Meeting of the Council on Graduate Medical Education, 55577-55578 [2019-22649]

Download as PDF Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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FOR FURTHER INFORMATION CONTACT: Keith Verrett, Division of User Fee Management and Budget Formulation, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 2179, Silver Spring, MD 20993, 301–796–7900, CDERCollections@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.’’ This guidance provides recommendations to applicants regarding requests for waivers, reductions, or refunds of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g and 379h). This guidance describes VerDate Sep<11>2014 17:26 Oct 16, 2019 Jkt 250001 the types of waivers, reductions, and refunds permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers, reductions, refunds, as well as requests for reconsiderations or appeals. The guidance also provides additional clarification on certain issues such as user fee exemptions for orphan drugs and FDA’s current thinking on considerations relevant to eligibility for user fee waivers, reductions, and refunds under the applicable statutory provisions. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information of this guidance has been approved under OMB control number 0910–0693. The collection of information associated with Form FDA 3397 has been approved under OMB control number 0910–0297. The collections of information associated with new drug applications or biologics license applications have been approved under OMB control numbers 0910–0001 and 0910–0338, respectively. See section X of the guidance document. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.regulations.gov. Dated: October 10, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–22690 Filed 10–16–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 55577 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Council on Graduate Medical Education Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2020 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https:// www.hrsa.gov/advisory-committees/ graduate-medical-edu/index.html. DATES: April 28–29, 2020, 8:30 a.m.– 5:00 p.m. Eastern Time (ET) and 8:30 a.m.–2:00 p.m. ET; July 17, 2020, 10:00 a.m.–5:00 p.m. ET; December 8–9, 2020, 8:30 a.m.–5:00 p.m. ET and 8:30 a.m.– 2:00 p.m. ADDRESSES: The meetings scheduled on April 28–29, 2020, and December 8–9, 2020, will be held in-person at 5600 Fishers Lane, Room 5E29, Rockville, Maryland 20857. The meeting scheduled on July 17, 2020, will be held by teleconference/Adobe Connect webinar. Instructions for joining the meetings either in person or remotely will be posted on the COGME website 30 business days before the date of the meeting. For meeting information updates, go to the COGME website meeting page at https://www.hrsa.gov/ advisory-committees/graduate-medicaledu/meetings/index.html. FOR FURTHER INFORMATION CONTACT: Kennita Carter, MD, Senior Advisor and Designated Federal Official (DFO), Division of Medicine and Dentistry, Bureau of Health Workforce (BHW), HRSA, 5600 Fishers Lane, 15N116, Rockville, Maryland 20857; 301–945– 9505; or BHWCOGME@hrsa.gov. SUPPLEMENTARY INFORMATION: COGME makes recommendations to the Secretary of HHS (Secretary) and Congress on policy, program development, and other matters of significance as specified by section 762 of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses; foreign medical school graduates; the nature and financing of undergraduate and graduate SUMMARY: E:\FR\FM\17OCN1.SGM 17OCN1 55578 Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Notices medical education; appropriation levels for certain programs under Title VII of the PHS Act and deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. COGME submits reports to the Secretary of HHS, the Senate Committee on Health, Education, Labor and Pensions, and the House of Representatives Committee on Energy and Commerce. Additionally, COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of the Council. Agenda items are subject to change as priorities dictate. During the CY 2020 COGME meetings, COGME will discuss topics surrounding the rural health workforce. Refer to the COGME website listed above for all current and updated information concerning the CY 2020 COGME meetings, including draft agendas and meeting materials that will be posted before the meeting. An agenda will be posted on the website at least 14 calendar days before the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meetings. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to the COGME should be sent to Kennita Carter using the contact information above at least 5 business days before the meeting dates. Individuals who need special assistance or another reasonable accommodation should notify Dr. Kennita Carter using the contact information listed above at least 10 business days before the meeting they wish to attend. Since all in person meetings occur in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2019–22649 Filed 10–16–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:26 Oct 16, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training and Primary Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2020 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisorycommittees/primarycare-dentist/ index.html. DATES: January 8–9, 2020, 8:30 a.m.– 5:00 p.m. Eastern Time (ET) and 8:30 a.m.–2:00 p.m. ET; and August 4, 2020, 10:00 a.m.–5:00 p.m. ET. ADDRESSES: The meeting scheduled on January 8–9, 2020, will be held inperson at 5600 Fishers Lane, Room 5E29, Rockville, Maryland 20857. The meeting scheduled on August 4, 2020, will be held by teleconference/Adobe Connect webinar. Instructions for joining the meetings either in person or remotely will be posted on the ACTPCMD website 30 business days before the date of the meeting. For meeting information updates, go to the ACTPCMD website meeting page at https://www.hrsa.gov/advisorycommittees/primarycare-dentist/ meetings.html. FOR FURTHER INFORMATION CONTACT: Kennita Carter, MD, Designated Federal Official (DFO) Division of Medicine and Dentistry, Bureau of Health Workforce (BHW), HRSA, 5600 Fishers Lane, 15N116, Rockville, Maryland 20857; 301–945–9505; or BHWACTPCMD@ hrsa.gov. SUPPLEMENTARY INFORMATION: ACTPCMD provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning the activities under Section 747 of Title VII of the Public Health Service (PHS) Act, as it existed upon the enactment of Section 749 of the PHS Act in 1998. ACTPCMD prepares an annual report describing the activities of the committee, including SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 findings and recommendations made by the committee concerning the activities under Section 747, as well as training programs in oral health and dentistry. The annual report is submitted to the Secretary as well as the Chairman and ranking members of the Senate Committee on Health, Education, Labor and Pensions and the House of Representatives Committee on Energy and Commerce. ACTPCMD develops, publishes, and implements performance measures and guidelines for longitudinal evaluations of programs authorized under Title VII, Part C of the PHS Act, and recommends appropriation levels for programs under this Part. During ACTPCMD’s CY 2020 meetings, the committee will discuss matters concerning policy, program development, and other matters of significance concerning medicine and dentistry activities. Agenda items are subject to change as priorities dictate. Refer to the ACTPCMD website listed above for all current and updated information concerning the CY 2020 meetings, including draft agendas and meeting materials that will be posted before the meeting. An agenda will be posted on the website at least 14 calendar days before each meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meetings. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to the ACTPCMD should be sent to Kennita Carter using the contact information above at least 5 business days before the meeting dates. Individuals who need special assistance or another reasonable accommodation should notify Kennita Carter using the contact information listed above at least 10 business days before the meeting they wish to attend. Since all in-person meetings occur in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2019–22650 Filed 10–16–19; 8:45 am] BILLING CODE 4165–15–P E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 84, Number 201 (Thursday, October 17, 2019)]
[Notices]
[Pages 55577-55578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the Council on Graduate Medical Education

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Council on Graduate Medical Education (COGME 
or Council) will hold public meetings for the 2020 calendar year (CY). 
Information about COGME, agendas, and materials for these meetings can 
be found on the COGME website at https://www.hrsa.gov/advisory-committees/graduate-medical-edu/index.html.

DATES: April 28-29, 2020, 8:30 a.m.-5:00 p.m. Eastern Time (ET) and 
8:30 a.m.-2:00 p.m. ET; July 17, 2020, 10:00 a.m.-5:00 p.m. ET; 
December 8-9, 2020, 8:30 a.m.-5:00 p.m. ET and 8:30 a.m.-2:00 p.m.

ADDRESSES: The meetings scheduled on April 28-29, 2020, and December 8-
9, 2020, will be held in-person at 5600 Fishers Lane, Room 5E29, 
Rockville, Maryland 20857. The meeting scheduled on July 17, 2020, will 
be held by teleconference/Adobe Connect webinar. Instructions for 
joining the meetings either in person or remotely will be posted on the 
COGME website 30 business days before the date of the meeting. For 
meeting information updates, go to the COGME website meeting page at 
https://www.hrsa.gov/advisory-committees/graduate-medical-edu/meetings/index.html.

FOR FURTHER INFORMATION CONTACT: Kennita Carter, MD, Senior Advisor and 
Designated Federal Official (DFO), Division of Medicine and Dentistry, 
Bureau of Health Workforce (BHW), HRSA, 5600 Fishers Lane, 15N116, 
Rockville, Maryland 20857; 301-945-9505; or [email protected].

SUPPLEMENTARY INFORMATION: COGME makes recommendations to the Secretary 
of HHS (Secretary) and Congress on policy, program development, and 
other matters of significance as specified by section 762 of Title VII 
of the Public Health Service (PHS) Act. Issues addressed by COGME 
include the supply and distribution of the physician workforce in the 
United States, including any projected shortages or excesses; foreign 
medical school graduates; the nature and financing of undergraduate and 
graduate

[[Page 55578]]

medical education; appropriation levels for certain programs under 
Title VII of the PHS Act and deficiencies in databases of the supply 
and distribution of the physician workforce and postgraduate programs 
for training physicians. COGME submits reports to the Secretary of HHS, 
the Senate Committee on Health, Education, Labor and Pensions, and the 
House of Representatives Committee on Energy and Commerce. 
Additionally, COGME encourages entities providing graduate medical 
education to conduct activities to voluntarily achieve the 
recommendations of the Council.
    Agenda items are subject to change as priorities dictate. During 
the CY 2020 COGME meetings, COGME will discuss topics surrounding the 
rural health workforce. Refer to the COGME website listed above for all 
current and updated information concerning the CY 2020 COGME meetings, 
including draft agendas and meeting materials that will be posted 
before the meeting. An agenda will be posted on the website at least 14 
calendar days before the meeting.
    Members of the public will have the opportunity to provide 
comments. Public participants may submit written statements in advance 
of the scheduled meetings. Oral comments will be honored in the order 
they are requested and may be limited as time allows. Requests to 
submit a written statement or make oral comments to the COGME should be 
sent to Kennita Carter using the contact information above at least 5 
business days before the meeting dates.
    Individuals who need special assistance or another reasonable 
accommodation should notify Dr. Kennita Carter using the contact 
information listed above at least 10 business days before the meeting 
they wish to attend. Since all in person meetings occur in a federal 
government building, attendees must go through a security check to 
enter the building. Non-U.S. Citizen attendees must notify HRSA of 
their planned attendance at least 20 business days prior to the meeting 
in order to facilitate their entry into the building. All attendees are 
required to present government-issued identification prior to entry.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-22649 Filed 10-16-19; 8:45 am]
 BILLING CODE 4165-15-P