Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16795 

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 

This document does not impose 

information collection and 

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 

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

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Disclosure ........................................................................................................ 1,167,097 1 0.17 198,406.49 

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 

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. 

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 http:// 

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. 


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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 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 http:// 

www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/ 

NationalAntimicrobialResistance

MonitoringSystem/default.htm, http:// 

www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/ 

NationalAntimicrobialResistance

MonitoringSystem/ucm062630.htm, 

http://www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/

NationalAntimicrobial

ResistanceMonitoringSystem/ 

ucm059135.htm, http://www.fda.gov/

ohrms/dockets/ac/07/briefing/2007- 

4329b_02_06_

NARMS%20Review%20Update.pdf, or 

http://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. 

SUMMARY: 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 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

grants.nih.gov/grants/guide/ (select the 

‘‘Request for Applications’’ link), http:// 

www.grants.gov/ (see ‘‘For Applicants’’ 

section), and http://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 


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