National Advisory Council on the National Health Service Corps; Notice of Meeting, 39738 [2013-15713]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 39738 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices have a narrow spectrum of activity or are only active against a single genus or species of bacteria). Efforts to develop new antibacterial drugs have diminished in the past few decades. Because bacteria continue to develop resistance to available antibacterial drugs, an increasing number of patients are suffering from bacterial diseases that do not respond to currently available antibacterial drugs and therefore have unmet medical needs for antibacterial therapy. To foster new antibacterial drug development that will have the potential to keep pace with continued pressures leading to antibacterial resistance, FDA is exploring approaches to help streamline development programs for new antibacterial drugs. This effort is intended not only to spur development of new drugs for populations with infections caused by resistant organisms, but also to facilitate development of drugs for broad indications that are associated with other unmet medical needs. In addition, the draft guidance outlines development approaches for pathogen-focused antibacterial drugs (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus and species of bacteria). This draft guidance describes some examples of approaches that may be used by sponsors as part of streamlined development programs. Some of these approaches are not novel, but are included to provide examples of various ways of collecting the evidence needed to demonstrate safety and efficacy to address unmet medical needs. FDA is inviting proposals for other innovative approaches that should be considered, particularly for infections caused by resistant organisms. FDA is interested in approaches such as using information from other sites of infection; pooling data from various sites; additional endpoints; an increased emphasis on the use of animal data to complement clinical data; or any other approaches that may be used to generate reliable evidence of efficacy. As part of FDA’s efforts to facilitate the development of antibacterial drugs for serious or life-threatening bacterial infections, particularly in areas of unmet need, this draft guidance specifies how nonclinical and clinical data can be used to inform an efficient and streamlined pathogen-focused antibacterial drug development program and provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens. As such, it is intended to fulfill the requirement in section 806(a), Title VIII (entitled ‘‘Generating VerDate Mar<15>2010 16:48 Jul 01, 2013 Jkt 229001 Antibiotic Incentives Now’’), of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) (Pub. L. 112–144), to publish a draft guidance on pathogen-focused antibacterial drug development. After consideration of comments submitted in response to this draft guidance, FDA intends to begin work on finalizing the guidance, as required by section 806(b) of FDASIA. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’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. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 and 21 part CFR 314 have been approved under OMB control numbers 0910–0014 and 0910–0001, respectively. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15783 Filed 7–1–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on the National Health Service Corps (NHSC) Date and Time: July 18, 2013— 2:00pm–3:30pm ET Place: The meeting will be via audio conference call. Status: The meeting will be open to the public. Agenda: The Council is holding a meeting via conference call to discuss the Affordable Care Act, NHSC retention resources, and partnerships. The public can join the meeting via audio conference call on the date and time specified above using the following information: Dial-in number: 1–800– 857–5081; Passcode: 1060359. There will be an opportunity for the public to comment towards the end of the call. FOR FURTHER INFORMATION CONTACT: Njeri Jones, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, Parklawn Building, Room 13–64, 5600 Fishers Lane, Rockville, MD 20857; email: NJones@hrsa.gov; telephone: 301–443–2541. Dated: June 25, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–15713 Filed 7–1–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice; Notice for Request for Nominations The Health Resources and Services Administration (HRSA) is requesting nominations to fill seven vacancies on the National Advisory Council on Nurse Education and Practice (NACNEP). SUMMARY: Authority: The National Advisory Council on Nurse Education and Practice is in accordance with the provisions of 42 United E:\FR\FM\02JYN1.SGM 02JYN1

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[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Page 39738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Advisory Council on the National Health Service Corps; 
Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Public Law 92-463), notice is hereby given of the 
following meeting:
    Name: National Advisory Council on the National Health Service 
Corps (NHSC)
    Date and Time: July 18, 2013--2:00pm-3:30pm ET
    Place: The meeting will be via audio conference call.
    Status: The meeting will be open to the public.
    Agenda: The Council is holding a meeting via conference call to 
discuss the Affordable Care Act, NHSC retention resources, and 
partnerships. The public can join the meeting via audio conference call 
on the date and time specified above using the following information: 
Dial-in number: 1-800-857-5081; Passcode: 1060359. There will be an 
opportunity for the public to comment towards the end of the call.

FOR FURTHER INFORMATION CONTACT: Njeri Jones, Bureau of Clinician 
Recruitment and Service, Health Resources and Services Administration, 
Parklawn Building, Room 13-64, 5600 Fishers Lane, Rockville, MD 20857; 
email: NJones@hrsa.gov; telephone: 301-443-2541.

    Dated: June 25, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-15713 Filed 7-1-13; 8:45 am]
BILLING CODE 4165-15-P