Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52755 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: Desk Officer for NIH. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Linda Kupfer, 

Fogarty International Center, National 

Institutes of Health, 16 Center Drive, 

Bethesda, MD 20892, or call non-tollfree number 301–496–3288, or e-mail 

your request, including your address to: 

Linda.Kupfer@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 23, 2010. 

Timothy J. Tosten, 

Executive Officer, John E. Fogarty 

International Center, National Institutes of 

Health. 

[FR Doc. 2010–21350 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0433] 

Draft Guidance for Industry on Acute 

Bacterial Skin and Skin Structure 

Infections: Developing Drugs for 

Treatment; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Acute Bacterial Skin 

and Skin Structure Infections: 

Developing Drugs for Treatment.’’ The 

purpose of this draft guidance is to 

assist clinical trial sponsors and 

investigators in the development of 

antimicrobial drugs for the treatment of 

acute bacterial skin and skin structure 

infections (ABSSSI), impetigo, and 

minor cutaneous abscesses. FDA’s 

thinking in this area has evolved in 

recent years, and this draft guidance, 

when finalized, will inform sponsors of 

the changes in the definitions of ABSSSI 

and the recommendations for clinical 

drug development. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 26, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance 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: 

Joseph G. Toerner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Acute Bacterial Skin and Skin 

Structure Infections: Developing Drugs 

for Treatment.’’ The purpose of this draft 

guidance is to assist clinical trial 

sponsors and investigators in the 

development of antimicrobial drugs for 

the treatment of ABSSSI, impetigo, and 

minor cutaneous abscesses. This 

guidance revises the draft guidance 

regarding uncomplicated and 

complicated skin and skin structure 

infections published in 1998. The 

guidance also addresses the clinical 

development of new drugs to treat drugresistant bacterial pathogens implicated 

in ABSSSI, such as methicillin-resistant 

Staphylococcus aureus. 

The definitions of ABSSSI and the 

designs of ABSSSI clinical trials were 

discussed at a meeting of the AntiInfective Drugs Advisory Committee on 

November 18, 2008. In addition, other 

advisory committee meetings have 

focused on the development of specific 

drugs for this indication. As a result of 

these public discussions, as well as 

review of applications at FDA, the 

agency’s thinking in this area has 

evolved in recent years and this draft 

guidance informs sponsors of the 

changes in our recommendations. 

Specifically, the guidance defines the 

clinical disease entities and provides a 

justification for a noninferiority margin 

for the design of active-controlled 

clinical trials that can be used to 

provide evidence of efficacy for the 

treatment of ABSSSI. The guidance 

describes a new responder efficacy 

endpoint for noninferiority trials that is 

based on the historical studies used to 

justify the noninferiority margin. 

Currently, there are ongoing efforts in 

the scientific community to develop and 

evaluate new efficacy endpoints for 

ABSSSI. The guidance also defines the 

clinical disease entities of skin 

infections for which a superiority trial is 

recommended. 

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 developing drugs for the treatment of 

ABSSSI. 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 guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014 and the collections 

of information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

III. 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. 

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. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

52756 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

Dated: August 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21328 Filed 8–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Fiscal Year (FY) 2010 Funding 

Opportunity 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice of Intent to award a 

Single Source Supplement Grant to the 

National Center for Mental Health 

Promotion and Youth Violence 

Prevention at Educational Development 

Corporation (EDC) of Newton, 

Massachusetts. 

SUMMARY: This notice is to inform the 

public that the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) intends to award 

approximately $250,000 for up to fifteen 

months to expand grant activities 

funded under the Technical Assistance 

Center for Mental Health Promotion and 

Youth Violence Prevention to 

implement a Back to School media 

campaign targeted at the Gulf Coast 

schools impacted by the Deepwater oil 

spill. This is not a formal request for 

applications. This award is contingent 

upon the availability of funding. 

Assistance will be provided only to the 

current grantee of the Technical 

Assistance Center for Mental Health 

Promotion and Youth Violence 

Prevention based on the receipt of a 

satisfactory application that is approved 

by an independent review group. 

Funding Opportunity Title: SM–10– 

020. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243. 

Authority: Sections 501(d)(5), 501(d)(18), 

520A, 231, of the Public Health Service (PHS) 

Act [42 U.S.C. 290aa; 42 U.S.C. 290bb–32, 42 

U.S.C. 238, respectively]. 

Justification: Only an application 

from the current grantee, National 

Center for Mental Health Promotion and 

Youth Violence Prevention at 

Educational Development Corporation 

(EDC), will be considered for funding 

under this announcement. Fifteenmonths funding may become available 

to implement a Back to School Media 

Support for Gulf Coast States Impacted 

by the Deepwater Oil Spill grant. The 

current grantee will provide technical 

assistance and is in a unique position to 

address the needs of communities 

rapidly. This Center currently provides 

technical assistance and training to 

strengthen the capacity of active Safe 

Schools/Healthy Students grantees to 

sustain the use of evidence-based 

strategies for mental health promotion 

and school violence prevention. There 

is no other potential organization with 

the required access and expertise. 

Eligibility for this program 

supplement is restricted to the current 

grantee, National Center for Mental 

Health Promotion and Youth Violence 

Prevention at Educational Development 

Corporation (EDC). Eligibility is limited 

because the magnitude of the Deepwater 

Horizon oil spill and its impact on the 

residents of the Gulf Coast region have 

led to an urgent need for disaster 

behavioral health communications 

services targeting school aged children, 

youth and their families. This 

supplement will serve to maximize 

efficiencies created under the current 

services infrastructure. It would be 

inefficient and duplicative to fund 

additional technical assistance services 

for a Back to School Media Support for 

Gulf Coast States Impacted by the 

Deepwater Oil Spill grant through a 

second organization. 

Contact: Shelly Hara, Substance 

Abuse and Mental Health Services 

Administration, 1 Choke Cherry Road, 

Room 8–1095, Rockville, MD 20857; 

telephone: (240) 276–2321; E-mail: 

shelly.hara@samhsa.hhs.gov. 

Dated: August 23, 2010. 

Toian Vaughn, 

SAMHSA Committee Management Officer. 

[FR Doc. 2010–21339 Filed 8–26–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

System and Method for Producing 

Nondiffracting Light Sheets that 

Improves the Performance of Selective 

Plane Illumination Microscopy (SPIM) 

Description of Invention: The 

technology offered for licensing relates 

to a system and method of producing 

nondiffracting beams of light that 

spatially overlap, but do not interfere 

with each other when intersecting the 

detection plane of an optical 

arrangement. The system includes an 

illumination source (i.e. ultrafast laser) 

for transmitting a beam of light through 

the optical arrangement that includes a 

diffraction grating for diffracting the 

light beam to produce beams of light 

having different wavelengths, which are 

then passed through an annular aperture 

that transforms the beams of light into 

nondiffracting beams having different 

wavelengths. The method can be readily 

utilized in Selective Plane Illumination 

Microscopy (SPIM), a system that 

provides optical sectioning of a sample 

that is labeled with fluorescent dyes. 

SPIM can provide quantitative threedimensional maps of the distribution of 

a flurophore within the sample with 

high spatiotemporal resolution and an 

excellent signal-to-noise ratio. The 

standard SPIM technique however 

produces nonuniform axial resolution, 

which is caused by the diffraction of the 

laser beam through the sample, causing 

degradation in the optical sectioning, 

and forcing a compromise between field 

of view and axial resolution. 

Techniques for decoupling field of view 

and axial resolution have previously 

utilized nondiffracting beams (e.g. 

Bessel beams) for sample illumination. 

The resulting interference from multiple 

nondiffracting beams degrades the 

quality of optical sectioning and the 

quality of the image. The present 

technology utilizing nondiffracting 

noninterfering beams is intended to 

alleviate the problems associated with 

the currently used SPIM techniques. 

Applications: In Selective Plane 

Illumination Microscopy (SPIM) used 

for optical sectioning and imaging of 

biological samples. 

Development Status: Proof of concept 

has been demonstrated. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES