Product Shortage Report; Availability; Request for Comments, 68770 [2011-28723]

Download as PDF 68770 Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 / Notices be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: November 1, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28722 Filed 11–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0690] Product Shortage Report; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing the availability of a medical product shortage report entitled ‘‘A Review of FDA’s Approach to Medical Product Shortages.’’ The Agency is making the report available by placing it in the docket opened for a previous public workshop on drug shortages. The report discusses the Agency’s approach to product shortages, particularly those products regulated by the FDA Center for Drug Evaluation and Research (CDER). FDA requests comments, until December 23, 2011, on the report and its recommendations, including whether there are additional suggestions for recommendations and how we should prioritize work on these recommendations. SUMMARY: Submit either electronic or written comments by December 23, 2011. DATES: mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 17:50 Nov 04, 2011 Jkt 226001 SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 29, 2011 (76 FR 60505), FDA opened a comment period for a public workshop notice which published in the Federal Register of July 28, 2011 (76 FR 45268). This document announces the availability of a product shortage report by placing it in the docket of the public workshop on drug shortages. This report provides background information on product shortages, discusses four FDA product centers’ various approaches to addressing product shortages, particularly those in CDER, and includes recommendations for FDA and others. FDA is requesting comment on the report and its recommendations, including whether there are additional suggestions for recommendations and how we should prioritize work on these recommendations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ ucm275051.htm or https:// www.regulations.gov. Dated: October 31, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28723 Filed 11–4–11; 8:45 am] Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Peter Lurie, Office of Policy and Planning, Food and Drug ADDRESSES: Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4220, Silver Spring, MD 20993–0002, (301) 796–4800. BILLING CODE 4160–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Proposed Eligibility Criteria for the Centers of Excellence Program in Health Professions Education for Under-Represented Minority Individuals Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: This notice requests comments on proposed eligibility criteria for the Centers of Excellence (COE) program in health professions education for under-represented minority (URM) individuals (See Title VII, Section 736 of the Public Health Service Act, 42 U.S.C. 293 (2011) as amended by the Patient Protection and Affordable Care Act, Public Law 111– 148, § 5401 (2010)). When finalized, these eligibility criteria will be used to determine the eligibility of designated health professions schools to apply for COE funding in fiscal year (FY) 2012 and subsequent fiscal years. Funding is dependent on the availability of appropriated funds for the COE program. The designated health professions schools are schools of allopathic medicine, osteopathic medicine, dentistry, pharmacy, and graduate programs in behavioral or mental health. This does not apply to Historically Black Colleges and Universities (HBCUs) eligible to establish a COE, under PHS Act section 736(c)(2). DATES: Interested persons are invited to comment within 30 days of the publication of this notice. All comments received on or before those 30 days complete will be considered. ADDRESSES: All written comments concerning this notice should be submitted to Dr. Joan Weiss, Director, Division of Public Health and Interdisciplinary Education, at the contact information below. FOR FURTHER INFORMATION CONTACT: Anyone requesting additional details should contact Dr. Joan Weiss, Bureau of Health Professions, Health Resources and Services Administration. Dr. Weiss may be reached in one of three following methods: (1) Via written request to: Dr. Joan Weiss, Designated Federal Official, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, Room 9–36, 5600 Fishers Lane, Rockville, Maryland 20852; (2) via SUMMARY: E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Page 68770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0690]


Product Shortage Report; Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a medical product shortage report entitled ``A Review 
of FDA's Approach to Medical Product Shortages.'' The Agency is making 
the report available by placing it in the docket opened for a previous 
public workshop on drug shortages. The report discusses the Agency's 
approach to product shortages, particularly those products regulated by 
the FDA Center for Drug Evaluation and Research (CDER). FDA requests 
comments, until December 23, 2011, on the report and its 
recommendations, including whether there are additional suggestions for 
recommendations and how we should prioritize work on these 
recommendations.

DATES: Submit either electronic or written comments by December 23, 
2011.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Peter Lurie, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 4220, Silver Spring, MD 20993-0002, (301) 796-4800.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 29, 2011 (76 FR 60505), FDA 
opened a comment period for a public workshop notice which published in 
the Federal Register of July 28, 2011 (76 FR 45268). This document 
announces the availability of a product shortage report by placing it 
in the docket of the public workshop on drug shortages. This report 
provides background information on product shortages, discusses four 
FDA product centers' various approaches to addressing product 
shortages, particularly those in CDER, and includes recommendations for 
FDA and others. FDA is requesting comment on the report and its 
recommendations, including whether there are additional suggestions for 
recommendations and how we should prioritize work on these 
recommendations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm275051.htm or https://www.regulations.gov.

    Dated: October 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28723 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P
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