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
Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Notices 43689 

respondents other than their time. The 

estimated annual burden hours are 405. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

HOPS study Patients ...................................... Behavioral survey (att 3a,b,9) ........................ 2,500 1 7/60 

HOPS Study Patients ..................................... Consent form (att 4) ....................................... 450 1 15/60 

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. 2018–18445 Filed 8–24–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10137 and CMS– 

10237] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

October 26, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ___, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–1326. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10137 Solicitation for 

Applications for Medicare 

Prescription Drug Plan 2020 Contracts 

CMS–10237 Medicare Advantage 

Application—Part C and 1876 Cost 

Plan Expansion Application 

Regulations under 42 CFR 422 

(Subpart K) & 417.400 

Under the 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. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2020 Contracts; Use: Coverage 

for the prescription drug benefit is 

provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 


amozie on DSK3GDR082PROD with NOTICES1