Agency Information Collection Activities; Submission for OMB Review; Comment Request; Infant Formula Recall Regulations and Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-0192]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request; Infant Formula Recall Regulations and

Correction

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). In addition, this

notice is correcting the title of the information collection. In the

Federal Register of February 23, 1999 (64 FR 8832 at 8833), the title

of the information collection was incorrectly listed as a

``Reinstatement;'' it should have been listed as an ``Extension.'' This

document corrects that error.

DATES: Submit written comments on the collection of information by June

16, 1999.

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:

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 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 Recall Regulations--21 CFR 107.230, 107.240,

107.250, 107.260, 107.280 (OMB Control Number 0910-0188--Extension)

Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the

act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant

formula has knowledge that reasonably supports the conclusion that an

infant formula processed by that manufacturer has left its control and

may not provide the nutrients required in section 412(i) of the act or

is otherwise adulterated or misbranded, the manufacturer must promptly

notify the Secretary of Health and Human Services (the Secretary). If

the Secretary determines that the infant formula presents a risk to

human health, the manufacturer must immediately take all actions

necessary to recall shipments of such infant formula from all wholesale

and retail establishments, consistent with recall regulations and

guidelines issued by the Secretary. Section 412(f)(2) of the act states

that the Secretary shall by regulation prescribe the scope and extent

of recalls of infant formula necessary and appropriate for the degree

of risk to human health presented by the formula subject to recall.

FDA's infant formula recall regulations (part 107, subpart E (21 CFR

part 107, subpart E)) implement these statutory provisions.

Section 107.230 requires each recalling firm to: (1) Evaluate the

hazard to human health, (2) devise a written recall strategy, (3)

promptly notify each affected direct account (customer) about the

recall, and (4) furnish the appropriate FDA district office with copies

of these documents. If the recalled formula presents a risk to human

health, the recalling firm must also request that each establishment

that sells the recalled formula post (at point of purchase) a notice of

the recall and provide FDA with a copy of the notice. Section 107.240

requires the recalling firm to: (1) Notify the appropriate FDA district

office of the recall by telephone within 24 hours, (2) submit a written

report to that office within 14 days, and (3) submit a written status

report at least every 14 days until the recall is terminated. Before

terminating a recall, the recalling firm is required to submit a

recommendation for termination of the recall to the appropriate FDA

district office and wait for written FDA concurrence (Sec. 107.250).

Where the recall strategy or implementation is determined to be

deficient, FDA may require the firm to change the extent of the recall,

carry out additional

[[Page 26766]]

effectiveness checks, and issue additional notifications

(Sec. 107.260). In addition, to facilitate location of the product

being recalled, the recalling firm is required to maintain distribution

records for at least 1 year after the expiration of the shelf life of

the infant formula (Sec. 107.280).

The reporting and recordkeeping requirements described previously

are designed to enable FDA to monitor the effectiveness of infant

formula recalls in order to protect babies from infant formula that may

be unsafe because of contamination or nutritional inadequacy or

otherwise adulterated or misbranded. FDA uses the information collected

under these regulations to help ensure that such products are quickly

and efficiently removed from the market. If manufacturers were not

required to provide this information to FDA, FDA's ability to ensure

that recalls are conducted properly would be greatly impaired.

In the Federal Register of February 23, 1999 (64 FR 8832), the

agency requested comments on the proposed collections of information.

No comments were received.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden\1\

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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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107.230 3 1 3 4,500 13,500

107.240 3 1 3 1,482 4,446

107.250 3 1 3 120 360

107.260 3 1 1 650 650

Total 18,956\2\

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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

\2\Due to clerical error, the reporting burden hours for Secs. 107.230, 107.240, 107.250, and the total burden

hours that appeared in a notice issued in the Federal Register of February 23, 1999 (64 FR 8832), were

incorrect. Table 1 of this document contains the correct estimates.

Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources

necessary to comply with a collection of information are excluded from

the burden estimate if the reporting, recordkeeping, or disclosure

activities needed to comply are usual and customary because they would

occur in the normal course of activities. No burden has been estimated

for the recordkeeping requirement in Sec. 107.280 because these records

are maintained as a usual and customary part of normal business

activities. Manufacturers keep infant formula distribution records for

the prescribed period as a matter of routine business practice.

The reporting burden estimate is based on agency records, which

show that there are five manufacturers of infant formula and that there

have been three recalls in the last 3 years, or one recall annually.

Dated: May 10, 1999.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 99-12283 Filed 5-14-99; 8:45 am]

BILLING CODE 4160-01-F