Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Maternal Vitamin D Status and Preterm Birth, DP11-002, Initial Review, 10908 [2011-4305]
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Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices
the District of Columbia. As funding
allows, CDC’s strategic plan calls for
expanding the program to health
departments in all U.S. States and
territories. CDC works with HDSP
program awardees to implement and
evaluate evidence-based public health
prevention and control strategies that
address risk factors and reduce
disparities, disease, disability, and
death from heart disease and stroke.
The DHDSP MIS provides a
standardized, electronic interface for the
collection of progress and activity
information from HDSP awardees. The
information collection includes work
plans, objectives, partners, data sources,
and policy and environmental
assessments. The MIS produces both
State-specific and aggregate reports that
are used for performance monitoring,
program evaluation, and technical
assistance. The monitoring and
evaluation plan for HDSP awardees is
part of an overall initiative within CDC’s
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP) to promote more efficient
ways of using resources and achieving
greater health impact.
CDC will continue to use the
information collected through the
DHDSP MIS to identify State-specific
heart disease and stroke prevention
priorities and objectives, and to describe
the impact and reach of program
interventions. Respondents will be 42
health departments in 41 States and the
District of Columbia (DC). Respondents
will continue to submit their progress
and activity information to CDC semiannually. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 504.
Estimated annualized burden hours
Respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
State-Based Heart Disease and Stroke Prevention Programs ...................................................
42
2
6
Dated: February 22, 2011.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–4330 Filed 2–25–11; 8:45 am]
BILLING CODE 4163–18–P
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 17, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–4305 Filed 2–25–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Maternal
Vitamin D Status and Preterm Birth,
DP11–002, Initial Review
Food and Drug Administration
[Docket No. FDA–2011–D–0074]
Correction: The notice was published
in the Federal Register on December 17,
2010, Volume 75, Number 242, Page
78999. The time and date should read
as follows:
srobinson on DSKHWCL6B1PROD with NOTICES
Time and Date: 11 a.m.–5 p.m., April 12,
2011 (Closed).
Contact Person for More Information:
Donald Blackman, Ph.D., Scientific
Review Officer, CDC, National Center
for Chronic Disease Prevention and
Health Promotion, Office of the Director,
Extramural Research Program Office,
4770 Buford Highway, NE., Mailstop K–
92, Atlanta, Georgia 30341, Telephone:
(770) 488–3023, E-mail: DBY7@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
18:30 Feb 25, 2011
Jkt 223001
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 31, 2011.
DATES:
Centers for Disease Control and
Prevention
VerDate Mar<15>2010
administration to a patient instead of
being dispensed directly to the patient
for self-administration or to the patient’s
caregiver for administration to the
patient. Second, the draft guidance
addresses when a Medication Guide
will be required as part of a REMS. The
draft guidance is intended to answer
questions that have arisen concerning
these topics.
Draft Guidance for Industry on
Medication Guides—Distribution
Requirements and Inclusion of
Medication Guides in Risk Evaluation
and Mitigation Strategies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Medication Guides—
Distribution Requirements and
Inclusion in Risk Evaluation and
Mitigation Strategies (REMS).’’ This
draft guidance addresses two topics
pertaining to Medication Guides for
drug and biological products. First, the
draft guidance addresses when FDA
intends to exercise enforcement
discretion regarding dispensing
requirements for Medication Guides that
must be distributed with a drug or
biological product dispensed to a
healthcare professional for
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
ADDRESSES:
E:\FR\FM\28FEN1.SGM
28FEN1
]]>Agencies
[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Page 10908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Maternal Vitamin D Status and Preterm Birth,
DP11-002, Initial Review
Correction: The notice was published in the Federal Register on
December 17, 2010, Volume 75, Number 242, Page 78999. The time and date
should read as follows:
Time and Date: 11 a.m.-5 p.m., April 12, 2011 (Closed).
Contact Person for More Information: Donald Blackman, Ph.D.,
Scientific Review Officer, CDC, National Center for Chronic Disease
Prevention and Health Promotion, Office of the Director, Extramural
Research Program Office, 4770 Buford Highway, NE., Mailstop K-92,
Atlanta, Georgia 30341, Telephone: (770) 488-3023, E-mail:
DBY7@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Dated: February 17, 2011.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2011-4305 Filed 2-25-11; 8:45 am]
BILLING CODE 4163-18-P
