Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry; Availability, 58602-58603 [2015-24685]

Download as PDF 58602 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection. It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register. IX. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday and are available electronically at https:// www.regulations.gov. 1. FDA Memorandum from H. Lee, Chemistry Review Group, Division of Petition Review, to S. Bhagan, Regulatory Group I, Division of Petition Review, May 19, 2015. 2. FDA Memorandum from S. Park, Toxicology Team, Division of Petition Review, to S. Bhagan, Regulatory Group I, Division of Petition Review, June 8, 2015. mstockstill on DSK4VPTVN1PROD with RULES List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 73 is amended as follows: PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 1. The authority citation for 21 CFR part 73 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. VerDate Sep<11>2014 17:12 Sep 29, 2015 Jkt 235001 2. Section 73.350 is amended by revising paragraph (c)(1)(ii)(A) to read as follows: ■ § 73.350 Mica-based pearlescent pigments. * * * * * (c) * * * (1) * * * (ii) * * * (A) Distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume. * * * * * Dated: September 25, 2015. Susan Bernard, Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition. [FR Doc. 2015–24795 Filed 9–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA–2010–N–0155] Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide and guidance for industry #120 entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ This guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule that published in the Federal Register on June 3, 2015. The purpose of this document is to describe the Veterinary Feed Directive requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a Veterinary Feed Directive drug (VFD feed). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 • 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2010–N–0155 for ‘‘Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry; Availability.’’ 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 Division of Dockets Management 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 E:\FR\FM\30SER1.SGM 30SER1 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402– 5944, dragan.momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 3, 2015 (80 FR 31520), FDA published a notice of availability for a draft guidance entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers’’ giving interested persons until August 3, 2015, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was VerDate Sep<11>2014 17:12 Sep 29, 2015 Jkt 235001 finalized. The guidance announced in this notice finalizes the draft guidance dated June 2015. This guidance also serves as a Small Entity Compliance Guide (SECG) to aid industry in complying with the requirements of the VFD final rule that published in the Federal Register on June 3, 2015 (80 FR 31708). FDA has prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104–121). This document is intended to provide guidance to small businesses on the requirements of the final rule. In 1996, Congress enacted the Animal Drug Availability Act (ADAA) to facilitate the approval and marketing of new animal drugs and medicated feeds. In passing the ADAA, Congress created a new regulatory category for certain animal drugs used in animal feed called VFD drugs. VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. FDA published final regulations implementing the VFDrelated provisions of the ADAA in 2000. On June 3, 2015, FDA published a VFD final rule that revised those VFD regulations and introduced clarifying changes to specified definitions, and published the draft revised guidance for comment. 58603 Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24685 Filed 9–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA–2015–N–3165] Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on VFD regulation questions and answers. 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. The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the steerable cardiac ablation catheter remote control system’s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective September 30, 2015. The classification was applicable on December 18, 2014. FOR FURTHER INFORMATION CONTACT: Deborah Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1321, Silver Spring, MD 20993–0002, 301–796–4908. SUPPLEMENTARY INFORMATION: III. Paperwork Reduction Act of 1995 I. Background 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 21 CFR 558.6 have been approved under OMB control number 0910–0363. In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless, and until, the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate II. Significance of Guidance IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 SUMMARY: E:\FR\FM\30SER1.SGM 30SER1

Agencies

[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58602-58603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24685]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0155]


Veterinary Feed Directive Regulation Questions and Answers; Small 
Entity Compliance Guide; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide and guidance for 
industry #120 entitled ``Veterinary Feed Directive Regulation Questions 
and Answers.'' This guidance aids industry in complying with the 
requirements of the Veterinary Feed Directive (VFD) final rule that 
published in the Federal Register on June 3, 2015. The purpose of this 
document is to describe the Veterinary Feed Directive requirements for 
veterinarians, feed manufacturers and other distributors, animal 
producers, and other parties involved in the distribution or use of 
medicated feed containing a Veterinary Feed Directive drug (VFD feed).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2010-N-0155 for ``Veterinary Feed Directive Regulation Questions 
and Answers; Small Entity Compliance Guide; Guidance for Industry; 
Availability.'' 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 Division of Dockets 
Management 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

[[Page 58603]]

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 Division of 
Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 7519 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5944, 
dragan.momcilovic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 3, 2015 (80 FR 31520), FDA 
published a notice of availability for a draft guidance entitled 
``Veterinary Feed Directive Regulation Questions and Answers'' giving 
interested persons until August 3, 2015, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice finalizes the draft guidance dated June 2015. 
This guidance also serves as a Small Entity Compliance Guide (SECG) to 
aid industry in complying with the requirements of the VFD final rule 
that published in the Federal Register on June 3, 2015 (80 FR 31708). 
FDA has prepared this SECG in accordance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). This 
document is intended to provide guidance to small businesses on the 
requirements of the final rule.
    In 1996, Congress enacted the Animal Drug Availability Act (ADAA) 
to facilitate the approval and marketing of new animal drugs and 
medicated feeds. In passing the ADAA, Congress created a new regulatory 
category for certain animal drugs used in animal feed called VFD drugs. 
VFD drugs are new animal drugs intended for use in or on animal feed 
which are limited to use under the professional supervision of a 
licensed veterinarian. FDA published final regulations implementing the 
VFD-related provisions of the ADAA in 2000. On June 3, 2015, FDA 
published a VFD final rule that revised those VFD regulations and 
introduced clarifying changes to specified definitions, and published 
the draft revised guidance for comment.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on VFD regulation questions and answers. 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 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 21 CFR 558.6 have been approved under OMB 
control number 0910-0363.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24685 Filed 9-29-15; 8:45 am]
 BILLING CODE 4164-01-P
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