Final National Occupational Research Agenda for Traumatic Injury Prevention, 43687-43688 [2018-18514]

Download as PDF 43687 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 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 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Form name Pease Study Participants Wave One Eligibility Screening Script ................. Wave Two Eligibility Screening Script ................. Wave Three Eligibility Screening Script .............. Appointment Reminder Telephone Script ........... Update Contact Information Hardcopy Form ...... Medication List ..................................................... Body and Blood Pressure Measures Form ......... Blood Draw and Urine Collection Form .............. Adult Questionnaire ............................................. Child Questionnaire—Long Form ........................ Child Questionnaire—Short Form ....................... Parent Neurobehavioral Test Battery .................. Child Neurobehavioral Test Battery .................... Child School Record Abstraction Form ............... Medical Record Abstraction Form—Adult ........... 526 47 96 542 542 542 542 542 367 140 35 175 175 15 25 1 1 1 1 1 1 1 1 1 1 1 1 1 12 15 10/60 15/60 15/60 5/60 5/60 3/60 5/60 10/60 30/60 30/60 15/60 15/60 90/60 20/60 20/60 88 12 24 45 45 27 45 90 184 70 9 44 263 60 125 Medical Record Abstraction Form—Child ........... 25 7 20/60 58 .............................................................................. ........................ ........................ ........................ 1,189 Education Specialists .... Medical Record Specialists. Total ........................ amozie on DSK3GDR082PROD with NOTICES1 Number of respondents Type of respondents 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2018–18446 Filed 8–24–18; 8:45 am] [CDC–2017–0104; Docket Number NIOSH– 304] BILLING CODE 4163–18–P Centers for Disease Control and Prevention Final National Occupational Research Agenda for Traumatic Injury Prevention National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease AGENCY: VerDate Sep<11>2014 17:51 Aug 24, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of availability. SUMMARY: NIOSH announces the availability of the final National Occupational Research Agenda for Traumatic Injury Prevention. The final document was published on August 20, 2018 on the CDC website. DATES: The document may be obtained at the following link: https:// ADDRESSES: E:\FR\FM\27AUN1.SGM 27AUN1 43688 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices www.cdc.gov/niosh/nora/crosssectors/ ti/agenda.html. FOR FURTHER INFORMATION CONTACT: Emily Novicki, M.A., M.P.H, (NORACoordinator@cdc.gov), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E–20, 1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498–2581 (not a toll free number). SUPPLEMENTARY INFORMATION: On December 7, 2017, NIOSH published a request for public review in the Federal Register [82 FR 57758] of the draft version of the National Occupational Research Agenda for Traumatic Injury Prevention. All comments received were reviewed and addressed where appropriate. Dated: August 22, 2018. Frank J. Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2018–18514 Filed 8–24–18; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–1080] amozie on DSK3GDR082PROD with NOTICES1 Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled [HIV Outpatient Study (HOPS)] to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on [September 26, 2017] to obtain comments from the public and affected agencies. CDC received [2] comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (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; VerDate Sep<11>2014 17:51 Aug 24, 2018 Jkt 244001 (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, 725 17th Street, NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project HIV Outpatient Study (HOPS) (OMB Control Number 0920–1080, Expiration Date 08/31/2018)—REVISION—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention requests a three year approval for the HIV Outpatient Study data collection activity. The HIV Outpatient Study (HOPS) is a prospective longitudinal cohort of HIVinfected outpatients at eight wellestablished private HIV care practices and university-based U.S. clinics. Clinical data are abstracted on ongoing basis from the medical records of adult HIV-infected HOPS study participants, who also complete an optional seven minute telephone/web-based behavioral assessment as part of their annual clinic visit. Before enrolling in this study, all potential study participants will undergo an informed consent process (including signing of a written informed consent) which is estimated to take 15 minutes. The core areas of HOPS research extending through the present HIV treatment era include (i) monitoring death rates and causes of death (ii) characterizing the optimal patient PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 management strategies to reduce HIVrelated morbidity and mortality (e.g., effectiveness of antiretroviral therapies and other clinical interventions (iii) monitoring of sexual and drug use behaviors to inform Prevention with Positives, and (iv) investigating disparities in the HIV care continuum by various demographic factors. In recent years, the HOPS has been instrumental in bringing attention to emerging issues in chronic HIV infection with actionable opportunities for prevention, including: Cardiovascular disease, fragility fractures, renal and hepatic disease, and cancers. The HOPS remains an important source for multi-year trend data concerning conditions and behaviors for which data are not readily available elsewhere, including: Rates of opportunistic illnesses, rates of comorbid conditions (e.g., hypertension, obesity, diabetes) and antiretroviral drug resistance. Data will be collected through medical record abstraction by trained abstractors and by telephone or internetbased, computer-assisted interviews at eight funded study sites in six U.S. cities. Collection of data abstracted from patient medical records provides data in five general categories: Demographics and risk behaviors for HIV infection; symptoms; diagnosed conditions (definitive and presumptive); medications prescribed (including dose, duration, and reasons for stopping); all laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma HIV–RNA determinations, and genotype, phenotype, and trophile results. Data on visit frequency, AIDS, and death are acquired from the clinic chart. Data collected using a brief Telephone Audio-Computer Assisted SelfInterview (T–ACASI) survey or an identical web-based Audio-Computer Assisted Self-Interview (ACASI) include: age, sex at birth, use of alcohol and drugs, cigarette smoking, adherence to antiretroviral medications, types of sexual intercourse, condom use, and disclosure of HIV status to partners. We estimate consenting 450 new participants per year across all HOPS study sites (50 participants at each of the eight sites). The consent process takes approximately 15 minutes to complete. Medical record abstractions will be completed on all eligible participants. All eligible participants will be offered the opportunity to participate in an optional short survey that will take approximately seven minutes. Participation of respondents is voluntary. There is no cost to the E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43687-43688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2017-0104; Docket Number NIOSH-304]


Final National Occupational Research Agenda for Traumatic Injury 
Prevention

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: NIOSH announces the availability of the final National 
Occupational Research Agenda for Traumatic Injury Prevention.

DATES: The final document was published on August 20, 2018 on the CDC 
website.

ADDRESSES: The document may be obtained at the following link: https://

[[Page 43688]]

www.cdc.gov/niosh/nora/crosssectors/ti/agenda.html.

FOR FURTHER INFORMATION CONTACT: Emily Novicki, M.A., M.P.H, 
([email protected]), National Institute for Occupational Safety 
and Health, Centers for Disease Control and Prevention, Mailstop E-20, 
1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498-2581 (not a 
toll free number).

SUPPLEMENTARY INFORMATION: On December 7, 2017, NIOSH published a 
request for public review in the Federal Register [82 FR 57758] of the 
draft version of the National Occupational Research Agenda for 
Traumatic Injury Prevention. All comments received were reviewed and 
addressed where appropriate.

    Dated: August 22, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2018-18514 Filed 8-24-18; 8:45 am]
 BILLING CODE 4163-19-P
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