Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 24124-24127 [2018-11114]
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Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
enzootic status and genetic factors
affecting the disease in each location,
thereby providing better inferential
value than the laboratory study.
Limitations of the field study are that
the exposure to infective D. immitis
larvae is assumed, but uncertain, and, in
cases of dogs with positive antigen tests,
the actual timing of the exposure is
unknown. Additionally, the relatively
short duration of the field study in
relationship to the heartworm life cycle
and testing limitations may not
adequately evaluate the entire dosing
period of the investigational new animal
drug. Assurance that individual dogs
were exposed to D. immitis larvae
during the critical first few months of
the study is lacking, which complicates
interpretation of a negative antigen test
at the end of the study. If the study is
started during a time of low
transmission, such as in winter,
exposure is even more uncertain.
Because of the delay in the ability to
detect an adult heartworm infection, it
is impossible to tell with certainty if
infections detected between 4 and 8
months after study initiation were preexisting infections or due to lack of
effectiveness of the preventative.
Obtaining false negative and false
positive antigen test results are possible
and, because worm counts are not
performed, the false results may result
in the misclassification of outcome for
individual dogs.
In recognition of the limitations of the
current recommended laboratory and
field effectiveness studies for heartworm
preventatives for use in dogs, we are
interested in evaluating alternative
approaches to these study designs that
would mitigate the limitations of such
studies while ensuring that the studies
generate data to support substantial
evidence of effectiveness as defined in
21 CFR 514.4.
Currently, there are gaps in
knowledge and understanding that
prevent us from fully evaluating
alternative approaches to meeting the
substantial evidence of effectiveness
standard. To address these gaps, we are
seeking public comment regarding the
following questions:
Population level effectiveness
endpoint. The design and evaluation of
effectiveness studies rely on an
understanding of the appropriate
outcome measure. In seeking to design
alternative study approaches, we would
like to determine a population level
effectiveness endpoint that could be
used to design future studies. Currently
we do not have a defined level of
performance that heartworm
preventatives are expected to meet
when applied to the entire United States
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canine population. Determining a
population level endpoint would allow
us to explore the suitability and
feasibility of alternative study designs
for the evaluation of effectiveness for
heartworm preventatives. Factors that
may contribute to a heartworm
preventative’s effectiveness include the
inherent potency of the drug,
differences in heartworm susceptibility,
and owner compliance.
1. Assuming that a product was
administered according to labeled
directions, what would be an acceptable
rate of failure of an approved heartworm
preventative in the overall United States
canine population to which it is
administered?
2. What would be the maximum
acceptable rate of failure in a high-risk
population?
3. Alternatively, if you do not have a
numerical estimate, what
recommendations do you have for
determining what an acceptable rate of
failure should be?
Exposure to infective D. immitis
larvae. For humane reasons, field
studies are not conducted with a
negative control group that would
reflect the study population’s level of
exposure to heartworm infection.
Therefore, it is necessary to have other
measures to ensure that the level of
exposure to infective D. immitis larvae
experienced in the study is sufficient to
adequately test the effectiveness of the
investigational new animal drug. Please
provide comment on other methods that
could reliably be used to ensure
adequate exposure of dogs enrolled in a
field study. Consider the following
points:
4. Can available tests be used to
determine an individual dog’s exposure
to infective larvae? What are the
sensitivity and specificity of those tests
in this application? How would the
level of sensitivity and specificity of
these tests impact the reliable
assessment of rate of failure in the
population?
5. Does the use of a heartworm
preventative, even if only partially
effective, have an impact on the results
of these tests?
6. Could methods that consider a
wider area (as opposed to an individual
animal) such as mosquito testing,
forecasting, or modeling be reliably used
to determine the likely exposure to
infective larvae of dogs at a specific
study site? What information would be
needed to create the methods or to
verify the validity of the methods? What
are the limitations to such an approach?
Outcome Assessment. Accurate
assessment of the outcome endpoint
(heartworm infection) is essential for
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field studies where necropsy worm
counts will not be performed.
7. What are the most reliable ways of
properly classifying the outcome in a
non-terminal study?
8. Are there critical pieces of
information supporting substantial
evidence of effectiveness that can only
be gained from a well-controlled
laboratory study? Are there elements
that could be added to a field study that
would partially address those data gaps?
Other.
9. Are there laboratory study designs
other than the traditional dose
confirmation study that provide
additional information or include a
model that is more representative of real
world exposure? For example, the use of
live mosquitoes to induce infection
rather than the mechanical injection of
larvae.
10. How might differences in the
route of administration, dosing
frequency, or pharmacokinetic factors
impact effectiveness? How might
studies be designed to incorporate these
factors? For example, a drug that
demonstrates an early peak, with
minimal to no drug levels in the dog for
the remainder of the dosing interval
versus a product with continuous drug
levels in the dog for the entire dosing
interval?
Dated: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11132 Filed 5–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1857]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
SUMMARY:
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Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements associated with
current good manufacturing practice,
hazard analysis, and risk-based
preventive controls for animal food.
DATES: Submit either electronic or
written comments on the collection of
information by July 23, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 23, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
sradovich on DSK3GMQ082PROD with NOTICES
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–N–1857 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
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Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals—21 CFR Part 507 OMB
Control Number 0910–0789—Extension
The information collection supports
FDA regulations. As amended by the
FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111–353), the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) enables the Agency to better
protect the public health by helping to
ensure the safety and security of the
food supply. It enables FDA to focus
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Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
industry plays in ensuring the safety of
the food supply, including the adoption
of modern systems of preventive
controls in food production.
Specifically, section 418 (21 U.S.C.
350g) of the FD&C Act sets forth
requirements for hazard analysis and
risk-based preventive controls for
facilities that produce food for animals.
To implement these provisions,
regulations were codified under 21 CFR
part 507—Current Good Manufacturing
Practice, Hazard Analysis, And RiskBased Preventive Controls For Food For
Animals. The regulations establish
requirements for a written food safety
plan; hazard analysis preventive
controls; monitoring; corrective actions
and corrections; verification; supplychain program; recall plan; and
associated records and became effective
November 16, 2015. Currently, we
continue to evaluate burden associated
with the information collection
requirements however, for purposes of
extending the information collection we
retain the currently approved figures as
shown below.
We estimate our burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR OMB CONTROL NO. 0910–0789 1
Number of
respondents
21 CFR section; activity
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total hours
507.7 exemption: Submit attestation of preventive controls or
compliance with State and local laws (non-federal).
507.67, 507.69, and 507.71; submission of an appeal, including
submission of a request for an informal hearing.
507.85(b); requests for reinstatement of exemption ....................
1,120
0.5
560
0.5 (30 minutes) ...
280
1
1
1
4 ............................
4
1
1
1
2 ............................
2
Total .......................................................................................
....................
....................
....................
...............................
286
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR section; activity
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total hours
Subpart A—General Provisions
507.7(e); records attesting that the facility is a ‘‘qualified’’ facility
507.4(d); documentation of animal food safety and hygiene
training.
1,120
7,469
0.5
0.75
560
5,579
0.1 (6 minutes) .....
0.05 (3 minutes) ...
56
279
3,876,411
0.1 (6 minutes) .....
387,641
3,876,411
0.1 (6 minutes) .....
387,641
Subpart C—Hazard Analysis and Risk-Based Preventive Controls
507.31 through 507.55; food safety plan—including hazard analysis, preventive controls, monitoring, corrective actions,
verification, validation reanalysis, modifications, and implementation records.
7,469
519
Subpart E—Supply-Chain Program
507.105 through 507.175; written supply-chain program—including records documenting program.
7,469
519
Subpart F—Requirements Applying to Records
507.200 through 507.215; general requirements, additional requirements applying to food safety plan, requirements for
record retention, use of existing records, and special requirements applicable to written assurance.
7,469
519
3,876,411
0.1 (6 minutes) .....
387,641
Totals .....................................................................................
....................
....................
11,635,372
...............................
1,163,258
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section; activity
507.27(b); labeling for the animal food product contains the specific information and instructions needed so the food can be
safely used for the intended animal species.
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18:10 May 23, 2018
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Frm 00046
Number of
responses
per
respondent
330
Fmt 4703
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10
Average
burden per
response
Total annual
responses
3,300
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0.25 (15 minutes)
24MYN1
Total hours
825
Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
24127
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
507.7(e)(1); change labels on products with labels .....................
507.7(e)(2); change address on labeling (sales documents) for
qualified facilities.
507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified.
507.28(b); holding and distribution of human food byproducts for
use as animal food.
Total .......................................................................................
1
Average
burden per
response
Total annual
responses
1,526
1,329
4
1
6,104
1,329
330
312
40,798
....................
Total hours
1 ............................
1 ............................
6,104
1,329
102,960
0.01 (36 seconds)
1,030
2
81,596
0.25 (15 minutes)
20,399
....................
....................
...............................
29,687
There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our
regulatory impact analysis in support of
the final rule on Preventive Controls for
Food for Animals, which published in
the Federal Register of September 17,
2015 (80 FR 56170). Using Agency data
we estimated the number of animal food
facilities that we believe are subject to
the regulations. We base our estimate of
the time necessary for the individual
reporting, recordkeeping, and thirdparty disclosure activities on our
experience with similar information
collections.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11114 Filed 5–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Marketing; Administrative Procedures,
Policies, and Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 25,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
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18:10 May 23, 2018
Jkt 244001
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0435. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Prescription Drug Marketing Act of
1987—Administrative Procedures,
Policies, and Requirements
[Docket No. FDA–2011–N–0279]
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses
per
respondent
OMB Control Number 0910–0435—
Extension
This information collection supports
FDA regulations codified at part 203 (21
CFR part 203) implementing the
Prescription Drug Marketing Act of 1987
(PDMA). The PDMA was intended to
ensure safe and effective drug products
and to avoid an unacceptable risk that
counterfeit, adulterated, misbranded,
subpotent, or expired drugs are sold to
consumers. The reporting and
recordkeeping requirements found in
the regulations are intended to help
achieve the following goals: (1) To ban
the reimportation of prescription drugs
produced in the United States, except
when reimported by the manufacturer
or under FDA authorization for
emergency medical care; (2) to ban the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of any
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prescription drug sample; (3) to limit
the distribution of drug samples to
practitioners licensed or authorized to
prescribe such drugs or to pharmacies of
hospitals or other healthcare entities at
the request of a licensed or authorized
practitioner; (4) to require licensed or
authorized practitioners to request
prescription drug samples in writing; (5)
to mandate storage, handling, and
recordkeeping requirements for
prescription drug samples; (6) to
prohibit, with certain exceptions, the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of prescription
drugs that were purchased by hospitals
or other healthcare entities or that were
donated or supplied at a reduced price
to a charitable organization; and (7) to
require unauthorized wholesale
distributors to provide, prior to the
wholesale distribution of a prescription
drug to another wholesale distributor or
retail pharmacy, a statement identifying
each prior sale, purchase, or trade of the
drug.
In the Federal Register of December
14, 2017 (82 FR 58808), we published a
notice soliciting public comment of the
information collection. One caller
responded to the notice asking about the
impact the Drug Supply Chain Security
Act (DSCSA) (Title II of the Drug
Quality Security Act of 2013) has on the
information collection. We note that the
Agency is currently proposing to amend
its regulations at part 203 to reflect
changes resulting from enactment of the
DSCSA (RIN 0910–AH56). While we
expect these changes will result in a
reduction of burden associated with the
information collection, current
regulations and associated information
collection requirements remain in effect.
Upon finalization of rulemaking, we
will revise the information collection
accordingly.
We therefore estimate the burden for
the information collection as follows:
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]]>Agencies
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24124-24127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11114]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1857]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Food for Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,
[[Page 24125]]
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements associated with current good manufacturing practice,
hazard analysis, and risk-based preventive controls for animal food.
DATES: Submit either electronic or written comments on the collection
of information by July 23, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 23, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-1857 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
for Animals.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals--21 CFR Part 507 OMB Control
Number 0910-0789--Extension
The information collection supports FDA regulations. As amended by
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) enables the Agency
to better protect the public health by helping to ensure the safety and
security of the food supply. It enables FDA to focus
[[Page 24126]]
more on preventing food safety problems rather than relying primarily
on reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production. Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act
sets forth requirements for hazard analysis and risk-based preventive
controls for facilities that produce food for animals. To implement
these provisions, regulations were codified under 21 CFR part 507--
Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based
Preventive Controls For Food For Animals. The regulations establish
requirements for a written food safety plan; hazard analysis preventive
controls; monitoring; corrective actions and corrections; verification;
supply-chain program; recall plan; and associated records and became
effective November 16, 2015. Currently, we continue to evaluate burden
associated with the information collection requirements however, for
purposes of extending the information collection we retain the
currently approved figures as shown below.
We estimate our burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden for OMB Control No. 0910-0789 \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
21 CFR section; activity respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
507.7 exemption: Submit attestation 1,120 0.5 560 0.5 (30 minutes)...... 280
of preventive controls or
compliance with State and local
laws (non-federal).
507.67, 507.69, and 507.71; 1 1 1 4..................... 4
submission of an appeal, including
submission of a request for an
informal hearing.
507.85(b); requests for 1 1 1 2..................... 2
reinstatement of exemption.
---------------------------------------------------------------------------
Total........................... ........... ........... ........... ...................... 286
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
21 CFR section; activity respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.7(e); records attesting that the 1,120 0.5 560 0.1 (6 minutes)....... 56
facility is a ``qualified''
facility.
507.4(d); documentation of animal 7,469 0.75 5,579 0.05 (3 minutes)...... 279
food safety and hygiene training.
----------------------------------------------------------------------------------------------------------------
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
----------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food safety 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641
plan--including hazard analysis,
preventive controls, monitoring,
corrective actions, verification,
validation reanalysis,
modifications, and implementation
records.
----------------------------------------------------------------------------------------------------------------
Subpart E--Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
507.105 through 507.175; written 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641
supply-chain program--including
records documenting program.
----------------------------------------------------------------------------------------------------------------
Subpart F--Requirements Applying to Records
----------------------------------------------------------------------------------------------------------------
507.200 through 507.215; general 7,469 519 3,876,411 0.1 (6 minutes)....... 387,641
requirements, additional
requirements applying to food
safety plan, requirements for
record retention, use of existing
records, and special requirements
applicable to written assurance.
---------------------------------------------------------------------------
Totals.......................... ........... ........... 11,635,372 ...................... 1,163,258
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
21 CFR section; activity respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal 330 10 3,300 0.25 (15 minutes)..... 825
food product contains the specific
information and instructions needed
so the food can be safely used for
the intended animal species.
[[Page 24127]]
507.7(e)(1); change labels on 1,526 4 6,104 1..................... 6,104
products with labels.
507.7(e)(2); change address on 1,329 1 1,329 1..................... 1,329
labeling (sales documents) for
qualified facilities.
507.25(a)(2); animal food, including 330 312 102,960 0.01 (36 seconds)..... 1,030
raw materials, other ingredients,
and rework, is accurately
identified.
507.28(b); holding and distribution 40,798 2 81,596 0.25 (15 minutes)..... 20,399
of human food byproducts for use as
animal food.
---------------------------------------------------------------------------
Total........................... ........... ........... ........... ...................... 29,687
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These figures are based on our regulatory impact analysis in
support of the final rule on Preventive Controls for Food for Animals,
which published in the Federal Register of September 17, 2015 (80 FR
56170). Using Agency data we estimated the number of animal food
facilities that we believe are subject to the regulations. We base our
estimate of the time necessary for the individual reporting,
recordkeeping, and third-party disclosure activities on our experience
with similar information collections.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11114 Filed 5-23-18; 8:45 am]
BILLING CODE 4164-01-P
