Request for Non-Material Change

UNITED STATES FOOD & DRUG ADMINISTRATION
OMB Control Nos. 0910-0256 – Infant Formula Requirements; and
OMB Control No. 0910-0811 – Exempt Infant Formula
REQUEST FOR NON-MATERIAL CHANGE and DISCONTINUATION:
Justification
The referenced information collections support Food and Drug Administration (FDA)
regulations and associated guidance regarding infant formula. Specifically, 21 CFR part
106 prescribes the steps manufacturers must take under section 412(b)(2) and (b)(3) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(2) and (b)(3)) in
processing infant formula. If the processing of the formula does not comply with any of
the applicable regulations, the infant formula will be deemed to be adulterated under
section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act.
Relatedly, 21 CFR part 107 sets forth the labeling requirements applicable to infant
formula under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 343).
Failure to comply with any of the applicable regulations will render an infant formula
misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act. Information
collection provisions supporting these regulations (21 CFR parts 106 and 107) are
currently approved under OMB Control No. 0910-0256, which expires May 31, 2021
While the infant formula regulations help ensure the consistent production of safe and
nutritionally adequate infant formulas for healthy, term infants, they apply with one
narrow exception. Section 412(h)(1) of the FD&C Act exempts an infant formula
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 sections 412(a), (b), and (c) of the FD&C Act. These formulas are
customarily referred to as “exempt infant formulas.” Section 412(h)(2) of the FD&C Act
authorizes us to establish terms and conditions for the exemption of an infant formula
from the requirements of sections 412(a), (b), and (c) of the FD&C Act. Although certain
terms and conditions are set forth in 21 CFR 107.50, we intend to promulgate regulations
to address any new terms and conditions for exempt infant formulas in future rulemaking.
Until then, we have issued the agency guidance document entitled, “Exempt Infant
Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control
Procedures, Conduct of Audits, and Records and Reports.” The guidance document
includes our recommendation that manufacturers of exempt infant formulas follow, to the
extent practicable, subparts A, B, C, D, and F of 21 CFR part 106. Burden attributable to
recommendations found in the guidance are currently approved under OMB Control No.
0910-0811, which expires March 31, 2019.

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Upon preparing our submission request to renew 0910-0811, a closer evaluation suggests
that the information collection may be consolidated into 0910-0256. Specifically, we
request consolidating the following IC into Control No. 0910-0256 and discontinuing
Control No. 0910-0811:
NEW IC
Exempt infant formula
production; GMP; audits,
recordkeeping, & reports

No. of
respondents
3

No. of
records per
respondent
634.3

Total
annual

Burden per
recordkeeping

Total
hours

1903

45 hours

85,889.64

Since establishing the latter information collection in 2016 we have increased the burden
estimate we attribute to recordkeeping associated with exempt infant formulas. However,
in accordance with 5 CFR 1320.8(d), we published both a 60-day and 30-day notice in
the Federal Register (83 FR 49393 and 84 FR 7381, respectively) requesting public
comment regarding the associated burden. As yet, no comments have been received. But
because the recordkeeping described in the guidance reflects recordkeeping set forth in
the regulations, we believe it is appropriate to consolidate them into one collection.
Additionally, we believe consolidation minimizes the chance of duplicative information
collection. Finally, since last approval of 0910-0811, there have been no program
changes affecting the information collection nor changes to the guidance document.
March 2019