28058 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

needs to withhold payments from an 

obligor who owes child support. One of 

the new fields on the form is for the 

attachment of lump sum payments by 

employers. This addition allows the 

issuing entity to instruct the employer 

with respect to the attachment and 

remittance of lump sum payments. 

Fields for child’s name and date of birth 

have been moved to the front of the 

form, allowing the employer community 

to easily identify who the form is for 

and to avoid implementation of 

duplicate orders. Other changes that 

have enhanced the form include: A 

simplified title, clear identification of 

who is sending the form, and 

modifications to allow the employer to 

easily report employee terminations. 

The electronic IWO (e-IWO) allows 

States to transmit IWOs electronically 

and employers to notify States 

electronically regarding the status of 

IWOs. 

Respondents: States, Territories, 

Tribes, and Courts. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Income Withholding for Support (IWO) ........................................................... 58 206,897 .0017 20,400 

ELECTRONIC Income Withholding for Support .............................................. 20 60,000 .0008 960 

IWO—Submitted Manually .............................................................................. 1,800 1,321 .0840 199,735 

Estimated Total Annual Burden 

Hours: 221,095. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202–

395–6974, Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: May 15, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–2479 Filed 5–17–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0166] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on Target 

Animal Safety for Veterinary 

Pharmaceutical Products, VICH GL43, 

Request for Comments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability for comments of a draft 

guidance document for industry (#185) 

entitled ‘‘Draft Guidance for Industry on 

Target Animal Safety for Veterinary 

Pharmaceutical Products,’’VICH GL43. 

This draft guidance has been developed 

for veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This draft VICH guidance 

document has been developed as a 

harmonized standard to aid in 

development of mutually acceptable 

target animal safety (TAS) studies for 

the relevant governmental regulatory 

bodies. 

DATES: Submit written or electronic 

comments on the draft guidance by June 

18, 2007, to ensure their adequate 

consideration in preparation of the final 

document. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Comments should be identified with the 

full title of the draft guidance and the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Laura Hungerford, Center for Veterinary 

Medicine, (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6439, email: laura.hungerford@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 


pwalker on PROD1PC71 with NOTICES
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