80 FR 75119 - Veterinary Feed Directive Common Format Questions and Answers; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 230 (December 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 230 (December 1, 2015)
| Page Range | 75119-75120 | |
| FR Document | 2015-30411 |
[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)] [Notices] [Pages 75119-75120] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30411] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0155] Veterinary Feed Directive Common Format Questions and Answers; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #233 entitled ``Veterinary Feed Directive Common Format Questions and Answers.'' On June 3, 2015, FDA published a final rule that revised the Agency's veterinary feed directive (VFD) regulations. During the rulemaking process, FDA received a few comments requesting that we require a uniform VFD form. Although we declined this request because we think that requiring a specific VFD form would be too prescriptive, we acknowledge that a common VFD format would help clients, veterinarians, and distributors (including feed mills) quickly identify relevant information on the VFD and are issuing this draft guidance to recommend a common VFD format. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 1, 2016. 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 Common Format Questions and Answers.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at [[Page 75120]] 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 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 draft 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. 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #233 entitled ``Veterinary Feed Directive Common Format Questions and Answers.'' 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 or on 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 at Sec. 558.6 (21 CFR 558.6) implementing the VFD-related provisions of the ADAA in 2000. On June 3, 2015 (80 FR 31707), FDA published a VFD final rule that revised those VFD regulations and introduced clarifying changes to specified definitions. During the latest rulemaking process, FDA received a few comments requesting the Agency to require a uniform VFD format. We declined this request because we thought that requiring a specific format would be too prescriptive. However, we acknowledge that a common VFD format would help clients, veterinarians, and distributors (including feed mills) quickly identify relevant information on the VFD. We are issuing this draft guidance to recommend a common VFD format. In the draft guidance, we use the term ``VFD'' to refer to the form used to convey the VFD order. This draft guidance describes the requirements in Sec. 514.1(b)(9) (21 CFR 514.1(b)(9)) for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal feed as a VFD drug, as well as the required and optional information to be included on the VFD. This draft guidance provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be prepopulated by a sponsor. 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 current thinking of FDA on ``Veterinary Feed Directive Common Format 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 draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in Sec. 514.1 have been approved under OMB control number 0910-0032. The collections of information in Sec. 558.6 have been approved under OMB control number 0910-0363. IV. 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: November 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-30411 Filed 11-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices 75119
ANNUAL BURDEN ESTIMATES—Continued
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response
Staff follow-up questionnaire for sites testing employment
intervention ....................................................................... 80 27 1 1.0 27
Participant focus groups ...................................................... 96 32 1 1.5 48
Mother focus groups in sites testing parenting intervention 80 27 1 1.0 27
Mobile device process survey ............................................. 2,000 667 5 0.08 278
Mobile device employment survey ...................................... 400 133 5 0.08 56
Mobile device parenting and co-parenting survey ............... 600 200 5 0.08 83
Post-workshop questionnaires for sites testing parenting
intervention ....................................................................... 750 250 5 0.05 63
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: http://
Hours: 3,876. HUMAN SERVICES www.regulations.gov. Follow the
In compliance with the requirements instructions for submitting comments.
Food and Drug Administration Comments submitted electronically,
of Section 3506(c)(2)(A) of the
including attachments, to http://
Paperwork Reduction Act of 1995, the
[Docket No. FDA–2010–N–0155] www.regulations.gov will be posted to
Administration for Children and
the docket unchanged. Because your
Families is soliciting public comment Veterinary Feed Directive Common comment will be made public, you are
on the specific aspects of the Format Questions and Answers; Draft solely responsible for ensuring that your
information collection described above. Guidance for Industry; Availability comment does not include any
Copies of the proposed collection of confidential information that you or a
information can be obtained and AGENCY: Food and Drug Administration, third party may not wish to be posted,
comments may be forwarded by writing HHS. such as medical information, your or
to the Administration for Children and ACTION: Notice of availability. anyone else’s Social Security number, or
Families, Office of Planning, Research confidential business information, such
and Evaluation, 330 C Street SW., SUMMARY: The Food and Drug as a manufacturing process. Please note
Washington, DC 20201, Attn: OPRE Administration (FDA or Agency) is that if you include your name, contact
Reports Clearance Officer. Email announcing the availability of a draft information, or other information that
address: guidance for industry #233 entitled identifies you in the body of your
OPREinfocollection@acf.hhs.gov. All ‘‘Veterinary Feed Directive Common comments, that information will be
Format Questions and Answers.’’ On posted on http://www.regulations.gov.
requests should be identified by the title
of the information collection.
June 3, 2015, FDA published a final rule • If you want to submit a comment
that revised the Agency’s veterinary with confidential information that you
The Department specifically requests feed directive (VFD) regulations. During do not wish to be made available to the
comments on (a) whether the proposed the rulemaking process, FDA received a public, submit the comment as a
collection of information is necessary few comments requesting that we written/paper submission and in the
for the proper performance of the require a uniform VFD form. Although manner detailed (see ‘‘Written/Paper
functions of the agency, including we declined this request because we Submissions’’ and ‘‘Instructions’’).
whether the information shall have think that requiring a specific VFD form
practical utility; (b) the accuracy of the would be too prescriptive, we Written/Paper Submissions
agency’s estimate of the burden of the acknowledge that a common VFD Submit written/paper submissions as
proposed collection of information; (c) format would help clients, follows:
the quality, utility, and clarity of the veterinarians, and distributors • Mail/Hand delivery/Courier (for
information to be collected; and (d) (including feed mills) quickly identify written/paper submissions): Division of
ways to minimize the burden of the relevant information on the VFD and are Dockets Management (HFA–305), Food
collection of information on issuing this draft guidance to and Drug Administration, 5630 Fishers
respondents, including through the use recommend a common VFD format. Lane, Rm. 1061, Rockville, MD 20852.
DATES: Although you can comment on • For written/paper comments
of automated collection techniques or
any guidance at any time (see 21 CFR submitted to the Division of Dockets
other forms of information technology. Management, FDA will post your
Consideration will be given to 10.115(g)(5)), to ensure that the Agency
considers your comment on this draft comment, as well as any attachments,
comments and suggestions submitted except for information submitted,
within 60 days of this publication. guidance before it begins work on the
final version of the guidance, submit marked and identified, as confidential,
Robert Sargis, either electronic or written comments if submitted as detailed in
on the draft guidance by February 1, ‘‘Instructions.’’
ACF Reports Clearance Officer.
2016. Instructions: All submissions received
[FR Doc. 2015–30337 Filed 11–30–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
must include the Docket No. FDA–
BILLING CODE 4184–73–P ADDRESSES: You may submit comments 2010–N–0155 for ‘‘Veterinary Feed
as follows: Directive Common Format Questions
and Answers.’’ Received comments will
Electronic Submissions be placed in the docket and, except for
Submit electronic comments in the those submitted as ‘‘Confidential
following way: Submissions,’’ publicly viewable at
VerDate Sep<11>2014 23:35 Nov 30, 2015 Jkt 238001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1](https://thefederalregister.org/doc/80_FR_75349/page/1.svg)
![75120 Federal Register / Vol. 80, No. 230 / Tuesday, December 1, 2015 / Notices
http://www.regulations.gov or at the Pl., Rockville, MD 20855, 240–402– rights for any person and is not binding
Division of Dockets Management 5944, dragan.momcilovic@fda.hhs.gov. on FDA or the public. You can use an
between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: alternative approach if it satisfies the
through Friday. requirements of the applicable statutes
I. Background and regulations.
• Confidential Submissions—To
submit a comment with confidential FDA is announcing the availability of
a draft guidance for industry #233 III. Paperwork Reduction Act of 1995
information that you do not wish to be
made publicly available, submit your entitled ‘‘Veterinary Feed Directive This draft guidance refers to
comments only as a written/paper Common Format Questions and previously approved collections of
submission. You should submit two Answers.’’ information found in FDA regulations.
In 1996, Congress enacted the Animal These collections of information are
copies total. One copy will include the
Drug Availability Act (ADAA) to subject to review by the Office of
information you claim to be confidential
facilitate the approval and marketing of Management and Budget (OMB) under
with a heading or cover note that states
new animal drugs and medicated feeds. the Paperwork Reduction Act of 1995
‘‘THIS DOCUMENT CONTAINS
In passing the ADAA, Congress created (44 U.S.C. 3501–3520). The collections
CONFIDENTIAL INFORMATION.’’ The
a new regulatory category for certain of information in § 514.1 have been
Agency will review this copy, including
animal drugs used in or on animal feed approved under OMB control number
the claimed confidential information, in
called VFD drugs. VFD drugs are new 0910–0032. The collections of
its consideration of comments. The
animal drugs intended for use in or on information in § 558.6 have been
second copy, which will have the
animal feed which are limited to use approved under OMB control number
claimed confidential information under the professional supervision of a
redacted/blacked out, will be available 0910–0363.
licensed veterinarian. FDA published
for public viewing and posted on final regulations at § 558.6 (21 CFR IV. Electronic Access
http://www.regulations.gov. Submit 558.6) implementing the VFD-related Persons with access to the Internet
both copies to the Division of Dockets provisions of the ADAA in 2000. On may obtain the draft guidance at either
Management. If you do not wish your June 3, 2015 (80 FR 31707), FDA http://www.fda.gov/AnimalVeterinary/
name and contact information to be published a VFD final rule that revised GuidanceComplianceEnforcement/
made publicly available, you can those VFD regulations and introduced GuidanceforIndustry/default.htm or
provide this information on the cover clarifying changes to specified http://www.regulations.gov.
sheet and not in the body of your definitions.
comments and you must identify this Dated: November 25, 2015.
During the latest rulemaking process,
information as ‘‘confidential.’’ Any Leslie Kux,
FDA received a few comments
information marked as ‘‘confidential’’ requesting the Agency to require a Associate Commissioner for Policy.
will not be disclosed except in uniform VFD format. We declined this [FR Doc. 2015–30411 Filed 11–30–15; 8:45 am]
accordance with 21 CFR 10.20 and other request because we thought that BILLING CODE 4164–01–P
applicable disclosure law. For more requiring a specific format would be too
information about FDA’s posting of prescriptive. However, we acknowledge
comments to public dockets, see 80 FR that a common VFD format would help DEPARTMENT OF HEALTH AND
56469, September 18, 2015, or access clients, veterinarians, and distributors HUMAN SERVICES
the information at: http://www.fda.gov/ (including feed mills) quickly identify
regulatoryinformation/dockets/ National Institutes of Health
relevant information on the VFD.
default.htm. We are issuing this draft guidance to Proposed Collection; 60-Day Comment
Docket: For access to the docket to recommend a common VFD format. In Request: NIH Information Collection
read background documents or the the draft guidance, we use the term Forms To Support Genomic Data
electronic and written/paper comments ‘‘VFD’’ to refer to the form used to Sharing for Research Purposes (OD)
received, go to http:// convey the VFD order. This draft
www.regulations.gov and insert the guidance describes the requirements in SUMMARY: In compliance with the
docket number, found in brackets in the § 514.1(b)(9) (21 CFR 514.1(b)(9)) for requirement of Section 3506(c)(2)(A) of
heading of this document, into the sponsor submission of a VFD to FDA as the Paperwork Reduction Act of 1995,
‘‘Search’’ box and follow the prompts part of the application process for for opportunity for public comment on
and/or go to the Division of Dockets approval of a new animal drug for use proposed data collection projects, the
Management, 5630 Fishers Lane, Rm. in or on animal feed as a VFD drug, as Office of the Director, the National
1061, Rockville, MD 20852. well as the required and optional Institutes of Health (NIH) will publish
information to be included on the VFD. periodic summaries of proposed
Submit written requests for single
This draft guidance provides examples projects to be submitted to the Office of
copies of the draft guidance to the
that illustrate how a common VFD Management and Budget (OMB) for
Policy and Regulations Staff (HFV–6),
format might appear and how some of review and approval.
Center for Veterinary Medicine, Food
the information on the VFD may be Written comments and/or suggestions
and Drug Administration, 7519 Standish
prepopulated by a sponsor. from the public and affected agencies
Pl., Rockville, MD 20855. Send one self-
are invited to address one or more of the
addressed adhesive label to assist that II. Significance of Guidance following points: (1) Whether the
office in processing your requests. See
This level 1 draft guidance is being proposed collection of information is
the SUPPLEMENTARY INFORMATION section
tkelley on DSK3SPTVN1PROD with NOTICES
issued consistent with FDA’s good necessary for the proper performance of
for electronic access to the draft guidance practices regulation (21 CFR the function of the agency, including
guidance document. 10.115). The draft guidance, when whether the information will have
FOR FURTHER INFORMATION CONTACT: finalized, will represent the current practical utility; (2) The accuracy of the
Dragan Momcilovic, Center for thinking of FDA on ‘‘Veterinary Feed agency’s estimate of the burden of the
Veterinary Medicine (HFV–226), Food Directive Common Format Questions proposed collection of information,
and Drug Administration, 7519 Standish and Answers.’’ It does not establish any including the validity of the
VerDate Sep<11>2014 23:35 Nov 30, 2015 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1](https://thefederalregister.org/doc/80_FR_75349/page/2.svg)
Document Created: 2018-03-02 09:09:49
Document Modified: 2018-03-02 09:09:49
| 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 | Notices | |
| Action | Notice of 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 February 1, 2016. | |
| 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 75119 |
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