83 FR 55543 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry Federal Register Volume 83, Issue 215 (November 6, 2018)
Agency for Toxic Substances and Disease Registry
Federal Register Volume 83, Issue 215 (November 6, 2018)
| Page Range | 55543-55545 | |
| FR Document | 2018-24234 |
[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)] [Notices] [Pages 55543-55545] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24234] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substance and Disease Registry [60Day-19-0048; Docket No. ATSDR-2018-0009] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Agency for Toxic Substance and Disease Registry, Department of Health and Human Services (HHS) ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Agency for Toxic Substance and Disease Registry, as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, Expiration Date 3/31/2019)-- Extension--Agency for Toxic Substances and Disease Registry (ATSDR). To evaluate public health issues at a site resulting from environmental exposure, ATSDR EIs fill data gaps by conducting environmental and biological sampling. DATES: CDC must receive written comments on or before January 7, 2019. [[Page 55544]] ADDRESSES: You may submit comments, identified by Docket No. ATSDR- 2018-0009 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. 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; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. 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 submissions of responses. 5. Assess information collection costs. Proposed Project ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, Expiration Date 3/31/2019)--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 Paperwork Reduction Act approval for the extension of the generic clearance titled ATSDR Exposure Investigations (OMB No. 0923-0048; OMB Exp. Date: 3/31/2019) 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 public, and ATSDR staff. 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, four of the EIs that ATSDR conducted in the past three years include the Anaconda Smelter (MT--blood lead and urine arsenic), Former United Zinc and Associated Smelters (KS--blood lead), Dimock Private Well Water Sampling (PA) and Follow-up arsenic urine testing in Hayden, Arizona. Example 1: Anaconda Smelter Blood Lead and Urine Arsenic Sampling, MT The site is a former smelter located in Anaconda, Montana. Past smelting activities resulted in high levels of heavy metals, primarily arsenic and lead, in community soil and in the slag piles. ATSDR sampled blood and urine in community members to evaluate lead (blood) and arsenic (urine). Given community concern about contamination, all members of the community were invited to participate in the testing. Urine samples were evaluated for total arsenic, speciated arsenic (organic and inorganic), creatinine and specific gravity. If arsenic is detected, speciation of the sample will determined whether the arsenic is organic (probably resulting from eating seafood) or inorganic (likely resulting from exposure to environmental arsenic). The results of the testing are currently being analyzed by the National Center for Environmental Health/Division of Laboratory Sciences (NCEH/DLS). Results will be sent individually to participants when the analysis is completed and a report will be prepared and presented to the community in a community meeting. Example 2: Former United Zinc and Associated Smelters Blood Lead Testing, Iola, Kansas The community is located in the vicinity of the Former United Zinc and Associated Smelters in Iola, Kansas. The smelters operated from 1902 to 1925 and operations resulted in heavy metal contamination in community soils. Limited sampling of the community in the past found elevated blood lead levels in young children. The blood testing was completed in two phases: One in December of 2016 and one in August 2017 and a total of 61 participants were tested: 24 Children younger than 6 years, 17 children aged 6-19 years and 20 adult women. One child younger than 6 years had a BLL greater than 5 [micro]g/dL. The child's parents were notified by phone of the results by the ATSDR Medical Officer and follow up was conducted by the local PEHSU (Pediatric Environmental Health Specialty Unit. All participants received their results by mail and the EI report was released and presented to the community in a public meeting in August 2018. Example 3: Private Well Water Sampling in Dimock, Pennsylvania Unconventional natural gas drilling activities have been conducted in the Dimock, PA area for approximately 10 years and local residents complain of poor water quality. In 2012, EPA sampled 64 private wells in the area for contaminants that may be present due to natural gas drilling activities. ATSDR assisted in the analysis of the 2012 data set and the following recommendations were made: [cir] People with elevated levels of inorganic analytes in their well water should install a home treatment system, and [cir] people with high levels of methane in their well water should vent their well and home and treat their water to eliminate potential buildup of explosive gases. [[Page 55545]] Example 4: Follow-Up Arsenic Urine Testing in Hayden, Arizona ATSDR completed an EI in 2015 at the ASARCO Hayden Smelter Site in Hayden, AZ. The EI included blood lead and urine arsenic testing. Air monitoring determined that the smelter was not operating during the sample collection period and that, given the short half-life of arsenic in the body, the arsenic results may not be valid. In 2017, ATSDR retested the participants from the 2015 EI to evaluate their urinary arsenic levels. It was determined that all urinary arsenic levels were below the follow-up level and air data indicate that air arsenic levels in the 2 weeks prior to testing were consistent with usual levels seen in the community. The EI report is being prepared and a community meeting will be held when the document is released. Additional water sampling was recommended and an EI was conducted in August in 2017. For the EI, the 64 residents previously sampled were invited to have their private wells retested: 25 residences agreed participate in the EI sampling. Residents were provided the results of their sampling and an EI report is currently being prepared. It will be presented to the community in a public meeting when completed. 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 Total burden respondents respondent (in hours) (in hours) ---------------------------------------------------------------------------------------------------------------- Exposure Investigation Chemical 1,200 1 30/60 600 Participants. Exposure Questions. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 600 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2018-24234 Filed 11-5-18; 8:45 am] BILLING CODE 4163-18-P
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(11) Under an order of a court of official capacity, or an individual national security, resulting from a
competent jurisdiction; and agency official or employee whom the suspected or confirmed breach.
(12) To a consumer reporting agency, Department of Justice has agreed to (24) May be disclosed to FTC
when trying to collect a claim of the represent, is or may likely become a contractors, volunteers, interns or other
Government, in accordance with 31 party, and (ii) the litigation is likely to authorized individuals who have a need
U.S.C. 3711(e). affect the agency or any component for the record in order to perform their
In addition, in accordance with thereof; or officially assigned or designated duties
paragraph (3) above, the ‘‘routine uses’’ (b) To obtain advice, including advice for or on behalf of the FTC.
set forth in paragraphs (13) through (24) concerning the accessibility of a record The routine uses contained in this
below shall apply to all records in all or information under the Privacy Act or Appendix are in addition to any routine
FTC Privacy Act systems of records. the Freedom of Information Act; uses contained in the system of records
Specifically, such records: (18) May be disclosed to a notice (SORN) for each FTC Privacy Act
(13) Where appropriately congressional office in response to an records system. Some of the authorized
incorporated into the records inquiry from that office made at the disclosures and routine uses may
maintained in FTC–II–6 (Discrimination written request of the subject overlap with one another. The FTC will
Complaint System–FTC), may be individual, but only to the extent that treat a routine use as valid and still in
disclosed under the routine uses the record would be legally accessible to effect, even if an overlapping routine
published for that system; that individual; use or disclosure is partly or fully
(14) May be disclosed to the National (19) May be disclosed to debt invalidated or repealed.
Archives and Records Administration collection contractors for the purpose of
for records management inspections collecting debts owed to the Heather Hippsley,
conducted under authority of 44 U.S.C. government, as authorized under the Deputy General Counsel.
2904 and 2906; Debt Collection Act of 1982, 31 U.S.C. [FR Doc. 2018–24226 Filed 11–5–18; 8:45 am]
(15) May be disclosed to other 3718, and subject to applicable Privacy BILLING CODE 6750–01–P
agencies, offices, establishments, and Act safeguards;
authorities, whether federal, state, local, (20) May be disclosed to a grand jury
foreign, or self-regulatory (including, agent pursuant either to a federal or
but not limited to organizations such as state grand jury subpoena, or to a DEPARTMENT OF HEALTH AND
professional associations or licensing prosecution request that such record be HUMAN SERVICES
boards), authorized or with the released for the purpose of its
responsibility to investigate, litigate, introduction to a grand jury, where the Agency for Toxic Substance and
prosecute, enforce, or implement a subpoena or request has been Disease Registry
statute, rule, regulation, or order, where specifically approved by a court;
the record or information by itself or in (21) May be disclosed to the Office of [60Day–19–0048; Docket No. ATSDR–2018–
connection with other records or Management and Budget (OMB) for the 0009]
information: purpose of obtaining advice regarding
(a) Indicates a violation or potential agency obligations under the Privacy Proposed Data Collection Submitted
violation of law, whether criminal, civil, Act, or in connection with the review of for Public Comment and
administrative, or regulatory in nature, private relief legislation pursuant to Recommendations
and whether arising by general statute OMB Circular A–19;
(22) To appropriate agencies, entities, AGENCY: Agency for Toxic Substance
or particular program statute, or by
and persons when (a) the FTC suspects and Disease Registry, Department of
regulation, rule, or order issued
or has confirmed that there has been a Health and Human Services (HHS)
pursuant thereto, or
(b) Indicates a violation or potential breach of the system of records; (b) the ACTION: Notice with comment period.
violation of a professional, licensing, or FTC has determined that as a result of
similar regulation, rule, or order, or the suspected or confirmed breach there SUMMARY: The Agency for Toxic
otherwise reflects on the qualifications is a risk of harm to individuals, the FTC Substance and Disease Registry, as part
or fitness of an individual who is (including its information systems, of its continuing effort to reduce public
licensed or seeking to be licensed; programs, and operations), the Federal burden and maximize the utility of
(16) May be disclosed to any source, Government, or national security; and government information, invites the
private or governmental, to the extent (c) the disclosure made to such general public and other Federal
necessary to secure from such source agencies, entities, and persons is agencies the opportunity to comment on
information relevant to and sought in reasonably necessary to assist in a proposed and/or continuing
furtherance of a legitimate investigation connection with the FTC’s efforts to information collection, as required by
or audit; respond to the suspected or confirmed the Paperwork Reduction Act of 1995.
(17) May be disclosed to any breach or to prevent, minimize, or This notice invites comment on a
authorized agency component of the remedy such harm. proposed information collection project
Federal Trade Commission, Department (23) To another Federal agency or titled ATSDR Exposure Investigations
of Justice, or other law enforcement Federal entity, when the FTC (EIs) (OMB Control No. 0923–0048,
authorities, and for disclosure by such determines that information from this Expiration Date 3/31/2019)—
parties: system of records is reasonably Extension—Agency for Toxic
(a) To the extent relevant and necessary to assist the recipient agency Substances and Disease Registry
khammond on DSK30JT082PROD with NOTICES
necessary in connection with litigation or entity in (a) responding to a (ATSDR). To evaluate public health
in proceedings before a court or other suspected or confirmed breach or (b) issues at a site resulting from
adjudicative body, where (i) the United preventing, minimizing, or remedying environmental exposure, ATSDR EIs fill
States is a party to or has an interest in the risk of harm to individuals, the data gaps by conducting environmental
the litigation, including where the recipient agency or entity (including its and biological sampling.
agency, or an agency component, or an information systems, programs, and DATES: CDC must receive written
agency official or employee in his or her operations), the Federal Government, or comments on or before January 7, 2019.
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Example 4: Follow-Up Arsenic Urine retested: 25 residences agreed ATSDR also collects information on
Testing in Hayden, Arizona participate in the EI sampling. Residents other possible confounding sources of
were provided the results of their chemical(s) exposure such as medicines
ATSDR completed an EI in 2015 at
sampling and an EI report is currently taken, foods eaten, hobbies, jobs, etc. In
the ASARCO Hayden Smelter Site in
being prepared. It will be presented to addition, ATSDR asks questions on
Hayden, AZ. The EI included blood lead
the community in a public meeting recreational or occupational activities
and urine arsenic testing. Air
when completed. that could increase a participant’s
monitoring determined that the smelter All of ATSDR’s targeted biological exposure potential. That information
was not operating during the sample assessments (e.g., urine, blood) and represents an individual’s exposure
collection period and that, given the some of the environmental history.
short half-life of arsenic in the body, the investigations (e.g., air, water, soil, or
arsenic results may not be valid. The number of questions can vary
food sampling) involve participants to
In 2017, ATSDR retested the depending on the number of chemicals
determine whether they are or have
participants from the 2015 EI to evaluate being investigated, the route of exposure
been exposed to unusual levels of
their urinary arsenic levels. It was (e.g., breathing, eating, touching), and
pollutants at specific locations (e.g.,
determined that all urinary arsenic number of other sources of the
where people live, spend leisure time,
levels were below the follow-up level chemical(s) (e.g., products used, jobs).
or anywhere they might come into
and air data indicate that air arsenic We use approximately 12–20 questions
contact with contaminants under
levels in the 2 weeks prior to testing about the pertinent environmental
investigation).
were consistent with usual levels seen Questionnaires, appropriate to the exposures per investigation.
in the community. The EI report is being specific contaminant, are generally Typically, the number of participants
prepared and a community meeting will needed in about half of the EIs (at most in an individual EI ranges from 10 to
be held when the document is released. approximately 12 per year) to assist in 100. Participation is completely
Additional water sampling was interpreting the biological or voluntary, and there are no costs to
recommended and an EI was conducted environmental sampling results. ATSDR participants other than their time. Based
in August in 2017. For the EI, the 64 collects contact information (e.g., name, on a maximum of 12 EIs per year and
residents previously sampled were address, phone number) to provide the 100 participants each, the estimated
invited to have their private wells participant with their individual results. annualized burden hours are 600.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Exposure Investigation Participants .. Chemical Exposure Questions ......... 1,200 1 30/60 600
Total ........................................... ........................................................... ........................ ........................ ........................ 600
Jeffrey M. Zirger, Submitted for Public Comment and are to respond, including, through the
Acting Lead, Information Collection Review Recommendations’’ notice on July 20, use of appropriate automated,
Office, Office of Scientific Integrity, Office 2018 to obtain comments from the electronic, mechanical, or other
of Science, Centers for Disease Control and public and affected agencies. CDC technological collection techniques or
Prevention. received one comment related to the other forms of information technology,
[FR Doc. 2018–24234 Filed 11–5–18; 8:45 am] previous notice. This notice serves to e.g., permitting electronic submission of
BILLING CODE 4163–18–P allow an additional 30 days for public responses; and
and affected agency comments. (e) Assess information collection
CDC will accept all comments for this costs.
DEPARTMENT OF HEALTH AND proposed information collection project.
HUMAN SERVICES The Office of Management and Budget To request additional information on
is particularly interested in comments the proposed project or to obtain a copy
Centers for Disease Control and that: of the information collection plan and
Prevention (a) Evaluate whether the proposed instruments, call (404) 639–7570 or
collection of information is necessary send an email to omb@cdc.gov. Direct
[30Day–19–18APJ] written comments and/or suggestions
for the proper performance of the
functions of the agency, including regarding the items contained in this
Agency Forms Undergoing Paperwork notice to the Attention: CDC Desk
Reduction Act Review whether the information will have
practical utility; Officer, Office of Management and
In accordance with the Paperwork (b) Evaluate the accuracy of the Budget, 725 17th Street NW,
Reduction Act of 1995, the Centers for agencies estimate of the burden of the Washington, DC 20503 or by fax to (202)
Disease Control and Prevention (CDC) 395–5806. Provide written comments
khammond on DSK30JT082PROD with NOTICES
proposed collection of information,
has submitted the information including the validity of the within 30 days of notice publication.
collection request titled Surveillance of methodology and assumptions used; Proposed Project
Nonfatal Injuries Among On-Duty Law (c) Enhance the quality, utility, and
Enforcement Officers to the Office of clarity of the information to be Surveillance of Nonfatal Injuries
Management and Budget (OMB) for collected; Among On-Duty Law Enforcement
review and approval. CDC previously (d) Minimize the burden of the Officers—New—National Institute for
published a ‘‘Proposed Data Collection collection of information on those who Occupational Safety and Health
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Document Created: 2018-11-06 00:18:29
Document Modified: 2018-11-06 00:18:29
| 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 | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before January 7, 2019. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 55543 |
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