
[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46270-46272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18665]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1027]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 information collection 
provisions in FDA's infant formula recall regulations.

DATES: Submit either electronic or written comments on the collection 
of information by October 6, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 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, and 107.280 (OMB Control Number 0910-0188)--Extension

    Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an 
infant formula has

[[Page 46271]]

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 FD&C 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 FD&C 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 in part 107 (21 CFR 
part 107) implement these statutory provisions.
    Section 107.230 requires each recalling firm to conduct an infant 
formula recall with the following elements: (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 conduct an infant formula recall with the following 
elements: (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 FDA's written 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, 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.
    FDA estimates the annual burden of this collection of information 
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR Section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2           4,450           8,900
 formula recall.................
107.240; Notification                          2               1               2           1,482           2,964
 requirements...................
107.250; Termination of infant                 2               1               2             120             240
 formula recall.................
107.260; Revision of an infant                 1               1               1             625             625
 formula recall \2\.............
                                                                                                 ---------------
    Total.......................  ..............  ..............  ..............  ..............          12,729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 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 and third-party disclosure burden estimates are based 
on FDA's records, which show that there are 5 manufacturers of infant 
formula and that there have been, on average, 2 infant formula recalls 
per year for the past 3 years. Based on this information, FDA estimates 
that there will be, on average, approximately 2 infant formula recalls 
per year over the next 3 years.
    Thus, FDA estimates that 2 respondents will conduct recalls 
annually pursuant to Sec. Sec.  107.230, 107.240, and 107.250. The 
estimated number of respondents for Sec.  107.260 is minimal because 
FDA seldom uses this section; therefore, FDA estimates that there will 
be 1 or fewer respondents annually for Sec.  107.260. The estimated 
number of hours per response is an average based on FDA's experience 
and information from firms that have conducted recalls. FDA estimates 
that 2 respondents will conduct infant formula recalls under Sec.  
107.230 and that it will take a respondent 4,450 hours to comply with 
the requirements of that section, for a total of 8,900 hours. FDA 
estimates that 2 respondents will conduct infant formula recalls under 
Sec.  107.240 and that it will take a respondent 1,482 hours to comply 
with the requirements of that section, for a total of 2,964 hours. FDA 
estimates that 2 respondents will submit recommendations for 
termination of infant formula recalls under Sec.  107.250 and that it 
will take a respondent 120 hours to comply with the requirements of 
that section, for a total of 240 hours. Finally, FDA estimates that one 
respondent will need to carry out additional effectiveness checks and 
issue additional notifications, for a total of 625 hours.
    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.

[[Page 46272]]



                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR Section; activity         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant                    2               1               2              50             100
 formula recall.................
107.260; Revision of an infant                 1               1               1              25              25
 formula recall.................
                                                                                                 ---------------
    Total.......................  ..............  ..............  ..............  ..............             125
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 2 reports FDA's third-party disclosure burden estimates for 
Sec. Sec.  107.230 and 107.260. The estimated burden hours per 
disclosure is an average based on FDA's experience. The third-party 
disclosure burden in Sec.  107.230 is the requirement to promptly 
notify each affected direct-account (customer) about the recall, and 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 a notice of the recall at the point of purchase. FDA 
estimates that 2 respondents will conduct infant formula recalls under 
Sec.  107.230 and that it will take a respondent 50 hours to comply 
with the third-party disclosure requirements of that section, for a 
total of 100 hours. The third-party disclosure burden in Sec.  107.260 
is the requirement to issue additional notifications where the recall 
strategy or implementation is determined to be deficient. FDA estimates 
that 1 respondent will issue additional notifications under Sec.  
107.260 and that it will take a respondent 25 hours to comply with the 
third-party disclosure requirements of that section, for a total of 25 
hours.

    Dated: August 1, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-18665 Filed 8-6-14; 8:45 am]
BILLING CODE 4164-01-P


