Advisory Committee on Infant Mortality; Notice of Meeting, 39112 [2011-16717]
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Federal Register / Vol. 76, No. 128 / Tuesday, July 5, 2011 / Notices
expected to be safe. If the required
premarket notification is not submitted
to FDA, section 413(a) of the FD&C Act
provides that the dietary supplement
containing the NDI is deemed to be
adulterated under section 402(f) of the
FD&C Act (21 U.S.C. 342(f)). Even if the
notification is submitted as required, the
dietary supplement containing the NDI
is adulterated under section 402(f)
unless there is a history of use or other
evidence of safety establishing that the
NDI, when used under the conditions
recommended or suggested in the
labeling of the dietary supplement, will
reasonably be expected to be safe.
To assist industry in complying with
DSHEA, FDA issued a regulation,
§ 190.6 (21 CFR 190.6), to implement
the FD&C Act’s premarket notification
requirements for dietary supplements
that contain an NDI (62 FR 49886,
September 23, 1997). The NDI
regulation specifies the information the
manufacturer or distributor must
include in its premarket NDI
notification (§ 190.6(b)) and establishes
the administrative procedures for these
notifications. FDA’s goal in issuing the
1997 regulation was to ensure that NDI
notifications contained the information
that would enable FDA to evaluate
whether a dietary supplement
containing an NDI is reasonably
expected to be safe.
On January 4, 2011, the President
signed into law the FDA Food Safety
Modernization Act (FSMA) (Pub. L.
111–353). Section 113(b) of FSMA
requires FDA to publish, not later than
180 days after the date of enactment,
guidance that clarifies when a dietary
supplement ingredient is an NDI, when
the manufacturer or distributor of a
dietary ingredient or dietary supplement
should submit an NDI notification to
FDA under section 413(a)(2) of the
FD&C Act, the evidence needed to
document the safety of an NDI, and
appropriate methods for establishing the
identity of an NDI. This draft guidance
is being published to comply with
section 113(b) of FSMA.
The draft guidance, when finalized,
will represent the Agency’s current
thinking on NDIs and dietary
supplements that contain NDIs. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternate
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
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and Budget (OMB) for each collection of
information they conduct or sponsor.
This draft guidance contains proposed
collections of information. ‘‘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 publish a 60-day notice in the
Federal Register soliciting public
comment on each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, FDA will
publish a 60-day notice on the proposed
collections of information in this draft
guidance in a future issue of the Federal
Register.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
21 CFR Part 111 have been approved
under OMB control number 0901–0606,
and the collections of information in
§ 190.6 have been approved under OMB
control number 0910–0330.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: August 2, 2011, 9 a.m.–
5 p.m. August 3, 2011, 9 a.m.–3 p.m.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814, (301) 657–
1234.
Status: The meeting is open to the public
with attendance limited to space availability.
Purpose: The Committee provides advice
and recommendations to the Secretary of
Health and Human Services on the following:
Department of Health and Human Services’
programs that focus on reducing infant
mortality and improving the health status of
infants and pregnant women; and factors
affecting the continuum of care with respect
to maternal and child health care. It includes
outcomes following childbirth; strategies to
coordinate the myriad of Federal, State, local
and private programs and efforts that are
designed to deal with the health and social
problems impacting on infant mortality; and
the implementation of the Healthy Start
program and Healthy People 2020 infant
mortality objectives.
Agenda: Topics that will be discussed
include the following: HRSA Update; MCHB
Update; Healthy Start Program Update;
Affordable Care Act and Infant Mortality;
Quality Improvement in Perinatal Health
Care; Patient Centered Medical Home;
Centering Pregnancy, and Fetal Infant
Mortality Review. Proposed agenda items are
subject to change as priorities dictate.
Time will be provided for public
comments limited to five minutes each.
Comments are to be submitted in writing no
later than 5 p.m. ET on July 19, 2011.
For Further Information Contact: Anyone
requiring information regarding the
Committee should contact Peter C. van Dyck,
M.D., M.P.H., Executive Secretary, ACIM,
Health Resources and Services
Administration, Room 18–05, Parklawn
Building, 5600 Fishers Lane, Rockville, MD
20857, Telephone: (301) 443–2170.
Individuals who are submitting public
comments or who have questions regarding
the meeting and location should contact
David S. de la Cruz, Ph.D., M.P.H., HRSA,
Maternal and Child Health Bureau,
telephone: (301) 443–0543, e-mail:
David.delaCruz@hrsa.hhs.gov.
Dated: June 29, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Dated: June 28, 2011,
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–16711 Filed 7–1–11; 8:45 am]
[FR Doc. 2011–16717 Filed 7–1–11; 8:45 am]
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[Federal Register Volume 76, Number 128 (Tuesday, July 5, 2011)]
[Notices]
[Page 39112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16717]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Infant Mortality; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Committee on Infant Mortality (ACIM).
Dates and Times: August 2, 2011, 9 a.m.-5 p.m. August 3, 2011, 9
a.m.-3 p.m.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814, (301) 657-1234.
Status: The meeting is open to the public with attendance
limited to space availability.
Purpose: The Committee provides advice and recommendations to
the Secretary of Health and Human Services on the following:
Department of Health and Human Services' programs that focus on
reducing infant mortality and improving the health status of infants
and pregnant women; and factors affecting the continuum of care with
respect to maternal and child health care. It includes outcomes
following childbirth; strategies to coordinate the myriad of
Federal, State, local and private programs and efforts that are
designed to deal with the health and social problems impacting on
infant mortality; and the implementation of the Healthy Start
program and Healthy People 2020 infant mortality objectives.
Agenda: Topics that will be discussed include the following:
HRSA Update; MCHB Update; Healthy Start Program Update; Affordable
Care Act and Infant Mortality; Quality Improvement in Perinatal
Health Care; Patient Centered Medical Home; Centering Pregnancy, and
Fetal Infant Mortality Review. Proposed agenda items are subject to
change as priorities dictate.
Time will be provided for public comments limited to five
minutes each. Comments are to be submitted in writing no later than
5 p.m. ET on July 19, 2011.
For Further Information Contact: Anyone requiring information
regarding the Committee should contact Peter C. van Dyck, M.D.,
M.P.H., Executive Secretary, ACIM, Health Resources and Services
Administration, Room 18-05, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857, Telephone: (301) 443-2170.
Individuals who are submitting public comments or who have
questions regarding the meeting and location should contact David S.
de la Cruz, Ph.D., M.P.H., HRSA, Maternal and Child Health Bureau,
telephone: (301) 443-0543, e-mail: David.delaCruz@hrsa.hhs.gov.
Dated: June 28, 2011,
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-16717 Filed 7-1-11; 8:45 am]
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