Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualified Facility Attestation, 27330-27332 [2018-12615]
Download as PDF
<![CDATA[
27330
Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
actions. It should be noted that the 1997
policy statement was created at a time
when electronic communication was
much less common than it is today and
no longer reflects the current practices
of the federal banking agencies in
coordinating formal enforcement
actions. Importantly, the formal
enforcement actions taken by the federal
banking agencies are now published on
the individual agencies’ public
websites, making it no longer necessary
for the agencies to provide written
notice of all such actions to each other.
Moreover, the FRB, FDIC, and OCC have
adopted a new policy that encourages
notification to other interested federal
banking agencies at the earliest
practicable date and promotes
coordination among the FBAs related to
formal enforcement actions as
appropriate. For the above reasons, the
1997 Policy Statement is being
rescinded.
Dated at Washington, DC, this 22nd day of
May 2018.
Federal Financial Institutions Examination
Council.
Judith E. Dupre,
Executive Secretary.
[FR Doc. 2018–12557 Filed 6–11–18; 8:45 am]
BILLING CODE 7535–01– 6714–01– 6210–01–4810–33–
4810–AM–P
FEDERAL RESERVE SYSTEM
sradovich on DSK3GMQ082PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
VerDate Sep<11>2014
16:21 Jun 11, 2018
Jkt 244001
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 5, 2018.
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Midwest Banc Holding Co., Pierce,
Nebraska; to acquire up to 100 percent
of the voting shares of Redstone Bank,
Centennial, Colorado.
A. Federal Reserve Bank of Richmond
(Adam M. Drimer, Assistant Vice
President) 701 East Byrd Street,
Richmond, Virginia 23219. Comments
can also be sent electronically to or
Comments.applications@rich.frb.org:
1. CBM Bancorp Inc., Parkville,
Maryland; to become a savings and loan
holding company by merging with
Banks of Chesapeake, M.H.C. Parkville,
Maryland, and thereby indirectly
acquire Chesapeake Bank of Maryland,
Parkville, Maryland.
In connection with the proposal,
Banks of Chesapeake M.H.C will convert
from mutual to stock form.
Board of Governors of the Federal Reserve
System, June 6, 2018.
Ann Misback,
Secretary of the Board.
Board of Governors of the Federal Reserve
System, June 6, 2018.
Ann Misback,
Secretary of the Board.
[FR Doc. 2018–12596 Filed 6–11–18; 8:45 am]
[FR Doc. 2018–12537 Filed 6–11–18; 8:45 am]
BILLING CODE 6210–01–P
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Savings and Loan Holding
Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Home Owners’ Loan Act
(12 U.S.C. 1461 et seq.) (HOLA),
Regulation LL (12 CFR part 238), and
Regulation MM (12 CFR part 239), and
all other applicable statutes and
regulations to become a savings and
loan holding company and/or to acquire
the assets or the ownership of, control
of, or the power to vote shares of a
savings association and nonbanking
companies owned by the savings and
loan holding company, including the
companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the HOLA (12 U.S.C. 1467a(e)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 10(c)(4)(B) of the
HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless
otherwise noted, nonbanking activities
will be conducted throughout the
United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 6, 2018.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1164]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Qualified Facility
Attestation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 12,
2018.
SUMMARY:
To ensure that comments on
the information collection are received,
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—NEW and
title ‘‘Qualified Facility Attestation.’’
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
ADDRESSES:
E:\FR\FM\12JNN1.SGM
12JNN1
Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
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.
Qualified Facility Attestation
sradovich on DSK3GMQ082PROD with NOTICES
OMB Control Number 0910—NEW
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. It enables FDA to
focus 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.
Section 103 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding section 418
(21 U.S.C. 350g) with requirements for
hazard analysis and risk-based
preventive controls for facilities that
produce food for humans or animals.
We have established regulations to
implement these requirements primarily
within subparts C and G, with
associated requirements in subparts A,
D, E, and F, of the rule entitled ‘‘Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food’’ (Preventive
Controls for Human Food Rule) (21 CFR
part 117) and primarily within subparts
C and E, with associated requirements
in subparts A, D, and F, of the rule
entitled ‘‘Current Good Manufacturing
Practice, Hazard Analysis, and RiskBased Preventive Controls for Food for
Animals’’ (Preventive Controls for
Animal Food Rule) (21 CFR part 507).
A business that meets the definition of
a ‘‘qualified facility’’ (see 21 CFR 117.3
or 21 CFR 507.3) is subject to modified
requirements in § 117.201 of the
Preventive Controls for Human Food
Rule or in § 507.7 of the Preventive
Controls for Animal Food Rule. These
modified requirements require the
business to submit a form to FDA,
attesting to its status as a qualified
facility.
Section 418(l)(2)(B)(ii) of the FD&C
Act directs FDA to issue guidance on
the documents a business is required to
submit to FDA to show its status as a
qualified facility. FDA issued a draft
guidance for industry entitled,
VerDate Sep<11>2014
16:21 Jun 11, 2018
Jkt 244001
‘‘Qualified Facility Attestation Using
Form FDA 3942a (for Human Food) or
Form FDA 3942b (for Animal Food):
Guidance for Industry.’’ This draft
guidance explains FDA’s current
thinking on how to determine whether
a business is a qualified facility, and
describes FDA procedures regarding the
submission of attestations as established
under both the Preventive Controls for
Human Food Rule and the Preventive
Controls for Animal Food Rule. FDA has
developed proposed Forms FDA 3942a
and FDA 3942b for use by a business in
reporting its status as a ‘‘qualified
facility’’ under the applicable
regulations.
Description of Respondents:
Respondents to the collection of
information are owners, operators, or
agents in charge of domestic or foreign
facilities that manufacture, process,
pack, or hold food for human or animal
consumption in the United States, are
required to register with FDA, and attest
that a facility is a ‘‘qualified facility’’
under applicable FDA regulations.
In the Federal Register of May 16,
2016 (81 FR 30219), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One individual submitted
several comments.
(Comment 1) One comment suggests
that Forms FDA 3942a and FDA 3942b
could be organized differently to help
respondents. Specifically, the
suggestion offered that the forms
themselves should follow the
submission type order as provided in
section 2 of both forms so that the
‘‘Status Change’’ section is at the end of
each form.
(Response) FDA agrees and will
reorganize Forms FDA 3942a and FDA
3942b so that the ‘‘Status Change’’
section will now be section 6.
(Comment 2) One comment
recommends changing the term
‘‘Biennial Submission’’ to ‘‘Biennial
(Renewal) Submission’’ or in some way
to indicate that biennial submission
happens in the years after the ‘‘Initial
Submission.’’
(Response) FDA agrees and will
change ‘‘Biennial Submission’’ to
‘‘Biennial (Renewal) Submission’’ for
both forms.
(Comment 3) One comment suggests
that any revisions applied to either the
forms or instructions should be
consistent between all the documents.
(Response) FDA agrees and will make
sure that revisions to the forms and
instructions are consistent.
(Comment 4) One comment suggests
that, for clarity, the instructions direct
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
27331
respondents to the guidance for
additional reference.
(Response) FDA agrees and will
include a reference to the guidance
document in each section of the
instruction document.
(Comment 5) One comment suggests
that, for clarity, Question II.A.1 (and
III.A. 1) of the guidance should advise
respondents that the definition for ‘‘very
small business’’ is forthcoming in the
next question.
(Response) FDA agrees, and for
clarity, will revise the final guidance to
indicate that the definition for ‘‘very
small business’’ is provided in the next
question in the guidance.
(Comment 6) One comment suggests
that Question II.A. 2 (and III.A.2) in the
guidance should provide clarity as to
the two options for meeting the
qualified facility definition.
(Response) FDA agrees and will revise
the final guidance to provide clarity as
to the two options for meeting the
qualified facility definition.
(Comment 7) One comment suggests
that the guidance should provide more
details about what other documentation
FDA would accept as to support the first
and second attestation options.
(Response) FDA agrees and will
provide more details about the types of
documentation FDA would accept to
support the first attestation option. FDA
will also include a list of examples of
documents that FDA would accept to
support the second attestation option
consistent with the preamble
discussions for §§ 117.201(a)(2)(ii) and
507.7(a)(2)(ii).
(Comment 8) One comment suggests
that Question II.C.6 (and III.C.6) of the
guidance oversimplifies the definition
of farm and should clarify that farms
that satisfy FDA’s definition of ‘‘farm’’
need not submit Form FDA 3942a.
(Response) FDA agrees and will revise
our responses to clarify that farms that
satisfy FDA’s definition of ‘‘farm’’ need
not submit Form FDA 3942a or Form
FDA 3942b.
(Comment 9) One comment suggests
that Question II.C.7 (and III.C 7) of the
guidance related to farm mixed-type
facilities is missing certain information
to assist farm mixed-type facilities to
determine their level of coverage and
compliance under regulations.
(Response) FDA agrees and will revise
our response to provide greater clarity
for farm mixed-type facilities to
determine their level of coverage and
compliance under the regulations.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\12JNN1.SGM
12JNN1
27332
Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance section
Number of
respondents
FDA form
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Section II; Human Food .....................
Section III; Animal Food ....................
3942a
3942b
37,134
1,120
.5
.5
18,567
560
.5 (30 minutes) ....
.5 (30 minutes) ....
9,284
280
Total ............................................
........................
........................
........................
........................
..............................
9,564
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with the estimates found
in our Preventive Controls for Human
Food Rule, we estimate that
approximately 37,134 human food
facilities will each spend approximately
30 minutes (0.5 hour) reporting their
status as a qualified facility to FDA
every 2 years. Thus, dividing this figure
by two to determine the annual burden,
we estimate there will be 18,567
responses and 9,284 burden hours
associated with this information
collection element.
Similarly, and consistent with the
estimates found in our Preventive
Controls for Animal Food Rule, we
estimate that approximately 1,120
animal food facilities will each spend
approximately 30 minutes (0.5 hour)
reporting their status as a qualified
facility to FDA every 2 years. Thus,
dividing this figure by two to determine
the annual burden, we estimate there
will be 560 responses and 280 burden
hours associated with this information
collection element.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 117 have been approved under
OMB control number 0910–0751. The
collections of information in 21 CFR
part 507 have been approved under
OMB control number 0910–0789.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12615 Filed 6–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Irradiation in the Production,
Processing, and Handling of Food
Food and Drug Administration
OMB Control Number 0910–0186—
Extension
[Docket No. FDA–2018–N–0073]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Irradiation in the
Production, Processing, and Handling
of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
SUMMARY:
Fax written comments on the
collection of information by July 12,
2018.
DATES:
To ensure that comments on
the information collection are received,
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 0910–0186. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:21 Jun 11, 2018
Jkt 244001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
This information collection supports
FDA regulations. Specifically, under
sections 201(s) and 409 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 321(s) and 348), food
irradiation is subject to regulation under
the food additive premarket approval
provisions of the FD&C Act. The
regulations providing for uses of
irradiation in the production,
processing, and handling of food are
found in part 179 (21 CFR part 179). To
ensure safe use of a radiation source,
§ 179.21(b)(1) requires that the label of
sources bear appropriate and accurate
information identifying the source of
radiation and the maximum (or
minimum and maximum) energy of the
emitted radiation. Section 179.21(b)(2)
requires that the label or accompanying
labeling bear adequate directions for
installation and use and a statement
supplied by FDA that indicates
maximum dose of radiation allowed.
Section 179.26(c) requires that the label
or accompanying labeling bear a logo
and a radiation disclosure statement.
Section 179.25(e) requires that food
processors who treat food with radiation
make and retain, for 1 year past the
expected shelf life of the products up to
a maximum of 3 years, specified records
relating to the irradiation process (e.g.,
the food treated, lot identification,
scheduled process, etc.). The records
required by § 179.25(e) are used by FDA
inspectors to assess compliance with the
regulation that establishes limits within
which radiation may be safely used to
treat food. We cannot ensure safe use
without a method to assess compliance
with the dose limits, and there are no
practicable methods for analyzing most
foods to determine whether they have
been treated with ionizing radiation and
are within the limitations set forth in
part 179. Records inspection is the only
way to determine whether firms are
complying with the regulations for
treatment of foods with ionizing
radiation.
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27330-27332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12615]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1164]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Qualified Facility
Attestation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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
12, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, 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 [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Qualified Facility Attestation.'' 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
[[Page 27331]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-5733, [email protected].
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.
Qualified Facility Attestation
OMB Control Number 0910--NEW
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus 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.
Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) by adding section 418 (21 U.S.C. 350g) with
requirements for hazard analysis and risk-based preventive controls for
facilities that produce food for humans or animals. We have established
regulations to implement these requirements primarily within subparts C
and G, with associated requirements in subparts A, D, E, and F, of the
rule entitled ``Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Human Food'' (Preventive
Controls for Human Food Rule) (21 CFR part 117) and primarily within
subparts C and E, with associated requirements in subparts A, D, and F,
of the rule entitled ``Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals''
(Preventive Controls for Animal Food Rule) (21 CFR part 507). A
business that meets the definition of a ``qualified facility'' (see 21
CFR 117.3 or 21 CFR 507.3) is subject to modified requirements in Sec.
117.201 of the Preventive Controls for Human Food Rule or in Sec.
507.7 of the Preventive Controls for Animal Food Rule. These modified
requirements require the business to submit a form to FDA, attesting to
its status as a qualified facility.
Section 418(l)(2)(B)(ii) of the FD&C Act directs FDA to issue
guidance on the documents a business is required to submit to FDA to
show its status as a qualified facility. FDA issued a draft guidance
for industry entitled, ``Qualified Facility Attestation Using Form FDA
3942a (for Human Food) or Form FDA 3942b (for Animal Food): Guidance
for Industry.'' This draft guidance explains FDA's current thinking on
how to determine whether a business is a qualified facility, and
describes FDA procedures regarding the submission of attestations as
established under both the Preventive Controls for Human Food Rule and
the Preventive Controls for Animal Food Rule. FDA has developed
proposed Forms FDA 3942a and FDA 3942b for use by a business in
reporting its status as a ``qualified facility'' under the applicable
regulations.
Description of Respondents: Respondents to the collection of
information are owners, operators, or agents in charge of domestic or
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States, are required to
register with FDA, and attest that a facility is a ``qualified
facility'' under applicable FDA regulations.
In the Federal Register of May 16, 2016 (81 FR 30219), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One individual submitted several comments.
(Comment 1) One comment suggests that Forms FDA 3942a and FDA 3942b
could be organized differently to help respondents. Specifically, the
suggestion offered that the forms themselves should follow the
submission type order as provided in section 2 of both forms so that
the ``Status Change'' section is at the end of each form.
(Response) FDA agrees and will reorganize Forms FDA 3942a and FDA
3942b so that the ``Status Change'' section will now be section 6.
(Comment 2) One comment recommends changing the term ``Biennial
Submission'' to ``Biennial (Renewal) Submission'' or in some way to
indicate that biennial submission happens in the years after the
``Initial Submission.''
(Response) FDA agrees and will change ``Biennial Submission'' to
``Biennial (Renewal) Submission'' for both forms.
(Comment 3) One comment suggests that any revisions applied to
either the forms or instructions should be consistent between all the
documents.
(Response) FDA agrees and will make sure that revisions to the
forms and instructions are consistent.
(Comment 4) One comment suggests that, for clarity, the
instructions direct respondents to the guidance for additional
reference.
(Response) FDA agrees and will include a reference to the guidance
document in each section of the instruction document.
(Comment 5) One comment suggests that, for clarity, Question II.A.1
(and III.A. 1) of the guidance should advise respondents that the
definition for ``very small business'' is forthcoming in the next
question.
(Response) FDA agrees, and for clarity, will revise the final
guidance to indicate that the definition for ``very small business'' is
provided in the next question in the guidance.
(Comment 6) One comment suggests that Question II.A. 2 (and
III.A.2) in the guidance should provide clarity as to the two options
for meeting the qualified facility definition.
(Response) FDA agrees and will revise the final guidance to provide
clarity as to the two options for meeting the qualified facility
definition.
(Comment 7) One comment suggests that the guidance should provide
more details about what other documentation FDA would accept as to
support the first and second attestation options.
(Response) FDA agrees and will provide more details about the types
of documentation FDA would accept to support the first attestation
option. FDA will also include a list of examples of documents that FDA
would accept to support the second attestation option consistent with
the preamble discussions for Sec. Sec. 117.201(a)(2)(ii) and
507.7(a)(2)(ii).
(Comment 8) One comment suggests that Question II.C.6 (and III.C.6)
of the guidance oversimplifies the definition of farm and should
clarify that farms that satisfy FDA's definition of ``farm'' need not
submit Form FDA 3942a.
(Response) FDA agrees and will revise our responses to clarify that
farms that satisfy FDA's definition of ``farm'' need not submit Form
FDA 3942a or Form FDA 3942b.
(Comment 9) One comment suggests that Question II.C.7 (and III.C 7)
of the guidance related to farm mixed-type facilities is missing
certain information to assist farm mixed-type facilities to determine
their level of coverage and compliance under regulations.
(Response) FDA agrees and will revise our response to provide
greater clarity for farm mixed-type facilities to determine their level
of coverage and compliance under the regulations.
FDA estimates the burden of this collection of information as
follows:
[[Page 27332]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance section FDA form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section II; Human Food.................... 3942a 37,134 .5 18,567 .5 (30 minutes)............. 9,284
Section III; Animal Food.................. 3942b 1,120 .5 560 .5 (30 minutes)............. 280
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. .............. ............................ 9,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with the estimates found in our Preventive Controls for
Human Food Rule, we estimate that approximately 37,134 human food
facilities will each spend approximately 30 minutes (0.5 hour)
reporting their status as a qualified facility to FDA every 2 years.
Thus, dividing this figure by two to determine the annual burden, we
estimate there will be 18,567 responses and 9,284 burden hours
associated with this information collection element.
Similarly, and consistent with the estimates found in our
Preventive Controls for Animal Food Rule, we estimate that
approximately 1,120 animal food facilities will each spend
approximately 30 minutes (0.5 hour) reporting their status as a
qualified facility to FDA every 2 years. Thus, dividing this figure by
two to determine the annual burden, we estimate there will be 560
responses and 280 burden hours associated with this information
collection element.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR part 117 have been approved under OMB control number 0910-
0751. The collections of information in 21 CFR part 507 have been
approved under OMB control number 0910-0789.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12615 Filed 6-11-18; 8:45 am]
BILLING CODE 4164-01-P
