Conference Grants to Support State Food Safety Task Force Meetings; Availability of Funds Grants; Request for Applications; Correction, 6015-6016 [05-2209]

Download as PDF Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices Act) to appoint a Practicing Physicians Advisory Council (the Council) based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and carrier manual instructions related to physicians’ services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the consultation must occur before publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services no later than December 31st of each year. The Council consists of 15 physicians, each of whom must have submitted at least 250 claims for physicians’ services under Medicare in the previous year. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, Statelicensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists and chiropractors. Members serve for overlapping 4-year terms; terms of more than 2 years are contingent upon the renewal of the Council by appropriate action prior to its termination. Section 1868(a)(1) of the Act provides that nominations to the Secretary for Council membership must be made by medical organizations representing physicians. The Council held its first meeting on May 11, 1992. The current members are—Jose Azocar, M.D.; James Bergeron, M.D.; Ronald Castellanos, M.D.; Rebecca Gaughan, M.D.; Peter Grimm, D.O.; Carlos R. Hamilton, M.D.; Dennis K. Iglar, M.D.; Joe Johnson, D.C.; Christopher Leggett, M.D.; Barbara McAneny, M.D.; Geraldine O’Shea, D.O.; Laura B. Powers, M.D.; Michael T. Rapp, M.D. (Chairperson); Anthony Senagore, M.D.; and Robert L. Urata, M.D. The meeting will commence with the swearing-in of three Council members. The Council’s Executive Director will give a status report and the CMS responses to the recommendations made by the Council at the November 22, 2004 meeting and prior meeting recommendations. Additionally, updates will be provided on the CMS Report to the Congress on Contractor Reform, and the Physician Regulatory Issues Team. In accordance with the Council charter, CMS is requesting assistance with the following agenda topics: VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 • Pay for Performance Initiatives. • Competitive Bidding on Drugs. • Physician Regulation Proposed Rule; and • Medicare Prescription Drug Benefit: CMS’ Physician Education Plan. For additional information and clarification on these topics, contact the Executive Director, listed under the FOR FURTHER INFORMATION CONTACT section of this notice. Individual physicians or medical organizations that represent physicians wishing to make a 5-minute oral presentation on agenda issues must contact the Executive Director by 12 noon (e.s.t.) on February 18, 2005, to be scheduled. Testimony is limited to agenda topics only. The number of oral presentations may be limited by the time available. A written copy of the presenter’s oral remarks must be submitted to John P. Lanigan, Designated Federal Official (DFO), no later than 12 noon (e.s.t) on February 18, 2005, for distribution to Council members for review prior to the meeting. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution at the same times as listed for oral presentations. The meeting is open to the public, but attendance is limited to the space available. Special Accommodations: Individuals requiring sign language interpretation or other special accommodation must contact John P. Lanigan by e-mail at JLanigan@cms.hhs.gov or by telephone at (410) 786–2312 at least 10 days before the meeting. Authority: (Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, section 10(a).) (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: January 31, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05–2175 Filed 2–3–05; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 6015 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Conference Grants to Support State Food Safety Task Force Meetings; Availability of Funds Grants; Request for Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is correcting notice document 04– 14395 beginning on page 35651 in the issue of Friday, June 25, 2004, by making the following corrections: On page 35651 in the second column, the DATES section is corrected to read: ‘‘DATES: The application receipt date for new applications is March 15, 2005. The application receipt date for new applications for each subsequent year this program is in effect will be March 15.’’ On page 35651, in the second column, the ‘‘ADDRESSES’’ section should read: ‘‘ADDRESSES: FDA is accepting new applications for this program electronically via Grants.gov.; applicants are strongly encouraged to apply electronically by visiting the Web site https://www.grants.gov. and following the instructions under ‘‘APPLY.’’ The applicant must register in the Central Contractor Registration (CCR) database in order to be able to submit the application.’’ Information about CCR is available at https://www.grants.gov/CCRRegister. The applicant must register with the Credential Provider for Grants.gov. Information about this requirement is available at https://www.grants.gov/ CredentialProvider. If it is necessary for applicants to submit applications other than through the electronic process, application forms are available from, and completed applications should be submitted to Michelle Caraffa, Division of Contracts and Grants Management (HFA–500), Food and Drug Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301–827– 7025, e-mail: mcaraffa@oc.fda.gov. Application forms PHS 5161–1 are available via the Internet at: https:// www.psc.gov/forms (Revised 7/00). Applications handcarried or commercially delivered should be addressed to 5630 Fishers Lane (HFA– 500), rm. 2129, Rockville, MD 20857. An application not received in time for orderly processing will be returned to the applicant without consideration. On page 35651, beginning in the second column, ‘‘FOR FURTHER INFORMATION CONTACT’’ should read: E:\FR\FM\04FEN1.SGM 04FEN1 6016 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices FOR FURTHER INFORMATION CONTACT: Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES). Regarding the programmatic aspects of this notice: Stephen Toigo, Division of Federal-State Relations (DFSR), Office of Regulatory Affairs, Food and Drug Administration (HFC–150), 5600 Fishers Lane, rm. 12–07, Rockville, MD 20857, 301– 827–6906, or access the Internet at: https://www.fda.gov/ora/fed_state/ default.htm. For general ORA program information contact your Regional Food Specialists at https:// www.fda.gov/ora/fed_state/ DFSR_Activities/ food_specialists.htm On page 35653 in the first column, under section V.A, a sentence is added at the end of the paragraph that reads: ‘‘A Current Listing of SPOCs can be found at https://www.whitehouse.gov/ omb/grants/spoc.html.’’ On page 35653 in the third column, under section VII, the paragraph is revised to read: ‘‘Applicants are encouraged to apply electronically (see ADDRESSES). If not, the original and two copies of the completed grant application Form PHS–5161–1 (Revised 7/00) for State and local governments should be delivered to the Grants Management Office. The receipt date is March 15, 2005. No supplemental material or addenda will be accepted after the receipt date.’’ On page 35653 in the third column, under section VIII.A in the second paragraph, the last sentence should read: ‘‘FDA is now accepting applications via the Internet.’’ Dated: January 31, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2209 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs 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. VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 Name of Committee: Oncologic Drugs 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 March 3, 2005, from 8 a.m. to 5 p.m. and March 4, 2005, from 8 a.m. to 1 p.m. Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Johanna M. Clifford, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: On March 3, 2005, the committee will do the following: (1) Discuss new drug application (NDA) 21–115, COMBIDEX (ferumoxtran–10), Advanced Magnetics, Inc., proposed indication for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases, and (2) discuss prostate cancer endpoints as a followup to the June 2004 FDA workshop. On March 4, 2005, the committee will do the following: (1) Discuss the results of a confirmatory trial for NDA 21–399, IRESSA (gefitinib) AstraZeneca Pharmaceticals LP, for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, and (2) discuss safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21–223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp. ZOMETA is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. It is also approved for hypercalcemia of malignancy. AREDIA is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 metastases of breast cancer and osteolytic lesions of multiple myeloma. It is also indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, and treatment of patients with moderate to severe Paget’s disease of bone. 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 by February 28, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on March 3, 2005, and between approximately 10:30 a.m. to 11 a.m. on March 4, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 28, 2005, 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. 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 Trevelin Prysock at 301–827–7001, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 27, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–2208 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Development of Revised Need for Assistance Criteria for Assessing Community Need for Comprehensive Primary and Preventive Health Care Services Under the President’s Health Centers Initiative Health Resources and Services Administration, HHS. AGENCY: E:\FR\FM\04FEN1.SGM 04FEN1

Agencies

[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Notices]
[Pages 6015-6016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2209]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Conference Grants to Support State Food Safety Task Force 
Meetings; Availability of Funds Grants; Request for Applications; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is correcting notice 
document 04-14395 beginning on page 35651 in the issue of Friday, June 
25, 2004, by making the following corrections:
    On page 35651 in the second column, the DATES section is corrected 
to read: ``DATES: The application receipt date for new applications is 
March 15, 2005. The application receipt date for new applications for 
each subsequent year this program is in effect will be March 15.''
    On page 35651, in the second column, the ``ADDRESSES'' section 
should read: ``ADDRESSES: FDA is accepting new applications for this 
program electronically via Grants.gov.; applicants are strongly 
encouraged to apply electronically by visiting the Web site https://
www.grants.gov. and following the instructions under ``APPLY.'' The 
applicant must register in the Central Contractor Registration (CCR) 
database in order to be able to submit the application.''
    Information about CCR is available at https://www.grants.gov/
CCRRegister. The applicant must register with the Credential Provider 
for Grants.gov.
    Information about this requirement is available at https://
www.grants.gov/CredentialProvider. If it is necessary for applicants to 
submit applications other than through the electronic process, 
application forms are available from, and completed applications should 
be submitted to Michelle Caraffa, Division of Contracts and Grants 
Management (HFA-500), Food and Drug Administration, 5600 Fishers Lane, 
rm. 2129, Rockville, MD 20857, 301-827-7025, e-mail: 
mcaraffa@oc.fda.gov. Application forms PHS 5161-1 are available via the 
Internet at: https://www.psc.gov/forms (Revised 7/00). Applications 
handcarried or commercially delivered should be addressed to 5630 
Fishers Lane (HFA-500), rm. 2129, Rockville, MD 20857. An application 
not received in time for orderly processing will be returned to the 
applicant without consideration.
    On page 35651, beginning in the second column, ``FOR FURTHER 
INFORMATION CONTACT'' should read:

[[Page 6016]]

    FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Michelle N. Caraffa (see ADDRESSES).
    Regarding the programmatic aspects of this notice: Stephen Toigo, 
Division of Federal-State Relations (DFSR), Office of Regulatory 
Affairs, Food and Drug Administration (HFC-150), 5600 Fishers Lane, rm. 
12-07, Rockville, MD 20857, 301-827-6906, or access the Internet at: 
https://www.fda.gov/ora/fed_state/default.htm. For general ORA program 
information contact your Regional Food Specialists at https://
www.fda.gov/ora/fed_state/DFSR_Activities/food_specialists.htm
    On page 35653 in the first column, under section V.A, a sentence is 
added at the end of the paragraph that reads: ``A Current Listing of 
SPOCs can be found at https://www.whitehouse.gov/omb/grants/spoc.html.''
    On page 35653 in the third column, under section VII, the paragraph 
is revised to read: ``Applicants are encouraged to apply electronically 
(see ADDRESSES). If not, the original and two copies of the completed 
grant application Form PHS-5161-1 (Revised 7/00) for State and local 
governments should be delivered to the Grants Management Office. The 
receipt date is March 15, 2005. No supplemental material or addenda 
will be accepted after the receipt date.''
    On page 35653 in the third column, under section VIII.A in the 
second paragraph, the last sentence should read: ``FDA is now accepting 
applications via the Internet.''

    Dated: January 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2209 Filed 2-3-05; 8:45 am]
BILLING CODE 4160-01-S

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