Advisory Committee on Immunization Practices (ACIP), 60500-60501 [2011-25012]
Download as PDF
<![CDATA[
60500
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Number of
respondents
Data collection method
Focus Groups (Online) ...................................
Short Surveys .................................................
Medium Surveys ............................................
In-depth Surveys ............................................
Dated: September 22, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–25005 Filed 9–28–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–240]
Request for Information:
Announcement of Carcinogen and
Recommended Exposure Limit (REL)
Policy Assessment
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice and extension of public
comment period.
AGENCY:
On August 23, 2011, the
Director of the National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC) published
a notice in the Federal Register (76 FR
52664) announcing its intent to ‘‘review
its approach to classifying carcinogens
and establishing recommended
exposure limits (RELs) for occupational
exposures to hazards associated with
cancer.’’ As part of this effort, NIOSH
requested initial input on issues, and
answers to 5 questions. NIOSH has also
created a new NIOSH Cancer and RELs
Policy Web Topic Page [see https://www.
cdc.gov/niosh/topics/cancer/policy.
html] to provide additional details about
this effort and progress updates.
Written comment was to be received
by September 22, 2011. NIOSH has
received a request to extend the
comment period to permit the public
more time to gather and submit
information. NIOSH is extending the
public comment period to Friday,
December 30, 2011.
Public Comment Period: Written or
electronic comments must be received
tkelley on DSKG8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:29 Sep 28, 2011
Jkt 223001
on or postmarked by Friday, December
30, 2011.
ADDRESSES: Written comments,
identified by docket number NIOSH–
240, may be submitted by any of the
following methods:
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
• Facsimile: (513) 533–8285.
• E-mail: nioshdocket@cdc.gov.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Room 111, Cincinnati, Ohio 45226. A
complete electronic docket containing
all comments submitted will be
available on the NIOSH Web page at
https://www.cdc.gov/niosh/docket, and
comments will be available in writing
by request. NIOSH includes all
comments received without change in
the docket, including any personal
information provided. All electronic
comments should be formatted as
Microsoft Word. Please make reference
to docket number NIOSH–240.
FOR FURTHER INFORMATION CONTACT: T.J.
Lentz, telephone (513) 533–8260, or
Faye Rice, telephone (513) 533–8335,
NIOSH, MS–C32, Robert A. Taft
Laboratories, 4676 Columbia Parkway,
Cincinnati, Ohio 45226.
Dated: September 23, 2011.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2011–25039 Filed 9–28–11; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices (ACIP)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
120
8,001
13,334
1,292
1
1
1
1
Average
burden per
response
1
10/60
25/60
1
the following meeting for the
aforementioned committee:
Times and Dates
8 a.m.–6 p.m., October 25, 2011.
8 a.m.–1:15 p.m., October 26, 2011.
Place: CDC, Tom Harkin Global
Communications Center, 1600 Clifton
Road, NE., Building 19, Kent ‘‘Oz’’
Nelson Auditorium, Atlanta, Georgia
30333.
Status: Open to the public, limited
only by the space available.
Purpose: The committee is charged
with advising the Director, CDC, on the
appropriate uses of immunizing agents.
In addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for
administration to vaccine-eligible
children through the Vaccines for
Children (VFC) program, along with
schedules regarding the appropriate
periodicity, dosage, and
contraindications applicable to the
vaccines.
Matters To Be Discussed: The agenda
will include discussions on: Child/
adolescent immunization schedules;
adult immunization schedule; human
papillomavirus vaccine; hepatitis B
vaccine; meningococcal vaccines;
influenza; 13-valent pneumococcal
conjugate vaccine; measles, mumps, and
rubella (MMR) vaccine; febrile seizures
and vaccines; pertussis; immunization
coverage among children and
adolescents; and vaccine supply.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Stephanie B. Thomas, National Center
for Immunization and Respiratory
Diseases, CDC, 1600 Clifton Road, NE.,
MS–A27, Atlanta, Georgia 30333,
telephone (404) 639–8836; E-mail
ACIP@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 Agency for Toxic
Substances and Disease Registry.
E:\FR\FM\29SEN1.SGM
29SEN1
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
Dated: September 21, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0435. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2011–25012 Filed 9–28–11; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0279]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Marketing Act of 1987; Administrative
Procedures, Policies, and
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Prescription Drug Marketing Act of
1987; Administrative Procedures,
Policies, and Requirements—21 CFR
Part 203—(OMB Control Number 0910–
0435)—Extension
FDA is requesting OMB approval
under the PRA (44 U.S.C. 3501–3520)
for the reporting and recordkeeping
requirements contained in the
regulations implementing the
Prescription Drug Marketing Act of 1987
(PDMA) (Pub. L. 100–293). PDMA was
intended to ensure that drug products
purchased by consumers are safe and
effective and to avoid an unacceptable
risk that counterfeit, adulterated,
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by October 31,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
60501
misbranded, subpotent, or expired drugs
are sold.
PDMA was enacted by Congress
because there were insufficient
safeguards in the drug distribution
system to prevent the introduction and
retail sale of substandard, ineffective, or
counterfeit drugs, and that a wholesale
drug diversion submarket had
developed that prevented effective
control over the true sources of drugs.
Congress found that large amounts of
drugs had been reimported into the
United States as U.S. goods returned
causing a health and safety risk to U.S.
consumers because the drugs may
become subpotent or adulterated during
foreign handling and shipping. Congress
also found that a ready market for
prescription drug reimports had been
the catalyst for a continuing series of
frauds against U.S. manufacturers and
had provided the cover for the
importation of foreign counterfeit drugs.
Congress also determined that the
system of providing drug samples to
physicians through manufacturers’
representatives had resulted in the sale
to consumers of misbranded, expired,
and adulterated pharmaceuticals.
The bulk resale of below-wholesale
priced prescription drugs by health care
entities for ultimate sale at retail also
helped to fuel the diversion market and
was an unfair form of competition to
wholesalers and retailers who had to
pay otherwise prevailing market prices.
FDA is requesting OMB approval for
the following reporting and
recordkeeping requirements:
TABLE 1—REPORTING REQUIREMENTS
21 CFR Section
Requirement
203.11 .................................................................
203.30(a)(1) and (b) ...........................................
203.30(a)(3), (a)(4), and (c) ................................
203.31(a)(1) and (b) ...........................................
Applications for reimportation to provide emergency medical care.
Drug sample requests (drug samples distributed by mail or common carrier).
Drug sample receipts (receipts for drug samples distributed by mail or common carrier).
Drug sample requests (drug samples distributed by means other than the mail or a common
carrier).
Drug sample receipts (drug samples distributed by means other than the mail or a common
carrier).
Investigation of falsification of drug sample records.
Investigation of a significant loss or known theft of drug samples.
Notification that a representative has been convicted of certain offenses involving drug samples.
Notification of the individual responsible for responding to a request for information about drug
samples.
Preparation by a charitable institution of a reconciliation report for donated drug samples.
203.31(a)(3), (a)(4), and (c) ................................
203.37(a) .............................................................
203.37(b) .............................................................
203.37(c) .............................................................
203.37(d) .............................................................
203.39(g) .............................................................
tkelley on DSKG8SOYB1PROD with NOTICES
TABLE 2—RECORDKEEPING REQUIREMENTS
21 CFR Section
Requirement
203.23(a) and (b) ................................................
203.23(c) .............................................................
203.30(a)(2) and 203.31(a)(2) ............................
Credit memo for returned drugs.
Documentation of proper storage, handling, and shipping conditions for returned drugs.
Verification that a practitioner requesting a drug sample is licensed or authorized by the appropriate State authority to prescribe the product.
Contents of the inventory record and reconciliation report required for drug samples distributed
by representatives.
203.31(d)(1) and (d)(2) .......................................
VerDate Mar<15>2010
15:29 Sep 28, 2011
Jkt 223001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60500-60501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices (ACIP)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announce the following meeting for the aforementioned
committee:
Times and Dates
8 a.m.-6 p.m., October 25, 2011.
8 a.m.-1:15 p.m., October 26, 2011.
Place: CDC, Tom Harkin Global Communications Center, 1600 Clifton
Road, NE., Building 19, Kent ``Oz'' Nelson Auditorium, Atlanta, Georgia
30333.
Status: Open to the public, limited only by the space available.
Purpose: The committee is charged with advising the Director, CDC,
on the appropriate uses of immunizing agents. In addition, under 42
U.S.C. 1396s, the committee is mandated to establish and periodically
review and, as appropriate, revise the list of vaccines for
administration to vaccine-eligible children through the Vaccines for
Children (VFC) program, along with schedules regarding the appropriate
periodicity, dosage, and contraindications applicable to the vaccines.
Matters To Be Discussed: The agenda will include discussions on:
Child/adolescent immunization schedules; adult immunization schedule;
human papillomavirus vaccine; hepatitis B vaccine; meningococcal
vaccines; influenza; 13-valent pneumococcal conjugate vaccine; measles,
mumps, and rubella (MMR) vaccine; febrile seizures and vaccines;
pertussis; immunization coverage among children and adolescents; and
vaccine supply.
Agenda items are subject to change as priorities dictate.
Contact Person for More Information: Stephanie B. Thomas, National
Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton
Road, NE., MS-A27, Atlanta, Georgia 30333, telephone (404) 639-8836; E-
mail ACIP@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 Agency for
Toxic Substances and Disease Registry.
[[Page 60501]]
Dated: September 21, 2011.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2011-25012 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-18-P
