Advisory Commission on Childhood Vaccines; Notice of Meeting, 70623 [05-23042]
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Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Notices
it to the agency. Thus, each firm
submitting a compliance extension
request will need 5 hours of employee
time to complete the request. Given that
56 businesses are expected to submit
written requests in year one, the total
burden hours for year one are 280.
In year two, FDA expects about onehalf as many firms to request a labeling
compliance extension. So for year two,
28 firms are expected to file a request
for an extension to the labeling
compliance date. Again, assuming that
it will take 5 hours to complete each
request, the total burden hours for year
two will be 140.
Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23040 Filed 11–21–05; 8:45 am]
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0571. The
approval expires on January 31, 2006. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: November 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23041 Filed 11–21–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Food and Drug Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
[Docket No. 2005N–0343]
70623
Administration (HRSA), Room 11C–26, 5600
Fishers Lane, Rockville, Maryland 20857 or
e-mail clee@hrsa.gov. Requests should
contain the name, address, telephone
number, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The allocation of time may be
adjusted to accommodate the level of
expressed interest. DVIC will notify each
presenter by mail or telephone of their
assigned presentation time. Persons who do
not file an advance request for a presentation,
but desire to make an oral statement, may
announce it at the time of the comment
period. These persons will be allocated time
as it permits.
For Further Information Contact: Anyone
requiring information regarding the ACCV
should contact Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, HSB, HRSA, Room 11C–
26, 5600 Fishers Lane, Rockville, MD 20857;
telephone (301) 443–2124 or e-mail
clee@hrsa.gov.
Dated: November 15, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–23042 Filed 11–21–05; 8:45 am]
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Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Requesting an Extension
to Use Existing Label Stock After the
Trans Fat Labeling Effective Date of
January 1, 2006
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Requesting an Extension
to Use Existing Label Stock after the
Trans Fat Labeling Effective Date of
January 1, 2006’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (the PRA). Elsewhere in this
issue of the Federal Register, FDA is
publishing a notice announcing an
opportunity for public comment on this
collection of information. Since this
collection received emergency approval
that expires on January 1, 2006, FDA is
following the normal PRA clearance
procedures by issuing that notice.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 1, 2005
(70 FR 52108), the agency announced
that the proposed information collection
VerDate Aug<31>2005
18:49 Nov 21, 2005
Jkt 208001
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 Commission on
Childhood Vaccines (ACCV).
Date and Time: December 12, 2005, 9
a.m.—5 p.m., EST.
Place: Audio Conference Call and
Parklawn Building, Conference Rooms G & H,
5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Monday,
December 12, from 9 a.m. to 5 p.m. The
public can join the meeting in person at the
address listed above or by audio conference
call by dialing 1–800–369–6048 on December
12 and providing the following information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the
December meeting will include, but are not
limited to: A summary of the U.S. Court of
Federal Claims’ 18th Judicial Conference; a
report from the ACCV Workgroup looking at
proposed guidelines for future changes to the
Vaccine Injury Table; and updates from the
Division of Vaccine Injury Compensation
(DVIC), Department of Justice, National
Vaccine Program Office, Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of Allergy and
Infectious Diseases (National Institutes of
Health), and Center for Biologics and
Evaluation Research (Food and Drug
Administration). Agenda items are subject to
change as priorities dictate.
Public Comments: Persons interested in
providing an oral presentation should submit
a written request, along with a copy of their
presentation to: Ms. Cheryl Lee, Principal
Staff Liaison, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and Services
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Publication of OIG Special Advisory
Bulletin on Patient Assistance
Programs for Medicare Part D
Enrollees
Office of Inspector General
(OIG), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: OIG periodically develops
and issues guidance, including Special
Advisory Bulletins, to alert and inform
the health care industry about potential
problems or areas of special interest.
This Federal Register notice sets forth
the recently issued OIG Special
Advisory Bulletin addressing patient
assistance programs for Medicare Part D
enrollees.
FOR FURTHER INFORMATION CONTACT:
Darlene M. Hampton, Office of Counsel
to the Inspector General, (202) 619–
0335.
SUPPLEMENTARY INFORMATION:
Special Advisory Bulletin: Patient
Assistance Programs for Medicare Part
D Enrollees (November 2005)
I. Introduction
Patient assistance programs (PAPs)
have long provided important safety net
assistance to patients of limited means
E:\FR\FM\22NON1.SGM
22NON1
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[Federal Register Volume 70, Number 224 (Tuesday, November 22, 2005)]
[Notices]
[Page 70623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23042]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines; 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 Commission on Childhood Vaccines (ACCV).
Date and Time: December 12, 2005, 9 a.m.--5 p.m., EST.
Place: Audio Conference Call and Parklawn Building, Conference
Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Monday, December 12, from 9 a.m. to 5 p.m.
The public can join the meeting in person at the address listed
above or by audio conference call by dialing 1-800-369-6048 on
December 12 and providing the following information:
Leader's Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the December meeting will include,
but are not limited to: A summary of the U.S. Court of Federal
Claims' 18th Judicial Conference; a report from the ACCV Workgroup
looking at proposed guidelines for future changes to the Vaccine
Injury Table; and updates from the Division of Vaccine Injury
Compensation (DVIC), Department of Justice, National Vaccine Program
Office, Immunization Safety Office (Centers for Disease Control and
Prevention), National Institute of Allergy and Infectious Diseases
(National Institutes of Health), and Center for Biologics and
Evaluation Research (Food and Drug Administration). Agenda items are
subject to change as priorities dictate.
Public Comments: Persons interested in providing an oral
presentation should submit a written request, along with a copy of
their presentation to: Ms. Cheryl Lee, Principal Staff Liaison,
DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services
Administration (HRSA), Room 11C-26, 5600 Fishers Lane, Rockville,
Maryland 20857 or e-mail clee@hrsa.gov. Requests should contain the
name, address, telephone number, and any business or professional
affiliation of the person desiring to make an oral presentation.
Groups having similar interests are requested to combine their
comments and present them through a single representative. The
allocation of time may be adjusted to accommodate the level of
expressed interest. DVIC will notify each presenter by mail or
telephone of their assigned presentation time. Persons who do not
file an advance request for a presentation, but desire to make an
oral statement, may announce it at the time of the comment period.
These persons will be allocated time as it permits.
For Further Information Contact: Anyone requiring information
regarding the ACCV should contact Ms. Cheryl Lee, Principal Staff
Liaison, DVIC, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville,
MD 20857; telephone (301) 443-2124 or e-mail clee@hrsa.gov.
Dated: November 15, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-23042 Filed 11-21-05; 8:45 am]
BILLING CODE 4165-15-P
