Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(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 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 

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:// 


amozie on DSK3GDR082PROD with NOTICES1
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] 

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; 

(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 

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 


amozie on DSK3GDR082PROD with NOTICES1