Assessing the Center of Drug Evaluation and Research's Safety-Related Regulatory Science Needs and Identifying Priorities; Report; Availability; Request for Comments, 14389-14390 [2015-06288]

Download as PDF Rmajette on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices manufacturing processes, or customer names. If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ apparelrulespra2, by following the instructions on the web-based form. 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Christopher Beach, Senior Grants Policy Specialist, Office of Administration. [FR Doc. 2015–06311 Filed 3–18–15; 8:45 am] [FR Doc. 2015–06352 Filed 3–18–15; 8:45 am] BILLING CODE 4184–01–P BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Administration For Children And Families Assessing the Center of Drug Evaluation and Research’s SafetyRelated Regulatory Science Needs and Identifying Priorities; Report; Availability; Request for Comments [CFDA Number 93.576] Announcement of the Award of an Emergency Single-Source Grant to the U.S. Committee for Refugees and Immigrants in Arlington, VA Office of Refugee Resettlement, ACF, HHS. AGENCY: Announcement of the award of an emergency single-source grant to the U.S. Committee for Refugees and Immigrants in Arlington, VA. ACTION: The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of an emergency single-source grant in the amount of $804,075 to the U.S. Committee for Refugees and Immigrants (USCRI) in Arlington, VA, to support resettlement services to Iranian refugee parolees. SUMMARY: Funds will support activities from December 15, 2014 through December 14, 2015. DATES: FOR FURTHER INFORMATION CONTACT: Kenneth Tota, Acting Director, Office of Refugee Resettlement, 901 D Street SW., Washington, DC 20047. Telephone: 202–401–4858. Email: kenneth.tota@ acf.hhs.gov. Award funds will provide resettlement services to approximately 100 Iranian individuals currently residing in a refugee camp in Iraq. USCRI will provide services to this refugee parolee population including, but not limited to: Initial reception, housing, employment, enhanced case management, staffing, interpreter services, and counseling. This emergency grant will support the provision of these much needed services to ensure these parolees are afforded a successful path to self-sufficiency. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 [Docket No. FDA–2011–D–0239] AGENCY: Food and Drug Administration, HHS. Notice of availability; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the availability of a report entitled ‘‘Assessing CDER’s Drug Safety-Related Regulatory Science Needs and Identifying Priorities.’’ This report identifies drug safety-related regulatory science needs and priorities related to the mission of FDA’s Center for Drug Evaluation and Research (CDER) that would benefit from external collaborations and resources. FDA hopes to foster collaborations with external partners and stakeholders to help address these needs and priorities. This notice asks stakeholders conducting research related to these needs to describe that research and indicate their interest in collaborating with FDA to address safety-related research priorities. DATES: Although you can comment on the report at any time, to ensure that FDA considers your comments on this report, submit either electronic or written comments on the report by May 18, 2015. ADDRESSES: Submit written requests for single copies of this report to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the report. Submit electronic comments on the report to https://www.regulations.gov. SUMMARY: E:\FR\FM\19MRN1.SGM 19MRN1 14390 Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices 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: Ruth Barratt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4540, Silver Spring, MD 20993–0002, 301–796–2600. SUPPLEMENTARY INFORMATION: Rmajette on DSK2VPTVN1PROD with NOTICES I. Background Since publication of the 2011 ‘‘Identifying CDER’s Science and Research Needs’’ report, FDA has been engaged in efforts to further assess and prioritize the needs articulated therein. As part of these efforts, CDER’s Safety Research Interest Group (SRIG), a subcommittee of the Science Prioritization and Review Committee, assessed CDER’s overall drug safetyrelated regulatory science needs in view of FDA’s ongoing research efforts and highlighted areas that would benefit from additional resources and collaboration. The SRIG identified the following seven overall needs for drug safetyrelated regulatory science: 1. Improve access to postmarket data sources and explore the feasibility of their use in safety signal analyses 2. Improve risk assessment and management strategies to reinforce the safe use of drugs 3. Evaluate the effectiveness of risk communications of drug safety information to health care providers and the public 4. Improve product quality and design, manufacturing processes, and product performance relating to safety 5. Develop and improve predictive models of safety in humans, including nonclinical biomarkers 6. Improve clinical trial statistical analyses for safety, including benefitrisk assessment 7. Investigate clinical biomarkers of safety, including standards for qualification. Particular priorities within the seven overall needs requiring further resources and outside participation were also identified. FDA seeks to stimulate collaborations with external partners and stakeholders to address these needs by asking them to: (1) Submit descriptions of their ongoing research and initiatives related to the seven overall needs, especially the identified priorities, and (2) indicate their interest in working with FDA to address these needs. Outside parties are being asked to submit comments to the docket and VerDate Sep<11>2014 15:18 Mar 18, 2015 Jkt 235001 email address CDER_Science_Needs@ fda.hhs.gov. II. Comments Interested persons may submit either electronic comments regarding the report to https://www.regulations.gov and email address CDER_Science_ Needs@fda.hhs.gov, or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the report at https:// www.regulations.gov. Dated: March 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–06288 Filed 3–18–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Ancillary R01 Telephone Review SEP. Date: April 3, 2015 Time: 2:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes Of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Collaborative Interdisciplinary Team Science in Diabetes and Obesity (R24). Date: April 6, 2015. Time: 2:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 759, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, 301–594–2242, jerkinsa@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 13, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–06266 Filed 3–18–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, March 31, 2015, 04:00 p.m. to April 01, 2015, 05:00 p.m., Churchill Hotel, 1914 Connecticut Avenue NW., Washington, DC, 20009 which was published in the Federal Register on March 09, 2015, 80 FR 12494. The meeting is being amended to reflect location change. The new meeting location is the Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. The meeting is closed to the public. E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 80, Number 53 (Thursday, March 19, 2015)]
[Notices]
[Pages 14389-14390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06288]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0239]


Assessing the Center of Drug Evaluation and Research's Safety-
Related Regulatory Science Needs and Identifying Priorities; Report; 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Assessing CDER's Drug Safety-
Related Regulatory Science Needs and Identifying Priorities.'' This 
report identifies drug safety-related regulatory science needs and 
priorities related to the mission of FDA's Center for Drug Evaluation 
and Research (CDER) that would benefit from external collaborations and 
resources. FDA hopes to foster collaborations with external partners 
and stakeholders to help address these needs and priorities. This 
notice asks stakeholders conducting research related to these needs to 
describe that research and indicate their interest in collaborating 
with FDA to address safety-related research priorities.

DATES: Although you can comment on the report at any time, to ensure 
that FDA considers your comments on this report, submit either 
electronic or written comments on the report by May 18, 2015.

ADDRESSES: Submit written requests for single copies of this report to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the report.
    Submit electronic comments on the report to https://www.regulations.gov.

[[Page 14390]]

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: Ruth Barratt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4540, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION:

I. Background

    Since publication of the 2011 ``Identifying CDER's Science and 
Research Needs'' report, FDA has been engaged in efforts to further 
assess and prioritize the needs articulated therein. As part of these 
efforts, CDER's Safety Research Interest Group (SRIG), a subcommittee 
of the Science Prioritization and Review Committee, assessed CDER's 
overall drug safety-related regulatory science needs in view of FDA's 
ongoing research efforts and highlighted areas that would benefit from 
additional resources and collaboration.
    The SRIG identified the following seven overall needs for drug 
safety-related regulatory science:
    1. Improve access to postmarket data sources and explore the 
feasibility of their use in safety signal analyses
    2. Improve risk assessment and management strategies to reinforce 
the safe use of drugs
    3. Evaluate the effectiveness of risk communications of drug safety 
information to health care providers and the public
    4. Improve product quality and design, manufacturing processes, and 
product performance relating to safety
    5. Develop and improve predictive models of safety in humans, 
including nonclinical biomarkers
    6. Improve clinical trial statistical analyses for safety, 
including benefit-risk assessment
    7. Investigate clinical biomarkers of safety, including standards 
for qualification.
    Particular priorities within the seven overall needs requiring 
further resources and outside participation were also identified. FDA 
seeks to stimulate collaborations with external partners and 
stakeholders to address these needs by asking them to: (1) Submit 
descriptions of their ongoing research and initiatives related to the 
seven overall needs, especially the identified priorities, and (2) 
indicate their interest in working with FDA to address these needs. 
Outside parties are being asked to submit comments to the docket and 
email address CDER_Science_Needs@fda.hhs.gov.

II. Comments

    Interested persons may submit either electronic comments regarding 
the report to https://www.regulations.gov and email address 
CDER_Science_Needs@fda.hhs.gov, or written comments to the Division of 
Dockets Management (see ADDRESSES). 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. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the report at https://www.regulations.gov.

    Dated: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06288 Filed 3-18-15; 8:45 am]
 BILLING CODE 4164-01-P
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