Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17047 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Hypertension, Thrombosis, Vascular 

Inflammation and Dysfunction. 

Date: April 23–24, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place:National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Natalia Komissarova, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1206, komissar@mail.nih.gov. 

(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). 

Dated: March 25, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07256 Filed 3–30–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0815] 

Electronic Study Data Submission; 

Data Standards; Recommending the 

Use of the World Health Organization 

Drug Dictionary 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing support for the World 

Health Organization (WHO) Drug 

Dictionary (available at http:// 

www.who-umc.org/), which is 

maintained and updated by the Uppsala 

Monitoring Centre. FDA is encouraging 

sponsors and applicants to use WHO 

Drug Dictionary codes in investigational 

study data provided in regulatory 

submissions to the Center for Drug 

Evaluation and Research and to the 

Center for Biologics Evaluation and 

Research. The WHO Drug Dictionary 

contains unique codes for identifying 

drug names and evaluating medicinal 

product information, including active 

ingredients and therapeutic uses. 

Typically, WHO Drug Dictionary is used 

to code concomitant medications used 

by subjects during the course of a 

clinical trial. WHO Drug Dictionary will 

be listed in the FDA Data Standards 

Catalog posted to FDA’s Study Data 

Standards Resources Web site at 

http://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm 

DATES: Although you can comment on 

this notice at any time, to ensure that 

the Agency considers your comments 

submit either electronic or written 

comments by May 5, 2015. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

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. 

Submit electronic comments 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: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 51, rm. 1192, Silver Spring, 

MD 20993–002, 

ronald.fitzmartin@fda.hhs.gov; 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, 

stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The use of a common dictionary to 

code concomitant medications is an 

important component of study data 

standardization. Generally, controlled 

terminology standards specify the key 

concepts that are represented as 

definitions, preferred terms, synonyms, 

codes, and code system. The analysis of 

study data is greatly facilitated by the 

use of controlled terms for clinical or 

scientific concepts that have standard, 

predefined meanings and 

representations. WHO Drug Dictionary 

contains unique codes as drug names 

and corresponding medicinal product 

information, including active 

ingredients and the Anatomical 

Therapeutic Chemical (ATC) 

classification system for the therapeutic 

uses. Typically, sponsors and applicants 

use WHO Drug Dictionary to code and 

analyze concomitant medications taken 

by subjects during the course of clinical 

trials. 

Although use of WHO Drug 

Dictionary codes are not required at this 

time, FDA now supports and encourages 

the use of WHO Drug Dictionary coded 

concomitant medications used in 

clinical trials. For purposes of this 

notice, ‘‘supported’’ means the receiving 

Center has established processes and 

technology to support receiving, 

processing, reviewing, and archiving 

files in the specified standard. 

FDA is now encouraging sponsors and 

applicants to provide WHO Drug 

Dictionary codes for concomitant 

medication data in investigational 

studies provided in regulatory 

submissions (e.g., investigational new 

drug applications, new drug 

applications, abbreviated new drug 

applications, and biologics license 

applications). The codes should include 

the drug product trade name where 

available, the active ingredient(s) and 

the ATC class. 

II. Comments 

Interested persons may submit either 

electronic comments to http:// 

www.regulations.gov or written 

comments regarding this notice 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. 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07269 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0839] 

Target Animal Safety Data 

Presentation and Statistical Analysis; 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
17048 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 

industry #226 entitled ‘‘Target Animal 

Safety Data Presentation and Statistical 

Analysis.’’ The purpose of this 

document is to provide 

recommendations to industry regarding 

the presentation and statistical analyses 

of target animal safety (TAS) data 

submitted to the Center for Veterinary 

Medicine (CVM) as part of a study 

report to support approval of a new 

animal drug. These recommendations 

apply to TAS data generated from both 

TAS and field effectiveness studies 

conducted in companion animals (e.g., 

dogs, cats, and horses) and food animals 

(e.g., swine, ruminants, fish, and 

poultry). 

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 June 1, 2015. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed 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: 

Virginia Recta, Center for Veterinary 

Medicine (HFV–164), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0840, 

virginia.recta@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #226 

entitled ‘‘Target Animal Safety Data 

Presentation and Statistical Analysis.’’ It 

is intended to provide recommendations 

to industry regarding the presentation 

and statistical analyses of TAS data 

submitted to CVM as part of a study 

report to support approval of a new 

animal drug. These recommendations 

apply to TAS data generated from both 

TAS and field effectiveness studies 

conducted in companion animals (e.g., 

dogs, cats, and horses) and food animals 

(e.g., swine, ruminants, fish, and 

poultry). 

II. Significance of Guidance 

This level 1 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 current 

thinking of FDA on ‘‘Target Animal 

Safety Data Presentation and Statistical 

Analysis.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. 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 part 514 have 

been approved under OMB control 

number 0910–0032. 

IV. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: March 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07264 Filed 3–30–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Same-sex relationships: Updates 

to Healthy Marriage and Relationship 

Education. 

OMB No.: New Collection 

Description: The Administration for 

Children and Families (ACF) will 

examine how healthy marriage 

programs currently approach, and could 

approach, serving sexual minority 

populations, that is, lesbian, gay, and 

bisexual populations. ACF expects to 

collect and analyze data from a range of 

information collection efforts— 

including interviews with program 

administrators, program managers, 

healthy marriage and relationship 

programming experts, and focus groups 

with program applicants and program 

attendees—to propose methods and 

practices for serving such couples/

individuals/youth. 

Respondents: Current healthy 

marriage program applicants and 

participants, program managers and 

facilitators, and experts in the field. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total/annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Focus Group Guide for Program Applicants ................................................... 30 1 1.5 45 

Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90 

Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90 

Interview Guide for Program Managers .......................................................... 6 1 1 6 

Interview Guide for Program Facilitators ......................................................... 12 1 1 12 

Interview Guide for Program Experts .............................................................. 12 1 1 12 


asabaliauskas on DSK5VPTVN1PROD with NOTICES