Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34135 

Affected Public: Individuals; Business 

or Other For-Profit Institutions; Not-ForProfit Institutions; State or Local 

Government. 

Estimated Annual Number of 

Respondents: 45,000. 

Projected average burden estimates for 

the next three years: 

Average Expected Annual Number of 

Activities: 40. 

Average Number of Respondents per 

Activity: 1,125. 

Responses per Respondent: 1. 

Annual Responses: 45,000. 

Average Minutes per Response: 3 

minutes. 

Annual Burden Hours: 2,250 hours. 

Frequency: On occasion. 

Request for Comments: Agency and 

public comment is again invited 

specifically on the need for and 

practical utility of this information 

collection, the accuracy of OGE’s 

burden estimate, the enhancement of 

quality, utility and clarity of the 

information collected, and the 

minimization of burden (including the 

use of information technology). The 

comments will become a matter of 

public record. 

Approved: July 11, 2018. 

David Apol, 

General Counsel and Acting Director, U.S. 

Office of Government Ethics. 

[FR Doc. 2018–15411 Filed 7–18–18; 8:45 a.m.] 

BILLING CODE 6345–03–P 

GULF COAST ECOSYSTEM 

RESTORATION COUNCIL 

[Docket No.: 107162018–1111–03] 

Notice of Proposed Subaward Under a 

Council-Selected Restoration 

Component Award 

AGENCY: Gulf Coast Ecosystem 

Restoration Council. 

ACTION: Notice. 

SUMMARY: The Gulf Coast Ecosystem 

Restoration Council (RESTORE Council) 

publishes notice of proposed subawards 

from the Mississippi Department of 

Environmental Quality (MDEQ) to the 

Mississippi Wildlife Federation and the 

Partnership for Gulf Coast Land 

Conservation, two Mississippi nonprofit 

organizations, for the purpose of 

education and outreach in accordance 

with the Sea Grant Education and 

Outreach (EOE) Award, as approved in 

the Initial Funded Priority List. 

FOR FURTHER INFORMATION CONTACT: 

Please send questions by email to 

joshua.easton@restorethegulf.gov. 

SUPPLEMENTARY INFORMATION: Section 

1321(t)(2)(E)(ii)(III) of the RESTORE Act 

(33 U.S.C. 1321(t)(2)(E)(ii)(III)) and 

Treasury’s implementing regulation at 

31 CFR 34.401(b) require that, for 

purposes of awards made under the 

Council-Selected Restoration 

Component, a State or Federal award 

recipient may make a grant or subaward 

to or enter into a cooperative agreement 

with a nongovernmental entity that 

equals or exceeds 10 percent of the total 

amount of the award provided to the 

State or Federal award recipient only if 

certain notice requirements are met. 

Specifically, at least 30 days before the 

State or Federal award recipient enters 

into such an agreement, the Council 

must publish in the Federal Register 

and deliver to specified Congressional 

Committees the name of the recipient 

and subrecipient; a brief description of 

the activity, including its purpose; and 

the amount of the award. This notice 

accomplishes the Federal Register 

requirement. 

Description of Proposed Action 

As specified in the Initial Funded 

Priority List, which is available on the 

Council’s website at https://

www.restorethegulf.gov/councilselected-restoration-component/fundedpriorities-list, RESTORE Act funds in 

the amount of $750,000 will support the 

Sea Grant Education and Outreach 

(EOE) Award to MDEQ. As part of this 

project, MDEQ will provide a subaward 

in the amount of $84,150 to the 

Mississippi Wildlife Federation for 

enhancement of the Mississippi Habitat 

Stewards Program. Through the 

subaward, the Mississippi Wildlife 

Federation will expand an existing 

curriculum that relays the ecosystem 

benefits of upstream land conservation, 

habitat restoration and water quality 

restoration. The expanded curriculum 

will be offered for three different 

targeted audiences at different levels: 

Habitat steward volunteers; youth, ages 

9–12; and local high school 

environmental clubs. 

MDEQ will also provide a subaward 

in the amount of $99,050 to the 

Partnership for Gulf Coast Land 

Conservation (PGCLC). The PGCLC will 

conduct an outreach initiative that 

includes three components: The 

development of science-based 

communication products for use with a 

general audience that summarize and 

explain the benefits of land 

conservation in the Gulf coast region in 

lay terminology; field visits that bring 

together stakeholders to illustrate, in the 

field and by boat, the connectivity that 

land conservation practices along our 

coastal streams have to water quality in 

the northern Gulf of Mexico and to our 

marine and estuarine living resources; 

and the development of a short digital 

film that illustrates the connection 

between riparian and wetland forests 

and marine and estuarine living 

resources in the northern Gulf of 

Mexico. 

Keala J. Hughes, 

Director of External Affairs & Tribal Relations, 

Gulf Coast Ecosystem Restoration Council. 

[FR Doc. 2018–15451 Filed 7–18–18; 8:45 am] 

BILLING CODE 6560–58–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substance and 

Disease Registry 

[60Day–18–18AJK Docket No. ATSDR– 

2018–0002] 

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 ‘‘Per- or 

Polyfluoroalkyl Substances (PFAS) 

Exposure Assessments.’’ ATSDR and the 

CDC National Center for Environmental 

Health (NCEH) will conduct a minimum 

of eight exposure assessments (EAs) at 

current or former military installations 

with known PFAS contamination in 

drinking water, groundwater, or another 

water source. 

DATES: ATSDR must receive written 

comments on or before September 17, 

2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. ATSDR–2018– 

0002 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. 


sradovich on DSK3GMQ082PROD with NOTICES
34136 Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 

Instructions: All submissions received 

must include the agency name and 

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 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: omb@cdc.gov. 

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 

Per- or Polyfluoroalkyl Substances 

(PFAS) Exposure Assessments—New— 

Agency for Toxic Substances and 

Disease Registry (ATSDR) and the 

National Center for Environmental 

Health (NCEH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

Per- and polyfluoroalkyl substances 

(PFAS) are a large group of man-made 

chemicals that have been used in 

industry and consumer products 

worldwide since the 1950s. Although 

some PFAS are no longer produced in 

the United States, they many remain in 

the environment and may impact 

people’s health. Thus, PFAS are 

contaminants that have gained national 

prominence over the last decade. 

Under Section 8006 of the 

Consolidated Appropriations Act, 2018, 

the Agency for Toxic Substances and 

Disease Registry and CDC National 

Center for Environmental Health 

(ATSDR/NCEH) are requesting a threeyear Paperwork Reduction Act clearance 

for a new information collection request 

(ICR). ATSDR/NCEH will conduct EAs 

at current or former domestic military 

installations known to have PFAS in 

drinking water, groundwater, or any 

other sources of water. The annualized 

number of EAs assumes the following. 

ATSDR/NCEH will conduct a minimum 

of eight EAs, but ATSDR/NCEH may 

complete an additional seven for a total 

of 15 EAs. Therefore, ATSDR/NCEH 

anticipates conducting five PFAS EAs 

each year for three years. 

All eligible respondents will be 

consented before being included in each 

EA. The consent forms will include 

adult consent, and parental permission 

and child assent forms, as appropriate. 

Each consented respondent will provide 

a serum and a urine sample. In addition, 

heads of households from ten percent of 

households using tap water for their 

drinking water will consent to provide 

tap water and indoor dust samples. The 

consent forms will include permission 

to store some biospecimens and 

environmental samples for future 

analysis and will include permission to 

recontact respondents for potential 

investigations or studies in the future. 

ATSDR will also collect contact 

information to provide respondents 

with their individual sampling results. 

Household Eligibility Screener: 

ATSDR/NCEH will conduct the PFAS 

EAs in communities with populations 

living on or near current or former 

military installations. ATSDR/NCEH 

will recruit a desired sample size of 379 

respondents per EA (1,895 total per 

year) using statistical household 

sampling methods. Eligibility criteria for 

individuals include specific age 

intervals (i.e., children older than three 

years given the lack of NHANES 

comparison data for younger children), 

lack of bleeding disorders that would 

prevent a blood draw, and time of 

residency (i.e., at least one year in the 

home). 

Applying an average U.S. household 

size of 2.5 members, per EA, ATSDR/ 

NCEH will enroll respondents from 152 

eligible households (379/2.5). To 

identify the 152 eligible households, we 

further assume a 65 percent household 

eligibility rate. This will require 

administering a 5-minute eligibility 

screener to 234 heads-of-households per 

EA (152*100/65), or to 1,170 heads-ofhouseholds per year (234 × 5). The 

annual time burden requested for 

eligibility screening is 98 hours. 

Exposure Assessment Questionnaire 

for Biological and Environmental 

Testing for Adults, Parents, or Children: 

ATSDR/NCEH will administer an 

exposure questionnaire to all consented 

respondents that includes questions 

associated with potential exposure to 

PFAS both inside and outside the home 

(e.g., work or school). In addition, the 

adult questionnaire also includes 

several questions associated with water 

use and flooring type while the child 

questionnaire includes questions 

regarding playing in soil; these 

questions are intended to evaluate 

potential exposure and to support the 

environmental testing. The time 

associated with administering the 

questionnaire and completing the 

biological sampling is approximately 30 

minutes for 1,440 adults (720 hours). 

The time associated is 15 minutes for 

264 parents responding for their 

children, 3–11 years old (66 hours), and 

for 191 children, 12–17 years old, who 

respond for themselves (48 hours). 

ATSDR/NCEH will use the 

questionnaire and laboratory results to 

identify likely exposure scenarios. 

Household Recruitment Script for 

Environmental Sampling: The 

households providing environmental 

samples will be randomly selected from 

households that report using tap water 

for drinking water. ATSDR/NCEH will 

recruit 10 percent subset of these 

eligible households to collect tap water 

and indoor dust samples. Assuming a 65 

percent response rate, ATSDR/NCEH 

will administer a 5-minute recruitment 

script to 23 heads-of households who 

are eligible to take part in each EA (152/ 

10*100/65). The time required to 

administer the recruitment script is 5 

minutes. This will result in annual 

recruitment from 117 heads-ofhouseholds and 10 hours for five EAs. 

Environmental Sample Collection 

Form: Again, assuming a 65 percent 

response rate, to meet our sample size 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 139 / Thursday, July 19, 2018 / Notices 34137 

goal of 10 percent of eligible 

households, ATSDR/NCEH will consent 

and collect samples from approximately 

15 households per EA or households 

annually (152*10/100*5). The average 

time burden is estimated as 15 minutes 

per response, or 19 hours annually. 

ATSDR estimates the total annualized 

time burden is 961 hours. Participation 

is voluntary, and there are no costs to 

respondents other than their time. 

Public health professionals, 

environmental risk managers, and other 

decision makers can use EA results to 

make informed decisions about the 

sources and impact of PFAS 

contamination in environmental media 

within their own community and 

jurisdiction. The data will support their 

recommendations for public health 

actions to reduce or eliminate harmful 

levels of PFAS in the local environment. 

These EAs are not intended to yield 

information about PFAS exposure that 

will be generalized beyond the defined 

boundaries of each investigation; 

however, ATSDR/NCEH will use these 

EA findings to inform a future national 

PFAS health study. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Potential EA Heads-of-Households ... Household Eligibility Screener ......... 1,170 1 5/60 98 

EA Adults ........................................... Exposure Questionnaire for Biological and Environmental Testing 

(Adults).

1,440 1 30/60 720 

EA Parents ........................................ EA Questionnaire for Biological 

Testing (Child).

264 1 15/60 66 

EA Children ....................................... EA Questionnaire for Biological 

Testing (Child).

191 1 15/60 48 

EA Heads-of-Households .................. Household Recruitment Script for 

Environmental Sampling.

117 1 5/60 10 

Environmental Sample Collection 

Form.

76 1 15/60 19 

Total ........................................... .......................................................... ........................ ........................ ........................ 961 

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. 2018–15437 Filed 7–18–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1224] 

Use of Electronic Health Record Data 

in Clinical Investigations; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Use of 

Electronic Health Record Data in 

Clinical Investigations.’’ The guidance 

provides recommendations for sponsors, 

clinical investigators, contract research 

organizations (CROs), institutional 

review boards (IRBs), and other 

interested parties on the use of 

electronic health record (EHR) data in 

FDA-regulated clinical investigations. 

The guidance finalizes the draft 

guidance issued in May 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 19, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–1224 for ‘‘Use of Electronic 

Health Record Data in Clinical 

Investigations; Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 


sradovich on DSK3GMQ082PROD with NOTICES