Standardized Medicated Feed Assay Limits; Draft Guidance for Industry; Availability, 11369-11371 [2020-03943]

Download as PDF Federal Register / Vol. 85, No. 39 / Thursday, February 27, 2020 / Notices The Technical Bulletin is available on the FASAB website at https://fasab.gov/ accounting-standards/. Copies can be obtained by contacting FASAB at (202) 512–7350. FOR FURTHER INFORMATION CONTACT: Ms. Monica R. Valentine, Executive Director, 441 G Street NW, Suite 1155, Washington, DC 20548, or call (202) 512–7350. Board of Governors of the Federal Reserve System, February 21, 2020. Yao-Chin Chao, Assistant Secretary of the Board. (Authority: Federal Advisory Committee Act (5 U.S.C. App.)) Formations of, Acquisitions by, and Mergers of Bank Holding Companies Dated: February 20, 2020. Monica R. Valentine, Executive Director. [FR Doc. 2020–03912 Filed 2–26–20; 8:45 am] BILLING CODE 1610–02–P FEDERAL RESERVE SYSTEM lotter on DSKBCFDHB2PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than March 27, 2020. A. Federal Reserve Bank of New York (Ivan Hurwitz, Senior Vice President) 33 Liberty Street, New York, New York 10045–0001. Comments can also be sent electronically to Comments.applications@ny.frb.org: 1. SBD Bancorp, Inc., Danbury, Connecticut; to become a bank holding company by acquiring The Savings Bank of Danbury, Danbury, Connecticut. VerDate Sep<11>2014 17:26 Feb 26, 2020 Jkt 250001 11369 GENERAL SERVICES ADMINISTRATION [Notice–MA–2020–01; Docket No. 2020– 0002; Sequence No. 5] [FR Doc. 2020–03909 Filed 2–26–20; 8:45 am] BILLING CODE P FEDERAL RESERVE SYSTEM The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue, NW, Washington DC 20551–0001, not later than March 29, 2020. A. Federal Reserve Bank of Cleveland (Mary S. Johnson, Vice President) 1455 East Sixth Street, Cleveland, Ohio 44101–2566. Comments can also be sent electronically to Comments.applications@clev.frb.org: 1. Bancorp of Baltic, Inc., Baltic, Ohio; to become a bank holding company by acquiring The Baltic State Bank, Baltic, Ohio. Board of Governors of the Federal Reserve System, February 24, 2020. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2020–03957 Filed 2–26–20; 8:45 am] BILLING CODE P PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Relocation Allowances: Withholding Tax Allowance (WTA) and Relocation Income Tax Allowance (RITA) Eligibility Office of Government-wide Policy (OGP), General Services Administration (GSA). ACTION: Notice. AGENCY: The purpose of this notice is to inform Federal agencies that Federal Travel Regulation (FTR) Bulletin 20–04, pertaining to changes to eligibility for WTA and RITA impacted by recent changes to Federal law, has been published and is now available online at www.gsa.gov/ftrbulletins. DATES: Applicability date: This notice applies to all individuals who are authorized reimbursement for relocation expenses under the FTR and who receive some or all reimbursements, direct payments, or indirect payments on or after January 1, 2018, and on or before December 31, 2025. FOR FURTHER INFORMATION CONTACT: For clarification of content, please contact Mr. Rick Miller, Program Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202–501–3822, or by email at travelpolicy@gsa.gov. Please cite Notice of FTR Bulletin 20–04. SUMMARY: Jessica Salmoiraghi, Associate Administrator, Office of Government-wide Policy. [FR Doc. 2020–03942 Filed 2–26–20; 8:45 am] BILLING CODE 6820–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–5664] Standardized Medicated Feed Assay Limits; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #264 entitled ‘‘Standardized Medicated Feed Assay Limits.’’ This draft guidance recommends a standardized set of assay limits for medicated feeds. Standardized SUMMARY: E:\FR\FM\27FEN1.SGM 27FEN1 11370 Federal Register / Vol. 85, No. 39 / Thursday, February 27, 2020 / Notices medicated feed assay limits allow predictability in the review process as sponsors can determine early in the drug development process what assay limits they should expect to meet for medicated feeds used in Target Animal Safety, Effectiveness, Chemistry, Manufacturing, and Controls, Bioequivalence, and Human Food Safety residue chemistry studies. DATES: Submit either electronic or written comments on the draft guidance by April 27, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). lotter on DSKBCFDHB2PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– VerDate Sep<11>2014 17:26 Feb 26, 2020 Jkt 250001 2019–D–5664 for ‘‘Standardized Medicated Feed Assay Limits.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Katie Ciesienski, Center for Veterinary Medicine (HFV–141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0676, Katie.Ciesienski@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft GFI #264 entitled ‘‘Standardized Medicated Feed Assay Limits.’’ This draft guidance recommends a standardized set of assay limits for medicated feeds. Standardized medicated feed assay limits allow predictability in the review process as the sponsor can determine early in the drug development process what assay limits they should expect to meet for medicated feeds used in Target Animal Safety, Effectiveness, Chemistry, Manufacturing, and Controls, Bioequivalence, and Human Food Safety residue chemistry studies. Assay limits are used pre-approval to ensure that medicated feeds in these studies contain the appropriate amount of drug, and post-approval for compliance and customer service purposes. II. Significance of Guidance This Level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Standardized Assay Limits for Medicated Feeds.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. 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. 3501–3521). The collections of information in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under OMB control number 0910–0669. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 85, No. 39 / Thursday, February 27, 2020 / Notices GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: February 21, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–03943 Filed 2–26–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0625] Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration’s (FDA or Agency) Center for Devices and Radiological Health (CDRH or Center) is announcing its voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program. The eSTAR Pilot Program is voluntary and intends to improve consistency and efficiency in both industry’s preparation and FDA’s review of premarket notification (510(k)) submissions. During the voluntary eSTAR Pilot Program, pilot participants will have the opportunity to provide input to FDA on eSTAR. DATES: FDA is seeking participation in the voluntary eSTAR Pilot Program beginning February 27, 2020. See section I.A. for instructions on how to submit a request to participate. The voluntary eSTAR Pilot Program will select up to nine participants who best match the selection criteria. This pilot program will begin February 27, 2020. ADDRESSES: You may submit comments as follows: SUMMARY: lotter on DSKBCFDHB2PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, VerDate Sep<11>2014 17:26 Feb 26, 2020 Jkt 250001 such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2020–N–0625 for ‘‘Voluntary eSTAR Pilot Program.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 11371 ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1655, Silver Spring, MD 20993, 240–402–9677, email: jacqueline.gertz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Medical Device User Fee Amendments of 2012 (MDUFA III) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to streamlining review processes by moving beyond paper-based review (Ref. 1). Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k–1), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144), an electronic copy (eCopy) is required for certain premarket submission types, including 510(k) submissions. FDA provided additional information about the submissions subject to the eCopy requirements in section 745A(b) of the FD&C Act and recommendations about the use of eCopy generally in a guidance initially issued in 2013 (Ref. 2), and subsequently published a final rule in the Federal Register of December 16, 2019 (84 FR 68334) amending FDA’s regulations, where appropriate, to reflect the requirement of a single submission in electronic format, including the use of eCopy requirements. In the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress (Ref. 3), FDA committed to developing ‘‘electronic submission templates that will serve as guided E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Notices]
[Pages 11369-11371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03943]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5664]


Standardized Medicated Feed Assay Limits; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #264 entitled 
``Standardized Medicated Feed Assay Limits.'' This draft guidance 
recommends a standardized set of assay limits for medicated feeds. 
Standardized

[[Page 11370]]

medicated feed assay limits allow predictability in the review process 
as sponsors can determine early in the drug development process what 
assay limits they should expect to meet for medicated feeds used in 
Target Animal Safety, Effectiveness, Chemistry, Manufacturing, and 
Controls, Bioequivalence, and Human Food Safety residue chemistry 
studies.

DATES: Submit either electronic or written comments on the draft 
guidance by April 27, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-5664 for ``Standardized Medicated Feed Assay Limits.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Katie Ciesienski, Center for 
Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0676, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #264 entitled 
``Standardized Medicated Feed Assay Limits.'' This draft guidance 
recommends a standardized set of assay limits for medicated feeds. 
Standardized medicated feed assay limits allow predictability in the 
review process as the sponsor can determine early in the drug 
development process what assay limits they should expect to meet for 
medicated feeds used in Target Animal Safety, Effectiveness, Chemistry, 
Manufacturing, and Controls, Bioequivalence, and Human Food Safety 
residue chemistry studies. Assay limits are used pre-approval to ensure 
that medicated feeds in these studies contain the appropriate amount of 
drug, and post-approval for compliance and customer service purposes.

II. Significance of Guidance

    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Standardized 
Assay Limits for Medicated Feeds.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

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. 3501-3521). The 
collections of information in section 512(n)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under 
OMB control number 0910-0669. The collections of information in 21 CFR 
part 514 have been approved under OMB control number 0910-0032.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/

[[Page 11371]]

GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03943 Filed 2-26-20; 8:45 am]
BILLING CODE 4164-01-P

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