President's Committee for People With Intellectual Disabilities; Notice of Meeting, 50066-50067 [E6-13996]
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50066
Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices
CDC Instructions for the Use of Vaccine
Information Statements.
FOR FURTHER INFORMATION CONTACT:
Anne Schuchat, M.D., Director, National
Immunization Program, Centers for
Disease Control and Prevention,
Mailstop E–05, 1600 Clifton Road, NE.,
Atlanta, Georgia 30333, telephone (404)
639–8200.
SUPPLEMENTARY INFORMATION: The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States, whether public or private, to any
patient (or to the parent or legal
representative in the case of a child)
receiving vaccines covered under the
National Vaccine Injury Compensation
Program. Development and revision of
the vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
The vaccines initially covered under
the National Vaccine Injury
Compensation Program were diphtheria,
tetanus, pertussis, measles, mumps,
rubella and poliomyelitis vaccines.
Since April 15, 1992, any health care
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since June 1, 1999, health care
providers are also required to provide
copies of vaccine information materials
for the following vaccines that were
added to the National Vaccine Injury
Compensation Program: hepatitis B,
haemophilus influenzae type b (Hib),
and varicella (chickenpox) vaccines. In
addition, use of vaccine information
materials for pneumococcal conjugate
vaccine has been required since
December 15, 2002, materials for
trivalent influenza vaccines since
January 1, 2006 and materials for
hepatitis A vaccine since July 1, 2006.
rmajette on PROD1PC67 with NOTICES1
Updated Influenza Vaccine Information
Materials
Inactivated Influenza Vaccine
Information Statement
Initial vaccine information materials
developed under 42 U.S.C. 300aa–26 for
15:15 Aug 23, 2006
Jkt 208001
Instructions for the Use of Vaccine
Information Statements
The CDC Instructions for the Use of
Vaccine Information Statements have
been updated to note the new edition
dates of the influenza vaccine
information materials. Those updated
instructions, dated June 30, 2006, can be
downloaded at the CDC Web site at:
https://www.cdc.gov/nip/publications/
VIS.
In addition, copies of the updated
influenza materials can be downloaded
in PDF format at the same Web site.
Alternatively, single camera-ready
copies are available from State health
departments. A list of State health
department contacts for obtaining
copies of these materials is included in
a December 17, 1999 Federal Register
notice (64 FR 70914).
Dated: August 16, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E6–14030 Filed 8–23–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities; Notice of
Meeting
ACTION:
PO 00000
Thursday, September 14, 2006,
from 9 a.m. to 5:30 p.m., and Friday,
September 15, 2006, from 9 a.m. to 5
p.m. The entire meeting of PCPID will
be open to the public.
DATES:
The meeting will be held in
Room 800 of the Hubert H. Humphrey
building, 200 Independence Ave., SW.,
Washington, DC 20201. Individuals who
will need accommodations for a
disability in order to attend the meeting
(e.g., interpreting services, assistive
listening devices, materials in
alternative format such as large print or
Braille) should notify Sally Atwater at
202–619–0634 no later than September
7, 2006. We will attempt to meet
requests made after that date, but cannot
guarantee availability. All meeting sites
are barrier free.
Agenda: Day One—The new
Committee members will take the oath
of office, be sworn in as members of the
President’s Committee for People with
Intellectual Disabilities and receive
guidance on ethics regulations and the
Federal Advisory Committee Act
(FACA). Committee members will also
hear from the various ex officio
members regarding the programs and
services provided by their respective
Federal agencies.
Agenda: Day Two—The Committee
will receive a briefing on the New
Freedom Initiative and then begin
discussion to set Committee priorities
for the coming year.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sally D. Atwater, Executive Director,
President’s Committee for People with
Intellectual Disabilities, The Aerospace
Center, Suite 701, 370 L’Enfant
Promenade, SW., Washington, DC
20447. Telephone: 202–619–0634, fax:
202–205–9591. E-mail:
satwater@acf.hhs.gov.
PCPID
acts in an advisory capacity to the
President and the Secretary of Health
and Human Services on a broad range
of topics relating to programs, services
and supports for persons with
intellectual disabilities. The Committee,
by Executive Order, is responsible for
evaluating the adequacy of current
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
SUPPLEMENTARY INFORMATION:
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AGENCY: President’s Committee for
People with Intellectual Disabilities
(PCPID), Department of Health And
Human Services.
Live, Intranasal Influenza Vaccine
Information Statement
VerDate Aug<31>2005
trivalent inactivated influenza vaccine
and for trivalent live, intranasal
influenza vaccine were published in the
Federal Register on November 10, 2005
(70 FR 68461). The edition date of those
materials was October 20, 2005. This
notice announces availability of the
2006–07 editions of these influenza
vaccine information materials. The only
substantive revisions that appear in
these updated materials are the addition
of the influenza season date of 2006–07,
the VIS edition date of 6/30/2006 and an
update to note the expanded
recommended schedule for
administration of inactivated influenza
vaccine to all children 6–59 months of
age and to the household contacts and
out-of-home caregivers of such children
(with either inactivated or live,
intranasal influenza vaccine as
applicable).
Notice of quarterly meeting.
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50067
Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices
Dated: August 14, 2006.
Sally D. Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. E6–13996 Filed 8–23–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0326]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the publication of the criteria FDA
intends to use to accredit third parties
to conduct inspections of eligible
manufacturers of class II or class III
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by October 23, 2006.
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘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 provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
ADDRESSES:
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
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.
Medical Devices: Inspection by
Accredited Persons Program Under
MDUFMA (OMB Control Number 0910–
0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons or APs) to
conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
Description of Respondents:
Businesses or other for profit
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Information Collection:
No. of
Respondents
Request for Accreditation
Annual Frequency
per Response
3
Total Annual
Responses
1
Hours per
Response
3
80
Total Hours
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1There
240
240
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
Total Hours
15:15 Aug 23, 2006
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PO 00000
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]]>Agencies
[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50066-50067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
President's Committee for People With Intellectual Disabilities;
Notice of Meeting
AGENCY: President's Committee for People with Intellectual Disabilities
(PCPID), Department of Health And Human Services.
ACTION: Notice of quarterly meeting.
-----------------------------------------------------------------------
DATES: Thursday, September 14, 2006, from 9 a.m. to 5:30 p.m., and
Friday, September 15, 2006, from 9 a.m. to 5 p.m. The entire meeting of
PCPID will be open to the public.
ADDRESSES: The meeting will be held in Room 800 of the Hubert H.
Humphrey building, 200 Independence Ave., SW., Washington, DC 20201.
Individuals who will need accommodations for a disability in order to
attend the meeting (e.g., interpreting services, assistive listening
devices, materials in alternative format such as large print or
Braille) should notify Sally Atwater at 202-619-0634 no later than
September 7, 2006. We will attempt to meet requests made after that
date, but cannot guarantee availability. All meeting sites are barrier
free.
Agenda: Day One--The new Committee members will take the oath of
office, be sworn in as members of the President's Committee for People
with Intellectual Disabilities and receive guidance on ethics
regulations and the Federal Advisory Committee Act (FACA). Committee
members will also hear from the various ex officio members regarding
the programs and services provided by their respective Federal
agencies.
Agenda: Day Two--The Committee will receive a briefing on the New
Freedom Initiative and then begin discussion to set Committee
priorities for the coming year.
FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director,
President's Committee for People with Intellectual Disabilities, The
Aerospace Center, Suite 701, 370 L'Enfant Promenade, SW., Washington,
DC 20447. Telephone: 202-619-0634, fax: 202-205-9591. E-mail:
satwater@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the
President and the Secretary of Health and Human Services on a broad
range of topics relating to programs, services and supports for persons
with intellectual disabilities. The Committee, by Executive Order, is
responsible for evaluating the adequacy of current practices in
programs, services and supports for persons with intellectual
disabilities, and for reviewing legislative proposals that impact the
quality of life experienced by citizens with intellectual disabilities
and their families.
[[Page 50067]]
Dated: August 14, 2006.
Sally D. Atwater,
Executive Director, President's Committee for People with Intellectual
Disabilities.
[FR Doc. E6-13996 Filed 8-23-06; 8:45 am]
BILLING CODE 4184-01-P
