Proposed Collection; 60-Day Comment Request; Self-Affirmation Construct Validity (NCI), 1958-1959 [2016-00545]
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1958
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
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Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and
Blood Products; Guidance for Industry.’’
The guidance document provides blood
collecting establishments and
manufacturers of plasma derivatives
with comprehensive recommendations
intended to minimize the possible risk
of transmission of CJD and vCJD from
blood and blood products. The guidance
is the latest in a series of guidances
addressing the risk of CJD and vCJD
transmission by blood and blood
products.
The guidance amends the 2010
guidance (May 27, 2010; 75 FR 29768)
and finalizes the 2012 draft guidance
(June 11, 2012; 77 FR 34390) by
providing revised labeling
recommendations for plasma-derived
products, including albumin and
products containing plasma-derived
albumin. The guidance also provides
manufacturers of plasma-derived
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products with recommendations on how
to report the labeling changes to FDA
under 21 CFR 601.12. Additional
changes to the guidance include adding
information in the background section
relevant to the new labeling
recommendations; providing updated
information on the global vCJD and
Bovine Spongiform Encephalopathy
epidemics; clarifying the reentry criteria
for a donor with a family history of CJD;
clarifying the requirements related to
biological product deviation reporting;
and, updating, adding, and removing
certain footnotes and references. FDA
received four comments on the 2012
draft guidance, and those comments
were considered in the finalization of
the draft guidance.
This guidance does not address
potential changes to the geographic
exposure based deferrals for risk of
vCJD. FDA discussed such potential
changes with its Transmissible
Spongiform Encephalopathies Advisory
Committee in June 2015 and intends to
address revised recommendations for
geographic donor deferrals in future
guidance documents.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on Revised Preventive
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products;
Guidance for Industry. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. 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 601.12 have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
606.100 have been approved under
OMB control number 0910–0116; and
the collections of information in 21 CFR
600.14 and 606.171 have been approved
under OMB control number 0910–0458.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
PO 00000
Frm 00022
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default.htm or https://
www.regulations.gov.
Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00536 Filed 1–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Self-Affirmation Construct
Validity (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact*: Rebecca Ferrer,
Program Director, Basic Biobehavioral
and Psychological Sciences Branch,
Behavioral Research Program, Division
of Cancer Control and Population
Sciences, National Cancer Institute,
9609 Medical Center Dr., Rockville MD
20852. or call non-toll-free number (240)
276–6914 or Email your request,
including your address to: ferrerra@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUMMARY:
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1959
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Self-affirmation
Construct Validity, 0925–NEW, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This information collection,
seeks to refine a theory about how selfcompetence and values play a role in
defensive responses to health
communications. Although
theoretically-driven research has shown
that self-affirmation—a process by
which individuals reflect on values that
are important to them—can improve
responses to health and cancer
communications, the ‘‘active
ingredient’’ (or mechanisms underlying
effectiveness) of self-affirmations is
unknown. Self-affirmation is a potent
means of augmenting the effectiveness
of threatening health communications.
Individuals tend to be defensive against
information suggesting their behavior
puts them at risk for disease or negative
health. Previous evidence suggests that
self-affirmation may reduce
defensiveness to threatening health
information, increasing openness to the
message and resulting in increased
disease risk perceptions, disease-related
worry, intentions to engage in
preventive behavior, and actual
behavioral change. Understanding the
mechanisms that explain these robust
effects would yield evidence important
for dissemination, including ways to
refine self-affirmation interventions and
make them more potent, which could
change the ways that public health
messages are constructed. This research
can inform NCI scientific priorities and
investments in self-affirmation research.
The results of the information collection
will be used to further develop and
improve self-affirmation theory. These
findings may allow future researchers to
develop and test cancer prevention
interventions.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
717.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Types of respondents
Screener ............................................
Study .................................................
General Public ..................................
General Public ..................................
Dated: January 7, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
[FR Doc. 2016–00545 Filed 1–13–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0085]
Agency Information Collection
Activities: Administrative Rulings
U.S. Customs and Border
Protection, Department of Homeland
Security
ACTION: 60-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:
U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Administrative Rulings.
CBP is proposing that this information
collection be extended with a change to
the burden hours but no change to the
information required. This document is
published to obtain comments from the
public and affected agencies.
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SUMMARY:
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10,000
1,100
Written comments should be
received on or before March 14, 2016 to
be assured of consideration.
ADDRESSES: Written comments may be
mailed to U.S. Customs and Border
Protection, Attn: Tracey Denning,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
The comments should address: (a)
Whether the collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
DATES:
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Fmt 4703
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Number of
responses per
respondent
1
1
Average time
per response
(in hours)
1/60
30/60
Total hour
burden
167
550
annual cost burden to respondents or
record keepers from the collection of
information (total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for OMB approval. All
comments will become a matter of
public record. In this document, CBP is
soliciting comments concerning the
following information collection:
Title: Administrative Rulings.
OMB Number: 1651–0085.
Abstract: The collection of
information in 19 CFR part 177 is
necessary in order to enable Customs
and Border Protection (CBP) to respond
to requests by importers and other
interested persons for the issuance of
administrative rulings. These rulings
pertain to the interpretation of
applicable laws related to prospective
and current transactions involving
classification, marking, and country of
origin. The collection of information in
Part 177 of the CBP Regulations is also
necessary to enable CBP to make proper
decisions regarding the issuance of
binding rulings that modify or revoke
prior CBP binding rulings. This
collection of information is authorized
by 19 U.S.C. 66, 1202, (General Note
3(i), Harmonized Tariff Schedule of the
United States). The application to obtain
an administrative ruling is accessible at:
https://apps.cbp.gov/erulings.
Action: CBP proposes to extend the
expiration date of this information
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]]>Agencies
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1958-1959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00545]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Self-Affirmation
Construct Validity (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute,
the National Institutes of Health (NIH) will publish periodic summaries
of proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
(1) Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) The quality, utility, and clarity of the information to be
collected; and (4) Minimize the burden of the collection of information
on those who are to respond, including the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact*: Rebecca
Ferrer, Program Director, Basic Biobehavioral and Psychological
Sciences Branch, Behavioral Research Program, Division of Cancer
Control and Population Sciences, National Cancer Institute, 9609
Medical Center Dr., Rockville MD 20852. or call non-toll-free number
(240) 276-6914 or Email your request, including your address to:
ferrerra@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
[[Page 1959]]
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Self-affirmation Construct Validity, 0925-NEW,
National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: This information
collection, seeks to refine a theory about how self-competence and
values play a role in defensive responses to health communications.
Although theoretically-driven research has shown that self-
affirmation--a process by which individuals reflect on values that are
important to them--can improve responses to health and cancer
communications, the ``active ingredient'' (or mechanisms underlying
effectiveness) of self-affirmations is unknown. Self-affirmation is a
potent means of augmenting the effectiveness of threatening health
communications. Individuals tend to be defensive against information
suggesting their behavior puts them at risk for disease or negative
health. Previous evidence suggests that self-affirmation may reduce
defensiveness to threatening health information, increasing openness to
the message and resulting in increased disease risk perceptions,
disease-related worry, intentions to engage in preventive behavior, and
actual behavioral change. Understanding the mechanisms that explain
these robust effects would yield evidence important for dissemination,
including ways to refine self-affirmation interventions and make them
more potent, which could change the ways that public health messages
are constructed. This research can inform NCI scientific priorities and
investments in self-affirmation research. The results of the
information collection will be used to further develop and improve
self-affirmation theory. These findings may allow future researchers to
develop and test cancer prevention interventions.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 717.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Types of Number of responses per per response Total hour
respondents respondents respondent (in hours) burden
----------------------------------------------------------------------------------------------------------------
Screener...................... General Public.. 10,000 1 1/60 167
Study......................... General Public.. 1,100 1 30/60 550
----------------------------------------------------------------------------------------------------------------
Dated: January 7, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-00545 Filed 1-13-16; 8:45 am]
BILLING CODE 4140-01-P
