Agency Forms Undergoing Paperwork Reduction Act Review, 28233-28234 [2018-12972]
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28233
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
practice. This study aligns with
National HIV/AIDS Strategy 2020 and
Healthy People 2020 objectives of
reducing new HIV infections, increasing
access to care and improving health
outcomes for people living with HIV,
and reducing HIV-related health
disparities. This study also aligns with
the Office of Management and Budget’s
emphasis on application of behavioral
insights in that it restructures the
context (i.e., after HIV testing) in which
health-related decision-making (i.e.,
health insurance enrollment) occurs in
order to promote the selection of
beneficial options (i.e., attending HIVrelated medical care appointments).
This proposed health insurance
enrollment assistance study has the
potential for widespread health
improvements for Black and Hispanic
MSM and transgender persons
regardless of their HIV status.
At this time, CDC is not partnering
with other HHS agencies for this study.
However, we have discussed the study
with HRSA/HAB and HHS/OD, and
plan to apprise CMS and HRSA of the
project before implementation and
invite CMS and HRSA representatives to
serve as consultants. HHS may also
direct us to the CMS regional officer for
Chicago, Illinois. Additionally, there is
the potential to have CMS grantee
navigators supplement partner agency
navigators during outreach HIV testing
events. For this study, CDC is not
engaged in research, and therefore not
involved in data collection activities.
The grantee is responsible for
implementing the intervention and
collecting data from the proposed 1,000
participants. Thus, CDC will not need
an interagency data-sharing agreement if
we do consult with HRSA or CMS.
The study will enroll 1,000
participants over 12 months to reach
adequate power calculations (500 into
the intervention arm, and 500 into the
control arm). Approximately 1,500
individuals will need to be screened to
identify and enroll 1,000 eligible study
participants. After an HIV testing
session at an outreach event or clinic
visit, partner agency staff will invite
individuals to participate in the study.
If individuals are interested, staff will
screen individuals for eligibility using
the Participant Eligibility Form
(Attachment 5) which will take
approximately 5 minutes to complete. If
they are determined eligible to
participate, and still interested in
participating, the individual will
complete an Informed Consent Form
(Attachment 6), which will take
approximately 10 minutes to complete,
and the Participant Enrollment Form
(Attachment 7), which will take
approximately 35 minutes to complete.
The total estimated annualized hourly
burden anticipated for this study is 875
hours. There is no cost to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Study participant .............................................
Study participant .............................................
Study participant .............................................
Participant Eligibility Form (Att 5) ..................
Informed Consent Form (Att 6) ......................
Participant Enrollment Form (Att 7) ...............
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–12971 Filed 6–15–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0530]
amozie on DSK3GDR082PROD with NOTICES1
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA) Dose Reconstruction
Interviews and Forms to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
VerDate Sep<11>2014
18:00 Jun 15, 2018
Jkt 244001
Submitted for Public Comment and
Recommendations’’ notice on February
20, 2018 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
1,500
1,000
1,000
Number of
responses per
respondent
Average
burden
per response
(in hours)
1
1
1
5/60
10/60
35/60
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
EEOICPA Dose Reconstruction
Interviews and Forms, OMB No. 0920–
0530, expires 04/30/2018—
Reinstatement without change—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy
Employees Occupational Illness
E:\FR\FM\18JNN1.SGM
18JNN1
28234
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
Compensation Program Act of 2000 (42
U.S.C. 7384–7385) was enacted. This
Act established a federal compensation
program for employees of the
Department of Energy (DOE) and certain
of its contractors, subcontractors and
vendors, who have suffered cancers and
other designated illnesses as a result of
exposures sustained in the production
and testing of nuclear weapons.
Executive Order 13179, issued on
December 7, 2000, delegated authorities
assigned to ‘‘the President’’ under the
Act to the Departments of Labor, Health
and Human Services, Energy and
Justice. The Department of Health and
Human Services (DHHS) was delegated
the responsibility of establishing
methods for estimating radiation doses
received by eligible claimants with
cancer applying for compensation.
NIOSH is applying the following
methods to estimate the radiation doses
of individuals applying for
compensation.
In performance of its dose
reconstruction responsibilities, under
the Act, NIOSH is providing voluntary
interview opportunities to claimants (or
their survivors) individually and
providing them with the opportunity to
assist NIOSH in documenting the work
history of the employee by
characterizing the actual work tasks
performed. In addition, NIOSH and the
claimant may identify incidents that
may have resulted in undocumented
radiation exposures, characterizing
radiological protection and monitoring
practices, and identify co-workers and
other witnesses as may be necessary to
confirm undocumented information. In
this process, NIOSH uses a computer
assisted telephone interview (CATI)
system, which allows interviews to be
conducted more efficiently and quickly
as opposed to a paper-based interview
instrument. Both interviews are
voluntary and failure to participate in
either or both interviews will not have
a negative effect on the claim, although
voluntary participation may assist the
claimant by adding important
information that may not be otherwise
available.
There are no changes to the questions
contained in the package, or the
estimated burden hours. This
Information Collection Request (ICR) is
being submitted as a reinstatement
because the previous ICR expired on
April 30, 2018 and the updated ICR was
not submitted before the expiration
date. NIOSH uses the data collected in
this process to complete an individual
dose reconstruction that accounts, as
fully as possible, for the radiation dose
incurred by the employee in the line of
duty for DOE nuclear weapons
production programs. After dose
reconstruction, NIOSH also performs a
brief, voluntary final interview with the
claimant to explain the results and to
allow the claimant to confirm or
question the records NIOSH has
compiled. This will also be the final
opportunity for the claimant to
supplement the dose reconstruction
record.
At the conclusion of the dose
reconstruction process, the claimant
submits a form to confirm that the
claimant has no further information to
provide to NIOSH about the claim at
this time. The form notifies the claimant
that signing the form allows NIOSH to
forward a dose reconstruction report to
DOL and to the claimant, and closes the
record on data used for the dose
reconstruction. Signing this form does
not indicate that the claimant agrees
with the outcome of the dose
reconstruction. The dose reconstruction
results will be supplied to the claimant
and to the DOL, the agency that will
utilize them as one part of its
determination of whether the claimant
is eligible for compensation under the
Act.
Total annualized burden is estimated
to be 3900 hours. There is no cost to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Claimant ..........................................................
Claimant ..........................................................
Initial Interview ...............................................
Conclusion form OCAS–1 ..............................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–12972 Filed 6–15–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0286]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Formal Meetings Between the
Food and Drug Administration and
Biosimilar Biological Product
Sponsors or Applicants
amozie on DSK3GDR082PROD with NOTICES1
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
VerDate Sep<11>2014
18:00 Jun 15, 2018
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PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
3,600
3,600
Number of
responses
per
respondent
Average
burden per
response
(in hours)
1
1
1
5/60
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on formal meetings
between FDA and biosimilar biological
product sponsors or applicants.
DATES: Submit either electronic or
written comments on the collection of
information by August 17, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 17,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
E:\FR\FM\18JNN1.SGM
18JNN1
Agencies
[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28233-28234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0530]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Energy Employees Occupational Illness
Compensation Program Act of 2000 (EEOICPA) Dose Reconstruction
Interviews and Forms to the Office of Management and Budget (OMB) for
review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
February 20, 2018 to obtain comments from the public and affected
agencies. CDC did not receive comments related to the previous notice.
This notice serves to allow an additional 30 days for public and
affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
EEOICPA Dose Reconstruction Interviews and Forms, OMB No. 0920-
0530, expires 04/30/2018--Reinstatement without change--National
Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy Employees Occupational Illness
[[Page 28234]]
Compensation Program Act of 2000 (42 U.S.C. 7384-7385) was enacted.
This Act established a federal compensation program for employees of
the Department of Energy (DOE) and certain of its contractors,
subcontractors and vendors, who have suffered cancers and other
designated illnesses as a result of exposures sustained in the
production and testing of nuclear weapons.
Executive Order 13179, issued on December 7, 2000, delegated
authorities assigned to ``the President'' under the Act to the
Departments of Labor, Health and Human Services, Energy and Justice.
The Department of Health and Human Services (DHHS) was delegated the
responsibility of establishing methods for estimating radiation doses
received by eligible claimants with cancer applying for compensation.
NIOSH is applying the following methods to estimate the radiation doses
of individuals applying for compensation.
In performance of its dose reconstruction responsibilities, under
the Act, NIOSH is providing voluntary interview opportunities to
claimants (or their survivors) individually and providing them with the
opportunity to assist NIOSH in documenting the work history of the
employee by characterizing the actual work tasks performed. In
addition, NIOSH and the claimant may identify incidents that may have
resulted in undocumented radiation exposures, characterizing
radiological protection and monitoring practices, and identify co-
workers and other witnesses as may be necessary to confirm undocumented
information. In this process, NIOSH uses a computer assisted telephone
interview (CATI) system, which allows interviews to be conducted more
efficiently and quickly as opposed to a paper-based interview
instrument. Both interviews are voluntary and failure to participate in
either or both interviews will not have a negative effect on the claim,
although voluntary participation may assist the claimant by adding
important information that may not be otherwise available.
There are no changes to the questions contained in the package, or
the estimated burden hours. This Information Collection Request (ICR)
is being submitted as a reinstatement because the previous ICR expired
on April 30, 2018 and the updated ICR was not submitted before the
expiration date. NIOSH uses the data collected in this process to
complete an individual dose reconstruction that accounts, as fully as
possible, for the radiation dose incurred by the employee in the line
of duty for DOE nuclear weapons production programs. After dose
reconstruction, NIOSH also performs a brief, voluntary final interview
with the claimant to explain the results and to allow the claimant to
confirm or question the records NIOSH has compiled. This will also be
the final opportunity for the claimant to supplement the dose
reconstruction record.
At the conclusion of the dose reconstruction process, the claimant
submits a form to confirm that the claimant has no further information
to provide to NIOSH about the claim at this time. The form notifies the
claimant that signing the form allows NIOSH to forward a dose
reconstruction report to DOL and to the claimant, and closes the record
on data used for the dose reconstruction. Signing this form does not
indicate that the claimant agrees with the outcome of the dose
reconstruction. The dose reconstruction results will be supplied to the
claimant and to the DOL, the agency that will utilize them as one part
of its determination of whether the claimant is eligible for
compensation under the Act.
Total annualized burden is estimated to be 3900 hours. There is no
cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Claimant........................... Initial Interview.......... 3,600 1 1
Claimant........................... Conclusion form OCAS-1..... 3,600 1 5/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of
Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-12972 Filed 6-15-18; 8:45 am]
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