80 FR 75865 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry Federal Register Volume 80, Issue 233 (December 4, 2015)
Agency for Toxic Substances and Disease Registry
Federal Register Volume 80, Issue 233 (December 4, 2015)
| Page Range | 75865-75866 | |
| FR Document | 2015-30595 |
[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)] [Notices] [Pages 75865-75866] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices 75865
information collection documents from responses; and (e) Assess information lived in the study area for at least 5
the General Services Administration, collection costs. years. Also, participants must consent to
Regulatory Secretariat Division (MVCB), To request additional information on receive prenatal care and deliver at one
1800 F Street NW., Washington, DC the proposed project or to obtain a copy of the healthcare facilities that are
20405, telephone 202–501–4755. Please of the information collection plan and taking part in the study.
cite OMB Control No. 3090–0283, instruments, call (404) 639–7570 or Since 2013, over 525 mother-infant
Contractor Information Worksheet; GSA send an email to omb@cdc.gov. Direct pairs and over 160 fathers have been
Form 850 in all correspondence. The written comments and/or suggestions enrolled. Biological sample analysis,
form can be downloaded from the GSA regarding the items contained in this surveys, and developmental screenings
Forms Library at http://www.gsa.gov/ notice to the Attention: CDC Desk are performed for each participant. An
forms. Type GSA 850 in the form search Officer, Office of Management and estimated 675 biomonitoring samples
field. Budget, Washington, DC 20503 or by fax have been analyzed for 36 metals/
to (202) 395–5806. Written comments metalloids including uranium, arsenic,
Dated: November 25, 2015.
should be received within 30 days of lead and mercury. Home environmental
David A. Shive, this notice.
Chief Information Officer. assessments (HEAs), conducted by field
[FR Doc. 2015–30698 Filed 12–3–15; 8:45 am] Proposed Project research staff, consist of gamma
Prospective Birth Cohort Study radiation surveys, indoor air radon tests,
BILLING CODE 6820–34–P
Involving Environmental Uranium and dust sample analysis of the
Exposure in the Navajo Nation (OMB participants’ primary residence during
Control No. 0923–0046, Expiration, pregnancy, and over 400 HEAs have
DEPARTMENT OF HEALTH AND been completed to date. Mothers must
2/29/2016)—Extension—Agency for
HUMAN SERVICES be present at home when field research
Toxic Substances and Disease Registry
(ATSDR). staff conduct the HEA. Study
Agency for Toxic Substances and participants receive report back letters
Disease Registry Background and Brief Description on their biomonitoring and HEA results
[30Day–16–0046] The Navajo Nation is the largest to inform them of uranium and other
Alaska Native/American Indian heavy metals in their bodies and in and
Agency Forms Undergoing Paperwork Reservation in the United States. From around their home environment.
Reduction Act Review 1948 to 1986, many uranium mining The survey instruments for pregnant
and milling operations took place in the mothers include the following:
The Agency for Toxic Substances and Navajo Nation, leaving a large amount of
Disease Registry (ATSDR) has submitted Eligibility Form, Mother Enrollment
uranium contamination on the Survey, Ages and Stages Questionnaire
the following information collection reservation. The House Committee on
request to the Office of Management and (ASQ), Mullen Scales for Early Learning
Oversight and Government Reform (MSEL), Postpartum Survey (2 months),
Budget (OMB) for review and approval requested that federal agencies develop
in accordance with the Paperwork Postpartum Survey (6,9,12 months),
a plan to address health and Food Frequency Questionnaire/WIC
Reduction Act of 1995. The notice for environmental impacts of uranium
the proposed information collection is Intake Form, and Home Environmental
contamination in the Navajo Nation. Assessments. An enrollment survey for
published to obtain comments from the As a result in 2013, ATSDR and its
public and affected agencies. fathers who agree to participate is also
research partners (University of New administered. Follow-up assessments
Written comments and suggestions Mexico Community Environmental
from the public and affected agencies including the Ages & Stages
Health Program [UNM–CEHP], Navajo Questionnaire and biomonitoring at 2, 6,
concerning the proposed collection of Area Indian Health Service [NAIHS],
information are encouraged. Your 9 and 12 months are currently being
Navajo Nation Department of Health conducted for the 387 infants delivered
comments should address any of the [NNDOH], Navajo Nation
following: (a) Evaluate whether the to date.
Environmental Protection Agency
proposed collection of information is [NNEPA], and Navajo culture and Community Health and
necessary for the proper performance of language specialists) initiated a research Environmental Research Specialists
the functions of the agency, including study titled ‘‘Prospective Birth Cohort (CHERS) administer the surveys using a
whether the information will have Study Involving Environmental CDC-approved electronic data entry
practical utility; (b) Evaluate the Uranium Exposure in the Navajo system. Survey instruments are used to
accuracy of the agencies estimate of the Nation’’ (OMB Control No. 0923–0046; collect demographic information and to
burden of the proposed collection of expiration date 02/29/2016). The goal of assess potential environmental health
information, including the validity of the research is to better understand and risks and mother-child interactions. The
the methodology and assumptions used; prevent unfavorable child and maternal final format of the survey instruments is
(c) Enhance the quality, utility, and health outcomes potentially related to based on review and input from the
clarity of the information to be prenatal exposures to uranium. As Navajo Nation community liaison group
collected; (d) Minimize the burden of ATSDR has received supplemental and associated Navajo staff to address
the collection of information on those funding to continue the study, a three issues such as cultural sensitivity,
who are to respond, including through year extension for PRA clearance is comprehension, and language
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the use of appropriate automated, requested to allow further recruitment translation.
electronic, mechanical, or other of mother-infant pairs. There is no cost to the respondents
technological collection techniques or Participants include Native American other than their time to participate in
other forms of information technology, mothers from age 14 to 45 with the study. The total estimated annual
e.g., permitting electronic submission of verification of pregnancy who have burden hours equals 4,455.
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![75866 Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden
Type of respondents Form name responses per
respondents response
respondent (hours)
Mothers ................................... Eligibility Form ......................................................................... 750 1 5/60
Mother Enrollment Survey ...................................................... 550 1 2
Ages and Stages Questionnaire (2,6,9,12 months) ............... 500 4 15/60
Mullen Scales of Early Learning ............................................. 500 1 20/60
Postpartum Survey (2 months) ............................................... 500 1 1
Post-partum Survey (6, 9, 12 months) ................................... 500 3 15/60
Food Frequency Questionnaire/WIC Intake Form .................. 500 1 45/60
Home Environmental Assessment .......................................... 550 1 1
Fathers ................................... Father Enrollment Survey ....................................................... 550 1 90/60
Leroy A. Richardson, 2. By regular mail. You may mail hand or courier delivery may be delayed
Chief, Information Collection Review Office, written comments to the following and received after the comment period.
Office of Scientific Integrity, Office of the address ONLY: Centers for Medicare & For information on viewing public
Associate Director for Science, Office of the Medicaid Services, Department of comments, see the beginning of the
Director, Centers for Disease Control and Health and Human Services, Attention: SUPPLEMENTARY INFORMATION section.
Prevention. CMS–3329–PN, P.O. Box 8010, FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–30595 Filed 12–3–15; 8:45 am] Baltimore, MD 21244–8010. Cindy Melanson, (410) 786–0310.
BILLING CODE 4163–18–P Please allow sufficient time for mailed Patricia Chmielewski, (410) 786–6899.
comments to be received before the Marie Vasbinder, (410) 786–8665.
close of the comment period. SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND 3. By express or overnight mail. You Inspection of Public Comments: All
HUMAN SERVICES may send written comments to the comments received before the close of
following address ONLY: Centers for the comment period are available for
Centers for Medicare & Medicaid Medicare & Medicaid Services,
Services viewing by the public, including any
Department of Health and Human personally identifiable or confidential
[CMS–3329–PN] Services, Attention: CMS–3329–PN, business information that is included in
Mail Stop C4–26–05, 7500 Security a comment. We post all comments
Medicare and Medicaid Programs: Boulevard, Baltimore, MD 21244–1850. received before the close of the
Application From the Institute for 4. By hand or courier. Alternatively, comment period on the following Web
Medical Quality for Initial CMS- you may deliver (by hand or courier) site as soon as possible after they have
Approval of Its Ambulatory Surgical your written ONLY to the following been received: http://
Center Accreditation Program addresses: www.regulations.gov. Follow the search
a. For delivery in Washington, DC— instructions on that Web site to view
AGENCY: Centers for Medicare and
Centers for Medicare & Medicaid public comments.
Medicaid Services, HHS.
Services, Department of Health and Comments received timely will also
ACTION: Notice with request for Human Services, Room 445–G, Hubert be available for public inspection as
comment. H. Humphrey Building, 200 they are received, generally beginning
SUMMARY: This proposed notice Independence Avenue SW., approximately 3 weeks after publication
acknowledges the receipt of an Washington, DC 20201. of a document, at the headquarters of
(Because access to the interior of the the Centers for Medicare & Medicaid
application from the Institute for
Hubert H. Humphrey Building is not Services, 7500 Security Boulevard,
Medical Quality (IMQ) for recognition
readily available to persons without Baltimore, Maryland 21244, Monday
as a national accrediting organization
Federal government identification, through Friday of each week from 8:30
(NAO) for Ambulatory Surgical Centers
commenters are encouraged to leave a.m. to 4 p.m. To schedule an
(ASCs) that wish to participate in the
their comments in the CMS drop slots appointment to view public comments,
Medicare or Medicaid programs.
located in the main lobby of the phone 1–800–743–3951.
DATES: To be assured consideration, building. A stamp-in clock is available
comments must be received at one of I. Background
for persons wishing to retain a proof of
the addresses provided below, no later filing by stamping in and retaining an Under the Medicare program, eligible
than 5 p.m. on January 4, 2016. extra copy of the comments being filed.) beneficiaries may receive covered
ADDRESSES: In commenting, please refer b. For delivery in Baltimore, MD— services from an Ambulatory Surgical
to file code CMS–3329–PN. Because of Centers for Medicare & Medicaid Center (ASC) provided certain
staff and resource limitations, we cannot Services, Department of Health and requirements are met. Section
accept comments by facsimile (FAX) 1832(a)(2)(F)(i) of the Social Security
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Human Services, 7500 Security
transmission. Boulevard, Baltimore, MD 21244–1850. Act (the Act) establishes distinct criteria
You may submit comments in one of If you intend to deliver your for facilities seeking designation as an
four ways (please choose only one of the comments to the Baltimore address, call ASC. Regulations concerning provider
ways listed): telephone number (410) 786–9994 in agreements are at 42 CFR part 489 and
1. Electronically. You may submit advance to schedule your arrival with those pertaining to activities relating to
electronic comments on this regulation one of our staff members. the survey and certification of facilities
to http://www.regulations.gov. Follow Comments erroneously mailed to the are at 42 CFR part 488. The regulations
the ‘‘Submit a comment’’ instructions. addresses indicated as appropriate for at 42 CFR part 416 specify the
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Document Created: 2015-12-14 13:52:54
Document Modified: 2015-12-14 13:52:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 75865 |
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