Human Food By-Products for Use as Animal Food; Draft Guidance for Industry; Availability, 58521-58522 [2016-20302]
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Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices
• 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’’).
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Animal Food; Draft Guidance for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.
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announcing the availability of a draft
guidance for industry (GIF) #239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 This draft
guidance helps domestic and foreign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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by November 23,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:
SUMMARY:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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.
VerDate Sep<11>2014
18:54 Aug 24, 2016
Jkt 238001
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 ByProducts 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 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
58521
56469, September 18, 2015, or access
the information at: https://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 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 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 selfaddressed 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,
jenny.murphy@fda.hhs.gov.
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 byproducts 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 RiskBased 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
E:\FR\FM\25AUN1.SGM
25AUN1
58522
Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices
thinking of FDA on human food byproducts 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
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Study To Estimate
Radiation Doses and Cancer Risks
From Radioactive Fallout From the
Trinity Nuclear Test—National Cancer
Institute (NCI)
National Institutes of Health,
Department of Health and Human
Services.
AGENCY:
ACTION:
Notice.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Study to
Estimate Radiation Doses and Cancer
Risks from Radioactive Fallout from the
Trinity Nuclear Test, 0925–NEW,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This Information Collection
Request is for a radiation-related cancer
risk projection study for the residents of
the state of New Mexico (NM)
potentially exposed to radioactive
fallout from the Trinity nuclear test
conducted in 1945. Data will be
collected on diet and lifestyle from three
groups in NM (non-Hispanic white,
Hispanic, and Native American) alive in
the 1940s via focus groups and key
informant interviews. These data will be
used to derive means and ranges of
exposure-related parameters. Little
information is currently available about
dietary patterns among Native American
community members or Hispanics in
New Mexico in the 1940s. Exposurerelated parameter values will be used
with historical fallout deposition data in
fallout dose assessment models to
estimate external and internal radiation
doses to representative persons in all
counties in New Mexico by ethnicity
and age. The estimated doses will be
used with literature-derived risk and
parameter values on risk/unit dose to
project the excess cancers expected (per
1,000 persons within each stratum)
including uncertainty on each estimate.
Endpoints are leukemia, thyroid cancer,
stomach cancer, colon cancer, and all
solid cancers combined.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
536.
In compliance with the
Paperwork Reduction Act of 1995, the
National Cancer Institute, the National
Institutes of Health, has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on May 13, 2016,
p 29875 and allowed 60-days for public
comment. One public comment was
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Steven L. Simon,
Dosimetry Unit Head and Staff Scientist,
Radiation Epidemiology Branch,
Division of Cancer Epidemiology &
Genetics, National cancer Institute, NIH,
9609 Medical Center Drive, MSC9778,
Bethesda, MD 20892–9778 or call nontoll-free number (240)-276–7371 or
email your request, including your
address to: ssimon@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
National Cancer Institute, NCI, National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
SUMMARY:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Annual burden
hours
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Type of respondents
Instrument
Individuals .........................................
Screener ...........................................
Consent Form ..................................
Focus Groups ...................................
Pre-Focus Group Guide ...................
Key Informant and Academic Interview.
315
210
168
168
42
1
1
1
1
1
10/60
10/60
120/60
10/60
120/60
53
35
336
28
84
Totals .........................................
...........................................................
210
525
........................
536
VerDate Sep<11>2014
18:54 Aug 24, 2016
Jkt 238001
PO 00000
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Sfmt 4703
E:\FR\FM\25AUN1.SGM
25AUN1
Agencies
[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58521-58522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20302]
[[Page 58521]]
-----------------------------------------------------------------------
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: 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-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 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.
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 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, jenny.murphy@fda.hhs.gov.
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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://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