Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Committee for Pharmaceutical Science; Notice of Meeting, 41027-41028 [E6-11471]

Download as PDF Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices payment of dues, administrative matters, or other policies. The proviso is intended to preserve existing or future rules or regulations of ACTRIS that ABOR can demonstrate are reasonably related to the legitimate and procompetitive purposes of the MLS. In addition, the proposed order requires ABOR, within thirty days after the Order becomes final, to conform its rules to the substantive provisions of the Order. ABOR is also required to notify ABOR members and participants in ACTRIS of the Order through e-mail communications and its Web site. The proposed order requires notification of changes in the structure of ABOR, and requires ABOR to file regular written reports of ABOR’s compliance with the terms of the Order. The proposed Order applies to ABOR and entities that it owns or controls, including ACTRIS and Austinhomesearch.com. The Order by its terms does not prohibit ABOR members, or other persons or entities independent of ABOR that receive listing information from ABOR for use on their Web sites, from making independent decisions concerning their use or display of ACTRIS listing information that are consistent with their contractual obligations to ACTRIS. The proposed order will expire in 10 years. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. E6–11389 Filed 7–18–06; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator; American Health Information Community Biosurveillance Data Steering Group Meeting ACTION: Announcement of meeting. SUMMARY: This notice announces the second meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App.). DATES: July 26, 2006 from 4 p.m to 6 p.m. Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 4090 (a photo ID is needed for access to a Federal building). sroberts on PROD1PC70 with NOTICES ADDRESSES: The meeting will be available via internet access. Go to https://www.hhs.gov/ healthit/ahic.html for additional information on the meeting. SUPPLEMENTARY INFORMATION: Dated: July 12, 2006. Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator. [FR Doc. 06–6342 Filed 7–18–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards and Security (SSS). Time and Date: July 28, 2006, 9 a.m.–12:30 p.m. Place: Crown Plaza Hotel, 1001 14th Street, NW., Washington, DC 20005. Status: Open. Purpose: The purpose of this meeting is to discuss issues and concerns relative to implementation of the National Provider Identifier (NDI), and to discuss preliminary recommendations of the Consolidated Health Informatics Initiative (CHI) Allergy Workgroup. For Further Information Contact: Substantive program information as well as summaries of meetings and a roster of Committee members may be obtained from Denise Buenning, Senior Adviser, Office of EHealth Standards and Services, Centers for Medicare and Medicaid Services, MS: C5– 24–04, 7500 Security Boulevard, Baltimore, MD 21244–1850, telephone: 410–786–6333 or Marjorie S. Greenberg, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, Room 1100, Presidential Building, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone: (301) 458–4245. Information also is available on the NCVHS home page of the HHS Web site: https:// www.ncvhs.hhs.gov/ where an agenda for the meeting will be posted when available. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458–4EEO (4336) as soon as possible. FOR FURTHER INFORMATION CONTACT: Dated: July 10, 2006. James Scanlon, Deputy Assistant Secretary for Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 06–6341 Filed 7–18–06; 8:45 am] https://www.hhs.gov/healthit/ahic.html. BILLING CODE 4151–05–M VerDate Aug<31>2005 18:28 Jul 18, 2006 Jkt 208001 PO 00000 Frm 00045 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Committee for Pharmaceutical Science; Notice of Meeting AGENCY: Sfmt 4703 Food and Drug Administration, HHS. ACTION: BILLING CODE 4150–24–M 41027 Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Committee for Pharmaceutical Science. General Function of the Committees: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 4, 2006, from 8 a.m. to 5 p.m. Location: Hilton, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301–977–8900. Contact Person: Victoria FerrettiAceto, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1076), Rockville, MD 20857, 301–827– 7001, e-mail: Victoria.FerrettiAceto@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), codes 3014512536 or 3014512539. Please call the Information Line for up-to-date information on this meeting. When available, background materials for this meeting will be posted one business day prior to the meeting on the FDA Web site at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm. (Click on the year 2006 and scroll down to Endocrinologic and Metabolic Drugs Advisory Committee or the Advisory Committee for Pharmaceutical Science.) Agenda: The joint committee will discuss FDA’s efforts to assess the product quality of currently marketed levothyroxine sodium drug products. Earlier this year, FDA requested that manufacturers of currently marketed levothyroxine sodium products provide to it certain product release and stability information. The joint committee will consider FDA’s analyses and any clinical significance. Procedure: Interested persons may present data, information, or views, E:\FR\FM\19JYN1.SGM 19JYN1 41028 Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 13, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. 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 September 13, 2006. 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 Victoria Ferretti-Aceto 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: July 13, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11471 Filed 7–18–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 0915–0176)—Extension Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) ‘‘Limitation on Prices of Drugs Purchased by Covered Entities.’’ Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B drug discount program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to develop audit guidelines and because of the potential sroberts on PROD1PC70 with NOTICES Responses per respondent Number of respondents Reporting requirement for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) has developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities. Audit Guidelines: A manufacturer will be permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer must notify the covered entity in writing when it believes the covered entity has violated the provisions of 340B. If the problem cannot be resolved, the manufacturer must then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA OPA for review. The office will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to the HRSA OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General. Dispute Resolution Guidelines: Because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA OPA has developed an informal dispute resolution process which can be used if an entity or manufacturer is believed to be in violation of section 340B. Prior to filing a request for resolution of a dispute with the HRSA OPA, the parties must attempt, in good faith, to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to the HRSA OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. The estimates of annualized burden are as follows: Total responses Hours per response Total burden hours Audits Audit Notification of Entity* .................................................. Audit Work Plan ................................................................... VerDate Aug<31>2005 18:28 Jul 18, 2006 Jkt 208001 PO 00000 Frm 00046 2 1 Fmt 4703 Sfmt 4703 1 1 E:\FR\FM\19JYN1.SGM 2 1 19JYN1 4 8 8 8

Agencies

[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41027-41028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory 
Committee and the Advisory Committee for Pharmaceutical Science; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committees: Endocrinologic and Metabolic Drugs Advisory 
Committee and the Advisory Committee for Pharmaceutical Science.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 4, 2006, from 8 
a.m. to 5 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. 
The hotel phone number is 301-977-8900.
    Contact Person: Victoria Ferretti-Aceto, Center for Drug Evaluation 
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 
(for express delivery, 5630 Fishers Lane, rm. 1076), Rockville, MD 
20857, 301-827-7001, e-mail: Victoria.FerrettiAceto@fda.hhs.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), codes 3014512536 or 3014512539. Please call 
the Information Line for up-to-date information on this meeting. When 
available, background materials for this meeting will be posted one 
business day prior to the meeting on the FDA Web site at https://
www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2006 and 
scroll down to Endocrinologic and Metabolic Drugs Advisory Committee or 
the Advisory Committee for Pharmaceutical Science.)
    Agenda: The joint committee will discuss FDA's efforts to assess 
the product quality of currently marketed levothyroxine sodium drug 
products. Earlier this year, FDA requested that manufacturers of 
currently marketed levothyroxine sodium products provide to it certain 
product release and stability information. The joint committee will 
consider FDA's analyses and any clinical significance.
    Procedure: Interested persons may present data, information, or 
views,

[[Page 41028]]

orally or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person on or before September 
13, 2006. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. 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 
September 13, 2006.
    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 Victoria Ferretti-
Aceto 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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11471 Filed 7-18-06; 8:45 am]
BILLING CODE 4160-01-S

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