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

take several actions with respect to antiepileptic drugs (AEDs), including that 

FDA narrow the bioequivalence range 

for all such drugs (Docket No. FDA– 

2006–P–0461). FDA is reviewing the 

issues raised in the petition. Although 

lamotrigine is not the sole focus of the 

petition, lamotrigine is discussed and it 

is indicated for use as an AED; 

therefore, FDA will consider any 

comments on the draft guidance on 

lamotrigine in responding to the 

petition. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for lamotrigine extended-release 

tablets. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. You 

can use an alternative approach if it 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: January 22, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01683 Filed 1–27–16; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 endof-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. 


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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-ofshelf-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 nonexempt infant formula were not 

currently adhering to the recordkeeping 

provisions under § 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 §§ 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 × 3 plants = 6 

workers) would each need to work 20 

hours to provide sufficient initial 

baseline records and documentation to 

develop records pertaining to 

production and in-process controls, for 

an industry total of 120 hours (2 

workers per plant × 3 plants × 20 hours 

per worker = 120 hours), as presented in 

line 1 of Table 1. 

For the recordkeeping specified under 

§ 106.35(c), in accordance with 

§ 106.100(f)(5), FDA estimates that a 

team of 10 senior validation engineers 

(or other similarly skilled employees) 

per plant would need to work full time 

for the 16 weeks (16 weeks/person × 40 

work hours/week = 640 work hours per 

person) to provide sufficient initial 

records and documentation pertaining 

to controls intended to prevent 

adulteration due to automatic 

equipment. The total burden for 10 

senior validation engineers each 

working 640 hours is 6,400 per plant in 

the first year (10 senior validation 

engineers × 640 hours = 6,400). For 

three plants, the total one-time hourly 

burden is 3 plants × 6,400 hours per 

plant = 19,200 hours, as presented in 

line 2 of Table 1. 

For the testing specified under 

§ 106.20(f)(3), manufacturers of exempt 

infant formulas should conduct water 

testing with appropriate frequency to 

meet Environmental Protection Agency 

primary standards for drinking water 

(40 CFR parts 9, 141, and 142), but shall 

conduct these tests at least annually for 

chemical contaminants, every 4 years 

for radiological contaminants, and 

weekly for bacteriological contaminants. 

FDA estimates that it is part of normal 

business practice for exempt infant 

formula plants to test for chemical 

contaminants and keep records of those 

tests on a regular basis; therefore, this is 

a new collection of information that 

does not present a burden (Ref. 1). 

It is estimated that the 

recommendation to manufacturers of 

exempt infant formulas to test at least 

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, 


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1.5 hours per plant × 12 plants = 18 total 

hours, every 4 years, or 4.5 hours per 

year, as seen in line 3 of Table 1. 

Furthermore, the draft guidance 

recommends that manufacturers of 

exempt infant formula make and retain 

records of the frequency and results of 

water testing as specified under 

§§ 106.20(f)(4) and 106.100(f)(1). For the 

12 plants that are estimated not to 

currently test for radiological 

contaminants, this burden is estimated 

to be 5 minutes per record every 4 years. 

Therefore, 0.08 hour per record × 12 

plants = 0.96 hour every 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 × 52 weeks = 

4.16 hours per year per plant, and 4.16 

hours per plant × 3 plants = 12.48 total 

annual hours, as seen on line 5 of Table 

1. Furthermore, for the three plants that 

are estimated to not currently test 

weekly for bacteriological contaminants, 

this burden is estimated to be 5 minutes 

per record, every week. Therefore, 0.08 

hour per record × 52 weeks = 4.16 hours 

per plant for the maintenance of records 

of bacteriological testing. Accordingly, 

4.16 hours per plant × 3 plants = 12.48 

annual hours, as seen on line 6 of 

Table 1. 

The draft guidance recommends that 

manufacturers of exempt infant 

formulas calibrate certain instruments 

against a known reference standard and 

that records of these calibration 

activities be made and retained, as 

specified in §§ 106.30(d)(1) and 

106.100(f)(2). FDA estimates that one 

senior validation engineer (or other 

similarly skilled employee) for each of 

the three (at most) plants would need to 

spend about 13 minutes per week to 

conduct the ongoing calibration 

recordkeeping. Therefore, 3 

recordkeepers × 0.21 hours per week per 

recordkeeper = 0.63 hours per week; 

0.63 hours per week × 52 weeks per year 

= 32.76 hours as the total industry 

annual burden, as presented in line 7 of 

Table 1. 

The draft guidance recommends that 

manufacturers of exempt infant formula 

make and retain records of the 

temperatures of each cold storage 

compartment as specified in 

§§ 106.30(e)(3)(iii) and 106.100(f)(3). 

Based on expert opinion, FDA estimates 

that three (at most) plants are not 

currently conducting recordkeeping, 

and that at each of these three plants, 

conducting this recordkeeping would 

take one senior validation engineer (or 

other similarly skilled employee) about 

13 minutes per week. Therefore, 3 

recordkeepers × 0.21 hours per week per 

recordkeeper = 0.63 hours per week; 

0.63 hours per week × 52 weeks = 32.76 

hours as the total industry annual 

burden, as presented in line 8 of 

Table 1. 

The draft guidance recommends the 

making and retention of records of 

ongoing sanitation efforts as specified 

under §§ 106.30(f)(2) and 106.100(f)(4). 

Based on expert opinion, FDA estimates 

that three (at most) plants are not 

currently making and retaining these 

records, and that at each of these three 

plants, it would take one senior 

validation engineer (or other similarly 

skilled employee) 0.19 hours per week 

to make and retain these records. 

Therefore, 3 recordkeepers × 0.19 hours 

per week per recordkeeper = 0.57 hours 

per week; 0.57 hours per week × 52 

weeks = 29.64 hours as the total 

industry annual burden, as presented in 

line 9 of Table 1. 

There will be annual recordkeeping 

associated with recommendations for 

preventing adulteration from 

equipment, as specified under 

§§ 106.35(c) and 106.100(f)(5). It is 

estimated that one senior validation 

engineer (or other similarly skilled 

employee) per plant would need to 

work 10 hours per week (520 work 

hours per year) to meet the ongoing 

recordkeeping recommendation. For the 

estimated three (at most) plants not 

conducting this recordkeeping, the total 

annual burden is 520 hours per plant × 

3 plants = 1,560 annual hours, as shown 

in line 10 of Table 1. In addition, this 

guidance recommends that an infant 

formula manufacturer revalidate its 

systems when it makes changes to 

automatic equipment. FDA estimates 

that such changes are likely to occur 

twice a year to any aspect of the plant’s 

system, and that on each of the two 

occasions, a team of four senior 

validation engineers (or other similarly 

skilled employees) per plant would 

need to work full time for 4 weeks (4 

weeks × 40 hours per week = 160 work 

hours per person) to provide 

revalidation of the plant’s automated 

systems sufficient to adhere to this 

section. The total annual burden for four 

senior validation engineers each 

working 160 hours twice a year is 1,280 

hours ((160 hours × 2 revalidations) × 4 

engineers = 1,280 total work hours) per 

plant. Therefore, 1,280 hours per plant 

× 3 plants = 3,840 annual hours, as 

shown on line 11 of Table 1. 

The draft guidance recommends 

written specifications for ingredients, 

containers, and closures, as specified 

under §§ 106.40(g) and 106.100(f)(6). 

FDA estimates that the exempt infant 

formula industry already establishes 

written specifications for these 

components. However, the guidance 

regarding controls to prevent 

adulteration caused by ingredients, 

containers, and closures may represent 

new recordkeeping for three (at most) 

plants (Ref. 1). It is not possible to 

predict how often a specification will 

not be met or how often documented 

reviews of reconditioned ingredients, 

closures, or containers will occur. FDA 

estimates that, on average, one senior 

validation engineer per plant would 

work about 10 minutes a week to 

complete this recordkeeping. Therefore, 

3 recordkeepers × 0.17 hours per week 

per recordkeeper = 0.51 hours per week; 

0.51 hours per week × 52 weeks = 26.52 

total annual hours, as presented in line 

12 of Table 1. 

This draft guidance recommends 

manufacturers of exempt infant formula 

to make and maintain records of 

controls to prevent adulteration during 

manufacturing, as specified in §§ 106.50 

and 106.100(e). It is not possible to 

predict how often changes to the master 

manufacturing order would be made or 

how often deviations from the master 

manufacturing order would occur. 

Based on expert opinion, FDA estimates 

that each year, three (at most) plants 

would change a master manufacturing 

order and that, on average, one senior 

validation engineer for each of the three 

(at most) plants would spend about 14 

minutes per week on recordkeeping 

pertaining to the master manufacturing 

order. Thus, 3 recordkeepers × 0.23 

hours per recordkeeper per week = 0.69 

hours per week; 0.69 hours per week × 

52 weeks = 35.88 hours as the total 

annual industry burden, as presented in 

line 13 of Table 1. 

The draft guidance recommends 

manufacturers of exempt infant formula 

make and retain records of the testing of 

infant formula for microorganisms, as 

specified in §§ 106.55(d) and 

106.100(e)(5)(ii) and (f)(7). We estimate 

that this recordkeeping represents a new 

collection of information for, at most, 

three plants (Ref. 1) and that one senior 

validation engineer per plant would 

spend 15 minutes per week on 

recordkeeping pertaining to 

microbiological testing. Thus, 3 

recordkeepers × 0.25 hours per 

recordkeeper per week = 0.75 hours; 

0.75 hours per week × 52 weeks 39 

hours as the total annual industry 

burden, as presented in line 14 of 

Table 1. 


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The draft guidance recommends that 

exempt infant formula manufacturers 

make and maintain records consistent 

with the requirements for the labeling of 

mixed-lot packages of infant formula 

that apply to non-exempt infant formula 

manufacturers, as specified under 

§ 106.60(c). We estimate that the draft 

guidance will result in infant formula 

diverters labeling infant formula 

packaging (such as packing cases) to 

facilitate product tracing and to keep 

specific records of the distribution of 

these mixed lot cases. (A diverter is 

considered to be a business or 

individual that purchases food, 

including occasionally infant formula, 

in a geographic area where a special 

allowance or deal is being offered and 

then resells that food at a lower price to 

wholesale or retail grocery, drug and 

mass merchandise chains in an area 

where the deal is not being offered.) 

There will be some cost associated with 

this recordkeeping and labeling, but the 

Agency estimates that this burden 

would be minimal as it is estimated that 

less than 1 percent of infant formula is 

handled by diverters. For the purposes 

of this analysis, it is estimated that, for 

all plants combined, it may take one 

worker using manual methods 15 

minutes, at most, to relabel one case of 

infant formula one time each month 

(0.25 hours per month × 12 months = 3 

annual hours), as presented in line 15 of 

Table 1. 

The draft guidance recommends 

nutrient testing for exempt infant 

formula manufacturers as specified in 

§ 106.91(a)(1) 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 § 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 × 2 plants = 4 annual 

hours as shown in line 16 of Table 1. 

The draft guidance recommends 

recordkeeping for test results as 

specified under §§ 106.91(d) and 

106.100(e)(5)(i). This represents new 

information collections for the two 

plants that are estimated not to be 

conducting all of the stability testing 

specified in § 106.91(b) (Ref. 1). For the 

purposes of this analysis, FDA estimates 

that one senior validation engineer per 

plant would spend about 9 minutes per 

week maintaining records related to 

testing. Thus, 2 recordkeepers × 0.15 

hours per recordkeeper per week = 0.3 

hours per week × 52 weeks = 15.6 hours 

as the annual total industry burden, as 

presented in lines 17, 18, and 19 of 

Table 1. 

The draft guidance recommends the 

creation of audit plans and procedures, 

as specified under § 106.94. FDA 

estimates that all exempt infant formula 

manufacturers currently conduct audits, 

but that 25 percent of infant formula 

plants (3 of 12 plants) do not conduct 

audits that include all elements 

specified in § 106.94 (Ref. 1). It is 

estimated that the ongoing review and 

updating of audit plans would require a 

senior validation engineer 8 hours per 

year, per plant. Therefore, 8 hours per 

year per plant × 3 plants = 24 annual 

hours to regularly review and update 

audit plans as shown in line 20 of 

Table 1. 

The infant formula final rule does not 

mandate a frequency of auditing, 

therefore, one is not recommended in 

the draft guidance. For the purposes of 

this analysis, FDA estimates that a 

manufacturer would choose to audit 

once per week. Each weekly audit is 

estimated to require a senior validation 

engineer 4 hours, or 52 weeks × 4 hours 

= 208 hours per plant per year. 

Therefore, the total annual burden for 

the estimated three plants not currently 

acting in accordance to this guidance to 

update audit plans is 208 hours × 3 

plants = 624 hours, as shown in line 21 

of Table 1. 

TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN

21 CFR Section Number of 

recordkeepers 

First year 

frequency of 

recordkeeping 

Total records Hours per 

record Total hours 

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 (Mechanical 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— 

Recordkeeping of Testing for Radiological Contaminants 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 Contaminants 106.20(f)(4) and 106.100(f)(1) ................................ 3 52 156 0.08 12.48 


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TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued 

21 CFR Section Number of 

recordkeepers 

First year 

frequency of 

recordkeeping 

Total records Hours per 

record Total hours 

7. Controls to Prevent Adulteration by Equipment or Utensils 106.30(d)(1) and 106.100(f)(2) .................................. 3 52 156 0.21 32.76 

8. Controls to Prevent Adulteration by Equipment or Utensils 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 Utensils 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 Ingredients, 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 

1As 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. 2As 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0380] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Product 

Jurisdiction: Assignment of Agency 

Component for Review of Premarket 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the procedure by which an applicant 

may obtain an assignment or 

designation determination for 

combination products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 28, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 


wgreen on DSK2VPTVN1PROD with NOTICES