OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Infant Formula Requirements

ICR 201006-0910-008 · OMB 0910-0256 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-06-30
IC Document Collections
IC ID
Document
Title
Status
5835 Modified
179355
Modified
179354
Modified
179353
Modified
179352
Modified
179351
Modified
179350
Modified
ICR Details
0910-0256 201006-0910-008
Historical Active 200703-0910-015
HHS/FDA
Infant Formula Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 10/01/2010
Retrieve Notice of Action (NOA) 06/30/2010
  Inventory as of this Action Requested Previously Approved
10/31/2013 36 Months From Approved 09/30/2010
218 0 218
30,202 0 30,202
0 0 0
Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the act (21 U.S.C. 350a), which was added by the Infant Formula Act of 1980 (IFA), requires manufacturers of infant formula to establish and adhere to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of distribution. FDA has issued regulations to implement the act's requirements for infant formula in 21 CFR part 106 and part 107 (21 CFR parts 106 and 107). FDA also regulates the labeling of infant formula under the authority of section 403 of the act (21 U.S.C. 343). Under the labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately.
US Code: 21 USC 350a Name of Law: FFDCA
   US Code: 21 USC 343 Name of Law: FFDCA
  
None
Not associated with rulemaking
  75 FR 23777 05/04/2010
75 FR 46777 06/30/2010
No
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 218 218 0 0 0 0
Annual Time Burden (Hours) 30,202 30,202 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$696,674
No
No
No
Uncollected
No
Uncollected
Denver Presley 3018271462
  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.
06/30/2010