Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production, 14134-14138 [2015-06117]
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1. FNBK Holdings, Inc., Dallas, Texas;
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BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0044]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recommended
Recordkeeping for Exempt Infant
Formula Production
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice invites comments on
the information collection provisions of
the draft guidance entitled ‘‘Draft
Guidance for Industry: Exempt Infant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 May 18, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
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SUMMARY:
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Spring, MD 20993–0002, 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
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.
Recommended Recordkeeping for
Exempt Infant Formula Production—
OMB Control Number 0910—NEW
I. Background
Section 412(h)(1) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 350a(h)(1)) exempts an infant
formula which 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.’’ In the
Federal Register of June 10, 2014 (79 FR
33057), we published a final rule that
adopted, with some modifications, an
interim final rule published on February
10, 2014 (79 FR 7933), that established
requirements for quality factors for
infant formulas and current good
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manufacturing practices (CGMPs),
including quality control procedures,
under section 412 of the FD&C Act. The
final rule 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 February
10, 2014 (79 FR 7610), we published a
notice of availability of the draft
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
draft guidance). The draft guidance,
when finalized, will describe our
current thinking on the manufacturing
of exempt infant formula in relation to
the requirements in part 106 (21 CFR
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 draft guidance at https://
www.fda.gov/FoodGuidances.
II. Analysis of the Proposed
Information Collection
The proposed information collection
seeks OMB approval of the
recordkeeping recommendations of the
draft guidance. 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.
Description of Respondents: The
respondent recordkeepers are
manufacturers of exempt infant formula.
Description: The records
recommended, to the extent practicable,
in the draft guidance 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 draft guidance
that exempt infant formula
manufacturers follow these
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requirements. As such, the records and
reporting requirements in part 106
subparts E and G are not part of this new
information collection.
FDA estimates the burden of this
collection of information as follows:
The total one-time estimated burden
imposed by this collection of
information is 19,320 hours. The total
annual estimated burden imposed by
this collection of information is 6,328.06
hours. There are no capital costs or
operating and maintenance costs
associated with this collection of
information. The estimated burden for
the draft guidance is based on
‘‘Evaluation of Recordkeeping Costs for
Food Manufacturers,’’ Eastern Research
Group Task Order No. 5, Contract No.
223–01–2461. FDA estimates that firms
will be able to fulfill recordkeeping
requirements with existing record
systems; that is, FDA estimates that it
will not be necessary for infant formula
firms to invest in new recordkeeping
systems.
As of the beginning of 2015, five
manufacturers produce exempt infant
formulas that are marketed in the
United States. Four out of these five
infant formula manufacturers produce
both exempt and non-exempt infant
formulas, with both types of infant
formula produced using the same
production lines and equipment. Our
experts believe that manufacturing
practices are similar for both exempt
and non-exempt infant formulas.
Furthermore, given expert estimations
of industry standard practices, it is
estimated that the manufacturer that
only produces exempt infant formula
has practices comparable to those
manufacturers producing both exempt
and non-exempt infant formulas (Ref. 1).
Together, these 5 manufacturers
produce exempt infant formula at 12
plants.
The number of recordkeepers in
column 3 of table 1 is based on FDA’s
expert estimation of the number of
plants that may not already be adhering
to the relevant recordkeeping provisions
of the final rule. The Regulatory Impact
Analysis for the final rule (79 FR 33057)
estimated that 25 percent of all infant
formula plants manufacturing nonexempt infant formula were not
currently adhering to the recordkeeping
provisions under § 106.100. Although
such recordkeeping requirements are
now effective for manufacturers of nonexempt infant formulas, and
manufacturers of exempt infant
formulas may have implemented similar
procedures for their exempt infant
formulas, it is estimated conservatively
that this same proportion (25 percent, or
3 out of 12 plants that manufacture
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exempt infant formula) are not currently
adhering to the recordkeeping
provisions, and unless otherwise
specified, burdens are estimated based
on these 3 plants. Furthermore, we
estimate that plants will collect the
same information across the various
exempt infant formulas produced by
each firm.
For records pertaining to production
and in-process controls, FDA estimates
that, at most, three plants do not
currently develop production records as
specified under §§ 106.6(c)(5) and
106.100(e)(1) and (e)(3). A team of two
senior validation engineers (or other
similarly skilled employees) per plant (2
workers per plant × 3 plants = 6
workers) would each need to work 20
hours to provide sufficient initial
baseline records and documentation to
develop records pertaining to
production and in-process controls, for
an industry total of 120 hours (2
workers per plant × 3 plants × 20 hours
per worker = 120 hours), as presented in
line 1 of table 1.
For the recordkeeping specified under
§ 106.35(c), in accordance with
§ 106.100(f)(5), FDA estimates that a
team of 10 senior validation engineers
(or other similarly skilled employees)
per plant would need to work full time
for 16 weeks (16 weeks/person × 40
work hours/week = 640 work hours per
person) to provide sufficient initial
records and documentation pertaining
to controls intended to prevent
adulteration due to automatic
equipment. The total burden for 10
senior validation engineers each
working 640 hours is 6,400 per plant in
the first year (10 senior validation
engineers × 640 hours = 6,400). For
three plants, the total one-time hourly
burden is 3 plants × 6,400 hours per
plant = 19,200 hours, as presented in
line 2 of table 1.
For the testing specified under
§ 106.20(f)(3), manufacturers of exempt
infant formulas should conduct water
testing with appropriate frequency to
meet Environmental Protection Agency
primary standards for drinking water
(40 CFR parts 9, 141, and 142), but shall
conduct these tests at least annually for
chemical contaminants, every 4 years
for radiological contaminants, and
weekly for bacteriological contaminants.
FDA estimates that it is part of normal
business practice for exempt infant
formula plants to test for chemical
contaminants and keep records of those
tests on a regular basis; therefore, this is
a new collection of information that
does not present a burden (Ref. 1).
It is estimated that the
recommendation to manufacturers of
exempt infant formulas to test at least
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14135
every 4 years for radiological
contaminants would represent a new
burden for all 12 infant formula plants
(Ref. 1). In addition, it is estimated that
collecting water for this testing takes
between 1 and 2 hours (Ref. 1). For the
purposes of this analysis, it is
conservatively estimated that water
collection takes, on average, 1.5 hours
and that water collection occurs
separately for each type of testing. It is
estimated that performing the test
(collecting the information) will take 1.5
hours per test, every 4 years. Therefore,
1.5 hours per plant × 12 plants = 18 total
hours, every 4 years, or 4.5 hours per
year, as seen in line 3 of table 1.
Furthermore, the draft guidance
recommends that manufacturers of
exempt infant formula make and retain
records of the frequency and results of
water testing as specified under
§§ 106.20(f)(4) and 106.100(f)(1). For the
12 plants that are estimated not to
currently test for radiological
contaminants, this burden is estimated
to be 5 minutes per record every 4 years.
Therefore, 0.08 hour per record × 12
plants = 0.96 hour every 4 years for the
maintenance of records of radiological
testing, or 0.24 hours per year, as seen
on line 4 of table 1.
It is estimated that the
recommendation to test weekly for
bacteriological contaminants is a new
burden for three infant formula plants.
It is estimated that performing the test
(collecting the information) will take 5
minutes per test once a week. Annually,
this burden is 0.08 hour × 52 weeks =
4.16 hours per year per plant, and 4.16
hours per plant × 3 plants = 12.48 total
annual hours, as seen on line 5 of table
1. Furthermore, for the three plants that
are estimated to not currently test
weekly for bacteriological contaminants,
this burden is estimated to be 5 minutes
per record, every week. Therefore, 0.08
hour per record × 52 weeks = 4.16 hours
per plant for the maintenance of records
of bacteriological testing. Accordingly,
4.16 hours per plant × 3 plants = 12.48
annual hours, as seen on line 6 of table
1.
The draft guidance recommends that
manufacturers of exempt infant
formulas calibrate certain instruments
against a known reference standard and
that records of these calibration
activities be made and retained, as
specified in §§ 106.30(d)(1) and
106.100(f)(2). FDA estimates that one
senior validation engineer (or other
similarly skilled employee) for each of
the three (at most) plants would need to
spend about 13 minutes per week to
conduct the ongoing calibration
recordkeeping. Therefore, 3
recordkeepers × 0.21 hours per week per
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recordkeeper = 0.63 hours per week;
0.63 hours per week × 52 weeks per year
= 32.76 hours as the total industry
annual burden, as presented in line 7 of
table 1.
The draft guidance recommends that
manufacturers of exempt infant formula
make and retain records of the
temperatures of each cold storage
compartment as specified in
§§ 106.30(e)(3)(iii) and 106.100(f)(3).
Based on expert opinion, FDA estimates
that three (at most) plants are not
currently conducting recordkeeping,
and that at each of these three plants,
conducting this recordkeeping would
take one senior validation engineer (or
other similarly skilled employee) about
13 minutes per week. Therefore, 3
recordkeepers × 0.21 hours per week per
recordkeeper = 0.63 hours per week;
0.63 hours per week × 52 weeks = 32.76
hours as the total industry annual
burden, as presented in line 8 of table
1.
The draft guidance recommends the
making and retention of records of
ongoing sanitation efforts as specified
under §§ 106.30(f)(2) and 106.100(f)(4).
Based on expert opinion, FDA estimates
that three (at most) plants are not
currently making and retaining these
records, and that at each of these three
plants, it would take one senior
validation engineer (or other similarly
skilled employee) 0.19 hours per week
to make and retain these records.
Therefore, 3 recordkeepers × 0.19 hours
per week per recordkeeper = 0.57 hours
per week; 0.57 hours per week × 52
weeks = 29.64 hours as the total
industry annual burden, as presented in
line 9 of table 1.
There will be annual recordkeeping
associated with recommendations for
preventing adulteration from
equipment, as specified under
§§ 106.35(c) and 106.100(f)(5). It is
estimated that one senior validation
engineer (or other similarly skilled
employee) per plant would need to
work 10 hours per week (520 work
hours per year) to meet the ongoing
recordkeeping recommendation. For the
estimated three (at most) plants not
conducting this recordkeeping, the total
annual burden is 520 hours per plant ×
3 plants = 1,560 annual hours, as shown
in line 10 of table 1. In addition, this
guidance recommends that an infant
formula manufacturer revalidate its
systems when it makes changes to
automatic equipment. FDA estimates
that such changes are likely to occur
twice a year to any aspect of the plant’s
system, and that on each of the two
occasions, a team of four senior
validation engineers (or other similarly
skilled employees) per plant would
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need to work full time for 4 weeks (4
weeks × 40 hours per week = 160 work
hours per person) to provide
revalidation of the plant’s automated
systems sufficient to adhere to this
section. The total annual burden for four
senior validation engineers each
working 160 hours twice a year is 1,280
hours ((160 hours × 2 revalidations) × 4
engineers = 1,280 total work hours) per
plant. Therefore, 1,280 hours per plant
× 3 plants = 3,840 annual hours, as
shown on line 11 of table 1.
The draft guidance recommends
written specifications for ingredients,
containers, and closures, as specified
under §§ 106.40(g) and 106.100(f)(6).
FDA estimates that the exempt infant
formula industry already establishes
written specifications for these
components. However, the guidance
regarding controls to prevent
adulteration caused by ingredients,
containers, and closures may represent
new recordkeeping for three (at most)
plants (Ref. 1). It is not possible to
predict how often a specification will
not be met or how often documented
reviews of reconditioned ingredients,
closures, or containers will occur. FDA
estimates that, on average, one senior
validation engineer per plant would
work about 10 minutes a week to
complete this recordkeeping. Therefore,
3 recordkeepers × 0.17 hours per week
per recordkeeper = 0.51 hours per week;
0.51 hours per week × 52 weeks = 26.52
total annual hours, as presented in line
12 of table 1.
This draft guidance recommends
manufacturers of exempt infant formula
to make and maintain records of
controls to prevent adulteration during
manufacturing, as specified in §§ 106.50
and 106.100(e). It is not possible to
predict how often changes to the master
manufacturing order would be made or
how often deviations from the master
manufacturing order would occur.
Based on expert opinion, FDA estimates
that each year, three (at most) plants
would change a master manufacturing
order and that, on average, one senior
validation engineer for each of the three
(at most) plants would spend about 14
minutes per week on recordkeeping
pertaining to the master manufacturing
order. Thus, 3 recordkeepers × 0.23
hours per recordkeeper per week = 0.69
hours per week; 0.69 hours per week ×
52 weeks = 35.88 hours as the total
annual industry burden, as presented in
line 13 of table 1.
The draft guidance recommends
manufacturers of exempt infant formula
make and retain records of the testing of
infant formula for microorganisms, as
specified in §§ 106.55(d) and
106.100(e)(5)(ii) and (f)(7). We estimate
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that this recordkeeping represents a new
collection of information for, at most,
three plants (Ref. 1) and that one senior
validation engineer per plant would
spend 15 minutes per week on
recordkeeping pertaining to
microbiological testing. Thus, 3
recordkeepers × 0.25 hours per
recordkeeper per week = 0.75 hours;
0.75 hours per week × 52 weeks = 39
hours as the total annual industry
burden, as presented in line 14 of table
1.
The draft guidance recommends that
exempt infant formula manufacturers
make and maintain records consistent
with the requirements for the labeling of
mixed-lot packages of infant formula
that apply to non-exempt infant formula
manufacturers, as specified under
§ 106.60(c). We estimate that the draft
guidance will result in infant formula
diverters labeling infant formula
packaging (such as packing cases) to
facilitate product tracing and to keep
specific records of the distribution of
these mixed lot cases. (A diverter is
considered to be a business or
individual that purchases food,
including occasionally infant formula,
in a geographic area where a special
allowance or deal is being offered and
then resells that food at a lower price to
wholesale or retail grocery, drug and
mass merchandise chains in an area
where the deal is not being offered.)
There will be some cost associated with
this recordkeeping and labeling, but the
Agency estimates that this burden
would be minimal as it is estimated that
less than 1 percent of infant formula is
handled by diverters. For the purposes
of this analysis, it is estimated that, for
all plants combined, it may take one
worker using manual methods 15
minutes, at most, to relabel one case of
infant formula one time each month
(0.25 hours per month × 12 months = 3
annual hours), as presented in line 15 of
table 1.
The draft guidance recommends
nutrient testing for exempt infant
formula manufacturers as specified in
§ 106.91(a)(1) to (a)(4). It is estimated
that the systems and processes of 100
percent of the exempt formula industry
test in accordance with these
provisions. Therefore, nutrient testing
does not represent a new recordkeeping
burden as nutrient testing is estimated
to be common business practice in the
exempt infant formula industry. Thus,
no burden is estimated for these
recommendations (Ref. 1).
The draft guidance also recommends
ongoing stability testing as specified
under § 106.91(b)(1), (b)(2), and (b)(3). It
is estimated that the systems and
processes of the infant formula industry
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partially adhere to this guidance in that
80 percent of infant formula plants
(about 10 of 12 plants) conduct stability
testing as recommended (Ref. 1). For the
20 percent of plants (2 of 12 plants) that
do not conduct stability testing, it is
estimated that these plants do conduct
initial stability testing, but may not do
so at the intervals specified in this
provision (Ref. 1). For the purposes of
this analysis, it is estimated that the
stability testing guidance represents a
new information collection burden of 2
annual hours, per plant. Therefore, 2
hours per plant × 2 plants = 4 annual
hours as shown in line 16 of table 1.
The draft guidance recommends
recordkeeping for test results as
specified under §§ 106.91(d) and
106.100(e)(5)(i). This represents new
information collections for the two
plants that are estimated not to be
conducting all of the stability testing
specified in § 106.91(b) (Ref. 1). For the
purposes of this analysis, FDA estimates
that one senior validation engineer per
plant would spend about 9 minutes per
week maintaining records related to
testing. Thus, 2 recordkeepers × 0.15
hours per recordkeeper per week = 0.3
hours per week × 52 weeks = 15.6 hours
as the annual total industry burden, as
presented in lines 17, 18, and 19 of
table 1.
The draft guidance recommends the
creation of audit plans and procedures,
as specified under § 106.94. FDA
estimates that all exempt infant formula
manufacturers currently conduct audits,
but that 25 percent of infant formula
plants (3 of 12 plants) do not conduct
audits that include all elements
specified in § 106.94 (Ref. 1). It is
estimated that the ongoing review and
updating of audit plans would require a
senior validation engineer 8 hours per
year, per plant. Therefore, 8 hours per
year per plant × 3 plants = 24 annual
hours to regularly review and update
audit plans as shown in line 20 of
table 1.
The infant formula final rule does not
mandate a frequency of auditing, and,
therefore, one is not recommended in
the draft guidance. For the purposes of
this analysis, FDA estimates that a
manufacturer would choose to audit
once per week. Each weekly audit is
estimated to require a senior validation
engineer 4 hours, or 52 weeks × 4 hours
= 208 hours per plant per year.
Therefore, the total annual burden for
the estimated three plants not currently
acting in accordance to this guidance to
update audit plans is 208 hours × 3
plants = 624 hours, as shown in line 21
of table 1.
TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN
Number of
recordkeepers
21 CFR Section
First year
frequency of
recordkeeping
Total
records
Hours per
record
Total
hours
First Year Hourly Burden
1 ........................
6
1
3
40
120
30
1
3
6,400
19,200
Total First Year Only Hourly Recordkeeping Burden.
2 ........................
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).
..........................
..........................
................
................
19,320
12
1
12
1.5
4.5
12
1
12
0.08
0.24
3
52
156
0.08
12.48
3
52
156
0.08
12.48
3
52
156
0.21
32.76
3
52
156
0.21
32.76
3
52
156
0.19
29.64
3
52
3
520
1,560
12
2
6
640
3,840
3
52
156
0.17
26.52
3
52
156
0.23
35.88
Recurring Annual Hourly Burden
3 ........................
4 ........................
5 ........................
6 ........................
7 ........................
8 ........................
9 ........................
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10 ......................
11 ......................
12 ......................
13 ......................
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Controls to Prevent Adulteration Caused by Facilities—Testing for Radiological Contaminants 1
106.20(f)(3).
Controls to Prevent Adulteration Caused by Facilities—Recordkeeping of Testing for Radiological
Contaminants 2 106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration Caused by Facilities—Testing for Bacteriological Contaminants
106.20(f)(3).
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).
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TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued
Number of
recordkeepers
21 CFR Section
14 ......................
First year
frequency of
recordkeeping
Total
records
Hours per
record
Total
hours
17 ......................
18 ......................
19 ......................
20 ......................
21 ......................
52
156
0.25
39
1
12
12
0.25
3
2
1
2
2
4
2
52
104
0.15
15.6
2
52
104
0.15
15.6
2
52
104
0.15
15.6
3
1
3
8
24
3
52
156
4
624
..........................
..........................
................
................
6,328.06
Total Recordkeeping Burden ...................................
16 ......................
3
Total Recurring Recordkeeping Burden ...................
15 ......................
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.
..........................
..........................
................
................
25,648.06
1 As
noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
2 As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
III. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Zink, Don. Statement of Donald L. Zink,
Ph.D.: Infant Formula Manufacturing
Practices, 2013.
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06117 Filed 3–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0197]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Emergency
Shortages Data Collection System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Sep<11>2014
19:00 Mar 17, 2015
Jkt 235001
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 Emergency Shortages Data
Collection System.
DATES: Submit either electronic or
written comments on the collection of
information by May 18, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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,
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14134-14138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06117]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0044]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recommended Recordkeeping for Exempt Infant Formula
Production
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies are required to publish notice in the Federal Register
concerning each proposed collection of information and to allow 60 days
for public comment in response to the notice. This notice invites
comments on the information collection provisions of the draft guidance
entitled ``Draft 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 May 18, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 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.
Recommended Recordkeeping for Exempt Infant Formula Production--OMB
Control Number 0910--NEW
I. Background
Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula which 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.'' In the Federal Register of June 10, 2014
(79 FR 33057), we published a final rule that adopted, with some
modifications, an interim final rule published on February 10, 2014 (79
FR 7933), that established requirements for quality factors for infant
formulas and current good manufacturing practices (CGMPs), including
quality control procedures, under section 412 of the FD&C Act. The
final rule 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 February 10, 2014 (79 FR 7610), we
published a notice of availability of the draft 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 draft
guidance). The draft guidance, when finalized, will describe our
current thinking on the manufacturing of exempt infant formula in
relation to the requirements in part 106 (21 CFR 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 draft guidance at https://www.fda.gov/FoodGuidances.
II. Analysis of the Proposed Information Collection
The proposed information collection seeks OMB approval of the
recordkeeping recommendations of the draft guidance. 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.
Description of Respondents: The respondent recordkeepers are
manufacturers of exempt infant formula.
Description: The records recommended, to the extent practicable, in
the draft guidance 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 draft guidance that exempt infant formula
manufacturers follow these
[[Page 14135]]
requirements. As such, the records and reporting requirements in part
106 subparts E and G are not part of this new information collection.
FDA estimates the burden of this collection of information as
follows:
The total one-time estimated burden imposed by this collection of
information is 19,320 hours. The total annual estimated burden imposed
by this collection of information is 6,328.06 hours. There are no
capital costs or operating and maintenance costs associated with this
collection of information. The estimated burden for the draft guidance
is based on ``Evaluation of Recordkeeping Costs for Food
Manufacturers,'' Eastern Research Group Task Order No. 5, Contract No.
223-01-2461. FDA estimates that firms will be able to fulfill
recordkeeping requirements with existing record systems; that is, FDA
estimates that it will not be necessary for infant formula firms to
invest in new recordkeeping systems.
As of the beginning of 2015, five manufacturers produce exempt
infant formulas that are marketed in the United States. Four out of
these five infant formula manufacturers produce both exempt and non-
exempt infant formulas, with both types of infant formula produced
using the same production lines and equipment. Our experts believe that
manufacturing practices are similar for both exempt and non-exempt
infant formulas. Furthermore, given expert estimations of industry
standard practices, it is estimated that the manufacturer that only
produces exempt infant formula has practices comparable to those
manufacturers producing both exempt and non-exempt infant formulas
(Ref. 1). Together, these 5 manufacturers produce exempt infant formula
at 12 plants.
The number of recordkeepers in column 3 of table 1 is based on
FDA's expert estimation of the number of plants that may not already be
adhering to the relevant recordkeeping provisions of the final rule.
The Regulatory Impact Analysis for the final rule (79 FR 33057)
estimated that 25 percent of all infant formula plants manufacturing
non-exempt infant formula were not currently adhering to the
recordkeeping provisions under Sec. 106.100. Although such
recordkeeping requirements are now effective for manufacturers of non-
exempt infant formulas, and manufacturers of exempt infant formulas may
have implemented similar procedures for their exempt infant formulas,
it is estimated conservatively that this same proportion (25 percent,
or 3 out of 12 plants that manufacture exempt infant formula) are not
currently adhering to the recordkeeping provisions, and unless
otherwise specified, burdens are estimated based on these 3 plants.
Furthermore, we estimate that plants will collect the same information
across the various exempt infant formulas produced by each firm.
For records pertaining to production and in-process controls, FDA
estimates that, at most, three plants do not currently develop
production records as specified under Sec. Sec. 106.6(c)(5) and
106.100(e)(1) and (e)(3). A team of two senior validation engineers (or
other similarly skilled employees) per plant (2 workers per plant x 3
plants = 6 workers) would each need to work 20 hours to provide
sufficient initial baseline records and documentation to develop
records pertaining to production and in-process controls, for an
industry total of 120 hours (2 workers per plant x 3 plants x 20 hours
per worker = 120 hours), as presented in line 1 of table 1.
For the recordkeeping specified under Sec. 106.35(c), in
accordance with Sec. 106.100(f)(5), FDA estimates that a team of 10
senior validation engineers (or other similarly skilled employees) per
plant would need to work full time for 16 weeks (16 weeks/person x 40
work hours/week = 640 work hours per person) to provide sufficient
initial records and documentation pertaining to controls intended to
prevent adulteration due to automatic equipment. The total burden for
10 senior validation engineers each working 640 hours is 6,400 per
plant in the first year (10 senior validation engineers x 640 hours =
6,400). For three plants, the total one-time hourly burden is 3 plants
x 6,400 hours per plant = 19,200 hours, as presented in line 2 of table
1.
For the testing specified under Sec. 106.20(f)(3), manufacturers
of exempt infant formulas should conduct water testing with appropriate
frequency to meet Environmental Protection Agency primary standards for
drinking water (40 CFR parts 9, 141, and 142), but shall conduct these
tests at least annually for chemical contaminants, every 4 years for
radiological contaminants, and weekly for bacteriological contaminants.
FDA estimates that it is part of normal business practice for exempt
infant formula plants to test for chemical contaminants and keep
records of those tests on a regular basis; therefore, this is a new
collection of information that does not present a burden (Ref. 1).
It is estimated that the recommendation to manufacturers of exempt
infant formulas to test at least every 4 years for radiological
contaminants would represent a new burden for all 12 infant formula
plants (Ref. 1). In addition, it is estimated that collecting water for
this testing takes between 1 and 2 hours (Ref. 1). For the purposes of
this analysis, it is conservatively estimated that water collection
takes, on average, 1.5 hours and that water collection occurs
separately for each type of testing. It is estimated that performing
the test (collecting the information) will take 1.5 hours per test,
every 4 years. Therefore, 1.5 hours per plant x 12 plants = 18 total
hours, every 4 years, or 4.5 hours per year, as seen in line 3 of table
1.
Furthermore, the draft guidance recommends that manufacturers of
exempt infant formula make and retain records of the frequency and
results of water testing as specified under Sec. Sec. 106.20(f)(4) and
106.100(f)(1). For the 12 plants that are estimated not to currently
test for radiological contaminants, this burden is estimated to be 5
minutes per record every 4 years. Therefore, 0.08 hour per record x 12
plants = 0.96 hour every 4 years for the maintenance of records of
radiological testing, or 0.24 hours per year, as seen on line 4 of
table 1.
It is estimated that the recommendation to test weekly for
bacteriological contaminants is a new burden for three infant formula
plants. It is estimated that performing the test (collecting the
information) will take 5 minutes per test once a week. Annually, this
burden is 0.08 hour x 52 weeks = 4.16 hours per year per plant, and
4.16 hours per plant x 3 plants = 12.48 total annual hours, as seen on
line 5 of table 1. Furthermore, for the three plants that are estimated
to not currently test weekly for bacteriological contaminants, this
burden is estimated to be 5 minutes per record, every week. Therefore,
0.08 hour per record x 52 weeks = 4.16 hours per plant for the
maintenance of records of bacteriological testing. Accordingly, 4.16
hours per plant x 3 plants = 12.48 annual hours, as seen on line 6 of
table 1.
The draft guidance recommends that manufacturers of exempt infant
formulas calibrate certain instruments against a known reference
standard and that records of these calibration activities be made and
retained, as specified in Sec. Sec. 106.30(d)(1) and 106.100(f)(2).
FDA estimates that one senior validation engineer (or other similarly
skilled employee) for each of the three (at most) plants would need to
spend about 13 minutes per week to conduct the ongoing calibration
recordkeeping. Therefore, 3 recordkeepers x 0.21 hours per week per
[[Page 14136]]
recordkeeper = 0.63 hours per week; 0.63 hours per week x 52 weeks per
year = 32.76 hours as the total industry annual burden, as presented in
line 7 of table 1.
The draft guidance recommends that manufacturers of exempt infant
formula make and retain records of the temperatures of each cold
storage compartment as specified in Sec. Sec. 106.30(e)(3)(iii) and
106.100(f)(3). Based on expert opinion, FDA estimates that three (at
most) plants are not currently conducting recordkeeping, and that at
each of these three plants, conducting this recordkeeping would take
one senior validation engineer (or other similarly skilled employee)
about 13 minutes per week. Therefore, 3 recordkeepers x 0.21 hours per
week per recordkeeper = 0.63 hours per week; 0.63 hours per week x 52
weeks = 32.76 hours as the total industry annual burden, as presented
in line 8 of table 1.
The draft guidance recommends the making and retention of records
of ongoing sanitation efforts as specified under Sec. Sec.
106.30(f)(2) and 106.100(f)(4). Based on expert opinion, FDA estimates
that three (at most) plants are not currently making and retaining
these records, and that at each of these three plants, it would take
one senior validation engineer (or other similarly skilled employee)
0.19 hours per week to make and retain these records. Therefore, 3
recordkeepers x 0.19 hours per week per recordkeeper = 0.57 hours per
week; 0.57 hours per week x 52 weeks = 29.64 hours as the total
industry annual burden, as presented in line 9 of table 1.
There will be annual recordkeeping associated with recommendations
for preventing adulteration from equipment, as specified under
Sec. Sec. 106.35(c) and 106.100(f)(5). It is estimated that one senior
validation engineer (or other similarly skilled employee) per plant
would need to work 10 hours per week (520 work hours per year) to meet
the ongoing recordkeeping recommendation. For the estimated three (at
most) plants not conducting this recordkeeping, the total annual burden
is 520 hours per plant x 3 plants = 1,560 annual hours, as shown in
line 10 of table 1. In addition, this guidance recommends that an
infant formula manufacturer revalidate its systems when it makes
changes to automatic equipment. FDA estimates that such changes are
likely to occur twice a year to any aspect of the plant's system, and
that on each of the two occasions, a team of four senior validation
engineers (or other similarly skilled employees) per plant would need
to work full time for 4 weeks (4 weeks x 40 hours per week = 160 work
hours per person) to provide revalidation of the plant's automated
systems sufficient to adhere to this section. The total annual burden
for four senior validation engineers each working 160 hours twice a
year is 1,280 hours ((160 hours x 2 revalidations) x 4 engineers =
1,280 total work hours) per plant. Therefore, 1,280 hours per plant x 3
plants = 3,840 annual hours, as shown on line 11 of table 1.
The draft guidance recommends written specifications for
ingredients, containers, and closures, as specified under Sec. Sec.
106.40(g) and 106.100(f)(6). FDA estimates that the exempt infant
formula industry already establishes written specifications for these
components. However, the guidance regarding controls to prevent
adulteration caused by ingredients, containers, and closures may
represent new recordkeeping for three (at most) plants (Ref. 1). It is
not possible to predict how often a specification will not be met or
how often documented reviews of reconditioned ingredients, closures, or
containers will occur. FDA estimates that, on average, one senior
validation engineer per plant would work about 10 minutes a week to
complete this recordkeeping. Therefore, 3 recordkeepers x 0.17 hours
per week per recordkeeper = 0.51 hours per week; 0.51 hours per week x
52 weeks = 26.52 total annual hours, as presented in line 12 of table
1.
This draft guidance recommends manufacturers of exempt infant
formula to make and maintain records of controls to prevent
adulteration during manufacturing, as specified in Sec. Sec. 106.50
and 106.100(e). It is not possible to predict how often changes to the
master manufacturing order would be made or how often deviations from
the master manufacturing order would occur. Based on expert opinion,
FDA estimates that each year, three (at most) plants would change a
master manufacturing order and that, on average, one senior validation
engineer for each of the three (at most) plants would spend about 14
minutes per week on recordkeeping pertaining to the master
manufacturing order. Thus, 3 recordkeepers x 0.23 hours per
recordkeeper per week = 0.69 hours per week; 0.69 hours per week x 52
weeks = 35.88 hours as the total annual industry burden, as presented
in line 13 of table 1.
The draft guidance recommends manufacturers of exempt infant
formula make and retain records of the testing of infant formula for
microorganisms, as specified in Sec. Sec. 106.55(d) and
106.100(e)(5)(ii) and (f)(7). We estimate that this recordkeeping
represents a new collection of information for, at most, three plants
(Ref. 1) and that one senior validation engineer per plant would spend
15 minutes per week on recordkeeping pertaining to microbiological
testing. Thus, 3 recordkeepers x 0.25 hours per recordkeeper per week =
0.75 hours; 0.75 hours per week x 52 weeks = 39 hours as the total
annual industry burden, as presented in line 14 of table 1.
The draft guidance recommends that exempt infant formula
manufacturers make and maintain records consistent with the
requirements for the labeling of mixed-lot packages of infant formula
that apply to non-exempt infant formula manufacturers, as specified
under Sec. 106.60(c). We estimate that the draft guidance will result
in infant formula diverters labeling infant formula packaging (such as
packing cases) to facilitate product tracing and to keep specific
records of the distribution of these mixed lot cases. (A diverter is
considered to be a business or individual that purchases food,
including occasionally infant formula, in a geographic area where a
special allowance or deal is being offered and then resells that food
at a lower price to wholesale or retail grocery, drug and mass
merchandise chains in an area where the deal is not being offered.)
There will be some cost associated with this recordkeeping and
labeling, but the Agency estimates that this burden would be minimal as
it is estimated that less than 1 percent of infant formula is handled
by diverters. For the purposes of this analysis, it is estimated that,
for all plants combined, it may take one worker using manual methods 15
minutes, at most, to relabel one case of infant formula one time each
month (0.25 hours per month x 12 months = 3 annual hours), as presented
in line 15 of table 1.
The draft guidance recommends nutrient testing for exempt infant
formula manufacturers as specified in Sec. 106.91(a)(1) to (a)(4). It
is estimated that the systems and processes of 100 percent of the
exempt formula industry test in accordance with these provisions.
Therefore, nutrient testing does not represent a new recordkeeping
burden as nutrient testing is estimated to be common business practice
in the exempt infant formula industry. Thus, no burden is estimated for
these recommendations (Ref. 1).
The draft guidance also recommends ongoing stability testing as
specified under Sec. 106.91(b)(1), (b)(2), and (b)(3). It is estimated
that the systems and processes of the infant formula industry
[[Page 14137]]
partially adhere to this guidance in that 80 percent of infant formula
plants (about 10 of 12 plants) conduct stability testing as recommended
(Ref. 1). For the 20 percent of plants (2 of 12 plants) that do not
conduct stability testing, it is estimated that these plants do conduct
initial stability testing, but may not do so at the intervals specified
in this provision (Ref. 1). For the purposes of this analysis, it is
estimated that the stability testing guidance represents a new
information collection burden of 2 annual hours, per plant. Therefore,
2 hours per plant x 2 plants = 4 annual hours as shown in line 16 of
table 1.
The draft guidance recommends recordkeeping for test results as
specified under Sec. Sec. 106.91(d) and 106.100(e)(5)(i). This
represents new information collections for the two plants that are
estimated not to be conducting all of the stability testing specified
in Sec. 106.91(b) (Ref. 1). For the purposes of this analysis, FDA
estimates that one senior validation engineer per plant would spend
about 9 minutes per week maintaining records related to testing. Thus,
2 recordkeepers x 0.15 hours per recordkeeper per week = 0.3 hours per
week x 52 weeks = 15.6 hours as the annual total industry burden, as
presented in lines 17, 18, and 19 of table 1.
The draft guidance recommends the creation of audit plans and
procedures, as specified under Sec. 106.94. FDA estimates that all
exempt infant formula manufacturers currently conduct audits, but that
25 percent of infant formula plants (3 of 12 plants) do not conduct
audits that include all elements specified in Sec. 106.94 (Ref. 1). It
is estimated that the ongoing review and updating of audit plans would
require a senior validation engineer 8 hours per year, per plant.
Therefore, 8 hours per year per plant x 3 plants = 24 annual hours to
regularly review and update audit plans as shown in line 20 of table 1.
The infant formula final rule does not mandate a frequency of
auditing, and, therefore, one is not recommended in the draft guidance.
For the purposes of this analysis, FDA estimates that a manufacturer
would choose to audit once per week. Each weekly audit is estimated to
require a senior validation engineer 4 hours, or 52 weeks x 4 hours =
208 hours per plant per year. Therefore, the total annual burden for
the estimated three plants not currently acting in accordance to this
guidance to update audit plans is 208 hours x 3 plants = 624 hours, as
shown in line 21 of table 1.
Table 1--Estimated Hourly Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
First year
21 CFR Section Number of frequency of Total Hours per Total
recordkeepers recordkeeping records record hours
----------------------------------------------------------------------------------------------------------------
First Year Hourly Burden
----------------------------------------------------------------------------------------------------------------
1........................... Production and 6 1 3 40 120
In-Process
Control System
106.6(c)(5)
and
106.100(e)(1)
and (e)(3).
2........................... Controls to 30 1 3 6,400 19,200
Prevent
Adulteration
due to
Automatic
(mechanical or
electronic)
Equipment
106.35(c) and
106.100(f)(5).
------------------------------------------------------------------
Total First ............... ............... ......... ......... 19,320
Year Only
Hourly
Recordkeeping
Burden.
----------------------------------------------------------------------------------------------------------------
Recurring Annual Hourly Burden
----------------------------------------------------------------------------------------------------------------
3........................... Controls to 12 1 12 1.5 4.5
Prevent
Adulteration
Caused by
Facilities--Te
sting for
Radiological
Contaminants
\1\
106.20(f)(3).
4........................... Controls to 12 1 12 0.08 0.24
Prevent
Adulteration
Caused by
Facilities--Re
cordkeeping of
Testing for
Radiological
Contaminants
\2\
106.20(f)(4)
and
106.100(f)(1).
5........................... Controls to 3 52 156 0.08 12.48
Prevent
Adulteration
Caused by
Facilities--Te
sting for
Bacteriologica
l Contaminants
106.20(f)(3).
6........................... Controls to 3 52 156 0.08 12.48
Prevent
Adulteration
Caused by
Facilities--Re
cordkeeping of
Testing for
Bacteriologica
l Contaminants
106.20(f)(4)
and
106.100(f)(1).
7........................... Controls to 3 52 156 0.21 32.76
Prevent
Adulteration
by Equipment
or Utensils
106.30(d)(1)
and
106.100(f)(2).
8........................... Controls to 3 52 156 0.21 32.76
Prevent
Adulteration
by Equipment
or Utensils
106.30(e)(3)(i
ii) and
106.100(f)(3).
9........................... Controls to 3 52 156 0.19 29.64
Prevent
Adulteration
by Equipment
or Utensils
106.30(f)(2)
and
106.100(f)(4).
10.......................... Controls to 3 52 3 520 1,560
Prevent
Adulteration
Due to
Automatic
(Mechanical or
Electronic)
Equipment
106.35(c) and
106.100(f)(5).
11.......................... Controls to 12 2 6 640 3,840
Prevent
Adulteration
Due to
Automatic
(Mechanical or
Electronic)
Equipment
106.35(c) and
106.100(f)(5).
12.......................... Controls to 3 52 156 0.17 26.52
Prevent
Adulteration
Caused by
Ingredients,
Containers,
and Closures
106.40(g) and
106.100(f)(6).
13.......................... Controls to 3 52 156 0.23 35.88
Prevent
Adulteration
During
Manufacturing
106.50 and
106.100(e).
[[Page 14138]]
14.......................... Controls to 3 52 156 0.25 39
Prevent
Adulteration
From
Microorganisms
106.55(d),
106.100(e)(5)(
ii), and
106.100(f)(7).
15.......................... Controls to 1 12 12 0.25 3
Prevent
Adulteration
During
Packaging and
Labeling of
Infant Formula
106.60(c).
16.......................... General Quality 2 1 2 2 4
Control--Testi
ng
106.91(b)(1),
106.91(b)(2)
and
106.91(b)(3).
17.......................... General Quality 2 52 104 0.15 15.6
Control
106.91(b)(1),
106.91(d), and
106.100(e)(5)(
i).
18.......................... General Quality 2 52 104 0.15 15.6
Control
106.91(b)(2)
106.91(d), and
106.100(e)(5)(
i).
19.......................... General Quality 2 52 104 0.15 15.6
Control
106.91(b)(3)
106.91(d), and
106.100(e)(5)(
i).
20.......................... Audit Plans and 3 1 3 8 24
Procedures
106.94--Ongoin
g review and
updating of
Audits.
21.......................... Audit Plans and 3 52 156 4 624
Procedures
106.94--Regula
r Audits.
------------------------------------------------------------------
Total Recurring ............... ............... ......... ......... 6,328.06
Recordkeeping
Burden.
------------------------------------------------------------------
Total ............... ............... ......... ......... 25,648.06
Recordkeeping
Burden.
----------------------------------------------------------------------------------------------------------------
\1\ As noted previously in the document, the burden for making and maintaining such records is expected to occur
once every 4 years. The total hours column reflects the total number of hours averaged over the 4-year period.
\2\ As noted previously in the document, the burden for making and maintaining such records is expected to occur
once every 4 years. The total hours column reflects the total number of hours averaged over the 4-year period.
III. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Zink, Don. Statement of Donald L. Zink, Ph.D.: Infant Formula
Manufacturing Practices, 2013.
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06117 Filed 3-17-15; 8:45 am]
BILLING CODE 4164-01-P
