81 FR 4917 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range		4917-4921
FR Document		2016-01690

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.

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016)

[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4917-4921]
From the Federal Register Online [www.thefederalregister.org]
[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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.

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

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
----------------------------------------------------------------------------------------------------------------
First year
21 CFR Section Number of frequency of Total records Hours per Total hours
recordkeepers recordkeeping record
----------------------------------------------------------------------------------------------------------------
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.......
----------------------------------------------------------------------------------------------------------------
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

Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4917

take several actions with respect to anti- ADDRESSES: To ensure that comments on finalized, will describe our current
epileptic drugs (AEDs), including that the information collection are received, thinking on the manufacturing of
FDA narrow the bioequivalence range OMB recommends that written exempt infant formula in relation to the
for all such drugs (Docket No. FDA– comments be faxed to the Office of requirements in part 106 (21 CFR part
2006–P–0461). FDA is reviewing the Information and Regulatory Affairs, 106) for CGMPs, quality control
issues raised in the petition. Although OMB, Attn: FDA Desk Officer, FAX: procedures, conduct of audits, and
lamotrigine is not the sole focus of the 202–395–7285, or emailed to oira_ records and reports that apply to
petition, lamotrigine is discussed and it submission@omb.eop.gov. All nonexempt infant formulas. Persons
is indicated for use as an AED; comments should be identified with the with access to the Internet may obtain
therefore, FDA will consider any OMB control number 0910—NEW. Also the draft guidance at http://
comments on the draft guidance on include the FDA docket number found www.fda.gov/FoodGuidances.
lamotrigine in responding to the in brackets in the heading of this
II. Analysis of the Proposed
petition. document.
This draft guidance is being issued Information Collection
FOR FURTHER INFORMATION CONTACT: FDA
consistent with FDA’s good guidance The proposed information collection
PRA Staff, Office of Operations, Food
practices regulation (21 CFR 10.115). seeks OMB approval of the
and Drug Administration, 8455
The draft guidance, when finalized, will recordkeeping recommendations of the
Colesville Rd., COLE–14526, Silver
represent the Agency’s current thinking draft guidance. Our estimate of the
Spring, MD 20993–0002, PRAStaff@
on the design of BE studies to support burden of the recordkeeping
fda.hhs.gov.
ANDAs for lamotrigine extended-release recommendations includes the one-time
tablets. It does not create or confer any SUPPLEMENTARY INFORMATION: In burden of developing production and
rights for or on any person and does not compliance with 44 U.S.C. 3507, FDA in-process control systems and the
operate to bind FDA or the public. You has submitted the following proposed annual burdens of developing and
can use an alternative approach if it collection of information to OMB for maintaining production aggregate
satisfies the requirements of the review and clearance. production and control records, records
applicable statutes and regulations. Recommended Recordkeeping for pertaining to the distribution of infant
Exempt Infant Formula Production— formula, and records pertaining to
II. Electronic Access regularly scheduled audits. Included in
OMB Control Number 0910—NEW
Persons with access to the Internet the burden estimate is the time for
may obtain the document at either I. Background reviewing instructions, searching
http://www.fda.gov/Drugs/ Section 412(h)(1) (21 U.S.C. existing data sources, gathering and
GuidanceCompliance 350a(h)(1)) of the Federal Food, Drug, maintaining the data needed, and
RegulatoryInformation/Guidances/ and Cosmetic Act (the FD&C Act) completing and reviewing each
default.htm or http:// exempts an infant formula which is collection of information.
www.regulations.gov. represented and labeled for use by an Description of Respondents: The
Dated: January 22, 2016. infant with an inborn error of respondent recordkeepers are
Leslie Kux, metabolism, low birth weight, or who manufacturers of exempt infant formula.
Associate Commissioner for Policy. otherwise has an unusual medical or Description: The records
dietary problem from the requirements recommended, to the extent practicable,
[FR Doc. 2016–01683 Filed 1–27–16; 8:45 am]
of section 412(a), (b), and (c) of the in the draft guidance include records
BILLING CODE 4164–01–P
FD&C Act (21 U.S.C. 350a(a), (b), and required by part 106, subparts A, B, C,
(c)). These formulas are customarily D, and F for non-exempt infant
DEPARTMENT OF HEALTH AND referred to as ‘‘exempt infant formulas.’’ formulas. Because the records and
HUMAN SERVICES In the Federal Register of June 10, 2014 reporting requirements related to part
(79 FR 33057), we published a final rule 106 subparts E and G are not generally
Food and Drug Administration that adopted, with some modifications, applicable to exempt infant formula
an interim final rule published on manufacturers, FDA is not
[Docket No. FDA–2014–D–0044] February 10, 2014 (79 FR 7934), that recommending in the draft guidance
Agency Information Collection established requirements for quality that exempt infant formula
Activities; Submission for Office of factors for infant formulas and current manufacturers follow these
Management and Budget Review; good manufacturing practices (CGMPs), requirements. As such, the records and
Comment Request; Recommended including quality control procedures, reporting requirements in part 106
Recordkeeping for Exempt Infant under section 412 of the FD&C Act. The subparts E and G are not part of this new
final rule will help prevent the information collection.
Formula Production
manufacture of adulterated infant In the Federal Register of March 18,
AGENCY: Food and Drug Administration, formula, ensure the safety of infant 2015 (80 FR 14134), FDA published a
HHS. formula, and ensure that the nutrients in 60-day notice requesting public
ACTION: Notice. infant formula are present in a form that comment on the proposed collection of
is bioavailable. information. We received one letter
SUMMARY: The Food and Drug In the Federal Register of February responsive to the notice, which
Administration (FDA) is announcing 10, 2014 (79 FR 7610), we published a contained comments.
that a proposed collection of notice of availability of the draft (Comment 1) One comment suggested
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information has been submitted to the guidance document entitled, ‘‘Guidance that we clarify the action level for end-
Office of Management and Budget for Industry: Exempt Infant Formula of-shelf-life verification testing and how
(OMB) for review and clearance under Production: Current Good this testing differs for exempt infant
the Paperwork Reduction Act of 1995. Manufacturing Practices, Quality formulas as compared to non-exempt
DATES: Fax written comments on the Control Procedures, Conduct of Audits, infant formulas.
collection of information by February and Records and Reports’’ (the draft (Response) We appreciate the
29, 2016. guidance). The draft guidance, when concerns discussed in the comment.

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4918 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices

The exempt infant formula guidance information. The estimated burden for 106.100(e)(1) and (3). A team of two
recommends that manufacturers of the draft guidance is based on senior validation engineers (or other
exempt infant formulas follow, to the ‘‘Evaluation of Recordkeeping Costs for similarly skilled employees) per plant (2
extent practicable, subparts A, B, C, D, Food Manufacturers,’’ Eastern Research workers per plant × 3 plants = 6
and F of 21 CFR part 106, as amended Group Task Order No. 5, Contract No. workers) would each need to work 20
or established by the final rule 223–01–2461. FDA estimates that firms hours to provide sufficient initial
published on June 10, 2014 (79 FR will be able to fulfill recordkeeping baseline records and documentation to
33057), in the production of their requirements with existing record develop records pertaining to
formula products. We do not plan to systems; that is, FDA estimates that it production and in-process controls, for
establish an action level for end-of- will not be necessary for infant formula an industry total of 120 hours (2
shelf-life verification testing in the firms to invest in new recordkeeping workers per plant × 3 plants × 20 hours
exempt infant formula guidance. systems. per worker = 120 hours), as presented in
Furthermore, our guidance documents As of the beginning of 2015, five line 1 of Table 1.
do not establish legally enforceable manufacturers produce exempt infant For the recordkeeping specified under
requirements and therefore cannot formulas that are marketed in the § 106.35(c), in accordance with
include mandatory language such as United States. Four out of these five § 106.100(f)(5), FDA estimates that a
‘‘shall, must, required, or requirement,’’ infant formula manufacturers produce team of 10 senior validation engineers
unless specific regulatory or statutory both exempt and non-exempt infant (or other similarly skilled employees)
requirements are cited. formulas, with both types of infant per plant would need to work full time
To the extent that the comment formula produced using the same for the 16 weeks (16 weeks/person × 40
requests us to engage in rulemaking, the production lines and equipment. Our work hours/week = 640 work hours per
comment is outside the scope of the experts believe that manufacturing person) to provide sufficient initial
comment request on the four collection practices are similar for both exempt records and documentation pertaining
of information topics as they relate to and non-exempt infant formulas. to controls intended to prevent
the provisions of the draft guidance Furthermore, given expert estimations adulteration due to automatic
document. of industry standard practices, it is equipment. The total burden for 10
(Comment 2) One comment asserted estimated that the manufacturer that senior validation engineers each
that we may have underestimated the only produces exempt infant formula working 640 hours is 6,400 per plant in
time it would take to test weekly for has practices comparable to those the first year (10 senior validation
bacteriological contaminants, as manufacturers producing both exempt engineers × 640 hours = 6,400). For
reported in Table 1. The comment noted and non-exempt infant formulas (Ref. 1). three plants, the total one-time hourly
our estimate of 5 minutes per test, once Together, these 5 manufacturers burden is 3 plants × 6,400 hours per
a week, for each of three infant formula produce exempt infant formula at 12 plant = 19,200 hours, as presented in
plants and added that including the plants. line 2 of Table 1.
performance of the test would The number of recordkeepers in For the testing specified under
significantly increase the time needed. column 3 of Table 1 is based on FDA’s § 106.20(f)(3), manufacturers of exempt
(Response) We appreciate the expert estimation of the number of infant formulas should conduct water
information provided in the comment. plants that may not already be adhering testing with appropriate frequency to
However, the comment did not provide to the relevant recordkeeping provisions meet Environmental Protection Agency
us data or information to support a of the final rule. The Regulatory Impact primary standards for drinking water
different estimate. In the absence of Analysis for the final rule (79 FR 33057) (40 CFR parts 9, 141, and 142), but shall
such data, we lack a basis on which to estimated that 25 percent of all infant conduct these tests at least annually for
revise our estimates. In addition, we formula plants manufacturing non- chemical contaminants, every 4 years
note that our estimate of 5 minutes per exempt infant formula were not for radiological contaminants, and
test, once a week, reflects the amount of currently adhering to the recordkeeping weekly for bacteriological contaminants.
time needed to fulfill the recordkeeping provisions under § 106.100 (21 CFR FDA estimates that it is part of normal
burdens associated with this 106.100). Although such recordkeeping business practice for exempt infant
requirement, not the time needed to requirements are now effective for formula plants to test for chemical
conduct the testing that is subject to the manufacturers of non-exempt infant contaminants and keep records of those
recordkeeping requirement. In formulas, and manufacturers of exempt tests on a regular basis; therefore, this is
preparation for the next regular infant formulas may have implemented a new collection of information that
information collection request, we will similar procedures for their exempt does not present a burden (Ref. 1).
consult with several establishments to infant formulas, it is estimated It is estimated that the
obtain additional data on the conservatively that this same proportion recommendation to manufacturers of
recordkeeping burdens and reevaluate (25 percent, or 3 out of 12 plants that exempt infant formulas to test at least
our estimates. We will then publish the manufacture exempt infant formula) are every 4 years for radiological
revised estimates for comment and not currently adhering to the contaminants would represent a new
consider additional information recordkeeping provisions, and unless burden for all 12 infant formula plants
submitted in response. otherwise specified, burdens are (Ref. 1). In addition, it is estimated that
FDA estimates the burden of this estimated based on these 3 plants. collecting water for this testing takes
collection of information as follows: Furthermore, we estimate that plants between 1 and 2 hours (Ref. 1). For the
The total one-time estimated burden will collect the same information across purposes of this analysis, it is
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imposed by this collection of the various exempt infant formulas conservatively estimated that water
information is 19,320 hours. The total produced by each firm. collection takes, on average, 1.5 hours
annual estimated burden imposed by For records pertaining to production and that water collection occurs
this collection of information is 6,328.06 and in-process controls, FDA estimates separately for each type of testing. It is
hours. There are no capital costs or that, at most, three plants do not estimated that performing the test
operating and maintenance costs currently develop production records as (collecting the information) will take 1.5
associated with this collection of specified under §§ 106.6(c)(5) and hours per test, every 4 years. Therefore,

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Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4919

1.5 hours per plant × 12 plants = 18 total and that at each of these three plants, The draft guidance recommends
hours, every 4 years, or 4.5 hours per conducting this recordkeeping would written specifications for ingredients,
year, as seen in line 3 of Table 1. take one senior validation engineer (or containers, and closures, as specified
Furthermore, the draft guidance other similarly skilled employee) about under §§ 106.40(g) and 106.100(f)(6).
recommends that manufacturers of 13 minutes per week. Therefore, 3 FDA estimates that the exempt infant
exempt infant formula make and retain recordkeepers × 0.21 hours per week per formula industry already establishes
records of the frequency and results of recordkeeper = 0.63 hours per week; written specifications for these
water testing as specified under 0.63 hours per week × 52 weeks = 32.76 components. However, the guidance
§§ 106.20(f)(4) and 106.100(f)(1). For the hours as the total industry annual regarding controls to prevent
12 plants that are estimated not to burden, as presented in line 8 of adulteration caused by ingredients,
currently test for radiological Table 1. containers, and closures may represent
contaminants, this burden is estimated The draft guidance recommends the new recordkeeping for three (at most)
to be 5 minutes per record every 4 years. making and retention of records of plants (Ref. 1). It is not possible to
Therefore, 0.08 hour per record × 12 ongoing sanitation efforts as specified predict how often a specification will
plants = 0.96 hour every four years for under §§ 106.30(f)(2) and 106.100(f)(4). not be met or how often documented
the maintenance of records of Based on expert opinion, FDA estimates reviews of reconditioned ingredients,
radiological testing, or 0.24 hours per that three (at most) plants are not closures, or containers will occur. FDA
year, as seen on line 4 of Table 1. currently making and retaining these estimates that, on average, one senior
It is estimated that the records, and that at each of these three validation engineer per plant would
recommendation to test weekly for plants, it would take one senior work about 10 minutes a week to
bacteriological contaminants is a new validation engineer (or other similarly complete this recordkeeping. Therefore,
burden for three infant formula plants. skilled employee) 0.19 hours per week 3 recordkeepers × 0.17 hours per week
It is estimated that performing the test per recordkeeper = 0.51 hours per week;
to make and retain these records.
(collecting the information) will take 5
Therefore, 3 recordkeepers × 0.19 hours 0.51 hours per week × 52 weeks = 26.52
minutes per test once a week. Annually, total annual hours, as presented in line
per week per recordkeeper = 0.57 hours
this burden is 0.08 hour × 52 weeks = 12 of Table 1.
per week; 0.57 hours per week × 52
4.16 hours per year per plant, and 4.16 This draft guidance recommends
weeks = 29.64 hours as the total
hours per plant × 3 plants = 12.48 total manufacturers of exempt infant formula
industry annual burden, as presented in
annual hours, as seen on line 5 of Table to make and maintain records of
line 9 of Table 1.
1. Furthermore, for the three plants that controls to prevent adulteration during
are estimated to not currently test There will be annual recordkeeping manufacturing, as specified in §§ 106.50
weekly for bacteriological contaminants, associated with recommendations for and 106.100(e). It is not possible to
this burden is estimated to be 5 minutes preventing adulteration from predict how often changes to the master
per record, every week. Therefore, 0.08 equipment, as specified under manufacturing order would be made or
hour per record × 52 weeks = 4.16 hours §§ 106.35(c) and 106.100(f)(5). It is how often deviations from the master
per plant for the maintenance of records estimated that one senior validation manufacturing order would occur.
of bacteriological testing. Accordingly, engineer (or other similarly skilled Based on expert opinion, FDA estimates
4.16 hours per plant × 3 plants = 12.48 employee) per plant would need to that each year, three (at most) plants
annual hours, as seen on line 6 of work 10 hours per week (520 work would change a master manufacturing
Table 1. hours per year) to meet the ongoing order and that, on average, one senior
The draft guidance recommends that recordkeeping recommendation. For the validation engineer for each of the three
manufacturers of exempt infant estimated three (at most) plants not (at most) plants would spend about 14
formulas calibrate certain instruments conducting this recordkeeping, the total minutes per week on recordkeeping
against a known reference standard and annual burden is 520 hours per plant × pertaining to the master manufacturing
that records of these calibration 3 plants = 1,560 annual hours, as shown order. Thus, 3 recordkeepers × 0.23
activities be made and retained, as in line 10 of Table 1. In addition, this hours per recordkeeper per week = 0.69
specified in §§ 106.30(d)(1) and guidance recommends that an infant hours per week; 0.69 hours per week ×
106.100(f)(2). FDA estimates that one formula manufacturer revalidate its 52 weeks = 35.88 hours as the total
senior validation engineer (or other systems when it makes changes to annual industry burden, as presented in
similarly skilled employee) for each of automatic equipment. FDA estimates line 13 of Table 1.
the three (at most) plants would need to that such changes are likely to occur The draft guidance recommends
spend about 13 minutes per week to twice a year to any aspect of the plant’s manufacturers of exempt infant formula
conduct the ongoing calibration system, and that on each of the two make and retain records of the testing of
recordkeeping. Therefore, 3 occasions, a team of four senior infant formula for microorganisms, as
recordkeepers × 0.21 hours per week per validation engineers (or other similarly specified in §§ 106.55(d) and
recordkeeper = 0.63 hours per week; skilled employees) per plant would 106.100(e)(5)(ii) and (f)(7). We estimate
0.63 hours per week × 52 weeks per year need to work full time for 4 weeks (4 that this recordkeeping represents a new
= 32.76 hours as the total industry weeks × 40 hours per week = 160 work collection of information for, at most,
annual burden, as presented in line 7 of hours per person) to provide three plants (Ref. 1) and that one senior
Table 1. revalidation of the plant’s automated validation engineer per plant would
The draft guidance recommends that systems sufficient to adhere to this spend 15 minutes per week on
manufacturers of exempt infant formula section. The total annual burden for four recordkeeping pertaining to
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make and retain records of the senior validation engineers each microbiological testing. Thus, 3
temperatures of each cold storage working 160 hours twice a year is 1,280 recordkeepers × 0.25 hours per
compartment as specified in hours ((160 hours × 2 revalidations) × 4 recordkeeper per week = 0.75 hours;
§§ 106.30(e)(3)(iii) and 106.100(f)(3). engineers = 1,280 total work hours) per 0.75 hours per week × 52 weeks 39
Based on expert opinion, FDA estimates plant. Therefore, 1,280 hours per plant hours as the total annual industry
that three (at most) plants are not × 3 plants = 3,840 annual hours, as burden, as presented in line 14 of
currently conducting recordkeeping, shown on line 11 of Table 1. Table 1.

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4920 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices

The draft guidance recommends that that the systems and processes of 100 plant would spend about 9 minutes per
exempt infant formula manufacturers percent of the exempt formula industry week maintaining records related to
make and maintain records consistent test in accordance with these testing. Thus, 2 recordkeepers × 0.15
with the requirements for the labeling of provisions. Therefore, nutrient testing hours per recordkeeper per week = 0.3
mixed-lot packages of infant formula does not represent a new recordkeeping hours per week × 52 weeks = 15.6 hours
that apply to non-exempt infant formula burden as nutrient testing is estimated as the annual total industry burden, as
manufacturers, as specified under to be common business practice in the presented in lines 17, 18, and 19 of
§ 106.60(c). We estimate that the draft exempt infant formula industry. Thus, Table 1.
guidance will result in infant formula no burden is estimated for these The draft guidance recommends the
diverters labeling infant formula recommendations (Ref. 1). creation of audit plans and procedures,
packaging (such as packing cases) to The draft guidance also recommends as specified under § 106.94. FDA
facilitate product tracing and to keep on-going stability testing as specified estimates that all exempt infant formula
specific records of the distribution of under § 106.91(b)(1) through (3). It is manufacturers currently conduct audits,
these mixed lot cases. (A diverter is estimated that the systems and but that 25 percent of infant formula
considered to be a business or processes of the infant formula industry plants (3 of 12 plants) do not conduct
individual that purchases food, partially adhere to this guidance in that audits that include all elements
including occasionally infant formula, 80 percent of infant formula plants specified in § 106.94 (Ref. 1). It is
in a geographic area where a special (about 10 of 12 plants) conduct stability estimated that the ongoing review and
allowance or deal is being offered and testing as recommended (Ref. 1). For the updating of audit plans would require a
then resells that food at a lower price to 20 percent of plants (2 of 12 plants) that senior validation engineer 8 hours per
wholesale or retail grocery, drug and do not conduct stability testing, it is year, per plant. Therefore, 8 hours per
mass merchandise chains in an area estimated that these plants do conduct year per plant × 3 plants = 24 annual
where the deal is not being offered.) initial stability testing, but may not do hours to regularly review and update
There will be some cost associated with so at the intervals specified in this audit plans as shown in line 20 of
this recordkeeping and labeling, but the provision (Ref. 1). For the purposes of Table 1.
Agency estimates that this burden this analysis, it is estimated that the The infant formula final rule does not
would be minimal as it is estimated that stability testing guidance represents a mandate a frequency of auditing,
less than 1 percent of infant formula is new information collection burden of 2 therefore, one is not recommended in
handled by diverters. For the purposes annual hours, per plant. Therefore, 2 the draft guidance. For the purposes of
of this analysis, it is estimated that, for hours per plant × 2 plants = 4 annual this analysis, FDA estimates that a
all plants combined, it may take one hours as shown in line 16 of Table 1. manufacturer would choose to audit
worker using manual methods 15 The draft guidance recommends once per week. Each weekly audit is
minutes, at most, to relabel one case of recordkeeping for test results as estimated to require a senior validation
infant formula one time each month specified under §§ 106.91(d) and engineer 4 hours, or 52 weeks × 4 hours
(0.25 hours per month × 12 months = 3 106.100(e)(5)(i). This represents new = 208 hours per plant per year.
annual hours), as presented in line 15 of information collections for the two Therefore, the total annual burden for
Table 1. plants that are estimated not to be the estimated three plants not currently
The draft guidance recommends conducting all of the stability testing acting in accordance to this guidance to
nutrient testing for exempt infant specified in § 106.91(b) (Ref. 1). For the update audit plans is 208 hours × 3
formula manufacturers as specified in purposes of this analysis, FDA estimates plants = 624 hours, as shown in line 21
§ 106.91(a)(1) through (4). It is estimated that one senior validation engineer per of Table 1.

TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN
First year
Number of Hours per
21 CFR Section frequency of Total records Total hours
recordkeepers record
recordkeeping

First Year Hourly Burden

1. Production and In-Process Control System 106.6(c)(5)
and 106.100(e)(1) and (3) ................................................ 6 1 3 40 120
2. Controls to Prevent Adulteration Due to Automatic (Me-
chanical or Electronic) Equipment 106.35(c) and
106.100(f)(5) ..................................................................... 30 1 3 6,400 19,200

Total First Year Only Hourly Recordkeeping Burden ... ........................ ........................ ........................ ........................ 19,320

Recurring Annual Hourly Burden

3. Controls to Prevent Adulteration Caused by Facilities—
Testing for Radiological Contaminants 1 106.20(f)(3) ...... 12 1 12 1.5 4.5
4. Controls to Prevent Adulteration Caused by Facilities—
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Recordkeeping of Testing for Radiological Contami-
nants 2 106.20(f)(4) and 106.100(f)(1) ............................. 12 1 12 0.08 0.24
5. Controls to Prevent Adulteration Caused by Facilities—
Testing for Bacteriological Contaminants 106.20(f)(3) .... 3 52 156 0.08 12.48
6. Controls to Prevent Adulteration Caused by Facilities—
Recordkeeping of Testing for Bacteriological Contami-
nants 106.20(f)(4) and 106.100(f)(1) ................................ 3 52 156 0.08 12.48

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Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4921

TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued
First year
Number of Hours per
21 CFR Section frequency of Total records Total hours
recordkeepers record
recordkeeping

7. Controls to Prevent Adulteration by Equipment or Uten-
sils 106.30(d)(1) and 106.100(f)(2) .................................. 3 52 156 0.21 32.76
8. Controls to Prevent Adulteration by Equipment or Uten-
sils 106.30(e)(3)(iii) and 106.100(f)(3) ............................. 3 52 156 0.21 32.76
9. Controls to Prevent Adulteration by Equipment or Uten-
sils 106.30(f)(2) and 106.100(f)(4) ................................... 3 52 156 0.19 29.64
10. Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c) and
106.100(f)(5) ..................................................................... 3 52 3 520 1,560
11. Controls to Prevent Adulteration Due to Automatic
(Mechanical or Electronic) Equipment 106.35(c) and
106.100(f)(5) ..................................................................... 12 2 6 640 3,840
12. Controls to Prevent Adulteration Caused by Ingredi-
ents, Containers, and Closures 106.40(g) and
106.100(f)(6) ..................................................................... 3 52 156 0.17 26.52
13. Controls to Prevent Adulteration During Manufacturing
106.50 and 106.100(e) ..................................................... 3 52 156 0.23 35.88
14. Controls to Prevent Adulteration From Microorganisms
106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7) ................ 3 52 156 0.25 39
15. Controls to Prevent Adulteration During Packaging and
Labeling of Infant Formula 106.60(c) ............................... 1 12 12 0.25 3
16. General Quality Control-Testing 106.91(b)(1) through
(3) ..................................................................................... 2 1 2 2 4
17. General Quality Control 106.91(b)(1) and (d), and
106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6
18. General Quality Control 106.91(b)(2) and (d), and
106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6
19. General Quality Control 106.91(b)(3) and (d), and
106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6
20. Audit Plans and Procedures 106.94—Ongoing Review
and Updating of Audits ..................................................... 3 1 3 8 24
21. Audit Plans and Procedures 106.94—Regular Audits .. 3 52 156 4 624

Total Recurring Recordkeeping Burden ....................... ........................ ........................ ........................ ........................ 6,328.06
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 DEPARTMENT OF HEALTH AND information including each proposed
HUMAN SERVICES extension of an existing collection of
The following reference has been information and to allow 60 days for
placed on display in the Division of Food and Drug Administration public comment in response to the
Dockets Management (HFA–305), Food notice. This notice solicits comments on
[Docket No. FDA–2009–N–0380]
and Drug Administration, 5630 Fishers the procedure by which an applicant
Lane, Rm. 1061, Rockville, MD 20852, Agency Information Collection may obtain an assignment or
and may be seen by interested persons Activities; Proposed Collection; designation determination for
between 9 a.m. and 4 p.m., Monday Comment Request; Product combination products.
through Friday. Jurisdiction: Assignment of Agency DATES: Submit either electronic or
1. Zink, Don. Statement of Donald L. Zink: Component for Review of Premarket written comments on the collection of
Infant Formula Manufacturing Practices, Applications information by March 28, 2016.
2013. ADDRESSES: You may submit comments
AGENCY: Food and Drug Administration,
Dated: January 22, 2016. HHS. as follows:
Leslie Kux, ACTION: Notice. Electronic Submissions
Associate Commissioner for Policy.
SUMMARY: The Food and Drug Submit electronic comments in the
[FR Doc. 2016–01690 Filed 1–27–16; 8:45 am]
Administration (FDA) is announcing an following way:
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BILLING CODE 4164–01–P
opportunity for public comment on the • Federal eRulemaking Portal: http://
proposed collection of certain www.regulations.gov. Follow the
information by the Agency. Under the instructions for submitting comments.
Paperwork Reduction Act of 1995 (the Comments submitted electronically,
PRA), Federal Agencies are required to including attachments, to http://
publish notice in the Federal Register www.regulations.gov will be posted to
concerning each proposed collection of the docket unchanged. Because your

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Document Created: 2018-02-02 12:41:00
Document Modified: 2018-02-02 12:41:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by February 29, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 4917

81 FR 4917 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration