Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11455 

DATES: Dates and Time: The scientific 

workshop will be held on March 20, 

2015, from 8:30 a.m. to 5:30 p.m. 

ADDRESSES: The scientific workshop 

will be held at FDA’s White Oak 

Campus, 10903 New Hampshire Ave., 

Bldg. 31 Conference Center, the Great 

Room (Rm. 1503A), Silver Spring, MD 

20993–0002. Participants must enter 

through Building 1 and undergo 

security screening. For parking and 

security information, please refer to 

http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Contact Persons: Mary Gross, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3519, 

mary.gross@fda.hhs.gov; or Georgiann 

Ienzi, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3515, georgiann.ienzi@

fda.hhs.gov. 

If you need special accommodations 

due to a disability, contact Mary Gross 

or Georgiann Ienzi at least 7 days in 

advance. 

Registration: The scientific workshop 

is free and seating will be on a firstcome, first-served basis. It may be 

necessary to limit both the number of 

attendees from individual organizations 

and the total number of attendees based 

on space limitations. Email registrations 

should be sent to Dystrophin_

Workshop@fda.hhs.gov by March 17, 

2015. If you cannot attend in person, the 

meeting will be Webcast live. 

Information about how to access the 

Webcast will be located at: http:// 

www.fda.gov/Drugs/NewsEvents/

ucm432429.htm. 

Comments and Meeting Summary: 

Submit electronic comments to http://

www.regulations.gov by May 20, 2015. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Please identify your 

comments with the docket number 

found in brackets in the heading of this 

document. It is only necessary to send 

one set of comments. 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. 

A summary of the scientific 

workshop’s highlights will be made 

available for review at the Division of 

Dockets Management and at http://

www.regulations.gov. You may submit a 

request to obtain a hard copy by sending 

a request to the Division of Freedom of 

Information (ELEM–1029), Office of 

Management Programs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: FDA and 

NIH are cosponsoring this scientific 

workshop to discuss current 

methodologies being used in drug 

development and scientific research for 

DMD. Recent scientific advances 

present an opportunity for the 

development and validation of robust 

methods for the objective, reliable, and 

quantitative measurement of DMDassociated proteins. 

I. Background 

Dystrophinopathies result from 

genetic mutations in the dystrophin 

gene that decrease dystrophin protein 

expression levels and result in altered 

dystrophin function. These changes can 

lead to muscle degeneration and, in 

many patients, downstream pathologies 

including inflammation and fibrosis that 

interfere with muscle regeneration, loss 

of movement, orthopedic complications, 

and ultimately respiratory and cardiac 

failure. 

II. Scope of the Scientific Workshop 

The workshop will include sessions 

which will focus on current 

technologies used in the detection of 

dystrophin. Presentations will provide 

overviews of the technologies (including 

limitations, detection sensitivities, 

linearity, and reproducibility). A panel 

discussion will help identify 

development challenges for each 

method. Muscle biopsy collection, 

sample handling, reference materials, 

and image analysis will also be 

discussed. 

FDA will post the agenda and other 

background material approximately 2 

days before the public scientific 

workshop at: http://www.fda.gov/Drugs/ 

NewsEvents/ucm432429.htm. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04384 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Pediatric Neurocognitive Workshop; 

Advancing the Development of 

Pediatric Therapeutics Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Division of 

Gastroenterology and Inborn Errors 

Products Division and Division of 

Pediatric and Maternal Health in the 

Center for Drug Evaluation and 

Research, and the Office of Pediatric 

Therapeutics in the Office of the 

Commissioner are announcing a 2-day 

public workshop. Day 1 of the workshop 

is entitled ‘‘Assessment of 

Neurocognitive Outcomes in the Inborn 

Errors of Metabolism’’. Day 2 of the 

workshop is entitled, ‘‘Advancing the 

Development of Pediatric Therapeutics: 

Assessment of Pediatric Neurocognitive 

Outcomes’’. The purpose of this 2-day 

workshop is to provide a forum to 

consider issues related to advancing 

pediatric regulatory science in the 

evaluation of neurocognitive outcomes 

in pediatric patients. 

DATES: The public workshop will be 

held on April 16 and 17, 2015, from 8 

a.m. to 5 p.m. 

ADDRESSES: The public workshop will 

be held in the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding Day 1 of the 

workshop, contact Richard (Wes) 

Ishihara, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–0069, richard.ishihara@

fda.hhs.gov. 

For questions regarding Day 2 of the 

workshop, contact Denise Pica-Branco, 

Center for Drug Evaluation and 

Research, Food and Drug 

mstockstill on DSK4VPTVN1PROD with NOTICES

11456 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993– 

0002,Telephone: 301–796–1732, FAX: 

301–796–9858, denise.picabranco@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The first 

day of the workshop will focus on 

approaches for assessing the efficacy of 

therapeutic products on neurocognitive 

outcomes in patients diagnosed with 

inborn errors of metabolism disorders. 

The session will address the role of 

natural history studies and 

methodological approaches for selecting 

appropriate assessment scales and 

standardizing neurocognitive 

assessments. The second day of the 

workshop will discuss identification of 

signals in animal studies and clinical 

trials that warrant further clinical 

investigation and testing that may be 

predictive of neurocognitive outcome in 

children. Additionally, strategies and 

methods to address the challenges of 

assessing long-term neurocognitive 

outcomes for products used to treat 

pediatric patients will be discussed. 

Participation in the Public Workshop 

Registration: There is no fee to attend 

the public workshop, but attendees 

should register in advance. Space is 

limited, and registration will be on a 

first-come, first-served basis. Persons 

interested in attending this workshop 

must register online at neurocognitive_

workshop@fda.hhs.gov before March 31, 

2015. For those without Internet access, 

please contact Denise Pica-Branco (see 

FOR FURTHER INFORMATION CONTACT) to 

register. Onsite registration will not be 

available. 

If you need special accommodations 

due to a disability, please contact 

Denise Pica-Branco (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance. 

Transcripts: Transcripts of the 

workshop will be available for review at 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, and at 

http://www.regulations.gov 

approximately 30 days after the 

workshop. A transcript will also be 

available in either hard copy or on CD– 

ROM, after submission of a Freedom of 

Information request. Send written 

requests to the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. Send faxed requests to 301–827– 

9267. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04376 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immunobiology of 

Xenotransplantation (U01, U19). 

Date: March 23–24, 2015. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3F100, 5601 Fishers Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: Nancy VazquezMaldonado, Ph.D., Scientific Review Officer, 

Scientific Review Program, DEA/NIAID/NIH/ 

DHHS, 6700B Rockledge Drive, MSC–7616, 

Bethesda, MD 20892–7616, 301–496–3253, 

nvazquez@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Mucosal Environment and 

HIV Prevention (MEHP II (R01)). 

Date: March 23–24, 2015. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3C100, 5601 Fishers Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: Kelly Y. Poe, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, Rockville, MD 20892, 240–669– 

5036, Kelly.poe@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Innovative Assays to 

Quantify the Latent HIV Reservoir (R01). 

Date: March 26, 2015. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

4F100, 5601 Fishers Lane, Rockville, MD 

20892. 

Contact Person: Jay R Radke, Ph.D., AIDS 

Review Branch, Scientific Review Program, 

DEA/NIAID/NIH/DHHS, Room 3G11B, 5601 

Fishers Lane, Rockville, MD 20892, 240–669– 

5046, jay.radke@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 25, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–04328 Filed 3–2–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Program 

Project: Structure/Function studies of 

Secondary Transporters in a Lipid 

Environment. 

Date: March 23–25, 2015. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Albert Wang, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 4146, MSC 7806, Bethesda, MD 

20892, 301–435–1016, wangca@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: March 24–25, 2015. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSK4VPTVN1PROD with NOTICES