Anti-Infective Drugs Advisory Committee; Notice of Meeting, 66384-66385 [2014-26442]

Download as PDF 66384 Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Notices 1. Access CMS’ Web site address at http://www.cms.hhs.gov/Paperwork ReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10371 Cooperative Agreement To Support Establishment of StateOperated Health Insurance Exchanges Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. mstockstill on DSK4VPTVN1PROD with NOTICES Information Collection 1. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Cooperative Agreement to Support Establishment of State-Operated Health Insurance Exchanges; Use: Section 1311 of the Affordable Care Act provides for grants to States for the planning and establishment of Marketplaces. Given the innovative nature of Marketplaces and the statutorily-prescribed relationship between the Secretary and States in their development and operation, it has been critical that the Secretary work closely with States to VerDate Sep<11>2014 19:12 Nov 06, 2014 Jkt 235001 provide necessary guidance and technical assistance to ensure that States can meet the prescribed timelines, federal requirements, and goals of the statute. These grants are funded through the Health Insurance Marketplaces Cooperative Agreement to Support Establishment of the Affordable Care Act’s Health Insurance Exchanges (Funding Opportunity Number: IE– HBE–12–001). A critical part of this guidance and assistance is the collection of precise information to measure the performance of the individual exchanges. The revised data collection instrument has been developed in coordination with the states, based on an understanding of their current data collection efforts and capabilities. The tool will enable us to: (1) Distinguish new enrollees from renewals; (2) capture language preference (Spanish, other language, or no preference) to assist in targeting potentially underserved individuals; (3) obtain a better understanding of enrollment activity by certain demographic breakdowns to better target our activities through more refined crosstabulations of data by age and gender, by age and Metal Level, and by financial assistance status (with/without) and Metal Level; (4) distinguish Special Enrollment Period activity for the 2014 coverage year during the period that overlaps with the first 2.5 months of Open Enrollment [November 15December 31] in order to avoid contamination of 2015 data, to assess the extent of Special Enrollment activity during the last phase of 2014 activity; (5) identify stand-alone dental plans to better measure the extent to which individuals are enrolling in these products in order to provide input into ASPE’s monthly report to the public; (6) codify providing enrollment data for all issuers in the individual marketplaces, if available, compared to the template that asks only for the top three in the individual marketplaces [These data, if available, have been provided to us as a write-in to the previous template on a voluntary basis.]. Form Number: CMS– 10371 (OMB control number: 0938– 1119); Frequency: Weekly; Affected Public: State, Local or Tribal Governments; Number of Respondents: 16; Total Annual Responses: 208; Total Annual Hours: 6,240. (For policy questions regarding this collection contact Dena Puskin 301–492–4342.) We are requesting OMB review and approval of this collection by November 15, 2014, with a 180-day approval period. Written comments and recommendations will be considered PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 from the public if received by the date and address noted above. Dated: November 4, 2014. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–26584 Filed 11–5–14; 4:15 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–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 December 5, 2014, from 8 a.m. to 4:30 p.m. Location: The Marriott Inn and Conference Center, University of Maryland University College, The Ballroom, 3501 University Blvd. East, Adelphi, MD 20783. The conference center’s telephone number is 301–985– 7300. Contact Person: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301–847–8533, AIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). 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 at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. E:\FR\FM\07NON1.SGM 07NON1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Notices Agenda: The committee will discuss new drug application 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections, including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options. 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 http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting 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 November 28, 2014. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 November 20, 2014. 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 November 21, 2014. 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 Jennifer Shepherd at least 7 days in advance of the meeting. VerDate Sep<11>2014 19:12 Nov 06, 2014 Jkt 235001 FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://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: October 31, 2014. Jill Hartzler Warner, Associate Commissioner for Special Programs. 66385 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Andrea B Kelly, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, MSC 7770, Bethesda, MD 20892, (301) 455– 1761, kellya2@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) [FR Doc. 2014–26442 Filed 11–6–14; 8:45 am] Dated: October 31, 2014. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. BILLING CODE 4164–01–P [FR Doc. 2014–26417 Filed 11–6–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Language and Communication. Date: December 1, 2014. Time: 3:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Andrea B Kelly, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, MSC 7770, Bethesda, MD 20892, (301) 455– 1761, kellya2@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biobehavioral Regulation, Learning and Ethology. Date: December 4–5, 2014. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Division of Intramural Research Board of Scientific Counselors, NIAID. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Division of Intramural Research Board of Scientific Counselors, NIAID. Date: December 8–10, 2014. Time: 8:00 a.m. to 4:30 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 50, Conference Room 1227/1233, 50 Center Drive, Bethesda, MD 20892. Contact Person: Kathryn C. Zoon, Ph.D., Director, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH, Building 31, Room 4A30, Bethesda, MD 20892, 301–496–3006, kzoon@ niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Notices]
[Pages 66384-66385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 December 5, 2014, from 8 
a.m. to 4:30 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College, The Ballroom, 3501 University Blvd. East, 
Adelphi, MD 20783. The conference center's telephone number is 301-985-
7300.
    Contact Person: Jennifer Shepherd, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, 
AIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

[[Page 66385]]

    Agenda: The committee will discuss new drug application 206494 for 
ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the 
proposed indications of: Complicated Intra-abdominal Infections, 
Complicated Urinary Tract Infections, including Acute Pyelonephritis 
and Limited Use Indication: Aerobic Gram-negative Infections with 
Limited Treatment Options.
    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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
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 
November 28, 2014. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making 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 November 20, 2014. 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 November 21, 2014.
    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 Jennifer Shepherd 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 http://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: October 31, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Programs.
[FR Doc. 2014-26442 Filed 11-6-14; 8:45 am]
BILLING CODE 4164-01-P