80 FR 31520 - Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 106 (June 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 106 (June 3, 2015)
| Page Range | 31520-31521 | |
| FR Document | 2015-13394 |
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)] [Proposed Rules] [Pages 31520-31521] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13394] ======================================================================= ----------------------------------------------------------------------- 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Administration 21 CFR Part 558 [Docket No. FDA-2010-N-0155] Veterinary Feed Directive Regulation Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Draft revised guidance; availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GIF) #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' The purpose of this document is to describe the current Veterinary Feed Directive (VFD) 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). This draft revised guidance reflects changes to the VFD requirements under the VFD final rule. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 3, 2015. ADDRESSES: 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856, dragan.momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: [[Page 31521]] I. Background FDA is announcing the availability of a draft revised GFI #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' The audience for this draft guidance is comprised of veterinarians issuing VFD orders, feed mills manufacturing VFD feeds and other distributors, animal producers who obtain VFD feeds for use in treating their animals, and others. This draft revised guidance reflects changes to the VFD requirements under the VFD final rule published elsewhere in this edition of the Federal Register. 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 veterinary feed directive (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. Elsewhere in this edition of the Federal Register, FDA is publishing a VFD final rule that revises those VFD regulations and introduces clarifying changes to specified definitions. This draft revised guidance includes revisions that are consistent with the requirements in that final rule. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on this topic. It does not establish any rights for or on any person and does is not binding on FDA or the public. An alternative approach may be used if such approach 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. 3501-3520). The collections of information in 21 CFR 558.6 have been approved under OMB control number 0910-0363. IV. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: May 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-13394 Filed 6-2-15; 8:45 am] BILLING CODE 4164-01-P
![31520 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules
‘‘software’’, refers to only that portion of ‘‘Technology’’ means: DEPARTMENT OF HEALTH AND
‘‘technology’’ or ‘‘software’’ which is (a) Except as set forth in paragraph (b) HUMAN SERVICES
peculiarly responsible for achieving or of this definition:
exceeding the controlled performance Food and Drug Administration
levels, characteristics or functions. Such (1) Information necessary for the
‘‘required’’ ‘‘technology’’ or ‘‘software’’ ‘‘development,’’ ‘‘production,’’ ‘‘use,’’ 21 CFR Part 558
may be shared by different products. For operation, installation, maintenance,
example, assume product ‘‘X’’ is repair, overhaul, or refurbishing (or [Docket No. FDA–2010–N–0155]
controlled if it operates at or above 400 other terms specified in ECCNs on the
MHz and is not controlled if it operates CCL that control ‘‘technology’’) of an Veterinary Feed Directive Regulation
below 400 MHz. If production item. ‘‘Technology’’ may be in any Questions and Answers; Draft
technologies ‘‘A’’, ‘‘B’’, and ‘‘C’’ allow tangible or intangible form, such as Guidance for Industry; Availability
production at no more than 399 MHz, written or oral communications,
AGENCY: Food and Drug Administration,
then technologies ‘‘A’’, ‘‘B’’, and ‘‘C’’ are blueprints, drawings, photographs, HHS.
not ‘‘required’’ to produce the plans, diagrams, models, formulae,
controlled product ‘‘X’’. If technologies ACTION: Draft revised guidance;
tables, engineering designs and
‘‘A’’, ‘‘B’’, ‘‘C’’, ‘‘D’’, and ‘‘E’’ are used availability.
specifications, computer-aided design
together, a manufacturer can produce files, manuals or documentation, SUMMARY: The Food and Drug
product ‘‘X’’ that operates at or above electronic media or information gleaned Administration (FDA) is announcing the
400 MHz. In this example, technologies through visual inspection; availability of a draft revised guidance
‘‘D’’ and ‘‘E’’ are ‘‘required’’ to make the for industry (GIF) #120 entitled
controlled product and are themselves Note to paragraph (a)(1) of this definition:
The modification of an existing item creates ‘‘Veterinary Feed Directive Regulation
controlled under the General Questions and Answers.’’ The purpose
a new item and technology for the
Technology Note. (See the General of this document is to describe the
modification is technical data for the
Technology Note.) current Veterinary Feed Directive (VFD)
development of the new item.
Note 1 to the definition of required: The (2) [Reserved]; requirements for veterinarians, feed
references to ‘‘characteristics’’ and (3) [Reserved]; manufacturers and other distributors,
‘‘functions’’ are not limited to entries on the animal producers, and other parties
(4) [Reserved]; or
CCL that use specific technical parameters to
describe the scope of what is controlled. The (5) Information, such as decryption keys, involved in the distribution or use of
‘‘characteristics’’ and ‘‘functions’’ of an item network access codes, or passwords, that medicated feed containing a veterinary
listed are, absent a specific regulatory would allow access to other ‘‘technology’’ in feed directive drug (VFD feed). This
definition, a standard dictionary’s definition clear text or ‘‘software.’’ draft revised guidance reflects changes
of the item. For example, ECCN 9A610.a (b) ‘‘Technology’’ does not include: to the VFD requirements under the VFD
controls ‘‘military aircraft specially designed (1) Non-proprietary general system final rule.
for a military use that are not enumerated in descriptions; DATES: Although you can comment on
USML paragraph VIII(a).’’ No performance (2) Information on basic function or
level is identified in the entry, but the control any guidance at any time (see 21 CFR
purpose of an item; or 10.115(g)(5)), to ensure that the Agency
characteristic of the aircraft is that it is (3) Telemetry data as defined in note 2 to
specially designed ‘‘for military use.’’ Thus, considers your comment on this draft
Category 9, Product Group E (see Supplement guidance before it begins work on the
any technology, regardless of significance,
peculiar to making an aircraft ‘‘for military No. 1 to Part 774 of the EAR). final version of the guidance, submit
use’’ as opposed to, for example, an aircraft either electronic or written comments
* * * * *
controlled under ECCN 9A991.a, would be on the draft guidance by August 3, 2015.
technical data ‘‘required’’ for an aircraft Transfer. A shipment, transmission,
ADDRESSES: Submit written requests for
specially designed for military use thus or release of items subject to the EAR
controlled under ECCN 9E610. single copies of the guidance to the
either within the United States or
Policy and Regulations Staff (HFV–6),
outside the United States. For in-
Note 2 to the definition of required: The Center for Veterinary Medicine, Food
ITAR and the EAR often divide within each country transfer/transfer (in-country), and Drug Administration, 7519 Standish
set of regulations or between each set of see § 734.16 of the EAR. Pl., Rockville, MD 20855. Send one self-
regulations: Note to definition of transfer: This addressed adhesive label to assist that
1. Controls on parts, components, definition of ‘‘transfer’’ does not apply to office in processing your requests. See
accessories, attachments, and software; and
2. Controls on the end items, systems,
§ 750.10 of the EAR or Supplement No. 8 to the SUPPLEMENTARY INFORMATION section
equipment, or other items into which those part 760 of the EAR. The term ‘‘transfer’’ may for electronic access to the draft
parts, components, accessories, attachments, also be included on licenses issued by BIS. guidance document.
and software are to be installed or In that regard, the changes that can be made Submit electronic comments on the
incorporated. to a BIS license are the non-material changes draft guidance to http://
Moreover, with the exception of technical described in § 750.7(c) of the EAR. Any other www.regulations.gov. Submit written
data specifically enumerated on the USML, change to a BIS license without authorization comments to the Division of Dockets
the jurisdictional status of unclassified is a violation of the EAR. See §§ 750.7(c) and Management (HFA–305), Food and Drug
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
technical data or ‘‘technology’’ is the same as 764.2(e) of the EAR. Administration, 5630 Fishers Lane, rm.
the jurisdictional status of the defense article
1061, Rockville, MD 20852.
or ‘‘item subject to the EAR’’ to which it is * * * * *
directly related. Thus, if technology is FOR FURTHER INFORMATION CONTACT:
directly related to the production of a Dated: May 18, 2015. Dragan Momcilovic, Center for
9A610.x aircraft component that is to be Kevin J. Wolf, Veterinary Medicine (HFV–226), Food
integrated or installed in a USML VIII(a) Assistant Secretary for Export and Drug Administration, 7519 Standish
aircraft, then the technology is controlled Administration. Pl., Rockville, MD 20855, 240–453–
under ECCN 9E610, not USML VIII(i).
[FR Doc. 2015–12843 Filed 6–2–15; 8:45 am] 6856, dragan.momcilovic@fda.hhs.gov.
* * * * * BILLING CODE P SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Proposed Rules 31521
I. Background document to http://www.regulations.gov DATES: Interested persons may file
FDA is announcing the availability of or written comments to the Division of written comments on this proposal in
a draft revised GFI #120 entitled Dockets Management (see ADDRESSES). It accordance with 21 CFR 1308.43(g).
‘‘Veterinary Feed Directive Regulation is only necessary to send one set of Electronic comments must be
Questions and Answers.’’ The audience comments. Identify comments with the submitted, and written comments must
for this draft guidance is comprised of docket number found in brackets in the be postmarked, on or before July 6,
veterinarians issuing VFD orders, feed heading of this document. Received 2015. Commenters should be aware that
mills manufacturing VFD feeds and comments may be seen in the Division the electronic Federal Docket
other distributors, animal producers of Dockets Management between 9 a.m. Management System will not accept
who obtain VFD feeds for use in treating and 4 p.m., Monday through Friday, and comments after 11:59 p.m. Eastern Time
their animals, and others. This draft will be posted to the docket at http:// on the last day of the comment period.
revised guidance reflects changes to the www.regulations.gov. Interested persons, defined at 21 CFR
VFD requirements under the VFD final 1300.01 as those ‘‘adversely affected or
V. Electronic Access aggrieved by any rule or proposed rule
rule published elsewhere in this edition
of the Federal Register. Persons with access to the Internet issuable pursuant to section 201 of the
In 1996, Congress enacted the Animal may obtain the draft guidance at either Act (21 U.S.C. 811)’’, may file a request
Drug Availability Act (ADAA) to http://www.fda.gov/AnimalVeterinary/ for hearing or waiver of participation
facilitate the approval and marketing of GuidanceComplianceEnforcement/ pursuant to 21 CFR 1308.44 and in
new animal drugs and medicated feeds. GuidanceforIndustry/default.htm or accordance with 21 CFR 1316.45,
In passing the ADAA, Congress created http://www.regulations.gov. 1316.47, 1316.48, or 1316.49, as
a new regulatory category for certain Dated: May 28, 2015. applicable. Requests for hearing, notices
animal drugs used in animal feed called Leslie Kux, of appearance, and waivers of an
veterinary feed directive (VFD) drugs. opportunity for a hearing or to
Associate Commissioner for Policy.
VFD drugs are new animal drugs participate in a hearing must be
[FR Doc. 2015–13394 Filed 6–2–15; 8:45 am]
intended for use in or on animal feed received on or before July 6, 2015.
BILLING CODE 4164–01–P
which are limited to use under the ADDRESSES: To ensure proper handling
professional supervision of a licensed of comments, please reference ‘‘Docket
veterinarian. FDA published final No. DEA–415’’ on all correspondence,
regulations implementing the VFD- DEPARTMENT OF JUSTICE including any attachments.
related provisions of the ADAA in 2000. • Electronic comments: The DEA
Elsewhere in this edition of the Drug Enforcement Administration encourages that all comments be
Federal Register, FDA is publishing a submitted through the Federal
VFD final rule that revises those VFD 21 CFR Part 1308 eRulemaking Portal, which provides the
regulations and introduces clarifying ability to type short comments directly
changes to specified definitions. This [Docket No. DEA–415] into the comment field on the Web page
draft revised guidance includes or to attach a file for lengthier
revisions that are consistent with the Schedules of Controlled Substances: comments. Please go to http://
requirements in that final rule. Removal of [123I]Ioflupane From www.regulations.gov and follow the
Schedule II of the Controlled online instructions at that site for
II. Significance of Guidance Substances Act submitting comments. Upon completion
This level 1 draft guidance is being of your submission you will receive a
issued consistent with FDA’s good AGENCY: Drug Enforcement
Administration, Department of Justice. Comment Tracking Number for your
guidance practices regulation (21 CFR comment. Please be aware that
10.115). The draft guidance, when ACTION: Notice of proposed rulemaking.
submitted comments are not
finalized, will represent the Agency’s instantaneously available for public
current thinking on this topic. It does SUMMARY: The Drug Enforcement
Administration proposes to remove view on Regulations.gov. If you have
not establish any rights for or on any received a Comment Tracking Number,
person and does is not binding on FDA [123I]ioflupane from the schedules of the
Controlled Substances Act. This action your comment has been successfully
or the public. An alternative approach submitted and there is no need to
may be used if such approach satisfies is pursuant to the Controlled Substances
Act which requires that such actions be resubmit the same comment.
the requirements of the applicable • Paper comments: Paper comments
statutes and regulations. made on the record after an opportunity
for a hearing through formal that duplicate an electronic submission
III. Paperwork Reduction Act of 1995 rulemaking. [123I]Ioflupane is, by are not necessary and are discouraged.
definition, a schedule II controlled Should you wish to mail a comment in
This draft guidance refers to
substance because it is derived from lieu of submitting a comment online, it
previously approved collections of
cocaine via ecgonine, both of which are should be sent via regular or express
information found in FDA regulations.
schedule II controlled substances. This mail to: Drug Enforcement
These collections of information are
action would remove the regulatory Administration, Attention: DEA Federal
subject to review by the Office of
controls and administrative, civil, and Register Representative/ODXL, 8701
Management and Budget (OMB) under
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
criminal sanctions applicable to Morrissette Drive, Springfield, Virginia
the Paperwork Reduction Act of 1995
controlled substances, including those 22152.
(44 U.S.C. 3501–3520). The collections
specific to schedule II controlled • Hearing requests: All requests for
of information in 21 CFR 558.6 have
substances, on persons who handle hearing must be sent to: DEA Federal
been approved under OMB control
(manufacture, distribute, reverse Register Representative/ODL, 8701
number 0910–0363.
distribute, dispense, conduct research, Morrissette Drive, Springfield, Virginia
IV. Comments import, export, or conduct chemical 22152.
Interested persons may submit either analysis) or propose to handle FOR FURTHER INFORMATION CONTACT: John
electronic comments regarding this [123I]ioflupane. R. Scherbenske, Office of Diversion
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Document Created: 2015-12-15 15:08:45
Document Modified: 2015-12-15 15:08:45
| 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 | Proposed Rules | |
| Action | Draft revised guidance; availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 3, 2015. | |
| Contact | Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856, [email protected] | |
| FR Citation | 80 FR 31520 |
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