Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices 61081 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2002–D–0268 (formerly 

Docket No. 2002D–0005)] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH 

GL30); Guidance for Industry on 

Pharmacovigilance of Veterinary 

Medicinal Products: Controlled List of 

Terms; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(GFI #143) entitled ‘‘Guidance for 

Industry on Pharmacovigilance of 

Veterinary Medicinal Products: 

Controlled List of Terms’’ (VICH GL30). 

This guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). The purpose of this VICH 

guidance document is to describe the 

controlled lists of terms critical to 

completing the controlled data fields as 

identified in the guidance entitled ‘‘Data 

Elements for Submission of Veterinary 

Adverse Event Reports to the Center for 

Veterinary Medicine’’ (GFI #188), 

available on the FDA Web site at: 

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

GuidanceComplianceEnforcement/

GuidanceforIndustry/ucm042450.htm. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

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 request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Margarita Brown, Center for Veterinary 

Medicine (HFV–240), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9048, 

CVMAESupport@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote the 

international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based, 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify, and then 

reduce, differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission, 

European Medicines Evaluation Agency, 

European Federation of Animal Health, 

Committee on Veterinary Medicinal 

Products, FDA, the U.S. Department of 

Agriculture, the Animal Health 

Institute, the Japanese Veterinary 

Pharmaceutical Association, the 

Japanese Association of Veterinary 

Biologics, and the Japanese Ministry of 

Agriculture, Forestry and Fisheries. 

Six observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

governments of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, one representative from the 

industry of Canada, one representative 

from the government of South Africa, 

and one representative from the 

industry of South Africa. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Guidance on Controlled Lists of 

Terms 

In the Federal Register of June 21, 

2007 (72 FR 34261), FDA published a 

notice of availability for a revised draft 

guidance entitled ‘‘Revised Draft 

Guidance for Industry on 

Pharmacovigilance of Veterinary 

Medicinal Products: Controlled List of 

Terms’’ (VICH GL30). Interested persons 

were given until July 23, 2007, to 

comment on the revised draft guidance. 

FDA received a few comments on the 

draft revised guidance, and those 

comments, as well as those received by 

other VICH member regulatory agencies, 

were considered as the guidance was 

finalized. The guidance announced in 

this document finalizes the draft revised 

guidance dated June 20, 2007. The final 

guidance is a product of the 

Pharmacovigilance Expert Working 

Group of the VICH. 

This VICH guidance document 

describes the controlled lists of terms 

critical to completing the controlled 

data fields as indicated in FDA’s 

‘‘Guidance for Industry, Data Elements 

for Submission of Veterinary Adverse 

Event Reports to the Center for 

Veterinary Medicine’’ (GFI #188). To 

assess the safety and efficacy of 

veterinary medicinal products, the use 

of controlled lists of terms is important 

in order to assure consistency, as well 

as to provide for comparison between 

products and across product classes. 

This guidance also includes an 

appropriate maintenance procedure to 

keep the lists of terms up to date. 

III. Significance of Guidance 

This guidance, developed under the 

VICH process, has been revised to 

conform to FDA’s good guidance 

practices regulation (21 CFR 10.115). 

For example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ In addition, guidance 

documents must not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. 

The guidance represents 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 applicable 

statutes and regulations. 

mstockstill on DSK4VPTVN1PROD with NOTICES

61082 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices 

IV. Paperwork Reduction Act of 1995 

This 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 

this guidance have been approved under 

OMB control numbers 0910–0284 and 

0910–0645. 

V. 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. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

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

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: October 6, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24152 Filed 10–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Science Advisory Board to the 

National Center for Toxicological 

Research Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Science 

Advisory Board (SAB) to the National 

Center for Toxicological Research 

(NCTR). 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on November 6, 2014, from 8:15 

a.m. to 4:15 p.m. and on November 7, 

2014, from 8 a.m. to 2 p.m. 

Location: NCTR SAB, 3900 NCTR Rd., 

Conference Room B–12, Jefferson, AR 

72079. 

Contact Person: Donna Mendrick, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

2208, Silver Spring, MD 20993–0002, 

301–796–8892, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

Agenda: On November 6, 2014, the 

NCTR Director will welcome the 

participants and provide a Center-wide 

update on scientific initiatives and 

accomplishments during the past year. 

The SAB will be presented with an 

overview of the Division of 

Microbiology Subcommittee and the 

Subcommittee Site Visit Report. 

Following the public session, the SAB 

will hear an update from each of 

NCTR’s research Divisions, the Office of 

Science Coordination, followed by an 

update on NCTR’s Global Interactions. 

On November 7, 2014, the Office of 

the Chief Scientist will update the SAB 

on their research needs, and discuss 

opportunities for collaboration to help 

address these needs, followed by a 

report from the National Toxicology 

Program of the National Institutes of 

Environmental Health Sciences on 

current and future collaboration. 

The Center for Biological Evaluation 

and Research, the Center for Drug 

Evaluation and Research, the Center for 

Devices and Radiological Health, the 

Center for Veterinary Medicine, the 

Center for Tobacco Products, the Office 

of Regulatory Affairs, and the Center for 

Food Safety and Applied Nutrition will 

each briefly discuss their Center-specific 

research strategic needs. 

Following an open discussion of all 

the information presented, the open 

session of the meeting will close so that 

SAB members can discuss personnel 

issues at NCTR. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 30, 2014. 

Oral presentations from the public will 

be scheduled between approximately 12 

noon to 1 p.m. on November 6, 2014. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 22, 2014. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 23, 2014. 

Closed Committee Deliberations: On 

November 7, 2014, from 12 noon to 2 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). This portion of the meeting 

will be closed to permit discussion of 

information concerning individuals 

associated with the research programs at 

NCTR. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Donna 

mstockstill on DSK4VPTVN1PROD with NOTICES