[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7381-7383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 April 
3, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0811. 
Also include the FDA docket number found

[[Page 7382]]

in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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

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)-(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 https://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 
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.
    In the Federal Register of October 1, 2018 (83 FR 49393), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection 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:
    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           ..............  ..............  ..............  .........................................          19,320
         Recordkeeping Burden.
Recurring Annual Burden:
    Controls to Prevent Adulteration Caused                 4               1               4  1.5......................................               6
     by Facilities--Testing for Radiological
     Contaminants--106.20(f)(3).
    Controls to Prevent Adulteration Caused                 4               1               4  0.08 (5 minutes).........................            0.32
     by Facilities--Recordkeeping of Testing
     for Radiological Contaminants--
     106.20(f)(4) and 106.100(f)(1).
    Controls to Prevent Adulteration Caused                 3              52             156  0.08 (5 minutes).........................           12.48
     by Facilities--Testing for
     Bacteriological Contaminants--
     106.20(f)(3).
    Controls to Prevent Adulteration Caused                 3              52             156  0.08 (5 minutes).........................           12.48
     by Facilities--Recordkeeping of Testing
     for Bacteriological Contaminants--
     106.20(f)(4) and 106.100(f)(1).
    Controls to Prevent Adulteration by                     3              52             156  0.21 (13 minutes)........................           32.76
     Equipment or Utensils--106.30(d)(1) and
     106.100(f)(2).
    Controls to Prevent Adulteration by                     3              52             156  0.21 (13 minutes)........................           32.76
     Equipment or Utensils--106.30(e)(3)(iii)
     and 106.100(f)(3).
    Controls to Prevent Adulteration by                     3              52             156  0.19 (11 minutes)........................           29.64
     Equipment or Utensils--106.30(f)(2) and
     106.100(f)(4).

[[Page 7383]]

 
    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                 3              52             156  0.17 (10 minutes)........................           26.52
     by 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--                       2               1               2  2........................................               4
     106.91(b)(1)-(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;                     3               1               3  8........................................              24
     Ongoing Review and Updating of Audits.
    Audit Plans and Procedures--106.94;                     3              52             156  4........................................             624
     Regular 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: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03824 Filed 3-1-19; 8:45 am]
 BILLING CODE 4164-01-P