CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment, 39264-39265 [2010-16613]
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Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / Notices
includes 29 specific questions and
answers for IRBs as well as guidance to
HDE holders on whether and how they
may become eligible to receive profit
from the sale of their device. In the
Federal Register of August 5, 2008 (73
FR 45460), FDA published a 60-day
notice requesting public comment. The
comment period closed on November 3,
2008. FDA published a 30-day notice on
September 30, 2009 (74 FR 50214), but
republished a 30-day notice on February
18, 2010 (75 FR 7270), to provide a more
descriptive response to the comments
received in response to the August 5,
2008, notice. This document
supersedes: Humanitarian Device
Exemption (HDE) Regulation: Questions
and Answers, issued July 18, 2006.
V. 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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: July 1, 2010.
Nancy Stade,
Acting Associate Director for Regulations and
Policy, Center for Devices and Radiological
Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Significance of Guidance
[FR Doc. 2010–16548 Filed 7–7–10; 8:45 am]
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the ‘‘HDE
Regulation: Questions and Answers.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
BILLING CODE 4160–01–S
Health Resources and Services
Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CDC/HRSA Advisory Committee on
HIV and STD Prevention and Treatment
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. To receive ‘‘HDE Regulation:
Questions and Answers,’’ you may
either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1668 to identify the guidance
you are requesting. A search capability
for all CDRH guidance documents is
available at https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or the
CBER Internet site at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
srobinson on DSKHWCL6B1PROD with NOTICES
IV. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance were approved under
OMB control number 0910–0661, May
31, 2013, expiration date.
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National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 Institute of
Child Health and Human Development
Special Emphasis Panel: Therapeutic
Application of Dyrk1A Inhibitors for Down
Syndrome.
Date: July 26, 2010.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Neelakanta Ravindranath,
PhD, Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, 6100 Executive
Boulevard, Room 5B01G, Bethesda, MD
20892–7510, (301) 435–6889,
ravindrn@mail.nih.gov.
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Dated: June 30, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–16472 Filed 7–7–10; 8:45 am]
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Centers for Disease Control and
Prevention
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC and HRSA
announce the following committee
meeting.
Time and Date: 2 p.m.–3:30 p.m., July 29,
2010.
Place: Teleconference. To participate,
please dial (877) 952–1988 and enter
passcode 2162797 for access.
Status: Open to the public, limited only by
availability of telephone ports.
Purpose: This Committee is charged with
advising the Director, CDC and the
Administrator, HRSA, regarding activities
related to prevention and control of HIV/
AIDS and other STDs, the support of health
care services to persons living with HIV/
AIDS, and education of health professionals
and the public about HIV/AIDS and other
STDs.
Matters To Be Discussed: The purpose of
the teleconference is for CHACHSPT to
deliberate and discuss the outcomes of a
CDC/HRSA Advisory Committee workgroup
that will convene on July 8, 2010. The
workgroup will conduct a program review to
provide information to CHACHSPT on the
strategic realignment of funding to support
priorities in sexual health and STD
disparities among racial and ethnic
minorities. The objectives of the workgroup
are: (1) To identify to CHACHSPT future
opportunities to accelerate the impact in
health disparities through programs, policy,
and research and public health ethics; (2) To
provide information to CHACHSPT regarding
potential use of realigned funding; and, (3)
To provide key principles (e.g., program,
policy, research) to be considered by
CHACHSPT in the development of a new
funding opportunity announcement for the
use of realigned resources.
For More Information Contact: Margie
Scott-Cseh, CDC, National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
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Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / Notices
Prevention, 1600 Clifton Road, NE., Mailstop
E–07, Atlanta, Georgia 30333, Telephone
(404) 639–8317.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 30, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–16613 Filed 7–7–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Health Statistics
(NCHS), Classifications and Public
Health Data Standards Staff,
Announces the Following Meeting
Name: ICD–9–CM Coordination and
Maintenance Committee meeting.
Time and Date: 9 a.m.–4:30 p.m.,
September 15–16, 2010.
Place: Centers for Medicare and
Medicaid Services (CMS) Auditorium,
7500 Security Boulevard, Baltimore,
Maryland.
Status: Open to the public.
Purpose: The ICD–9–CM Coordination
and Maintenance (C&M) Committee will
hold its second meeting of the 2010
calendar year cycle on Wednesday and
Thursday September 15–16, 2010. The
C&M meeting is a public forum for the
presentation of proposed modifications
to the International Classification of
Diseases, Ninth-Revision, Clinical
Modification.
srobinson on DSKHWCL6B1PROD with NOTICES
Matters To Be Discussed
Section 10109(c) of the Patient
Protection and Affordable Care Act and
the Reconciliation Act of 2010 (PPACA)
requires the Secretary of Health and
Human Services (HHS) to task the C&M
Committee to convene a meeting before
January 1, 2011, to receive stakeholder
input regarding the crosswalk between
the Ninth and Tenth Revisions of the
International Classification of Diseases
(ICD–9, and ICD–10, respectively),
posted to the CMS Web site at https://
www.cms.gov/ICD10, for the purpose of
making appropriate revisions to said
crosswalk. Section 10109(c) further
states that any revised crosswalk be
treated as a code set for which a
standard has been adopted by the
Secretary, and that revisions to this
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17:09 Jul 07, 2010
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crosswalk be posted to the CMS Web
site.
The C&M Committee will use the first
half of the first day of the September
C&M Committee meeting, 9 a.m. to
12:30 p.m. Wednesday, September 15,
2010, to fulfill the above-referenced
PPACA requirements for this meeting to
be held prior to January 1, 2011, and
receive public input regarding the
above-referenced crosswalk revision. No
other meeting will be convened by the
C&M Committee for this purpose.
Interested parties and stakeholders
should be prepared to submit their
written comments and other relevant
documentation at the meeting, or no
later than November 12, 2010 to the
following addresses:
Pat Brooks, RHIA, Senior Technical
Advisor, Centers for Medicare &
Medical Services, Hospital and
Ambulatory Policy Group, Mail Stop
C4–08–06, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Patricia.brooks2@cms.hhs.gov.
Donna Pickett, RHIA, MPH, Medical
Systems Administrator, National
Center for Health Statistics, Centers
for Disease Control and Prevention,
Classifications and Public Health Data
Standards, 3311 Toledo Road, Room
2337, Hyattsville, MD 20782.
DPickett@cdc.gov.
Additional Information: Additional
information regarding the tentative
diagnosis and procedures topics will be
published in a separate notice one
month prior to the meeting.
Notice: Because of increased security
requirements CMS has instituted
stringent procedures for entrance into
the building by non-government
employees. Persons without a
government I.D. will need to show an
official form of picture I.D., (such as a
drivers license), and sign-in at the
security desk upon entering the
building.
Those who wish to attend a specific
ICD–9–CM C&M meeting in the CMS
auditorium must submit their name and
organization for addition to the meeting
visitor list. Those wishing to attend the
September 15–16, 2010 meeting must
submit their name and organization by
September 10, 2010 for inclusion on the
visitor list. This visitor list will be
maintained at the front desk of the CMS
building and used by the guards to
admit visitors to the meeting. Those
who attended previous ICD–9–CM C&M
meetings will no longer be
automatically added to the visitor list.
You must request inclusion of your
name prior to each meeting you attend.
Register to attend the meeting on-line at:
https://www.cms.hhs.gov/apps/events/.
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39265
Notice: This is a public meeting,
however, due to fire code requirements
seating may be limited.
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 CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: June 30, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–16610 Filed 7–7–10; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Request for Nominations of
Candidates To Serve on the Board of
Scientific Counselors (BSC), National
Center for Environmental Health/
Agency for Toxic Substances and
Disease Registry (NCEH/ATSDR),
Centers for Disease Control and
Prevention, Department of Health and
Human Services (HHS)
The NCEH/ATSDR is soliciting
nominations for possible membership
on the BSC. The BSC, NCEH/ATSDR
provides advice and guidance to the
Secretary, HHS; the Director, CDC and
the Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agencies’
mission to protect and promote people’s
health. The Board provides advice and
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the Board’s
objectives. Nominees will be selected
from experts having experience in
preventing human diseases and
disabilities caused by environmental
conditions. Experts in the disciplines of
toxicology, epidemiology,
environmental or occupational
medicine, behavioral science, risk
assessment, exposure assessment, and
experts in public health and other
related disciplines will be considered.
Consideration is given to representation
from diverse geographic areas, gender,
ethnic and minority groups, and the
disabled. Members may be invited to
E:\FR\FM\08JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 130 (Thursday, July 8, 2010)]
[Notices]
[Pages 39264-39265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16613]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Health Resources and Services Administration
CDC/HRSA Advisory Committee on HIV and STD Prevention and
Treatment
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the CDC and HRSA announce the following
committee meeting.
Time and Date: 2 p.m.-3:30 p.m., July 29, 2010.
Place: Teleconference. To participate, please dial (877) 952-
1988 and enter passcode 2162797 for access.
Status: Open to the public, limited only by availability of
telephone ports.
Purpose: This Committee is charged with advising the Director,
CDC and the Administrator, HRSA, regarding activities related to
prevention and control of HIV/AIDS and other STDs, the support of
health care services to persons living with HIV/AIDS, and education
of health professionals and the public about HIV/AIDS and other
STDs.
Matters To Be Discussed: The purpose of the teleconference is
for CHACHSPT to deliberate and discuss the outcomes of a CDC/HRSA
Advisory Committee workgroup that will convene on July 8, 2010. The
workgroup will conduct a program review to provide information to
CHACHSPT on the strategic realignment of funding to support
priorities in sexual health and STD disparities among racial and
ethnic minorities. The objectives of the workgroup are: (1) To
identify to CHACHSPT future opportunities to accelerate the impact
in health disparities through programs, policy, and research and
public health ethics; (2) To provide information to CHACHSPT
regarding potential use of realigned funding; and, (3) To provide
key principles (e.g., program, policy, research) to be considered by
CHACHSPT in the development of a new funding opportunity
announcement for the use of realigned resources.
For More Information Contact: Margie Scott-Cseh, CDC, National
Center for HIV/AIDS, Viral Hepatitis, STD, and TB
[[Page 39265]]
Prevention, 1600 Clifton Road, NE., Mailstop E-07, Atlanta, Georgia
30333, Telephone (404) 639-8317.
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 CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: June 30, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-16613 Filed 7-7-10; 8:45 am]
BILLING CODE 4163-18-P
