80 FR 25304 - 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 80, Issue 85 (May 4, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 85 (May 4, 2015)
| Page Range | 25304-25306 | |
| FR Document | 2015-10355 |
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)] [Notices] [Pages 25304-25306] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10355] ----------------------------------------------------------------------- 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 AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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. DATES: Comments on this ICR should be received no later than June 3, 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 [[Page 25305]] submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 594-4306. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Partnerships for Care (P4C) Supplemental Funding Progress Reports OMB No. 0915-xxxx--New Abstract: Partnerships for Care (P4C): Health Departments and Health Centers Collaborating to Improve HIV Health Outcomes is a 3-year partnership cross-HHS project. The activities described in this notice were funded in part by HRSA through the Secretary's Minority AIDS Initiative Fund, established by annual appropriations acts (most recently, the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235, Division G, title II) and the Community Health Center Fund established by section 10503 of the Affordable Care Act, Public Law 111-148, as amended. The goals of the P4C project are to build sustainable partnerships between HRSA-funded health centers and CDC-funded state health departments (including Massachusetts, New York, Maryland, and Florida) to support expanded HIV service delivery in communities highly impacted by HIV, especially among racial/ethnic minorities. State health departments and health centers will work together to increase the identification of undiagnosed HIV infection, establish new access points for HIV care and treatment, and improve HIV outcomes along the continuum of care for people living with HIV (PLWH) (see P4C fact sheet at http://www.cdc.gov/hiv/prevention/demonstration/p4c/index.html and HHS press release at http://www.hhs.gov/news/press/2014pres/07/20140715a.html). Eligible health centers (22 in 4 states) will receive up to $500,000 annually in HRSA supplemental funding (totaling $33M across the 3-year project period) to integrate high- quality, comprehensive HIV services into their primary care programs; and to work in collaboration with their state health department to (1) identify people with undiagnosed HIV infection, (2) link newly diagnosed individuals to care, and (3) retain patients living with HIV in care. Health centers must implement activities in five focus areas, including workforce development, infrastructure development, HIV service delivery, partnership development, and quality improvement and evaluation. Health centers must demonstrate progress toward implementing all required P4C activities and improving health care outcomes across the HIV care continuum (see http://aids.gov/federal-resources/policies/care-continuum/). Need and Proposed Use of the Information: HRSA/Bureau of Primary Healthcare (BPHC) proposes standardized data collection and reporting through submission of five progress reports by the 22 health centers participating in the 3-year P4C project to achieve the following purposes: 1. Ensure appropriate stewardship of federal funds. 2. Support HHS efforts to streamline HIV data collection and reporting. 3. Assess health center progress in implementing approved work plans and meeting other P4C goals and objectives. 4. Assess health center progress in improving HIV outcomes across the HIV care continuum. 5. Support health center use of patient data to improve quality of HIV care. 6. Identify training and technical assistance needs among participating health centers. 7. Support identification and dissemination of effective models and promising practices for the integration of HIV services into primary care. Proposed data collection closely aligns with (1) core HIV indicators established by HHS (see http://blog.aids.gov/2012/08/secretary-sebelius-approves-indicators-for-monitoring-hhs-funded-hiv-services.html), (2) measures endorsed by the National Quality Forum (see http://www.qualityforum.org/News_And_Resources/Press_Releases/2013/NQF_Endorses_Infectious_Disease_Measures.aspx), (3) performance measures used by the Ryan White HIV/AIDS Program (see http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html), (4) the Health Center Program's Uniform Data System (see http://bphc.hrsa.gov/healthcenterdatastatistics/index.html#whatisuds), and (5) P4C project requirements. Specifically, HRSA/BPHC proposes submission of two progress reports each year by participating health centers to include aggregate, HIV-related, patient data (quantitative) and other information regarding implementation of approved work plans and budgets (narrative). Likely Respondents: Health Center Program grantees receiving supplemental awards under the P4C project (22 total). 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. As health centers develop reporting proficiencies and advance from initial start-up activities to establishing routine data abstraction methods for the new outcome measures, it is expected that the annualized burden will decrease by 20% each year. Total Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of responses Average burden per Total burden Form name Number of respondents per respondent Total responses response (in hours) hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Progress Report...... 22..................... 1..................... 22.................... 5..................... 110 Outcomes Progress Report............ 22..................... 1..................... 22.................... 25.................... 550 ------------------------------------------------------------------------------------------------------------------- Total........................... 22..................... ...................... 44.................... ...................... 660 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 25306]] Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-10355 Filed 5-1-15; 8:45 am] BILLING CODE 4165-15-P
![25304 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
requested that FDA determine the be submitted to http:// address and phone number below.
product’s regulatory review period. www.regulations.gov, Docket No. FDA– Interested parties should refer to the
FDA has determined that the 2013–S–0610. meeting subject as the HRSA Council on
applicable regulatory review period for Comments and petitions that have not Graduate Medical Education.
TUDORZA PRESSAIR is 3,136 days. Of been made publicly available on http:// The conference call-in number is:
this time, 2,739 days occurred during www.regulations.gov may be viewed in 888–566–5974. The passcode is:
the testing phase of the regulatory the Division of Dockets Management 4439136.
review period, while 397 days occurred between 9 a.m. and 4 p.m., Monday The webinar link is https://
during the approval phase. These through Friday. hrsa.connectsolutions.com/bhw_
periods of time were derived from the Dated: April 28, 2015.
cogmemay2015/.
following dates: Contact: Anyone requesting
Leslie Kux, information regarding the COGME
1. The date an exemption under
section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. should contact Dr. Joan Weiss,
and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2015–10336 Filed 5–1–15; 8:45 am] Designated Federal Official within the
U.S.C. 355(i)) became effective: BILLING CODE 4164–01–P Bureau of Health Workforce, Health
December 24, 2003. FDA has verified Resources and Services Administration,
the applicant’s claim that the date the in one of three ways: (1) Send a request
investigational new drug application DEPARTMENT OF HEALTH AND to the following address: Dr. Joan Weiss,
became effective was on December 24, HUMAN SERVICES Designated Federal Official, Bureau of
2003. Health Workforce, Health Resources and
Health Resources and Service
2. The date the application was Services Administration, Parklawn
initially submitted with respect to the Administration Building, Room 12C–05, 5600 Fishers
human drug product under section Council on Graduate Medical Lane, Rockville, Maryland 20857; (2)
505(b) of the FD&C Act: June 23, 2011. Education; Notice of Meeting call (301) 443–0430; or (3) send an email
FDA has verified the applicant’s claim to jweiss@hrsa.gov.
that the new drug application (NDA) for In accordance with section 10(a)(2) of
Jackie Painter,
TUDORZA PRESSAIR (NDA 202–450) the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given Director, Division of the Executive Secretariat.
was submitted on June 23, 2011.
3. The date the application was of the following meeting: [FR Doc. 2015–10354 Filed 5–1–15; 8:45 am]
approved: July 23, 2012. FDA has Name: Council on Graduate Medical
BILLING CODE 4165–15–P
verified the applicant’s claim that NDA Education (COGME).
202–450 was approved on July 23, 2012. Dates and Times: May 21, 2015 (10:00
This determination of the regulatory a.m.–4:00 p.m. EST). DEPARTMENT OF HEALTH AND
review period establishes the maximum Place: Webinar, and Conference Call HUMAN SERVICES
potential length of a patent extension. Format.
Status: The meeting will be open to the Health Resources and Services
However, the USPTO applies several
public. Administration
statutory limitations in its calculations Purpose: The COGME provides advice and
of the actual period for patent extension. recommendations to the Secretary of the Agency Information Collection
In its applications for patent extension, Department of Health and Human Services Activities: Submission to OMB for
this applicant seeks 1,679 or 1,298 days and to Congress on a range of issues Review and Approval; Public Comment
of patent term extension. including the supply and distribution of Request
Anyone with knowledge that any of physicians in the United States, current and
the dates as published are incorrect may future physician shortages or excesses, issues AGENCY: Health Resources and Services
submit to the Division of Dockets relating to foreign medical school graduates, Administration, HHS.
the nature and financing of medical
Management (see ADDRESSES) either ACTION: Notice.
education training, and the development of
electronic or written comments and ask performance measures and longitudinal
for a redetermination by July 6, 2015. SUMMARY: In compliance with section
evaluation of medical education programs.
Furthermore, any interested person may The COGME members will continue their
3507(a)(1)(D) of the Paperwork
petition FDA for a determination discussion on Graduate Medical Education Reduction Act of 1995, the Health
regarding whether the applicant for (GME) innovations. Resources and Services Administration
extension acted with due diligence Agenda: The COGME agenda includes an (HRSA) has submitted an Information
during the regulatory review period by opportunity for members to continue their Collection Request (ICR) to the Office of
discussion on Graduate Medical Education Management and Budget (OMB) for
November 2, 2015. To meet its burden, (GME) innovations including GME
the petition must contain sufficient facts review and approval. Comments
architecture, reform, and financing. submitted during the first public review
to merit an FDA investigation. (See H. The official agenda will be available 2 days
Rept. 857, part 1, 98th Cong., 2d sess., of this ICR will be provided to OMB.
prior to the meeting on the HRSA Web site
pp. 41–42, 1984.) Petitions should be in at http://www.hrsa.gov/advisorycommittees/ OMB will accept further comments from
the format specified in 21 CFR 10.30. bhpradvisory/cogme/index.html the public during the review and
Interested persons may submit to the SUPPLEMENTARY INFORMATION: Members approval period.
Division of Dockets Management (see of the public will have the opportunity DATES: Comments on this ICR should be
ADDRESSES) electronic or written to provide comments. Requests to make received no later than June 3, 2015.
ADDRESSES: Submit your comments,
mstockstill on DSK4VPTVN1PROD with NOTICES
comments and written or electronic oral comments or provide written
petitions. It is only necessary to send comments to the COGME should be sent including the Information Collection
one set of comments. Identify comments to Dr. Joan Weiss, Designated Federal Request Title, to the desk officer for
with the docket number found in Official, using the address and phone HRSA, either by email to OIRA_
brackets in the heading of this number below. Individuals who plan to submission@omb.eop.gov or by fax to
document. If you submit a written participate on the conference call or 202–395–5806.
petition, two copies are required. A webinar should notify Dr. Weiss at least FOR FURTHER INFORMATION CONTACT: To
petition submitted electronically must 3 days prior to the meeting, using the request a copy of the clearance requests
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![25306 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
Jackie Painter, including findings and NACNEP, as well as per diem and travel
Director, Division of the Executive Secretariat. recommendations made by the NACNEP expenses as authorized by section 5
[FR Doc. 2015–10355 Filed 5–1–15; 8:45 am] concerning the activities under Title U.S.C. 5703 for persons employed
BILLING CODE 4165–15–P VIII. intermittently in government service.
The Department of Health and Human Appointments shall be made without
Services is requesting at least 16 discrimination on the basis of age,
DEPARTMENT OF HEALTH AND nominations for members of the ethnicity, gender, sexual orientation and
HUMAN SERVICES NACNEP from leading authorities in the cultural, religious, or socioeconomic
various fields of nursing, higher and status. Qualified candidates will be
Health Resources and Services secondary education, and associate invited to serve up to a 4-year term.
Administration degree schools of nursing; and from Authority: The National Advisory Council
representatives of advanced education on Nurse Education and Practice is in
National Advisory Council on Nurse nursing groups (such as nurse accordance with the provisions of 42 United
Education and Practice; Notice for practitioners, nurse midwives, and States Code (U.S.C.) 297t; section 851 of the
Request for Nominations nurse anesthetists); from hospitals and Public Health Service Act, as amended. The
AGENCY: Health Resources and Services other institutions and organizations Council is governed by provisions of Pub. L.
which provide nursing services; from 92–463, which sets forth standards for the
Administration, Department of Health formation and use of advisory committees.
and Human Services. practicing professional nurses; from the
ACTION: Notice. general public; and full-time students Jackie Painter,
enrolled in schools of nursing. The Director, Division of the Executive Secretariat.
SUMMARY: The Health Resources and majority of NACNEP members shall be [FR Doc. 2015–10356 Filed 5–1–15; 8:45 am]
Services Administration (HRSA) is nurses.
BILLING CODE 4165–15–P
requesting nominations to fill at least 16 HRSA has special interest in the
vacancies on the National Advisory legislative requirements of having a fair
Council on Nurse Education and balance between the nursing profession DEPARTMENT OF HEALTH AND
Practice (NACNEP). with a broad geographic representation HUMAN SERVICES
DATES: The Agency must receive of members, a balance between urban
nominations on or before July 15, 2015. and rural members, and the adequate National Institutes of Health
ADDRESSES: All nominations are to be
representation of minorities. HRSA
submitted either by email to Kristen encourages nominations from qualified National Heart, Lung, and Blood
Hansen, Acting Designated Federal candidates from these groups as well as Institute; Notice of Closed Meeting
Official, NACNEP, at nacnep@hrsa.gov individuals with disabilities and
veterans. Pursuant to section 10(d) of the
or by mail to Kristen Hansen, Division Federal Advisory Committee Act, as
Interested persons may nominate one
of Nursing and Public Health, Bureau of amended (5 U.S.C. App.), notice is
or more qualified persons for
Health Workforce, Health Resources and hereby given of the following meeting.
membership. Self-nominations are
Administration, Parklawn Building, The meeting will be closed to the
accepted. Nominations must be
Room 9–89, 5600 Fishers Lane, public in accordance with the
typewritten. The following information
Rockville, Maryland 20857. should be included in the package of provisions set forth in sections
FOR FURTHER INFORMATION CONTACT: For materials submitted for each individual 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
additional information, contact Kristen being nominated: (1) a letter of as amended. The grant applications and
Hansen, Division of Nursing and Public nomination that clearly states the name the discussions could disclose
Health, Bureau of Health Workforce, by and affiliation of the nominee, the basis confidential trade secrets or commercial
email at nacnep@hrsa.gov or telephone for the nomination (i.e., specific property such as patentable material,
at (301) 443–2796. A copy of the current attributes that qualify the nominee for and personal information concerning
committee membership, charter, and service in this capacity), a statement individuals associated with the grant
reports can be obtained by accessing the that the nominee is willing to serve as applications, the disclosure of which
NACNEP Web site (http:// a member of the council and appears to would constitute a clearly unwarranted
www.hrsa.gov/advisorycommittees/ have no conflict of interest that would invasion of personal privacy.
bhpradvisory/nacnep/index.html). preclude this council membership. Name of Committee: National Heart, Lung,
SUPPLEMENTARY INFORMATION: Under the Potential candidates will be asked to and Blood Institute Special Emphasis Panel;
authorities that established the NACNEP provide detailed information concerning Short-Term Training to Promote Diversity in
and the Federal Advisory Committee such matters as financial holdings, Health Research.
Act, HRSA is requesting nominations Date: May 28, 2015.
consultancies, research grants, and/or
Time: 2:00 p.m. to 5:00 p.m.
for at least 16 new committee members. contracts to permit an evaluation of Agenda: To review and evaluate grant
The NACNEP provides advice and possible sources of conflicts of interest; applications.
recommendations to the Secretary and (2) the nominator’s name, address, and Place: National Institutes of Health, 6701
Congress in preparation of general daytime telephone number; the home/or Rockledge Drive, Room 7198, Bethesda, MD
regulations and concerning policy work address and telephone number; 20892, (Telephone Conference Call).
matters arising in the administration of and the email address of the individual Contact Person: Stephanie L. Constant,
Title VIII, including the range of issues being nominated; (3) a current copy of Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
mstockstill on DSK4VPTVN1PROD with NOTICES
related to nurse workforce education the nominee’s curriculum vitae; and (4)
Lung, and Blood Institute, 6701 Rockledge
and practice improvement. Annually, a statement of interest from the nominee Drive, Room 7189, Bethesda, MD 20892, 301–
the NACNEP prepares and submits to to support experience working with 443–8784, constantsl@nhlbi.nih.gov.
the Secretary, the Committee on Labor Title VIII nursing programs, expertise in (Catalogue of Federal Domestic Assistance
and Human Resources of the Senate, the field, and a personal desire in Program Nos. 93.233, National Center for
and the Committee on Commerce of the participating on the NACNEP. Sleep Disorders Research; 93.837, Heart and
House of Representatives, a report Members will receive a stipend for Vascular Diseases Research; 93.838, Lung
describing the activities of the council, each official meeting day of the Diseases Research; 93.839, Blood Diseases
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Document Created: 2018-02-21 10:22:38
Document Modified: 2018-02-21 10:22:38
| 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 ICR should be received no later than June 3, 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 25304 |
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