National Cancer Institute; Notice of Meeting, 5189-5190 [05-1837]
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Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices
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,
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,
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:
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 (part 107 (21 CFR part
107), subpart E) 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
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency
per Response
No. of Respondents
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
1 There
12,854
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.
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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: January 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1815 Filed 1–31–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2), notice
is hereby given of the meeting of the
National Cancer Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
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Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
A portion of the meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4), and 552b(c)(6), as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Advisory Board Subcommittee on Planning
and Budget.
Open: February 15, 2005, 7 p.m. to 9 p.m.
Agenda: To discuss activities related to the
Subcommittee on Planning and Budget.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: Ms. Cherie Nichols,
Executive Secretary, National Cancer
Institutes, National Institutes of Health, 6116
Executive Boulevard, 2nd Floor, Room 205,
Bethesda, MD 20892–2590, (301) 496–6515.
Name of Committee: National Cancer
Advisory Board.
Open: February 16, 2005, 8:30 a.m. to 6
p.m.
Agenda: Program reports and
presentations; Business of the Board.
Place: National Cancer Institute, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institute of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327, (301) 496–5147.
Name of Committee: National Cancer
Advisory Board.
Open: February 17, 2005, 8:30 a.m. to 10:30
a.m.
Agenda: Program reports and
presentations; Business of the Board.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327, (301) 496–5147.
Name of Committee: National Cancer
Advisory Board.
Closed: February 17, 2005, 10:30 a.m. to 12
p.m.
Agenda: Review of grant applications.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327, (301) 496–5147.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
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Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.gov/advisory/ncab.htm, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: January 25, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–1837 Filed 1–31–05; 8:45 am]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: January 25, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–1838 Filed 1–31–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–M
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Center on Minority Health and
Health Disparities
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2), notice
is hereby given of the following meeting
of the National Advisory Council on
Minority Health and Health Disparities.
The meeting will be open to the
public as indicated below, with
accordance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group, Subcommittee
G—Education.
Date: March 15–16, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Select, 480 King Street,
Alexandria, VA 22314.
Contact Person: Ilda M. McKenna,
Scientific Review Administrator, Research
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 6116 Executive Boulevard, Room
8111, Bethesda, MD 20892, 301–496–7481,
mckennai@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
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Name of Committee: National Advisory
Council on Minority Health and Health
Disparities.
Date: February 23, 2005.
Open: 8:30 a.m. to 4 p.m.
Agenda: The Agenda will include Opening
Remarks, Administrative Matters, Director’s
Report, NCMHD, Advisory Council
Subcommittee Reports, NIH IC Health
Disparities Update, Program Highlights:
Select NCMHD Grantees, and other business
of the Council.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Closed: 4 p.m to 6 p.m.
Agenda: To review and evaluate grant
applications.
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[Federal Register Volume 70, Number 20 (Tuesday, February 1, 2005)]
[Notices]
[Pages 5189-5190]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1837]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. appendix 2), notice is hereby given of the meeting of
the National Cancer Advisory Board.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign
[[Page 5190]]
language interpretation or other reasonable accommodations, should
notify the Contact Person listed below in advance of the meeting.
A portion of the meeting will be closed to the public in accordance
with the provisions set forth in sections 552b(c)(4), and 552b(c)(6),
as amended. The grant applications and the discussions could disclose
confidential trade secrets or commercial property such as patentable
material, and personal information concerning individuals associated
with the grant applications, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Advisory Board Subcommittee
on Planning and Budget.
Open: February 15, 2005, 7 p.m. to 9 p.m.
Agenda: To discuss activities related to the Subcommittee on
Planning and Budget.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center,
Bethesda, MD 20814.
Contact Person: Ms. Cherie Nichols, Executive Secretary,
National Cancer Institutes, National Institutes of Health, 6116
Executive Boulevard, 2nd Floor, Room 205, Bethesda, MD 20892-2590,
(301) 496-6515.
Name of Committee: National Cancer Advisory Board.
Open: February 16, 2005, 8:30 a.m. to 6 p.m.
Agenda: Program reports and presentations; Business of the
Board.
Place: National Cancer Institute, 9000 Rockville Pike, Building
31, C Wing, 6th Floor, Conference Room 10, Bethesda, MD 20892.
Contact Person: Dr. Paulette S. Gray, Executive Secretary,
National Cancer Institute, National Institute of Health, 6116
Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,
(301) 496-5147.
Name of Committee: National Cancer Advisory Board.
Open: February 17, 2005, 8:30 a.m. to 10:30 a.m.
Agenda: Program reports and presentations; Business of the
Board.
Contact Person: Dr. Paulette S. Gray, Executive Secretary,
National Cancer Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,
(301) 496-5147.
Name of Committee: National Cancer Advisory Board.
Closed: February 17, 2005, 10:30 a.m. to 12 p.m.
Agenda: Review of grant applications.
Contact Person: Dr. Paulette S. Gray, Executive Secretary,
National Cancer Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,
(301) 496-5147.
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's home
page: https://deainfo.nci.gov/advisory/ncab.htm, where an agenda and
any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: January 25, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-1837 Filed 1-31-05; 8:45 am]
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