Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 67725 

comments regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 7, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22268 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0146] 

Guidance for Industry: Validation of 

Analytical Procedures for Type C 

Medicated Feeds; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a final guidance for 

industry (#135) entitled ‘‘Validation of 

Analytical Procedures for Type C 

Medicated Feeds.’’ This guidance 

represents the agency’s current thinking 

on the characteristics that should be 

considered during the validation of nonmicrobiological analytical procedures 

for the analysis of drugs in Type C 

medicated feeds included as part of 

original and supplemental new animal 

drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs) for Type A 

medicated articles submitted to FDA. 

This guidance is the first in a series of 

three guidances that will discuss assay 

methods for Type C medicated feeds. 

DATES: Submit written or electronic 

comments on agency guidance 

documents 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 requests. 

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. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Mary G. Leadbetter, Center for 

Veterinary Medicine (HFV–141), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 301–827–

6964, e-mail: mleadbet@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 28, 

2004 (69 FR 23209), FDA published a 

notice of availability for a draft guidance 

entitled ‘‘Validation of Analytical 

Procedures for Type C Medicated 

Feeds’’ giving interested persons until 

July 12, 2004, to comment on the draft 

guidance. FDA received no comments 

on the draft guidance and no 

substantive changes were made in 

finalizing this guidance document. 

II. Paperwork Reduction Act of 1995 

According to the Paperwork 

Reduction Act of 1995, a collection of 

information must display a valid OMB 

control number. The existing valid OMB 

control numbers for this information 

collection are 0910–0032 and 0910–

0154. This guidance contains no new 

collections of information. 

III. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on the 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 alternate method 

may be used as long as it satisfies the 

requirements of applicable statutes and 

regulations. 

IV. Comments 

As with all FDA’s guidances, the 

public is encouraged to submit written 

or electronic comments with new data 

or other new information pertinent to 

this guidance. FDA periodically will 

review the comments in the docket, and 

where appropriate, will amend the 

guidance. The agency will notify the 

public of any such amendments through 

a notice in the Federal Register. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance at any time. 

Two copies of any comments are to be 

submitted, except that individuals may 

submit one copy. Comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. A copy of the document and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Copies of the guidance document 

entitled ‘‘Validation of Analytical 

Procedures for Type C Medicated 

Feeds’’ may be obtained from the CVM 

Home Page (http://www.fda.gov/cvm) 

and from the Division of Dockets 

Management Web site (http:// 

www.fda.gov/ohrms/dockets/ 

default.htm). 

Dated: October 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22222 Filed 11–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Proposed Collection: Indian Health 

Service Background Investigations of 

Individuals in Positions Involving 

Regular Contact With or Control Over 

Indian Children OPM—306 Request for 

Public Comment: 30-Day Notice 

AGENCY: Indian Health Service, HHS. 

ACTION: Request for Public Comment: 

30-day Proposed Information Collection: 

Indian Health Service Background 

Investigations of Individuals in 

Positions Involving Regular Contact 

With or Control Over Indian Children 

OPM–306. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, for opportunity 

for public comment on proposed 

information collection projects, the 

Indian Health Service (IHS) has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

listed below. This proposed information 

collection project was published in the 

August 3, 2005, Federal Register (70 

51826) and allowed 60 days for public 

comment. No public comment was 

received in response to the notice. The 

purpose of this notice is to allow 30 

days for public comment to be 

submitted to OMB. 

PROPOSED COLLECTION: Title: 

0917–0028, ‘‘Indian Health Service 

Background Investigations of 

Individuals in Positions Involving 

Regular Contact With or Control Over 

67726 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices 

Indian Children OPM–306’’. Type of 

Information Collection Request: 

Extention of a currently approved 

collection which expires November 30, 

2005. Type of Information Collection 

Request: Extension of a currently 

approved collection which expires 

November 30, 2005. Form Number: OF–

306 Addendum to Declaration for 

Federal Employment (OF 306) Indian 

Health Service Child Care & Indian 

Child Care Worker Positions. Need and 

Use of Information Collection: This is a 

request for approval of collection 

information required by section 408 of 

the Indian Child Protection and Family 

Violence Prevention Act, Public Law 

101–630, 104 Stat. 4544, 25 U.S.C. 

3201–3211. The IHS is required to 

compile a list of all authorized positions 

within the IHS where the duties and 

responsibilities involve regular contact 

with, or control over, Indian children; 

and to conduct an investigation of the 

character of each individual who is 

employed, or is being considered for 

employment in a position having 

regular contact with, or control over, 

Indian children. Section 3207(b) of the 

Indian Child Protection and Family 

Violence Prevention Act was amended 

by Section 814 of S. 3031, the Native 

American Laws Technical Corrections 

Act of 2000, which requires that the 

regulations prescribing the minimum 

standards of character ensure that none 

of the individuals appointed to 

positions involving regular contact with, 

or control over Indian children have 

been found guilty of, or entered a plea 

of nolo contendere or guilty to any 

felonious offense, or any of two or more 

misdemeanor offenses under Federal, 

State, or Tribal law involving crimes of 

violence; sexual assault, molestation, 

exploitation, contact or prostitution, 

crimes against persons; or offenses 

committed against children. In addition, 

42 U.S.C. 13041 requires each agency of 

the Federal government and every 

facility operated by the Federal 

government (or operated under contract 

with the Federal government), that hires 

(or contracts for hire) individuals 

involved with children under the age of 

18 or child care services to assure that 

all existing and newly-hired employees 

undergo a criminal history background 

check. The background is to be initiated 

through the personnel program of the 

applicable Federal agency. This section 

requires employment applications for 

individuals who are seeking work for an 

agency of the Federal government, or for 

a facility or program operated by (or 

through contract with) the Federal 

government, in positions involved with 

the provision to children under the age 

of 18 or child care services, to contain 

a question asking whether the 

individual has ever been arrested for or 

charged with a crime involving a child. 

Affected Public: Individual and 

households. Type of Respondents: 

Individuals. Table 1 below provides the 

following: Types of data collection 

instruments, estimated number of 

respondents, number of responses per 

respondent, annual number of 

responses, average burden hour per 

response, and total annual burden hour. 

ESTIMATED BURDEN HOURS

42 CFR Part 36 

Estimated 

number of 

respondents 

Responses 

per 

respondent 

Average 

burden hour 

per response * 

Total annual 

burden hrs 

Addendum to OF306 Declaration for Federal Employment ............................ 200 1 0.25 (15 min) 500 

* For ease of understanding, burden hours are also provided in actual minutes. 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

IHS processes the information collected 

in a useful and timely fashion; (c) the 

accuracy of the public burden estimate 

(the estimated amount of time needed 

for individual respondents to provide 

the requested information); (d) whether 

the methodology and assumptions used 

to determine the estimate are logical; (e) 

ways to enhance the quality, utility, and 

clarity of the information being 

collected; and (f) ways to minimize the 

public burden through the use of 

automated, electronic, mechanical, or 

other technological collection 

techniques or other forms of information 

technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, to: Office of Management and 

Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

To request more information on the 

proposed collection or to obtain a copy 

of the data collection instrument(s) and/ 

or instruction(s), contact: Mrs. Christina 

Rouleau, IHS Reports Clearance Officer, 

801 Thompson Avenue, TMP Suite 450, 

Rockville, MD 20852–1601, or call nontoll free (301) 443–5938 or send via 

facsimile to (301) 443–2316, or send 

your e-mail requests, comments, and 

return address to: crouleau@hqe.ihs.gov. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received on or before 30 days of the date 

of this publication. 

Dated: October 28, 2005. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 05–22221 Filed 11–7–05; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

[Funding Opportunity Number HHS–2006–

IHS–SP–0001] [CFDA Numbers: 93.971, 

93.123, and 93.972] 

Health Professions Preparatory, Health 

Professions Pregraduate and Indian 

Health Professions Scholarship 

Programs 

Announcement Type: Initial. 

Key Dates: Application Deadline: 

February 28, 2006. Application Review: 

March 27–31, 2006. Application 

Notification: Third week of June 2006. 

Award Start Date: August 1, 2006. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) is 

committed to encouraging American 

Indians and Alaska Natives to enter the 

health professions and to assuring the 

availability of Indian health 

professionals to serve Indians. The IHS 

is committed to the recruitment of 

students for the following programs: 

• The Indian Health Professions 

Preparatory Scholarships authorized by