Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket, 52732-52733 [2014-21051]

Download as PDF 52732 Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices Dated: August 29, 2014. Karen V. Gregory, Secretary. [FR Doc. 2014–21080 Filed 9–3–14; 8:45 am] BILLING CODE 6730–01–P FEDERAL MARITIME COMMISSION mstockstill on DSK4VPTVN1PROD with NOTICES Ocean Transportation Intermediary License Applicants The Commission gives notice that the following applicants have filed an application for an Ocean Transportation Intermediary (OTI) license as a NonVessel-Operating Common Carrier (NVO) and/or Ocean Freight Forwarder (OFF) pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101). Notice is also given of the filing of applications to amend an existing OTI license or the Qualifying Individual (QI) for a licensee. Interested persons may contact the Office of Ocean Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573, by telephone at (202) 523–5843 or by email at OTI@fmc.gov. AHC Logistics Cargo Consultant, Inc. (NVO & OFF), 10540 NW. 26th Street, Suite G–108, Doral, FL 33172, Officers: Alvaro HernandezCrassus, President (QI), Any A. Vega, Vice President, Application Type: New NVO & OFF License. Caucas International LLC (NVO & OFF), 1950 Old Gallows Road, Vienna, VA 22182, Officers: Angela M. Moore, Logistics Manager (QI), Fadi S. Abuhamdeh, Member, Application Type: New NVO & OFF License. Del Corona & Scardigli USA Inc. (OFF), 15 W. 36th Street, Suite 11th Floor, New York, NY 10018, Officers: Fabio Goldoni, Vice President Sales (QI), Stefano D’Angelo, CEO, Application Type: New OFF License. Easy Express Inc. (NVO & OFF), 11222 S. La Cienega Boulevard, Suite 688, Inglewood, CA 90304, Officers: Xin (a.k.a. Keith) Tu, CFO (QI), Yang Su, CEO, Application Type: QI Change. Ed Cury Enterprises Inc. (NVO & OFF), 3053 NW. 82nd Avenue, Doral, FL 33122, Officers: Roberta M. Cury, Vice President (QI), Edson Silva, President, Application Type: New NVO & OFF License. Lasus Group LLC (NVO & OFF), 2625 Collins Avenue, Apt. 1903, Miami, FL 33140, Officers: Susana I. Arce, Manager (QI), Rodrigo R. Arce, Manager, Application Type: New NVO & OFF License. VerDate Mar<15>2010 18:14 Sep 03, 2014 Jkt 232001 Lead Young Logistics International, Inc. (NVO), 1032 Edwards Road, Burlingame, CA 94010, Officer: Denis Cheng, President (QI), Application Type: New NVO License. Quartz Logistics Inc. (NVO & OFF), 780 S. Nogales Street, Suite #D, City of Industry, CA 91748, Officers: Robert Wu, CEO (QI), Tai R. Wang, Secretary, Application Type: QI Change. Razor Enterprise Inc. (NVO & OFF), 175–01 Rockaway Blvd., Suite 212, Jamaica, NY 11434, Officers: Bibi R. Juman, Vice President (QI), Edmond Yau, President, Application Type: Add Trade Name Razor Cargo Services. Shock Value International, Inc. dba JP Global Logistics (NVO & OFF), 377 Oyster Point Blvd., Suite 11, South San Francisco, CA 94080, Officers: John S. Kim, Vice President (QI), Paul H. Choe, President, Application Type: New NVO & OFF License. Southern Export Services, Inc. (NVO & OFF), 5192 Southridge Parkway, Suite 109, College Park, GA 30349, Officers: Joel Fischer-Columbo, Vice President—Tulsa Operations (QI), Andrew J. Senter, President, Application Type: QI Change. Top Logistics NJ Inc (NVO), 53 Knapp Avenue, Edison, NJ 08817, Officers: Wenjie Wu, Vice President (QI), Rongfang Chai, Director, Application Type: New NVO License. Vilden Global Trade Solutions SDN BHD, Inc. (NVO), 21515 Hawthorne Blvd., Suite 1030, Torrance, CA 90503, Officers: Gregory H. Pearson, President (QI), Po H. Lai, Vice President, Application Type: New NVO License. Dated: August 29, 2014. By the Commission. Karen V. Gregory, Secretary. [FR Doc. 2014–21079 Filed 9–3–14; 8:45 am] BILLING CODE 6730–01–P PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1264] Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is establishing a public docket to discuss issues related to developing drugs for Duchenne muscular dystrophy (DMD). During a public-private policy forum for DMD on December 12, 2013, FDA agreed that Parent Project Muscular Dystrophy (PPMD) and other interested parties in the DMD community could submit for FDA consideration a proposal for a draft guidance for industry on developing drugs for DMD. That proposed draft guidance was submitted to FDA on June 25, 2014. FDA values the guidance provided by the DMD community and is posting the document to seek additional guidance and public comment. DATES: Submit electronic or written comments by October 6, 2014. ADDRESSES: Submit written requests for single copies of the proposed draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the proposed draft guidance document. 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. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Colleen LoCicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4242, Silver Spring, MD 20993–0002, 301– 796–1114, colleen.locicero@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: E:\FR\FM\04SEN1.SGM 04SEN1 Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices I. Comments FDA invites comment on all matters relating to topics for consideration regarding DMD drug development. This request is not limited to comments on the proposal described in the submission by PPMD. Interested persons may submit either electronic comments to https:// www.regulations.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. II. Electronic Access Persons with access to the Internet may obtain the proposed draft guidance document at https:// www.regulations.gov. Dated: August 29, 2014. Leslie Kux, Assistant Commissioner for Policy. Authority: Section 2692 of the Public Health Service Act, 42, U.S.C. 300ff–111. [FR Doc. 2014–21051 Filed 9–3–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Ryan White HIV/AIDS Program, Special Projects of National Significance (SPNS), the Albert Einstein College of Medicine, Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of a deviation from competition requirements to award a program expansion supplement for the HIV/AIDS Bureau’s (HAB’s) Ryan White HIV/AIDS Program, Special Projects of National Significance (SPNS), the Albert Einstein College of Medicine, Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative. AGENCY: HRSA will be issuing a noncompetitive award under the SPNS Program to current grantee, the Albert Einstein College of Medicine (Grant #5 H97HA15152–05–00), for approximately $55,000 during the budget period September 1, 2014, to August 31, 2015. This will allow the Albert Einstein College of Medicine to cover the costs mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:14 Sep 03, 2014 Jkt 232001 associated with the publication of a special supplemental issue of the journal AIDS Patient Care and STD’s, which will feature eight articles on findings from the Special Projects of National Significance (SPNS) Program Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative. A program expansion supplement will allow SPNS wider dissemination of the most current best practices and lessons learned for the care of women of color living with HIV. The journal AIDS Patient Care and STD’s has a combined 18,200 print and online subscribers, and the publisher will also extend online distribution to readers of the Journal of Women’s Health (approximately 32,000 additional subscribers) and to attendees of the Congress on Women’s Health (approximately 800 physicians and nurses). SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Albert Einstein College of Medicine (Grant #5 H97HA15152–05–00). The amount of the noncompetitive award is $55,000. CFDA Number: 93.145. Period of Supplemental Funding: September 1, 2014, through August 31, 2015. Justification: SPNS Program is charged with the development of innovative models of HIV treatment, in order to respond to emerging needs of those with HIV/AIDS, including clients served by the Ryan White HIV/AIDS Program. A major goal of the SPNS Program is to disseminate findings and innovative models of care and treatment to the broader HIV provider community and encourage replication of successful models/interventions. The SPNS Women of Color Initiative began September 1, 2009, and involved 11 demonstration site grantees and an Evaluation and Technical Assistance Center—the Albert Einstein College of Medicine. The Initiative enrolled 921 women of color living with HIV/AIDS in its multi-site evaluation; the findings from this initiative can improve the care of women living with HIV through the identification of best practices and lessons learned. The Albert Einstein College of Medicine has served as the Evaluation and Technical Assistance Center for the SPNS Women of Color Initiative from September 1, 2009, to the present. As such, this grantee has been tasked to lead and coordinate all dissemination activities for this initiative, and is best-positioned to lead and facilitate the publication process. This program expansion would allow PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 52733 for the publication of findings from the Women of Color Initiative in the journal of AIDS Patient Care and STD’s in support of HRSA’s and HAB’s commitment to ensuring that comprehensive and effective models of care and treatment are available to underserved, un/under-insured populations, including those from communities of color. FOR FURTHER INFORMATION CONTACT: Adan Cajina, MSc, Branch Chief, Special Programs of National Significance (SPNS), Division of Training and Capacity Development, HAB/HRSA, 5600 Fishers Lane, Rockville, Maryland 20857, by email at acajina@hrsa.gov, or by phone at (301) 443–3180. Dated: August 27, 2014. Mary K. Wakefield, Administrator. [FR Doc. 2014–21011 Filed 9–3–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Ryan White HIV/AIDS Program, AIDS Education and Training Centers, The University of Washington, Northwest AIDS Education and Training Center Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of a deviation from competition requirements to award a program expansion supplement for the HIV/AIDS Bureau’s (HAB) Ryan White HIV/AIDS Program, AIDS Education and Training Centers (AETC) (H4A), The University of Washington, Northwest AIDS Education and Training Center (NWAETC). AGENCY: HRSA will be issuing a noncompetitive award under the AETC Program, to current grantee, the University of Washington NWAETC, for approximately $250,239 during the budget period July 1, 2014, to June 30, 2015. This will allow the University of Washington NWAETC to develop a unique and flexible HIV distance learning curriculum that can be used in a variety of health care settings by a variety of health care providers. This on-line curriculum will enhance our ability to reach and so increase the numbers of health care providers skilled in delivering HIV/AIDS care and treatment at a time when there is a greater demand for these professionals— especially primary care physicians. SUMMARY: E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52732-52733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21051]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1264]


Submission of a Proposed Draft Guidance for Industry on 
Developing Drugs for Treatment of Duchenne Muscular Dystrophy; 
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to discuss issues related to developing drugs for 
Duchenne muscular dystrophy (DMD). During a public-private policy forum 
for DMD on December 12, 2013, FDA agreed that Parent Project Muscular 
Dystrophy (PPMD) and other interested parties in the DMD community 
could submit for FDA consideration a proposal for a draft guidance for 
industry on developing drugs for DMD. That proposed draft guidance was 
submitted to FDA on June 25, 2014. FDA values the guidance provided by 
the DMD community and is posting the document to seek additional 
guidance and public comment.

DATES: Submit electronic or written comments by October 6, 2014.

ADDRESSES: Submit written requests for single copies of the proposed 
draft guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the proposed draft guidance document.
    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. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen LoCicero, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4242, Silver Spring, MD 20993-0002, 301-
796-1114, colleen.locicero@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 52733]]

I. Comments

    FDA invites comment on all matters relating to topics for 
consideration regarding DMD drug development. This request is not 
limited to comments on the proposal described in the submission by 
PPMD.
    Interested persons may submit either electronic comments to https://www.regulations.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.

II. Electronic Access

    Persons with access to the Internet may obtain the proposed draft 
guidance document at https://www.regulations.gov.

    Dated: August 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21051 Filed 9-3-14; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.