600 of the women included in the baseline questionnaire. Each of the women will be contacted one year after they complete the baseline survey. The researchers anticipate a 15 percent attrition of the sample between baseline and follow-up. In the follow-up, women will be asked a series of questions over a 15-minute time period. The purpose of this data collection effort is to determine if risk perception has changed and to ask about screening for ovarian cancer, since the baseline questionnaire was administered. All data will be collected over a three-year time period. The total estimated annualized burden hours are 1,411. There are no costs to the respondents other than their time. Estimated Annualized Burden Hours Group Type of respondents No. of respondents No. of responses per respondent Avg. burden per response (in hours) Eligibility Screener Women 30 and older 10,667 1 5/60 Baseline Survey Women 30 and older (high, elevated or average risk of ovarian cancer) 667 1 35/60 Follow-Up Survey Women who completed the baseline survey 533 1 15/60 Dated: April 3, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6583 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Arthritis and Disability: Biracial Cohort Study of Knee and Hip Osteoarthritis, Potential Extramural Project
(PEP)2007-R-06 and Evaluating Sustainable Delivery Systems for Arthritis Intervention Programs, PEP 2007-R-08 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned SEP. *Time and Date:* 12 p.m.-4 p.m., May 14, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of “Arthritis and Disability: Biracial Cohort Study of Knee and Hip Osteoarthritis,” Potential Extramural Project
(PEP)2007-R-06 and “Evaluating Sustainable Delivery Systems for Arthritis Intervention Programs,” PEP 2007- R-08. *For Further Information Contact:* Juliana Cyril, M.P.H., Ph.D., CDC, 1600 Clifton Road NE, Mailstop D-72, Atlanta, GA 30333, Telephone
(404)639-4639. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6582 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Pre-Knowledge of Early Hearing Detection and Intervention Program Process and Its Effect on Maternal Stress and Compliance With Follow-Up, Potential Extramural Project
(PEP)2007-R-07 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Time and Date:* 12 p.m.-4 p.m., May 16, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of PEP 2007-R-07, “Pre-Knowledge of Early Hearing Detection and Intervention Program Process and Its Effect on Maternal Stress and Compliance with Follow-Up.” *For Further Information Contact:* Juliana Cyril, M.P.H., Ph.D., Associate Director for Policy and Peer Review, CDC, 1600 Clinton Road, NE., Mailstop D72, Atlanta, GA 30333, telephone 404-639-4639. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6588 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Epidemiological Studies of Epilepsy, Potential Extramural Project
(PEP)2007-R-05 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned SEP. *Time and Date:* 12 p.m.-4 p.m., May 10, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of scientific merit of applications for “Epidemiological Studies of Epilepsy,” PEP 2007-R-05. *For Further Information Contact:* Juliana Cyril, M.P.H., Ph.D., Associate Director for Policy and Peer Review, CDC, 1600 Clifton Road, NE., Mailstop D-72, Atlanta, GA 30333, Telephone
(404)639-3098. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6589 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: NIOSH Education and Research Center, Program Announcement Number
(PAR)06-485 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following Meeting of the aforementioned Special Emphasis Panel: *Time and Date:* 10 a.m.-1 p.m., April 24, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Purpose:* The work groups which were convened at specific sites listed below advised and made recommendations to the Disease, Disability, and Injury Prevention and Control SEP: NIOSH Education and Research Center, PAR 06-485. Specifically, the SEP makes recommendations regarding policies, strategies, and funding. Times, Dates, and Places of the Work Group Meetings 8 a.m.-5 p.m. November 13, 2006 (Closed) Women's Faculty Club on the University of California Berkeley campus 510-642-4175. 8 a.m.-5 p.m. November 28, 2006 (Closed) University of Alabama at Birmingham, Administration Building Penthouse, 701 20th Street South, 14th floor, Conference Room 1, 205-934-0771. 8 a.m.-5 p.m. December 11, 2006 (Closed) Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD 21205. 8 a.m.-5 p.m. December 14, 2006 (Closed) College of Public Health 13201 Bruce B. Downs Blvd Tampa, FL 33612. 8 a.m.-5 p.m. January 9, 2007 (Closed) Fitzsimons Campus, Nighthorse Campbell Building. Room 304 Denver, CO. 8 a.m.-5 p.m. January 16, 2007 (Closed) Coffman Memorial Union 300 Washington Ave. SE Minneapolis, MN 55455. 8 a.m.-5 p.m. February 13, 2007 (Closed) University Park Marriott 480 Wakara Way Salt Lake City, UT 84108 801-584-3312. *Matters to be Discussed:* The SEP meeting will include the review, discussion, and evaluation of research grant applications in response to “NIOSH Education and Research Center,” PAR 06-485. *For Further Information Contact:* Dr. Charles N. Rafferty, Ph.D., B.S., Scientific Review Administrator, 1600 Clifton Road NE, MS E74, Atlanta, GA, 30333, telephone 404.498.2582. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 3, 2007. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6591 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry; The Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), CDC and ATSDR announce the following meeting of the aforementioned committee: *Times and Dates:* 8 a.m.-4:45 p.m., May 17, 2007. 8 a.m.-12 p.m., May 18, 2007. *Place:* 1825 Century Boulevard, Atlanta, Georgia 30345. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. *Purpose:* The Secretary, Department of Health and Human Services (HHS), and by delegation, the Director, CDC, are authorized under Section 301 (42 U.S.C. 241) and Section 311 (42 U.S.C. 243) of the Public Health Service Act, as amended, to:
(1)Conduct, encourage, cooperate with, and assist other appropriate public authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments;
(2)assist states and their political subdivisions in the prevention of infectious diseases and other preventable conditions and in the promotion of health and well being; and
(3)train state and local personnel in health work. The BSC, NCEH/ATSDR provides advice and guidance to the Secretary, HHS; the Director, CDC, and Administrator, ATSDR; and the Director, NCEH/ATSDR, regarding program goals, objectives, strategies, and priorities in fulfillment of the agency's mission to protect and promote people's health. The board provides advice and guidance that will assist NCEH/ATSDR in ensuring scientific quality, timeliness, utility, and dissemination of results. The board also provides guidance to help NCEH/ATSDR work more efficiently and effectively with its various constituents and to fulfill its mission in protecting America's health. *Matters To Be Discussed:* An update on NCEH/ATSDR's Office of the Director; an update on Science and Public Health and Reports; an update on the Health Department Subcommittee, the Community and Tribal Subcommittee, and the Program Peer Review Subcommittee
(PPRS)Reports and Discussion; a presentation on CDC's Web site redesign and the NCEH/ATSDR Web site; an update on Climate Change Initiative; a presentation on the Office of Tribal Affairs' Expert Panel Report; an update on issues from the Board; a discussion on the Office of Management and Budget Performance Assessment and Review Techniques goals and objectives; an update on the National Exposure Report; an update on Preparedness and Emergency Response priorities and portfolio; and a discussion on BSC—PPRS Draft Peer Review Report on ATSDR Site-Specific Activities. Agenda items are tentative and subject to change. FOR FURTHER INFORMATION CONTACT: Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28, Atlanta, Georgia 30303; telephone 404/498-0003, fax 404/498-0622; E-mail: *smalcom@cdc.gov* . The deadline for notification of attendance is May 4, 2007. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and NCEH/ATSDR. Dated: April 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6585 Filed 4-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1978N-0224 (formerly Docket No. 78N-0224); DESI 11853] Trimethobenzamide Hydrochloride Suppositories; Withdrawal of Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the resolution of issues concerning trimethobenzamide hydrochloride suppositories. This notice announces the withdrawal of approval of the new drug application
(NDA)for Tigan (trimethobenzamide hydrochloride) Suppositories. The notice also declares that the marketing of unapproved trimethobenzamide hydrochloride suppository products is unlawful and subject to FDA regulatory action. FDA is taking these actions because trimethobenzamide hydrochloride suppositories lack substantial evidence of effectiveness. ADDRESSES: Requests for an opinion on the applicability of this notice to a specific trimethobenzamide hydrochloride suppository product should be identified with Docket No. 1978N-0224 and reference number DESI 11853 and directed to the Office of Compliance, Division of New Drugs and Labeling Compliance (HFD-310), New Drugs and Labeling Team, Center for Drug Evaluation and Research, Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852. DATE: Effective May 9, 2007. FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: I. Background As part of its Drug Efficacy Study Implementation
(DESI)program, in a notice published in the **Federal Register** on February 24, 1971 (36 FR 3435) (the 1971 notice), FDA announced the following conclusions regarding certain drug products that contain trimethobenzamide hydrochloride:
(1)The products were probably effective for nausea and vomiting due to radiation therapy or travel sickness and for emesis associated with operative procedures, labyrinthitis, or Meniere's syndrome;
(2)they were lacking substantial evidence of effectiveness for the treatment of nausea and vomiting due to infections, underlying disease processes, or drug administration; and
(3)they were possibly effective for all other labeled indications. The 1971 notice listed three trimethobenzamide hydrochloride products: Tigan Solution for Injection (NDA 11-853), Tigan Capsules (NDA 11-854), and Tigan Suppositories (NDA 11-855). Roche Laboratories held the NDAs for these three products. On January 9, 1979, we published a notice in the **Federal Register** (44 FR 2021) (the 1979 suppository notice) announcing that we were reclassifying trimethobenzamide hydrochloride suppositories to lacking substantial evidence of effectiveness and proposing to withdraw approval of the NDAs for trimethobenzamide hydrochloride suppositories. The 1979 suppository notice stated that NDA 17-529 for Tigan Suppositories, held by Beecham Laboratories (Beecham), had not been included in the 1971 notice, but was affected by the new notice. (In the same issue of the January 9, 1979, **Federal Register** (44 FR 2017) (the 1979 injection and capsule notice), we published a notice announcing that we were reclassifying trimethobenzamide hydrochloride injection and capsules to effective for certain indications and to lacking substantial evidence of effectiveness for their other (previously designated) less-than-effective indications. On December 24, 2002, we published the final evaluation for trimethobenzamide hydrochloride injection and capsules (67 FR 78476).) In the 1979 suppository notice, we gave notice of an opportunity for a hearing to the holders of the NDAs for trimethobenzamide hydrochloride suppositories, and to all other interested persons, stating that we proposed 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 NDAs and all amendments and supplements thereto (44 FR 2021 at 2021 to 2022). We stated that the notice of an opportunity for a hearing encompassed all issues relating to the legal status of the drug products subject to the notice, including identical, related, or similar drug products as defined in § 310.6 (21 CFR 310.6) of our regulations. In accordance with section 505 of the act and parts 310 and 314 (21 CFR parts 310 and 314), we gave the holders of the NDAs and all other persons who manufacture or distribute a drug product that is identical, related, or similar to a drug product named in the notice an opportunity for a hearing to show why approval of the NDAs involved should not be withdrawn, and an opportunity to raise, for administrative determination, all issues relating to the legal status of a named drug product and all identical, related, or similar drug products (44 FR 2021 at 2022). The 1979 suppository notice stated that the failure of an applicant or any other person subject to the notice to file a timely written appearance and request for a hearing, as required by § 314.200, constituted an election by the person not to make use of the opportunity for a hearing and a waiver of any contentions concerning the legal status of any drug product subject to the notice. The notice further stated that any such drug product could not thereafter lawfully be marketed, and we would initiate appropriate regulatory action to remove such drug products from the market (44 FR 2021 at 2022). In a letter dated January 30, 1979, Beecham requested a hearing on the proposed withdrawal of NDA 17-529 for Tigan Suppositories. In a letter dated March 5, 1979, Beecham submitted data in support of its request for a hearing. Beecham was the only party to request a hearing. On April 13, 1979, we published a notice in the **Federal Register** announcing that we were withdrawing the approval of NDA 11-8550 (the only other NDA named in the 1979 suppository notice), effective April 23, 1979 (44 FR 22199). On November 12, 1999, King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 (King), purchased from Roberts Pharmaceutical Corp. the NDAs for the Tigan products previously held by Beecham: NDA 17-529 (suppositories), NDA 17-530 (injection), and NDA 17-531 (capsules). We subsequently initiated discussions with King on bringing the Tigan products into compliance with the 1979 notices on trimethobenzamide hydrochloride drugs. In an agreement that became effective on August 16, 2001 (the Agreement), FDA and King agreed to take several actions to resolve the matter of the compliance of Tigan products with the 1979 notices. Among other things, King agreed to withdraw the request for a hearing (originally submitted by Beecham) on matters related to NDAs 17-529 (Tigan Suppositories), 17-530 (Tigan Injection), and 17-531 (Tigan Capsules), and all amendments and supplements thereto, within 10 days of the effective date of the Agreement. In a letter dated August 24, 2001, King withdrew its request for a hearing on these matters in accordance with the Agreement. The issues relating to Tigan Capsules and Injection were resolved in 2001 and 2002, and on December 24, 2002, we published a notice in the **Federal Register** announcing our final evaluation of these products (67 FR 78476). II. Resolution of Issues Concerning Tigan Suppositories King notified us in a letter dated March 21, 2005, that it had decided not to pursue additional studies for Tigan Suppositories. In a letter dated August 19, 2005, we asked King, in accordance with the Agreement, to request the withdrawal of NDA 17-529 for Tigan Suppositories. In a letter dated September 6, 2005, King requested that we withdraw NDA 17-529. As stated in section I of this document, King has withdrawn its request for a hearing on matters related to NDA 17-529. No party other than Beecham (a previous holder of NDA 17-529) submitted a request for a hearing in response to the 1979 suppository notice. Therefore, all other parties waived any possible contentions regarding the legal status of their trimethobenzamide hydrochloride suppository products. III. Withdrawal of Approval of NDA 17-529 for Tigan Suppositories As a result of the events described in section II of this document, we have concluded that Tigan Suppositories have not been shown to be effective. Therefore, we are withdrawing approval of the NDA for this product. Under § 310.6, this notice applies to any drug product that is identical, related, or similar to Tigan Suppositories and is not the subject of an approved NDA. Any person who wishes to determine whether a specific product is covered by this notice should write to the Division of New Drugs and Labeling Compliance (see ADDRESSES ). The Director of the Center for Drug Evaluation and Research, under section 505(e) of the act and under the authority delegated to him, finds that, on the basis of the information in this docket on Tigan Suppositories (NDA 17-529), evaluated together with the evidence available to FDA when the application for this product was approved, there is a lack of substantial evidence that this product has the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling. Therefore, based on the foregoing finding, the approval of NDA 17-529, including all amendments and supplements thereto, is withdrawn effective May 9, 2007. Shipment in interstate commerce of Tigan Suppositories or any identical, related, or similar trimethobenzamide hydrochloride suppository product that is not the subject of an approved NDA will then be unlawful. We note that under enforcement policies regarding drugs marketed without required applications described in the agency's guidance entitled *Marketed Unapproved Drugs—Compliance Policy Guide* , it is a high priority for the agency to take enforcement action against those unapproved drug products that lack evidence of effectiveness. Firms should be aware that we intend to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice after May 9, 2007. Firms that discontinue or have already discontinued manufacturing products covered by this notice may want to notify us that they are no longer manufacturing those products. A firm that wishes to notify us of product discontinuation should send a letter, signed by the firm's chief executive officer, fully identifying the discontinued product, including its National Drug Code
(NDC)number. The firm should send the letter to the Division of New Drugs and Labeling Compliance, New Drugs and Labeling Team (see ADDRESSES ). Firms should also update the listing of their products under section 510(j) of the act (21 U.S.C. 360(j)) to reflect discontinuation of unapproved or otherwise discontinued products. We plan to rely on our existing records, the results of a subsequent inspection, or other available information when we evaluate whether to take enforcement action. Dated: March 14, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7-6593 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products 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 Committee* : Blood Products Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on April 26, 2007, from 2 p.m. to 6 p.m. and on April 27, 2007, from 8 a.m. to 3:30 p.m. *Location* : Hilton Hotel, Washington, DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. *Contact Person* : Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On April 26, 2007, the committee will hear an update on a summary of August 30 and 31, 2006, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. The committee will then discuss issues related to implementation of blood donor screening for infection with *Trypanosoma cruzi* and issues related to transmissibility of *Trypanosoma cruzi* in donors of human cells, tissue, and cellular and tissue-based products. On April 27, 2007, the committee will hear updates on summary of December 15, 2006, meeting of the Transmissible Spongiform Encephelopathies Advisory Committee, FDA's risk communication on plasma-derived Factor VIII and Factor XI, and summary of September 25 and 26, 2006, FDA Workshop on Molecular Methods in Immunohematology. The committee will then discuss transfusion related acute lung injury, and discuss issues related to implementation of blood donor screening for infection with West Nile Virus. FDA intends to make background material available to the public no later than 1 business day 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 April 18, 2007. Oral presentations from the public will be scheduled between approximately 4:30 p.m. and 5 p.m. on April 26, 2007, and between approximately 10:45 a.m. and 11:15 a.m. on April 27, 2007. 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 April 10, 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 April 11, 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 Donald W. Jehn or Pearline K. Muckelvene 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: April 3, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-6594 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General Hospital and Personal Use Devices Panel of the Medical Devices 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 Committee* : General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on May 4, 2007, from 8 a.m. to 5 p.m. *Location* : Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Scott Colburn, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville MD, 20850, 240-276-3707, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512520. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss and make recommendations on the scientific and clinical issues raised by the addition of antimicrobial agents to personal protective equipment (PPE). The PPE to be discussed are surgical masks/respirators, medical gloves, and surgical/isolation gowns. *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 April 20, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes during the morning deliberations and for approximately 30 minutes during the afternoon deliberations. 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 April 12, 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 April 13, 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 AnnMarie Williams, Committee Management Staff, at 301-827-7291 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: April 3, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-6645 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0121] Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a public hearing to obtain feedback on FDA's Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients. *Dates and Times* : The public hearing will be held on June 12 and 13, 2007, from 8:30 a.m. to 4:30 p.m. on both days. Submit written or electronic notices of participation by 4:30 p.m. on May 12, 2007. Written and electronic comments will be accepted until July 12, 2007. *Location* : The public hearing will be held at the National Transportation and Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (Metro: L'Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines). *Addresses* : Submit written or electronic notices of participation to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at *http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm* . Submit written or electronic comments to *http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm* or to the Division of Dockets Management. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at *http://www.fda.gov/ohrms/dockets* approximately 21 days after the hearing. *For Registration to Attend and/or to Participate in the Meeting* : Seating at the meeting is limited. People interested in attending should register at *http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm* or submit a written request for registration to the Division of Dockets Management (see *Addresses* ) by 4:30 p.m. on May 12, 2007. Registration is free and will be on a first-come, first-served basis. If you wish to make an oral presentation during the open session of the meeting, you must state this intention on your notice of participation (see *Addresses* ) and provide an abstract of your presentation by May 12, 2007. In the notice, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. FDA has identified questions and subject matter of special interest in section II of this document. You should also identify the subject matter and question number you wish to address in your presentation, and the approximate time requested for your presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. We will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. You must submit final electronic presentations, if any, to Mary Gross (see *Contacts* ) by no later than June 6, 2007. *Contacts* : Mary C. Gross, Safety Policy and Communication Staff (HFD-001), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5421, e-mail: *mary.gross@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background FDA is committed to ensuring that prescribers, patients, and their families have the information needed to support the safe and effective use of prescription medications. In the **Federal Register** of December 1, 1998 (63 FR 66378), FDA published its final rule entitled “Prescription Drug Product Labeling; Medication Guide Requirements” (effective June 1, 1999). The final rule included provisions that require the distribution of FDA-approved written patient information, Medication Guides, for certain prescription drug and biological products that pose a serious and significant public health concern (see part 208 (21 CFR part 208)). Medication Guides are intended to provide information that FDA has determined is necessary to patients' safe and effective use of drug products. Under § 208.24, manufacturers who ship drug products for which Medication Guides are required are responsible for ensuring that Medication Guides are provided in sufficient numbers to allow distributors, packers, or authorized dispensers to provide the guides to all patients who receive the drug product. Alternatively, manufacturers may provide the means for distributors, packers, or authorized dispensers to produce and provide Medication Guides to patients. Section 208.24 also requires each authorized dispenser of a prescription drug for which a Medication Guide is required to provide the guide to the patient, or to the patient's agent, when the product is dispensed, unless exempt from this requirement under § 208.26. The failure to provide a Medication Guide when such a product is dispensed would cause the product to be misbranded in violation of the Federal Food, Drug, and Cosmetic Act (the act) (see sections 502(a), 201(n), and 503(b)(2) of the act (21 U.S.C. 352(a), 321(n), and 353(b)(2)). Consumers may receive prescription drug information through sources other than Medication Guides. For example, patient package inserts
(PPIs)are FDA-approved patient information required to be dispensed with certain drugs such as estrogens (21 CFR 310.515) and oral contraceptives (21 CFR 310.501) to ensure the safe and effective use of these products. PPIs are considered part of the product labeling. Products with Medication Guides do not have PPIs; a required Medication Guide would replace an existing PPI for a product. Consumer medication information
(CMI)is another source of prescription drug information. CMI, which is not FDA-approved, is a private sector initiative based on Public Law 104-180. This law sets specific distribution and quality goals and timeframes for the private sector distribution of written prescription drug information to consumers. The law requires that the Secretary of the Department of Health and Human Services evaluate the private sector progress toward meeting these goals, including that, by 2006, 95 percent of people receiving new prescriptions would receive useful written patient information with their prescriptions. For this public hearing, FDA is not soliciting comments on PPIs or the CMI initiative. Comments should be limited to the Medication Guide program, including the questions listed in section II of this document. A list of drug products with Medication Guides is available on FDA's Web site at *http://www.fda.gov/cder/offices/ods/medication_guides.htm* . II. Scope of Hearing FDA is interested in obtaining public comment on ways to improve communication to patients consistent with the requirement that Medication Guides, FDA-approved patient information, be distributed for selected prescription drugs that pose a serious and significant public health concern. As stated in § 208.1, patient labeling in the form of a Medication Guide is required if one or more of the following circumstances exist: 1. The drug product is one for which patient labeling could help prevent serious adverse effects. 2. The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect the patients' decision to use, or continue to use, the product. 3. The drug product is important to health and patient adherence to directions for use is crucial to the effectiveness of the drug. The following questions are organized according to consumers, pharmacies/mail order pharmacies, manufacturers, information vendors/wholesalers, and academicians/researchers. Specifically, we are seeking input on the following issues: *Consumers* 1. What is the best way for consumers to be informed about the serious risks of a drug product or other important prescribing information? Do Medication Guides have a unique or important role in educating consumers about these risks compared to other written medication information distributed at the pharmacy? Should the information be combined or simplified into fewer or one communication vehicle(s)? 2. How do consumers prefer to receive Medication Guide information (e.g., paper, e-mail, Internet)? When should they receive Medication Guide information (e.g., when prescribed, when dispensed, when they download it from a Web site or e-mail message)? 3. Are Medication Guides easy to read and understand? How can Medication Guides be improved? Do they serve as useful adjuncts to counseling by physicians or pharmacists? *Pharmacies/Mail Order Pharmacies* 1. Currently, how are you informed that a Medication Guide is required to be distributed with a specific medication? 2. How do you receive Medication Guides from the manufacturers (e.g., in what format)? Should the way you receive these be changed? If so, how? 3. What are the challenges in complying with the Medication Guide regulation, maintaining an adequate supply of Medication Guides, and distributing Medication Guides to consumers? What changes should be made to the Medication Guide program to address these challenges? 4. What steps would you need to take to facilitate electronic distribution of Medication Guides (e.g., e-mailed to patients)? 5. Do you consider the Medication Guide to be a valuable tool in counseling patients about drugs with serious risks? 6. Do Medication Guides have a unique role compared to other communication vehicles that patients receive at the pharmacy? Should the information be combined or simplified into fewer communication vehicles? 7. What process improvements could be made to ensure that patients receive appropriate drug risk information at the pharmacy? 8. What are the advantages and disadvantages of having Medication Guides to cover a class of drugs versus Medication Guides for each individual product in a class? *Manufacturers* 1. What steps do you take to ensure compliance with the Medication Guide requirements? What challenges do you encounter in complying with the requirement to distribute Medication Guides with the product to pharmacies and others? How do you ensure that pharmacies are receiving a sufficient supply of Medication Guides? 2. Have means other than paper, such as electronic files, been used to supply Medication Guides to pharmacies or third-party vendors? If so, please describe your experience. If not, please explain why not. 3. How do you instruct pharmacies that Medication Guides must be dispensed with certain prescription drugs per § 208.24(d)? 4. Should standardized language and/or a uniform symbol on the container label be used for the required instruction to dispensers? If so, please propose standardized language and suggest a uniform symbol that might be appropriate. 5. What can be done by means of packaging, such as “unit-of-use,” to ensure that a Medication Guide is shipped with the drug product so that it is distributed with each prescription? What are the advantages and disadvantages of using unit-of-use packaging for any product that requires a Medication Guide? 6. What are the advantages and disadvantages of developing Medication Guides to cover a class of drugs rather than having a separate Medication Guide for each product in a class? *Information Vendors/Wholesalers* 1. What challenges or issues regarding distribution of Medication Guides have you encountered? What changes should be made to the Medication Guide program to address these challenges? 2. What challenges do information vendors face when offering electronic versions of Medication Guides in the FDA-approved format? What ideas do you have regarding how Medication Guides could be integrated into other consumer information? *Academicians/Researchers* 1. Please describe any research that is available regarding how often patients receive, read, and/or understand Medication Guides. 2. What research is available about Medication Guide comprehensibility and understandability for the diverse range of health literacy levels or special populations (e.g., elderly, adolescents, non-English speaking)? Please describe your recommendations as to how FDA should modify Medication Guides to more effectively inform a broader audience about drug risk information. III. Notice of Hearing Under 21 CFR Part 15 The Commissioner of the FDA is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The presiding officer will be the Commissioner or his designee. The presiding officer will be accompanied by a panel of FDA employees with relevant expertise. Persons who wish to participate in the part 15 hearing must file a written or electronic notice of participation with the Division of Dockets Management (see *Addresses* ). To ensure timely handling, any outer envelope should be clearly marked with the docket number listed in brackets in the heading of this document along with the statement “FDA Public Hearing: Use of Medication Guides to Distribute Drug Risk Information to Patients.” Groups should submit two written copies. Requests to make a presentation should contain the potential presenter's name, address, telephone number, affiliation, if any, the sponsor of the presentation (e.g., the organization paying travel expenses or fees), if any, a brief summary of the presentation, and the approximate amount of time requested for the presentation. The agency requests that interested persons and groups having similar interests consolidate their comments and present them through a single representative. After reviewing the notices of participation and accompanying information, FDA will schedule each appearance and notify each participant of the time allotted to the presenter and the approximate time that presenter's oral testimony is scheduled to begin. If time permits, FDA may allow interested persons attending the hearing who did not submit a written or electronic notice of participation in advance to make an oral presentation at the conclusion of the hearing. The hearing schedule will be available at the hearing. After the hearing, the schedule will be placed on file in the Division of Dockets Management under the docket number listed in brackets in the heading of this document. Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. Any handicapped persons requiring special accommodations to attend the hearing should direct those needs to the contact person (see *Contacts* ). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of these provisions as specified in § 15.30(h). IV. Request for Comments Interested persons may submit to the Division of Dockets Management (see *Addresses* ) written or electronic notices of participation and comments for consideration at the hearing (see *Dates and Times* ). To permit time for all interested persons to submit data, information, or views on this subject, the administrative record of the hearing will remain open until July 12, 2007. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management (see *Addresses* ). You should annotate and organize your comments to identify the specific questions to which they refer (see section II of this document). Two copies of any mailed comments are to be submitted, 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. V. Transcripts The hearing will be transcribed as stipulated in § 15.30(b). The transcript of the hearing will be available 30 days after the hearing on the Internet at *http://www.fda.gov/ohrms/dockets* , and orders for copies of the transcript can be placed at the meeting or through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page. Dated: April 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6506 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0118] Draft Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; 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 “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This draft guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products (71 FR 3922, January 24, 2006). This draft guidance is intended to help applicants select information for inclusion in the “Dosage and Administration” section of labeling and to help them organize that information. DATES: Submit written or electronic comments on the draft guidance by July 9, 2007. General comments on agency guidance documents are welcome at any time. 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; or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the 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: Joseph P. Griffin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-796-1077; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” The draft guidance provides recommendations on how to select information for inclusion in the “Dosage and Administration” section of labeling and how to organize information within the section. This draft guidance is one of a series guidances FDA is developing, or has developed, to assist applicants and reviewers with the format and content of certain sections of the labeling for prescription drugs. In the **Federal Register** of January 24, 2006 (71 FR 3998 and 3999), FDA issued final guidances on the format and content of the “Adverse Reactions” and “Clinical Studies” sections of labeling and draft guidances on implementing the new labeling requirements for prescription drugs and the format and content of the “Warnings and Precautions,” “Contraindications,” and “Boxed Warning” sections of labeling. The new labeling requirements (71 FR 3922) and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement 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 the draft guidance. 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. Paperwork Reduction Act of 1995 This draft 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 201.57 have been approved under OMB control number 0910-0572. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm,* or *http://www.fda.gov/cber/guidelines.htm* . Dated: March 30, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6508 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0106] Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting—Improving Human Subject Protection; 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 “Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting—Improving Human Subject Protection.” This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board (IRB). FDA developed this draft guidance in response to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. DATES: Submit written or electronic comments on the draft guidance by June 8, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Critical Path Programs (HF-18), Office of the Commissioner, 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 telephone requests to 800-835-4709 or 301-827-1800. 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: Terrie L. Crescenzi, Office of Critical Path Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7864. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for clinical investigators, sponsors, and IRBs entitled “Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting—Improving Human Subject Protection.” Under the regulations in 21 CFR part 50 (Protection of Human Subjects), part 56 (21 CFR part 56) (Institutional Review Boards), part 312 (21 CFR part 312) (Investigational New Drug Application), and part 812 (21 CFR part 812) (Investigational Device Exemptions), an IRB must review and approve a clinical study before the study is initiated. Additionally, after an IRB's initial review and approval, an IRB must conduct continuing review of the study at intervals appropriate to the degree of risk presented by the study, at least annually. The primary purpose of both the initial review of a study and the periodic review of the conduct of the study is to assure the protection of the rights and welfare of human subjects. To assure the protection of the rights and welfare of human subjects during the conduct of a clinical study, an IRB must have information concerning unanticipated problems in the study and changes in the research activity. Such information may be important to the IRB's review. This draft guidance discusses adverse event reporting to IRBs by sponsors, and investigators, and emphasizes the greater value of well-analyzed adverse event data to an IRBs review. 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 adverse event reporting for the purpose of improving human subject protection. 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. The Paperwork Reduction Act of 1995 This draft 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 part 56 have been approved under OMB Control No. 0910-0130; the collections of information in part 312 have been approved under OMB Control No. 0910-0014; and the collections of information in part 812 have been approved under OMB Control No. 0910-0078. III. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: April 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6595 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0117] Draft Guidance for Industry on Orally Disintegrating Tablets; 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 “Orally Disintegrating Tablets.” The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet
(ODT)and also provides recommendations to applicants who would like to designate a proposed product as an ODT. DATES: Submit written or electronic comments on the draft guidance by June 8, 2007. General comments on agency guidance documents are welcome at any time. 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: Frank O. Holcombe, Jr., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9310. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Orally Disintegrating Tablets.” The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an ODT and also provides recommendations to applicants who would like to designate proposed products as ODTs. In an effort to develop drug products that are more convenient to use and to address potential issues of patient compliance for certain product indications and patient populations, pharmaceutical manufacturers have developed products that can be ingested simply by placing them on the tongue. The products are designed to disintegrate or dissolve rapidly on contact with saliva, thus eliminating the need for chewing the tablet, swallowing an intact tablet, or taking the tablet with water. This mode of administration was initially expected to be beneficial to pediatric and geriatric patients, to people with conditions related to impaired swallowing, and for treatment of patients when compliance may be difficult (e.g., for psychiatric disorders). As firms started developing additional products using different technology and formulations, many of these later products exhibited wide variation in product characteristics from the initial products. Because this shift in product characteristics can affect a product's suitability for particular uses, the agency developed this guidance for industry. 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 orally disintegrating tablets. 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/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: March 30, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6509 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Council on Graduate Medical Education; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Council on Graduate Medical Education (COGME). *Dates and Times:* April 30, 2007, 8:30 a.m.- 5 p.m.; and May 1, 2007, 8:30 a.m.-2:30 p.m. *Place:* Hilton Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852-1699. *Status:* The meeting will be open to the public. *Agenda:* The agenda for April 30 in the morning will include: Welcome and opening comments from the Chair and Executive Secretary of COGME and senior management staff of the Health Resources and Services Administration. On April 30, following the welcoming remarks from the COGME Chair, the Executive Secretary of COGME, and Agency senior management, there will be a review and discussion of the draft paper “Enhancing GME Flexibility,” by Barbara Chang, M.D., and other writing group members. After lunch there will be a review and discussion of the draft paper “New Paradigms for Physician Training for Improving Access to Healthcare” by Earl Reisdorff, M.D. and other writing group members. At 3 p.m. there will be a breakout of Council members into the two draft writing groups for further report revisions. On May 1 there will be reports to the Council and further discussion on writing group activities and reports. The Council will conclude with a discussion of the timeframe and next steps for producing the Reports. Agenda items are subject to change as priorities dictate. FOR FURTHER INFORMATION CONTACT: Jerald M. Katzoff, Executive Secretary, COGME, Division of Medicine and Dentistry, Bureau of Health Professions, Parklawn Building, Room 9A-27, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone
(301)443-6785. Dated: April 2, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-6597 Filed 4-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Request for Public Comment. SUMMARY: HRSA is soliciting comments on the proposed eligibility criteria for the *Reimbursement of Travel and Subsistence Expenses toward Living Organ Donations* Program. Eligibility criteria were proposed by the program grantee, the Regents of the University of Michigan, to HRSA. HRSA has determined that the proposed eligibility criteria constitute a proper interpretation of the authorizing statute's requirements, including determinations as to which individuals would otherwise be unable to meet the eligible expenses authorized under this Program. HRSA is soliciting public comment on the criteria outlined in this notice. HRSA will consider the comments in light of the authorizing statute and seek feedback from the Regents of the University of Michigan concerning the comments. HRSA will then approve final criteria. The final program eligibility criteria will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, *http://www.livingdonorassistance.org* . DATES: Written comments must be submitted to the office in the address section below by mail or e-mail on or before May 24, 2007. ADDRESSES: Please send all written comments to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone
(301)443-7577; fax
(301)594-6095; or e-mail: *jburdick@hrsa.gov* . FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone
(301)443-7577; fax
(301)594-6095; or e-mail: *jburdick@hrsa.gov* . SUPPLEMENTARY INFORMATION: Congress has provided specific authority under section 377 of the Public Health Service
(PHS)Act, as amended, 42 U.S.C. 274f, for providing reimbursement of travel and subsistence expenses for certain living organ donors, with preference for those for whom paying such expenses would create a financial hardship. On September 25, 2006, HRSA awarded a 4-year, $8,000,000, Cooperative Agreement to the Regents of the University of Michigan to establish this program. The authorizing statute stipulates that the Secretary, in carrying out this program, shall give preference to those individuals that the Secretary determines are more likely to be otherwise unable to meet such expenses. HRSA asked the grantee to propose eligibility criteria to HRSA to satisfy this requirement. The two main issues raised in developing the program eligibility criteria are:
(1)Which criteria should be used to identify potential living organ donors who may be unable to pay for travel and subsistence expenses associated with living organ donation? This issue is important because such donors are to receive priority under this program; and
(2)Which criteria should be established to assess the potential organ recipient's ability to pay the living donor's travel and subsistence expenses? This determination is significant because the authorizing statute provides that payments are not to be made if a donor's eligible expenses have been, or reasonably can be expected to be, paid by the organ recipient. This program is intended for individuals with end stage organ failure for whom a transplant from a suitable living donor is a viable therapy. The purpose of this solicitation of comments is to obtain feedback from the public on the proposed eligibility criteria. These comments are important to assure that the needs and concerns of the general public, including its views as to the optimal means of carrying out the program's objectives, are addressed. After considering the comments, HRSA will approve final criteria, which will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, *http://www.livingdonorassistance.org* . Proposed Eligibility Guidelines The program's authorizing legislation explicitly states that funds “will not be expended to pay the qualifying expenses of a donating individual to the extent that payment has been made, or can reasonably be expected to be made, with respect to such expenses:
(1)Under any State compensation program, under an insurance policy, or under any Federal or State health benefits program;
(2)By an entity that provides health services on a prepaid basis; or
(3)By the recipient of the organ.” In implementing this authority, the proposed threshold of income eligibility for the recipient of the organ is 200% of the HHS Poverty Guidelines (described below). At any income above this measure, it can reasonably be expected that the recipient of the organ could pay for the donor's qualifying expenses. However, the transplant social worker or appropriate transplant center personnel involved in the potential transplant recipient's evaluation process can provide a written justification that notwithstanding the potential transplant recipient's income level, significant financial hardship is likely to be encountered by the potential transplant recipient of the organ for the payment of the donor's qualifying expenses in the course of the donation process. This justification will be given consideration by the program's Review Committee. All live organ donors are eligible for reimbursement of qualifying expenses provided all the criteria for donor reimbursement are fulfilled. However, subject to availability of funds, preference will be given to donors who are more likely to be otherwise unable to meet the qualifying expenses, in the following proposed order of priority: *Preference Category 1:* Donor income and recipient anticipated income each is ≤200% of the HHS Poverty Guidelines in their respective States of primary residence. *Preference Category 2:* Donor income is ≤200% of the HHS Poverty Guidelines in the State of primary residence. *Preference Category 3:* Recipient anticipated income is ≤200% of the HHS Poverty Guidelines in the State of primary residence. *Preference Category 4:* Donors who can demonstrate that notwithstanding their income level, significant financial hardship is likely to be encountered for qualifying non-medical expenses in the course of the donation process. *Preference Category 5:* Any live organ donor, notwithstanding income level or financial hardship, who meets the criteria for donor reimbursement. Recipient anticipated income is the total income from all sources that the recipient is expected to receive in the year in which live donor organ transplantation will occur for the patient with previous existing organ failure or the subsequent calendar year after the year of onset of end stage organ failure for a new patient with end stage organ failure. The HHS Poverty Guidelines are updated periodically and the guidelines in effect at the time of application will be applied. As an illustration, the HHS Poverty Guidelines for 2006 (71 Fed. Reg. 3848) are shown in the table below. 2006 HHS Poverty Guidelines Persons in family or household 48 Contiguous states and DC Alaska Hawaii 1 $9,800 $12,250 $11,270 2 13,200 16,500 15,180 3 16,600 20,750 19,090 4 20,000 25,000 23,000 5 23,400 29,250 26,910 6 26,800 33,500 30,820 7 30,200 37,750 34,730 8 33,600 42,000 38,640 For each additional person, add 3,400 4,250 3,910 Source: 71 FR 3848 (Jan. 24, 2006). Proposed Criteria for Donor Reimbursement In addition to the eligibility and priority guidelines discussed above, the following criteria for donor reimbursement are proposed: 1. Any individual who in good faith incurs qualifying expenses toward the intended donation of an organ but with respect to whom, for such reasons as the Secretary determines to be appropriate, no donation of the organ occurs (see special provision). This criteria is specifically discussed in the authorizing statute. 2. Donor and recipient of the organ are either U.S. citizens or lawfully admitted residents of the U.S. 3. Donor and recipient have primary residence in the U.S. or its territories. 4. Travel is originating from the donor's primary residence. 5. Donor meets the criteria for informed consent for the planned procedure according to applicable State and Federal laws. 6. Donor and recipient are not participating in a paired exchange program or a living donor/deceased donor exchange for the particular donation procedure for which reimbursement is being sought unless the legality of such practices is clarified by the Federal Government. 7. Donor and recipient attest to full compliance with section 301 of the National Organ Transplant Act (NOTA), as amended (42 U.S.C. 274e) which stipulates in part that “ * * * [i]t shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.” 8. The transplant center where the donation procedure occurs attests to its status of good standing with the Organ Procurement and Transplantation Network ( *i.e.* , it is not a Member Not in Good Standing) and assurance that the program follows best practices for the health and safety of living donors such as the recommendations provided in the Consensus Statement of the Ethics Committee of the Vancouver Forum on living organ donation (Source: *Pruett TL, Tibell A, Alabdulkareem A, Bhandari M, Cronin DC, Dew MA, Dib-Kuri A, Gutmann T, Matas A, McMurdo L, Rahmel A, Rizvi SA, Wright L, Delmonico FL. The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor* . Transplantation 81(10):1386-1387; (2006). The public is invited to submit comments on these criteria. Proposed Qualifying Expenses For the purpose of the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program, qualifying expenses presently include only travel, lodging, and meals and incidental expenses incurred by the donor and/or accompanying person(s) as part of:
(1)Donor evaluation clinic visit or hospitalization;
(2)Hospitalization for the living donor surgical procedure; and/or
(3)Medical or surgical follow-up clinic visit or hospitalization within 90 days after the living donation procedure. The Program will pay for up to five trips per donation or intended donation. Three of these trips may be for the potential living donor and up to two trips may be for any accompanying person(s). The total Federal reimbursement for qualified expenses during the donation process for the donor and accompanying individuals shall not exceed $6,000. The public is invited to submit comments on these criteria. Special Provisions The authorizing statute provides that the Secretary may consider as an eligible donating individual a person who in good faith incurs qualifying expenses toward the intended donation of an organ but with respect to whom, for reasons the Secretary determines to be appropriate, no donation of the organ occurs. Many factors may prevent the intended and willing donor from proceeding with the donation. Such circumstances include present health status of the intended donor or recipient that would prevent the transplant or donation from proceeding, perceived long-term risks to the intended donor, circumstances such as acts of God (e.g., major storms or hurricanes), or other unforeseen events outside of the intended donor's control. In such cases, the intended donor and accompanying persons may receive reimbursement for the qualified expenses incurred. In the case that a potential donor no longer wishes to donate, he or she may receive reimbursement for qualified expenses incurred. However, payments received for expenses that were not incurred by the intended donor and accompanying persons must be refunded. Otherwise, such payment will be treated as income to the intended donor, and in accordance with Internal Revenue Service
(IRS)regulations, the Regents of the University of Michigan shall notify the IRS (Form 1099) that a payment has been made to the intended donor in the amount equivalent to the unexpended payment. Dated: March 30, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-6598 Filed 4-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Establishment; Pursuant to the Federal Advisory Committee Act, as Amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), Announces the Establishment of the Council of Councils (Council) The Council shall provide advice and recommendations to the Director, NIH, or other appropriate delegated officials on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives including making recommendations with respect to the conduct and support of research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between two or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning. Duration of this committee is two years from the date the Charter is filed. Dated: March 29, 2007. Elias A. Zerhouni, Director, National Institutes of Health. [FR Doc. 07-1730 Filed 4-6-07; 8:45 am]
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Traces to 18 documents
13 references not yet in our index
  • 12 CFR 225
  • 38 Stat. 721
  • Pub. L. 92-463
  • 21 CFR 208
  • Pub. L. 104-180
  • 21 CFR 15
  • 21 CFR 10
  • 44 USC 3501-3520
  • 21 CFR 50
  • 21 CFR 56
  • 21 CFR 312
  • 21 CFR 812
  • 71 FR 3848
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Notices
Proposed Consent Agreement
U.S.C.§ 1841
U.S.C.§ 1842
U.S.C.§ 1843
C.F.R.§ 4.9
U.S.C.§ 46
C.F.R.§ 2.34
U.S.C.§ 241
U.S.C.§ 243
U.S.C.§ 355
Cite12 CFR 225
Stat.38 Stat. 721
Pub. L.Pub. L. 92-463
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