This ICR supports the recordkeeping,
reporting, and labeling requirements for the manufacture and
distribution of infant formula. Respondents to this collection are
infant formula manufacturers who must ensure that their products
adhere to the quality control provisions and procedures found in
FDA regulations, and that nutrient information and directions for
use are disclosed in their product labeling.
FDA is submitting this
request memorandum in accordance with 5 CFR 1320.13. As disruptions
in the supply of infant formula continue, we are pursuing
longer-term information collection pertaining to our exercise of
enforcement discretion to provide certain manufacturers a pathway
to market covered products that may not currently meet certain
applicable requirements. Immediate implementation of the
information collection is critical to providing predictability,
stability, and continuity in the infant formula market,
specifically with respect to products currently available to
infants in the U.S. under FDA’s exercise of enforcement discretion.
Because we believe that routine procedures allowing for a 60-day
comment period would have prevented our ability to immediately
implement the information collection, we requested a waiver from
the requirement to publish notice in the Federal Register under 5
CFR 1320.13(a)(2)(iii).
US Code:
21 USC 301 et seq. Name of Law: Federal Food, Drug, and
Cosmetic Act (FFDCA)
FDA is temporarily exercising
enforcement discretion with respect to how respondents comply with
applicable requirements, including adjustments to existing ways to
comply with such requirements (see 5 CFR 1320.3(b)(1)(v)) to
address an immediate threat to the public health resulting from the
disruption in the supply of necessary products.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Reports under FFDCA section 412(d)