21032 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

inspection program. The correction is 

being made to reflect a change in 

location for the April 30, 2007, meeting. 

The location of the meeting is being 

changed because of water damage in the 

original meeting location. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding this notice and 

the original notice, contact: Erik Mettler, 

Office of Policy and Planning, Food and 

Drug Administration (HF–11), 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3360, FAX 301–594–6777, 

email: Erik.Mettler@fda.hhs.gov. For 

information regarding registration, 

contact: Cynthia Garris, Office of 

Communication, Education, and 

Radiation Programs, Center for Devices 

and Radiological Health, Food and Drug 

Administration (HFZ–220), 1350 

Piccard Ave., Rockville, MD 20850, 

240–276–3150 ext. 121, FAX: 240–276–

3151, email: cynthia.garris@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

07–1919, appearing on page 19528 in 

the Federal Register of Wednesday, 

April 18, 2007, the following correction 

is made: 

1. On page 19528, in the third 

column, the first sentence under 

‘‘ADDRESSES’’ is corrected to read ‘‘The 

public meeting will be held at the Food 

and Drug Administration, White Oak 

site, at 10903 New Hampshire Ave., 

Silver Spring, MD 20993, Bldg. 2, rm. 

2031.’’

Dated: April 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–2085 Filed 4–24–07; 3:18 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0441] 

Guidance for Industry: Protocols for 

the Conduct of Method Transfer 

Studies for Type C Medicated Feed 

Assay Methods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

(#136) entitled ‘‘Guidance for Industry: 

Protocols for the Conduct of Method 

Transfer Studies for Type C Medicated 

Feed Assay Methods.’’ This guidance 

provides our recommendations for 

protocols for conducting the transfer 

study of a single-laboratory validated 

Type C medicated feed assay method to 

laboratories that have no experience 

with the test method. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine (CVM), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

on the guidance document to http:// 

www.fda.gov/dockets/ecomments. 

Comments should be identified with the 

full title of the guidance and the docket 

number found in brackets in the 

heading of this document. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca L. Owen, Center for Veterinary 

Medicine (HFV–141), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9842, email: rebecca.owen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

14, 2006 (71 FR 66335), FDA published 

a notice of availability for a draft 

guidance entitled ‘‘Guidance for 

Industry: Protocols for the Conduct of 

Method Transfer Studies for Type C 

Medicated Feed Assay Methods’’ giving 

interested persons until January 29, 

2007, to comment on the draft guidance. 

No comments were received. Therefore, 

the final guidance has not been 

substantively changed from the draft 

version. 

Section 512(b) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360b) establishes the 

requirements for a new animal drug 

approval. FDA regulations specify the 

information you (the sponsor) must 

submit as part of your new animal drug 

application (NADA) and the proper 

format for the NADA submission 

(§ 514.1 (21 CFR 514.1)). As part of your 

NADA submission, you must describe 

analytical procedures capable of 

determining the active component(s) of 

the new animal drug within a 

reasonable degree of accuracy and of 

assuring the identity of such 

components (21 CFR 514.1(b)(5)(vii)). 

This includes a description of 

practicable methods of analysis (assay 

methods) that have adequate sensitivity 

to determine the amount of the new 

animal drug in the final dosage form (21 

CFR 514.1(b)(5)(vii)(a)). In the case of a 

Type A medicated article, the Type C 

medicated feed is a final dosage form 

used to treat the animal. Thus, as part 

of the NADA review process, FDA looks 

at assay methods for determining the 

amount of a new animal drug in Type 

C medicated feed. 

This guidance provides 

recommendations for protocols for 

conducting the transfer study of a 

single-laboratory validated Type C 

medicated feed assay method to 

laboratories that have no experience 

with the test method. Many testing 

laboratories, including state feed 

laboratories and contract laboratories, 

use Type C medicated feed assay 

methods to determine whether the drug 

in a medicated feed is within the assay 

limits. The term ‘‘assay limits’’ refers to 

the amount of the drug detected when 

a Type B/C feed is assayed. The limit is 

a range that is codified at 21 CFR 

558.4(d). When feed assay values fall 

within this range, it indicates that the 

feed has been prepared with the correct 

amount of Type A medicated article. 

Because many different laboratories use 

medicated feed assays, it is important 

that the assay methods are reproducible. 

Sponsors should conduct method 

transfer studies to evaluate 

reproducibility. A method transfer study 

is part of the evaluation process for a 

Type C medicated feed assay method 

and demonstrates the transferability of 

the feed assay method among different 

laboratories by comparing the results 

each laboratory obtains when using the 

method to analyze a specific set of feed 

samples. Sponsors may expand the 

method transfer study to include other 

medicated feed products, such as Top 

Dress Type C, Free-Choice Type C, and 

Type B medicated feeds. 

II. 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 

§ 514.1 have been approved under OMB 

Control Nos. 0910–0032 and 0910–0154. 

III. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21033 

This guidance will represent 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 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic 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 should be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance 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 

Persons with access to the Internet 

may obtain the guidance at CVM’s Web 

site (http://www.fda.gov/cvm) and from 

the Division of Dockets Management’s 

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

dockets/default.htm. 

Dated: April 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8042 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[DHS–2007–0022] 

Data Privacy and Integrity Advisory 

Committee 

AGENCY: Office of the Secretary, 

Department of Homeland Security. 

ACTION: Notice of Federal Advisory 

Committee Meeting. 

SUMMARY: The Data Privacy and 

Integrity Advisory Committee will meet 

on May 7, 2007 in Arlington, VA. This 

meeting will be open to the public. 

DATES: The Data Privacy and Integrity 

Advisory Committee will meet on 

Monday, May 7, 2007 from 10 a.m. to 

12 p.m. Please note that the meeting 

may close early if the committee has 

completed its business. 

ADDRESSES: The meeting will be held in 

the in the Town Hall at the 

Transportation Security Administration, 

601 South 12th Street, Arlington, 

Virginia 22202. Send any written 

material for the meeting or comments 

for the Committee to Ken Hunt, 

Executive Director, Data Privacy and 

Integrity Advisory Committee, 

Department of Homeland Security, 

Washington, DC 20528. Written 

materials for the meeting or comments 

for the committee should reach the 

contact person listed by May 2, 2007. 

Requests to have a copy of your material 

distributed to each member of the 

committee prior to the meeting should 

reach the persons listed under FOR

FURTHER INFORMATION CONTACT below, by 

May 2, 2007. All submissions received 

must include the docket number: DHS–

2007–0022 and may be submitted by 

any one of the following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow 

instructions for submitting comments 

on the Web site. 

• E-mail: PrivacyCommittee@dhs.gov. 

Include docket number in the subject 

line of the message. 

• Fax: (866) 466–5370. 

• Mail: Mr. Ken Hunt, Executive 

Director, Data Privacy and Integrity 

Advisory Committee, Department of 

Homeland Security, Washington, DC 

20528. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security Data Privacy and 

Integrity Advisory Committee’’ and the 

docket number: DHS–2007–0022. 

Comments received on this notice will 

also be posted without alteration at 

http://www.regulations.gov, including 

any personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received by the DHS Data 

Privacy and Integrity Committee, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Hugo Teufel III, Chief Privacy Officer, or 

Ken Hunt, Executive Director, Data 

Privacy and Integrity Advisory 

Committee, Department of Homeland 

Security, Washington, DC 20528, by 

telephone (571) 227–3813, by fax (571) 

227–4171, or by e-mail 

PrivacyCommittee@dhs.gov. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. App. 

(Pub. L. 92–463). 

During the meeting, the Data Privacy 

and Integrity Advisory Committee will 

discuss its recommendations on Notice 

of Proposed Rule Making (NPRM), 

Minimum Standards for Driver’s 

Licenses and Identification Cards 

Acceptable by Federal Agencies for 

Official Purposes, 72 FR 10820 (March 

9, 2007), implementing the REAL ID 

Act. Division B—REAL ID Act of 2005, 

the Emergency Supplemental 

Appropriations Act for Defense, the 

Global War on Terror, and Tsunami 

Relief, 2005, Pub. L. 109–13, 119 Stat. 

231, 301 (2005) (codified at 49 U.S.C. 

30301 note). The committee will hear a 

Subcommittee report and deliberate on 

those findings. A tentative agenda has 

been posted on the Privacy Advisory 

Committee Web site at http:// 

www.dhs.gov/privacy. 

The committee will not solicit oral 

comments from the public during the 

meeting. Interested individuals may 

submit written comments on the 

meeting/subcommittee 

recommendations to the Committee 

following one of the methods described 

in this notice. Comments on the meeting 

will be considered by the Committee in 

the development of any final 

recommendations on the REAL ID 

program for submission to the Chief 

Privacy Officer 

Notice of this meeting appears in the 

Federal Register for less than fifteen 

calendar days, because the DHS Privacy 

Office moved and did not have access 

to the electronic equipment and 

network necessary to complete the 

notice on time. 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact Ken Hunt as soon as 

possible. 

Dated: April 20, 2007. 

Hugo Teufel III, 

Chief Privacy Officer. 

[FR Doc. E7–8059 Filed 4–26–07; 8:45 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Extension of an Existing 

Information Collection; Comment 

Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form I–602, 

Application by Refugee for Waiver of 

Grounds of Excludability; OMB No. 

1615–0069. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services has submitted the 

following information collection request 


cprice-sewell on PROD1PC66 with NOTICES