[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Pages 66634-66635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0309]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
January 20, 1998.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St., NW., rm. 10235, Washington, DC 20503, Attn: Desk 
Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(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 106.100, 21 CFR 106.120(b), 21 
CFR 107.10(a), 21 CFR 107.20, 21 CFR 107.50(e)(2), 21 CFR 
107.50(b)(3), 21 CFR 107.50(b)(4), 21 CFR 107.50(c)(3))--(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 manufacturer's 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 parts 106 and 107.
    FDA also regulates the labeling of infant formula under the 
authority of section 403 (21 U.S.C. 343). Under the labeling 
regulations for infant formula in 21 CFR 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 document 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 below. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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106.120(b)                              4               7              28               0               0       
107.10(a) 107.20                        4               7              28               8             224       
107.50(b)(3), (b)(4)                    3               4              12               4              48       
107.50(e)(2)                            3               4              12               0               0       
Total                                                                                                 272       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


                                Table 2.--Estimated Annual Recordkeeping Burden1                                
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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106.100                                 4              10              40           4,000          16,000       
107.50(c)(3)                            4              10              40               0               0       
Total                                                                                              16,000       
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\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. The figures 
for hours per response are based on estimates from experienced persons 
in the agency and in industry. Because these infant formula regulations 
implement statutory information collection requirements, only the 
additional burden attributable to the regulations has been included in 
the estimates.
    Due to clerical error, the burden estimates that appeared in FDA's 
previous notice soliciting comments on this collection of information 
(62 FR 42256, August 6, 1997) were incorrect. The tables above contain 
the correct estimates.


[[Page 66635]]


    Dated: December 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33092 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F