81 FR 58521 - Human Food By-Products for Use as Animal Food; Draft Guidance for Industry; Availability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		58521-58522
FR Document		2016-20302

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #239 entitled ``Human Food By-Products For Use As Animal Food.'' This draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), because they manufacture, process, pack, or hold human food for consumption in the United States, determine what requirements to follow for their human food by-products for use as animal food and provides examples and recommendations for how to meet those requirements.

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

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58521-58522]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20302]



[[Page 58521]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1220]


Human Food By-Products for Use as Animal Food; Draft Guidance for 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the availability of a draft guidance for industry (GIF) #239 entitled 
``Human Food By-Products For Use As Animal Food.'' This draft guidance 
helps domestic and foreign facilities that are required to register as 
food facilities under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act), because they manufacture, process, pack, or hold human food 
for consumption in the United States, determine what requirements to 
follow for their human food by-products for use as animal food and 
provides examples and recommendations for how to meet those 
requirements.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 23, 2016.

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-1220 for ``Human Food By-Products for Use as Animal Food; 
Draft Guidance for Industry.'' 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 Pl., 
Rockville, MD 20855, 240-402-6246, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft GIF #239 entitled 
``Human Food By-Products for Use as Animal Food.'' 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 human food for consumption in the 
United States, which results in by-products for use as animal food.
    This draft guidance contains information for these facilities to 
determine what requirements to follow for their human food by-products 
for use as animal food and provides examples and recommendations for 
how they might meet those requirements. The requirements were 
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 requirements 
are codified in 21 CFR parts 117 and 507.

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

[[Page 58522]]

thinking of FDA on human food by-products for use as animal food. 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. 2016-20302 Filed 8-24-16; 8:45 am]
 BILLING CODE 4164-01-P

58522 Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices

thinking of FDA on human food by- SUMMARY: In compliance with the In compliance with section
products for use as animal food. It does Paperwork Reduction Act of 1995, the 3507(a)(1)(D) of the Paperwork
not establish any rights for any person National Cancer Institute, the National Reduction Act of 1995, the National
and is not binding on FDA or the public. Institutes of Health, has submitted to the Institutes of Health (NIH) has submitted
You can use an alternative approach if Office of Management and Budget to the Office of management and Budget
it satisfies the requirements of the (OMB) a request for review and (OMB) a request for review and
applicable statutes and regulations. approval of the information collection approval of the information collection
listed below. This proposed information listed below.
III. Paperwork Reduction Act of 1995 collection was previously published in Proposed Collection: Study to
This draft guidance refers to the Federal Register on May 13, 2016, Estimate Radiation Doses and Cancer
previously approved collections of p 29875 and allowed 60-days for public Risks from Radioactive Fallout from the
information found in FDA regulations. comment. One public comment was Trinity Nuclear Test, 0925–NEW,
These collections of information are received. The purpose of this notice is National Cancer Institute (NCI),
subject to review by the Office of to allow an additional 30 days for public National Institutes of Health (NIH).
Management and Budget (OMB) under comment. Need and Use of Information
the Paperwork Reduction Act of 1995 DATES: Comments regarding this Collection: This Information Collection
(44 U.S.C. 3501–3520). The collections information collection are best assured Request is for a radiation-related cancer
of information in 21 CFR part 507 have of having their full effect if received risk projection study for the residents of
been approved under OMB control within 30-days of the date of this the state of New Mexico (NM)
number 0910–0789. publication potentially exposed to radioactive
ADDRESSES: Written comments and/or fallout from the Trinity nuclear test
IV. Electronic Access
suggestions regarding the item(s) conducted in 1945. Data will be
Persons with access to the Internet contained in this notice, especially collected on diet and lifestyle from three
may obtain the draft guidance at either regarding the estimated public burden groups in NM (non-Hispanic white,
http://www.fda.gov/AnimalVeterinary/ and associated response time, should be Hispanic, and Native American) alive in
GuidanceComplianceEnforcement/ directed to the: Office of Management the 1940s via focus groups and key
GuidanceforIndustry/default.htm or and Budget, Office of Regulatory Affairs, informant interviews. These data will be
http://www.regulations.gov. OIRA_submission@omb.eop.gov or by used to derive means and ranges of
fax to 202–395–6974, Attention: Desk exposure-related parameters. Little
Dated: August 19, 2016.
Officer for NIH. information is currently available about
Jeremy Sharp,
FOR FURTHER INFORMATION CONTACT: To dietary patterns among Native American
Deputy Commissioner for Policy, Planning, community members or Hispanics in
request more information on the
Legislation, and Analysis.
proposed project or to obtain a copy of New Mexico in the 1940s. Exposure-
[FR Doc. 2016–20302 Filed 8–24–16; 8:45 am] related parameter values will be used
the data collection plans and
BILLING CODE 4164–01–P
instruments, contact: Steven L. Simon, with historical fallout deposition data in
Dosimetry Unit Head and Staff Scientist, fallout dose assessment models to
Radiation Epidemiology Branch, estimate external and internal radiation
DEPARTMENT OF HEALTH AND Division of Cancer Epidemiology & doses to representative persons in all
HUMAN SERVICES Genetics, National cancer Institute, NIH, counties in New Mexico by ethnicity
National Institutes of Health 9609 Medical Center Drive, MSC9778, and age. The estimated doses will be
Bethesda, MD 20892–9778 or call non- used with literature-derived risk and
Submission for OMB Review; 30-Day toll-free number (240)-276–7371 or parameter values on risk/unit dose to
Comment Request Study To Estimate email your request, including your project the excess cancers expected (per
Radiation Doses and Cancer Risks address to: ssimon@mail.nih.gov. 1,000 persons within each stratum)
From Radioactive Fallout From the SUPPLEMENTARY INFORMATION: The including uncertainty on each estimate.
Trinity Nuclear Test—National Cancer National Cancer Institute, NCI, National Endpoints are leukemia, thyroid cancer,
Institute (NCI) Institutes of Health, may not conduct or stomach cancer, colon cancer, and all
sponsor, and the respondent is not solid cancers combined.
AGENCY: National Institutes of Health, required to respond to, an information OMB approval is requested for 3
Department of Health and Human collection that has been extended, years. There are no costs to respondents
Services. revised, or implemented on or after other than their time. The total
October 1, 1995, unless it displays a estimated annualized burden hours are
ACTION: Notice.
currently valid OMB control number. 536.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Annual burden
Type of respondents Instrument per response
respondents response hours
(in hours)
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Individuals ......................................... Screener ........................................... 315 1 10/60 53
Consent Form .................................. 210 1 10/60 35
Focus Groups ................................... 168 1 120/60 336
Pre-Focus Group Guide ................... 168 1 10/60 28
Key Informant and Academic Inter- 42 1 120/60 84
view.

Totals ......................................... ........................................................... 210 525 ........................ 536

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Document Created: 2016-08-25 00:34:48
Document Modified: 2016-08-25 00:34:48

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 Pl., Rockville, MD 20855, 240-402-6246, [email protected]
FR Citation		81 FR 58521

81 FR 58521 - Human Food By-Products for Use as Animal Food; 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