81 FR 12498 - Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12498-12499 | |
| FR Document | 2016-05222 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12498-12499] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1180] Ensuring Safety of Animal Feed Maintained and Fed On-Farm; 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 (GFI) # 203 entitled ``Ensuring Safety of Animal Feed Maintained and Fed On-Farm.'' This guidance is intended to help animal producers (persons who feed animals) develop and implement on-farm practices to ensure the safety of animal feed maintained and fed to animals on the farm. 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-2014-D-1180 for ``Ensuring Safety of Animal Feed Maintained and Fed On-Farm.'' 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. 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: Phares Okelo, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5921, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 20, 2015 (80 FR 15014), FDA published the notice of availability for a draft GFI #203 entitled ``Ensuring Safety of Animal Feed Maintained and Fed On-Farm'' giving interested persons until June 3, 2015, to comment on the draft guidance. FDA received several comments on the [[Page 12499]] draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated March 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 ensuring safety of animal feed maintained and fed on-farm. 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 FDA concludes that there are no collections of information under the Paperwork Reduction Act of 1995. 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: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05222 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![12498 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
Estimated total annual burden hours: Electronic Submissions with a heading or cover note that states
95. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Additional Information: Copies of the following way: CONFIDENTIAL INFORMATION.’’ The
proposed collection may be obtained by • Federal eRulemaking Portal: http:// Agency will review this copy, including
writing to the Administration for www.regulations.gov. Follow the the claimed confidential information, in
Children and Families, Office of instructions for submitting comments. its consideration of comments. The
Planning, Research and Evaluation, 330 Comments submitted electronically, second copy, which will have the
C Street SW., Washington, DC 20201, including attachments, to http:// claimed confidential information
Attn: OPRE Reports Clearance Officer. www.regulations.gov will be posted to redacted/blacked out, will be available
All requests should be identified by the the docket unchanged. Because your for public viewing and posted on http://
title of the information collection. Email comment will be made public, you are www.regulations.gov. Submit both
address: OPREinfocollection@ solely responsible for ensuring that your copies to the Division of Dockets
acf.hhs.gov. comment does not include any Management. If you do not wish your
OMB Comment: OMB is required to confidential information that you or a name and contact information to be
make a decision concerning the third party may not wish to be posted, made publicly available, you can
collection of information between 30 such as medical information, your or provide this information on the cover
and 60 days after publication of this anyone else’s Social Security number, or sheet and not in the body of your
document in the Federal Register. confidential business information, such comments and you must identify this
Therefore, a comment is best assured of as a manufacturing process. Please note information as ‘‘confidential.’’ Any
having its full effect if OMB receives it that if you include your name, contact information marked as ‘‘confidential’’
within 30 days of publication. Written information, or other information that will not be disclosed except in
comments and recommendations for the identifies you in the body of your accordance with 21 CFR 10.20 and other
proposed information collection should comments, that information will be applicable disclosure law. For more
be sent directly to the following: Office posted on http://www.regulations.gov. information about FDA’s posting of
of Management and Budget, Paperwork • If you want to submit a comment comments to public dockets, see 80 FR
Reduction Project, Email: OIRA_ with confidential information that you 56469, September 18, 2015, or access
SUBMISSION@OMB.EOP.GOV, Attn: do not wish to be made available to the the information at: http://www.fda.gov/
Desk Officer for the Administration for public, submit the comment as a regulatoryinformation/dockets/
Children and Families. written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Robert Sargis, read background documents or the
Submissions’’ and ‘‘Instructions’’).
ACF Certifying Officer. electronic and written/paper comments
[FR Doc. 2016–05240 Filed 3–8–16; 8:45 am] Written/Paper Submissions received, go to http://
BILLING CODE 4184–01–P Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
DEPARTMENT OF HEALTH AND written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
HUMAN SERVICES Dockets Management (HFA–305), Food and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
Food and Drug Administration 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single
[Docket No. FDA–2014–D–1180] submitted to the Division of Dockets copies of the guidance to the Policy and
Management, FDA will post your Regulations Staff (HFV–6), Center for
Ensuring Safety of Animal Feed Veterinary Medicine, Food and Drug
comment, as well as any attachments,
Maintained and Fed On-Farm; Administration, 7519 Standish Pl.,
except for information submitted,
Guidance for Industry; Availability Rockville, MD 20855. Send one self-
marked and identified, as confidential,
if submitted as detailed in addressed adhesive label to assist that
AGENCY: Food and Drug Administration, office in processing your requests. See
HHS. ‘‘Instructions.’’
Instructions: All submissions received the SUPPLEMENTARY INFORMATION section
ACTION: Notice of availability. for electronic access to the guidance
must include the Docket No. FDA–
2014–D–1180 for ‘‘Ensuring Safety of document.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is Animal Feed Maintained and Fed On- FOR FURTHER INFORMATION CONTACT:
announcing the availability of a Farm.’’ Received comments will be Phares Okelo, Center for Veterinary
guidance for industry (GFI) # 203 placed in the docket and, except for Medicine (HFV–226), Food and Drug
entitled ‘‘Ensuring Safety of Animal those submitted as ‘‘Confidential Administration, 7519 Standish Pl.,
Feed Maintained and Fed On-Farm.’’ Submissions,’’ publicly viewable at Rockville, MD 20855, 240–402–5921,
This guidance is intended to help http://www.regulations.gov or at the email: phares.okelo@fda.hhs.gov.
animal producers (persons who feed Division of Dockets Management SUPPLEMENTARY INFORMATION:
animals) develop and implement on- between 9 a.m. and 4 p.m., Monday
through Friday. I. Background
farm practices to ensure the safety of
animal feed maintained and fed to • Confidential Submissions—To In the Federal Register of March 20,
Lhorne on DSK5TPTVN1PROD with NOTICES
animals on the farm. submit a comment with confidential 2015 (80 FR 15014), FDA published the
information that you do not wish to be notice of availability for a draft GFI #203
DATES: Submit either electronic or made publicly available, submit your entitled ‘‘Ensuring Safety of Animal
written comments on Agency guidances comments only as a written/paper Feed Maintained and Fed On-Farm’’
at any time. submission. You should submit two giving interested persons until June 3,
ADDRESSES: You may submit comments copies total. One copy will include the 2015, to comment on the draft guidance.
as follows: information you claim to be confidential FDA received several comments on the
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![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12499
draft guidance and those comments ongoing dialogue between industry and • Describe the application of statistical
were considered as the guidance was regulatory Agencies—emphasizing the methodologies and thinking regarding
finalized. The guidance announced in regulatory and statistical challenges the development of new therapeutic
this notice finalizes the draft guidance associated with innovative approaches biologics and drugs
dated March 2015. to the design and analysis of clinical • Assess the impact of regulations and
trials and measuring the progress being guidance on statistical practice
II. Significance of Guidance • Discuss ideas for improving the
made in designing and implementing
This level 1 guidance is being issued innovative solutions. communication between industry
consistent with FDA’s good guidance DATES: The main meeting will be held statisticians and regulatory reviewers
practices regulation (21 CFR 10.115). over 3 days: April 25, 2016, from 1 p.m. A description of the planned activities
The guidance represents the current to 5:30 p.m.; April 26, 2016, from 8:30 of the working groups can be found at
thinking of FDA on ensuring safety of a.m. to 5 p.m.; and April 27, 2016, from http://www.diaglobal.org/en/
animal feed maintained and fed on- 8:30 a.m. to 3:30 p.m. On April 25, there conference-listing/meetings/2016/04/
farm. It does not establish any rights for will also be pre-meeting tutorials from dia-fda-statistics-2016-forum.
any person and is not binding on FDA 8:30 a.m. to 12 p.m. and a scientific
or the public. You can use an alternative II. Registration and Accommodations
working group session from 5:40 p.m. to
approach if it satisfies the requirements 7 p.m. A. Registration
of the applicable statutes and
ADDRESSES: The meeting will be held at There is a registration fee to attend
regulations.
the Marriott Bethesda North Hotel and this meeting. The registration fee is to
III. Paperwork Reduction Act of 1995 Conference Center, 5701 Marinelli Rd., help defray the costs of the event;
FDA concludes that there are no North Bethesda, MD 20852, 301–822– including meeting facilities, program
collections of information under the 9200. materials, refreshments, staff time and
Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT:
administrative overhead, and costs
Meredith Kaganovskiy, DIA, 800 involved in getting speakers to the
IV. Electronic Access events; and will not result in any
Enterprise Rd., Horsham, PA 19044,
Persons with access to the Internet 215–442–6117, profits. Seats are limited, and
may obtain the guidance at either http:// Meredith.Kaganovskiy@DIAglobal.orgM; registration will be on a first-come, first-
www.fda.gov/AnimalVeterinary/ or Stephen Wilson, Food and Drug served basis. On-site registration will be
GuidanceComplianceEnforcement/ Administration, 10903 New Hampshire available to the extent that space is
GuidanceforIndustry/default.htm or Ave., Bldg. 21, Rm. 3630, Silver Spring, available on the day of the conference.
http://www.regulations.gov. MD 20993–0002, 301–796–0579, Please note: Registration will open at
Dated: March 2, 2016. Stephen.Wilson@fda.hhs.gov. 7:30 a.m. each day.
To register, please complete
Leslie Kux, SUPPLEMENTARY INFORMATION: registration online at http://
Associate Commissioner for Policy. www.diaglobal.org/en/conference-
[FR Doc. 2016–05222 Filed 3–8–16; 8:45 am] I. Background
listing/meetings/2016/04/dia-fda-
BILLING CODE 4164–01–P FDA and DIA will sponsor an open statistics-2016-forum/register. (FDA has
public discussion between industry, verified the Web address, but is not
academia, contract research responsible for subsequent changes to
DEPARTMENT OF HEALTH AND organizations, regulatory scientists, and the Web site after this document
HUMAN SERVICES other parties on topics related to the publishes in the Federal Register.) The
innovative statistical methodologies and costs of registration for the different
Food and Drug Administration quantitative approaches used by categories of attendees are as follows:
[Docket No. FDA 2016–N–0001] sponsors to provide evidence for the
approval of new therapies. Category Cost
Tenth Annual Drug Information The forum will provide a unique
Association/Food and Drug opportunity for all of the relevant Industry Representatives ................ $1,350
Administration Statistics Forum— stakeholders to collaboratively describe Charitable Nonprofit/Academic (Full
2016; Public Conference the issues and discuss appropriate time) ............................................ 675
Government (Full time) ................... 405
AGENCY: Food and Drug Administration, solutions. It is important that all of the
Tutorial Fees ................................... 405
HHS. stakeholders examine their roles in
making the necessary changes and All registrants will be required to pay
ACTION: Notice of public conference.
improvements in the framework used to the applicable fee, with the exception of
SUMMARY: The Food and Drug develop evidence for the regulatory a limited number of speakers/organizers
Administration (FDA), in co- decisions and work to foster a mutual who will have a complimentary
sponsorship with the Drug Information understanding of relevant scientific registration.
Association (DIA), is announcing a issues and challenges.
public conference entitled ‘‘Tenth The conference will benefit FDA by B. Accommodations
Annual DIA/Food and Drug enhancing communication with the Attendees are responsible for their
Administration Statistics Forum— broader statistical community. own hotel accommodations. Attendees
2016.’’ This public conference is The goals of the program are as making reservations at the Bethesda
Lhorne on DSK5TPTVN1PROD with NOTICES
intended to be an open forum for the follows: North Marriot Hotel and Conference
timely discussion of topics of mutual • Explore and implement innovative Center, 5701 Marinelli Rd., North
theoretical and practical interest to statistical solutions to important Bethesda, MD 20852 are eligible for a
statisticians and clinical trialists who issues associated with the quantitative reduced rate of $199, not including
develop and review new drugs and evidence needed for the regulatory applicable taxes.
biologics. A primary focus for this review of therapeutic drugs and The Marriott Bethesda North Hotel
public conference will be to establish an biologics and Conference Center has a limited
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Document Created: 2016-03-09 00:13:17
Document Modified: 2016-03-09 00:13:17
| 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 | Phares Okelo, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5921, email: [email protected] | |
| FR Citation | 81 FR 12498 |
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