Council on Graduate Medical Education; Notice of Meeting, 25304 [2015-10354]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 25304 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for TUDORZA PRESSAIR is 3,136 days. Of this time, 2,739 days occurred during the testing phase of the regulatory review period, while 397 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 24, 2003. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on December 24, 2003. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 23, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for TUDORZA PRESSAIR (NDA 202–450) was submitted on June 23, 2011. 3. The date the application was approved: July 23, 2012. FDA has verified the applicant’s claim that NDA 202–450 was approved on July 23, 2012. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,679 or 1,298 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 6, 2015. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 2, 2015. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 be submitted to http:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on http:// www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10336 Filed 5–1–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Council on Graduate Medical Education; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Council on Graduate Medical Education (COGME). Dates and Times: May 21, 2015 (10:00 a.m.–4:00 p.m. EST). Place: Webinar, and Conference Call Format. Status: The meeting will be open to the public. Purpose: The COGME provides advice and recommendations to the Secretary of the Department of Health and Human Services and to Congress 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, the nature and financing of medical education training, and the development of performance measures and longitudinal evaluation of medical education programs. The COGME members will continue their discussion on Graduate Medical Education (GME) innovations. Agenda: The COGME agenda includes an opportunity for members to continue their discussion on Graduate Medical Education (GME) innovations including GME architecture, reform, and financing. The official agenda will be available 2 days prior to the meeting on the HRSA Web site at http://www.hrsa.gov/advisorycommittees/ bhpradvisory/cogme/index.html Members of the public will have the opportunity to provide comments. Requests to make oral comments or provide written comments to the COGME should be sent to Dr. Joan Weiss, Designated Federal Official, using the address and phone number below. Individuals who plan to participate on the conference call or webinar should notify Dr. Weiss at least 3 days prior to the meeting, using the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 address and phone number below. Interested parties should refer to the meeting subject as the HRSA Council on Graduate Medical Education. The conference call-in number is: 888–566–5974. The passcode is: 4439136. The webinar link is https:// hrsa.connectsolutions.com/bhw_ cogmemay2015/. Contact: Anyone requesting information regarding the COGME should contact Dr. Joan Weiss, Designated Federal Official within the Bureau of Health Workforce, Health Resources and Services Administration, in one of three ways: (1) Send a request to the following address: Dr. Joan Weiss, Designated Federal Official, Bureau of Health Workforce, Health Resources and Services Administration, Parklawn Building, Room 12C–05, 5600 Fishers Lane, Rockville, Maryland 20857; (2) call (301) 443–0430; or (3) send an email to jweiss@hrsa.gov. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–10354 Filed 5–1–15; 8:45 am] BILLING CODE 4165–15–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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: 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 OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests SUMMARY: E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Page 25304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Council on Graduate Medical Education; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:

    Name: Council on Graduate Medical Education (COGME).
    Dates and Times: May 21, 2015 (10:00 a.m.-4:00 p.m. EST).
    Place: Webinar, and Conference Call Format.
    Status: The meeting will be open to the public.
    Purpose: The COGME provides advice and recommendations to the 
Secretary of the Department of Health and Human Services and to 
Congress 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, the nature and financing of medical education training, 
and the development of performance measures and longitudinal 
evaluation of medical education programs. The COGME members will 
continue their discussion on Graduate Medical Education (GME) 
innovations.
    Agenda: The COGME agenda includes an opportunity for members to 
continue their discussion on Graduate Medical Education (GME) 
innovations including GME architecture, reform, and financing.
    The official agenda will be available 2 days prior to the 
meeting on the HRSA Web site at http://www.hrsa.gov/advisorycommittees/bhpradvisory/cogme/index.html

SUPPLEMENTARY INFORMATION: Members of the public will have the 
opportunity to provide comments. Requests to make oral comments or 
provide written comments to the COGME should be sent to Dr. Joan Weiss, 
Designated Federal Official, using the address and phone number below. 
Individuals who plan to participate on the conference call or webinar 
should notify Dr. Weiss at least 3 days prior to the meeting, using the 
address and phone number below. Interested parties should refer to the 
meeting subject as the HRSA Council on Graduate Medical Education.
    The conference call-in number is: 888-566-5974. The passcode is: 
4439136.
    The webinar link is https://hrsa.connectsolutions.com/bhw_cogmemay2015/.
    Contact: Anyone requesting information regarding the COGME should 
contact Dr. Joan Weiss, Designated Federal Official within the Bureau 
of Health Workforce, Health Resources and Services Administration, in 
one of three ways: (1) Send a request to the following address: Dr. 
Joan Weiss, Designated Federal Official, Bureau of Health Workforce, 
Health Resources and Services Administration, Parklawn Building, Room 
12C-05, 5600 Fishers Lane, Rockville, Maryland 20857; (2) call (301) 
443-0430; or (3) send an email to jweiss@hrsa.gov.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-10354 Filed 5-1-15; 8:45 am]
 BILLING CODE 4165-15-P