Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods; Availability, 21032-21033 [E7-8042]

Download as PDF 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. cprice-sewell on PROD1PC66 with NOTICES 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 VerDate Aug<31>2005 15:18 Apr 26, 2007 Jkt 211001 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. 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 https:// 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. ADDRESSES: 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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). E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 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 (https://www.fda.gov/cvm) and from the Division of Dockets Management’s Web site https://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 Office of the Secretary, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee Meeting. AGENCY: 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, cprice-sewell on PROD1PC66 with NOTICES SUMMARY: VerDate Aug<31>2005 17:25 Apr 26, 2007 Jkt 211001 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: https:// 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 https://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 https://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. 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 21033 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 https:// 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 60-Day Notice of Information Collection Under Review: Form I–602, Application by Refugee for Waiver of Grounds of Excludability; OMB No. 1615–0069. ACTION: The Department of Homeland Security, U.S. Citizenship and Immigration Services has submitted the following information collection request E:\FR\FM\27APN1.SGM 27APN1

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[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Notices]
[Pages 21032-21033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8042]


-----------------------------------------------------------------------

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 https://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, e-mail: 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 (Sec.  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 Sec.  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).

[[Page 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 (https://www.fda.gov/cvm) and from the Division of 
Dockets Management's Web site https://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

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