Agency Information Collection Activities: Submission for OMB Review; Comment Request, 71578-71579 [2011-29830]
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Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices
will be required as part of a REMS.
Under section 505–1(e) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355–1(e)), FDA
may require that a REMS for a drug
include one or more of the elements
described in section 505–1(e), including
the requirement for an applicant to
develop a Medication Guide for
distribution to each patient when the
drug is dispensed (when the criteria in
part 208 (21 CFR part 208) are met).
Since the enactment of the Food and
Drug Administration Amendments Act
of 2007, FDA has, as a matter of policy,
considered any new Medication Guide
(or safety-related changes to an existing
Medication Guide) to be part of a REMS.
However, the Agency has the authority
to determine, based on the risks of a
drug and public health concern, how a
Medication Guide should be required
when the standard in part 208 is met.
Based on the risks and public health
concern, the Agency may require: (1) A
Medication Guide in accordance with
part 208 that is not an element of a
REMS or (2) A Medication Guide in
accordance with part 208 and section
505–1 of the FD&C Act that is an
element of a REMS, which may include
other elements of a REMS (such as
elements to assure safe use).
In the Federal Register of February
28, 2011 (76 FR 10908), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Medication Guides—
Distribution Requirements and
Inclusion in Risk Evaluation and
Mitigation Strategies (REMS).’’ The
notice gave interested parties the
opportunity to comment by May 31,
2011. The Agency considered all of the
comments received and made minor
editorial and clarifying changes to the
guidance.
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 when FDA intends
to exercise enforcement discretion
regarding Medication Guide distribution
and inclusion of Medication Guides in
REMS. 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 statutes
and regulations.
II. 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
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17:44 Nov 17, 2011
Jkt 226001
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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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
21 CFR 314.70 and 601.12 have been
approved under OMB control numbers
0910–0001 and 0910–0338, respectively;
the collections of information in part
208 have been approved under OMB
control number 0910–0393.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29877 Filed 11–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To obtain a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Proposed Project: National Survey of
Organ Donation Attitudes and Practices
(OMB No. 0915–xxxx)—[New]
The Division of Transplantation
(DoT), Healthcare Systems Bureau,
Health Resources and Services
Administration (HRSA), is planning to
conduct a telephone survey of public
knowledge, perceptions, opinion, and
behaviors related to organ donation.
Two key missions of the DoT are (1) to
provide oversight for the Organ
Procurement and Transplantation
Network and policy development
related to organ donation and
transplantation and (2) to implement
efforts to increase public knowledge
about the need for increased organ
donation.
With a constantly growing deficit
between the number of Americans
needing donor organs (currently
approximately 112,000) and the annual
number of donors (14,505 in 2010),
raising the American public’s
willingness to donate becomes
increasingly critical. Effective education
and outreach campaigns need to be
based on knowledge of the public’s
attitudes and perceptions about, and
perceived impediments to, organ
donation. Two national surveys using
nearly identical survey instruments to
identify public views and behaviors
related to organ donation were
conducted in 1993 and 2005.
The proposed study will identify
current organ donation views and
practices of the American public and
various population subgroups using a
survey instrument similar to the two
earlier studies in order to track changes
over time. It will measure issues such as
public knowledge about and attitudes
toward organ donation, public
commitment to or willingness to donate,
impediments to public willingness to
donate, and attitudes toward living
donation, donation practices, policy
issues, allocation policy, presumed
consent, and financial incentives for
donation. Demographic information also
will be collected. The randomly drawn
sample will consist of 3,250 adults (age
18 and over), including an oversample
of Asians, Hispanics, African
Americans, and Native Americans, and
will be geographically representative of
the United States. The survey
instrument will be administered in both
English and Spanish through computerassisted telephone interviews.
In addition to being useful to the DoT
(especially in its donation outreach
initiatives), results of this survey also
will be of assistance to the donation and
transplant community, DoT grantees
and other research efforts, and to the
E:\FR\FM\18NON1.SGM
18NON1
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Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Notices
Secretary’s Advisory Committee on
Organ Transplantation (ACOT) as it
fulfills its charge to advise the Secretary
of Health and Human Services on the
numerous and often controversial issues
related to donation and transplantation.
In its first meeting, the ACOT suggested
such a survey to gather information to
inform both public education efforts and
Number of
respondents
Instrument
Responses
per
respondent
policy decisions on the issue of organ
donation.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total
burden hours
Telephone survey ................................................................
3,250
1
3,250
0.3
975
Total ..............................................................................
3,250
1
3,250
0.3
975
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
A similar request for public comments
was published in the Federal Register
on September 20, 2011 (76 FR 58282).
Dated: November 14, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–29830 Filed 11–17–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, RFA Panel:
Interventions for SIDS and Other Sleep
Related Infant Deaths.
Date: December 7–8, 2011.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Mar<15>2010
17:44 Nov 17, 2011
Jkt 226001
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Kevin Walton, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, (301) 435–
1785, kevin.walton@nih.hhs.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Program
Project: Cell Biology.
Date: December 13–14, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Homewood Suites Hotel, 2 Farm
Glen Boulevard, Farmington, CT 06032.
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, (301) 435–
1022, balasundaramd@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 9, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–29891 Filed 11–17–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 9990
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: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Integrative Neurosensory Studies.
Date: December 7–8, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181
MSC 7846, Bethesda, MD 20892–7846, (301)
435–1236, zhaow@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Integrative Neuroscience.
Date: December 15, 2011.
Time: 5 p.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Kirk Thompson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
MSC 7844, Bethesda, MD 20892, (301) 435–
1242, kgt@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–29887 Filed 11–17–11; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71578-71579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To obtain a
copy of the clearance requests submitted to OMB for review, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: National Survey of Organ Donation Attitudes and
Practices (OMB No. 0915-xxxx)--[New]
The Division of Transplantation (DoT), Healthcare Systems Bureau,
Health Resources and Services Administration (HRSA), is planning to
conduct a telephone survey of public knowledge, perceptions, opinion,
and behaviors related to organ donation. Two key missions of the DoT
are (1) to provide oversight for the Organ Procurement and
Transplantation Network and policy development related to organ
donation and transplantation and (2) to implement efforts to increase
public knowledge about the need for increased organ donation.
With a constantly growing deficit between the number of Americans
needing donor organs (currently approximately 112,000) and the annual
number of donors (14,505 in 2010), raising the American public's
willingness to donate becomes increasingly critical. Effective
education and outreach campaigns need to be based on knowledge of the
public's attitudes and perceptions about, and perceived impediments to,
organ donation. Two national surveys using nearly identical survey
instruments to identify public views and behaviors related to organ
donation were conducted in 1993 and 2005.
The proposed study will identify current organ donation views and
practices of the American public and various population subgroups using
a survey instrument similar to the two earlier studies in order to
track changes over time. It will measure issues such as public
knowledge about and attitudes toward organ donation, public commitment
to or willingness to donate, impediments to public willingness to
donate, and attitudes toward living donation, donation practices,
policy issues, allocation policy, presumed consent, and financial
incentives for donation. Demographic information also will be
collected. The randomly drawn sample will consist of 3,250 adults (age
18 and over), including an oversample of Asians, Hispanics, African
Americans, and Native Americans, and will be geographically
representative of the United States. The survey instrument will be
administered in both English and Spanish through computer-assisted
telephone interviews.
In addition to being useful to the DoT (especially in its donation
outreach initiatives), results of this survey also will be of
assistance to the donation and transplant community, DoT grantees and
other research efforts, and to the
[[Page 71579]]
Secretary's Advisory Committee on Organ Transplantation (ACOT) as it
fulfills its charge to advise the Secretary of Health and Human
Services on the numerous and often controversial issues related to
donation and transplantation. In its first meeting, the ACOT suggested
such a survey to gather information to inform both public education
efforts and policy decisions on the issue of organ donation.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Telephone survey................ 3,250 1 3,250 0.3 975
-------------------------------------------------------------------------------
Total....................... 3,250 1 3,250 0.3 975
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
A similar request for public comments was published in the Federal
Register on September 20, 2011 (76 FR 58282).
Dated: November 14, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-29830 Filed 11-17-11; 8:45 am]
BILLING CODE 4165-15-P
