Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28059 

Requirements for Approval 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. VICH is a 

parallel initiative for veterinary 

medicinal products. 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. 

Four 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, and one representative from the 

industry of Canada. 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. Draft Guidance on Target Animal 

Safety 

The VICH steering committee held a 

meeting in December 2006 and agreed 

that the draft guidance document 

entitled ‘‘Draft Guidance for Industry on 

Target Animal Safety for Veterinary 

Pharmaceutical Products,’’VICH GL43 

should be made available for public 

comment. This draft VICH guidance 

document has been developed as a 

harmonized standard to aid in 

development of mutually acceptable 

TAS studies for the relevant 

governmental regulatory bodies. This 

draft guidance document is intended to 

cover TAS studies for any 

Investigational Veterinary 

Pharmaceutical Product used in the 

following species: Bovine, ovine, 

caprine, feline, canine, porcine, equine, 

and poultry (chickens and turkeys). 

Minor species and minor uses may be 

excluded from this guidance for local 

registration. The guidance does not 

provide information for the design of 

TAS studies in other species including 

aquatic animals. For other species, TAS 

studies should be designed following 

local guidance. 

FDA and the VICH Expert Working 

Group will consider comments about 

the draft guidance document. 

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 section 1-5 of the draft 

guidance have been approved under 

OMB Control No. 0910–0032. 

IV. Significance of Guidance 

This draft document, 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 draft VICH guidance (GFI #185) is 

consistent with the agency’s current 

thinking on this topic. This guidance 

does not create or confer any rights for 

or on any person and will not operate 

to bind FDA or the public. An 

alternative method may be used as long 

as it satisfies the requirements of 

applicable statutes and regulations. 

IV. Comments 

This draft guidance document is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit written or electronic comments 

regarding this draft guidance document 

to the Division of Dockets Management 

(see ADDRESSES). Submit a single copy 

of electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments may be seen in 

the Division of Dockets Management 

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

through Friday. 

V. Electronic Access 

Electronic comments may also be 

submitted electronically on the Web site 

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

ecomments. Once on this Internet site, 

select Docket No. 2007D–0166 entitled 

‘‘Draft Guidance for Industry on Target 

Animal Safety for Veterinary 

Pharmaceutical Products,’’VICH GL43 

and follow the directions. 

Copies of the draft guidance 

document entitled ‘‘Draft Guidance for 

Industry on Target Animal Safety for 

Veterinary Pharmaceutical 

Products,’’VICH GL43 may be obtained 

on the Web site from the Center for 

Veterinary Medicine home page at 

http://www.fda.gov/cvm. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9592 Filed 5–17–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: OAT Telehealth 

Outcome Measures: NEW. 

In order to help carry out its mission, 

the Office for the Advancement of 

Telehealth (OAT) created a set of 

performance measures that grantees can 

use to evaluate the effectiveness of their 

services programs and monitor their 

progress through the use of performance 

reporting data. 

As required by the Government 

Performance and Review Act of 1993 

(GPRA), all Federal agencies must 

develop strategic plans describing their 

overall goal and objectives. The Office 

for the Advancement of Telehealth 

(OAT) has worked with its grantees to 

develop performance measures to be 

used to evaluate and monitor the 


pwalker on PROD1PC71 with NOTICES
28060 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

progress of the grantees. Grantee goals 

are to: Improve access to needed 

services, reduce rural practitioner 

isolation, improve health system 

productivity and efficiency, and 

improve patient outcomes. In each of 

these categories, specific indicators 

were designed to be reported through a 

performance monitoring Web site. 

The Program Assessment Response 

Tool (PART) is the newest instrument 

created for use by Federal agencies. The 

Office of Management and Budget 

(OMB) uses the PART to assess Federal 

programs. The PART is a series of 

diagnostic questions used to assess and 

evaluate programs across a set of 

performance-related criteria including 

program design and purpose, strategic 

planning, program management, and 

results. PART results are used to inform 

the budget process and improve 

program management. OAT’s Telehealth 

Network Grant Program has been 

undergoing a PART assessment this 

year. Thus, in addition to responding to 

the GPRA initiative, OAT now has the 

added responsibility of responding to 

the PART assessment of its Telehealth 

Network Grant Program. The proposed 

performance measures will provide 

performance data that will address the 

PART assessment, monitor progress, 

and evaluate program effectiveness. 

The estimates of burden are as 

follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses Hour burden Total burden hours 

Performance Measurement Tool ......................................... 667 2 1,334 7 9,338 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

Karen Matsuoka, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503. 

Dated: May 11, 2007. 

Caroline Lewis, 

Associate Administrator for Management. 

[FR Doc. E7–9536 Filed 5–17–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects (44 

U.S.C. 3506(c)(2)(A)), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Data System for 

Organ Procurement and 

Transplantation Network (42 CFR Part 

121, OMB No. 0915–0184): Extension 

The operation of the Organ 

Procurement and Transplantation 

Network (OPTN) necessitates certain 

recordkeeping and reporting 

requirements in order to perform the 

functions related to organ 

transplantation under contract to HHS. 

This is a request for an extension of the 

current recordkeeping and reporting 

requirements associated with the OPTN. 

These data will be used by HRSA in 

monitoring the contracts for the OPTN 

and the Scientific Registry of Transplant 

Recipients (SRTR) and in carrying out 

other statutory responsibilities. 

Information is needed to match donor 

organs with recipients, to monitor 

compliance of member organizations 

with OPTN rules and requirements, to 

ensure that all qualified entities are 

accepted for membership in the OPTN, 

and to ensure patient safety. 

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Section and Activity Number of 

respondents 

Responses per 

respondents 

Total 

responses 

Hours per 

response 

Total burden 

hours 

121.3(b)(2).

OPTN membership and application requirements for 

OPOs, hospitals, and histocompatibility laboratories 40 3 120 15 1, 800 

121.3(b)(4) 

Appeal for OPTN membership ................................. 2 1 2 3 6 

121.6(c) (Reporting) 

Submitting criteria for organ acceptance .................. 900 1 900 0 .5 450 

121.6(c) (Disclosure) 

Sending criteria to OPOs .......................................... 900 1 900 0 .5 450 

121.7(b)(4) 

Reasons for Refusal ................................................. 900 38 34,200 0 .5 17,100 

121.7(e) 

Transplant to prevent organ wastage ....................... 260 1 .5 390 0 .5 195 

121.9(b) 

Designated Transplant Program Requirements ....... 10 1 10 5 .0 50 

121.9(d) 


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