The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015; Request for Comments; Extension of Comment Period, 16795-16796 [2011-7068]

Download as PDF 16795 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices Therefore, based on the review and observations described in section III of this final notice, we have determined that NCQA’s requirements for HMOs and local PPOs continue to meet or exceed our requirements. We renew the MA deeming authority of the NCQA for HMOS and PPOs for a term of 4 years. The new term of approval began October 19, 2010, and ends October 18, 2014. IV. Results of the Review Process Using the information listed in section III of this final notice, we determined that NCQA’s current accreditation program for HMO and PPO MA plans continues to be at least as stringent as the MA requirements contained in the 6 categories specified in section 1852(e)(4)(C) of the Act and our methods of evaluation for those areas. V. Collection of Information Requirements recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 9, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2011–6222 Filed 3–24–11; 8:45 am] BILLING CODE 4120–01–P This document does not impose information collection and DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Voluntary Establishment of Paternity—NPRM. OMB No.: 0970–0175. Description: Section 466(a)(5)(C) of the Social Security Act requires States to pass laws ensuring a simple civil process for voluntarily acknowledging paternity under which the State must provide that the mother and putative father must be given notice, orally and in writing, of the benefits and legal responsibilities and consequences of acknowledging paternity. The information is to be used by hospitals, birth record agencies, and other entities participating in the voluntary paternity establishment program that collect information from the parents of children that are born out of wedlock. Respondents: ANNUAL BURDEN ESTIMATES Number of respondents Instrument erowe on DSK5CLS3C1PROD with NOTICES Disclosure ........................................................................................................ Estimated Total Annual Burden Hours: 198,406.49. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the VerDate Mar<15>2010 15:16 Mar 24, 2011 Jkt 223001 1,167,097 Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–7077 Filed 3–24–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0620] The National Antimicrobial Resistance Monitoring System Strategic Plan 2011–2015; Request for Comments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice; request for comments; extension of comment period. ACTION: The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of January 24, 2011 (76 FR 4120). In the notice, FDA requested comments on a SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response 0.17 Total burden hours 198,406.49 document for the National Antimicrobial Resistance Monitoring System (NARMS) entitled ‘‘NARMS Strategic Plan 2011–2015.’’ The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. Based on requests received, additional information is being placed in the docket related to the development of the Strategic Plan. This information can also be viewed at the Web sites listed in section III of this document. DATES: Submit either electronic or written comments by May 24, 2011. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Patrick McDermott, Center for Veterinary Medicine (HFV–530), Food and Drug Administration, 8401 Muirkirk Rd., Laurel, MD 20708, 301– 210–4213, e-mail: patrick.mcdermott@ fda.hhs.gov. E:\FR\FM\25MRN1.SGM 25MRN1 16796 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 24, 2011 (76 FR 4120), FDA published a notice with a 60-day comment period to request comments from stakeholders on strategies to address a document for the NARMS program entitled ‘‘NARMS Strategic Plan 2011–2015.’’ The notice expressed FDA’s interest in receiving comments on the goals and objectives in the Strategic Plan and whether the goals and objectives meet the recommendations of the subcommittee. The Agency has received requests for a 60-day extension of the comment period along with request for background material on the development of the ‘‘NARMS Strategic Plan 2011–2015.’’ The requests conveyed concern that the current 60day comment period does not allow respondents sufficient time to address fully the many important issues FDA raised in the notice. FDA has considered the requests and is extending the comment period for the notice for 60 days, until May 24, 2011. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying the Agency’s consideration of these important issues. erowe on DSK5CLS3C1PROD with NOTICES II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain documents at either https:// www.fda.gov/AnimalVeterinary/ SafetyHealth/AntimicrobialResistance/ NationalAntimicrobialResistance MonitoringSystem/default.htm, https:// www.fda.gov/AnimalVeterinary/ SafetyHealth/AntimicrobialResistance/ NationalAntimicrobialResistance MonitoringSystem/ucm062630.htm, https://www.fda.gov/AnimalVeterinary/ SafetyHealth/AntimicrobialResistance/ NationalAntimicrobial ResistanceMonitoringSystem/ ucm059135.htm, https://www.fda.gov/ ohrms/dockets/ac/07/briefing/20074329b_02_06_ VerDate Mar<15>2010 15:16 Mar 24, 2011 Jkt 223001 NARMS%20Review%20Update.pdf, or https://www.regulations.gov. Dated: March 21, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–7068 Filed 3–24–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0155] Pediatric Anesthesia Safety Initiative (PASI) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Pediatric Anesthesia Safety Initiative (PASI). The goal of PASI is to bridge the scientific and clinical gaps in the field of pediatrics to ensure the safe use of anesthetic and sedative agents in children. FDA seeks under PASI to encourage and facilitate scientific collaboration among multiple stakeholders within a public-private partnership (PPP) framework and to support the conduct of non-clinical and clinical studies to answer unknown questions regarding the effects of anesthetics and sedatives in the pediatric population. The output from PASI will help to inform the work of FDA as part of its public health mission. DATES: Important dates are as follows: 1. The application due date is April 29, 2011. 2. The anticipated start date is July 14, 2011. 3. The opening date is March 30, 2011. 4. The expiration date is April 30, 2011. For Further Information and Additional Requirements Contact: ShaAvhree Buckman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4554, Silver Spring, MD 20993, 301–796– 1653, e-mail: ShaAvhreeBuckman@fda.hhs.gov. Vieda Hubbard, Office of Acquisitions & Grant Services, Food and Drug Administration, 5630 Fishers Lane (HFA–500), Rockville, MD 20857, 301– 827–7177, e-mail: vieda.hubbard@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 to obtain detailed requirements, please refer to the full FOA located at https:// grants.nih.gov/grants/guide/ (select the ‘‘Request for Applications’’ link), https:// www.grants.gov/ (see ‘‘For Applicants’’ section), and https://www.fda.gov/ AboutFDA/PartnershipsCollaborations/ PublicPrivatePartnershipProgram/ ucm166082.htm. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description RFA–FD–11–005. 93.103. A. Background Non-clinical studies in juvenile animal models have shown that exposure to some anesthestics and sedatives is associated with neurodegenerative changes in the central nervous system, as well as memory and learning deficits. Anesthetic agents that have been specifically implicated are N-methyl-Daspartate (NMDA) receptor antagonists, such as ketamine, and gamma aminobutyric acid (GABA) agonists, such as sevoflurane. The anesthesia community and FDA acknowledge that there are insufficient human data to either support or refute the clinical relevance of these findings for pediatric patients. Therefore, numerous nonclinical and clinical studies are needed to assess the effect of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children. However, the planning and performance of the numerous studies needed to address the aforementioned issues will involve enormous challenges in terms of design, assurance of validity and reliability of the outcome measures, and ethical considerations. It is unlikely that any one entity will possess the necessary expertise and resources to accomplish all the work needed to address the issues in an expeditious manner. B. Objectives PASI aims to bridge the scientific and clinical gaps in the field of pediatrics to ensure the safe use of anesthetic and sedative agents in children. Specific activities to be funded through this announcement include, but are not limited to: 1. Project management of PASI PPP: • Development, implementation, and management of a scientific and administrative infrastructure to support the creation and execution of a series of projects aligned with PASI. • Coordination of the overall governance board, to include luminary experts to lead the overall PPP; said governance board to establish necessary E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16795-16796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7068]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0620]


The National Antimicrobial Resistance Monitoring System Strategic 
Plan 2011-2015; Request for Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice that appeared in the Federal Register of 
January 24, 2011 (76 FR 4120). In the notice, FDA requested comments on 
a document for the National Antimicrobial Resistance Monitoring System 
(NARMS) entitled ``NARMS Strategic Plan 2011-2015.'' The Agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments. Based on 
requests received, additional information is being placed in the docket 
related to the development of the Strategic Plan. This information can 
also be viewed at the Web sites listed in section III of this document.

DATES: Submit either electronic or written comments by May 24, 2011.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patrick McDermott, Center for 
Veterinary Medicine (HFV-530), Food and Drug Administration, 8401 
Muirkirk Rd., Laurel, MD 20708, 301-210-4213, e-mail: 
patrick.mcdermott@fda.hhs.gov.

[[Page 16796]]


SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 24, 2011 (76 FR 4120), FDA 
published a notice with a 60-day comment period to request comments 
from stakeholders on strategies to address a document for the NARMS 
program entitled ``NARMS Strategic Plan 2011-2015.'' The notice 
expressed FDA's interest in receiving comments on the goals and 
objectives in the Strategic Plan and whether the goals and objectives 
meet the recommendations of the subcommittee.
    The Agency has received requests for a 60-day extension of the 
comment period along with request for background material on the 
development of the ``NARMS Strategic Plan 2011-2015.'' The requests 
conveyed concern that the current 60-day comment period does not allow 
respondents sufficient time to address fully the many important issues 
FDA raised in the notice.
    FDA has considered the requests and is extending the comment period 
for the notice for 60 days, until May 24, 2011. The Agency believes 
that a 60-day extension allows adequate time for interested persons to 
submit comments without significantly delaying the Agency's 
consideration of these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain documents at either 
https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/default.htm, https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm062630.htm, https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm059135.htm, https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_06_NARMS%20Review%20Update.pdf, or https://www.regulations.gov.

    Dated: March 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7068 Filed 3-24-11; 8:45 am]
BILLING CODE 4160-01-P
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