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on the draft guidance.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few comments on the draft guidance, 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finalizes the draft guidance dated 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been set forth within the draft guidance 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 

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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73325 

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. 

Dated: December 4, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28881 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–1998] 

Patient-Focused Drug Development 

Public Meeting on Chagas Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting and an opportunity for 

public comment on Patient-Focused 

Drug Development for Chagas disease. 

Patient-Focused Drug Development is 

part of FDA’s performance 

commitments in the fifth authorization 

of the Prescription Drug User Fee Act 

(PDUFA V). The meeting is intended to 

allow FDA to obtain patients’ 

perspectives on the impact that Chagas 

disease has on their daily lives, as well 

as their perspectives on the available 

therapies for Chagas disease. FDA is 

also interested in discussing issues 

related to scientific challenges in 

developing drugs to treat Chagas 

disease. In the afternoon, FDA will 

provide information for and gain 

perspective from patients and patient 

advocacy organizations, health care 

providers, academic experts, and 

industry on various aspects of clinical 

development of drug products intended 

to treat Chagas disease. The input from 

this public meeting will help in 

developing topics for further discussion. 

DATES: The meeting will be held on 

April 28, 2015, from 9 a.m. to 5 p.m. 

Registration to attend the meeting must 

be received by April 20, 2015. See the 

SUPPLEMENTARY INFORMATION section for 

information on how to register for the 

meeting. Submit electronic or written 

comments by June 29, 2015. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, Sections B and C of 

the Great Room (Rm. 1503), Silver 

Spring, MD 20993. Participants must 

enter through Building 1 and undergo 

security screening. For more 

information on parking and security 

procedures, please visit http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

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, Room 1061, Rockville, MD 20852. 

All comments should be identified with 

the docket number found in brackets in 

the heading of this document. 

FDA will post the agenda 

approximately 5 days before the meeting 

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

NewsEvents/ucm420130.htm. 

FOR FURTHER INFORMATION CONTACT: 

Pujita Vaidya, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1144, 

Silver Spring, MD 20993, 301–796– 

0684, FAX: 301–847–8443, 

Pujita.Vaidya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on Patient-Focused Drug 

Development 

FDA has selected Chagas disease as 

the focus of a meeting under PatientFocused Drug Development, an 

initiative that involves obtaining a better 

understanding of patients’ perspectives 

on the severity of the disease and the 

available therapies for the condition. 

Patient-Focused Drug Development is 

being conducted to fulfill FDA’s 

performance commitments made as part 

of the authorization of PDUFA V under 

Title I of the Food and Drug Safety and 

Innovation Act (Public Law 112–144). 

The full set of performance 

commitments is available on the FDA 

Web site at http://www.fda.gov/

downloads/forindustry/userfees/

prescriptiondruguserfee/

ucm270412.pdf. 

FDA has committed to obtain the 

patient perspective in 20 disease areas 

during the course of PDUFA V. For each 

disease area, the Agency will conduct a 

public meeting to discuss the disease 

and its impact on patients’ daily lives, 

the types of treatment benefit that 

matter most to patients, and patients’ 

perspectives on the adequacy of the 

available therapies. These meetings will 

include participation of FDA review 

divisions, the relevant patient 

community, and other interested 

stakeholders. 

On April 11, 2013, FDA published a 

notice (78 FR 21613) in the Federal 

Register announcing the disease areas 

for meetings in fiscal years (FYs) 2013 

through 2015, the first 3 years of the 5- 

year PDUFA V time frame. To develop 

the list of disease areas, the Agency 

used several criteria that were outlined 

in the April 11 notice. The Agency 

obtained public comment on these 

criteria and potential disease areas 

through a notice for public comment 

published in the Federal Register on 

September 24, 2012 (77 FR 58849), and 

through a public meeting held on 

October 25, 2012. In selecting the 

disease areas, FDA carefully considered 

the public comments received and the 

perspectives of its review divisions. On 

October 8, 2014, FDA published a notice 

in the Federal Register to initiate 

another public process to determine the 

disease areas for FYs 2016 through 2017 

(79 FR 60857). More information, 

including the list of disease areas and a 

general schedule of meetings, is posted 

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

UserFees/PrescriptionDrugUserFee/

ucm326192.htm. 

II. Public Meeting Information 

A. Purpose and Scope of the Meeting 

As part of Patient-Focused Drug 

Development, FDA will obtain patient 

and patient stakeholder input on 

symptoms of Chagas disease (American 

trypanosomiasis) that matter most to 

patients and on current approaches to 

treating Chagas disease. When left 

untreated, acute Chagas disease may 

progress to chronic Chagas disease. 

There are currently no FDA-approved 

drug therapies to treat acute or chronic 

Chagas disease. FDA is committed to 

working with all stakeholders to 

develop safe and effective therapies for 

affected individuals. 

The questions that will be asked of 

patients and patient stakeholders at the 

meeting are listed in this section and 

organized by topic. For each topic, a 

brief patient panel discussion will begin 

the dialogue, followed by a facilitated 

discussion inviting comments from 

other patients and patient stakeholders. 

In addition to input received through 

this public meeting, FDA is interested in 

receiving patient input addressing these 

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