Federal Register / Vol. 80, No. 53 / Thursday, March 19, 2015 / Notices 14389 

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. If 

this Notice appears at http://

www.regulations.gov, you also may file 

a comment through that Web site. 

If you file your comment on paper, 

write ‘‘Apparel Rules: FTC File No. 

P074201’’ on your comment and on the 

envelope, and mail or deliver it to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

600 Pennsylvania Avenue NW., Suite 

CC–5610 (Annex J), Washington, DC 

20580, or deliver your comment to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Constitution Center, 400 7th Street SW., 

5th Floor, Suite 5610 (Annex J), 

Washington, DC 20024. If possible, 

submit your paper comment to the 

Commission by courier or overnight 

service. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before April 20, 2015. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

http://www.ftc.gov/ftc/privacy.shtm. 

Comments on the information 

collection requirements subject to 

review under the PRA should also be 

submitted to OMB. If sent by U.S. mail, 

address comments to: Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Attention: Desk Officer for the Federal 

Trade Commission, New Executive 

Office Building, Docket Library, Room 

10102, 725 17th Street NW., 

Washington, DC 20503. Comments sent 

to OMB by U.S. postal mail, however, 

are subject to delays due to heightened 

security precautions. Thus, comments 

instead should be sent by facsimile to 

(202) 395–5167. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2015–06352 Filed 3–18–15; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration For Children And 

Families 

[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 

AGENCY: Office of Refugee Resettlement, 

ACF, HHS. 

ACTION: Announcement of the award of 

an emergency single-source grant to the 

U.S. Committee for Refugees and 

Immigrants in Arlington, VA. 

SUMMARY: 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. 

DATES: Funds will support activities 

from December 15, 2014 through 

December 14, 2015. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

Statutory Authority: Section 412(c)(1)(A) 

of the Immigration and Nationality Act, as 

amended (8 U.S.C. 1522(c)(1)(A)). 

Christopher Beach, 

Senior Grants Policy Specialist, Office of 

Administration. 

[FR Doc. 2015–06311 Filed 3–18–15; 8:45 am] 

BILLING CODE 4184–01–P 

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 SafetyRelated 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 http://www.regulations.gov. 


Rmajette on DSK2VPTVN1PROD with NOTICES
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. 


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