83 FR 43685 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substance and Disease Registry Federal Register Volume 83, Issue 166 (August 27, 2018)
Agency for Toxic Substance and Disease Registry
Federal Register Volume 83, Issue 166 (August 27, 2018)
| Page Range | 43685-43687 | |
| FR Document | 2018-18446 |
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)] [Notices] [Pages 43685-43687] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18446] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substance and Disease Registry [60Day-18-18AUZ; Docket No. ATSDR-2018-0008] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study).'' The purpose of this research is to use sound study methods to see if drinking water exposure to PFAS is related to health outcomes in this New Hampshire community. DATES: ATSDR must receive written comments on or before October 26, 2018. ADDRESSES: You may submit comments, identified by Docket No. ATSDR- 2018-0008 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 [[Page 43686]] Docket Number. ATSDR 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 Jeffery 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 Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)--NEW--Agency for Toxic Substances and Disease Registry (ATSDR). Background and Brief Description Per- and polyfluoroalkyl substances (PFAS) are a family of environmentally and biologically persistent chemicals used in industrial applications such as aqueous film-forming foam (AFFF), used to extinguish flammable liquid fires. Since the 1970s, military bases in the U.S. have used AFFF with PFAS constituents for firefighting training as well as to extinguish fires. At some military bases, AFFF use has resulted in the migration of PFAS chemicals through soils to ground water and/or surface water sources of drinking water for bases and/or surrounding communities. In 2016, the U.S. Environmental Protection Agency (USEPA) issued a lifetime health advisory level of 0.07 total micrograms of perfluorooctanoate (PFOA) and perfluorooctane sulfonate (PFOS) combined per liter of drinking water ([micro]g/L). In response to growing awareness of the extent of PFAS contamination across the U.S., Section 8006 of the Consolidated Appropriations Act, 2018, authorized the Agency for Toxic Substances and Disease Registry (ATSDR) to conduct a study on the human health effects of PFAS contamination in drinking water. In response, ATSDR is requesting a three-year Paperwork Reduction Act (PRA) clearance for the Pease Study, which will serve as a proof- of-concept model for a national multi-site study of PFAS health effects. The existence of a large body of state and local environmental monitoring and population blood testing data makes the Pease community in Portsmouth, NH, particularly suitable as ATSDR's initial PFAS research study site. From approximately 1970 until 1991, the Air Force used AFFF for firefighting and training at Pease Air Force Base. The base closed in 1991, and was converted to a large business and aviation industrial park in 1993, the Pease International Tradeport. In 2014, PFAS drinking water concentrations were detected (0.35 [micro]g/L PFOA and 2.4 [micro]g/L PFOS) at levels well above what was to become the USEPA lifetime health advisory level (0.07 [micro]g/L PFOA/PFOS). In 2015-7, the New Hampshire Department of Health and Human Services (NH DHHS) offered a PFAS blood testing program to the community. The blood testing program showed that the Pease population had concentrations of some types of PFAS that were two to three times higher than national estimates. The Pease Study will be cross-sectional in design, drawing from a convenience sample of people with and without exposure to PFAS- contaminated drinking water from Pease. The main goals of the study are to: (1) Evaluate the study procedures and methods to identify any issues that need to be addressed before embarking on a national multi- site study; and (2) examine associations between health outcomes and measured and historically reconstructed serum levels of PFAS. ATSDR will examine the association between PFAS compounds and lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults. In addition, ATSDR will investigate if PFAS is related to differences in sex hormones and sexual maturation, vaccine response, and neurobehavioral outcomes in children. In adults, additional outcomes of interest include cardiovascular disease, osteoarthritis, osteoporosis, endometriosis, and autoimmune disease. Adults will be 18 years or older, and children will be 4-17 years of age at enrollment. In total, ATSDR seeks to enroll 1,625 participants (1,100 adults and 525 children and their parents). Annualized estimates are 542 participants (367 adults and 175 children). For the exposure group (n=1,350), ATSDR will enroll 1,000 adults and 350 children. Annualized estimates are 450 exposed participants (333 adults and 117 children). Eligible participants had to work at, live on, or attend childcare at the former Pease Air Force Base or the Pease International Tradeport, or live in a nearby home that was served by a PFAS-contaminated private well. Drinking water exposures must have occurred at some time between 2004 and May 2014, after which remediation of the public water supply occurred. For the referent group (n=275), ATSDR will enroll 100 adults and 175 children. Annualized estimates are 92 referent participants (34 adults and 58 children). Eligible participants, never exposed to PFAS- contaminated drinking water from Pease, will come from other areas of Portsmouth, NH. Birth mothers of referent children likewise must never have had PFAS drinking water exposure. ATSDR will recruit, screen for eligibility, and enroll in three waves. The exposure group will be recruited in Waves One and Two. ATSDR estimates that 90% of the exposure group will be [[Page 43687]] enrolled in Wave 1 (n=1,215, or 405 per year), that is, will be past participants of the 2015-7 NH DHHS PFAS blood testing program. NH DHHS will assist ATSDR by sending out letters of invitation to its former blood testing program participants. To achieve the desired sample size, the other 10 percent of the exposure group (n=135, or 45 per year) will be recruited in Wave 2. These will be people who were eligible for the PFAS blood testing program but did not take part. The referent group will be recruited in Wave Three (n=275, or 92 per year), which can occur concurrently with Wave 1 and Wave 2. Wave 2 and Wave 3 recruits will call to volunteer after ATSDR opens those waves to enrollment. To restrict this study to drinking water exposures, any adult occupationally exposed to PFAS will not be eligible for the study (i.e. ever firefighters or in chemical manufacture). Likewise, children whose birth mothers were occupationally exposed will not be eligible. This restriction applies to both the exposure and the referent group. ATSDR assumes that 5% of the people who volunteer will not meet eligibility requirements. ATSDR will screen the 1,578 people from the NH DHHS PFAS blood testing program in Wave One (n=526 per year). ATSDR will screen at least 142 exposed people in Wave 2 (or 47 per year), and at least 289 unexposed people in Wave 3 (or 96 per year). This will require an annual time burden of 124 hours for eligibility screening. At enrollment, ATSDR will obtain adult consent, parental permission, and child assent before data collection begins. Each child will enroll with a parent, who ideally will be the child's birth mother, as ATSDR will ask details about the child's exposure, pregnancy, and breastfeeding history. For each participant, ATSDR will take body measures, collect blood and urine samples for chemical and biomarker analysis, and administer a questionnaire on exposures and medical history. For purposes of burden estimation, ATSDR assumes that 20% of parents will also enroll as adults; therefore, 420 parents will take the child questionnaire long form (n=140 per year), while 105 parents will take the short form to reduce burden (n=35 per year). Parents and children will also complete assessments of the child's attention and behaviors. After eligibility screening, the annual time burden for participation in the study is 58 hours for adults and 208 hours for children and their parents. ATSDR will ask for permission to compare adults' and children's medical histories with their medical records. ATSDR will also ask for permission to check children's school records to compare their behavioral assessment results. The annual time burden for medical and educational record abstraction is estimated to be 125 hours for adult records and 118 hours for children's records. The total annualized time burden requested is 1,189 hours. There is no cost to the respondents other than their time. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in (in hours) respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Pease Study Participants....................... Wave One Eligibility Screening Script.. 526 1 10/60 88 Wave Two Eligibility Screening Script.. 47 1 15/60 12 Wave Three Eligibility Screening Script 96 1 15/60 24 Appointment Reminder Telephone Script.. 542 1 5/60 45 Update Contact Information Hardcopy 542 1 5/60 45 Form. Medication List........................ 542 1 3/60 27 Body and Blood Pressure Measures Form.. 542 1 5/60 45 Blood Draw and Urine Collection Form... 542 1 10/60 90 Adult Questionnaire.................... 367 1 30/60 184 Child Questionnaire--Long Form......... 140 1 30/60 70 Child Questionnaire--Short Form........ 35 1 15/60 9 Parent Neurobehavioral Test Battery.... 175 1 15/60 44 Child Neurobehavioral Test Battery..... 175 1 90/60 263 Education Specialists.......................... Child School Record Abstraction Form... 15 12 20/60 60 Medical Record Specialists..................... Medical Record Abstraction Form--Adult. 25 15 20/60 125 Medical Record Abstraction Form--Child. 25 7 20/60 58 --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 1,189 -------------------------------------------------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting 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. 2018-18446 Filed 8-24-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43685
that consumer reporting agencies will Commission by courier or overnight more information, including routine
use third-party contractors (instead of service. uses permitted by the Privacy Act, in
their own employees) to increase the Because your comment will be placed the Commission’s privacy policy, at
capacity of their systems. Because of the on the publicly accessible FTC website https://www.ftc.gov/site-information/
way these contracts are typically at https://www.ftc.gov, you are solely privacy-policy.
established, these costs will likely be responsible for making sure that your
comment does not include any sensitive Heather Hippsley,
incurred on a continuing basis, and will
be calculated based on the number of or confidential information. In Acting Principal Deputy General Counsel.
requests handled by the systems. Staff particular, your comment should not [FR Doc. 2018–18448 Filed 8–24–18; 8:45 am]
estimates that the total annual amount include any sensitive personal BILLING CODE 6750–01–P
to be paid for services delivered under information, such as your or anyone
these contracts is $13,919,400.9 else’s Social Security number; date of
birth; driver’s license number or other DEPARTMENT OF HEALTH AND
H. Net Burden for FTC, After 50:50 Split state identification number, or foreign HUMAN SERVICES
After halving the updated estimates to country equivalent; passport number;
split the PRA burden with the CFPB financial account number; or credit or Agency for Toxic Substance and
regarding the Rule, the FTC’s burden debit card number. You are also solely Disease Registry
totals are 214,538 hours, $4,246,441 in responsible for making sure that your
comment does not include any sensitive [60Day–18–18AUZ; Docket No. ATSDR–
associated labor costs, and $6,959,700 in 2018–0008]
non-labor/capital costs. health information, such as medical
records or other individually Proposed Data Collection Submitted
Request for Comments identifiable health information. In for Public Comment and
You can file a comment online or on addition, your comment should not Recommendations
paper. For the FTC to consider your include any ‘‘trade secret or any
comment, we must receive it on or commercial or financial information AGENCY: Agency for Toxic Substances
before October 26, 2018. Write which . . . . is privileged or and Disease Registry (ATSDR),
‘‘Paperwork Reduction Act: FTC File confidential’’—as provided by Section Department of Health and Human
No. P072108’’ on your comment. Your 6(f) of the FTC Act, 15 U.S.C. 46(f), and Services (HHS).
comment—including your name and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— ACTION: Notice with comment period.
your state—will be placed on the public including in particular competitively
sensitive information such as costs, SUMMARY: The Agency for Toxic
record of this proceeding, including, to
the extent practicable, on the public sales statistics, inventories, formulas, Substances and Disease Registry
Commission website, at https:// patterns, devices, manufacturing (ATSDR), as part of its continuing effort
www.ftc.gov/policy/public-comments. processes, or customer names. to reduce public burden and maximize
Comments containing material for the utility of government information,
Postal mail addressed to the
which confidential treatment is invites the general public and other
Commission is subject to delay due to
requested must be filed in paper form, Federal agencies the opportunity to
heightened security screening. As a
must be clearly labeled ‘‘Confidential,’’ comment on a proposed and/or
result, we encourage you to submit your
and must comply with FTC Rule 4.9(c). continuing information collection, as
comments online. To make sure that the
In particular, the written request for required by the Paperwork Reduction
Commission considers your online
confidential treatment that accompanies Act of 1995. This notice invites
comment, you must file it at https:// the comment must include the factual
ftcpublic.commentworks.com/ftc/ comment on a proposed information
and legal basis for the request, and must collection project titled ‘‘Human Health
regulationVsubpartNpra by following identify the specific portions of the
the instructions on the web based form. Effects of Drinking Water Exposures to
comment to be withheld from the public Per- and Polyfluoroalkyl Substances
If this Notice appears at https:// record. See FTC Rule 4.9(c). Your
www.regulations.gov, you also may file (PFAS) at Pease International Tradeport,
comment will be kept confidential only Portsmouth, NH (The Pease Study).’’
a comment through that website. if the General Counsel grants your The purpose of this research is to use
If you file your comment on paper, request in accordance with the law and sound study methods to see if drinking
write ‘‘Paperwork Reduction Act: FTC the public interest. Once your comment water exposure to PFAS is related to
File No. P072108’’ on your comment has been posted on the public FTC health outcomes in this New Hampshire
and on the envelope, and mail it to the website—as legally required by FTC community.
following address: Federal Trade Rule 4.9(b)—we cannot redact or
Commission, Office of the Secretary, DATES: ATSDR must receive written
remove your comment from the FTC
600 Pennsylvania Avenue NW, Suite comments on or before October 26,
website, unless you submit a
CC–5610 (Annex J), Washington, DC 2018.
confidentiality request that meets the
20580, or deliver your comment to the requirements for such treatment under ADDRESSES: You may submit comments,
following address: Federal Trade FTC Rule 4.9(c), and the General identified by Docket No. ATSDR–2018–
Commission, Office of the Secretary, Counsel grants that request. 0008 by any of the following methods:
Constitution Center, 400 7th Street SW, Visit the Commission website at • Federal eRulemaking Portal:
5th Floor, Suite 5610 (Annex J), https://www.ftc.gov to read this Notice. Regulations.gov. Follow the instructions
Washington, DC 20024. If possible, The FTC Act and other laws that the for submitting comments.
amozie on DSK3GDR082PROD with NOTICES1
submit your paper comment to the Commission administers permit the • Mail: Jeffrey M. Zirger, Information
collection of public comments to Collection Review Office, Centers for
9 This consists of an estimated $9,302,400 for consider and use in this proceeding as Disease Control and Prevention, 1600
automated telephone cost ($1.36 per request × 6.84 appropriate. The Commission will Clifton Road NE, MS–D74, Atlanta,
million requests) and an estimated $4,617,000
($0.15 per request × 30.78 million requests) for
consider all timely and responsive Georgia 30329.
internet web service cost. Per unit cost estimates are public comments that it receives on or Instructions: All submissions received
based on staff’s knowledge of the industry. before October 26, 2018. You can find must include the agency name and
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43687
enrolled in Wave 1 (n=1,215, or 405 per the exposure and the referent group. enroll as adults; therefore, 420 parents
year), that is, will be past participants of ATSDR assumes that 5% of the people will take the child questionnaire long
the 2015–7 NH DHHS PFAS blood who volunteer will not meet eligibility form (n=140 per year), while 105
testing program. NH DHHS will assist requirements. ATSDR will screen the parents will take the short form to
ATSDR by sending out letters of 1,578 people from the NH DHHS PFAS reduce burden (n=35 per year). Parents
invitation to its former blood testing blood testing program in Wave One and children will also complete
program participants. To achieve the (n=526 per year). ATSDR will screen at assessments of the child’s attention and
desired sample size, the other 10 least 142 exposed people in Wave 2 (or behaviors. After eligibility screening,
percent of the exposure group (n=135, 47 per year), and at least 289 unexposed the annual time burden for participation
or 45 per year) will be recruited in Wave people in Wave 3 (or 96 per year). This in the study is 58 hours for adults and
2. These will be people who were will require an annual time burden of 208 hours for children and their parents.
eligible for the PFAS blood testing 124 hours for eligibility screening.
At enrollment, ATSDR will obtain ATSDR will ask for permission to
program but did not take part. The
adult consent, parental permission, and compare adults’ and children’s medical
referent group will be recruited in Wave
child assent before data collection histories with their medical records.
Three (n=275, or 92 per year), which
begins. Each child will enroll with a ATSDR will also ask for permission to
can occur concurrently with Wave 1 and
parent, who ideally will be the child’s check children’s school records to
Wave 2. Wave 2 and Wave 3 recruits
birth mother, as ATSDR will ask details compare their behavioral assessment
will call to volunteer after ATSDR opens
those waves to enrollment. about the child’s exposure, pregnancy, results. The annual time burden for
To restrict this study to drinking and breastfeeding history. medical and educational record
water exposures, any adult For each participant, ATSDR will take abstraction is estimated to be 125 hours
occupationally exposed to PFAS will body measures, collect blood and urine for adult records and 118 hours for
not be eligible for the study (i.e. ever samples for chemical and biomarker children’s records.
firefighters or in chemical manufacture). analysis, and administer a questionnaire The total annualized time burden
Likewise, children whose birth mothers on exposures and medical history. For requested is 1,189 hours. There is no
were occupationally exposed will not be purposes of burden estimation, ATSDR cost to the respondents other than their
eligible. This restriction applies to both assumes that 20% of parents will also time.
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)
Pease Study Participants Wave One Eligibility Screening Script ................. 526 1 10/60 88
Wave Two Eligibility Screening Script ................. 47 1 15/60 12
Wave Three Eligibility Screening Script .............. 96 1 15/60 24
Appointment Reminder Telephone Script ........... 542 1 5/60 45
Update Contact Information Hardcopy Form ...... 542 1 5/60 45
Medication List ..................................................... 542 1 3/60 27
Body and Blood Pressure Measures Form ......... 542 1 5/60 45
Blood Draw and Urine Collection Form .............. 542 1 10/60 90
Adult Questionnaire ............................................. 367 1 30/60 184
Child Questionnaire—Long Form ........................ 140 1 30/60 70
Child Questionnaire—Short Form ....................... 35 1 15/60 9
Parent Neurobehavioral Test Battery .................. 175 1 15/60 44
Child Neurobehavioral Test Battery .................... 175 1 90/60 263
Education Specialists .... Child School Record Abstraction Form ............... 15 12 20/60 60
Medical Record Special- Medical Record Abstraction Form—Adult ........... 25 15 20/60 125
ists.
Medical Record Abstraction Form—Child ........... 25 7 20/60 58
Total ........................ .............................................................................. ........................ ........................ ........................ 1,189
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND Control and Prevention (CDC),
Acting Chief, Information Collection Review HUMAN SERVICES Department of Health and Human
Office, Office of Scientific Integrity, Office Services (HHS).
of the Associate Director for Science, Office Centers for Disease Control and
ACTION: Notice of availability.
of the Director, Centers for Disease Control Prevention
and Prevention.
SUMMARY: NIOSH announces the
[FR Doc. 2018–18446 Filed 8–24–18; 8:45 am] [CDC–2017–0104; Docket Number NIOSH–
availability of the final National
BILLING CODE 4163–18–P 304]
Occupational Research Agenda for
amozie on DSK3GDR082PROD with NOTICES1
Final National Occupational Research Traumatic Injury Prevention.
Agenda for Traumatic Injury DATES: The final document was
Prevention published on August 20, 2018 on the
AGENCY: National Institute for CDC website.
Occupational Safety and Health ADDRESSES: The document may be
(NIOSH) of the Centers for Disease obtained at the following link: https://
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Document Created: 2018-08-25 01:49:35
Document Modified: 2018-08-25 01:49:35
| 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 | ATSDR must receive written comments on or before October 26, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery 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 43685 |
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