Veterinary Feed Directive Common Format Questions and Answers; Guidance for Industry; Availability, 65360-65361 [2016-22775]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 65360 Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 14, 2016. Oral presentations from the public will be scheduled between approximately 10 a.m. to 10:30 a.m. and 3 p.m. to 3:30 p.m. on October 25, 2016, and between approximately 10:15 a.m. to 10:45 a.m. and 2:30 p.m. to 3 p.m. on October 26, 2016. 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FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at AnnMarie.Williams@ fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 16, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016–22808 Filed 9–21–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:58 Sep 21, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Food and Drug Administration Written/Paper Submissions [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. 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: SUMMARY: 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 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 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. E:\FR\FM\22SEN1.SGM 22SEN1 Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Notices 65361 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. 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. [FR Doc. 2016–22775 Filed 9–21–16; 8:45 am] FOR FURTHER INFORMATION CONTACT: Jason E. Bennett, Director, Division of the Executive Secretariat. BILLING CODE 4164–01–P [FR Doc. 2016–22858 Filed 9–21–16; 8:45 am] Dragan Momcilovic, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402– 5944, email: dragan.momcilovic@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:58 Sep 21, 2016 Jkt 238001 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 16, 2016. Leslie Kux, Associate Commissioner for Policy. the National Organ Transplant Act of 1984, as amended. On August 31, 2016, the Secretary approved the ACOT charter to be renewed. The filing date of the renewed charter was September 1, 2016. Renewal of the ACOT charter gives authorization for the Committee to operate until September 1, 2018. A copy of the ACOT charter is available on the ACOT Web site at https://www.organdonor.gov/legislation/ advisory.html. A copy of the charter also can be obtained by accessing the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The Web site address for the FACA database is https:// www.facadatabase.gov/. BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Renewal of Charter for the Advisory Committee on Organ Transplantation DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting Announcement for the Technical Advisory Panel on Medicare Trustee Reports Notice of public meeting. AGENCY: ACTION: HRSA is giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been rechartered. The effective date of the renewed charter is September 1, 2016. FOR FURTHER INFORMATION CONTACT: Robert Walsh, Executive Secretary, Advisory Committee on Organ Transplantation, HRSA, Room 08W60, 5600 Fishers Lane, Rockville, MD 20857. Phone: (301) 443–6839; fax: (301) 594–6095; email: rwalsh@hrsa.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. Section 217a, Section 222 of the Public Health Service Act, as amended, 42 CFR 121.12 (2000), and in accordance with the Federal Advisory Committee Act (FACA), Public Law 92–463, ACOT was initially chartered on September 1, 2000, and was renewed at appropriate intervals. ACOT provides advice to the Secretary of HHS (the Secretary) on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines. The recommendations of ACOT facilitate Department efforts to oversee the Organ Procurement and Transplantation Network, as set forth in This notice announces the meeting date for the second Technical Advisory Panel on Medicare Trustee Reports on Friday, September 30, 2016 in Washington, DC. DATES: The meeting will be held on Friday, September 30, 2016 from 9:00 a.m. to 5:00 p.m.. Eastern Daylight Time (EDT) and it is open to the public. ADDRESSES: This will be a virtual meeting held via WebEx. FOR FURTHER INFORMATION CONTACT: Dr. Donald Oellerich, Designated Federal Officer, at the Office of Human Services Policy, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC 20201, (202) 690–8410. SUPPLEMENTARY INFORMATION: I. Purpose: The Panel will discuss the long-term rate of change in health spending and may make recommendations to the Secretary on how the Medicare Trustees might more accurately estimate health spending in the short and long run. The Panel’s discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. This Committee is governed Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65360-65361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22775]


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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: 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 Common Format Questions 
and Answers.'' 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 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.

[[Page 65361]]

    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, email: 
dragan.momcilovic@fda.hhs.gov.

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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://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
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