[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4917-4921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0044]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 29, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--NEW. 
Also include the FDA 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, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Recommended Recordkeeping for Exempt Infant Formula Production--OMB 
Control Number 0910--NEW

I. Background

    Section 412(h)(1) (21 U.S.C. 350a(h)(1)) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) 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 (21 U.S.C. 350a(a), (b), and (c)). 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 7934), 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, 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 requirements. As such, the records and 
reporting requirements in part 106 subparts E and G are not part of 
this new information collection.
    In the Federal Register of March 18, 2015 (80 FR 14134), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one letter responsive to the 
notice, which contained comments.
    (Comment 1) One comment suggested that we clarify the action level 
for end-of-shelf-life verification testing and how this testing differs 
for exempt infant formulas as compared to non-exempt infant formulas.
    (Response) We appreciate the concerns discussed in the comment.

[[Page 4918]]

The exempt infant formula guidance recommends that manufacturers of 
exempt infant formulas follow, to the extent practicable, subparts A, 
B, C, D, and F of 21 CFR part 106, as amended or established by the 
final rule published on June 10, 2014 (79 FR 33057), in the production 
of their formula products. We do not plan to establish an action level 
for end-of-shelf-life verification testing in the exempt infant formula 
guidance. Furthermore, our guidance documents do not establish legally 
enforceable requirements and therefore cannot include mandatory 
language such as ``shall, must, required, or requirement,'' unless 
specific regulatory or statutory requirements are cited.
    To the extent that the comment requests us to engage in rulemaking, 
the comment is outside the scope of the comment request on the four 
collection of information topics as they relate to the provisions of 
the draft guidance document.
    (Comment 2) One comment asserted that we may have underestimated 
the time it would take to test weekly for bacteriological contaminants, 
as reported in Table 1. The comment noted our estimate of 5 minutes per 
test, once a week, for each of three infant formula plants and added 
that including the performance of the test would significantly increase 
the time needed.
    (Response) We appreciate the information provided in the comment. 
However, the comment did not provide us data or information to support 
a different estimate. In the absence of such data, we lack a basis on 
which to revise our estimates. In addition, we note that our estimate 
of 5 minutes per test, once a week, reflects the amount of time needed 
to fulfill the recordkeeping burdens associated with this requirement, 
not the time needed to conduct the testing that is subject to the 
recordkeeping requirement. In preparation for the next regular 
information collection request, we will consult with several 
establishments to obtain additional data on the recordkeeping burdens 
and reevaluate our estimates. We will then publish the revised 
estimates for comment and consider additional information submitted in 
response.
    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 (21 CFR 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 (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 the 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,

[[Page 4919]]

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 four 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 
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.

[[Page 4920]]

    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) through (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 on-going stability testing as 
specified under Sec.  106.91(b)(1) through (3). It is estimated that 
the systems and processes of the infant formula industry 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, 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
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                                                    First year
         21 CFR Section              Number of     frequency of    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
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                                            First Year Hourly Burden
----------------------------------------------------------------------------------------------------------------
1. Production and In-Process                   6               1               3              40             120
 Control System 106.6(c)(5) and
 106.100(e)(1) and (3)..........
2. Controls to Prevent                        30               1               3           6,400          19,200
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
                                 -------------------------------------------------------------------------------
    Total First Year Only Hourly  ..............  ..............  ..............  ..............          19,320
     Recordkeeping Burden.......
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                                         Recurring Annual Hourly Burden
----------------------------------------------------------------------------------------------------------------
3. Controls to Prevent                        12               1              12             1.5             4.5
 Adulteration Caused by
 Facilities--Testing for
 Radiological Contaminants \1\
 106.20(f)(3)...................
4. Controls to Prevent                        12               1              12            0.08            0.24
 Adulteration Caused by
 Facilities--Recordkeeping of
 Testing for Radiological
 Contaminants \2\ 106.20(f)(4)
 and 106.100(f)(1)..............
5. Controls to Prevent                         3              52             156            0.08           12.48
 Adulteration Caused by
 Facilities--Testing for
 Bacteriological Contaminants
 106.20(f)(3)...................
6. Controls to Prevent                         3              52             156            0.08           12.48
 Adulteration Caused by
 Facilities--Recordkeeping of
 Testing for Bacteriological
 Contaminants 106.20(f)(4) and
 106.100(f)(1)..................

[[Page 4921]]

 
7. Controls to Prevent                         3              52             156            0.21           32.76
 Adulteration by Equipment or
 Utensils 106.30(d)(1) and
 106.100(f)(2)..................
8. Controls to Prevent                         3              52             156            0.21           32.76
 Adulteration by Equipment or
 Utensils 106.30(e)(3)(iii) and
 106.100(f)(3)..................
9. Controls to Prevent                         3              52             156            0.19           29.64
 Adulteration by Equipment or
 Utensils 106.30(f)(2) and
 106.100(f)(4)..................
10. Controls to Prevent                        3              52               3             520           1,560
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
11. Controls to Prevent                       12               2               6             640           3,840
 Adulteration Due to Automatic
 (Mechanical or Electronic)
 Equipment 106.35(c) and
 106.100(f)(5)..................
12. Controls to Prevent                        3              52             156            0.17           26.52
 Adulteration Caused by
 Ingredients, Containers, and
 Closures 106.40(g) and
 106.100(f)(6)..................
13. Controls to Prevent                        3              52             156            0.23           35.88
 Adulteration During
 Manufacturing 106.50 and
 106.100(e).....................
14. Controls to Prevent                        3              52             156            0.25              39
 Adulteration From
 Microorganisms 106.55(d),
 106.100(e)(5)(ii), and
 106.100(f)(7)..................
15. Controls to Prevent                        1              12              12            0.25               3
 Adulteration During Packaging
 and Labeling of Infant Formula
 106.60(c)......................
16. General Quality Control-                   2               1               2               2               4
 Testing 106.91(b)(1) through
 (3)............................
17. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(1) and (d), and
 106.100(e)(5)(i)...............
18. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(2) and (d), and
 106.100(e)(5)(i)...............
19. General Quality Control                    2              52             104            0.15            15.6
 106.91(b)(3) and (d), and
 106.100(e)(5)(i)...............
20. Audit Plans and Procedures                 3               1               3               8              24
 106.94--Ongoing Review and
 Updating of Audits.............
21. Audit Plans and Procedures                 3              52             156               4             624
 106.94--Regular Audits.........
                                 -------------------------------------------------------------------------------
    Total Recurring               ..............  ..............  ..............  ..............        6,328.06
     Recordkeeping Burden.......
    Total Recordkeeping Burden..  ..............  ..............  ..............  ..............       25,648.06
----------------------------------------------------------------------------------------------------------------
\1\ As noted previously, 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, the burden for making and maintaining such records is expected to occur once every four
  years. The total hours column reflects the total number of hours averaged over the four-year period.

III. Reference

    The following reference has 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: Infant Formula 
Manufacturing Practices, 2013.

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01690 Filed 1-27-16; 8:45 am]
 BILLING CODE 4164-01-P