Agency Forms Undergoing Paperwork Reduction Act Review, 75865-75866 [2015-30595]
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 3090–0283,
Contractor Information Worksheet; GSA
Form 850 in all correspondence. The
form can be downloaded from the GSA
Forms Library at https://www.gsa.gov/
forms. Type GSA 850 in the form search
field.
Dated: November 25, 2015.
David A. Shive,
Chief Information Officer.
Proposed Project
Prospective Birth Cohort Study
Involving Environmental Uranium
Exposure in the Navajo Nation (OMB
Control No. 0923–0046, Expiration,
2/29/2016)—Extension—Agency for
Toxic Substances and Disease Registry
(ATSDR).
[FR Doc. 2015–30698 Filed 12–3–15; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day–16–0046]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Agency for Toxic Substances and
Disease Registry (ATSDR) has submitted
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (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
VerDate Sep<11>2014
18:41 Dec 03, 2015
Jkt 238001
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, Washington, DC 20503 or by fax
to (202) 395–5806. Written comments
should be received within 30 days of
this notice.
Background and Brief Description
The Navajo Nation is the largest
Alaska Native/American Indian
Reservation in the United States. From
1948 to 1986, many uranium mining
and milling operations took place in the
Navajo Nation, leaving a large amount of
uranium contamination on the
reservation. The House Committee on
Oversight and Government Reform
requested that federal agencies develop
a plan to address health and
environmental impacts of uranium
contamination in the Navajo Nation.
As a result in 2013, ATSDR and its
research partners (University of New
Mexico Community Environmental
Health Program [UNM–CEHP], Navajo
Area Indian Health Service [NAIHS],
Navajo Nation Department of Health
[NNDOH], Navajo Nation
Environmental Protection Agency
[NNEPA], and Navajo culture and
language specialists) initiated a research
study titled ‘‘Prospective Birth Cohort
Study Involving Environmental
Uranium Exposure in the Navajo
Nation’’ (OMB Control No. 0923–0046;
expiration date 02/29/2016). The goal of
the research is to better understand and
prevent unfavorable child and maternal
health outcomes potentially related to
prenatal exposures to uranium. As
ATSDR has received supplemental
funding to continue the study, a three
year extension for PRA clearance is
requested to allow further recruitment
of mother-infant pairs.
Participants include Native American
mothers from age 14 to 45 with
verification of pregnancy who have
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
75865
lived in the study area for at least 5
years. Also, participants must consent to
receive prenatal care and deliver at one
of the healthcare facilities that are
taking part in the study.
Since 2013, over 525 mother-infant
pairs and over 160 fathers have been
enrolled. Biological sample analysis,
surveys, and developmental screenings
are performed for each participant. An
estimated 675 biomonitoring samples
have been analyzed for 36 metals/
metalloids including uranium, arsenic,
lead and mercury. Home environmental
assessments (HEAs), conducted by field
research staff, consist of gamma
radiation surveys, indoor air radon tests,
and dust sample analysis of the
participants’ primary residence during
pregnancy, and over 400 HEAs have
been completed to date. Mothers must
be present at home when field research
staff conduct the HEA. Study
participants receive report back letters
on their biomonitoring and HEA results
to inform them of uranium and other
heavy metals in their bodies and in and
around their home environment.
The survey instruments for pregnant
mothers include the following:
Eligibility Form, Mother Enrollment
Survey, Ages and Stages Questionnaire
(ASQ), Mullen Scales for Early Learning
(MSEL), Postpartum Survey (2 months),
Postpartum Survey (6,9,12 months),
Food Frequency Questionnaire/WIC
Intake Form, and Home Environmental
Assessments. An enrollment survey for
fathers who agree to participate is also
administered. Follow-up assessments
including the Ages & Stages
Questionnaire and biomonitoring at 2, 6,
9 and 12 months are currently being
conducted for the 387 infants delivered
to date.
Community Health and
Environmental Research Specialists
(CHERS) administer the surveys using a
CDC-approved electronic data entry
system. Survey instruments are used to
collect demographic information and to
assess potential environmental health
risks and mother-child interactions. The
final format of the survey instruments is
based on review and input from the
Navajo Nation community liaison group
and associated Navajo staff to address
issues such as cultural sensitivity,
comprehension, and language
translation.
There is no cost to the respondents
other than their time to participate in
the study. The total estimated annual
burden hours equals 4,455.
E:\FR\FM\04DEN1.SGM
04DEN1
75866
Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Mothers ...................................
Eligibility Form .........................................................................
Mother Enrollment Survey ......................................................
Ages and Stages Questionnaire (2,6,9,12 months) ...............
Mullen Scales of Early Learning .............................................
Postpartum Survey (2 months) ...............................................
Post-partum Survey (6, 9, 12 months) ...................................
Food Frequency Questionnaire/WIC Intake Form ..................
Home Environmental Assessment ..........................................
Father Enrollment Survey .......................................................
Fathers ...................................
Leroy A. Richardson,
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. 2015–30595 Filed 12–3–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3329–PN]
Medicare and Medicaid Programs:
Application From the Institute for
Medical Quality for Initial CMSApproval of Its Ambulatory Surgical
Center Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Notice with request for
comment.
AGENCY:
This proposed notice
acknowledges the receipt of an
application from the Institute for
Medical Quality (IMQ) for recognition
as a national accrediting organization
(NAO) for Ambulatory Surgical Centers
(ASCs) that wish to participate in the
Medicare or Medicaid programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on January 4, 2016.
ADDRESSES: In commenting, please refer
to file code CMS–3329–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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18:41 Dec 03, 2015
Jkt 238001
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3329–PN, P.O. Box 8010,
Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3329–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written ONLY to the following
addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
750
550
500
500
500
500
500
550
550
Number of
responses per
respondent
1
1
4
1
1
3
1
1
1
Average
burden
response
(hours)
5/60
2
15/60
20/60
1
15/60
45/60
1
90/60
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
Marie Vasbinder, (410) 786–8665.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from an Ambulatory Surgical
Center (ASC) provided certain
requirements are met. Section
1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as an
ASC. Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 416 specify the
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75865-75866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30595]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-16-0046]
Agency Forms Undergoing Paperwork Reduction Act Review
The Agency for Toxic Substances and Disease Registry (ATSDR) has
submitted the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (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 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,
Washington, DC 20503 or by fax to (202) 395-5806. Written comments
should be received within 30 days of this notice.
Proposed Project
Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation (OMB Control No. 0923-0046, Expiration,
2/29/2016)--Extension--Agency for Toxic Substances and Disease Registry
(ATSDR).
Background and Brief Description
The Navajo Nation is the largest Alaska Native/American Indian
Reservation in the United States. From 1948 to 1986, many uranium
mining and milling operations took place in the Navajo Nation, leaving
a large amount of uranium contamination on the reservation. The House
Committee on Oversight and Government Reform requested that federal
agencies develop a plan to address health and environmental impacts of
uranium contamination in the Navajo Nation.
As a result in 2013, ATSDR and its research partners (University of
New Mexico Community Environmental Health Program [UNM-CEHP], Navajo
Area Indian Health Service [NAIHS], Navajo Nation Department of Health
[NNDOH], Navajo Nation Environmental Protection Agency [NNEPA], and
Navajo culture and language specialists) initiated a research study
titled ``Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation'' (OMB Control No. 0923-0046; expiration
date 02/29/2016). The goal of the research is to better understand and
prevent unfavorable child and maternal health outcomes potentially
related to prenatal exposures to uranium. As
ATSDR has received supplemental funding to continue the study, a
three year extension for PRA clearance is requested to allow further
recruitment of mother-infant pairs.
Participants include Native American mothers from age 14 to 45 with
verification of pregnancy who have lived in the study area for at least
5 years. Also, participants must consent to receive prenatal care and
deliver at one of the healthcare facilities that are taking part in the
study.
Since 2013, over 525 mother-infant pairs and over 160 fathers have
been enrolled. Biological sample analysis, surveys, and developmental
screenings are performed for each participant. An estimated 675
biomonitoring samples have been analyzed for 36 metals/metalloids
including uranium, arsenic, lead and mercury. Home environmental
assessments (HEAs), conducted by field research staff, consist of gamma
radiation surveys, indoor air radon tests, and dust sample analysis of
the participants' primary residence during pregnancy, and over 400 HEAs
have been completed to date. Mothers must be present at home when field
research staff conduct the HEA. Study participants receive report back
letters on their biomonitoring and HEA results to inform them of
uranium and other heavy metals in their bodies and in and around their
home environment.
The survey instruments for pregnant mothers include the following:
Eligibility Form, Mother Enrollment Survey, Ages and Stages
Questionnaire (ASQ), Mullen Scales for Early Learning (MSEL),
Postpartum Survey (2 months), Postpartum Survey (6,9,12 months), Food
Frequency Questionnaire/WIC Intake Form, and Home Environmental
Assessments. An enrollment survey for fathers who agree to participate
is also administered. Follow-up assessments including the Ages & Stages
Questionnaire and biomonitoring at 2, 6, 9 and 12 months are currently
being conducted for the 387 infants delivered to date.
Community Health and Environmental Research Specialists (CHERS)
administer the surveys using a CDC-approved electronic data entry
system. Survey instruments are used to collect demographic information
and to assess potential environmental health risks and mother-child
interactions. The final format of the survey instruments is based on
review and input from the Navajo Nation community liaison group and
associated Navajo staff to address issues such as cultural sensitivity,
comprehension, and language translation.
There is no cost to the respondents other than their time to
participate in the study. The total estimated annual burden hours
equals 4,455.
[[Page 75866]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden
Type of respondents Form name respondents responses per response
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Mothers............................... Eligibility Form........ 750 1 5/60
Mother Enrollment Survey 550 1 2
Ages and Stages 500 4 15/60
Questionnaire (2,6,9,12
months).
Mullen Scales of Early 500 1 20/60
Learning.
Postpartum Survey (2 500 1 1
months).
Post-partum Survey (6, 500 3 15/60
9, 12 months).
Food Frequency 500 1 45/60
Questionnaire/WIC
Intake Form.
Home Environmental 550 1 1
Assessment.
Fathers............................... Father Enrollment Survey 550 1 90/60
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
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. 2015-30595 Filed 12-3-15; 8:45 am]
BILLING CODE 4163-18-P
