Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. 00N-1441]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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.
 DATES: Submit written comments on the collection of information by December 11, 2000.
 ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
 FOR FURTHER INFORMATION CONTACT: Peggy 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 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Infant Formula Requirements (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: (1) Establish and adhere to quality control procedures, (2) notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and (3) 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 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 in tables 1 and 2 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 August 18, 2000 (65 FR 50539), the agency requested comments 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 (the Act) or 21 CFR Section
No. of ­Respondents
Annual ­Frequency per ­Response
Total Annual Responses
Hours per ­Response
Total HoursSection 412(d) of the act
4
7
28
10
280106.120(b)
4
0.25
1
4
4107.10(a) and 107.20
4
7
28
8
224107.50(b)(3) and (b)(4)
3
4
12
4
48107.50(e)(2)
3
0.33
1
4
4Total




5601
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 
 
 **Table**
                         2.—
                        **Estimated Annual Recordkeeping Burden**1
21 CFR Section
No. of ­Recordkeepers
Annual ­Frequency per Recordkeeping
Total Annual Records
Hours per ­Recordkeeper
Total Hours106.100
4
10
40
4,000
16,000107.50(c)(3)
3
10
30
3,000
9,000Total




25,0001
                         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. Dated: November 6, 2000. Margaret M. Dotzel, Associate Commissioner for Policy.


[FR Doc. 00-28852 Filed 11-8-00; 8:45 am] BILLING CODE 4160-01-F