Proposed Data Collections Submitted for Public Comment and Recommendations, 75759-75760 [E6-21527]
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jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices
Zantac business to Boehringer
Ingelheim Pharmaceuticals by requiring
that: (1) J&J divest to Boehringer
Ingelheim Pharmaceuticals all assets
relating to Pfizer’s Zantac line of
products, including all research and
development, intellectual property, and
customer and supply contracts; (2) J&J
and Pfizer take steps to ensure that
confidential business information
relating to Zantac will not be obtained
or used by J&J; (3) Boehringer Ingelheim
Pharmaceuticals have the opportunity to
enter into employment contracts with
certain key individuals who have
experience relating to Zantac; and (4)
certain management employees of Pfizer
who were substantially involved in the
research, development or marketing of
Zantac be precluded from working on
competitive H–2 blocker products at J&J
for a period of two years.2
The Commission is also satisfied that
Chattem is a well-qualified acquirer of
the Cortisone, Unisom, and Balmex
businesses. Chattem is a leading
manufacturer and marketer of a broad
portfolio of branded OTC healthcare
products, toiletries, and dietary
supplements, including brands such as
Icy Hot, Gold Bond, Selsun blue,
Garlique, Pamprin, and BullFrog.
Chattem’s products are among the
market leaders in their respective
categories across food, drug and mass
merchandisers. Chattem has an
experienced sales force with existing
relationships with major retailers and
has a strong record of integrating prior
product acquisitions successfully.
The proposed Consent Agreement
contains several provisions designed to
ensure the successful divestiture of the
Cortisone, Unisom, and Balmex
businesses to Chattem by requiring that:
(1) J&J divest to Chattem all assets
relating to the Cortisone, Unisom,
and Balmex line of products,
including all research and development,
intellectual property, and customer and
supply contracts; (2) J&J and Pfizer take
steps to ensure that confidential
business information relating to
Cortisone, Unisom, and Balmex
will not be obtained or used by J&J; and
(3) Chattem have the opportunity to
enter into employment contracts with
certain key individuals who have
experience relating to Cortisone,
Unisom, and Balmex.
The Order to Maintain Assets that is
included in the proposed Consent
Agreement requires that J&J and Pfizer
maintain the viability of the Divested
2 This firewall will prevent J&J from taking
competitive advantage of know-how, product
development, marketing, and sales plans relating to
Zantac.
VerDate Aug<31>2005
16:16 Dec 15, 2006
Jkt 211001
Assets for the brief transition period
between the time the Commission
approves the proposed Order and when
the divestitures take place, which will
not be later than January 2, 2007. Even
though such a period is relatively short,
maintenance of current supply,
advertising and promotional levels and
activities at all times prior to divestiture
is of paramount importance. The
proposed Consent Agreement
incorporates this plan in the Order to
Maintain Assets, detailing requirements
for the assets that must be held separate,
services that may be shared with the
ongoing business, and the employee
positions that are necessary for the held
separate business.
The Commission has appointed David
Painter of LECG as Interim Monitor to
oversee the transfer of assets, the
establishment of appropriate firewalls to
prevent the transfer or use of
confidential business information and to
ensure that J&J and Pfizer comply with
all other provisions of the Order. To
ensure that the Commission remains
informed about the status of the
Divested Assets and their transfer, the
proposed Consent Agreement requires
J&J and Pfizer to file reports with the
Commission periodically until the
divestitures are accomplished.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Decision
and Order or the Order to Maintain
Assets, or to modify their terms in any
way.
By direction of the Commission with
Commissioners Harbour, Kovacic and Rosch
recused.
Donald S. Clark,
Secretary.
[FR Doc. E6–21519 Filed 12–15–06; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–07AA]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
75759
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Pilot Project for a National Monitoring
System for Major Adverse Effects of
Medication Use During Pregnancy and
Lactation—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
This data collection is based on the
following components of the Public
Health Service Act: (1) Act 42 U.S.C.
241, Section 301, which authorizes
‘‘research, investigations, experiments,
demonstrations, and studies relating to
the causes, diagnosis, treatment, control,
and prevention of physical and mental
diseases and impairments of man.’’ (2)
42 U.S.C. 247b–4, Section 317 C, which
authorizes the activities of the National
Center on Birth Defects and
Developmental Disabilities. This section
was created by Public Law 106–310,
also known as ‘‘the Children’s Health
Act of 2000.’’ This portion of the code
has also been amended by Public Law
108–154, which is also known as the
‘‘Birth Defects and Developmental
Disabilities Prevention Act of 2003’’.
The use of a number of medications
during pregnancy is known to be
associated with serious adverse effects
in children. However, because pregnant
and lactating women are traditionally
excluded from clinical trials, and
because premarketing animal studies do
not necessarily predict the experience of
humans, little information is available
about the safety of most prescription
E:\FR\FM\18DEN1.SGM
18DEN1
75760
Federal Register / Vol. 71, No. 242 / Monday, December 18, 2006 / Notices
medications during pregnancy and
lactation at the time they are marketed.
Nevertheless, many women
inadvertently use medications early in
gestation before realizing they are
pregnant, and many maternal conditions
require treatment during pregnancy and
breastfeeding to safeguard the health of
both mother and infant. Currently, the
United States does not have a
comprehensive early warning system for
major adverse pregnancy or infant
outcomes related to medication
exposures.
Teratology Information Services (TIS)
utilize trained specialists to provide free
phone consultation, risk assessment,
and counseling about exposures during
pregnancy and breastfeeding—including
medications—to women and healthcare
providers. Altogether, they respond to
approximately 70,000–100,000 inquiries
each year in the United States and
Canada. Because they have direct
contact with pregnant and breastfeeding
women, TIS are in a unique position to
monitor the adverse effects of
medication exposures during pregnancy
and lactation. The objective of this
participate in a follow-up study.
Informed consent to participate will be
obtained from each woman by
telephone. For each pregnant woman
who agrees to participate, the TIS will
conduct 4 telephone interviews:(1) At
enrollment; (2) during the third
trimester of pregnancy; (3)
approximately one month after delivery;
and (4) when the infant is about 3
months old. For each breastfeeding
woman who agrees to participate, the
TIS will conduct 3 telephone
interviews:(1) At enrollment; (2)
approximately one month after
enrollment; and (3) 3 months after
enrollment, if the woman is still taking
medication and still breastfeeding. The
interviews will assess maternal and fetal
health throughout pregnancy, and
maternal and infant health at delivery,
during the newborn and early infancy
period, and while breastfeeding, and
correlate these outcomes with
medication exposure during pregnancy
and while breastfeeding. There is no
cost to respondents other than their
time.
project is to conduct a pilot study to
assess whether TIS in the United States
can serve as an effective monitoring and
early warning system for major adverse
effects on (1) pregnancy outcomes (e.g.,
live birth, stillbirth, premature birth,
low birth weight, etc.) and (2) maternal
and infant health. The project will
assess the willingness of pregnant and
breastfeeding women who contact a TIS
about medication exposure to
participate in and complete a follow-up
study; whether these women are similar
in demographic characteristics to the
U.S. population of child-bearing age
women; the specificity and
completeness of the information
obtained from such a study about
adverse pregnancy outcomes, and
maternal and infant health; and the
amount of time required to conduct the
follow-up.
Within a continuous six-month
period, three individual TIS will recruit
all women who contact their service
(approximately 250 enrollees per TIS)
who have used any prescription or overthe-counter medication during
pregnancy or while breastfeeding to
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondent
Avg. burden
per response
(in hours)
Total burden
(in hours)
Prenatal exposure group alone .......................................................................
Lactation exposure group alone ......................................................................
Prenatal exposure group and lactation exposure group (pregnant women
who subsequently breastfeed) .....................................................................
338
74
4
3
20/60
20/60
451
74
338
4
30/60
676
Total ..........................................................................................................
750
........................
........................
1,201
Dated: December 12, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–21527 Filed 12–15–06; 8:45 am]
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.
BILLING CODE 4163–18–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
Fax written comments on the
collection of information by January 17,
2007.
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.
Food and Drug Administration
[Docket No. 2006D–0246]
jlentini on PROD1PC65 with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Manufactured
Food Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Notice.
16:16 Dec 15, 2006
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Aug<31>2005
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
Jkt 211001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
collection of information to OMB for
review and clearance.
Manufactured Food Regulatory
Program Standards
The Food and Drug Administration
(FDA) is announcing the availability of
a draft document entitled
‘‘Manufactured Food Regulatory
Program Standards: (draft program
standards). The draft program standards,
which establish a uniform foundation
for the design and management of State
programs responsible for regulation of
plants that manufacture, process, pack,
or hold foods in the United States, are
being distributed for comment purposed
only. This document is neither final nor
is it intended for implementation.
The elements of the draft program
standards are intended to ensure that
the States have the best practices of a
high-quality regulatory program to use
for self-assessment and continuous
improvement and innovation. The ten
standards describe the critical elements
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 71, Number 242 (Monday, December 18, 2006)]
[Notices]
[Pages 75759-75760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21527]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-07AA]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Pilot Project for a National Monitoring System for Major Adverse
Effects of Medication Use During Pregnancy and Lactation--New--National
Center on Birth Defects and Developmental Disabilities (NCBDDD),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This data collection is based on the following components of the
Public Health Service Act: (1) Act 42 U.S.C. 241, Section 301, which
authorizes ``research, investigations, experiments, demonstrations, and
studies relating to the causes, diagnosis, treatment, control, and
prevention of physical and mental diseases and impairments of man.''
(2) 42 U.S.C. 247b-4, Section 317 C, which authorizes the activities of
the National Center on Birth Defects and Developmental Disabilities.
This section was created by Public Law 106-310, also known as ``the
Children's Health Act of 2000.'' This portion of the code has also been
amended by Public Law 108-154, which is also known as the ``Birth
Defects and Developmental Disabilities Prevention Act of 2003''.
The use of a number of medications during pregnancy is known to be
associated with serious adverse effects in children. However, because
pregnant and lactating women are traditionally excluded from clinical
trials, and because premarketing animal studies do not necessarily
predict the experience of humans, little information is available about
the safety of most prescription
[[Page 75760]]
medications during pregnancy and lactation at the time they are
marketed. Nevertheless, many women inadvertently use medications early
in gestation before realizing they are pregnant, and many maternal
conditions require treatment during pregnancy and breastfeeding to
safeguard the health of both mother and infant. Currently, the United
States does not have a comprehensive early warning system for major
adverse pregnancy or infant outcomes related to medication exposures.
Teratology Information Services (TIS) utilize trained specialists
to provide free phone consultation, risk assessment, and counseling
about exposures during pregnancy and breastfeeding--including
medications--to women and healthcare providers. Altogether, they
respond to approximately 70,000-100,000 inquiries each year in the
United States and Canada. Because they have direct contact with
pregnant and breastfeeding women, TIS are in a unique position to
monitor the adverse effects of medication exposures during pregnancy
and lactation. The objective of this project is to conduct a pilot
study to assess whether TIS in the United States can serve as an
effective monitoring and early warning system for major adverse effects
on (1) pregnancy outcomes (e.g., live birth, stillbirth, premature
birth, low birth weight, etc.) and (2) maternal and infant health. The
project will assess the willingness of pregnant and breastfeeding women
who contact a TIS about medication exposure to participate in and
complete a follow-up study; whether these women are similar in
demographic characteristics to the U.S. population of child-bearing age
women; the specificity and completeness of the information obtained
from such a study about adverse pregnancy outcomes, and maternal and
infant health; and the amount of time required to conduct the follow-
up.
Within a continuous six-month period, three individual TIS will
recruit all women who contact their service (approximately 250
enrollees per TIS) who have used any prescription or over-the-counter
medication during pregnancy or while breastfeeding to participate in a
follow-up study. Informed consent to participate will be obtained from
each woman by telephone. For each pregnant woman who agrees to
participate, the TIS will conduct 4 telephone interviews:(1) At
enrollment; (2) during the third trimester of pregnancy; (3)
approximately one month after delivery; and (4) when the infant is
about 3 months old. For each breastfeeding woman who agrees to
participate, the TIS will conduct 3 telephone interviews:(1) At
enrollment; (2) approximately one month after enrollment; and (3) 3
months after enrollment, if the woman is still taking medication and
still breastfeeding. The interviews will assess maternal and fetal
health throughout pregnancy, and maternal and infant health at
delivery, during the newborn and early infancy period, and while
breastfeeding, and correlate these outcomes with medication exposure
during pregnancy and while breastfeeding. There is no cost to
respondents other than their time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Respondent Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Prenatal exposure group alone................... 338 4 20/60 451
Lactation exposure group alone.................. 74 3 20/60 74
Prenatal exposure group and lactation exposure 338 4 30/60 676
group (pregnant women who subsequently
breastfeed)....................................
---------------------------------------------------------------
Total....................................... 750 .............. .............. 1,201
----------------------------------------------------------------------------------------------------------------
Dated: December 12, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-21527 Filed 12-15-06; 8:45 am]
BILLING CODE 4163-18-P
