11998 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

person with an approved or pending 

drug product application he will be 

subject to civil money penalties. In 

addition, FDA will not accept or review 

any abbreviated new drug applications 

submitted by or with the assistance of 

Dr. Hargrave during his period of 

debarment. 

Any application by Dr. Hargrave for 

termination of debarment under section 

306(d) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0299 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). Publicly 

available submissions may be seen in 

the Division of Dockets Management 

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

through Friday. Persons with access to 

the Internet may obtain documents in 

the Docket at http://

www.regulations.gov/. 

Dated: February 24, 2015. 

Stephen Ostroff, 

Director, Office of the Chief Scientist. 

[FR Doc. 2015–05046 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0586] 

Clinical Trial Imaging Endpoint 

Process Standards; Draft Guidance for 

Industry; 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availability of a draft guidance for 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 ‘‘Clinical Trial Imaging 

Endpoint Process Standards.’’ This 

guidance assists sponsors in optimizing 

the quality of imaging data obtained in 

clinical trials intended to support 

approval of drugs and biological 

products. This guidance focuses on 

imaging acquisition, display, archiving, 

and interpretation process standards 

that FDA regards as important when 

imaging is used to assess a trial’s 

primary endpoint or a component of 

that endpoint. This draft guidance 

revises the draft guidance entitled 

‘‘Standards for Clinical Trial Imaging 

Endpoints’’ issued on August 19, 2011. 

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on the draft guidance by May 4, 2015. 

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, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993–0002, or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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: 

Louis Marzella, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5406, 

Silver Spring, MD 20993–0002, 301– 

796–1414; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Trial Imaging Endpoint 

Process Standards.’’ The purpose of this 

guidance is to assist sponsors in 

optimizing the quality of imaging data 

obtained in clinical trials intended to 

support approval of drugs and biological 

products. It focuses on imaging 

acquisition, display, archiving, and 

interpretation standards that FDA 

regards as important when imaging is 

used to assess the trial’s primary 

endpoint or a component of that 

endpoint. The guidance describes the 

minimum standards a sponsor should 

use to help ensure that clinical trial 

imaging data are obtained in a manner 

that complies with a trial’s protocol, 

maintains imaging data quality, and 

provides a verifiable record of the 

imaging process. 

This guidance addresses the 

background considerations for 

determining the role of imaging in a 

clinical trial as well as the major 

considerations in the development of an 

imaging charter that describes the trial’s 

imaging methods. The guidance 

specifically addresses the technical 

components of a charter’s description of 

the image acquisition, image 

interpretation, and image data 

development methods. 

This draft guidance revises the draft 

guidance entitled ‘‘Standards for 

Clinical Trial Imaging Endpoints’’ 

issued on August 19, 2011 (76 FR 

51993). Comments we received on the 

draft guidance have been considered 

and the guidance has been revised as 

follows: (1) It has been made clear that 

the guidance pertains to imaging in 

clinical trials intended to support 

approval of drugs and biological 

products and focuses upon standards 

that FDA regards as important when 

imaging is used to assess a trial’s 

primary endpoint; (2) it has been made 

clear that the imaging charter can be 

either a single document or an ensemble 

of documents, depending on multiple 

factors; (3) it is emphasized that imaging 

risks are best described in the clinical 

protocol and should be addressed in 

consent documents instead of including 

this information in the imaging charter; 

(4) it has been emphasized that this 

guidance does not address whether 

imaging outcomes are clinically 

meaningful and are acceptable for drug 

approval evidence; (5) it has been noted 

that image acquisition phantoms may or 

may not be necessary, depending on the 

nature of the imaging in a clinical trial; 

(6) it has been modified to emphasize 

the need for the clinical protocol (not 

the charter) to describe how incidental 

findings will be handled; (7) it has been 

noted that the charter should identify 

any use of investigational equipment 

(for international trials, the guidance 

encourages use of equipment that is 

lawfully marketed in the area); and (8) 

a section has been added that describes 

the importance of having the clinical 

trial sponsor ensure the fidelity of all 

charter components with the clinical 

protocol. 

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 the major considerations for 

standardization of imaging primary 

endpoints in clinical trials of drugs and 

biological products. 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 

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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 11999 

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 (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 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 http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

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

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: February 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05016 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

the Draft National Adult Immunization 

Plan; Extension of Comment Period 

AGENCY: National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Office of the Secretary, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS), through the 

National Vaccine Program Office 

(NVPO) is extending the public 

comment period for a draft document 

titled ‘‘The National Adult 

Immunization Plan (NAIP).’’ The 

availability of that draft document was 

published in the Federal Register on 

February 6, 2015, Volume 80, Number 

25, pages 6721–6722. 

DATES: The comment period is extended 

by 14 days and thus will end on March 

23, 2015. 

ADDRESSES: (1) The draft NAIP is 

available on the Web at www.hhs.gov/

nvpo/. 

(2) Electronic responses are preferred 

and may be addressed to: Rebecca.Fish@

hhs.gov. 

(3) Written responses should be 

addressed to: National Vaccine Program 

Office, U.S. Department of Health and 

Human Services, 200 Independence 

Avenue SW., Room 733G, Washington, 

DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Fish, National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Department of Health and 

Human Services; telephone (202) 260– 

9283; fax (202) 260–1165; email: 

Rebecca.Fish@hhs.gov. 

SUPPLEMENTARY INFORMATION: The notice 

of availability of the draft National 

Adult Immunization Plan (NAIP) was 

published in the Federal Register on 

February 6, 2015, Volume 80, Number 

25, pages 6721–6722, with a deadline 

for comments of March 9, 2015. The 

NAIP is a national plan that will require 

engagement from a wide range of 

stakeholders to achieve its full vision. 

The plan emphasizes collaboration and 

prioritization of efforts that will have 

the greatest impact. NVPO is soliciting 

public comment on the draft NAIP from 

a variety of stakeholders, including the 

general public, for consideration as they 

develop their final report to the 

Secretary. Since the notice of 

availability and draft guidance 

documents were published, the 

Department has received requests to 

extend the comment period to allow 

sufficient time for a full review of the 

draft NAIP. NVPO is committed to 

affording the public a meaningful 

opportunity to comment on the draft 

NAIP and welcomes comments. 

Persons with access to the Internet 

may obtain the draft National Adult 

Immunization Plan on NVPO’s Web site 

at http://www.hhs.gov/nvpo. 

Dated: February 25, 2015. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office, 

Executive Secretary, National Vaccine 

Advisory Committee. 

[FR Doc. 2015–05030 Filed 3–4–15; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Gene 

Regulation. 

Date: February 26, 2015. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Richard A Currie, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1108, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

1219, currieri@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Topics in 

Biomaterials. 

Date: March 5–6, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Joseph D Mosca, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5158, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

2344, moscajos@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

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