51994 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 

1See ‘‘Section A: PDUFA Reauthorization 

Performance Goals and Procedures Fiscal Years 

2008 Through 2012’’ (http://www.fda.gov/

ForIndustry/UserFees/PrescriptionDrugUserFee/

ucm119243.htm). 

2See http://www.rsna.org/snm/index.html. 

the Committee on Health, Education, 

Labor, and Pensions of the Senate and 

the Chairman of the Committee on 

Energy and Commerce of the House of 

Representatives, as set forth in the 

Congressional Record).1 This draft 

guidance addresses one of these goals 

with the creation of a guidance 

document that addresses the ‘‘imaging 

standards for use as an endpoint in 

clinical trials.’’ This draft guidance also 

follows the April 13, 2010, public 

workshop ‘‘Standards for Imaging 

Endpoints in Clinical Trials’’ 

cosponsored by FDA, the Society of 

Nuclear Medicine, and the Radiological 

Society of North America.2

This draft guidance outlines the major 

considerations for standardization of 

image acquisition, image interpretation 

methods, and other procedures to help 

ensure imaging data quality. The draft 

guidance describes two categories of 

image acquisition and interpretation 

standardization, a medical practice 

standard and a clinical trial standard, 

and provides guidance on the role of 

each standard in a clinical trial. With a 

medical practice standard, the image 

acquisition and interpretation methods 

in the trial do not exceed those used in 

medical practice. In contrast, a clinical 

trial standard involves imaging methods 

that exceed those used in medical 

practice. The draft guidance focuses on 

the methods important for image 

acquisition and interpretation and 

provides a detailed outline of other 

procedures important for optimizing 

clinical trial imaging data quality. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 standards for clinical trial imaging 

endpoints. 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This draft guidance refers to 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 found in FDA regulations. 

These collections of information 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 parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

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 http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http://www.

egulations.gov. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21244 Filed 8–18–11; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, National 

Center for Biotechnology Information. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for review, discussion, and evaluation of 

individual intramural programs and 

projects conducted by the National 

Library of Medicine, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, National Center for 

Biotechnology Information. 

Date: November 8, 2011. 

Open: 8:30 am to 12:00 pm. 

Agenda: Program Discussion. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD. 20892. 

Closed: 12:00 pm to 2:00 pm. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board, Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Open: 2:00 pm to 3:00 pm. 

Agenda: Program Discussion. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: David J. Lipman, MD, 

Director, National Center of Biotechnology 

Information, National Library of Medicine, 

Department of Health and Human Services, 

Building 38A, Room 8N805, Bethesda, MD 

20892, 301–435–5985, 

dlipman@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

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or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS). 

Dated: August 15, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–21238 Filed 8–18–11; 8:45 am] 

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