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Federal Register / Vol. 70, No.

198 / Friday, October 14, 2005 / Notices 60093

Information Collection: Application for DEPARTMENT OF HEALTH AND Annual Responses: 92,789; Total
Participation in the Medicare Care HUMAN SERVICES Annual Hours: 51,314.
Management Performance To obtain copies of the supporting
Demonstration; Form Number: CMS– Centers for Medicare & Medicaid statement and any related forms for
10165 (OMB#: 0938–0965); Use: The Services these paperwork collections referenced
Medicare Care Management above, access CMS Web site address at
[Document Identifier: CMS–10064] http://www.cms.hhs.gov/regulations/
Performance (MCMP) Demonstration
and its corresponding Report to Agency Information Collection pra/, or e-mail your request, including
Congress are mandated by the section Activities: Submission for OMB your address, phone number, OMB
649 of the Medicare Prescription Drug, Review; Comment Request number, and CMS document identifier,
Improvement, and Modernization Act of to Paperwork@cms.hhs.gov, or call the
2003 (MMA). Section 649 of the MMA AGENCY: Centers for Medicare & Reports Clearance Office on (410) 786–
provides for the implementation of a Medicaid Services, HHS. 1326.
In compliance with the requirement To be assured consideration,
‘‘pay for performance’’ demonstration
of section 3506(c)(2)(A) of the comments and recommendations for the
under which Medicare would pay
Paperwork Reduction Act of 1995, the proposed information collections must
incentive payments to physicians who
Centers for Medicare & Medicaid be received by the OMB Desk Officer at
(1) adopt and use health information the address below, no later than 5 p.m.
technology; and (2) meet established Services (CMS), Department of Health
and Human Services, is publishing the on November 14, 2005. OMB Human
standards on clinical performance Resources and Housing Branch,
measures. This demonstration will be following summary of proposed
collections for public comment. Attention: CMS Desk Officer, New
held in four states, Arkansas, California, Executive Office Building, Room 10235,
Interested persons are invited to send
Massachusetts, and Utah. Providers that Washington, DC 20503.
comments regarding this burden
are enrolled in the Doctors’ Office
estimate or any other aspect of this Dated: October 6, 2005.
Quality—Information Technology
collection of information, including any Martique S. Jones,
(DOQ–IT) project are eligible to
of the following subjects: (1) The Acting Director, Regulations Development
participate in the demonstration. To necessity and utility of the proposed Group, Office of Strategic Operations and
enroll in the MCMP Demonstration, a information collection for the proper Regulatory Affairs.
physician/provider must submit an performance of the Agency’s function; [FR Doc. 05–20521 Filed 10–13–05; 8:45 am]
application form. The information (2) the accuracy of the estimated BILLING CODE 4120–01–P
collected will be used to assess burden; (3) ways to enhance the quality,
eligibility for the demonstration; utility, and clarity of the information to
Frequency: Reporting—One-time only; be collected; and (4) the use of DEPARTMENT OF HEALTH AND
Affected Public: Business or other for- automated collection techniques or HUMAN SERVICES
profit; Number of Respondents: 800; other forms of information technology to
Total Annual Responses: 800; Total minimize the information collection Food and Drug Administration
Annual Hours: 133. burden.
1. Type of Information Collection Blood Products Advisory Committee;
To obtain copies of the supporting
Request: Extension of a currently Notice of Meeting
statement and any related forms for the
proposed paperwork collections approved collection; Title of AGENCY: Food and Drug Administration,
referenced above, access CMS’ Web site Information Collection: Minimum Data HHS.
address at http://www.cms.hhs.gov/ Set (MDS) for Swing Bed Hospitals and ACTION: Notice.
regulations/pra/, or E-mail your request, Supporting Regulations in 42 CFR
including your address, phone number, 483.20 and 413.337; Form No.: CMS– This notice announces a forthcoming
OMB number, and CMS document 10064 (OMB # 0938–0872); Use: As meeting of a public advisory committee
identifier, to Paperwork@cms.hhs.gov, required under Section 1888(e)(7) of the of the Food and Drug Administration
Social Security Act, swing bed hospitals (FDA). At least one portion of the
or call the Reports Clearance Office on
must be reimbursed under the skilled meeting will be closed to the public.
(410) 786–1326.
nursing facility prospective payment Name of Committee: Blood Products
To be assured consideration, system. CMS uses the MDS data to Advisory Committee.
comments and recommendations for the reimburse swing bed hospitals for SNF- General Function of the Committee:
proposed information collections must level care furnished to Medicare To provide advice and
be received at the address below, no beneficiaries. The MDS3.0 is currently recommendations to the agency on
later than 5 p.m. on December 13, 2005. being developed with plans for field FDA’s regulatory issues.
CMS, Office of Strategic Operations and testing to begin in 2006 with the Date and Time: The meeting will be
Regulatory Affairs, Division of expectation of completion in 2007. At held on November 3, 2005, from 8 a.m.
Regulations Development, Attention: that time, CMS will analyze the data to 5:30 p.m., and on November 4, 2005,
Melissa Musotto, Room C4–26–05, 7500 derived from the study, including the from 8 a.m. to 3:30 p.m.
Security Boulevard, Baltimore, implementation of the new version of Location: Holiday Inn Gaithersburg, 2
Maryland 21244–1850. the MDS for swing bed hospitals. Since Montgomery Village Ave., Gaithersburg,
we do not have the MDS3.0 version MD 20879.
Dated: October 6, 2005.
available, we are requesting an Contact Person: Donald W. Jehn or
Michelle Shortt, extension for the current SB–MDS.; Pearline K. Muckelvene, Center for
Director, Regulations Development Group, Frequency: Reporting—Other (days 5, Biologics Evaluation and Research,
Office of Strategic Operations and Regulatory 14, 30, 60, and 90 of stay); Affected Food and Drug Administration, 1401
Affairs. Public: Not-for-profit institutions, and Rockville Pike, Rockville, MD 20852,
[FR Doc. 05–20517 Filed 10–13–05; 8:45 am] State, Local, and Tribal governments; 301–827–0314, or FDA Advisory
BILLING CODE 4120–01–P Number of Respondents: 820; Total Committee Information Line, 1–800–

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60094 Federal Register / Vol. 70, No. 198 / Friday, October 14, 2005 / Notices

741–8138 (301–443–0572 in the would constitute a clearly unwarranted 7001, FAX: 301–827–6776, e-mail:
Washington, DC area), code invasion of personal privacy (5 U.S.C. cliffordj@cder.fda.gov, or FDA Advisory
3014519516. Please call the Information 552b(c)(6)), and to permit discussion Committee Information Line, 1–800–
Line for up-to-date information on this and review of trade secret and/or 741–8138 (301–443–0572 in the
meeting. confidential information (5 U.S.C. Washington, DC area), code
Agenda: On November 3, 2005, in the 552b(c)(4)). The committee will discuss 3014512542. Please call the Information
morning, the committee will hear a subcommittee’s report of the internal Line for up-to-date information on this
updates on the following topics: (1) research programs in the Office of Blood meeting. The background material will
West Nile Virus; (2) draft guidance on Research and Review, CBER. become available no later than the day
nucleic acid testing (NAT) for human Persons attending FDA’s advisory before the meeting and will be posted
immunodeficiency virus (HIV)–1 and committee meetings are advised that the on FDA’s Web site at http://
hepatitis C virus (HCV): Testing, agency is not responsible for providing www.fda.gov/ohrms/dockets/ac/
product disposition, and donor deferral access to electrical outlets. acmenu.htm under the heading
and re-entry; (3) summary of the FDA welcomes the attendance of the ‘‘Oncologic Drugs Advisory Committee
Department of Health and Human public at its advisory committee (ODAC).’’ (Click on the year 2005 and
Services Advisory Committee on Blood meetings and will make every effort to scroll down to ODAC meetings.)
Safety and Availability held on accommodate persons with physical Agenda: The committee will discuss
September 19 and 20, 2005; and (4) re- disabilities or special needs. If you new drug applications approved under
entry of donors deferred based on require special accommodations due to 21 CFR 314.500 and 601.40 (subparts H
hepatitis B core antigen (anti-HBc) test a disability, please contact Donald W. and subpart E, respectively, accelerated
results. The committee will discuss Jehn or Pearline K. Muckelvene at least approval regulations) in an open session
approaches to over-the-counter (OTC) 7 days in advance of the meeting. to do the following: (1) Review the
home-use HIV test kits the rest of the Notice of this meeting is given under status of phase IV clinical studies; (2)
day. On November 4, 2005, in the the Federal Advisory Committee Act (5 identify difficulties associated with
morning, the committee will hear U.S.C. app. 2). completion of phase IV commitments;
information on serious adverse events
Dated: October 6, 2005. and (3) provide advice to sponsors to
resulting from interference with
Jason Brodsky, assist in the planning and execution of
measurement of blood glucose following
Acting Associate Commissioner for External postmarketing commitments of newly
infusion of maltose-containing immune
globulin intravenous (human) and will Relations. approved drugs. The committee will
discuss Alpha-1-Proteinase Inhibitor [FR Doc. 05–20560 Filed 10–13–05; 8:45 am] discuss phase IV commitments of: (1)
products. In the afternoon, the BILLING CODE 4160–01–S
new drug application (NDA) 50–718,
committee will hear an overview of the DOXIL (doxorubicin hydrochloride
research programs of the Office of Blood liposome injection, Johnson and
Research and Review, Center for DEPARTMENT OF HEALTH AND Johnson Pharmaceutical Research and
Biologics Evaluation and Research, as HUMAN SERVICES Development, L.L.C.) for the treatment
presented to a subcommittee of the of acquired immune deficiency
Blood Products Advisory Committee Food and Drug Administration syndrome (AIDS) related Kaposi’s
during their site visit on July 22, 2005, sarcoma in patients with disease that
Oncologic Drugs Advisory Committee; has progressed on prior combination
and discuss a subcommittee report. Notice of Meeting
Procedure: On November 3, 2005, the therapy or in patients who are intolerant
entire meeting is open to the public. On AGENCY: Food and Drug Administration, to such therapy; (2) NDA 20–221/S–002,
November 4, 2005, from 8 a.m. to 2:15 HHS. ETHYOL for injection (amifostine,
p.m. the meeting is open to the public. MedImmune Oncology, Inc.) for
ACTION: Notice.
Interested persons may present data, reducing the cumulative renal toxicity
information, or views, orally or in This notice announces a forthcoming associated with repeated administration
writing, on issues pending before the meeting of a public advisory committee of cisplatin in patients with advanced
committee. Written submissions may be of the Food and Drug Administration nonsmall cell lung cancer; (3) biologics
made to the contact person by October (FDA). The meeting is open to the license application (BLA) 103767/0,
25, 2005. Oral presentations from the public. ONTAK (denileukin diftitox, Seragen
public will be scheduled on November Incorporated) for the treatment of
3, 2005, between approximately 2 p.m. Name of Committee: Oncologic Drugs patients with persistent or recurrent
and 3:45 p.m. and on November 4, 2005, Advisory Committee. cutaneous T-cell lymphoma whose
between 10:30 a.m. and 11 a.m. Time General Function of the Committee: malignant cells express the CD25
allotted for each presentation may be To provide advice and component of the interleukin-2 receptor;
limited. Those desiring to make formal recommendations to the agency on (4) NDA 21–041, DEPOCYT (cytarabine
oral presentations should notify the FDA’s regulatory issues. liposome injection, SkyePharma Inc.)
contact person before October 25, 2005, Date and Time: The meeting will be for the intrathecal treatment of
and submit a brief statement of the held November 8, 2005, from 8 a.m. to lymphomatous meningitis; and (5) NDA
general nature of the evidence or 5 p.m. 21–156, CELEBREX (celecoxib capsules,
arguments they wish to present, the Location: Holiday Inn, The Ballrooms, Pfizer, Inc.) for reducing the number of
names and addresses of proposed Two Montgomery Village Ave., adenomatous colorectal polyps in
participants, and an indication of the Gaithersburg, MD. familial adenomatous polyposis, as an
approximate time requested to make Contact Person: Johanna M. Clifford, adjunct to usual care (e.g., endoscopic
their presentation. Center for Drug Evaluation and Research surveillance, surgery); (6) NDA 21–174,
Closed Committee Deliberations: On (HFD–21), Food and Drug MYLOTARG (gemtuzumab ozogamicin
November 4, 2005, from 2:15 p.m. to 3 Administration, 5600 Fishers Lane, (for for injection, Wyeth Pharmaceuticals,
p.m., the meeting will be closed to express delivery, 5630 Fishers Lane, rm. Inc.) for the treatment of patients with
permit discussion where disclosure 1093) Rockville, MD 20857, 301–827– CD33 positive acute myeloid leukemia

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