Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations, 35699-35700 [E8-14258]
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35699
Federal Register / Vol. 73, No. 122 / Tuesday, June 24, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
606.160(b)(1)(viii)
HIV consignee notification
2,000
10.50
21,000
.17
3,570
4,980
4.21
21,000
.17
3,570
2,000
23.40
46,800
.17
7,956
4,980
9.4
46,800
.17
7,956
HIV recipient notification
4,980
0.35
1,755
.17
298
HCV recipient notification
4,980
0.41
2,050
.17
349
606.160(b)(1)(ix)
2,081
840.94
1,750,000
0.05
875,000
606.160(b)(1)(xi)
2,000
3.375
6,750
0.05
338
606.165
3535
793.20
280,000
0.083
23,240
606.170(a)
3535
12
4,236
1.00
4,236
610.40(g)(1)
2,081
1
2,081
0.50
1,041
HCV consignee notification
Total
1,149,926
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b).
3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included
in the estimate for § 606.110(a).
4The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and
(c); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various
records are included in the estimate for § 606.160.
5Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that transfuse blood and components
and FDA-registered blood establishments (0.05 x 4,980 + 2,081).
6Five percent of plateletpheresis and leukopheresis establishments (0.05 x 696).
2The
Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14248 Filed 6–23–08; 8:45 am]
BILLING CODE 4160–01–S
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
collection of information to OMB for
review and clearance.
Fax written comments on the
collection of information by July 24,
2008.
Infant Formula Recall Regulations—
(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
DATES:
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:
202–395–6974, or e-mailed to
baguilar@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.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0169]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC60 with NOTICES
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
VerDate Aug<31>2005
12:39 Jun 23, 2008
Jkt 214001
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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35700
Federal Register / Vol. 73, No. 122 / Tuesday, June 24, 2008 / Notices
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
(§ 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 March 26,
2008 (73 FR 16018), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
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
107.250
2
1
2
120
240
107.260
1
1
1
650
650
Total
1There
12,854
are no capital costs or operating and maintenance costs associated with this collection of information.
ebenthall on PRODPC60 with NOTICES
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.
Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14258 Filed 6–23–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
12:39 Jun 23, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Novel Fluorinated Dmt-Tic Analogues
for Use as PET Radiotracers
Description of Technology:
Researchers at the NIH have developed
fluorine-18 (18F) labeled analogues
specific for the delta-opioid receptors.
These radioligands include analogues of
the Dmt-Tic pharmacophore, containing
a delta-opioid receptor antagonist that
may be useful for imaging opioid
receptors expressed in lung malignant
tumors or other peripheral tumors that
express delta-opioid receptors. This
methodology might be readily
applicable to Dmt-Tic pharmacophoric
ligands that exhibit dual antagonism for
delta-/mu-opioid receptors.
Studies by the inventors have shown
that injected radioligand failed to cross
the blood-brain barrier (BBB) of rats;
therefore, these compounds could serve
as radiotracers for assessing and locating
certain carcinomas that contain high
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 73, Number 122 (Tuesday, June 24, 2008)]
[Notices]
[Pages 35699-35700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0169]
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 July
24, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: 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: 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--(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
[[Page 35700]]
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.
In the Federal Register of March 26, 2008 (73 FR 16018), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14258 Filed 6-23-08; 8:45 am]
BILLING CODE 4160-01-S
