81 FR 11815 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 44 (March 7, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11815-11816 | |
| FR Document | 2016-04984 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Pages 11815-11816] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04984] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email [email protected] or call the HRSA Reports Clearance Office at (301) 443-1984. DATES: Deadline: Comments on this ICR should be received no later than April 6, 2016. ADDRESSES: Submit your comments to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806. Please direct all correspondence to the ``attention of the desk officer for HRSA.'' SUPPLEMENTARY INFORMATION: Information Collection Request Title: Health Center Controlled Networks (OMB No. 0915-0360) Extension. Abstract: One goal of the Health Resources and Services Administration (HRSA) is to ensure that all Health Center Program grantees effectively implement health information technology (HIT) systems that enable all providers to adopt and implement HIT, including Electronic Health Records (EHRs); to become meaningful users of EHRs and use HIT systems to increase access to care, improve quality of care, and reduce the costs of care delivered. [[Page 11816]] The Health Center Controlled Network (HCCN) Program serves as a major component of HRSA's HIT initiative to support these goals. The HCCN model focuses on the integration of certain functions and the sharing of skills, resources, and data to improve health center operations and care provision, and generating efficiencies and economies of scale. Through this grant, HCCNs will provide support for the adoption and implementation of HIT, including meaningful use of EHRs, to improve the quality of care provided by existing Health Center Program grantees (i.e., Section 330 funded health centers) by engaging in the following program components:Adoption and Implementation: Assist participating health centers with effectively adopting and implementing certified EHR technology. Meaningful Use: Support participating health centers in meeting Meaningful Use requirements and accessing incentive payments under the Medicare and Medicaid Electronic Health Records Incentive Programs. Quality Improvement (QI): Advance participating health centers' QI initiatives to improve clinical and operational quality, including their obtaining of Patient Centered Medical Home (PCMH) recognition. HRSA collects and evaluates network outcome measures. HRSA requires that HCCNs report such measures to HRSA in annual work plan updates as part of their annual, non-competing continuation progress reports through an electronic reporting system. The work plan includes information on grantees' plans and progress on the following: Adoption and Implementation of HIT (including EHR); Attainment of Meaningful Use Requirements; and Improvement of quality measures (e.g., Healthy People 2020 clinical quality measures, PCMH recognition status, etc.). The annual, non-competing continuation progress reports describe each grantee's progress in achieving key activity goals such as quality improvement, data access and exchange, efficiency and effectiveness of network services, and the ability to track and monitor patient outcomes, as well as emerging needs, challenges and barriers encountered customer satisfaction, and plans to meet goals for the next year. Grantees submit their work plan updates and annual, non-competing continuation progress reports each fiscal year of the grant; the submission and subsequent HRSA approval of each report triggers the budget period renewal and release of each subsequent year of funding. 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 ICR are summarized in the table below. The annual estimate of burden is as follows: ---------------------------------------------------------------------------------------------------------------- Number of Responses per Total Hours per Total burden Form name respondents respondent responses response hours ---------------------------------------------------------------------------------------------------------------- Work Plan Update............... 43 1 43 10.9 468.7 Annual Progress Report......... 43 1 43 44.5 1913.5 -------------------------------------------------------------------------------- Total...................... 86 ............... .............. .............. 2382.2 ---------------------------------------------------------------------------------------------------------------- Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2016-04984 Filed 3-4-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices 11815
DEPARTMENT OF HEALTH AND presence of good bone stock along with public conduct during advisory
HUMAN SERVICES the following clinical conditions: hallux committee meetings.
valgus or hallux limitus, hallux rigidus, Notice of this meeting is given under
Food and Drug Administration and an unstable or painful the Federal Advisory Committee Act (5
metatarsophalangeal joint. U.S.C. app. 2).
[Docket No. FDA–2016–N–0001]
FDA intends to make background Dated: February 29, 2016.
Orthopaedic and Rehabilitation material available to the public no later Jill Hartzler Warner,
Devices Panel of the Medical Devices than 2 business days before the meeting.
Associate Commissioner for Special Medical
Advisory Committee; Notice of Meeting If FDA is unable to post the background Programs.
material on its Web site prior to the
[FR Doc. 2016–04927 Filed 3–4–16; 8:45 am]
AGENCY: Food and Drug Administration, meeting, the background material will
HHS. BILLING CODE 4164–01–P
be made publicly available at the
ACTION: Notice. location of the advisory committee
meeting, and the background material DEPARTMENT OF HEALTH AND
This notice announces a forthcoming will be posted on FDA’s Web site after
meeting of a public advisory committee HUMAN SERVICES
the meeting. Background material is
of the Food and Drug Administration available at http://www.fda.gov/ Health Resources and Services
(FDA). The meeting will be open to the AdvisoryCommittees/Calendar/ Administration
public. default.htm. Scroll down to the
Name of Committee: Orthopaedic and appropriate advisory committee meeting Agency Information Collection
Rehabilitation Devices Panel of the link. Activities: Submission to OMB for
Medical Devices Advisory Committee. Procedure: Interested persons may Review and Approval; Public Comment
General Function of the Committee: present data, information, or views, Request
To provide advice and orally or in writing, on issues pending
recommendations to the Agency on before the committee. Written ACTION: Notice.
FDA’s regulatory issues. submissions may be made to the contact
Date and Time: The meeting will be SUMMARY: In compliance with section
person on or before April 13, 2016. Oral
held on Wednesday, April 20, 2016, 3506(c)(2)(A) of the Paperwork
presentations from the public will be
from 8 a.m. to 6 p.m. Reduction Act of 1995 (44 U.S.C.
scheduled between approximately 1
Location: Hilton Washington, DC/ Chapter 35), the Health Resources and
p.m. and 2 p.m. Those individuals
North, Salons A, B, C, and D, 620 Perry Services Administration (HRSA) will
interested in making formal oral
Pkwy., Gaithersburg, MD 20877. The submit an Information Collection
presentations should notify the contact
hotel telephone number is 301–977– Request (ICR) to the Office of
person and submit a brief statement of
8900. Management and Budget (OMB).
the general nature of the evidence or
Contact Person: S.J. Anderson, Center Comments submitted during the first
arguments they wish to present, the
for Devices and Radiological Health, public review of this ICR will be
names and addresses of proposed
Food and Drug Administration, Bldg. provided to OMB. OMB will accept
participants, and an indication of the
66, rm. 1643, 10903 New Hampshire further comments from the public
approximate time requested to make
Ave., Silver Spring, MD 20993, email: during the review and approval period.
their presentation on or before April 5,
Sara.Anderson@fda.hhs.gov, 301 796– To request a copy of the clearance
2016. Time allotted for each
7047, or FDA Advisory Committee requests submitted to OMB for review,
presentation may be limited. If the
Information Line, 1–800–741–8138 number of registrants requesting to email paperwork@hrsa.gov or call the
(301–443–0572 in the Washington, DC speak is greater than can be reasonably HRSA Reports Clearance Office at (301)
area). A notice in the Federal Register accommodated during the scheduled 443–1984.
about last minute modifications that open public hearing session, FDA may DATES: Deadline: Comments on this ICR
impact a previously announced conduct a lottery to determine the should be received no later than April
advisory committee meeting cannot speakers for the scheduled open public 6, 2016.
always be published quickly enough to hearing session. The contact person will ADDRESSES: Submit your comments to
provide timely notice. Therefore, you notify interested persons regarding their the desk officer for HRSA, either by
should always check the Agency’s Web request to speak by April 6, 2016. email to OIRA_submission@
site at http://www.fda.gov/ Persons attending FDA’s advisory omb.eop.gov or by fax to 202–395–5806.
AdvisoryCommittees/default.htm and committee meetings are advised that the Please direct all correspondence to the
scroll down to the appropriate advisory Agency is not responsible for providing ‘‘attention of the desk officer for HRSA.’’
committee meeting link, or call the access to electrical outlets. SUPPLEMENTARY INFORMATION:
advisory committee information line to FDA welcomes the attendance of the Information Collection Request Title:
learn about possible modifications public at its advisory committee Health Center Controlled Networks
before coming to the meeting. meetings and will make every effort to (OMB No. 0915–0360) Extension.
Agenda: The Committee will discuss, accommodate persons with disabilities. Abstract: One goal of the Health
make recommendations, and vote on the If you require accommodations due to a Resources and Services Administration
premarket approval application for the disability, please contact AnnMarie (HRSA) is to ensure that all Health
Cartiva Synthetic Cartilage Implant Williams at 301–796–5966 at least 7 Center Program grantees effectively
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(SCI), sponsored by Cartiva, Inc. The days in advance of the meeting. implement health information
Cartiva Synthetic Cartilage Implant FDA is committed to the orderly technology (HIT) systems that enable all
(SCI) is an organic polymer-based conduct of its advisory committee providers to adopt and implement HIT,
biomaterial to mimic biologic cartilage. meetings. Please visit our Web site at including Electronic Health Records
The device is to be indicated for http://www.fda.gov/ (EHRs); to become meaningful users of
treatment of degenerative and post- AdvisoryCommittees/ EHRs and use HIT systems to increase
traumatic arthritis in the first AboutAdvisoryCommittees/ access to care, improve quality of care,
metatarsophalangeal joint in the ucm111462.htm for procedures on and reduce the costs of care delivered.
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![11816 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
The Health Center Controlled Network operational quality, including their plans to meet goals for the next year.
(HCCN) Program serves as a major obtaining of Patient Centered Medical Grantees submit their work plan
component of HRSA’s HIT initiative to Home (PCMH) recognition. updates and annual, non-competing
support these goals. The HCCN model HRSA collects and evaluates network continuation progress reports each fiscal
focuses on the integration of certain outcome measures. HRSA requires that year of the grant; the submission and
functions and the sharing of skills, HCCNs report such measures to HRSA subsequent HRSA approval of each
resources, and data to improve health in annual work plan updates as part of report triggers the budget period
center operations and care provision, their annual, non-competing renewal and release of each subsequent
and generating efficiencies and continuation progress reports through year of funding.
economies of scale. Through this grant, an electronic reporting system. The Burden Statement: Burden in this
HCCNs will provide support for the work plan includes information on context means the time expended by
adoption and implementation of HIT, grantees’ plans and progress on the persons to generate, maintain, retain,
including meaningful use of EHRs, to following: disclose or provide the information
improve the quality of care provided by • Adoption and Implementation of requested. This includes the time
existing Health Center Program grantees HIT (including EHR); needed to review instructions, to
(i.e., Section 330 funded health centers) • Attainment of Meaningful Use develop, acquire, install and utilize
by engaging in the following program Requirements; and technology and systems for the purpose
components: • Improvement of quality measures of collecting, validating and verifying
• Adoption and Implementation: (e.g., Healthy People 2020 clinical information, processing and
Assist participating health centers with quality measures, PCMH recognition maintaining information, and disclosing
effectively adopting and implementing status, etc.). and providing information, to train
certified EHR technology. The annual, non-competing personnel and to be able to respond to
• Meaningful Use: Support continuation progress reports describe a collection of information, to search
participating health centers in meeting each grantee’s progress in achieving key data sources, to complete and review
Meaningful Use requirements and activity goals such as quality the collection of information, and to
accessing incentive payments under the improvement, data access and exchange, transmit or otherwise disclose the
Medicare and Medicaid Electronic efficiency and effectiveness of network information. The total annual burden
Health Records Incentive Programs. services, and the ability to track and hours estimated for this ICR are
• Quality Improvement (QI): Advance monitor patient outcomes, as well as summarized in the table below.
participating health centers’ QI emerging needs, challenges and barriers The annual estimate of burden is as
initiatives to improve clinical and encountered customer satisfaction, and follows:
Responses
Number of Total Hours per Total burden
Form name per
respondents responses response hours
respondent
Work Plan Update .............................................................. 43 1 43 10.9 468.7
Annual Progress Report .................................................... 43 1 43 44.5 1913.5
Total ............................................................................ 86 .......................... ........................ ........................ 2382.2
Jackie Painter, applications, the disclosure of which Contact Person: Tony L Creazzo, Ph.D.,
Director, Division of the Executive Secretariat. would constitute a clearly unwarranted Scientific Review Officer, Office of Scientific
[FR Doc. 2016–04984 Filed 3–4–16; 8:45 am] invasion of personal privacy. Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
BILLING CODE 4165–15–P Name of Committee: National Heart, Lung,
7180, Bethesda, MD 20892–7924, 301–435–
and Blood Institute Special Emphasis Panel;
Bioreactors for Reparative Medicine (STTR). 0725, creazzotl@mail.nih.gov.
DEPARTMENT OF HEALTH AND Date: March 24, 2016. (Catalogue of Federal Domestic Assistance
HUMAN SERVICES Time: 1:00 p.m. to 2:00 p.m. Program Nos. 93.233, National Center for
Agenda: To review and evaluate grant Sleep Disorders Research; 93.837, Heart and
National Institutes of Health applications. Vascular Diseases Research; 93.838, Lung
Place: National Institutes of Health, 6701 Diseases Research; 93.839, Blood Diseases
National Heart, Lung, and Blood Rockledge Drive, Room 7180, Bethesda, MD and Resources Research, National Institutes
Institute; Notice of Closed Meetings 20892, (Telephone Conference Call).
of Health, HHS)
Contact Person: Tony L Creazzo, Ph.D.,
Pursuant to section 10(d) of the Scientific Review Officer, Office of Scientific Dated: March 1, 2016.
Federal Advisory Committee Act, as Review/DERA, National Heart, Lung, and Michelle Trout,
amended (5 U.S.C. App.), notice is Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435– Program Analyst, Office of Federal Advisory
hereby given of the following meetings. Committee Policy.
The meetings will be closed to the 0725, creazzotl@mail.nih.gov.
Name of Committee: National Heart, Lung, [FR Doc. 2016–04915 Filed 3–4–16; 8:45 am]
public in accordance with the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
provisions set forth in sections and Blood Institute Special Emphasis Panel; BILLING CODE 4140–01–P
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Bioreactors for Reparative Medicine (SBIR).
Date: March 24, 2016.
as amended. The grant applications and
Time: 2:00 p.m. to 5:00 p.m.
the discussions could disclose Agenda: To review and evaluate grant
confidential trade secrets or commercial applications.
property such as patentable material, Place: National Institutes of Health, 6701
and personal information concerning Rockledge Drive, Room 7180, Bethesda, MD
individuals associated with the grant 20892, (Telephone Conference Call).
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Document Created: 2018-02-02 15:07:43
Document Modified: 2018-02-02 15:07:43
| 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 | Deadline: Comments on this ICR should be received no later than April 6, 2016. | |
| FR Citation | 81 FR 11815 |
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