11556 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

1Prior to the 2007 reauthorization of the Best 

Pharmaceuticals for Children Act (Pub. L. 107–109), 

the priority list included specific drugs instead of 

therapeutic areas. 

sponsors. Known as ‘‘Information 

Sheets,’’ these guidances have provided 

recommendations to IRBs, clinical 

investigators, and sponsors to help them 

fulfill their responsibilities to protect 

human subjects who participate in 

research regulated by the FDA. The 

Information Sheet Guidance Initiative is 

intended to ensure that the Information 

Sheets are updated, consistent with the 

FDA’s good guidance practices (GGPs). 

As part of the initiative, which will be 

ongoing, the Agency plans to rescind 

Information Sheets that are obsolete, 

revise and reissue guidances that 

address current issues, and develop new 

guidance documents as needed. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. 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. 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 the document at either 

http://www.regulations.gov or 

http://www.fda.gov/ScienceResearch/ 

SpecialTopics/RunningClinicalTrials/ 

GuidancesInformationSheetsandNotices

/ucm113709.htm. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4425 Filed 2–24–12; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0918] 

Pediatric Studies of Meropenem 

Conducted in Accordance With 

Section 409I of the Public Health 

Service Act; Establishment of Public 

Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a public docket to make 

available to the public a report of the 

pediatric studies of meropenem that 

were conducted in accordance with 

section 409I of the Public Health Service 

Act (PHS Act) and submitted to the 

Director of the National Institutes of 

Health (NIH) and the Commissioner of 

Food and Drugs. 

DATES: Submit either electronic or 

written comments by March 28, 2012. 

ADDRESSES: You may submit comments, 

identified by FDA–2011–N–0918, by 

any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Denise Pica-Branco, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6402, 

Silver Spring, MD 20993–0002, Email: 

denise.picabranco@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under 

section 409I of the PHS Act (42 U.S.C. 

284m), the Secretary of the Department 

of Health and Human Services (the 

Secretary) acting through the Director of 

the NIH, in consultation with FDA and 

experts in pediatric research, must 

develop, prioritize, and publish a list of 

priority needs in pediatric therapeutics, 

including drugs and indications that 

require study.1 For drugs and 

indications on this list, FDA, acting in 

consultation with NIH, is authorized to 

issue a written request to holders of a 

new drug application (NDA) or 

abbreviated new drug application 

(ANDA) for a drug for which pediatric 

studies are needed to provide safety and 

efficacy information for pediatric 

labeling. If the sponsors receiving the 

written request decline to conduct the 

studies or if FDA does not receive a 

response to the written request within 

30 days of the date the written request 

was issued, the Secretary, acting 

through the Director of NIH and in 

consultation with FDA, must publish a 

request for proposals to conduct the 

pediatric studies described in the 

written request and award funds to an 

entity with appropriate expertise for the 

conduct of the pediatric studies 

described in the written request. Upon 

completion of the pediatric studies, a 

study report that includes all data 

generated in connection with the 

studies must be submitted to FDA and 

NIH and placed in a public docket 

assigned by FDA. 

Meropenem, an antibiotic medication, 

is labeled for pediatric patients from 3 

months of age through adolescence as a 

single agent antimicrobial therapy for 

meningitis and complicated intraabdominal infections, and is a 

recommended option for monotherapy 

of high severity complicated intraabdominal infections in adults. Off-label 

use of meropenem in newborn and 

infant patients younger than 3 months 

of age is significant, despite the lack of 

adequate pharmacokinetic, dosing, 

tolerability, and safety data for this age 

group. 

On August 13, 2003, NIH published a 

Federal Register notice (68 FR 48402) 

announcing the addition of several 

drugs, including meropenem, to the 

priority list of drugs most in need of 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11557 

study for use by children to ensure their 

safety and efficacy. A written request for 

pediatric studies of meropenem was 

issued on September 10, 2004, to 

AstraZeneca Pharmaceuticals, the 

holder of the new drug application for 

meropenem. FDA did not receive a 

response to the written request. 

Accordingly, NIH issued a request for 

proposals to conduct the pediatric 

studies described in the written request 

on August 15, 2005, and awarded funds 

to Duke University on September 28, 

2007, to complete the studies described 

in the written request. Upon completion 

of the pediatric studies, a report of the 

pediatric studies of meropenem was 

submitted to NIH and FDA. As required 

under section 409I of the PHS act, FDA 

opened a public docket and NIH placed 

in the docket the report of pediatric 

studies of meropenem that was 

submitted to NIH and FDA. The report 

includes all data generated in 

connection with the study, including 

the written request. 

We invite interested parties to review 

the report and submit comments to the 

docket. The public docket is available 

for public review in the Division of 

Dockets Management (see ADDRESSES) 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4426 Filed 2–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on the 

National Health Service Corps; 

Request for Nominations 

AGENCY: Health Resources and Services 

Administration, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill five 

vacancies on the National Advisory 

Council (NAC) on the National Health 

Service Corps (NHSC). The NAC on the 

NHSC was established in 1978. 

DATES: The agency must receive 

nominations on or before March 28, 

2012. 

ADDRESSES: All nominations should be 

sent electronically to Njeri Jones at 

NJones@hrsa.gov or mailed to 5600 

Fishers Lane, Room 13–64, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: Kim 

Huffman, Executive Secretary, National 

Advisory Council on the National 

Health Service Corps, at (301) 443–3863 

or via email at KHuffman@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

National Advisory Council on the 

National Health Service Corps (hereafter 

referred to as NAC) was established 

under 42 U.S.C. 254j (Section 337 of the 

Public Health Service Act), as amended 

by Section 10501 of the Affordable Care 

Act. The NAC is governed by provisions 

of Public Law 92–463 (5 U.S.C. App. 2), 

also known as the Federal Advisory 

Committee Act, which sets forth 

standards for the formation and use of 

advisory committees. 

The NAC on the NHSC is a group of 

health care providers and health care 

site administrators who are experts in 

the issues that communities with a 

shortage of primary care professionals 

face in meeting their health care needs. 

The NAC is a frontline source of 

information to the NHSC senior 

management. The NAC is committed to 

effectively implementing its mandate to 

advise the Secretary of the Department 

of Health and Human Services (HHS) 

and, by designation, the Administrator 

of the Health Resources and Services 

Administration (HRSA). 

The NAC consists of 15 members who 

are Special Government Employees. 

Responsibilities of the Council include: 

(1) Serving as a forum to identify the 

priorities for the NHSC and bring 

forward and anticipate future program 

issues and concerns through ongoing 

communication with program staff, 

professional organizations, communities 

and program participants; (2) 

functioning as a sounding board for 

proposed policy changes by utilizing the 

varying levels of expertise represented 

on the Council to advise on specific 

program areas; (3) developing and 

distributing white papers and briefs that 

clearly state issues and/or concerns 

relating to the NHSC with specific 

recommendations for necessary policy 

revisions. 

Specifically, HRSA is requesting 

nominations for individuals with a 

background in primary care, dental 

health, and mental health, representing 

the following areas of expertise: 

Working with underserved populations, 

health care policy, recruitment and 

retention, site administration, customer 

service, marketing, organizational 

partnerships, research, and clinical 

practice. We are looking for nominees 

that either currently or have previously 

filled a role as site administrators, 

physicians, dentists, mid-level 

professionals (i.e., nurses, physician 

assistants), mental or behavioral health 

professionals, and NHSC scholars or 

loan repayors. Nominees will be invited 

to serve a 3-year term beginning after 

July 2012. 

HHS will consider nominations of all 

qualified individuals with a view to 

ensuring that the NAC includes the 

areas of subject matter expertise noted 

above and reflects the diverse primary 

care health care workforce and health 

delivery sites. Individuals may 

nominate themselves or other 

individuals, and professional 

associations and organizations may 

nominate one or more qualified persons 

for membership on the Council. 

Nominations shall state that the 

nominee is willing to serve as a member 

of the NAC and appears to have no 

conflict of interest that would preclude 

the membership. Potential candidates 

will be asked to provide detailed 

information concerning financial 

interests, consultancies, research grants, 

and/or contracts that might be affected 

by recommendations of the Committee 

to permit evaluation of possible sources 

of conflicts of interest. 

A nomination package should include 

the following information for each 

nominee: (1) A Letter of nomination 

stating the name, affiliation, and contact 

information for the nominee, the basis 

for the nomination (i.e., what specific 

attributes, perspectives, and/or skills 

does the individual possess that would 

benefit the workings of NAC), and the 

nominee’s field(s) of expertise; (2) a 

biographical sketch of the nominee and 

a copy of his/her curriculum vitae; and 

(3) the name, address, daytime 

telephone number, and email address at 

which the nominator can be contacted. 

HHS has special interest in assuring 

that women, minority groups, and the 

physically disabled are adequately 

represented on advisory committees; 

and therefore, extends particular 

encouragement to nominations for 

appropriately qualified female, 

minority, or disabled candidates. 

Dated: February 21, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–4572 Filed 2–24–12; 8:45 am] 

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srobinson on DSK4SPTVN1PROD with NOTICES