Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations, 46270-46272 [2014-18665]

Download as PDF 46270 Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR 100.1(d) Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Form of petition .................................................................... 1 1 1 40 40 1 There 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, we have received one new petition for exemption from preemption; therefore, we estimate that one or fewer petitions will be submitted annually. Dated: August 1, 2014. Leslie Kux, Assistant Commissioner for Policy. control number 0910–0621. The approval expires on July 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: July 31, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18600 Filed 8–6–14; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2014–18640 Filed 8–6–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1027] Food and Drug Administration [Docket No. FDA–2011–N–0017] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Voluntary National Retail Food Regulatory Program Standards’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. SUMMARY: On May 29, 2014, the Agency submitted a proposed collection of information entitled ‘‘Voluntary National Retail Food Regulatory Program Standards’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB emcdonald on DSK67QTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:14 Aug 06, 2014 Jkt 232001 Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 https:// 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. SUMMARY: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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. FOR FURTHER INFORMATION CONTACT: 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 E:\FR\FM\07AUN1.SGM 07AUN1 46271 Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices 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. appropriate FDA district office and wait FDA’s written 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, 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: 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 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 107.230; 107.240; 107.250; 107.260; Number of responses per respondent Number of respondents 21 CFR Section; activity Average burden per response Total annual responses Total hours Elements of infant formula recall .......................... Notification requirements ...................................... Termination of infant formula recall ...................... Revision of an infant formula recall 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. emcdonald on DSK67QTVN1PROD with NOTICES 2 No 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 §§ 107.230, 107.240, and 107.250. The estimated number of respondents for § 107.260 is minimal because FDA seldom uses this section; therefore, FDA estimates that there will be 1 or fewer respondents annually for § 107.260. The estimated number of hours per response is an VerDate Mar<15>2010 17:14 Aug 06, 2014 Jkt 232001 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 § 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 § 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 § 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 § 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\07AUN1.SGM 07AUN1 46272 Federal Register / Vol. 79, No. 152 / Thursday, August 7, 2014 / Notices TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Section; activity Average burden per disclosure Total annual disclosures Total hours 107.230; Elements of infant formula recall .......................... 107.260; Revision of an infant formula recall ...................... 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. Table 2 reports FDA’s third-party disclosure burden estimates for §§ 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 § 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 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 § 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. FDA estimates that 1 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 1, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Radioactive Drug Research Committees’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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: On May 9, 2014, the Agency submitted a proposed collection of information entitled ‘‘Radioactive Drug Research Committees’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0053. The approval expires on July 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: Dated: July 31, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18665 Filed 8–6–14; 8:45 am] [FR Doc. 2014–18609 Filed 8–6–14; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2007–N–0383] emcdonald on DSK67QTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2014–N–1088] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees Center for Devices and Radiological Health: Experiential Learning Program; General Training Program AGENCY: Food and Drug Administration, HHS. ACTION: 17:14 Aug 06, 2014 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for SUMMARY: Notice. VerDate Mar<15>2010 AGENCY: Jkt 232001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Devices and Radiological Health (CDRH or Center) is announcing a new component of the Experiential Learning Program (ELP) identified as the ELP General Training Program. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the ELP General Training Program. DATES: Submit either an electronic or written request for participation in the ELP General Training Program by September 8, 2014. ADDRESSES: Submit either electronic requests to https://www.regulations.gov or written requests to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify proposals with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993–0002, 301–796–6965, FAX: 301–827–3079, Latonya.powell@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices and safe radiation-emitting products. In support of this mission, the Center launched various training and development initiatives to enhance performance of its staff involved in regulatory review and E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[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]

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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 https://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

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