[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
