Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records, 49393-49395 [2018-21207]
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21243 Filed 9–28–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3490]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exempt Infant
Formula Production: Current Good
Manufacturing Practices, Quality
Control Procedures, Conduct of
Audits, and Records
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,
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 provisions of the guidance
entitled ‘‘Guidance for Industry: Exempt
Infant Formula Production: Current
Good Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records and Reports.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 30, 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 November 30,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. midnight
Eastern Time at the end of November
amozie on DSK3GDR082PROD with NOTICES
SUMMARY:
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30, 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–3490 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Exempt
Infant Formula Production: Current
Good Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records.’’ 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
PO 00000
Frm 00041
Fmt 4703
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49393
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
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
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49394
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
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.
Exempt Infant Formula Production:
Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures,
Conduct of Audits, and Records
OMB Control Number 0910–0811—
Extension
Section 412(h)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 350a(h)(1)) exempts an infant
formula that is represented and labeled
for use by an infant with an inborn error
of metabolism, low birth weight, or who
otherwise has an unusual medical or
dietary problem from the requirements
of section 412(a), (b), and (c) of the
FD&C Act. These formulas are
customarily referred to as ‘‘exempt
infant formulas.’’ Under part 106 (21
CFR part 106), we established
requirements for quality factors for
infant formulas and CGMPs, including
quality control procedures. This
collection of information will help
prevent the manufacture of adulterated
infant formula, ensure the safety of
infant formula, and ensure that the
nutrients in infant formula are present
in a form that is bioavailable.
In the Federal Register of April 15,
2016 (81 FR 22174), we published a
notice of availability for the guidance
document entitled ‘‘Guidance for
Industry: Exempt Infant Formula
Production: Current Good
Manufacturing Practices (CGMPs),
Quality Control Procedures, Conduct of
Audits, and Records and Reports.’’ The
guidance describes our current thinking
on the manufacturing of exempt infant
formula in relation to the requirements
in part 106 for CGMPs, quality control
procedures, conduct of audits, and
records and reports that apply to
nonexempt infant formulas. Persons
with access to the internet may obtain
the guidance at https://www.fda.gov/
FoodGuidances.
Our estimate of the burden of the
recordkeeping recommendations
includes the one-time burden of
developing production and in-process
control systems and the annual burdens
of developing and maintaining
production aggregate production and
control records, records pertaining to
the distribution of infant formula, and
records pertaining to regularly
scheduled audits. Included in the
burden estimate is the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information.
The guidance recommended, to the
extent practicable, that respondents
include records required by part 106,
subparts A, B, C, D, and F for nonexempt infant formulas. Because the
records and reporting requirements
related to part 106, subparts E and G are
not generally applicable to exempt
infant formula manufacturers, FDA is
not recommending in the guidance that
exempt infant formula manufacturers
follow these requirements. As such, the
records and reporting requirements in
part 106, subparts E and G are not part
of this information collection.
Description of Respondents: The
respondent recordkeepers are
manufacturers of exempt infant formula.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeper
Total
hours
First-Year Annual Burden
Production
and
In-Process
Control
System
106.6(c)(5) and 106.100(e)(1) and (e)(3).
Controls to Prevent Adulteration due to Automatic
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Total First Year Only Hourly Recordkeeping Burden.
3
1
3
40 ..........................
120
3
1
3
6,400 .....................
19,200
........................
........................
........................
...............................
19,320
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Recurring Annual Burden
Controls to Prevent Adulteration Caused by Facilities—Testing
for
Radiological
Contaminants
106.20(f)(3).
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Radiological
Contaminants 106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration Caused by Facilities—Testing for Bacteriological Contaminants
106.20(f)(3).
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4
1
4
1.5 .........................
6
4
1
4
0.08 (5 minutes) ....
0.32
3
52
156
0.08 (5 minutes) ....
12.48
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
49395
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Bacteriological
Contaminants 106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(e)(3)(iii) and 106.100(f)(3).
Controls to Prevent Adulteration by Equipment or
Utensils 106.30(f)(2) and 106.100(f)(4).
Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Caused by Ingredients, Containers, and Closures 106.40(g) and
106.100(f)(6).
Controls to Prevent Adulteration During Manufacturing
106.50 and 106.100(e).
Controls to Prevent Adulteration From Microorganisms
106.55(d),
106.100(e)(5)(ii),
and
106.100(f)(7).
Controls to Prevent Adulteration During Packaging
and Labeling of Infant Formula 106.60(c).
General Quality Control—Testing 106.91(b)(1),
106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1), 106.91(d), and
106.100(e)(5)(i).
General Quality Control 106.91(b)(2) 106.91(d), and
106.100(e)(5)(i).
General Quality Control 106.91(b)(3) 106.91(d), and
106.100(e)(5)(i).
Audit Plans and Procedures 106.94—Ongoing Review and Updating of Audits.
Audit Plans and Procedures 106.94—Regular Audits
Total
annual
records
Average
burden per
recordkeeper
Total
hours
3
52
156
0.08 (5 minutes) ....
12.48
3
52
156
0.21 (13 minutes) ..
32.76
3
52
156
0.21 (13 minutes) ..
32.76
3
52
156
0.19 (11 minutes) ..
29.64
3
52
156
520 ........................
81,120
3
2
6
640 ........................
3,840
3
52
156
0.17 (10 minutes) ..
26.52
3
52
156
0.23 (14 minutes) ..
35.88
3
52
156
0.25 (15 minutes) ..
39
1
12
12
0.25 (15 minutes) ..
3
2
1
2
2 ............................
4
2
52
104
0.15 (9 minutes) ....
15.6
2
52
104
0.15 (9 minutes) ....
15.6
2
52
104
0.15 (9 minutes) ....
15.6
3
1
3
8 ............................
24
3
52
156
4 ............................
624
Total Recurring Recordkeeping Burden ...............
........................
........................
........................
...............................
85,889.64
Total Recordkeeping Burden .........................
........................
........................
........................
...............................
105,209.64
1 There
amozie on DSK3GDR082PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we made a correction since
the last OMB approval. While the onetime estimated recordkeeping burden
remains as 19,320 hours, we increased
the annual estimated recurring
recordkeeping burden to 85,889.64
hours due to a calculation error (a
79,561.58 hour increase) for a total
recordkeeping burden of 105,209.64
hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2018–21207 Filed 9–28–18; 8:45 am]
SUMMARY:
BILLING CODE 4164–01–P
VerDate Sep<11>2014
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Jkt 247001
Food and Drug Administration
[Docket No. FDA–2018–N–3353]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Federal Register concerning each
proposed collection of information,
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 provisions of our reporting
and recordkeeping requirements for
antimicrobial animal drug sales and
distribution.
Submit either electronic or
written comments on the collection of
information by November 30, 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 November 30,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 30, 2018.
DATES:
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]]>Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49393-49395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21207]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3490]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exempt Infant Formula Production: Current Good
Manufacturing Practices, Quality Control Procedures, Conduct of Audits,
and Records
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, 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 provisions of
the guidance entitled ``Guidance for Industry: Exempt Infant Formula
Production: Current Good Manufacturing Practices (CGMPs), Quality
Control Procedures, Conduct of Audits, and Records and Reports.''
DATES: Submit either electronic or written comments on the collection
of information by November 30, 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 November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. midnight Eastern Time at the end of November 30, 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-3490 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Exempt Infant Formula Production:
Current Good Manufacturing Practices (CGMPs), Quality Control
Procedures, Conduct of Audits, and Records.'' 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
[[Page 49394]]
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.
Exempt Infant Formula Production: Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records
OMB Control Number 0910-0811--Extension
Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is
represented and labeled for use by an infant with an inborn error of
metabolism, low birth weight, or who otherwise has an unusual medical
or dietary problem from the requirements of section 412(a), (b), and
(c) of the FD&C Act. These formulas are customarily referred to as
``exempt infant formulas.'' Under part 106 (21 CFR part 106), we
established requirements for quality factors for infant formulas and
CGMPs, including quality control procedures. This collection of
information will help prevent the manufacture of adulterated infant
formula, ensure the safety of infant formula, and ensure that the
nutrients in infant formula are present in a form that is bioavailable.
In the Federal Register of April 15, 2016 (81 FR 22174), we
published a notice of availability for the guidance document entitled
``Guidance for Industry: Exempt Infant Formula Production: Current Good
Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of
Audits, and Records and Reports.'' The guidance describes our current
thinking on the manufacturing of exempt infant formula in relation to
the requirements in part 106 for CGMPs, quality control procedures,
conduct of audits, and records and reports that apply to nonexempt
infant formulas. Persons with access to the internet may obtain the
guidance at https://www.fda.gov/FoodGuidances.
Our estimate of the burden of the recordkeeping recommendations
includes the one-time burden of developing production and in-process
control systems and the annual burdens of developing and maintaining
production aggregate production and control records, records pertaining
to the distribution of infant formula, and records pertaining to
regularly scheduled audits. Included in the burden estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing each
collection of information.
The guidance recommended, to the extent practicable, that
respondents include records required by part 106, subparts A, B, C, D,
and F for non-exempt infant formulas. Because the records and reporting
requirements related to part 106, subparts E and G are not generally
applicable to exempt infant formula manufacturers, FDA is not
recommending in the guidance that exempt infant formula manufacturers
follow these requirements. As such, the records and reporting
requirements in part 106, subparts E and G are not part of this
information collection.
Description of Respondents: The respondent recordkeepers are
manufacturers of exempt infant formula.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
First-Year Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Production and In-Process Control System 3 1 3 40...................................... 120
106.6(c)(5) and 106.100(e)(1) and (e)(3).
Controls to Prevent Adulteration due to 3 1 3 6,400................................... 19,200
Automatic (Mechanical or Electronic)
Equipment 106.35(c) and 106.100(f)(5).
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Total First Year Only Hourly Recordkeeping .............. .............. .............. ........................................ 19,320
Burden.
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Recurring Annual Burden
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Controls to Prevent Adulteration Caused by 4 1 4 1.5..................................... 6
Facilities--Testing for Radiological
Contaminants 106.20(f)(3).
Controls to Prevent Adulteration Caused by 4 1 4 0.08 (5 minutes)........................ 0.32
Facilities--Recordkeeping of Testing for
Radiological Contaminants 106.20(f)(4) and
106.100(f)(1).
Controls to Prevent Adulteration Caused by 3 52 156 0.08 (5 minutes)........................ 12.48
Facilities--Testing for Bacteriological
Contaminants 106.20(f)(3).
[[Page 49395]]
Controls to Prevent Adulteration Caused by 3 52 156 0.08 (5 minutes)........................ 12.48
Facilities--Recordkeeping of Testing for
Bacteriological Contaminants 106.20(f)(4) and
106.100(f)(1).
Controls to Prevent Adulteration by Equipment 3 52 156 0.21 (13 minutes)....................... 32.76
or Utensils 106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment 3 52 156 0.21 (13 minutes)....................... 32.76
or Utensils 106.30(e)(3)(iii) and
106.100(f)(3).
Controls to Prevent Adulteration by Equipment 3 52 156 0.19 (11 minutes)....................... 29.64
or Utensils 106.30(f)(2) and 106.100(f)(4).
Controls to Prevent Adulteration Due to 3 52 156 520..................................... 81,120
Automatic (Mechanical or Electronic)
Equipment 106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Due to 3 2 6 640..................................... 3,840
Automatic (Mechanical or Electronic)
Equipment 106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Caused by 3 52 156 0.17 (10 minutes)....................... 26.52
Ingredients, Containers, and Closures
106.40(g) and 106.100(f)(6).
Controls to Prevent Adulteration During 3 52 156 0.23 (14 minutes)....................... 35.88
Manufacturing 106.50 and 106.100(e).
Controls to Prevent Adulteration From 3 52 156 0.25 (15 minutes)....................... 39
Microorganisms 106.55(d), 106.100(e)(5)(ii),
and 106.100(f)(7).
Controls to Prevent Adulteration During 1 12 12 0.25 (15 minutes)....................... 3
Packaging and Labeling of Infant Formula
106.60(c).
General Quality Control--Testing 106.91(b)(1), 2 1 2 2....................................... 4
106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1), 2 52 104 0.15 (9 minutes)........................ 15.6
106.91(d), and 106.100(e)(5)(i).
General Quality Control 106.91(b)(2) 2 52 104 0.15 (9 minutes)........................ 15.6
106.91(d), and 106.100(e)(5)(i).
General Quality Control 106.91(b)(3) 2 52 104 0.15 (9 minutes)........................ 15.6
106.91(d), and 106.100(e)(5)(i).
Audit Plans and Procedures 106.94--Ongoing 3 1 3 8....................................... 24
Review and Updating of Audits.
Audit Plans and Procedures 106.94--Regular 3 52 156 4....................................... 624
Audits.
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Total Recurring Recordkeeping Burden...... .............. .............. .............. ........................................ 85,889.64
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Total Recordkeeping Burden............ .............. .............. .............. ........................................ 105,209.64
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection, we made a
correction since the last OMB approval. While the one-time estimated
recordkeeping burden remains as 19,320 hours, we increased the annual
estimated recurring recordkeeping burden to 85,889.64 hours due to a
calculation error (a 79,561.58 hour increase) for a total recordkeeping
burden of 105,209.64 hours.
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21207 Filed 9-28-18; 8:45 am]
BILLING CODE 4164-01-P
