Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations, 51371-51373 [2011-21040]
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51371
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of responses per
respondent
No. of respondents
21 CFR section
Average burden per response
Total annual
responses
Total hours
130.17(i) ...............................................................................
1
2
2
2
4
Total ..............................................................................
........................
........................
........................
........................
654
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on the Agency’s experience with
applications received for the past 3
years, and information from firms that
have submitted recent requests for
temporary marketing permits. Based on
this information, we estimate that there
will be, on average, approximately 13
firms submitting requests for two
temporary marketing permits per year
over the next 3 years.
Thus, FDA estimates that 13
respondents will submit 2 requests for
temporary marketing permits annually
under § 130.17(c). The estimated
number of respondents for § 130.17(i) is
minimal because this section is seldom
used by the respondents; therefore, the
Agency estimates that there will be one
or fewer respondents annually with two
or fewer requests for extension of the
marketing permit under § 130.17(i). The
estimated number of hours per response
is an average based on the Agency’s
experience and information from firms
that have submitted recent requests for
temporary marketing permits. We
estimate that 13 respondents each will
submit 2 requests for temporary
marketing permits under § 130.17(c) and
that it will take a respondent 25 hours
per request to comply with the
requirements of that section, for a total
of 650 hours. We estimate that one
respondent will submit two requests for
extension of its temporary marketing
permits under § 130.17(i) and that it will
take a respondent 2 hours per request to
comply with the requirements of that
section, for a total of 4 hours.
Dated: August 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2011–21039 Filed 8–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0425]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
19, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0188. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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 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)
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16:04 Aug 17, 2011
Jkt 223001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
(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 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
E:\FR\FM\18AUN1.SGM
18AUN1
51372
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
for termination of the recall to the
appropriate FDA district office and wait
for written FDA concurrence
(§ 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
(§ 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 (§ 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.
In the Federal Register of June 7, 2011
(76 FR 32976), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA has added a new table 2 to this
document to comply with the new
requirement to report third-party
disclosure burden hours in a separate
table. The third-party disclosure burden
hours were previously reported in the
60-day notice under the reporting
burden table (table 1). In compliance
with the new requirement, we have
broken out the third-party disclosure
burden hours in a new third-party
disclosure burden table (table 2). FDA
has moved 50 hours per recall from line
1 of table 1 to line 1 of table 2, and 25
hours per recall from line 4 of table 1
to line 2 of table 2. This is being done
to show the third-party disclosure
burden previously disclosed in table 1.
The total estimated burden of this
collection remains unchanged at 12,864
hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of responses per respondent
Number of respondents
21 CFR Section
Total annual responses
Average burden
per response (in
hours)
Total hours
107.230 ............................................................
107.240 ............................................................
107.250 ............................................................
107.260 2 ..........................................................
2
2
2
1
1
1
1
1
2
2
2
1
4,450
1,482
120
625
8,900
2,964
240
625
Total ..........................................................
............................
............................
............................
............................
12,729
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden has been estimated for the recordkeeping requirement in § 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
2 No
The reporting and third-party
disclosure burden estimates are based
on Agency records, which show that
there are five manufacturers of infant
formula and that there have been, on
average, two infant formula recalls per
year for the past 3 years. Based on this
information, we estimate that there will
be, on average, approximately two
infant formula recalls per year over the
next 3 years.
Thus, FDA estimates that two
respondents will conduct recalls
annually under §§ 107.230, 107.240, and
107.250. The estimated number of
respondents for § 107.260 is minimal
because this section is seldom used by
FDA; therefore, the Agency estimates
that there will be one or fewer
respondents annually for § 107.260.
The estimated number of reporting
burden hours per response is an average
based on the Agency’s experience and
information from firms that have
conducted recalls. We estimate that two
respondents will conduct infant formula
recalls under § 107.230 and that it will
VerDate Mar<15>2010
16:04 Aug 17, 2011
Jkt 223001
take a respondent 4,450 hours to comply
with the requirements of that section,
for a total of 8,900 hours. In the 60-day
notice, we estimated that it will take a
respondent 4,500 hours per recall to
comply with § 107.230 for a total of
9,000 hours. As noted, we have added
a new table 2 to report third-party
disclosure burden hours. The new lower
figure of 4,450 hours per recall reflects
that 50 hours are being reported in new
table 2. We estimate that two
respondents will conduct infant formula
recalls under § 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. We estimate
that two respondents will submit
recommendations for termination of
infant formula recalls under § 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, we estimate that one
respondent will need to carry out
additional effectiveness checks and
issue additional notifications under
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
§ 107.260, for a total of 625 hours. In the
60-day notice, we estimated that it will
take a respondent 650 hours per recall
to comply with § 107.260 for a total of
650 hours. As noted, we have added a
new table 2 to report third-party
disclosure burden hours. The new lower
figure of 625 hours per recall reflects
that 25 hours are being reported in new
table 2.
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 § 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.
E:\FR\FM\18AUN1.SGM
18AUN1
51373
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN1
Number of
disclosures per
respondent
Number of
respondents
21 CFR Section
Average burden
per disclosure
(in hours)
Total annual
disclosures
Total hours
107.230 ............................................................
107.260 ............................................................
2
1
1
1
2
1
50
25
100
25
Total ..........................................................
............................
............................
............................
............................
125
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
New table 2 reports the Agency’s
third-party disclosure burden estimates
for §§ 107.230 and 107.260. The
estimated burden hours per disclosure
is an average based on the Agency’s
experience. The third-party disclosure
burden in § 107.230 is the requirement
to promptly notify each affected directaccount (customer) about the recall and
if the recalled formula presents a risk to
human health, the requirement that the
recalling firm must also request that
each establishment that sells the
recalled formula post (at the point of
purchase) a notice of the recall. We
estimate that two respondents will
conduct infant formula recalls under
§ 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
§ 107.260 is the requirement to issue
additional notifications where the recall
strategy or implementation is
determined to be deficient. We estimate
that one respondent will issue
additional notifications under § 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 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–21040 Filed 8–17–11; 8:45 am]
BILLING CODE 4160–01–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
Food and Drug Administration
[Docket No. FDA–2011–N–0402]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
19, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0277. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
State Petitions for Exemption From
Preemption—21 CFR 100.1(d) (OMB
Control Number 0910–0277)—Extension
Under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 343–1(b)), States
may petition FDA for exemption from
Federal preemption of State food
labeling and standard of identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under § 100.1(d) enables FDA to
determine whether the State food
labeling or standard of identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
In the Federal Register of June 10,
2011 (76 FR 34082), FDA published a
60-day notice requesting public
comment 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
mstockstill on DSK4VPTVN1PROD with NOTICES
100.1(d) ................................................................................
1 There
Number of responses per
respondent
Number of
respondents
21 CFR section
1
Average
burden per
response
Total annual
responses
1
1
40
Total hours
40
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
FDA has not received any new petitions
VerDate Mar<15>2010
16:04 Aug 17, 2011
Jkt 223001
for exemption from preemption;
therefore, the Agency estimates that one
or fewer petitions will be submitted
annually. Although FDA has not
received any new petitions for
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
exemption from preemption in the last
3 years, it believes these information
collection provisions should be
extended to provide for the potential
future need of a State or local
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51371-51373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0425]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula Recall
Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
September 19, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0188.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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 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 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
[[Page 51372]]
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.
In the Federal Register of June 7, 2011 (76 FR 32976), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA has added a new table 2 to this document to comply with the new
requirement to report third-party disclosure burden hours in a separate
table. The third-party disclosure burden hours were previously reported
in the 60-day notice under the reporting burden table (table 1). In
compliance with the new requirement, we have broken out the third-party
disclosure burden hours in a new third-party disclosure burden table
(table 2). FDA has moved 50 hours per recall from line 1 of table 1 to
line 1 of table 2, and 25 hours per recall from line 4 of table 1 to
line 2 of table 2. This is being done to show the third-party
disclosure burden previously disclosed in table 1. The total estimated
burden of this collection remains unchanged at 12,864 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response (in Total hours
respondents respondent responses hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.230....................................................... 2 1 2 4,450 8,900
107.240....................................................... 2 1 2 1,482 2,964
107.250....................................................... 2 1 2 120 240
107.260 \2\................................................... 1 1 1 625 625
-----------------------------------------------------------------------------------------
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 Agency records, which show that there are five manufacturers of
infant formula and that there have been, on average, two infant formula
recalls per year for the past 3 years. Based on this information, we
estimate that there will be, on average, approximately two infant
formula recalls per year over the next 3 years.
Thus, FDA estimates that two respondents will conduct recalls
annually under Sec. Sec. 107.230, 107.240, and 107.250. The estimated
number of respondents for Sec. 107.260 is minimal because this section
is seldom used by FDA; therefore, the Agency estimates that there will
be one or fewer respondents annually for Sec. 107.260.
The estimated number of reporting burden hours per response is an
average based on the Agency's experience and information from firms
that have conducted recalls. We estimate that two 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. In the 60-day notice, we estimated
that it will take a respondent 4,500 hours per recall to comply with
Sec. 107.230 for a total of 9,000 hours. As noted, we have added a new
table 2 to report third-party disclosure burden hours. The new lower
figure of 4,450 hours per recall reflects that 50 hours are being
reported in new table 2. We estimate that two 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. We estimate that two 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, we estimate that one respondent will need to carry out
additional effectiveness checks and issue additional notifications
under Sec. 107.260, for a total of 625 hours. In the 60-day notice, we
estimated that it will take a respondent 650 hours per recall to comply
with Sec. 107.260 for a total of 650 hours. As noted, we have added a
new table 2 to report third-party disclosure burden hours. The new
lower figure of 625 hours per recall reflects that 25 hours are being
reported in new table 2.
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 51373]]
Table 2--Estimated Annual Third-Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of disclosures per Total annual per disclosure Total hours
respondents respondent disclosures (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.230....................................................... 2 1 2 50 100
107.260....................................................... 1 1 1 25 25
-----------------
Total..................................................... ................ ................ ................ ................ 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
New table 2 reports the Agency'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 the Agency'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
requirement that the recalling firm must also request that each
establishment that sells the recalled formula post (at the point of
purchase) a notice of the recall. We estimate that two 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. We estimate that one 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 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21040 Filed 8-17-11; 8:45 am]
BILLING CODE 4160-01-P
