Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73323 

current thinking on the content and 

format of the Patient Counseling 

Information section of labeling for 

human prescription drug 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 used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. 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. 

III. The 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 

21 CFR 201.56 and 201.57 have been 

approved under OMB control number 

0910–0572. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

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

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://

www.regulations.gov. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28888 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0588] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; 

Guidance for Industry on 

Pharmacovigilance of Veterinary 

Medicinal Products: Electronic 

Standards for Transfer of Data; 

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 #214) entitled ‘‘Pharmacovigilance 

of Veterinary Medicinal Products: 

Electronic Standards for Transfer of 

Data’’ (VICH GL35). This guidance has 

been developed for veterinary use by the 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH). 

This VICH guidance document is 

intended to provide recommended 

standards to construct a single Adverse 

Event Report (AER) electronic message 

to transmit VICH GL42 contents to all 

member regions and Product Problem 

Reports (PPR) to FDA for veterinary 

medicinal products. Please note that 

VICH GL42 has been harmonized in GFI 

#188, ‘‘Data Elements for Submission of 

Veterinary Adverse Event Reports to the 

Center for Veterinary Medicine.’’ 

DATES: Submit either electronic or 

written comments on Agency guidance 

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, 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 

government 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 

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73324 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Guidance on Electronic Standards 

for Transfer of Data 

In the Federal Register of September 

15, 2011 (76 FR 57060), FDA published 

a notice of availability for a draft 

guidance document entitled 

‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Electronic 

Standards for Transfer of Data’’ (VICH 

GL35). Interested persons were given 

until November 14, 2011, to comment 

on the draft guidance. FDA received a 

few comments on the draft 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 guidance dated 

September 15, 2011. The final guidance 

is a product of the Pharmacovigilance 

Expert Working Group of the VICH. 

In order to allow for electronic 

exchange of this information between 

stakeholders, further specification of the 

field descriptors and their relationships, 

including agreement on format of the 

electronic message is essential. This 

VICH guidance document is intended to 

provide recommended standards to 

construct a single electronic message to 

transmit data elements for submission of 

AERs to all member regions. The need 

to transfer and disseminate information 

quickly, accurately and easily between 

Regulatory Authorities and Marketing 

Authorization Holders on a worldwide 

scope is especially pertinent to the 

notification and assimilation of 

information for pharmacovigilance. 

Whereas the recommended definition of 

the pharmacovigilance information has 

been set forth within the draft guidance 

entitled, ‘‘Pharmacovigilance of 

Veterinary Medicinal Products: 

Management of Adverse Event Reports 

(AER’s)’’ (VICH GL24), and the final 

guidances entitled ‘‘Pharmacovigilance 

of Veterinary Medicinal Products: 

Controlled Lists of Terms’’ (VICH GL30) 

and ‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Data Elements for 

Submission of Adverse Event Reports’’ 

(VICH GL42), this guidance defines 

recommended electronic standards for 

transfer of data. Please note that VICH 

GL42 has been harmonized in GFI #188, 

‘‘Data Elements for Submission of 

Veterinary Adverse Event Reports to the 

Center for Veterinary Medicine.’’ 

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. 

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 number 0910–0645. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to 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. 

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: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28830 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

Advisory Committee; Notice of 

Postponement of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is postponing the 

meeting of the Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices Advisory scheduled for 

December 12, 2014. The meeting was 

announced in the Federal Register of 

September 22, 2014 (79 FR 56589). The 

meeting is postponed from December 

12, 2014, until February 20, 2015. The 

location of the meeting has also 

changed. 

Date and Time: The meeting will be 

held February 20, 2015, from 8 a.m. to 

6 p.m. 

Location: Hilton/Washington DC 

North, 620 Perry Pkwy., Gaithersburg, 

MD 20877. The hotel’s telephone 

number is 301–977–8900. 

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 February 13, 2015. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. 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 February 

4, 2015. 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 February 6, 2015. 

Contact Person: Sara Anderson, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 1611, Silver Spring, MD 20993– 

0002, or FDA Advisory Committee 

mstockstill on DSK4VPTVN1PROD with NOTICES