[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14134-14138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06117]


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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.

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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comments on the information collection provisions of the draft guidance 
entitled ``Draft Guidance for Industry: Exempt Infant Formula 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 http://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, <a href="/cdn-cgi/l/email-protection#49191b081a3d282f2f092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="2b7b796a785f4a4d4d6b4d4f4a05434358054c445d">[email protected]</span></a>.

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 http://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


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