81_FR_89350 81 FR 89113 - Council on Graduate Medical Education

81 FR 89113 - Council on Graduate Medical Education

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 237 (December 9, 2016)

Page Range89113-89114
FR Document2016-29499

HHS is hereby giving notice that the Council on Graduate Medical Education (COGME) has been renewed. The effective date of the renewed charter is September 30, 2016.

Federal Register, Volume 81 Issue 237 (Friday, December 9, 2016) 
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89113-89114]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29499]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Council on Graduate Medical Education

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

ACTION: Notice of charter renewal.

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

SUMMARY: HHS is hereby giving notice that the Council on Graduate 
Medical Education (COGME) has been renewed. The effective date of the 
renewed charter is September 30, 2016.

FOR FURTHER INFORMATION CONTACT:  Dr. Kennita Carter, Senior Advisor 
and Designated Federal Official, Division of Medicine and Dentistry, 
HRSA, HHS, 15M116, 5600 Fishers Lane, Rockville, MD 20857. Phone: (301) 
945-3505; email: [email protected].

SUPPLEMENTARY INFORMATION:  COGME is authorized by section 762 (42 
U.S.C. 294o) of the Public Health Service Act,

[[Page 89114]]

as amended. Except where otherwise indicated, COGME is governed by 
provisions of the Federal Advisory Committee Act (5 U.S.C. App. 2), as 
amended, which sets forth standards for the formation and use of 
advisory committees. In accordance with the Federal Advisory Committee 
Act (FACA), COGME was initially chartered on September 30, 1996, and 
has been renewed at appropriate intervals.
    COGME provides advice to the Secretary of HHS (Secretary) on a 
range of issues including: The supply and distribution of physicians in 
the United States; current and future physician shortages or excesses; 
issues relating to foreign medical school graduates; Federal policies 
related to the previously listed topics, including policies concerning 
changes in the financing of medical education training; and the 
development of performance measures and longitudinal evaluation of 
medical education programs. COGME's reports are submitted to the 
Secretary and Chairmen and Ranking Members of the Senate Committee on 
Health, Education, Labor, and Pensions and the House of Representatives 
Committee on Energy and Commerce.
    Renewal of the COGME charter authorizes the Committee to operate 
until September 30, 2018.
    A copy of the COGME charter is available on the COGME Web site at 
http://www.hrsa.gov/advisorycommittees/bhpradvisory/cogme/index.html. A 
copy of the charter also can be obtained by accessing the FACA database 
that is maintained by the Committee Management Secretariat under the 
General Services Administration. The Web site address for the FACA 
database is http://www.facadatabase.gov/.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-29499 Filed 12-8-16; 8:45 am]
BILLING CODE 4165-15-P

Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices 89113 information as ‘‘confidential.’’ Any suspect product entering the practices regulation (21 CFR 10.115). information marked as ‘‘confidential’’ pharmaceutical distribution supply The guidance represents the current will not be disclosed except in chain, and provides recommendations thinking of FDA on ‘‘Drug Supply Chain accordance with 21 CFR 10.20 and other on how trading partners can identify Security Act Implementation: applicable disclosure law. For more such product and determine whether Identification of Suspect Product and information about FDA’s posting of the product is a suspect product as soon Notification.’’ It does not establish any comments to public dockets, see 80 FR as practicable. rights for any person and, with the 56469, September 18, 2015, or access Beginning January 1, 2015, section exception of section IV.B, is not binding the information at http://www.fda.gov/ 582 of the FD&C Act required trading on FDA or the public. You can use an regulatoryinformation/dockets/ partners, upon determining that a alternative approach if it satisfies the default.htm. product in their possession or control is requirements of the applicable statutes Docket: For access to the docket to illegitimate, to notify: (1) FDA and (2) and regulations. read background documents or the all immediate trading partners that they have reason to believe may have II. Electronic Access electronic and written/paper comments received, go to https:// received the illegitimate product, not Persons with access to the Internet www.regulations.gov and insert the later than 24 hours after making the may obtain the guidance at http:// docket number, found in brackets in the determination. Manufacturers are www.fda.gov/Drugs/Guidance heading of this document, into the additionally required under section ComplianceRegulatoryInformation/ ‘‘Search’’ box, and follow the prompts; 582(b)(4)(B)(ii)(II) of the FD&C Act to Guidances/default.htm, http:// and/or go to the Division of Dockets notify FDA and any immediate trading www.fda.gov/BiologicsBloodVaccines/ Management, 5630 Fishers Lane, Rm. partners that the manufacturer has GuidanceComplianceRegulatory 1061, Rockville, MD 20852. reason to believe may possess a product Information/Guidances/default.htm, or Submit written requests for single manufactured by (or purported to be https://www.regulations.gov. copies of this guidance to the Division manufactured by) the manufacturer, not later than 24 hours after the III. Paperwork Reduction Act of 1995 of Drug Information, Center for Drug Evaluation and Research, Food and manufacturer determines or is notified This guidance contains information Drug Administration, 10001 New by FDA or a trading partner that there collection provisions that are subject to Hampshire Ave., Hillandale Bldg. 4th is a high risk that a product is review by the Office of Management and Floor, Silver Spring, MD 20993–0002; or illegitimate. Section III.C of this Budget (OMB) under the Paperwork the Office of Communication, Outreach guidance, entitled ‘‘For Manufacturers: Reduction Act of 1995 (44 U.S.C. 3501– and Development, Center for Biologics High Risk of Illegitimacy Notification’’ 3520). The collection of information in Evaluation and Research, Food and and highlighted in grey, describes this guidance was approved under OMB Drug Administration, 10903 New notifications related to products that control number 0910–0806. Hampshire Ave., Bldg. 71, Rm. 3128, pose a high risk of illegitimacy, and is Dated: December 5, 2016. Silver Spring, MD 20993–0002. Send marked ‘‘for comment purposes only’’ to Leslie Kux, one self-addressed adhesive label to provide an opportunity for comment Associate Commissioner for Policy. assist that office in processing your before it is finalized. The guidance also [FR Doc. 2016–29588 Filed 12–8–16; 8:45 am] requests. See the SUPPLEMENTARY addresses how trading partners should notify FDA using Form FDA 3911. In BILLING CODE 4164–01–P INFORMATION section for electronic access to the guidance document. addition, in accordance with section 582(h)(2) of the FD&C Act, the guidance FOR FURTHER INFORMATION CONTACT: sets forth the process by which trading DEPARTMENT OF HEALTH AND Office of Compliance, Center for Drug partners must terminate the HUMAN SERVICES Evaluation and Research, Food and notifications using Form FDA 3911, in Drug Administration, 10903 New Health Resources and Services consultation with FDA, regarding Administration Hampshire Ave., Silver Spring, MD illegitimate product and, for a 20993–0002, 301–796–3130, manufacturer, a product with a high risk Council on Graduate Medical drugtrackandtrace@fda.hhs.gov. of illegitimacy, under section Education SUPPLEMENTARY INFORMATION: 582(b)(4)(B), (c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act. AGENCY: Health Resources and Services I. Background Administration (HRSA), Department of In the Federal Register of June 11, FDA is announcing the availability of 2014 (79 FR 33564), FDA announced the Health and Human Services (HHS). a guidance for industry entitled ‘‘Drug availability of a draft guidance entitled ACTION: Notice of charter renewal. Supply Chain Security Act ‘‘Drug Supply Chain Security Act Implementation: Identification of Implementation: Identification of SUMMARY: HHS is hereby giving notice Suspect Product and Notification.’’ The Suspect Product and Notification.’’ FDA that the Council on Graduate Medical guidance addresses provisions in the has carefully considered the comments Education (COGME) has been renewed. FD&C Act, as amended by the DSCSA received and made the following The effective date of the renewed (Pub. L. 113–54). Section 202 of the changes in response to the comments: charter is September 30, 2016. DSCSA adds section 582(h)(2) to the Section C, ‘‘For Manufacturers: High FOR FURTHER INFORMATION CONTACT: Dr. FD&C Act (21 U.S.C. 360eee–1(h)(2)), Risk of Illegitimacy Notifications,’’ on Kennita Carter, Senior Advisor and which requires FDA to issue guidance to pgs. 8–11 of the guidance, is a new Designated Federal Official, Division of mstockstill on DSK3G9T082PROD with NOTICES aid certain trading partners section added in response to comments Medicine and Dentistry, HRSA, HHS, (manufacturers, repackagers, wholesale and questions received. In addition, 15M116, 5600 Fishers Lane, Rockville, distributors, and dispensers) in FDA made minor changes to the Form MD 20857. Phone: (301) 945–3505; identifying a suspect product and FDA 3911 and to the instructions for email: kcarter@hrsa.gov. terminating notifications. The guidance completing the form. SUPPLEMENTARY INFORMATION: COGME is identifies specific scenarios that could This guidance is being issued authorized by section 762 (42 U.S.C. significantly increase the risk of a consistent with FDA’s good guidance 294o) of the Public Health Service Act, VerDate Sep<11>2014 18:13 Dec 08, 2016 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

89114 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices as amended. Except where otherwise ACTION: Notice. children’s hospitals are now required to indicated, COGME is governed by electronically communicate their provisions of the Federal Advisory SUMMARY: In compliance with the financial information to the Payment Committee Act (5 U.S.C. App. 2), as requirement for opportunity for public Management System through the amended, which sets forth standards for comment on proposed data collection Electronic Handbook. the formation and use of advisory projects (Section 3506(c)(2)(A) of the The form changes are only applicable committees. In accordance with the Paperwork Reduction Act of 1995), to the HRSA 99–1 (also known as Federal Advisory Committee Act HRSA announces plans to submit an Exhibit O (2)) and HRSA 99–5 forms. (FACA), COGME was initially chartered Information Collection Request (ICR), All other hospital and auditor forms are on September 30, 1996, and has been described below, to the Office of the same as currently approved. The renewed at appropriate intervals. Management and Budget (OMB). Prior changes to the HRSA 99–1 and HRSA COGME provides advice to the to submitting the ICR to OMB, HRSA 99–5 forms require OMB approval and Secretary of HHS (Secretary) on a range seeks comments from the public are as follows: of issues including: The supply and regarding the burden estimate, below, or 1. HRSA 99–1: Add additional distribution of physicians in the United any other aspect of the ICR. description to Line 4.06 (both Page 2 States; current and future physician DATES: Comments on this ICR should be and Page 2 Supplemental), 5.06 and shortages or excesses; issues relating to received no later than January 9, 2017. 6.06. The current description is ‘‘FTE foreign medical school graduates; ADDRESSES: Submit your comments to adjusted cap.’’ The new description will Federal policies related to the paperwork@hrsa.gov or mail the HRSA be ‘‘FTE adjusted cap or 2013 CHGME previously listed topics, including Information Collection Clearance Reauthorization cap due to Public Law policies concerning changes in the Officer, Room 14N–39, 5600 Fishers 113–98.’’ financing of medical education training; Lane, Rockville, MD 20857. 2. HRSA 99–5: Remove Payment and the development of performance Information question and check boxes, FOR FURTHER INFORMATION CONTACT: To measures and longitudinal evaluation of applicable only to: (1) Hospitals which request more information on the have not previously participated in the medical education programs. COGME’s proposed project or to obtain a copy of reports are submitted to the Secretary CHGME Payment Program, and (2) the data collection plans and draft hospitals in which financial institution and Chairmen and Ranking Members of instruments, email paperwork@hrsa.gov the Senate Committee on Health, information has changed since or call the HRSA Information Collection submission of its last application. Education, Labor, and Pensions and the Clearance Officer at (301) 443–1984. House of Representatives Committee on Need and Proposed Use of the SUPPLEMENTARY INFORMATION: When Information: Data on the number of FTE Energy and Commerce. Renewal of the COGME charter submitting comments or requesting residents trained are collected from authorizes the Committee to operate information, please include the children’s hospitals applying for until September 30, 2018. information request collection title for CHGME Payment Program funding. A copy of the COGME charter is reference. These data are used to determine the available on the COGME Web site at Information Collection Request Title: amount of direct and indirect medical http://www.hrsa.gov/advisory Children’s Hospitals Graduate Medical education payments to be distributed to committees/bhpradvisory/cogme/ Education Payment Program participating children’s hospitals. index.html. A copy of the charter also Application and Full-Time Equivalent Indirect medical education payments can be obtained by accessing the FACA Resident Assessment Forms OMB No. are derived from a formula that requires database that is maintained by the 0915–0247 Revision. the reporting of discharges, beds, and Committee Management Secretariat Abstract: The Children’s Hospitals case mix index information from under the General Services Graduate Medical Education (CHGME) participating children’s hospitals. As Administration. The Web site address Payment Program was enacted by Public required by statute, the FTE resident for the FACA database is http:// Law 106–129, and reauthorized by the assessment shall determine any changes www.facadatabase.gov/. CHGME Support Reauthorization Act of to the FTE resident counts initially 2013 (Pub. L. 113–98) to provide reported to the CHGME Payment Jason E. Bennett, Federal support for graduate medical Program. Director, Division of the Executive Secretariat. education (GME) to freestanding Likely Respondents: The likely [FR Doc. 2016–29499 Filed 12–8–16; 8:45 am] children’s hospitals. The legislation respondents include the estimated 60 BILLING CODE 4165–15–P indicates that eligible children’s children’s hospitals that apply and hospitals will receive payments for both receive CHGME Payment Program direct and indirect medical education. funding, as well as the 30 auditors DEPARTMENT OF HEALTH AND The CHGME Payment Program contracted by HRSA to perform the FTE HUMAN SERVICES application and full-time equivalent resident assessments of the children’s (FTE) resident assessment forms hospitals participating in the CHGME Health Resources and Services received OMB clearance on June 30, Payment Program. Children’s hospitals Administration 2014. applying for CHGME Payment Program The CHGME Support Reauthorization funding are required by the CHGME Agency Information Collection Act of 2013 included a provision to Payment Program statute to submit data Activities: Proposed Collection: Public allow certain newly qualified children’s on the number of FTE residents trained Comment Request; Children’s hospitals to apply for CHGME Payment in an annual application. Once funded mstockstill on DSK3G9T082PROD with NOTICES Hospitals Graduate Medical Education Program funding. The CHGME Payment by the CHGME Payment Program, these Payment Program Application and Program application forms have been same children’s hospitals are required to Full-Time Equivalent Resident revised to accommodate the new statute. submit audited data on the number of Assessment Forms In addition, a payment question FTE residents trained during the federal AGENCY: Health Resources and Services included in the CHGME Payment fiscal year to participate in the Administration (HRSA), Department of Program application forms has been reconciliation payment process. Health and Human Services. removed, since the participating Contracted auditors are requested by VerDate Sep<11>2014 18:13 Dec 08, 2016 Jkt 241001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1


Document Created: 2018-02-14 09:03:50
Document Modified: 2018-02-14 09:03:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of charter renewal.
ContactDr. Kennita Carter, Senior Advisor and Designated Federal Official, Division of Medicine and Dentistry, HRSA, HHS, 15M116, 5600 Fishers Lane, Rockville, MD 20857. Phone: (301) 945-3505; email: [email protected]
FR Citation81 FR 89113 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR