Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8203 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–16–1019] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (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. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Integrating Community Pharmacists 

and Clinical Sites for Patient-Centered 

HIV Care (OMB 0920–1019, expires 8/

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 

Medication Therapy Management 

(MTM) is a group of pharmacist 

provided services that is independent 

of, but can occur in conjunction with, 

provision of medication. Medication 

Therapy Management encompasses a 

broad range of professional activities 

and cognitive services within the 

licensed pharmacists’ scope of practice 

and can include monitoring prescription 

filling patterns and timing of refills, 

checking for medication interactions, 

patient education, and monitoring of 

patient response to drug therapy. 

HIV specific MTM programs have 

demonstrated success in improving HIV 

medication therapy adherence and 

persistence. While MTM programs have 

be shown to be effective in increasing 

medication adherence for HIV-infected 

persons, no MTM programs have been 

expanded to incorporate primary 

medical providers in an effort to 

establish patient-centered HIV care. To 

address this problem, CDC has entered 

into a public-private partnership with 

Walgreen Company (a.k.a. Walgreens 

pharmacies, a national retail pharmacy 

chain) to develop and implement a 

model of HIV care that integrates 

community pharmacists with primary 

medical providers for patient-centered 

HIV care. The model program will be 

implemented in ten sites and will 

provide patient-centered HIV care for 

approximately 1,000 persons. 

The patient-centered HIV care model 

will include the core elements of MTM 

as well as additional services such as 

individualized medication adherence 

counseling, active monitoring of 

prescription refills and active 

collaboration between pharmacists and 

medical clinic providers to identify and 

resolve medication related treatment 

problems such as treatment 

effectiveness, adverse events and poor 

adherence. The expected outcomes of 

the model program are increased 

retention in HIV care, adherence to HIV 

medication therapy and viral load 

suppression. 

On May 16, 2014 OMB approved the 

collection of standardized information 

from ten project sites over the three-year 

project period and one retrospective 

data collection during the first year of 

the three-year project period. The 

retrospective data collection will 

provide information about clients’ 

baseline characteristics prior to 

participation in the model program 

which is needed to compare outcomes 

before and after program 

implementation. On August 17, 2015, 

OMB approved the conduct of key 

informant interviews with program 

clinic and pharmacy staff in order to 

evaluate the program processes, 

administration of a staff communication 

questionnaire, and OMB approved the 

collection of time and cost data to be 

used to estimate the cost of the model 

program. 

CDC newly requests approval to 

administer a staff communication 

questionnaire for medical providers in 

order to determine how and if the model 

program improves patient outcomes 

through improved communication and 

collaboration between patients’ clinical 

providers and pharmacists. The staff 

communication questionnaire for 

medical providers will be administered 

twice to program clinic staff. The staff 

communication questionnaire for 

medical providers is different from the 

previously improved staff 

communication questionnaire; the staff 

communication questionnaire for 

medical providers will be administered 

to program clinic staff whereas the staff 

communication questionnaire will be 

administered to program pharmacy staff. 

Pharmacy, laboratory, and medical 

data will be collected through 

abstraction of all participant clients’ 

pharmacy and medical records. 

Pharmacy, laboratory and medical data 

are needed to monitor retention in care, 

adherence to therapy, viral load 

suppression and other health outcomes. 

Program specific data, such as the 

number of MTM elements completed 

per project site and time spent on 

program activities, will be collected by 

program. Qualitative data will be 

gathered from program staff through inperson or telephone interviews and 

through a questionnaire to program 

pharmacy staff and a separate 

questionnaire to program clinic staff. 

The data collection will allow CDC to 

conduct continuous program 

performance monitoring which includes 

identification of barriers to program 

implementation, solutions to those 

barriers, and documentation of client 

health outcomes. Performance 

monitoring will allow the model 

program to be adjusted, as needed, in 

order to develop a final implementation 

model that is self-sustaining and which 

can be used to establish similar 

collaborations in a variety of clinical 

settings. Collection of cost data will 

allow for the cost of the program to be 

estimated. 

There is no cost to participants other 

than their time. The total estimated 

annualized burden hours are 6,043. 

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8204 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Clinic Data Manager ....................................... Project clinic characteristics form .................. 10 3 30/60 

Pharmacist ...................................................... Project pharmacy characteristics form ........... 10 3 30/60 

Clinic Data Manager ....................................... *Patient Demographic Information form ......... 10 100 5/60 

Clinic Data Manager ....................................... *Initial patient information form ...................... 10 100 1 

Clinic Data Manager ....................................... Quarterly patient information form ................. 10 400 30/60 

Pharmacist ...................................................... Pharmacy record abstraction form ................. 10 400 30/60 

Key informants ................................................ Interviewer data collection worksheet ............ 60 2 30/60 

Project staff (pharmacists) .............................. Staff communication questionnaire ................ 30 2 30/60 

Project staff (medical providers) ..................... Staff communication questionnaire for medical providers.40 2 30/60 

Clinic staff ....................................................... Clinic cost form .............................................. 20 2 10 

Pharmacy staff ................................................ Pharmacy cost form ....................................... 20 2 10 

Leroy A. Richardson, 

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. 2016–03304 Filed 2–17–16; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of a New 

Routine Use for a CMS System of 

Records 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Altered System Notice, Adding 

a New Routine Use for a CMS System 

of Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974 

(5 U.S.C. 552a), CMS is adding a new 

routine use to the existing system of 

records titled Enrollment Data Base 

(EDB), System No. 09–70–0502, last 

modified 73 Federal Register 10249 

(February 26, 2008), to assist with 

transmitting data to the Internal 

Revenue Service (IRS) for 10958 

processing. 

The new routine use will authorize 

CMS to disclose information maintained 

in the system ‘‘to the IRS for the 

purposes of reporting Medicare Part A 

enrollment information and to provide 

statements to the individual enrollees 

with respect to whom information is 

reported to the IRS. Disclosures made 

pursuant to the routine use will be 

coordinated through CMS’ Division of 

Medicare Enrollment Coordination, 

Medicare Enrollment and Appeals 

Group, Center for Medicare. 

DATES: Effective Dates: The new routine 

use described in this notice will become 

effective without further notice 30 days 

after publication of this notice in the 

Federal Register, unless comments are 

received that warrant revisions to this 

Notice. Written comments should be 

submitted within 30 days. 

ADDRESSES: The public should address 

comments to: CMS Privacy Officer, 

Division of Security, Privacy Policy and 

Governance, Information Security and 

Privacy Group, Office of Enterprise 

Information, CMS, 7500 Security 

Boulevard, Baltimore, MD 21244–1870, 

Mailstop: N 1–24–08, Office: (410) 786– 

5357 or via email: walter.stone@

cms.hhs.gov. Comments received will be 

available for review at this location, by 

appointment, during regular business 

hours, Monday through Friday from 

9:00 a.m.–3:00 p.m., Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: 

Roland Herrera, Health Insurance 

Specialist, Division of Medicare 

Enrollment Coordination, Medicare 

Enrollment and Appeals Group, CMS 

Center for Medicare, 7500 Security 

Boulevard, Mail Stop C2–12–16, 

Baltimore, MD 21244, Office phone: 

410.786.0668, Facsimile: 443.380.5418, 

Email: roland.herrara@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: CMS is 

required to produce reports and 

statements of enrollment in Medicare 

Part A to confirm enrollment in 

minimum essential coverage under 

Section 6055 of the Affordable Care Act. 

The enrollment information must be 

provided to the IRS for tax 

administration purposes to enable the 

IRS to properly assess tax returns filed 

to ensure that Medicare Part A Enrollees 

are not assessed a tax penalty for not 

beenrolled in health care coverage. 

For the reason explained above, the 

following routine use is added to 

Enrollment Data Base (EDB), System No. 

09–70–0502: 

11. To the IRS for the purposes of reporting 

Medicare Part A enrollment information and 

to provide statements to the individual 

enrollees with respect to whom information 

is reported to the IRS. 

Celeste Dade-Vinson, 

Health Insurance Specialist, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2016–03241 Filed 2–17–16; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Information Collection; New Funding 

Formula for the State Councils on 

Developmental Disabilities (SCDDs) 

and Protection and Advocacy Systems 

(P&As) Located in Each State and 

Territory 

AGENCY: Administration on Intellectual 

and Developmental Disabilities (AIDD), 

Administration on Disabilities (AoD), 

Administration for Community Living 

(ACL), Department of Health and 

Human Services (HHS), HHS. 

ACTION: Notice of guidance. 

SUMMARY: The Administration on 

Intellectual and Developmental 

Disabilities (AIDD) within the 

Administration on Disabilities (AoD), 

located within the Administration for 

Community Living (ACL) at the United 

States Department of Health and Human 

Services (HHS), is soliciting comments 

from the public on the New Funding 

Formula for the State Councils on 

Developmental Disabilities (SCDDs) and 

Protection and Advocacy Systems 

(P&As) located in each State and 

Territory. 

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