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: 

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 

email address CDER_Science_Needs@

fda.hhs.gov. 

II. Comments 

Interested persons may submit either 

electronic comments regarding the 

report to http://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 http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the report at http://

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). 

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. 


Rmajette on DSK2VPTVN1PROD with NOTICES