80 FR 43441 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 140 (July 22, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 140 (July 22, 2015)
| Page Range | 43441-43442 | |
| FR Document | 2015-17883 |
[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)] [Notices] [Pages 43441-43442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17883] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than August 21, 2015. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 594- 4306. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Providing Primary Care and Preventive Medical Services in Ryan White-funded Medical Care Settings: OMB No. 0915-XXXX--New. Abstract: Since Congress passed the Ryan White Comprehensive AIDS Resource Emergency (CARE) Act in 1990, the Ryan White HIV/AIDS Program (Ryan White Program) has funded the provision of care eligible to persons living with HIV (PLWH). Many Ryan White-funded clinics have long promoted the medical home model, which involves the provision of comprehensive and coordinated care services, including prevention and other non-medical care services to promote access and adherence to HIV/ AIDS treatment. As PLWH live longer and normal lives with effective antiretroviral treatment, this model has become more complex. In recent years, clinics providing care to PLWH are also seeing their patients develop other common chronic diseases such as diabetes, heart disease, and hypertension associated with normal and aging populations. Guidelines \1\ on primary care for PLWH have recently been released to help providers navigate the integration of primary and preventative care into HIV care. With already limited budgets, staffing and other resources, Ryan White-funded clinics may struggle to provide primary and preventative care services in-house or have insufficient referral systems. However, under the Affordable Care Act (ACA), most PLWH can obtain more affordable health insurance which can alleviate some burden on clinics and improve accessibility to primary and preventative care services. --------------------------------------------------------------------------- \1\ JA Aberg, JE Gallant, KG Ghanem, P Emmanuel, BS Zingman and MA Horberg. Primary Care Guidelines for the Management of Persons Infected with HIV: 2013 Update by the HIV Medicine Association of the Infectious Disease Society of America; CID 201_58 (January 1, 2014). New York State Department of Health AIDS Institute, Office of the Medical Director. Primary Care Approach to the HIV-Infected Patient; http://www.hivguidelines.org/clinical-guidelines/adults/primary-care-approach-to-the-hiv-infected-patient/ (Updated November 2014). --------------------------------------------------------------------------- This study will examine how Ryan White-funded clinics are integrating the provision of primary and preventative care services to the overall HIV care model. Specifically, it will look at the protocols and strategies used by clinics to manage care for PLWH, specifically care coordination, referral systems, and patient-centered strategies to keep PLWH in care. [[Page 43442]] Need and Proposed Use of the Information: The proposed study will provide HRSA HIV/AIDS Bureau (HAB) and policymakers with a better understanding of how the RWHAP currently provides primary and preventative care to PLWH. The first online survey will be targeted to clinic directors from a sample of about 160 Ryan White-funded clinics and will collect data on care models used; primary care services, including preventive services; and coordination of care. Data collected from this survey will provide a general overview of the various HIV care models used as well as insight to possible facilitators and barriers to providing primary and preventative care services. More in- depth data collection will be conducted with a smaller number of 30 clinics representing clinic type (publicly funded community health organization, other community-based organization, health department, and hospital or university-based) and size. There will be three data collection instruments used: (1) An online survey completed by three clinicians at each of the clinics (clinician survey); (2) a data extraction of select primary and preventative care services; and (3) a telephone interview with the medical director. The clinician survey will provide a more in-depth look at the clinic protocols and strategies and how they are being used and implemented by the clinicians. The data extraction will provide quantitative information on the provision of select primary and preventative care services within a certain time period. With these data, the study team can assess the accuracy of information provided in the online surveys on the provision of care as well as the frequency at which primary and preventative care screenings are provided. Lastly, the interviews with the medical director will allow the study team to follow-up on the results of the clinician survey and data extraction and collect qualitative data and more in-depth details on the provision of primary and preventative care services from a clinic wide perspective, specifically any facilitators and barriers. These data will provide HAB the background to make informed policies and changes to the Ryan White Program in this new era when the well-being of PLWH demands a more complex and long-term HIV care model. Likely Respondents: Clinics funded by the Ryan White HIV/AIDS Program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized burden hours: ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Number of Total burden per Total burden respondents responses responses response hours ---------------------------------------------------------------------------------------------------------------- Clinic Director................. 130 1 130 1 130 Clinician....................... 30 1 30 1 30 Data Extraction................. 30 1 30 3 90 Medical Director................ 30 1 30 1 30 ------------------------------------------------------------------------------- Total....................... 220 .............. .............. .............. 280 ---------------------------------------------------------------------------------------------------------------- HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-17883 Filed 7-21-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices 43441
before the committee. Written fda.hhs.gov or 301–796–5966 at least 7 information, please include the
submissions may be made to the contact days in advance of the meeting. information request collection title for
person on or before September 4, 2015. FDA is committed to the orderly reference.
Oral presentations from the public will conduct of its advisory committee Information Collection Request Title:
be scheduled between approximately 9 meetings. Please visit our Web site at Providing Primary Care and Preventive
a.m. and 10 a.m. on September 24, 2015. http://www.fda.gov/ Medical Services in Ryan White-funded
Those individuals interested in making AdvisoryCommittees/AboutAdvisory Medical Care Settings: OMB No. 0915–
formal oral presentations should notify Committees/ucm111462.htm for XXXX—New.
the contact person and submit a brief procedures on public conduct during Abstract: Since Congress passed the
statement of the general nature of the advisory committee meetings. Ryan White Comprehensive AIDS
evidence or arguments they wish to Notice of this meeting is given under Resource Emergency (CARE) Act in
present, the names and addresses of the Federal Advisory Committee Act (5 1990, the Ryan White HIV/AIDS
proposed participants, and an U.S.C. app. 2). Program (Ryan White Program) has
indication of the approximate time Dated: July 17, 2015. funded the provision of care eligible to
requested to make their presentation on persons living with HIV (PLWH). Many
Jill Hartzler Warner,
or before August 24, 2015. Time allotted Ryan White-funded clinics have long
for each presentation may be limited. If Associate Commissioner for Special Medical
Programs. promoted the medical home model,
the number of registrants requesting to which involves the provision of
[FR Doc. 2015–17985 Filed 7–21–15; 8:45 am]
speak is greater than can be reasonably comprehensive and coordinated care
accommodated during the scheduled BILLING CODE 4164–01–P
services, including prevention and other
open public hearing session, FDA may non-medical care services to promote
conduct a lottery to determine the access and adherence to HIV/AIDS
speakers for the scheduled open public DEPARTMENT OF HEALTH AND
HUMAN SERVICES treatment. As PLWH live longer and
hearing session. The contact person will normal lives with effective antiretroviral
notify interested persons regarding their Health Resources and Services treatment, this model has become more
request to speak by August 28, 2015. Administration complex. In recent years, clinics
FDA is opening a docket for public
providing care to PLWH are also seeing
comment on this document. The docket Agency Information Collection their patients develop other common
will close on October 24, 2015. Activities: Proposed Collection: Public chronic diseases such as diabetes, heart
Interested persons are encouraged to use Comment Request disease, and hypertension associated
the docket to submit electronic or
AGENCY: Health Resources and Services with normal and aging populations.
written comments regarding this
Administration, Department of Health Guidelines 1 on primary care for PLWH
meeting. Comments received on or
and Human Services. have recently been released to help
before August 31, 2015, will be
providers navigate the integration of
provided to the committee. Comments ACTION: Notice.
received after that date will be taken primary and preventative care into HIV
into consideration by the Agency. SUMMARY: In compliance with the care. With already limited budgets,
Submit electronic comments to http:// requirement for opportunity for public staffing and other resources, Ryan
www.regulations.gov. Submit written comment on proposed data collection White-funded clinics may struggle to
comments to the Division of Dockets projects (section 3506(c)(2)(A) of the provide primary and preventative care
Management, Food and Drug Paperwork Reduction Act of 1995), the services in-house or have insufficient
Administration, 5630 Fishers Lane, rm. Health Resources and Services referral systems. However, under the
1061, Rockville, MD 20852. Submit a Administration (HRSA) announces Affordable Care Act (ACA), most PLWH
single copy of electronic comments or plans to submit an Information can obtain more affordable health
two paper copies of any mailed Collection Request (ICR), described insurance which can alleviate some
comments. Comments are to be below, to the Office of Management and burden on clinics and improve
identified with the docket number Budget (OMB). Prior to submitting the accessibility to primary and
found in brackets in the heading of this ICR to OMB, HRSA seeks comments preventative care services.
document. Received comments may be from the public regarding the burden This study will examine how Ryan
seen in the Divisions of Dockets estimate, below, or any other aspect of White-funded clinics are integrating the
Management between 9 a.m. and 4 p.m., the ICR. provision of primary and preventative
Monday through Friday, and will be DATES: Comments on this Information
care services to the overall HIV care
posted to the docket at http:// Collection Request must be received no model. Specifically, it will look at the
www.regulations.gov. later than August 21, 2015. protocols and strategies used by clinics
For press inquiries, please contact the to manage care for PLWH, specifically
ADDRESSES: Submit your comments,
Office of Media Affairs at fdaoma@ care coordination, referral systems, and
including the Information Collection patient-centered strategies to keep
fda.hhs.gov or 301–796–4540.
Request Title, to the desk officer for PLWH in care.
Persons attending FDA’s advisory
HRSA, either by email to OIRA_
committee meetings are advised that the
submission@omb.eop.gov or by fax to
Agency is not responsible for providing 1 JA Aberg, JE Gallant, KG Ghanem, P Emmanuel,
202–395–5806. BS Zingman and MA Horberg. Primary Care
access to electrical outlets.
FDA welcomes the attendance of the FOR FURTHER INFORMATION CONTACT: To Guidelines for the Management of Persons Infected
request a copy of the clearance requests with HIV: 2013 Update by the HIV Medicine
tkelley on DSK3SPTVN1PROD with NOTICES
public at its advisory committee Association of the Infectious Disease Society of
meetings and will make every effort to submitted to OMB for review, email the America; CID 201_58 (January 1, 2014).
accommodate persons with physical HRSA Information Collection Clearance New York State Department of Health AIDS
disabilities or special needs. If you Officer at paperwork@hrsa.gov or call Institute, Office of the Medical Director. Primary
(301) 594–4306. Care Approach to the HIV-Infected Patient; http://
require special accommodations due to www.hivguidelines.org/clinical-guidelines/adults/
a disability, please contact Ann Marie SUPPLEMENTARY INFORMATION: When primary-care-approach-to-the-hiv-infected-patient/
Williams, at AnnMarie.Williams@ submitting comments or requesting (Updated November 2014).
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![43442 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices
Need and Proposed Use of the (clinician survey); (2) a data extraction and changes to the Ryan White Program
Information: The proposed study will of select primary and preventative care in this new era when the well-being of
provide HRSA HIV/AIDS Bureau (HAB) services; and (3) a telephone interview PLWH demands a more complex and
and policymakers with a better with the medical director. The clinician long-term HIV care model.
understanding of how the RWHAP survey will provide a more in-depth Likely Respondents: Clinics funded by
currently provides primary and look at the clinic protocols and the Ryan White HIV/AIDS Program.
preventative care to PLWH. The first strategies and how they are being used Burden Statement: Burden in this
online survey will be targeted to clinic and implemented by the clinicians. The context means the time expended by
directors from a sample of about 160 data extraction will provide quantitative persons to generate, maintain, retain,
Ryan White-funded clinics and will information on the provision of select disclose or provide the information
collect data on care models used; primary and preventative care services requested. This includes the time
primary care services, including within a certain time period. With these needed to review instructions; to
preventive services; and coordination of data, the study team can assess the develop, acquire, install and utilize
care. Data collected from this survey accuracy of information provided in the technology and systems for the purpose
will provide a general overview of the online surveys on the provision of care of collecting, validating and verifying
various HIV care models used as well as as well as the frequency at which information, processing and
insight to possible facilitators and primary and preventative care maintaining information, and disclosing
barriers to providing primary and screenings are provided. Lastly, the and providing information; to train
preventative care services. More in- interviews with the medical director personnel and to be able to respond to
depth data collection will be conducted will allow the study team to follow-up a collection of information; to search
with a smaller number of 30 clinics on the results of the clinician survey data sources; to complete and review
representing clinic type (publicly and data extraction and collect the collection of information; and to
funded community health organization, qualitative data and more in-depth transmit or otherwise disclose the
other community-based organization, details on the provision of primary and information. The total annual burden
health department, and hospital or preventative care services from a clinic hours estimated for this Information
university-based) and size. There will be wide perspective, specifically any Collection Request are summarized in
three data collection instruments used: facilitators and barriers. the table below.
(1) An online survey completed by three These data will provide HAB the Total Estimated Annualized burden
clinicians at each of the clinics background to make informed policies hours:
Average Total
Number of Number of Total
Form name burden per burden
respondents responses responses response hours
Clinic Director ....................................................................... 130 1 130 1 130
Clinician ................................................................................ 30 1 30 1 30
Data Extraction .................................................................... 30 1 30 3 90
Medical Director ................................................................... 30 1 30 1 30
Total .............................................................................. 220 ........................ ........................ ........................ 280
HRSA specifically requests comments DEPARTMENT OF HEALTH AND AIDS Training and Capacity
on (1) the necessity and utility of the HUMAN SERVICES Development (RVT); (3) abolishes the
proposed information collection for the Division of HIV/AIDS Training and
proper performance of the agency’s Health Resources and Services Capacity Development (RV7); (4)
functions, (2) the accuracy of the Administration establishes the Division of Domestic
estimated burden, (3) ways to enhance Programs (RVT1), and; (5) establishes
Statement of Organization, Functions the Division of Global Programs (RVT2).
the quality, utility, and clarity of the
and Delegations of Authority
information to be collected, and (4) the Chapter RV—HIV/AIDS Bureau
use of automated collection techniques This notice amends Part R of the
or other forms of information Statement of Organization, Functions Section RV–10, Organization
technology to minimize the information and Delegations of Authority of the Delete the organization for the HIV/
collection burden. Department of Health and Human AIDS Bureau (RV) in its entirety and
Services (HHS), Health Resources and replace with the following:
Jackie Painter, Services Administration (HRSA) (60 FR The HIVAIDS Bureau (RV) is headed
Director, Division of the Executive Secretariat. 56605, as amended November 6, 1995; by the Associate Administrator, who
[FR Doc. 2015–17883 Filed 7–21–15; 8:45 am] as last amended at 80 FR 37639–37640 reports directly to the Administrator,
BILLING CODE 4165–15–P dated July 1, 2015). Health Resources and Services
This notice reflects organizational Administration. The HIV/AIDS Bureau
changes in the Health Resources and includes the following components:
Services Administration (HRSA), HIV/
(1) Office of the Associate
tkelley on DSK3SPTVN1PROD with NOTICES
AIDS Bureau (RV). Specifically, this
notice: (1) Establishes the Office of HIV/ Administrator (RV);
AIDS Training and Capacity (2) Office of Operations and
Development (RVT); (2) transfers the Management (RV2);
Division of HIV/AIDS Training and (3) Division of Policy and Data (RVA);
Capacity Development (RV7) function to (4) Division of Metropolitan HIV/
the newly established Office of HIV/ AIDS Programs (RV5);
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Document Created: 2015-12-15 12:55:13
Document Modified: 2015-12-15 12:55:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this Information Collection Request must be received no later than August 21, 2015. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 594- 4306. | |
| FR Citation | 80 FR 43441 |
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