Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28233 

practice. This study aligns with 

National HIV/AIDS Strategy 2020 and 

Healthy People 2020 objectives of 

reducing new HIV infections, increasing 

access to care and improving health 

outcomes for people living with HIV, 

and reducing HIV-related health 

disparities. This study also aligns with 

the Office of Management and Budget’s 

emphasis on application of behavioral 

insights in that it restructures the 

context (i.e., after HIV testing) in which 

health-related decision-making (i.e., 

health insurance enrollment) occurs in 

order to promote the selection of 

beneficial options (i.e., attending HIVrelated medical care appointments). 

This proposed health insurance 

enrollment assistance study has the 

potential for widespread health 

improvements for Black and Hispanic 

MSM and transgender persons 

regardless of their HIV status. 

At this time, CDC is not partnering 

with other HHS agencies for this study. 

However, we have discussed the study 

with HRSA/HAB and HHS/OD, and 

plan to apprise CMS and HRSA of the 

project before implementation and 

invite CMS and HRSA representatives to 

serve as consultants. HHS may also 

direct us to the CMS regional officer for 

Chicago, Illinois. Additionally, there is 

the potential to have CMS grantee 

navigators supplement partner agency 

navigators during outreach HIV testing 

events. For this study, CDC is not 

engaged in research, and therefore not 

involved in data collection activities. 

The grantee is responsible for 

implementing the intervention and 

collecting data from the proposed 1,000 

participants. Thus, CDC will not need 

an interagency data-sharing agreement if 

we do consult with HRSA or CMS. 

The study will enroll 1,000 

participants over 12 months to reach 

adequate power calculations (500 into 

the intervention arm, and 500 into the 

control arm). Approximately 1,500 

individuals will need to be screened to 

identify and enroll 1,000 eligible study 

participants. After an HIV testing 

session at an outreach event or clinic 

visit, partner agency staff will invite 

individuals to participate in the study. 

If individuals are interested, staff will 

screen individuals for eligibility using 

the Participant Eligibility Form 

(Attachment 5) which will take 

approximately 5 minutes to complete. If 

they are determined eligible to 

participate, and still interested in 

participating, the individual will 

complete an Informed Consent Form 

(Attachment 6), which will take 

approximately 10 minutes to complete, 

and the Participant Enrollment Form 

(Attachment 7), which will take 

approximately 35 minutes to complete. 

The total estimated annualized hourly 

burden anticipated for this study is 875 

hours. There is no cost to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Study participant ............................................. Participant Eligibility Form (Att 5) .................. 1,500 1 5/60 

Study participant ............................................. Informed Consent Form (Att 6) ...................... 1,000 1 10/60 

Study participant ............................................. Participant Enrollment Form (Att 7) ............... 1,000 1 35/60 

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. 2018–12971 Filed 6–15–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–0530] 

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 Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(EEOICPA) Dose Reconstruction 

Interviews and Forms 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 February 

20, 2018 to obtain comments from the 

public and affected agencies. CDC did 

not receive 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 

EEOICPA Dose Reconstruction 

Interviews and Forms, OMB No. 0920– 

0530, expires 04/30/2018— 

Reinstatement without change— 

National Institute for Occupational 

Safety and Health (NIOSH), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

On October 30, 2000, the Energy 

Employees Occupational Illness 


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28234 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

Compensation Program Act of 2000 (42 

U.S.C. 7384–7385) was enacted. This 

Act established a federal compensation 

program for employees of the 

Department of Energy (DOE) and certain 

of its contractors, subcontractors and 

vendors, who have suffered cancers and 

other designated illnesses as a result of 

exposures sustained in the production 

and testing of nuclear weapons. 

Executive Order 13179, issued on 

December 7, 2000, delegated authorities 

assigned to ‘‘the President’’ under the 

Act to the Departments of Labor, Health 

and Human Services, Energy and 

Justice. The Department of Health and 

Human Services (DHHS) was delegated 

the responsibility of establishing 

methods for estimating radiation doses 

received by eligible claimants with 

cancer applying for compensation. 

NIOSH is applying the following 

methods to estimate the radiation doses 

of individuals applying for 

compensation. 

In performance of its dose 

reconstruction responsibilities, under 

the Act, NIOSH is providing voluntary 

interview opportunities to claimants (or 

their survivors) individually and 

providing them with the opportunity to 

assist NIOSH in documenting the work 

history of the employee by 

characterizing the actual work tasks 

performed. In addition, NIOSH and the 

claimant may identify incidents that 

may have resulted in undocumented 

radiation exposures, characterizing 

radiological protection and monitoring 

practices, and identify co-workers and 

other witnesses as may be necessary to 

confirm undocumented information. In 

this process, NIOSH uses a computer 

assisted telephone interview (CATI) 

system, which allows interviews to be 

conducted more efficiently and quickly 

as opposed to a paper-based interview 

instrument. Both interviews are 

voluntary and failure to participate in 

either or both interviews will not have 

a negative effect on the claim, although 

voluntary participation may assist the 

claimant by adding important 

information that may not be otherwise 

available. 

There are no changes to the questions 

contained in the package, or the 

estimated burden hours. This 

Information Collection Request (ICR) is 

being submitted as a reinstatement 

because the previous ICR expired on 

April 30, 2018 and the updated ICR was 

not submitted before the expiration 

date. NIOSH uses the data collected in 

this process to complete an individual 

dose reconstruction that accounts, as 

fully as possible, for the radiation dose 

incurred by the employee in the line of 

duty for DOE nuclear weapons 

production programs. After dose 

reconstruction, NIOSH also performs a 

brief, voluntary final interview with the 

claimant to explain the results and to 

allow the claimant to confirm or 

question the records NIOSH has 

compiled. This will also be the final 

opportunity for the claimant to 

supplement the dose reconstruction 

record. 

At the conclusion of the dose 

reconstruction process, the claimant 

submits a form to confirm that the 

claimant has no further information to 

provide to NIOSH about the claim at 

this time. The form notifies the claimant 

that signing the form allows NIOSH to 

forward a dose reconstruction report to 

DOL and to the claimant, and closes the 

record on data used for the dose 

reconstruction. Signing this form does 

not indicate that the claimant agrees 

with the outcome of the dose 

reconstruction. The dose reconstruction 

results will be supplied to the claimant 

and to the DOL, the agency that will 

utilize them as one part of its 

determination of whether the claimant 

is eligible for compensation under the 

Act. 

Total annualized burden is estimated 

to be 3900 hours. There is no cost to 

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) 

Claimant .......................................................... Initial Interview ............................................... 3,600 1 1 

Claimant .......................................................... Conclusion form OCAS–1 .............................. 3,600 1 5/60 

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. 2018–12972 Filed 6–15–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0286] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Formal Meetings Between the 

Food and Drug Administration and 

Biosimilar Biological Product 

Sponsors or Applicants 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on formal meetings 

between FDA and biosimilar biological 

product sponsors or applicants. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 17, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 17, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 


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