[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49393-49395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3490]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Exempt Infant Formula Production: Current Good 
Manufacturing Practices, Quality Control Procedures, Conduct of Audits, 
and Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection provisions of 
the guidance entitled ``Guidance for Industry: Exempt Infant Formula 
Production: Current Good Manufacturing Practices (CGMPs), Quality 
Control Procedures, Conduct of Audits, and Records and Reports.''

DATES: Submit either electronic or written comments on the collection 
of information by November 30, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. midnight Eastern Time at the end of November 30, 2018. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3490 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Exempt Infant Formula Production: 
Current Good Manufacturing Practices (CGMPs), Quality Control 
Procedures, Conduct of Audits, and Records.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or

[[Page 49394]]

provide information to a third party. Section 3506(c)(2)(A) of the PRA 
(44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Exempt Infant Formula Production: Current Good Manufacturing Practices 
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records

OMB Control Number 0910-0811--Extension

    Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is 
represented and labeled for use by an infant with an inborn error of 
metabolism, low birth weight, or who otherwise has an unusual medical 
or dietary problem from the requirements of section 412(a), (b), and 
(c) of the FD&C Act. These formulas are customarily referred to as 
``exempt infant formulas.'' Under part 106 (21 CFR part 106), we 
established requirements for quality factors for infant formulas and 
CGMPs, including quality control procedures. This collection of 
information 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 April 15, 2016 (81 FR 22174), we 
published a notice of availability for the guidance document entitled 
``Guidance for Industry: Exempt Infant Formula Production: Current Good 
Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of 
Audits, and Records and Reports.'' The guidance describes our current 
thinking on the manufacturing of exempt infant formula in relation to 
the requirements in 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 
guidance at http://www.fda.gov/FoodGuidances.
    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.
    The guidance recommended, to the extent practicable, that 
respondents 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 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 
information collection.
    Description of Respondents: The respondent recordkeepers are 
manufacturers of exempt infant formula.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                   Number of
                21 CFR section                     Number of      records per    Total  annual      Average  burden per  recordkeeper      Total  hours
                                                 recordkeepers   recordkeeper       records
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                                                                First-Year Annual Burden
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Production and In-Process Control System                     3               1               3  40......................................             120
 106.6(c)(5) and 106.100(e)(1) and (e)(3).
Controls to Prevent Adulteration due to                      3               1               3  6,400...................................          19,200
 Automatic (Mechanical or Electronic)
 Equipment 106.35(c) and 106.100(f)(5).
                                               ---------------------------------------------------------------------------------------------------------
    Total First Year Only Hourly Recordkeeping  ..............  ..............  ..............  ........................................          19,320
     Burden.
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                                                                 Recurring Annual Burden
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Controls to Prevent Adulteration Caused by                   4               1               4  1.5.....................................               6
 Facilities--Testing for Radiological
 Contaminants 106.20(f)(3).
Controls to Prevent Adulteration Caused by                   4               1               4  0.08 (5 minutes)........................            0.32
 Facilities--Recordkeeping of Testing for
 Radiological Contaminants 106.20(f)(4) and
 106.100(f)(1).
Controls to Prevent Adulteration Caused by                   3              52             156  0.08 (5 minutes)........................           12.48
 Facilities--Testing for Bacteriological
 Contaminants 106.20(f)(3).

[[Page 49395]]

 
Controls to Prevent Adulteration Caused by                   3              52             156  0.08 (5 minutes)........................           12.48
 Facilities--Recordkeeping of Testing for
 Bacteriological Contaminants 106.20(f)(4) and
 106.100(f)(1).
Controls to Prevent Adulteration by Equipment                3              52             156  0.21 (13 minutes).......................           32.76
 or Utensils 106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment                3              52             156  0.21 (13 minutes).......................           32.76
 or Utensils 106.30(e)(3)(iii) and
 106.100(f)(3).
Controls to Prevent Adulteration by Equipment                3              52             156  0.19 (11 minutes).......................           29.64
 or Utensils 106.30(f)(2) and 106.100(f)(4).
Controls to Prevent Adulteration Due to                      3              52             156  520.....................................          81,120
 Automatic (Mechanical or Electronic)
 Equipment 106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Due to                      3               2               6  640.....................................           3,840
 Automatic (Mechanical or Electronic)
 Equipment 106.35(c) and 106.100(f)(5).
Controls to Prevent Adulteration Caused by                   3              52             156  0.17 (10 minutes).......................           26.52
 Ingredients, Containers, and Closures
 106.40(g) and 106.100(f)(6).
Controls to Prevent Adulteration During                      3              52             156  0.23 (14 minutes).......................           35.88
 Manufacturing 106.50 and 106.100(e).
Controls to Prevent Adulteration From                        3              52             156  0.25 (15 minutes).......................              39
 Microorganisms 106.55(d), 106.100(e)(5)(ii),
 and 106.100(f)(7).
Controls to Prevent Adulteration During                      1              12              12  0.25 (15 minutes).......................               3
 Packaging and Labeling of Infant Formula
 106.60(c).
General Quality Control--Testing 106.91(b)(1),               2               1               2  2.......................................               4
 106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1),                        2              52             104  0.15 (9 minutes)........................            15.6
 106.91(d), and 106.100(e)(5)(i).
General Quality Control 106.91(b)(2)                         2              52             104  0.15 (9 minutes)........................            15.6
 106.91(d), and 106.100(e)(5)(i).
General Quality Control 106.91(b)(3)                         2              52             104  0.15 (9 minutes)........................            15.6
 106.91(d), and 106.100(e)(5)(i).
Audit Plans and Procedures 106.94--Ongoing                   3               1               3  8.......................................              24
 Review and Updating of Audits.
Audit Plans and Procedures 106.94--Regular                   3              52             156  4.......................................             624
 Audits.
                                               ---------------------------------------------------------------------------------------------------------
    Total Recurring Recordkeeping Burden......  ..............  ..............  ..............  ........................................       85,889.64
                                               ---------------------------------------------------------------------------------------------------------
        Total Recordkeeping Burden............  ..............  ..............  ..............  ........................................      105,209.64
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we made a 
correction since the last OMB approval. While the one-time estimated 
recordkeeping burden remains as 19,320 hours, we increased the annual 
estimated recurring recordkeeping burden to 85,889.64 hours due to a 
calculation error (a 79,561.58 hour increase) for a total recordkeeping 
burden of 105,209.64 hours.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21207 Filed 9-28-18; 8:45 am]
 BILLING CODE 4164-01-P