80 FR 58602 - Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 189 (September 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 189 (September 30, 2015)
| Page Range | 58602-58603 | |
| FR Document | 2015-24685 |
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)] [Rules and Regulations] [Pages 58602-58603] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://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
![58602 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations
each numbered objection, you must ■ 2. Section 73.350 is amended by • Federal eRulemaking Portal: http://
specifically state whether you are revising paragraph (c)(1)(ii)(A) to read as www.regulations.gov. Follow the
requesting a hearing on the particular follows: instructions for submitting comments.
provision that you specify in that Comments submitted electronically,
numbered objection. If you do not § 73.350 Mica-based pearlescent including attachments, to http://
pigments.
request a hearing for any particular www.regulations.gov will be posted to
objection, you waive the right to a * * * * * the docket unchanged. Because your
hearing on that objection. If you request (c) * * * comment will be made public, you are
a hearing, your objection must include (1) * * * solely responsible for ensuring that your
a detailed description and analysis of (ii) * * * comment does not include any
the specific factual information you (A) Distilled spirits containing not confidential information that you or a
intend to present in support of the less than 18 percent and not more than third party may not wish to be posted,
objection in the event that a hearing is 25 percent alcohol by volume. such as medical information, your or
held. If you do not include such a * * * * * anyone else’s Social Security number, or
description and analysis for any Dated: September 25, 2015. confidential business information, such
particular objection, you waive the right Susan Bernard,
as a manufacturing process. Please note
to a hearing on the objection. that if you include your name, contact
It is only necessary to send one set of Director, Office of Regulations, Policy and
information, or other information that
Social Sciences, Center for Food Safety and
documents. Identify documents with the identifies you in the body of your
Applied Nutrition.
docket number found in brackets in the comments, that information will be
[FR Doc. 2015–24795 Filed 9–29–15; 8:45 am]
heading of this document. Any posted on http://www.regulations.gov.
objections received in response to the BILLING CODE 4164–01–P
• If you want to submit a comment
regulation may be seen in the Division with confidential information that you
of Dockets Management between 9 a.m. do not wish to be made available to the
DEPARTMENT OF HEALTH AND
and 4 p.m., Monday through Friday, and public, submit the comment as a
will be posted to the docket at http:// HUMAN SERVICES
written/paper submission and in the
www.regulations.gov. We will publish Food and Drug Administration manner detailed (see ‘‘Written/Paper
notice of the objections that we have Submissions’’ and ‘‘Instructions’’).
received or lack thereof in the Federal 21 CFR Part 558
Register. Written/Paper Submissions
[Docket No. FDA–2010–N–0155] Submit written/paper submissions as
IX. References follows:
The following references have been Veterinary Feed Directive Regulation • Mail/Hand delivery/Courier (for
placed on display in the Division of Questions and Answers; Small Entity written/paper submissions): Division of
Dockets Management (see ADDRESSES) Compliance Guide; Guidance for Dockets Management (HFA–305), Food
and may be seen by interested persons Industry; Availability and Drug Administration, 5630 Fishers
between 9 a.m. and 4 p.m., Monday Lane, Rm. 1061, Rockville, MD 20852.
through Friday and are available AGENCY: Food and Drug Administration, • For written/paper comments
electronically at http:// HHS. submitted to the Division of Dockets
www.regulations.gov. ACTION: Notification of availability. Management, FDA will post your
1. FDA Memorandum from H. Lee, Chemistry comment, as well as any attachments,
SUMMARY: The Food and Drug
Review Group, Division of Petition except for information submitted,
Administration (FDA) is announcing the
Review, to S. Bhagan, Regulatory Group marked and identified, as confidential,
availability of a small entity compliance
I, Division of Petition Review, May 19, if submitted as detailed in
2015. guide and guidance for industry #120
‘‘Instructions.’’
2. FDA Memorandum from S. Park, entitled ‘‘Veterinary Feed Directive Instructions: All submissions received
Toxicology Team, Division of Petition Regulation Questions and Answers.’’ must include the Docket No. FDA–
Review, to S. Bhagan, Regulatory Group This guidance aids industry in 2010–N–0155 for ‘‘Veterinary Feed
I, Division of Petition Review, June 8, complying with the requirements of the
2015. Directive Regulation Questions and
Veterinary Feed Directive (VFD) final Answers; Small Entity Compliance
List of Subjects in 21 CFR Part 73 rule that published in the Federal Guide; Guidance for Industry;
Register on June 3, 2015. The purpose Availability.’’ Received comments will
Color additives, Cosmetics, Drugs,
of this document is to describe the be placed in the docket and, except for
Medical devices.
Veterinary Feed Directive requirements those submitted as ‘‘Confidential
Therefore, under the Federal Food, for veterinarians, feed manufacturers
Drug, and Cosmetic Act and under Submissions,’’ publicly viewable at
and other distributors, animal http://www.regulations.gov or at the
authority delegated to the Commissioner producers, and other parties involved in
of Food and Drugs, and redelegated to Division of Dockets Management
the distribution or use of medicated feed between 9 a.m. and 4 p.m., Monday
the Director, Center for Food Safety and containing a Veterinary Feed Directive
Applied Nutrition, 21 CFR part 73 is through Friday.
drug (VFD feed). • Confidential Submissions—To
amended as follows:
DATES: Submit either electronic or submit a comment with confidential
PART 73—LISTING OF COLOR written comments on Agency guidances information that you do not wish to be
mstockstill on DSK4VPTVN1PROD with RULES
ADDITIVES EXEMPT FROM at any time. made publicly available, submit your
CERTIFICATION ADDRESSES: You may submit comments comments only as a written/paper
as follows: submission. You should submit two
■ 1. The authority citation for 21 CFR copies total. One copy will include the
part 73 continues to read as follows: Electronic Submissions information you claim to be confidential
Authority: 21 U.S.C. 321, 341, 342, 343, Submit electronic comments in the with a heading or cover note that states
348, 351, 352, 355, 361, 362, 371, 379e. following way: ‘‘THIS DOCUMENT CONTAINS
VerDate Sep<11>2014 17:12 Sep 29, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1](https://thefederalregister.org/doc/80_FR_58791/page/1.svg)
![Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations 58603
CONFIDENTIAL INFORMATION’’. The finalized. The guidance announced in Dated: September 23, 2015.
Agency will review this copy, including this notice finalizes the draft guidance Leslie Kux,
the claimed confidential information, in dated June 2015. This guidance also Associate Commissioner for Policy.
its consideration of comments. The serves as a Small Entity Compliance [FR Doc. 2015–24685 Filed 9–29–15; 8:45 am]
second copy, which will have the Guide (SECG) to aid industry in BILLING CODE 4164–01–P
claimed confidential information complying with the requirements of the
redacted/blacked out, will be available VFD final rule that published in the
for public viewing and posted on http:// Federal Register on June 3, 2015 (80 FR DEPARTMENT OF HEALTH AND
www.regulations.gov. Submit both 31708). FDA has prepared this SECG in HUMAN SERVICES
copies to the Division of Dockets accordance with section 212 of the
Management. If you do not wish your Small Business Regulatory Enforcement Food and Drug Administration
name and contact information to be Fairness Act (Pub. L. 104–121). This
made publicly available, you can document is intended to provide 21 CFR Part 870
provide this information on the cover guidance to small businesses on the [Docket No. FDA–2015–N–3165]
sheet and not in the body of your requirements of the final rule.
comments and you must identify this In 1996, Congress enacted the Animal Medical Devices; Cardiovascular
information as ‘‘confidential.’’ Any Drug Availability Act (ADAA) to Devices; Classification of the Steerable
information marked as ‘‘confidential’’ facilitate the approval and marketing of Cardiac Ablation Catheter Remote
will not be disclosed except in new animal drugs and medicated feeds. Control System
accordance with 21 CFR 10.20 and other In passing the ADAA, Congress created
applicable disclosure law. For more a new regulatory category for certain AGENCY: Food and Drug Administration,
information about FDA’s posting of animal drugs used in animal feed called HHS.
comments to public dockets, see 80 FR VFD drugs. VFD drugs are new animal ACTION: Final order.
56469, September 18, 2015, or access drugs intended for use in or on animal
the information at: http://www.fda.gov/ feed which are limited to use under the SUMMARY: The Food and Drug
regulatoryinformation/dockets/ professional supervision of a licensed Administration (FDA) is classifying the
default.htm. veterinarian. FDA published final steerable cardiac ablation catheter
Docket: For access to the docket to regulations implementing the VFD- remote control system into class II
read background documents or the related provisions of the ADAA in 2000. (special controls). The special controls
electronic and written/paper comments On June 3, 2015, FDA published a VFD that will apply to the device are
received, go to http:// final rule that revised those VFD identified in this order and will be part
www.regulations.gov and insert the regulations and introduced clarifying of the codified language for the steerable
docket number, found in brackets in the changes to specified definitions, and cardiac ablation catheter remote control
heading of this document, into the published the draft revised guidance for system’s classification. The Agency is
‘‘Search’’ box and follow the prompts comment. classifying the device into class II
and/or go to the Division of Dockets (special controls) in order to provide a
Management, 5630 Fishers Lane, Rm. II. Significance of Guidance reasonable assurance of safety and
1061, Rockville, MD 20852. effectiveness of the device.
This guidance is being issued
Submit written requests for single consistent with FDA’s good guidance DATES: This order is effective September
copies of the guidance to the Policy and practices regulation (21 CFR 10.115). 30, 2015. The classification was
Regulations Staff (HFV–6), Center for The guidance represents the current applicable on December 18, 2014.
Veterinary Medicine, Food and Drug thinking of FDA on VFD regulation FOR FURTHER INFORMATION CONTACT:
Administration, 7519 Standish Pl., questions and answers. It does not Deborah Castillo, Center for Devices and
Rockville, MD 20855. Send one self- establish any rights for any person and Radiological Health, Food and Drug
addressed adhesive label to assist that is not binding on FDA or the public. Administration, 10903 New Hampshire
office in processing your requests. See You can use an alternative approach if Ave., Bldg. 66, Rm. 1321, Silver Spring,
the SUPPLEMENTARY INFORMATION section it satisfies the requirements of the MD 20993–0002, 301–796–4908.
for electronic access to the guidance applicable statutes and regulations. SUPPLEMENTARY INFORMATION:
document.
III. Paperwork Reduction Act of 1995 I. Background
FOR FURTHER INFORMATION CONTACT:
Dragan Momcilovic, Center for This guidance refers to previously In accordance with section 513(f)(1) of
Veterinary Medicine (HFV–226), Food approved collections of information the Federal Food, Drug, and Cosmetic
and Drug Administration, 7519 Standish found in FDA regulations. These Act (the FD&C Act) (21 U.S.C.
Pl., Rockville, MD 20855, 240–402– collections of information are subject to 360c(f)(1)), devices that were not in
5944, dragan.momcilovic@fda.hhs.gov. review by the Office of Management and commercial distribution before May 28,
SUPPLEMENTARY INFORMATION: Budget (OMB) under the Paperwork 1976 (the date of enactment of the
Reduction Act of 1995 (44 U.S.C. 3501– Medical Device Amendments of 1976),
I. Background 3520). The collections of information in generally referred to as postamendments
In the Federal Register of June 3, 2015 21 CFR 558.6 have been approved under devices, are classified automatically by
(80 FR 31520), FDA published a notice OMB control number 0910–0363. statute into class III without any FDA
of availability for a draft guidance rulemaking process. These devices
IV. Electronic Access
mstockstill on DSK4VPTVN1PROD with RULES
entitled ‘‘Veterinary Feed Directive remain in class III and require
Regulation Questions and Answers’’ Persons with access to the Internet premarket approval, unless, and until,
giving interested persons until August 3, may obtain the guidance at either http:// the device is classified or reclassified
2015, to comment on the draft guidance. www.fda.gov/AnimalVeterinary/ into class I or II, or FDA issues an order
FDA received several comments on the GuidanceComplianceEnforcement/ finding the device to be substantially
draft guidance and those comments GuidanceforIndustry/default.htm or equivalent, in accordance with section
were considered as the guidance was http://www.regulations.gov. 513(i) of the FD&C Act, to a predicate
VerDate Sep<11>2014 17:12 Sep 29, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1](https://thefederalregister.org/doc/80_FR_58791/page/2.svg)
Document Created: 2015-12-15 09:31:20
Document Modified: 2015-12-15 09:31:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5944, [email protected] | |
| FR Citation | 80 FR 58602 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR