81 FR 65360 - Veterinary Feed Directive Common Format Questions and Answers; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 184 (September 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 184 (September 22, 2016)
| Page Range | 65360-65361 | |
| FR Document | 2016-22775 |
[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)] [Notices] [Pages 65360-65361] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22775] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0155] Veterinary Feed Directive Common Format Questions and Answers; 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 guidance for industry #233 entitled ``Veterinary Feed Directive Common Format Questions and Answers.'' FDA had received comments requesting that we require a uniform Veterinary Feed Directive (VFD) form. We declined this request because we think that requiring a specific VFD form would be too prescriptive. However, we acknowledge that a common VFD format would help veterinarians, their clients (i.e., animal producers), and distributors (including feed mills) quickly identify relevant information on the VFD. We are issuing this guidance to recommend a common VFD format. We expect this guidance will reduce potential errors on VFDs. 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 Common Format Questions and Answers.'' 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 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. [[Page 65361]] 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, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background Following publication of the proposed rule to update FDA's veterinary feed directive (VFD) regulation in December 2013 (78 FR 75515), in the Federal Register of December 1, 2015 (80 FR 75119), FDA published the notice of availability for a draft guidance entitled ``Veterinary Feed Directive Common Format Questions and Answers'' giving interested persons until February 1, 2016, 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 December 2015. II. Significance of Guidance This level 1 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 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 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 514.1 have been approved under OMB Control No. 0910-0032. The collections of information in 21 CFR 558.6 have been approved under OMB Control No. 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 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22775 Filed 9-21-16; 8:45 am] BILLING CODE 4164-01-P
![65360 Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
link. HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
Procedure: Interested persons may Written/Paper Submissions
Food and Drug Administration
present data, information, or views,
orally or in writing, on issues pending [Docket No. FDA–2010–N–0155] Submit written/paper submissions as
before the committee. Written follows:
submissions may be made to the contact Veterinary Feed Directive Common • Mail/Hand delivery/Courier (for
person on or before October 14, 2016. Format Questions and Answers; written/paper submissions): Division of
Oral presentations from the public will Guidance for Industry; Availability Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
be scheduled between approximately 10 AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
a.m. to 10:30 a.m. and 3 p.m. to 3:30 HHS.
p.m. on October 25, 2016, and between • For written/paper comments
ACTION: Notice of availability. submitted to the Division of Dockets
approximately 10:15 a.m. to 10:45 a.m.
SUMMARY: The Food and Drug Management, FDA will post your
and 2:30 p.m. to 3 p.m. on October 26,
Administration (FDA or Agency) is comment, as well as any attachments,
2016. Those individuals interested in
announcing the availability of a except for information submitted,
making formal oral presentations should
guidance for industry #233 entitled marked and identified, as confidential,
notify the contact person and submit a
‘‘Veterinary Feed Directive Common if submitted as detailed in
brief statement of the general nature of
Format Questions and Answers.’’ FDA ‘‘Instructions.’’
the evidence or arguments they wish to
had received comments requesting that Instructions: All submissions received
present, the names and addresses of
we require a uniform Veterinary Feed must include the Docket No. FDA–
proposed participants, and an
Directive (VFD) form. We declined this 2010–N–0155 for ‘‘Veterinary Feed
indication of the approximate time
request because we think that requiring Directive Common Format Questions
requested to make their presentation on
a specific VFD form would be too and Answers.’’ Received comments will
or before October 6, 2016. Time allotted
prescriptive. However, we acknowledge be placed in the docket and, except for
for each presentation may be limited. If
that a common VFD format would help those submitted as ‘‘Confidential
the number of registrants requesting to Submissions,’’ publicly viewable at
speak is greater than can be reasonably veterinarians, their clients (i.e., animal
producers), and distributors (including http://www.regulations.gov or at the
accommodated during the scheduled Division of Dockets Management
open public hearing session, FDA may feed mills) quickly identify relevant
information on the VFD. We are issuing between 9 a.m. and 4 p.m., Monday
conduct a lottery to determine the through Friday.
speakers for the scheduled open public this guidance to recommend a common
VFD format. We expect this guidance • Confidential Submissions—To
hearing session. The contact person will submit a comment with confidential
notify interested persons regarding their will reduce potential errors on VFDs.
DATES: Submit either electronic or information that you do not wish to be
request to speak by October 7, 2016. made publicly available, submit your
written comments on Agency guidances
Persons attending FDA’s advisory at any time. comments only as a written/paper
committee meetings are advised that the submission. You should submit two
ADDRESSES: You may submit comments
Agency is not responsible for providing as follows: copies total. One copy will include the
access to electrical outlets. information you claim to be confidential
FDA welcomes the attendance of the Electronic Submissions with a heading or cover note that states
public at its advisory committee Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
meetings and will make every effort to following way: CONFIDENTIAL INFORMATION.’’ The
accommodate persons with disabilities. • Federal eRulemaking Portal: http:// Agency will review this copy, including
If you require accommodations due to a www.regulations.gov. Follow the the claimed confidential information, in
disability, please contact AnnMarie instructions for submitting comments. its consideration of comments. The
Williams at AnnMarie.Williams@ Comments submitted electronically, second copy, which will have the
fda.hhs.gov or 301–796–5966 at least 7 including attachments, to http:// claimed confidential information
days in advance of the meeting. www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http://
FDA is committed to the orderly comment will be made public, you are www.regulations.gov. Submit both
conduct of its advisory committee solely responsible for ensuring that your copies to the Division of Dockets
meetings. Please visit our Web site at comment does not include any Management. If you do not wish your
http://www.fda.gov/ confidential information that you or a name and contact information to be
AdvisoryCommittees/ third party may not wish to be posted, made publicly available, you can
AboutAdvisoryCommittees/ such as medical information, your or provide this information on the cover
ucm111462.htm for procedures on anyone else’s Social Security number, or sheet and not in the body of your
public conduct during advisory confidential business information, such comments and you must identify this
committee meetings. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Notice of this meeting is given under that if you include your name, contact information marked as ‘‘confidential’’
the Federal Advisory Committee Act (5 information, or other information that will not be disclosed except in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
U.S.C. app. 2). identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
Dated: September 16, 2016.
posted on http://www.regulations.gov. information about FDA’s posting of
Janice M. Soreth, • If you want to submit a comment comments to public dockets, see 80 FR
Acting Associate Commissioner, Special with confidential information that you 56469, September 18, 2015, or access
Medical Programs. do not wish to be made available to the the information at: http://www.fda.gov/
[FR Doc. 2016–22808 Filed 9–21–16; 8:45 am] public, submit the comment as a regulatoryinformation/dockets/
BILLING CODE 4164–01–P written/paper submission and in the default.htm.
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![Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices 65361
Docket: For access to the docket to collections of information are subject to the National Organ Transplant Act of
read background documents or the review by the Office of Management and 1984, as amended.
electronic and written/paper comments Budget (OMB) under the Paperwork On August 31, 2016, the Secretary
received, go to http:// Reduction Act of 1995 (44 U.S.C. 3501– approved the ACOT charter to be
www.regulations.gov and insert the 3520). The collections of information in renewed. The filing date of the renewed
docket number, found in brackets in the 21 CFR 514.1 have been approved under charter was September 1, 2016. Renewal
heading of this document, into the OMB Control No. 0910–0032. The of the ACOT charter gives authorization
‘‘Search’’ box and follow the prompts collections of information in 21 CFR for the Committee to operate until
and/or go to the Division of Dockets 558.6 have been approved under OMB September 1, 2018.
Management, 5630 Fishers Lane, Rm. Control No. 0910–0363. A copy of the ACOT charter is
1061, Rockville, MD 20852. available on the ACOT Web site at
IV. Electronic Access
Submit written requests for single http://www.organdonor.gov/legislation/
copies of the guidance to the Policy and Persons with access to the Internet advisory.html. A copy of the charter also
Regulations Staff (HFV–6), Center for may obtain the guidance at either http:// can be obtained by accessing the FACA
Veterinary Medicine, Food and Drug www.fda.gov/AnimalVeterinary/ database that is maintained by the
Administration, 7519 Standish Pl., GuidanceComplianceEnforcement/ Committee Management Secretariat
Rockville, MD 20855. Send one self- GuidanceforIndustry/default.htm or under the General Services
addressed adhesive label to assist that http://www.regulations.gov. Administration. The Web site address
office in processing your requests. See Dated: September 16, 2016. for the FACA database is http://
the SUPPLEMENTARY INFORMATION section Leslie Kux, www.facadatabase.gov/.
for electronic access to the guidance Associate Commissioner for Policy. Jason E. Bennett,
document. [FR Doc. 2016–22775 Filed 9–21–16; 8:45 am] Director, Division of the Executive Secretariat.
FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P [FR Doc. 2016–22858 Filed 9–21–16; 8:45 am]
Dragan Momcilovic, Center for BILLING CODE 4165–15–P
Veterinary Medicine (HFV–226), Food
and Drug Administration, 7519 Standish DEPARTMENT OF HEALTH AND
Pl., Rockville, MD 20855, 240–402– HUMAN SERVICES DEPARTMENT OF HEALTH AND
5944, email: dragan.momcilovic@ HUMAN SERVICES
fda.hhs.gov. Health Resources and Services
Administration Meeting Announcement for the
SUPPLEMENTARY INFORMATION:
Renewal of Charter for the Advisory Technical Advisory Panel on Medicare
I. Background Trustee Reports
Committee on Organ Transplantation
Following publication of the proposed
AGENCY: Health Resources and Services ACTION: Notice of public meeting.
rule to update FDA’s veterinary feed
directive (VFD) regulation in December Administration (HRSA), Department of
SUMMARY: This notice announces the
2013 (78 FR 75515), in the Federal Health and Human Services (HHS).
meeting date for the second Technical
Register of December 1, 2015 (80 FR ACTION: Notice. Advisory Panel on Medicare Trustee
75119), FDA published the notice of Reports on Friday, September 30, 2016
SUMMARY: HRSA is giving notice that the
availability for a draft guidance entitled in Washington, DC.
Advisory Committee on Organ
‘‘Veterinary Feed Directive Common DATES: The meeting will be held on
Transplantation (ACOT) has been
Format Questions and Answers’’ giving Friday, September 30, 2016 from 9:00
rechartered. The effective date of the
interested persons until February 1, a.m. to 5:00 p.m.. Eastern Daylight Time
renewed charter is September 1, 2016.
2016, to comment on the draft guidance. (EDT) and it is open to the public.
FOR FURTHER INFORMATION CONTACT:
FDA received several comments on the
Robert Walsh, Executive Secretary, ADDRESSES: This will be a virtual
draft guidance and those comments
Advisory Committee on Organ meeting held via WebEx.
were considered as the guidance was
finalized. The guidance announced in Transplantation, HRSA, Room 08W60, FOR FURTHER INFORMATION CONTACT: Dr.
this notice finalizes the draft guidance 5600 Fishers Lane, Rockville, MD Donald Oellerich, Designated Federal
dated December 2015. 20857. Phone: (301) 443–6839; fax: (301) Officer, at the Office of Human Services
594–6095; email: rwalsh@hrsa.gov. Policy, Assistant Secretary for Planning
II. Significance of Guidance SUPPLEMENTARY INFORMATION: Under the and Evaluation, U.S. Department of
This level 1 guidance is being issued authority of 42 U.S.C. Section 217a, Health and Human Services, 200
consistent with FDA’s good guidance Section 222 of the Public Health Service Independence Ave. SW., Washington,
practices regulation (21 CFR 10.115). Act, as amended, 42 CFR 121.12 (2000), DC 20201, (202) 690–8410.
The guidance represents the current and in accordance with the Federal SUPPLEMENTARY INFORMATION:
thinking of FDA on Veterinary Feed Advisory Committee Act (FACA), Public I. Purpose: The Panel will discuss the
Directive Common Format Questions Law 92–463, ACOT was initially long-term rate of change in health
and Answers. It does not establish any chartered on September 1, 2000, and spending and may make
rights for any person and is not binding was renewed at appropriate intervals. recommendations to the Secretary on
ACOT provides advice to the Secretary how the Medicare Trustees might more
asabaliauskas on DSK3SPTVN1PROD with NOTICES
on FDA or the public. You can use an
alternative approach if it satisfies the of HHS (the Secretary) on all aspects of accurately estimate health spending in
requirements of the applicable statutes organ donation, procurement, the short and long run. The Panel’s
and regulations. allocation, and transplantation, and on discussion is expected to be very
such other matters that the Secretary technical in nature and will focus on the
III. Paperwork Reduction Act of 1995 determines. The recommendations of actuarial and economic assumptions
This guidance refers to previously ACOT facilitate Department efforts to and methods by which Trustees might
approved collections of information oversee the Organ Procurement and more accurately measure health
found in FDA regulations. These Transplantation Network, as set forth in spending. This Committee is governed
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Document Created: 2016-09-22 01:03:54
Document Modified: 2016-09-22 01:03:54
| 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 | 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: [email protected] | |
| FR Citation | 81 FR 65360 |
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