Draft Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods; Availability, 66335-66336 [E6-19204]

Download as PDF 66335 Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: November 6, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–19151 Filed 11–13–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0329] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 14, 2006 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medicated Feed Mill Licensing Application—21 CFR Part 515 (OMB Control No. 0910–0337)—Extension The Animal Drug Availability Act (ADAA) of October 9, 1996, amended section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) to replace the system for the approval of specific medicated feed with a general licensing system for feed mills. Before passage of the ADAA, medicated feed manufacturers were required to obtain approval of Medicated Feed Applications (MFAs) in order to manufacture certain types of medicated feeds. An individual approved MFA was required for each and every applicable medicated feed. The ADAA streamlined the paperwork process for gaining approval to manufacture medicated feeds by replacing the MFA system with a facility license for each medicated feed manufacturing facility. Implementing regulations are at part 515 (21 CFR part 515). In the Federal Register of August 25, 2006 (71 FR 50433), FDA solicited comments on the information collection provisions of this proposed collection. In response to that request, FDA received no comments. Description of Respondents: Medicated feed manufacturers. FDA estimates the burden for this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 515.10(b) 515.11(b) 515.23 515.30(c) Total 1There Annual Frequency per Response 7 100 25 0.15 Total Annual Responses 1 1 1 1 Hours per Response 7 100 25 0.15 Total Hours 0.25 0.25 0.25 24 1.75 25 6.25 3.6 36.6 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records 1,070 21 CFR Section 1 1,070 510.305 sroberts on PROD1PC70 with NOTICES 1There Hours per Recordkeeper Total Hours 0.03 32.10 are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting burden on industry is 36.6 hours as shown in table 1 of this document. Industry estimates it takes about 1/4 hour to submit the application. We estimate 132 original and supplemental applications, and voluntary revocations for a total of 33 hours (132 submissions x 1/4 hour). An additional 3.6 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 36 hours for maintaining and retrieving labels as required by 21 CFR 510.305. VerDate Aug<31>2005 19:07 Nov 13, 2006 Jkt 211001 We estimated .03 hours for each of approximately 1,070 licensees. Thus, the total burden for recordkeeping requirements is 32.10 hours (1,070 x 0.03). DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–19152 Filed 11–13–06; 8:45 am] [Docket No. 2006D–0441] BILLING CODE 4160–01–S PO 00000 Food and Drug Administration Draft 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. Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM 14NON1 66336 ACTION: Federal Register / Vol. 71, No. 219 / Tuesday, November 14, 2006 / Notices Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry (#136) entitled ‘‘Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods.’’ This draft 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 this draft guidance by January 29, 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 requests. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft 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: sroberts on PROD1PC70 with NOTICES I. Background Section 512(b) of the Federal Food, Drug, and Cosmetic 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)). VerDate Aug<31>2005 19:07 Nov 13, 2006 Jkt 211001 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 draft guidance provides our (the Office of New Animal Drug Evaluation or ONADE) 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 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 § 514.1 have been approved under OMB control nos. 0910–0032 and 0910–0154. III. Significance of Guidance This draft level 1 guidance is being issued consistent with FDA’s good PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, 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 This draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this draft guidance 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. V. Electronic Access Electronic comments may be submitted on the Internet at https:// www.fda.gov/dockets/ecomments. Copies of the draft guidance document entitled ‘‘Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods’’ may be obtained from the CVM Home Page (https://www.fda.gov/cvm) and from the Division of Dockets Management Web site (https://www.fda.gov/ohrms/dockets/ default.htm). Dated: November 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–19204 Filed 11–13–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0419] Draft Voluntary National Retail Food Regulatory Program Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Voluntary National Retail Food E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Notices]
[Pages 66335-66336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19204]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0441]


Draft 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.

[[Page 66336]]


ACTION: Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of draft guidance for industry (136) entitled 
``Protocols for the Conduct of Method Transfer Studies for Type C 
Medicated Feed Assay Methods.'' This draft 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 this draft guidance by 
January 29, 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 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. 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. Submit electronic comments to https://
www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft 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

    Section 512(b) of the Federal Food, Drug, and Cosmetic 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 draft guidance provides our (the Office of New Animal Drug 
Evaluation or ONADE) 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 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 Sec.  514.1 have been approved under OMB 
control nos. 0910-0032 and 0910-0154.

III. Significance of Guidance

    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, 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

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding this draft guidance 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.

V. Electronic Access

    Electronic comments may be submitted on the Internet at https://
www.fda.gov/dockets/ecomments. Copies of the draft guidance document 
entitled ``Protocols for the Conduct of Method Transfer Studies for 
Type C Medicated Feed Assay Methods'' may be obtained from the CVM Home 
Page (https://www.fda.gov/cvm) and from the Division of Dockets 
Management Web site (https://www.fda.gov/ohrms/dockets/default.htm).

    Dated: November 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19204 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S

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