76576 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

RFA–CK–21–001, US Travelers Health 

Research, Surveillance, 

Communication, and Outreach 

Network; RFA–CK–21–002, Emerging 

Infections Network—Research for 

Preventing, Detecting, and Managing 

Travelers who Acquire Infectious 

Diseases Abroad; and RFA–CK–21–003, 

Monitoring Cause-specific School 

Absenteeism for Estimating Communitywide Influenza and SARS-CoV–2 

Transmission. 

Date: February 10–11, 2021. 

Time: 10:00 a.m.–5:00 p.m., EST. 

Place: Teleconference, Centers for 

Disease Control and Prevention, Room 

1080, 8 Corporate Square Boulevard, 

Atlanta, GA 30329. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Gregory Anderson, M.S., M.P.H., 

Scientific Review Officer, CDC, 1600 

Clifton Road NE, Mailstop US8–1, 

Atlanta, Georgia 30329–4027, (404) 718– 

8833, GAnderson@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–26258 Filed 11–27–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Solicitation of Nominations for 

Appointment to the Clinical Laboratory 

Improvement Advisory Committee 

(CLIAC) 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) is seeking 

nominations for membership on the 

CLIAC. The CLIAC consists of 20 

experts including the Chair who 

represents a diverse membership across 

laboratory specialties, professional roles 

(laboratory management, technical 

specialists, physicians, nurses) and 

practice settings (academic, clinical, 

public health), and includes a consumer 

representative. 

DATES: Nominations for membership on 

the CLIAC must be received no later 

than March 1, 2021. Packages received 

after this time will not be considered for 

the current membership cycle. 

ADDRESSES: All nominations should be 

mailed to Nancy Anderson, MMSc, 

MT(ASCP), CLIAC Secretary, Senior 

Advisor for Clinical Laboratories, 

Division of Laboratory Systems, Center 

for Surveillance, Epidemiology and 

Laboratory Services, Office of Public 

Health Scientific Services, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, Mailstop V24–3, 

Atlanta, Georgia 30329–4018; telephone 

(404) 498–2741; or via email at CLIAC@

cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Heather Stang, MS, Deputy Branch 

Chief, Quality and Safety Systems 

Branch, Division of Laboratory Systems, 

Center for Surveillance, Epidemiology 

and Laboratory Services, Office of 

Public Health Scientific Services, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE, 

Mailstop V24–3, Atlanta, Georgia 

30329–4018; telephone (404) 498–2769; 

HStang@cdc.gov. 

SUPPLEMENTARY INFORMATION: The 

Committee also includes three ex officio 

members (or designees), including the 

Director, CDC; the Administrator, 

Centers for Medicare and Medicaid 

Services (CMS); and the Commissioner, 

Food and Drug Administration (FDA). A 

nonvoting representative from the 

Advanced Medical Technology 

Association (AdvaMed) serves as the 

industry liaison. The Designated Federal 

Official (DFO) or their designee and the 

Executive Secretary are present at all 

meetings to ensure meetings are within 

applicable statutory, regulatory, and 

HHS General Administration manual 

directives. 

Nominations are being sought for 

individuals who have the expertise and 

qualifications necessary to contribute to 

the accomplishments of the committee’s 

objectives. Nominees will be selected 

based on expertise in the fields of 

microbiology (including bacteriology, 

mycobacteriology, mycology, 

parasitology, and virology), immunology 

(including histocompatibility), 

chemistry, hematology, pathology 

(including histopathology and cytology), 

or genetic testing (including 

cytogenetics); from representatives in 

the fields of medical technology, 

bioinformatics, public health, and 

clinical practice; and from consumer 

representatives. Federal employees will 

not be considered for membership. 

Members may be invited to serve for up 

to four-year terms. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of CLIAC 

objectives (https://www.cdc.gov/cliac/). 

The U.S. Department of Health and 

Human Services policy stipulates that 

committee membership be balanced in 

terms of points of view represented, and 

the committee’s function. Appointments 

shall be made without discrimination 

on the basis of age, race, ethnicity, 

gender, sexual orientation, gender 

identity, HIV status, disability, and 

cultural, religious, or socioeconomic 

status. Nominees must be U.S. citizens, 

and cannot be full-time employees of 

the U.S. Government. Current 

participation on federal workgroups or 

prior experience serving on a federal 

advisory committee does not disqualify 

a candidate; however, HHS policy is to 

avoid excessive individual service on 

advisory committees and multiple 

committee memberships. Committee 

members are Special Government 

Employees (SGEs), requiring the filing 

of financial disclosure reports at the 

beginning and annually during their 

terms. CDC reviews potential candidates 

for CLIAC membership each year and 

provides a slate of nominees for 

consideration to the Secretary of HHS 

for final selection. HHS notifies selected 

candidates of their appointment near 

the start of the term in July, or as soon 

as the HHS selection process is 

completed. Note that the need for 

different expertise varies from year to 

year and a candidate who is not selected 

in one year may be reconsidered in a 

subsequent year. Candidates should 

submit the following items: 

■ Current curriculum vitae, including 

complete contact information 

(telephone numbers, mailing address, 

email address) 

■ At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. 

(Candidates may submit letter(s) from 

current HHS employees if they wish, 

but at least one letter must be submitted 

by a person not employed by an HHS 

agency (e.g., CDC, NIH, FDA, etc.). 

Nominations may be submitted by the 

candidate, or by the person/organization 

recommending the candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76577 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–26257 Filed 11–27–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifiers: CMS–304/–304a, 

CMS–367a—d, and CMS–368/–R–144] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare and 

Medicaid Services, Health and Human 

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 

January 29, 2021. 

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 llll, 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 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html 

2. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

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–304/–304a Reconciliation of 

State Invoice (ROSI) and Prior Quarter 

Adjustment Statement (PQAS) 

CMS–367a–d Medicaid Drug Rebate 

Program Labeler Reporting Format 

CMS–368/–R–144 Medicaid Drug 

Rebate Program State Reporting Forms 

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: Reconciliation 

of State Invoice (ROSI) and Prior 

Quarter Adjustment Statement (PQAS); 

Use: Form CMS–304 (ROSI) is used by 

manufacturers to respond to the state’s 

rebate invoice for current quarter 

utilization. Form CMS–304a (PQAS) is 

required only in those instances where 

a change to the original rebate data 

submittal is necessary. Effective July 1, 

2021, the Medicaid Drug Rebate 

Program (MDRP) is updating to a new 

Medicaid Drug Programs (MDP) system 

which will now accept a delimited text 

file format, Comma Separated Values 

(.CSV), in addition to the current Text 

(.TXT) file format. We have also 

increased several file format data field 

sizes in order to accommodate the 

higher priced drugs that are entering the 

market. These changes in conjunction 

with numerous edits to verbiage are 

applicable to Forms CMS–304 and 

–304a. Separately, we are also updating 

corresponding collection of information 

requests (OMB 0938–0578 and OMB 

0938–0582) so that all the MDP file 

formats, field sizes, and verbiage will 

align across the MDRP. Form Number: 

CMS–304 and –304a (OMB control 

number: 0938–0676); Frequency: 

Quarterly; Affected Public: Private 

sector (Business or other for-profits); 

Number of Respondents: 749; Total 

Annual Responses: 5,841; Total Annual 

Hours: 248,584. (For policy questions 

regarding this collection contact Andrea 

Wellington at 410–786–3490.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid Drug 

Rebate Program Labeler Reporting 

Format; Use: Labelers transmit drug 

product and pricing data to CMS within 

30 days after the end of each calendar 

month and quarter. CMS calculates the 

unit rebate amount (URA) and the unit 

rebate offset amount (UROA) for each 

new drug application (NDC) and 

distributes to all State Medicaid 

agencies. States use the URA to invoice 

the labeler for rebates and the UROA to 

report onto CMS–64. The monthly data 

is used to calculate Federal Upper Limit 

(FUL) prices for applicable drugs and 

for states that opt to use this data to 

establish their pharmacy reimbursement 

methodology. Effective July 1, 2021, the 

MDRP is updating to a new Medicaid 

Drug Programs (MDP) system which 

will now accept a delimited text file 

format, Comma Separated Values 

(.CSV), in addition to the current Text 


TKELLEY on DSKBCP9HB2PROD with NOTICES