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.
$272,773
No
No
No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
No
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)