81 FR 58519 - Current Good Manufacturing Practice Requirements for Food for Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 165 (August 25, 2016)

Page Range		58519-58520
FR Document		2016-20300

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.

Federal Register, Volume 81 Issue 165 (Thursday, August 25, 2016)

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58519-58520]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1229]


Current Good Manufacturing Practice Requirements for Food for 
Animals; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry #235 entitled 
``Current Good Manufacturing Practice Requirements for Food for 
Animals.'' This draft guidance helps domestic and foreign facilities 
that are required to register as food facilities under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) determine whether and how they 
need to comply with the current good manufacturing practice 
requirements of the Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Food for Animals final 
rule.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 23, 2016.

[[Page 58520]]


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-2016-D-1229 for ``Current Good Manufacturing Practice Requirements 
for Food for 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.

FOR FURTHER INFORMATION CONTACT: Jeanette Murphy, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, 
Rockville, MD 20855, 240-402-6246, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#235 entitled ``Current Good Manufacturing Practice Requirements for 
Food for Animals.'' This draft guidance is intended for domestic and 
foreign facilities that are required to register as food facilities 
under the FD&C Act because they manufacture, process, pack, or hold 
animal food for consumption in the United States.
    This draft guidance contains information to help these facilities 
determine whether they need to comply with the current good 
manufacturing practice (CGMP) requirements for animal food established 
in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals final rule published on 
September 17, 2015. (80 FR 56170). The CGMP requirements are codified 
in 21 CFR part 507, subpart B, and related requirements are codified in 
21 CFR part 507, subpart A. The draft guidance additionally provides 
recommendations for compliance with the CGMP requirements for animal 
food, training, and recordkeeping.

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 CGMP 
requirements for food for 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 507 have been approved under 
OMB control number 0910-0789.

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: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20300 Filed 8-24-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices 58519

submission to CFSAN. The following have for preparing an EA? Although information collection provisions in the
questions are covered in this guidance: CFSAN encourages industry to use the guidance.
(1) What types of industry-initiated EA formats described in the guidance Description of Respondents: The
actions are subject to a claim of because standardized documentation likely respondents include businesses
categorical exclusion? (2) What must a submitted by industry increases the
engaged in the manufacture or sale of
claim of categorical exclusion include efficiency of the review process,
food, food ingredients, and substances
by regulation? (3) What is an EA? (4) alternative approaches may be used if
When is an EA required by regulation these approaches satisfy the used in materials that come into contact
and what format should be used? (5) requirements of the applicable statutes with food.
What are extraordinary circumstances? and regulations. We are requesting the We estimate the burden of this
and (6) What suggestions does CFSAN extension of OMB approval for the collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section burden per Total hours
respondents per responses response
respondent

25.15 (a) & (d) (to cover CE’s under 25.32(i)) .................... 47 1 47 8 376
25.15 (a) & (d) (to cover CE’s under 25.32(o)) ................... 1 1 1 8 8
25.15 (a) & (d) (to cover CE’s under 25.32(q)) ................... 3 1 3 8 24
25.40 (a) & (c) EA’s ............................................................. 57 1 57 180 10,260

Total .............................................................................. ........................ ........................ ........................ ........................ 10,668
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates for respondents and For the information requested for the DEPARTMENT OF HEALTH AND
numbers of responses are based on the environmental assessments in § 25.40(a) HUMAN SERVICES
annualized numbers of petitions and and (c), we believe that submitters will
notifications qualifying for categorical submit an average of 57 environmental Food and Drug Administration
exclusions listed under § 25.32(i) and assessments annually. We estimate that
(q) that the Agency has received in the each submitter will prepare an EA [Docket No. FDA–2016–D–1229]
past 3 years. Please note that, in the past within 3 weeks (120 hours) and revise
3 years, there have been no submissions the EA based on Agency comments Current Good Manufacturing Practice
that requested an action that would (between 40 to 60 hours), for a total Requirements for Food for Animals;
have been subject to the categorical preparation time of 180 hours. The Draft Guidance for Industry;
exclusion in § 25.32(o). To avoid Availability
burden relating to this collection has
counting this burden as zero, we have been previously approved under OMB AGENCY: Food and Drug Administration,
estimated the burden for this categorical control number 0910–0322, HHS.
exclusion at one respondent making one ‘‘Environmental Impact Consideration—
submission a year for a total of one ACTION: Notice of availability.
21 CFR part 25’’. Upon approval of this
annual submission. The burden for collection of information by OMB, FDA SUMMARY: The Food and Drug
submitting a categorical exclusion is will revise OMB control number 0910– Administration (FDA or Agency) is
captured under § 25.15(a) and (c). 0322 to remove the annual reporting announcing the availability of a draft
To calculate the estimate for the hours burden for categorical exclusions and guidance for industry #235 entitled
per response values, we assumed that environmental assessment requests ‘‘Current Good Manufacturing Practice
the information requested in this related to food additive petitions, color Requirements for Food for Animals.’’
guidance for each of these three additive petitions, requests from This draft guidance helps domestic and
categorical exclusions is readily exemption from regulation as a food foreign facilities that are required to
available to the submitter. For the additive, and submission of a food register as food facilities under the
information requested for the exclusion contact notification for a food contact Federal Food, Drug, and Cosmetic Act
in § 25.32(i), we expect that submitter substance. The future burden for (FD&C Act) determine whether and how
will need to gather information from they need to comply with the current
categorical exclusion or environmental
appropriate persons in the submitter’s good manufacturing practice
assessments for these requests will be
company and to prepare this requirements of the Current Good
captured under OMB control number Manufacturing Practice, Hazard
information for attachment to the claim
0910–0541, this collection of Analysis, and Risk-Based Preventive
for categorical exclusion. We believe
information. Controls for Food for Animals final rule.
that this effort should take no longer
than 8 hours per submission. For the Dated: August 19, 2016. DATES: Although you can comment on
asabaliauskas on DSK3SPTVN1PROD with NOTICES

information requested for the categorical Jeremy Sharp, any guidance at any time (see 21 CFR
exclusions in § 25.32(o) and (q), the Deputy Commissioner for Policy, Planning, 10.115(g)(5)), to ensure that the Agency
submitters will almost always merely Legislation, and Analysis. considers your comment on this draft
need to copy existing documentation [FR Doc. 2016–20369 Filed 8–24–16; 8:45 am] guidance before it begins work on the
and attach it to the claim for categorical BILLING CODE 4164–01–P
final version of the guidance, submit
exclusion. We believe that collecting either electronic or written comments
this information should also take no on the draft guidance by November 23,
longer than 8 hours per submission. 2016.

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Document Created: 2016-08-25 00:35:01
Document Modified: 2016-08-25 00:35:01

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 November 23, 2016.
Contact		Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-6246, [email protected]
FR Citation		81 FR 58519

81 FR 58519 - Current Good Manufacturing Practice Requirements for Food for Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 165 (August 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration