Document ID: FDA-2010-N-0190-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Infant Formula Requirements
Posted Date: 2010-08-10T04:00Z

[Federal Register: August 10, 2010 (Volume 75, Number 153)]
[Notices]               
[Page 48350-48351]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au10-57]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0190]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Infant Formula 
Requirements

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 
September 9, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0256. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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.

Infant Formula Requirements--21 CFR Parts 106 and 107 (OMB Control 
Number 0910-0256)--Extension

    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) 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 
parts 106 and 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. In a notice of 
proposed rulemaking published in the Federal Register of July 9, 1996 
(61 FR 36154), FDA proposed changes in the infant formula regulations, 
including some of those listed in tables 1, 2, and 3 of this document. 
The document included revised burden estimates for the proposed changes 
and solicited public comment. In the interim, however, FDA is seeking 
an extension of OMB approval for the current regulations so that it can 
continue to collect information while the proposal is pending.
    In the Federal Register of May 4, 2010 (75 FR 23777), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Food, Drug, and Cosmetic Act or  21 CFR        No. of         Annual Frequency      Total Annual          Hours per
                    Section                          Respondents        per  Response         Responses           Response             Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 412(d) of the act                                         5                  13                  65                  10                      650
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 106.120(b)                                                 1                   1                   1                   4                        4
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(b)(3) and (b)(4)                                    3                   2                   6                   4                       24
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(e)(2)                                               1                   1                   1                   4                        4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                682
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 48351]]

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       No. of         Annual Frequency      Total Annual
                 21 CFR Section                     Recordkeepers    per  Recordkeeping        Records        Hours per  Record        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
106.100                                                           5                  10                  50                 400                   20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.50(c)(3)                                                      3                  10                  30                 300                    9,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             29,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3.--Estimated Annual Third Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       No. of         Annual Frequency      Total Annual          Hours per
                 21 CFR Section                      Respondents        of Disclosure        Disclosures         Disclosure            Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.10(a) and 107.20                                              5                  13                  65                   8                      520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In compiling these estimates, FDA consulted its records of the 
number of infant formula submissions received in the past. All infant 
formula submissions to FDA may be provided in electronic format. The 
hours per response reporting estimates are based on FDA's experience 
with similar programs and information received from industry.
    FDA estimates that it will receive 13 reports from 5 manufacturers 
annually under section 412(d) of the act, for a total annual response 
of 65 reports. Each report is estimated to take 10 hours per response 
for a total of 650 hours. FDA also estimates that it will receive one 
notification under Sec.  106.120(b). The notification is expected to 
take 4 hours per response, for a total of 4 hours.
    For exempt infant formula, FDA estimates that it will receive 2 
reports from 3 manufacturers annually under Sec. Sec.  107.50(b)(3) and 
(b)(4), for a total annual response of 6 reports. Each report is 
estimated to take 4 hours per response for a total of 24 hours. FDA 
also estimates that it will receive one notification under Sec.  
107.50(e)(2). The notification is expected to take four hours per 
response, for a total of four hours.
    FDA estimates that 5 firms will expend approximately 20,000 hours 
per year to fully satisfy the recordkeeping requirements in Sec.  
106.100. It is estimated that 3 firms will expend approximately 9,000 
hours per year to fully satisfy the recordkeeping requirements in Sec.  
107.50(c)(3).
    FDA estimates that compliance with the labeling requirements of 
Sec. Sec.  107.10(a) and 107.20 will require 520 hours annually by 5 
manufacturers.

    Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19640 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S