Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations, 16018-16020 [E8-6060]
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
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.
Electronic Records; Electronic
Signatures—21 CFR Part 11 (OMB
Control Number 0910–0303)—Extension
The FDA regulations in 21 CFR part
11 (part 11) provide criteria for
acceptance of electronic records,
electronic signatures, and handwritten
signatures executed to electronic
records as equivalent to paper records.
Under these regulations, records and
reports may be submitted to FDA
electronically provided the agency has
stated its ability to accept the records
electronically in an agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require standard operating procedures
to assure appropriate use of, and
precautions for, systems using
electronic records and signatures; (1)
§ 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) § 11.30
specifies procedures and controls for
persons who use open systems to create,
modify, maintain, or transmit electronic
records; (3) § 11.50 specifies procedures
and controls for persons who use
electronic signatures; and (4) § 11.300
specifies controls to ensure the security
and integrity of electronic signatures
based upon use of identification codes
in combination with passwords. The
reporting provision (§ 11.100) requires
persons to certify in writing to FDA that
they will regard electronic signatures
used in their systems as the legally
binding equivalent of traditional
handwritten signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The agency anticipates the
use of electronic media will
substantially reduce the paperwork
burden associated with maintaining
FDA required records.
The respondents will be businesses
and other for-profit organizations, state
or local governments, Federal agencies,
and nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
11.100
1 There
Annual Frequency
per Response
4,500
Total Annual
Responses
1
Hours per
Response
4,500
Total Hours
1
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
11.10
2,500
1
2,500
20
50,000
11.30
2,500
1
2,500
20
50,000
11.50
4,500
1
4,500
20
90,000
11.300
4,500
1
4,500
20
90,000
Total
pwalker on PROD1PC71 with NOTICES
1 There
280,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6055 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0169]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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18:52 Mar 25, 2008
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Notice.
26MRN1
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
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 or electronic
comments on the collection of
information by May 27, 2008.
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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
SUPPLEMENTARY INFORMATION:
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 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 in part 107 (21 CFR
16019
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
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
pwalker on PROD1PC71 with NOTICES
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
107.230
2
1
2
4,500
9,000
107.240
2
1
2
1,482
2,964
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18:52 Mar 25, 2008
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Fmt 4703
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16020
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
107.250
2
1
2
120
240
107.260
1
1
1
650
650
Total
12,854
1There
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 § 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,
on average, two infant formula recalls
per year for the past 3 years.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6060 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pwalker on PROD1PC71 with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
18:52 Mar 25, 2008
Jkt 214001
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.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2008–N–0170]
AGENCY:
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
the procedure by which a manufacturer
or distributor of dietary supplements or
of a new dietary ingredient is to submit
to FDA information upon which the
manufacturer or distributor has based its
conclusion that a dietary supplement
containing a new dietary ingredient will
reasonably be expected to be safe.
DATES: Submit written or electronic
comments on the collection of
information by May 27, 2008.
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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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.
Premarket Notification for a New
Dietary Ingredient—21 CFR 190.6
(OMB Control Number 0910–0330)—
Extension
Section 413(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 350b(a)) provides that at least 75
days before the introduction or delivery
for introduction into interstate
commerce of a dietary supplement that
contains a new dietary ingredient, a
manufacturer or distributor of dietary
supplements or of a new dietary
ingredient is to submit to FDA (as
delegate for the Secretary of Health and
Human Services) information upon
which the manufacturer or distributor
has based its conclusion that a dietary
supplement containing a new dietary
ingredient will reasonably be expected
to be safe. Part 190 (21 CFR part 190)
implements these statutory provisions.
Section 190.6(a) requires each
E:\FR\FM\26MRN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16018-16020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0169]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Recall Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 16019]]
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 or electronic comments on the collection of
information by May 27, 2008.
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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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
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 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.230 2 1 2 4,500 9,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.240 2 1 2 1,482 2,964
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 16020]]
107.250 2 1 2 120 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.260 1 1 1 650 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 12,854
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, on average, two infant formula recalls per year for the past
3 years.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6060 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
