81 FR 47397 - General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

Page Range		47397-47398
FR Document		2016-17188

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry #3 entitled ``General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals.'' This draft revised guidance describes the type of information that FDA's Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals.

Federal Register, Volume 81 Issue 140 (Thursday, July 21, 2016)

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47397-47398]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0155 (formerly 2005D-0219)]


General Principles for Evaluating the Human Food Safety of New 
Animal Drugs Used in Food-Producing Animals; Draft Guidance for 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 revised guidance for industry #3 entitled 
``General Principles for Evaluating the Human Food Safety of New Animal 
Drugs Used in Food-Producing Animals.'' This draft revised guidance 
describes the type of information that FDA's Center for Veterinary 
Medicine (CVM) recommends sponsors provide to address the human food 
safety of new animal drugs used in food-producing animals.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 19, 2016.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-2005-D-0155 for ``General Principles for Evaluating the Human Food 
Safety of New Animal Drugs used in Food-Producing Animals.'' 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 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.

[[Page 47398]]


FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0788, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft revised guidance for 
industry #3 entitled ``General Principles for Evaluating the Human Food 
Safety of New Animal Drugs used in Food-Producing Animals.'' This draft 
revised guidance is intended to inform sponsors of the scientific data 
and/or information that may provide an acceptable basis to determine 
that the residue of a new animal drug in or on food, when consumed, 
presents a reasonable certainty of no harm to humans. This guidance 
describes a recommended approach for providing human food safety 
scientific data and/or information. CVM acknowledges that alternate 
approaches also may be appropriate and encourages sponsors to discuss 
with CVM whether an alternate approach may be appropriate for specific 
new animal drugs.

II. Significance of Guidance

    This level 1 draft revised guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
revised guidance, when finalized, will represent the current thinking 
of FDA on the type of information sponsors provide to address the human 
food safety of new animal drugs used in food-producing animals. 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 21 CFR part 514 have been approved under 
OMB control number 0910-0032.

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: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17188 Filed 7-20-16; 8:45 am]
 BILLING CODE 4164-01-P

47398 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices

FOR FURTHER INFORMATION CONTACT: Julia Dated: July 14, 2016. Evaluation of the Program for
Oriani, Center for Veterinary Medicine Leslie Kux, Enhanced Review Transparency and
(HFV–151), Food and Drug Associate Commissioner for Policy. Communication for New Molecular
Administration, 7500 Standish Pl., [FR Doc. 2016–17188 Filed 7–20–16; 8:45 am]
Entity New Drug Applications (NME
Rockville, MD 20855, 240–402–0788, NDAs) and Original Biologics License
BILLING CODE 4164–01–P
julia.oriani@fda.hhs.gov. Applications (BLAs) in Prescription
SUPPLEMENTARY INFORMATION: Drug User Fee Acts (OMB Control
DEPARTMENT OF HEALTH AND Number 0910–0746)—Extension
I. Background
HUMAN SERVICES As part of its commitments in the
FDA is announcing the availability of
Prescription Drug User Fee Act
a draft revised guidance for industry #3
Food and Drug Administration (PDUFA) V, FDA established a new
entitled ‘‘General Principles for
review Program to promote greater
Evaluating the Human Food Safety of
[Docket No. 2013–N–0093] transparency and increased
New Animal Drugs used in Food-
communication between the FDA
Producing Animals.’’ This draft revised
Agency Information Collection review team and the applicant on the
guidance is intended to inform sponsors
Activities; Submission for Office of most innovative products reviewed by
of the scientific data and/or information
Management and Budget Review; the Agency. The Program applies to all
that may provide an acceptable basis to
Comment Request; Evaluation of the NME NDAs and original BLAs that are
determine that the residue of a new
Program for Enhanced Review received from October 1, 2012, through
animal drug in or on food, when
Transparency and Communication for September 30, 2017. The Program is
consumed, presents a reasonable
New Molecular Entity New Drug described in detail in section II.B of the
certainty of no harm to humans. This
Applications and Original Biologics document entitled ‘‘PDUFA
guidance describes a recommended
Reauthorization Performance Goals and
approach for providing human food License Applications in Prescription
Procedures Fiscal Years 2013 through
safety scientific data and/or Drug User Fee Acts
2017’’ (the Commitment Letter)
information. CVM acknowledges that
AGENCY: Food and Drug Administration, (available at http://www.fda.gov/
alternate approaches also may be
downloads/ForIndustry/UserFees/
appropriate and encourages sponsors to HHS.
PrescriptionDrugUserFee/
discuss with CVM whether an alternate
ACTION: Notice. UCM270412.pdf.
approach may be appropriate for
The goals of the Program are to
specific new animal drugs.
SUMMARY: The Food and Drug increase the efficiency and effectiveness
II. Significance of Guidance Administration (FDA) is announcing of the first review cycle and decrease
This level 1 draft revised guidance is that a proposed collection of the number of review cycles necessary
being issued consistent with FDA’s good information has been submitted to the for approval so that patients have timely
guidance practices regulation (21 CFR Office of Management and Budget access to safe, effective, and high-
10.115). The draft revised guidance, (OMB) for review and clearance under quality new drugs and biologics. A key
when finalized, will represent the the Paperwork Reduction Act of 1995 aspect of the Program is an interim and
current thinking of FDA on the type of final assessment that will evaluate how
(the PRA).
information sponsors provide to address well the parameters of the Program have
the human food safety of new animal DATES: Fax written comments on the achieved the intended goals. The
drugs used in food-producing animals. collection of information by August 22, PDUFA V Commitment Letter specifies
It does not establish any rights for any 2016. that the assessments be conducted by an
person and is not binding on FDA or the independent contractor and that they
ADDRESSES: To ensure that comments on include interviews of pharmaceutical
public. You can use an alternative the information collection are received,
approach if it satisfies the requirements manufacturers who submit NME NDAs
OMB recommends that written and original BLAs to the Program in
of the applicable statutes and comments be faxed to the Office of
regulations. PDUFA V. The contractor for the
Information and Regulatory Affairs, assessments of the Program is Eastern
III. Paperwork Reduction Act of 1995 OMB, Attn: FDA Desk Officer, FAX: Research Group, Inc. (ERG), and the
This draft guidance refers to 202–395–7285, or emailed to oira_ statement of work for the assessments is
previously approved collections of submission@omb.eop.gov. All available at http://www.fda.gov/
information found in FDA regulations. comments should be identified with the downloads/ForIndustry/UserFees/
These collections of information are OMB control number 0910–0746. Also PrescriptionDrugUserFee/
subject to review by the Office of include the FDA docket number found UCM304793.pdf.
Management and Budget (OMB) under in brackets in the heading of this In accordance with the PDUFA V
the Paperwork Reduction Act of 1995 document. Commitment Letter, FDA contracted
(44 U.S.C. 3501–3520). The collections with ERG to conduct independent
of information in 21 CFR part 514 have FOR FURTHER INFORMATION CONTACT: interviews of applicants after FDA
been approved under OMB control Food and Drug Administration, 8455 issues a first-cycle action for
Colesville Rd., COLE–14526, Silver applications reviewed under the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

number 0910–0032.
Spring, MD 20993–0002, PRAStaff@ Program. The purpose of these
IV. Electronic Access fda.hhs.gov. interviews is to collect feedback from
Persons with access to the Internet applicants on the success of the Program
may obtain the draft guidance at either SUPPLEMENTARY INFORMATION: In in increasing review transparency and
http://www.fda.gov/AnimalVeterinary/ compliance with 44 U.S.C. 3507, FDA communication during the review
GuidanceComplianceEnforcement/ has submitted the following proposed process. ERG will anonymize and
GuidanceforIndustry/default.htm or collection of information to OMB for aggregate sponsor responses prior to
http://www.regulations.gov. review and clearance. inclusion in the assessments and any

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Document Created: 2018-02-08 07:59:03
Document Modified: 2018-02-08 07:59:03

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 September 19, 2016.
Contact		Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, [email protected]
FR Citation		81 FR 47397

81 FR 47397 - General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration