Agency Information Collection Activities: Submission for OMB Review; Comment Request, 34390-34391 [2012-14001]
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34390
Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. However, if you submit a
written petition, you must submit three
copies of the petition. Identify
comments with the docket number
found in brackets in the heading of this
document.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2012–14000 Filed 6–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0307]
Draft Guidance for Industry:
Amendment to ‘‘Guidance for Industry:
Revised Preventive Measures To
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood
Products,’’ Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Amendment
(revisions to labeling recommendations
for potential risk of vCJD) to ‘Guidance
for Industry: Revised Preventive
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products’ ’’ dated June 2012. The
draft guidance document proposes
amendments to the labeling
recommendations for plasma-derived
products, including albumin and
products containing plasma-derived
albumin, in the guidance document
entitled ‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’ dated
May 2010 (2010 CJD/vCJD guidance).
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SUMMARY:
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When finalized, the revised labeling
recommendations will be incorporated
into the 2010 CJD/vCJD guidance, but
FDA will otherwise continue with its
recommendations in the 2010 CJD/vCJD
guidance as currently provided.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 10,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Amendment (revisions to
labeling recommendations for potential
risk of vCJD) to ‘Guidance for Industry:
Revised Preventive Measures to Reduce
the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’ ’’ dated
April 2012. The draft guidance
document proposes amendments to
labeling recommendations in the 2010
CJD/vCJD guidance for plasma-derived
products, including albumin and
products containing plasma-derived
albumin, to reflect current knowledge of
vCJD transmission through blood. When
finalized, the revised labeling
recommendations will be incorporated
into the 2010 CJD/vCJD guidance.
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The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. 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
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. 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.
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. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://www.
regulations.gov.
Dated: April 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14034 Filed 6–8–12; 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 request 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–
1984.
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34391
Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Nursing Scholarship
Program (OMB No. 0915–0301)—
[Revision]
The Nursing Scholarship Program
(NSP) is a competitive Federal program,
which awards scholarships to
individuals for attendance at accredited
schools of nursing. The Bureau of
Clinician Recruitment and Service
(BCRS) in HRSA administers the
program. The scholarship consists of
payment of tuition, fees, other
reasonable educational costs, and a
monthly support stipend. In return, the
students agree to provide a minimum of
2 years of full-time clinical service (or
an equivalent part-time commitment, as
approved by the NSP) at a health care
facility with a critical shortage of nurses
as defined by the program.
NSP recipients must be willing to and
are required to fulfill their NSP service
commitment at a health care facility
with a critical shortage of nurses in the
United States, which includes, in
addition to the States, the District of
Columbia, Guam, the Commonwealth of
Puerto Rico, the Northern Mariana
Islands, the U.S. Virgin Islands,
American Samoa, the Federated States
of Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau. Students who are uncertain of
their commitment to provide nursing
care in a health care facility with a
critical shortage of nurses in the United
States or these territories are advised not
to participate in this program.
The NSP needs to collect data to
determine an applicant’s eligibility for
the program, to monitor a participant’s
continued enrollment in a school of
nursing, to monitor the participant’s
compliance with the NSP service
Number of
respondents
Instrument
Responses
per
respondent
obligation, and to obtain data on its
program to ensure compliance with
statutory mandates and prepare annual
reports to Congress. The following
information will be collected: (1) From
the applicants and/or the schools—
general applicant and nursing school
data such as full name, location, tuition/
fees, and enrollment status; (2) from the
schools (on an annual basis)—data
concerning tuition/fees and student
enrollment status; and (3) from the
participants and their health care
facilities with a critical shortage of
nurses (on a biannual basis)—data
concerning the participant’s
employment status, work schedule, and
leave usage. BCRS enters the cost
information into its information data
system, along with the projected amount
for the monthly stipend, to determine
the amount of each scholarship award.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Application ............................................................................
In-School Monitoring ............................................................
In-Service Monitoring ...........................................................
4,000
500
600
1
1
2
4,000
500
1,200
2
2
1
8,000
1,000
1,200
Total ..............................................................................
5,100
........................
5,700
........................
10,200
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.’’
Dated: June 5, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–14001 Filed 6–8–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with NOTICES
National Institutes of Health
Submission for OMB Review;
Comment Request Generic Clearance
to Conduct Voluntary Customer/
Partner Surveys
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Library of Medicine (NLM), the National
Institutes of Health (NIH) has submitted
SUMMARY:
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to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on April 2, 2012 (Vol. 77, No.
63, p. 19673) and allowed 60-days for
public comment. A single public
comment was received. The purpose of
this notice is to allow an additional 30
days for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: Generic
Clearance to Conduct Voluntary
Customer/Partner Surveys; Type of
Information Collection Request:
Extension of currently approved
collection [OMB No. 0925–0476,
expiration date 06/30/2012] Form
Number: NA; Need and Use of
Information Collection: Executive Order
12962 directed agencies that provide
significant services directly to the
public to survey customers to determine
the kind and quality of services they
want and their level of satisfaction with
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existing services. Additionally, since
1994, the NLM has been a ‘‘Federal
Reinvention Laboratory’’ with a goal of
improving its methods of delivering
information to the public. An essential
strategy in accomplishing reinvention
goals is the ability to periodically
receive input and feedback from
customers about the design and quality
of the services they receive. The NLM
provides significant services directly to
the public including health providers,
researchers, universities, other federal
agencies, state and local governments,
and to others through a range of
mechanisms, including publications,
technical assistance, and Web sites.
These services are primarily focused on
health and medical information
dissemination activities. The purpose of
this submission is to obtain OMB’s
generic approval to continue to conduct
satisfaction surveys of NLM’s
customers. The NLM will use the
information provided by individuals
and institutions to identify strengths
and weaknesses in current services and
to make improvements where feasible.
The ability to periodically survey NLM’s
customers is essential to continually
update and upgrade methods of
providing high quality service.
E:\FR\FM\11JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34390-34391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14001]
-----------------------------------------------------------------------
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 request
a copy of the clearance requests submitted to OMB for review, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1984.
[[Page 34391]]
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Nursing Scholarship Program (OMB No. 0915-0301)--
[Revision]
The Nursing Scholarship Program (NSP) is a competitive Federal
program, which awards scholarships to individuals for attendance at
accredited schools of nursing. The Bureau of Clinician Recruitment and
Service (BCRS) in HRSA administers the program. The scholarship
consists of payment of tuition, fees, other reasonable educational
costs, and a monthly support stipend. In return, the students agree to
provide a minimum of 2 years of full-time clinical service (or an
equivalent part-time commitment, as approved by the NSP) at a health
care facility with a critical shortage of nurses as defined by the
program.
NSP recipients must be willing to and are required to fulfill their
NSP service commitment at a health care facility with a critical
shortage of nurses in the United States, which includes, in addition to
the States, the District of Columbia, Guam, the Commonwealth of Puerto
Rico, the Northern Mariana Islands, the U.S. Virgin Islands, American
Samoa, the Federated States of Micronesia, the Republic of the Marshall
Islands, and the Republic of Palau. Students who are uncertain of their
commitment to provide nursing care in a health care facility with a
critical shortage of nurses in the United States or these territories
are advised not to participate in this program.
The NSP needs to collect data to determine an applicant's
eligibility for the program, to monitor a participant's continued
enrollment in a school of nursing, to monitor the participant's
compliance with the NSP service obligation, and to obtain data on its
program to ensure compliance with statutory mandates and prepare annual
reports to Congress. The following information will be collected: (1)
From the applicants and/or the schools--general applicant and nursing
school data such as full name, location, tuition/fees, and enrollment
status; (2) from the schools (on an annual basis)--data concerning
tuition/fees and student enrollment status; and (3) from the
participants and their health care facilities with a critical shortage
of nurses (on a biannual basis)--data concerning the participant's
employment status, work schedule, and leave usage. BCRS enters the cost
information into its information data system, along with the projected
amount for the monthly stipend, to determine the amount of each
scholarship award.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Application..................... 4,000 1 4,000 2 8,000
In-School Monitoring............ 500 1 500 2 1,000
In-Service Monitoring........... 600 2 1,200 1 1,200
-------------------------------------------------------------------------------
Total....................... 5,100 .............. 5,700 .............. 10,200
----------------------------------------------------------------------------------------------------------------
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.''
Dated: June 5, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-14001 Filed 6-8-12; 8:45 am]
BILLING CODE 4165-15-P
