Agency Information Collection Activities: Proposed Collection; Comment Request; Infant Formula Recall Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-0192]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Infant Formula Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on requirements related to the

recall of infant formula.

DATES: Submit written comments on the collection of information by

April 26, 1999.

ADDRESSES: Submit written comments on the collection of information to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should

be identified with the docket number found in brackets in the heading

of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed extension of an existing collection of information,

before submitting the collection to OMB for approval. To comply with

this requirement, FDA is publishing notice of the proposed collection

of information set forth below.

With respect to the following collection of information, FDA

invites comments on: (1) Whether the proposed collection of information

is necessary for the proper performance of FDA's functions, including

whether the information will have practical utility; (2) the accuracy

of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the

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burden of the collection of information on respondents, including

through the use of automated collection techniques, when appropriate,

and other forms of information technology.

Infant Formula Recall Regulations--21 CFR 107.230, 107.240,

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

Reinstatement)

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 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.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden

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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 1 1 1 4,500 4,500

107.240 1 1 1 1,482 1,482

107.250 1 1 1 120 120

107.260 1 1 1 650 650

Total 6,752

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

information.

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: February 8, 1999.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 99-4338 Filed 2-22-99; 8:45 am]

BILLING CODE 4160-01-F