80 FR 78234 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 241 (December 16, 2015)

Page Range		78234-78236
FR Document		2015-31581
Federal Register, Volume 80 Issue 241 (Wednesday, December 16, 2015)
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78234-78236]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

Centers for Disease Control and Prevention

[30Day-16-0048]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) 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 [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, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

    ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, 
Expiration Date 5/31/2016)--Extension--Agency for Toxic Substances and 
Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year extension of this generic clearance to allow 
the agency to conduct exposure investigations (EIs), through methods 
developed by ATSDR. After a chemical release or suspected release into 
the environment, EIs are usually requested by officials of a state 
health agency, county health departments, the Environmental Protection 
Agency (EPA), the general public, and ATSDR staff.

[[Page 78235]]

    EI results are used by public health professionals, environmental 
risk managers, and other decision makers to determine if current 
conditions warrant intervention strategies to minimize or eliminate 
human exposure. For example, three of the EIs that ATSDR conducted in 
the past three years include the Colorado Smelter (CO--blood lead and 
urine arsenic), ASARCO Hayden Smelter Site (AZ--blood lead and urine 
arsenic), and Decatur (AL--perfluorochemicals [PFCs] in serum).

Example 1: Colorado Smelter Blood Lead and Urine Arsenic Sampling, CO

    The site is a former smelter located in Pueblo, Colorado. Past 
sampling found elevated levels of lead and arsenic in residential soils 
and a slag pile associated with the smelter. ATSDR sampled blood lead 
levels (BLLs) in children and adults and found seven children that had 
BLLs near or exceeding the level of 5 micrograms per deciliter (mg/
dL)(a level identified by ATSDR as a level of concern for lead effects 
in children). One adult had an elevated level of arsenic in their 
urine. Speciation of the sample determined that it was primarily 
organic arsenic, probably resulting from eating seafood.
     The local health department conducted a Healthy Homes 
Inspection for these families having children with elevated BLLs and 
ATSDR recommended that the children follow up with their primary care 
provider.
     On June 10, 2014, the local health department obtained a 
six year grant from the EPA Region 8 to conduct health education, BLL 
screening, assist in the coordination of developmental and cognitive 
evaluations in affected children from a designated area of Pueblo, and 
conduct other public health actions/investigations as stipulated in the 
grant.
     On December 11, 2014, EPA listed the Colorado Smelter site 
on the National Priority List (NPL).

Example 2: ASARCO Hayden Smelter Site, AZ

    The community is located in the vicinity of the ASARCO Hayden 
Smelter, which has been operating for 100 years as a copper ore 
processer. The processing has resulted in lead and arsenic 
contamination in the surrounding residential area and in tailing piles 
used for recreation. Limited sampling of the community in the past 
found elevated BLLs and arsenic in urine. Based on community concerns, 
EPA requested that ATSDR conduct an EI to assess potential exposure of 
the community to lead and arsenic.
     In April, 2015, ATSDR collected 83 BLL and 58 urine 
arsenic samples from the community.
     Participants have been notified of their results and the 
EI report is being prepared.

Example 3: Perfluorochemical Serum Sampling, Decatur, AL

    Perfluorochemicals (PFC) are a class of organofluorine compounds 
that are used in a variety of industrial and consumer products 
including fire-fighting foams; personal care and cleaning products; and 
oil, stain, grease, and water repellent coatings. These coatings are 
used on carpet, textiles, leather, ``non-stick'' cookware, and paper 
wrappers used on fast food items. As a result, United States (U.S.) 
general population exposure to PFCs is common.
    In 2007, PFCs were released by a chemical manufacturer near 
Decatur, AL, and impacted environmental media in the area. In 2010, 
ATSDR conducted an EI to assess exposure of residents to PFCs in blood. 
PFCs were found in the serum of people that regularly used the public 
water system in the area as their primary drinking water source.
    Recommendations of the EI included continued monitoring for PFCs in 
the public water supply and continued biological PFC testing in the 
community to determine if PFCs in the community had been reduced.
    Based on the results of the 2010 EI, ATSDR is preparing to conduct 
another EI at the site in 2016 (approved by OMB on 8/10/2015), 
including biological sampling of serum and urine to:
     Compare individuals' current serum PFC concentrations with 
their 2010 serum PFC concentrations.
     Compare individuals' serum PFC concentrations to the 
national population reference values (NHANES 2011-2012).
     Calculate the biological half-life for each PFC species 
using paired blood and urine PFC concentrations to improve the 
understanding of the pharmacokinetic behavior of these compounds in 
humans.
     Evaluate the potential existence of non-drinking water PFC 
exposure pathways through physiologically-based pharmacokinetic (PBPK) 
modeling.
    All of ATSDR's targeted biological assessments (e.g., urine, blood) 
and some of the environmental investigations (e.g., air, water, soil, 
or food sampling) involve participants to determine whether they are or 
have been exposed to unusual levels of pollutants at specific locations 
(e.g., where people live, spend leisure time, or anywhere they might 
come into contact with contaminants under investigation).
    Questionnaires, appropriate to the specific contaminant, are 
generally needed in about half of the EIs (at most approximately 12 per 
year) to assist in interpreting the biological or environmental 
sampling results. ATSDR collects contact information (e.g., name, 
address, phone number) to provide the participant with their individual 
results. ATSDR also collects information on other possible confounding 
sources of chemical(s) exposure such as medicines taken, foods eaten, 
hobbies, jobs, etc. In addition, ATSDR asks questions on recreational 
or occupational activities that could increase a participant's exposure 
potential. That information represents an individual's exposure 
history.
    The number of questions can vary depending on the number of 
chemicals being investigated, the route of exposure (e.g., breathing, 
eating, touching), and number of other sources of the chemical(s) 
(e.g., products used, jobs). We use approximately 12-20 questions about 
the pertinent environmental exposures per investigation. Typically, the 
number of participants in an individual EI ranges from 10 to 100. 
Participation is completely voluntary, and there are no costs to 
participants other than their time. Based on a maximum of 12 EIs per 
year and 100 participants each, the estimated annualized burden hours 
are 600.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of     Average  burden
         Type of respondents                 Form name            Number of      responses per    per  response
                                                                 respondents       respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Exposure Investigation Participants.  Chemical Exposure                 1,200                1            30/60
                                       Questions.
----------------------------------------------------------------------------------------------------------------



[[Page 78236]]

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. 2015-31581 Filed 12-15-15; 8:45 am]
BILLING CODE 4163-18-P
78234 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices

notice was published in the Federal the name and activity of the isotope, the (OMB) for review and approval in
Register at 80 FR 58253 on September manufacturer of the materials, and any accordance with the Paperwork
28, 2015. No comments were received. other information known to the Reduction Act of 1995. The notice for
DATES: Submit comments on or before contractor which will put users of the the proposed information collection is
January 15, 2016. items on notice as to the hazards published to obtain comments from the
ADDRESSES: Submit comments regarding involved. public and affected agencies.
this burden estimate or any other aspect Written comments and suggestions
B. Annual Reporting Burden from the public and affected agencies
of this collection of information,
Respondents: 535. concerning the proposed collection of
including suggestions for reducing this
Responses per Respondent: 5. information are encouraged. Your
burden to: Office of Information and
Annual Responses: 2,675. comments should address any of the
Regulatory Affairs of OMB, Attention:
Hours per Response: 1. following: (a) Evaluate whether the
Desk Officer for GSA, Room 10236,
Total Burden Hours: 2,675. proposed collection of information is
NEOB, Washington, DC 20503.
necessary for the proper performance of
Additionally submit a copy to GSA by C. Public Comments the functions of the agency, including
any of the following methods:
Public comments are particularly whether the information will have
• Regulations.gov: http://
invited on: Whether this collection of practical utility; (b) Evaluate the
www.regulations.gov. Submit comments
information is necessary for the proper accuracy of the agencies estimate of the
via the Federal eRulemaking portal by
performance of functions of the FAR, burden of the proposed collection of
searching the OMB control number.
and whether it will have practical information, including the validity of
Select the link ‘‘Submit a Comment’’
utility; whether our estimate of the the methodology and assumptions used;
that corresponds with ‘‘Information
public burden of this collection of (c) Enhance the quality, utility, and
Collection 9000–0107, Notice of
information is accurate, and based on clarity of the information to be
Radioactive Materials’’. Follow the collected; (d) Minimize the burden of
valid assumptions and methodology;
instructions provided at the ‘‘Submit a the collection of information on those
ways to enhance the quality, utility, and
Comment’’ screen. Please include your who are to respond, including through
clarity of the information to be
name, company name (if any), and the use of appropriate automated,
collected; and ways in which we can
‘‘Information Collection 9000–0107, electronic, mechanical, or other
minimize the burden of the collection of
Notice of Radioactive Materials’’ on technological collection techniques or
information on those who are to
your attached document. other forms of information technology,
• Mail: General Services respond, through the use of appropriate
technological collection techniques or e.g., permitting electronic submission of
Administration, Regulatory Secretariat
other forms of information technology. responses; and (e) Assess information
Division (MVCB), 1800 F Street NW.,
Obtaining Copies of Proposals: collection costs.
Washington, DC 20405. ATTN: Ms. To request additional information on
Flowers/IC 9000–0107, Notice of Requesters may obtain a copy of the
information collection documents from the proposed project or to obtain a copy
Radioactive Materials. of the information collection plan and
Instructions: Please submit comments the General Services Administration,
Regulatory Secretariat Division (MVCB), instruments, call (404) 639–7570 or
only and cite Information Collection send an email to omb@cdc.gov. Direct
9000–0107, Notice of Radioactive 1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please written comments and/or suggestions
Materials, in all correspondence related regarding the items contained in this
to this collection. Comments received cite OMB Control No. 9000–0107,
Notice of Radioactive Materials, in all notice to the Attention: CDC Desk
generally will be posted without change Officer, Office of Management and
to http://www.regulations.gov, including correspondence.
Budget, Washington, DC 20503 or by fax
any personal and/or business Edward Loeb, to (202) 395–5806. Written comments
confidential information provided. To Acting Director, Federal Acquisition Policy should be received within 30 days of
confirm receipt of your comment(s), Division, Office of Governmentwide this notice.
please check www.regulations.gov, Acquisition Policy, Office of Acquisition
approximately two to three days after Policy, Office of Governmentwide Policy. Proposed Project
submission to verify posting (except [FR Doc. 2015–31562 Filed 12–15–15; 8:45 am] ATSDR Exposure Investigations (EIs)
allow 30 days for posting of comments BILLING CODE 6820–EP–P (OMB Control No. 0923–0048,
submitted by mail). Expiration Date 5/31/2016)—
FOR FURTHER INFORMATION CONTACT: Mr. Extension—Agency for Toxic
Charles Gray, Procurement Analyst, DEPARTMENT OF HEALTH AND Substances and Disease Registry
Office of Acquisition Policy, GSA, 703– HUMAN SERVICES (ATSDR).
795–6328 or email charles.gray@
Agency for Toxic Substances and Background and Brief Description
gsa.gov.
Disease Registry The Agency for Toxic Substances and
A. Purpose Disease Registry (ATSDR) is requesting
The clause at FAR 52.223–7, Notice of Centers for Disease Control and a three-year extension of this generic
Radioactive Materials, requires Prevention clearance to allow the agency to conduct
contractors to notify the Government exposure investigations (EIs), through
prior to delivery of items containing [30Day–16–0048] methods developed by ATSDR. After a
tkelley on DSK9F6TC42PROD with NOTICES

radioactive materials. The purpose of Agency Forms Undergoing Paperwork chemical release or suspected release
the notification is to alert receiving Reduction Act Review into the environment, EIs are usually
activities that appropriate safeguards requested by officials of a state health
may need to be instituted. The notice The Centers for Disease Control and agency, county health departments, the
shall specify the part or parts of the Prevention (CDC) has submitted the Environmental Protection Agency
items which contain radioactive following information collection request (EPA), the general public, and ATSDR
materials, a description of the materials, to the Office of Management and Budget staff.

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Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices 78235

EI results are used by public health arsenic contamination in the • Calculate the biological half-life for
professionals, environmental risk surrounding residential area and in each PFC species using paired blood
managers, and other decision makers to tailing piles used for recreation. Limited and urine PFC concentrations to
determine if current conditions warrant sampling of the community in the past improve the understanding of the
intervention strategies to minimize or found elevated BLLs and arsenic in pharmacokinetic behavior of these
eliminate human exposure. For urine. Based on community concerns, compounds in humans.
example, three of the EIs that ATSDR EPA requested that ATSDR conduct an • Evaluate the potential existence of
conducted in the past three years EI to assess potential exposure of the non-drinking water PFC exposure
include the Colorado Smelter (CO— community to lead and arsenic. pathways through physiologically-based
blood lead and urine arsenic), ASARCO • In April, 2015, ATSDR collected 83 pharmacokinetic (PBPK) modeling.
Hayden Smelter Site (AZ—blood lead BLL and 58 urine arsenic samples from All of ATSDR’s targeted biological
and urine arsenic), and Decatur (AL— the community. assessments (e.g., urine, blood) and
perfluorochemicals [PFCs] in serum). • Participants have been notified of some of the environmental
Example 1: Colorado Smelter Blood their results and the EI report is being investigations (e.g., air, water, soil, or
Lead and Urine Arsenic Sampling, CO prepared. food sampling) involve participants to
determine whether they are or have
The site is a former smelter located in Example 3: Perfluorochemical Serum
been exposed to unusual levels of
Pueblo, Colorado. Past sampling found Sampling, Decatur, AL
pollutants at specific locations (e.g.,
elevated levels of lead and arsenic in Perfluorochemicals (PFC) are a class where people live, spend leisure time,
residential soils and a slag pile of organofluorine compounds that are or anywhere they might come into
associated with the smelter. ATSDR used in a variety of industrial and contact with contaminants under
sampled blood lead levels (BLLs) in consumer products including fire- investigation).
children and adults and found seven fighting foams; personal care and Questionnaires, appropriate to the
children that had BLLs near or cleaning products; and oil, stain, grease, specific contaminant, are generally
exceeding the level of 5 micrograms per and water repellent coatings. These needed in about half of the EIs (at most
deciliter (mg/dL)(a level identified by coatings are used on carpet, textiles, approximately 12 per year) to assist in
ATSDR as a level of concern for lead leather, ‘‘non-stick’’ cookware, and interpreting the biological or
effects in children). One adult had an paper wrappers used on fast food items. environmental sampling results. ATSDR
elevated level of arsenic in their urine. As a result, United States (U.S.) general collects contact information (e.g., name,
Speciation of the sample determined population exposure to PFCs is address, phone number) to provide the
that it was primarily organic arsenic, common. participant with their individual results.
probably resulting from eating seafood. In 2007, PFCs were released by a
• The local health department ATSDR also collects information on
chemical manufacturer near Decatur, other possible confounding sources of
conducted a Healthy Homes Inspection
AL, and impacted environmental media chemical(s) exposure such as medicines
for these families having children with
in the area. In 2010, ATSDR conducted taken, foods eaten, hobbies, jobs, etc. In
elevated BLLs and ATSDR
an EI to assess exposure of residents to addition, ATSDR asks questions on
recommended that the children follow
PFCs in blood. PFCs were found in the recreational or occupational activities
up with their primary care provider.
• On June 10, 2014, the local health serum of people that regularly used the that could increase a participant’s
department obtained a six year grant public water system in the area as their exposure potential. That information
from the EPA Region 8 to conduct primary drinking water source. represents an individual’s exposure
health education, BLL screening, assist Recommendations of the EI included history.
in the coordination of developmental continued monitoring for PFCs in the The number of questions can vary
and cognitive evaluations in affected public water supply and continued depending on the number of chemicals
children from a designated area of biological PFC testing in the community being investigated, the route of exposure
Pueblo, and conduct other public health to determine if PFCs in the community (e.g., breathing, eating, touching), and
actions/investigations as stipulated in had been reduced. number of other sources of the
the grant. Based on the results of the 2010 EI, chemical(s) (e.g., products used, jobs).
• On December 11, 2014, EPA listed ATSDR is preparing to conduct another We use approximately 12–20 questions
the Colorado Smelter site on the EI at the site in 2016 (approved by OMB about the pertinent environmental
National Priority List (NPL). on 8/10/2015), including biological exposures per investigation. Typically,
sampling of serum and urine to: the number of participants in an
Example 2: ASARCO Hayden Smelter • Compare individuals’ current serum individual EI ranges from 10 to 100.
Site, AZ PFC concentrations with their 2010 Participation is completely voluntary,
The community is located in the serum PFC concentrations. and there are no costs to participants
vicinity of the ASARCO Hayden • Compare individuals’ serum PFC other than their time. Based on a
Smelter, which has been operating for concentrations to the national maximum of 12 EIs per year and 100
100 years as a copper ore processer. The population reference values (NHANES participants each, the estimated
processing has resulted in lead and 2011–2012). annualized burden hours are 600.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
tkelley on DSK9F6TC42PROD with NOTICES

Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)

Exposure Investigation Participants ................ Chemical Exposure Questions ....................... 1,200 1 30/60

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Document Created: 2015-12-16 01:00:59
Document Modified: 2015-12-16 01:00:59
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 78234
80 FR 78234 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Toxic Substances and Disease RegistryCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 241 (December 16, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
