Anti-Infective Drugs Advisory Committee; Notice of Meeting, 16148-16149 [2010-7113]

Download as PDF 16148 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices and Cooperative Agreements to State, Local and Tribal Governments. • 45 CFR Part 74—Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations. C. Grants Policy: • HHS Grants Policy Statement, Revised 01/2007. D. Cost Principles: • OMB Circular A–87—State, Local, and Indian Tribal Governments (Title 2 Part 225). • OMB Circular A–122—Non-Profit Organizations (Title 2 Part 230). E. Audit Requirements • OMB Circular A–133—Audits of States, Local Governments, and NonProfit Organizations. 3. Indirect Costs This section applies to all grant recipients that request reimbursement of indirect costs in their grant application. In accordance with HHS Grants Policy Statement, Part II–27, IHS requires applicants to obtain a current indirect cost rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award’s budget period. If the current rate is not on file with the DGO at the time of award, the indirect cost portion of the budget will be restricted. The restrictions remain in place until the current rate is provided to the DGO. Generally, indirect costs rates for IHS grantees are negotiated with the HHS Division of Cost Allocation https:// rates.psc.gov/ and the Department of the Interior (National Business Center) at https://www.aqd.nbc.gov/indirect/ indirect.asp. If your organization has questions regarding the indirect cost policy, please contact the DGO at (301) 443–5204. 4. Reporting Requirements The DDTP and the DGO have requirements for progress reports and financial reports based on the terms and conditions of this grant as noted below. jlentini on DSKJ8SOYB1PROD with NOTICES A. Progress Reports Program progress reports are required semi-annually. These reports must include at a minimum: Reporting of Best Practice measures; and a brief comparison of actual accomplishments to the goals established for the budget period or provide sound justification for the lack of progress. VerDate Nov<24>2008 19:40 Mar 30, 2010 Jkt 220001 B. Financial Status Reports Annual financial status reports are required until the end of the project period. Reports must be submitted annually no later than 30 days after the end of each specified reporting period. The final financial status report is due within 90 days after the end of the 24 month project period. Standard Form 269 (long form for those reporting program income; short form for all others) will be used for financial reporting. Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports (FSR). According to SF–269 instructions, the final SF–269 must be verified from the grantee records to support the information outlined in the FSR. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) The imposition of special award provisions; and (2) the nonfunding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. C. FY 2007 and FY 2008 Single Audit Reports (OMB A–133) Applicants who have an active SDPI grant are required to be up-to-date in the submission of required audit reports. These are the annual financial audit reports required by OMB A–133, audits of state, local governments, and nonprofit organizations that are submitted. Documentation of (or proof of submission) of current FY 2007 and FY 2008 Financial Audit Reports is mandatory. Acceptable forms of documentation include: e-mail confirmation from FAC that audits were submitted; or face sheets from audit reports. Face sheets can be found on the FAC Web site: https:// harvester.census.gov/fac/dissem/ accessoptions.html?submit= Retrieve+Records. Telecommunication for the hearing impaired is available at: TTY (301) 443– 6394. VII. Agency Contacts • For Grants Budget Management, contact: PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 • Denise Clark, Lead Grants Management Specialist, DGO (denise.clark@ihs.gov), Division of Grants Operations, 801 Thompson Avenue, TMP, Suite 360, Rockville, MD 20852, (301) 443–5204. • For Grants.gov electronic application process, contact: • Tammy Bagley, Grants Policy, DGP (tammy.bagley@ihs.gov), (301) 443– 5204, Grants Policy Web site:https:// www.ihs.gov/NonMedicalPrograms/ gogp/index.cfm?module=gogp_funding. • For programmatic questions, contact: • Bonnie Bowekaty, Program Assistant, DDTP (bonnie.bowekaty@ihs.gov), (505) 248– 4182; • Lorraine Valdez, Deputy Director, DDTP (s.lorraine.valdez@ihs.gov), (505) 248–4182; • Area Diabetes Consultants Web site: https://www.ihs.gov/MedicalPrograms/ diabetes/index.cfm?module= peopleADCDirectory. Dated: March 12, 2010. Yvette Roubideaux, Director, Indian Health Service. [FR Doc. 2010–7103 Filed 3–30–10; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Anti-Infective 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. Name of Committee: Anti-Infective 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 April 29, 2010, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301–589–5200. Contact Person: Minh Doan, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, E:\FR\FM\31MRN1.SGM 31MRN1 jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: minh.doan@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512530. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On April 29, 2010, the committee will discuss the efficacy and safety of new drug application (NDA) 21–242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. 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 15, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 7, 2010. 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 VerDate Nov<24>2008 19:40 Mar 30, 2010 Jkt 220001 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 8, 2010. 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 Minh Doan at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 25, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–7113 Filed 3–30–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice Of Amendment—OS ARRA Expansion of Research Capabilities To Study CE Complex Patients (R24) SEP Meeting With this correction notice, the Agency for Healthcare Research and Quality (AHRQ) informs the public of an amendment made to the notice subject mentioned above published on March 18, 2010 Vol. 75, No. 52, Second paragraph of pages 13 135–13136. The revised should read: ‘‘DATE: April 15–16, 2010 (Open on April 15 from 8 a.m. to 8:15 am. and closed for the remainder of the meeting)’’. Dated: March 19, 2010. Carolyn M. Clancy, Director. [FR Doc. 2010–6784 Filed 3–30–10; 8:45 am] BILLING CODE 4160–90–M PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 16149 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–2312–N] DEPARTMENT OF LABOR Employee Benefits Security Administration Medicaid and CHIP Programs; Meeting of the CHIP Working Group—April 26, 2010 AGENCIES: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS); Employee Benefits Security Administration (EBSA), Department of Labor (DOL). ACTION: Notice. SUMMARY: This notice announces the first meeting of the Medicaid, Children’s Health Insurance Program (‘‘CHIP’’), and Employer-Sponsored Coverage Coordination Working Group (referred to as the ‘‘CHIP Working Group’’). The CHIP Working Group will meet to address objectives specified under section 311(b)(1)(C) of the Children’s Health Insurance Program Reauthorization Act of 2009. This meeting is open to the public. DATES: Meeting Date: Monday, April 26, 2010 from 9 a.m. to 5 p.m., Eastern Standard Time (E.S.T.). Deadline for Registration without Oral Presentation: April 21, 2010, 12 p.m., E.S.T. Deadline for Registration of Oral Presentations: April 12, 2010 12 p.m., E.S.T. Deadline for Submission of Oral Remarks and Written Comments: April 12, 2010 12 p.m., E.S.T. Deadline for Requesting Special Accommodations: April 12, 2010 12 p.m., E.S.T. ADDRESSES: Meeting Location: The meeting will be held at the Omni Shoreham, 2500 Calvert Street, NW. at Connecticut Avenue in Washington, DC 20008. Submission of Testimony: Testimonies should be mailed to Stacey Green, Designated Federal Official (DFO), Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop C2–04–04, Baltimore, MD 21244– 1850, or contact the DFO via e-mail at stacey.green@cms.hhs.gov. FOR FURTHER INFORMATION CONTACT: Stacey Green, DFO, Centers for Medicare & Medicaid Services, DHHS at (410) 786–6102, or Amy Turner, E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16148-16149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Anti-Infective 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.
    Name of Committee: Anti-Infective 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 April 29, 2010, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Minh Doan, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery,

[[Page 16149]]

5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 
301-827-6776, e-mail: minh.doan@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512530. Please call the Information Line for up-to-date 
information on this meeting. A notice in the Federal Register about 
last minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the agency's Web site 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On April 29, 2010, the committee will discuss the efficacy 
and safety of new drug application (NDA) 21-242, artesunate rectal 
suppositories, submitted by the World Health Organization, for the 
proposed use as a single dose for the initial treatment of patients 
with acute malaria who cannot take medication by mouth and for whom 
injectable treatment is not available.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 15, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before April 7, 2010. 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 8, 
2010.
    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 Minh Doan at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-7113 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S

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