Agency Forms Undergoing Paperwork Reduction Act Review, 78234-78236 [2015-31581]

Download as PDF 78234 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices notice was published in the Federal Register at 80 FR 58253 on September 28, 2015. No comments were received. DATES: Submit comments on or before January 15, 2016. ADDRESSES: Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods: • Regulations.gov: http:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link ‘‘Submit a Comment’’ that corresponds with ‘‘Information Collection 9000–0107, Notice of Radioactive Materials’’. Follow the instructions provided at the ‘‘Submit a Comment’’ screen. Please include your name, company name (if any), and ‘‘Information Collection 9000–0107, Notice of Radioactive Materials’’ on your attached document. • Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000–0107, Notice of Radioactive Materials. Instructions: Please submit comments only and cite Information Collection 9000–0107, Notice of Radioactive Materials, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). FOR FURTHER INFORMATION CONTACT: Mr. Charles Gray, Procurement Analyst, Office of Acquisition Policy, GSA, 703– 795–6328 or email charles.gray@ gsa.gov. tkelley on DSK9F6TC42PROD with NOTICES A. Purpose The clause at FAR 52.223–7, Notice of Radioactive Materials, requires contractors to notify the Government prior to delivery of items containing radioactive materials. The purpose of the notification is to alert receiving activities that appropriate safeguards may need to be instituted. The notice shall specify the part or parts of the items which contain radioactive materials, a description of the materials, VerDate Sep<11>2014 17:21 Dec 15, 2015 Jkt 238001 the name and activity of the isotope, the manufacturer of the materials, and any other information known to the contractor which will put users of the items on notice as to the hazards involved. B. Annual Reporting Burden Respondents: 535. Responses per Respondent: 5. Annual Responses: 2,675. Hours per Response: 1. Total Burden Hours: 2,675. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the 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. 9000–0107, Notice of Radioactive Materials, in all correspondence. Edward Loeb, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2015–31562 Filed 12–15–15; 8:45 am] BILLING CODE 6820–EP–P 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 (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 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. E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices 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 78235 • 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 Example 3: Perfluorochemical Serum been exposed to unusual levels of Sampling, Decatur, AL pollutants at specific locations (e.g., Perfluorochemicals (PFC) are a class where people live, spend leisure time, of organofluorine compounds that are or anywhere they might come into used in a variety of industrial and contact with contaminants under consumer products including fireinvestigation). fighting foams; personal care and Questionnaires, appropriate to the cleaning products; and oil, stain, grease, specific contaminant, are generally and water repellent coatings. These needed in about half of the EIs (at most coatings are used on carpet, textiles, approximately 12 per year) to assist in leather, ‘‘non-stick’’ cookware, and interpreting the biological or paper wrappers used on fast food items. environmental sampling results. ATSDR As a result, United States (U.S.) general collects contact information (e.g., name, population exposure to PFCs is address, phone number) to provide the common. participant with their individual results. In 2007, PFCs were released by a ATSDR also collects information on chemical manufacturer near Decatur, other possible confounding sources of AL, and impacted environmental media chemical(s) exposure such as medicines in the area. In 2010, ATSDR conducted taken, foods eaten, hobbies, jobs, etc. In an EI to assess exposure of residents to addition, ATSDR asks questions on PFCs in blood. PFCs were found in the recreational or occupational activities serum of people that regularly used the that could increase a participant’s public water system in the area as their exposure potential. That information primary drinking water source. represents an individual’s exposure Recommendations of the EI included history. continued monitoring for PFCs in the The number of questions can vary public water supply and continued depending on the number of chemicals biological PFC testing in the community being investigated, the route of exposure to determine if PFCs in the community (e.g., breathing, eating, touching), and had been reduced. number of other sources of the Based on the results of the 2010 EI, chemical(s) (e.g., products used, jobs). ATSDR is preparing to conduct another We use approximately 12–20 questions EI at the site in 2016 (approved by OMB about the pertinent environmental on 8/10/2015), including biological exposures per investigation. Typically, sampling of serum and urine to: the number of participants in an • Compare individuals’ current serum individual EI ranges from 10 to 100. PFC concentrations with their 2010 Participation is completely voluntary, serum PFC concentrations. and there are no costs to participants other than their time. Based on a • Compare individuals’ serum PFC maximum of 12 EIs per year and 100 concentrations to the national participants each, the estimated population reference values (NHANES annualized burden hours are 600. 2011–2012). 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. tkelley on DSK9F6TC42PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hrs.) Exposure Investigation Participants ................ Chemical Exposure Questions ....................... 1,200 1 30/60 VerDate Sep<11>2014 17:21 Dec 15, 2015 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\16DEN1.SGM 16DEN1 78236 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than January 15, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Shortage Designation Management System OMB No. 0915–xxxx—NEW Abstract: HRSA’s Bureau of Health Workforce (BHW) is committed to improving the health of the nation’s underserved communities and vulnerable populations by developing, tkelley on DSK9F6TC42PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:21 Dec 15, 2015 Jkt 238001 implementing, evaluating, and refining programs that strengthen the nation’s health workforce. The Department of Health and Human Services relies on two federal shortage designations to identify and dedicate resources to areas and populations in greatest need of providers: Health Professional Shortage Area (HPSA) designations and Medically Underserved Area/Medically Underserved Population (MUA/P) designations. HPSA designations are geographic areas, population groups, and facilities that are experiencing a shortage of health professionals. MUA/ P designations are areas, or populations within areas, that are experiencing a shortage of health care services. MUAs are designated for the entire population of a particular geographic area. MUP designations are limited to particular groups of underserved people within an area. These designations are currently used in a number of Departmental programs that provide both federal and state government grant/program benefits for communities, health care facilities, and providers. BHW has the responsibility for designating and dedesignating HPSAs and MUA/Ps on behalf of the Secretary. HPSA designations are required to be reviewed and updated annually to reflect current data. Individual states— through their Primary Care Office (PCO)—have primary responsibility for initiating an application for a new or updated HPSA designation, or withdrawing HPSAs that no longer meet the designation criteria. HRSA reviews the application and makes the final determination on the HPSA designation. Requests come from the PCOs who have access to the online application and review system, Shortage Designation Management System (SDMS). Requests that come from other sources are referred to the PCOs for their review and concurrence. In addition, interested parties, including the Governor, the State Primary Care Association, and state professional associations are notified of each request submitted for their comments and recommendations. In order to obtain a federal shortage designation for an area, population, or facility, PCOs must submit a shortage designation application through SDMS for review and approval by BHW. Both the HPSA and MUA/P applications request local, state, and national data on the population that is experiencing a PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 shortage of health professionals and the number of health professionals relative to the population covered by the proposed designation. The information collected on the applications is used to determine which areas, populations, and facilities have shortages. The lists of designated HPSAs are annually published in the Federal Register. In addition, lists of HPSAs are updated on the HRSA Web site, http:// www.hrsa.gov/shortage/, so that interested parties can access the information. Need and Proposed Use of the Information: The need and purpose of this information collection is to obtain information to designate HPSAs and MUA/Ps. The information obtained from the SDMS is used to determine which areas, populations, and facilities have critical shortages of health professionals. The SDMS HPSA application and SDMS MUA/P application are used for these designation determinations. Applicants must submit a SDMS application to BHW to obtain a federal shortage designation. The application asks for local, state, and national data required for determining the application’s eligibility to obtain a federal shortage designation. In addition, applicants must enter detailed information explaining how the area, population, or facility faces a critical shortage of health professionals. Likely Respondents: State PCOs interested in obtaining a primary care, dental, or mental HPSA designation or a MUA/P in their state. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78234-78236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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