Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments; Postponement, 21445-21446 [2020-08167]

Download as PDF 21445 Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices 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. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/ do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Management Information Systems for Comprehensive Cancer Control Programs (OMB Control No. 0920–0841, Exp. 6/30/2019)—Reinstatement with Change—National Center for Chronic Disease and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In 2017, 66 awardees, representing all 50 states, the District of Columbia, seven United States Association Pacific Islands and territories, and eight tribes and tribal organizations, were selected for funding under NOFO (DP17–1701, ‘‘Cancer Prevention and Control Programs for State, Territorial, and Tribal Organizations’’). Under this cooperative agreement, awardees implement cancer prevention and control programs to reduce cancer morbidity, mortality, and disparities. To facilitate program monitoring, performance assessment, and evaluation, a web-based management information system (MIS) is needed for collection and abstraction of information about program resources, partnerships, work plan activities, and evaluation efforts. Information collection is organized into eight areas (MIS tabs): (1) FOA & Recipients; (2) Program Information; (3) Resources; (4) Leadership Team; (5) Financial; (6) Planning; (7) Action Plan; and (8) Reports. The Leadership Team tab is new. CDC conducted user acceptability testing of the leadership team tab data elements which allowed for an accurate estimate of burden per response. All information collected by CDC will be analyzed and used in aggregate to describe program efforts. OMB approval is requested for three years, which coincides with the last three years of the program. All awardees will submit information to CDC annually. Participation is required as a condition of funding under the cooperative agreement. The estimated burden per response is one hour and the total estimated annualized burden is 66 hours. ESTIMATED ANNUALIZED BURDEN HOURS Form name Program Director for State- Tribal-, or Territorial- based Cancer Prevention and Control Program. Data Elements for All CPC Programs: Annual Reporting. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–08164 Filed 4–16–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0907] jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Type of respondents Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments; Postponement AGENCY: Food and Drug Administration, HHS. Notice of public meeting; postponed. ACTION: VerDate Sep<11>2014 18:19 Apr 16, 2020 Jkt 250001 The Food and Drug Administration (FDA) is announcing that the public meeting entitled ‘‘Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments’’ that was scheduled in the Federal Register on April 3, 2020, to take place on May 5, 2020, is postponed until further notice. DATES: The public meeting will be rescheduled for a future date. Information about the rescheduled meeting will be provided when available. Submit either electronic or written comments on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program. FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and Radiological Health, Food and Drug SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 66 Number of responses per respondent 1 Average burden per response (in hours) 1 Administration, Bldg. 66, Rm. 1664, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–4322, ellen.olson@fda.hhs.gov or CDRHOPEQ-StrategicInitiatives@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The public meeting entitled ‘‘Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments’’ was originally announced in the Federal Register of March 6, 2020 (85 FR 13165), and was initially scheduled for April 7, 2020. On April 3, 2020, the meeting was postponed to May 5, 2020, and was planned to take place by webcast only due to extenuating circumstances (85 FR 18992). FDA continues to evaluate whether and how to proceed with upcoming scheduled meetings while our day-to-day operations are impacted by the COVID–19 public health emergency, and we have decided to E:\FR\FM\17APN1.SGM 17APN1 21446 Federal Register / Vol. 85, No. 75 / Friday, April 17, 2020 / Notices postpone this public meeting until further notice. Information on the rescheduled meeting will be provided in the future when available. The web page for the ‘‘Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting’’ is available at https://www.fda.gov/ medical-devices/workshopsconferences-medical-devices/2020medical-device-meetings-andworkshops. Interested persons may continue to submit comments on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program to the public docket. Dated: April 14, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–08167 Filed 4–16–20; 8:45 am] BILLING CODE 4164–01–P 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; Information Collection Request Title: Advanced Nursing Education Workforce, OMB No. 0915– 0375 Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, 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 have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30 day comment period for this Notice has closed. SUMMARY: Comments on this ICR should be received no later than May 18, 2020. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent jbell on DSKJLSW7X2PROD with NOTICES DATES: VerDate Sep<11>2014 18:19 Apr 16, 2020 Jkt 250001 within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Advanced Nursing Education Workforce Program-Specific Data Collection Forms, OMB No. 0915–0375 Extension. Abstract: HRSA provides advanced education nursing training grants to educational institutions to increase the numbers of advanced education nurses through the Advanced Nursing Education Workforce (ANEW) Program. The ANEW Program is authorized by Section 811 of the Public Health Service Act (42 U.S.C. 296j), as amended. This request is to extend the use of ANEW Program Specific forms, specifically Tables #1 and #2. There are no proposed changes to these tables. ANEW Table #1 collects information on the types of practice settings where graduates, who received ANEW support as students, are currently employed. The data on graduates’ employment practice settings demonstrate the distribution of specialties, i.e., nurse practitioners, clinical nurse specialists and nurse midwives, who are practicing in rural, underserved, public health nursing, and Health Professional Shortage Areas (HPSA) practice settings. ANEW Table #2 requests information on the projected number of primary care advanced practice registered nursing student enrollees/trainees who will receive traineeship support for each upcoming budget year over the entire project period. This data provides a baseline for comparison to data collected on the numbers of students/enrollees/trainees supported that are reported on the Annual Performance Reports. A 60-day notice published in the Federal Register on January 22, 2020, vol. 85, No. 14; pp. 3697–3698. There were no public comments. Need and Proposed Use of the Information: ANEW Program-Specific Table #1 captures data on the number of graduates of the academic partner PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 applicant who received HRSA support and are currently employed in rural areas, undeserved areas, public health nursing, and HPSA practice settings. The graduate data collected measure the impact of the ANEW Program in meeting the legislative and program goals. ANEW Program-Specific Table #2 collects information on the projected number of students/enrollees to receive traineeship support each budget year of the project period and provides a baseline for student/enrollee support that is reported in the Annual Performance Reports. Collecting this data assists HRSA in carrying out the most impactful program and ensuring resources are used responsibly. Likely Respondents: Likely respondents will be current ANEW awardees, who will submit the data tables as part of a Noncompeting Continuation progress report, and applicants for the ANEW program, including schools of nursing, nursing centers, academic health centers, state or local governments, and other public or private nonprofit entities determined appropriate by the Secretary that are accredited to carry out primary care nurse practitioner and nurse midwifery programs by a national nurse education accrediting agency recognized by the Secretary of the U.S. Department of Education. The school must be located in one of the 50 U.S. States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, or the Republic of Palau. 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. E:\FR\FM\17APN1.SGM 17APN1

Agencies

[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Notices]
[Pages 21445-21446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0907]


Medical Device User Fee Amendments for Fiscal Years 2023 Through 
2027; Public Meeting; Request for Comments; Postponement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; postponed.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
public meeting entitled ``Medical Device User Fee Amendments for Fiscal 
Years 2023 Through 2027; Public Meeting; Request for Comments'' that 
was scheduled in the Federal Register on April 3, 2020, to take place 
on May 5, 2020, is postponed until further notice.

DATES: The public meeting will be rescheduled for a future date. 
Information about the rescheduled meeting will be provided when 
available. Submit either electronic or written comments on the medical 
device user fee program and suggestions regarding the commitments FDA 
should propose for the next reauthorized program.

FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1664, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4322, 
[email protected] or [email protected].

SUPPLEMENTARY INFORMATION: The public meeting entitled ``Medical Device 
User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; 
Request for Comments'' was originally announced in the Federal Register 
of March 6, 2020 (85 FR 13165), and was initially scheduled for April 
7, 2020. On April 3, 2020, the meeting was postponed to May 5, 2020, 
and was planned to take place by webcast only due to extenuating 
circumstances (85 FR 18992). FDA continues to evaluate whether and how 
to proceed with upcoming scheduled meetings while our day-to-day 
operations are impacted by the COVID-19 public health emergency, and we 
have decided to

[[Page 21446]]

postpone this public meeting until further notice. Information on the 
rescheduled meeting will be provided in the future when available. The 
web page for the ``Medical Device User Fee Amendments for Fiscal Years 
2023 Through 2027; Public Meeting'' is available at https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/2020-medical-device-meetings-and-workshops. Interested persons may continue 
to submit comments on the medical device user fee program and 
suggestions regarding the commitments FDA should propose for the next 
reauthorized program to the public docket.

    Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08167 Filed 4-16-20; 8:45 am]
BILLING CODE 4164-01-P


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