11454 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

312.120(b), Number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND ....................... 280 9 .82 2,750 32 88,000 

312.120(c), Number of waiver requests submitted to FDA 

related to the use of foreign clinical studies not conducted under an IND ...................................................... 7 2 .29 16 24 384 

312.130, Number of requests for disclosable information 

in an IND and for investigations involving an exception 

from informed consent under § 50.24 ............................ 350 1 .34 470 8 3,760 

312.310(b) and 312.305(b), Number of submissions related to expanded access and treatment of an individual patient .................................................................. 78 1 .08 84 8 672 

312.310(d), Number of submissions related to emergency use of an investigational new drug ..................... 76 2 .76 210 16 3,360 

312.315(c) and 312.305(b), Number of submissions related to expanded access and treatment of an intermediate-size patient population ..................................... 9 1 9 120 1,080 

312.320(b), Number of submissions related to a treatment IND or treatment protocol ..................................... 1 1 1 300 300 

Total ............................................................................ ........................ .......................... ........................ ........................ 3,254,062 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

312.52(a), Sponsor records for the transfer of obligations 

to a contract research organization ............................... 75 1 .40 105 2 210 

312.57, Sponsor recordkeeping showing the receipt, 

shipment, or other disposition of the investigational 

drug, and any financial interests .................................... 335 2 .70 904 100 90,400 

312.62(a), Investigator recordkeeping of the disposition 

of drugs .......................................................................... 453 1 453 40 18,120 

312.62(b), Investigator recordkeeping of case histories of 

individuals ....................................................................... 453 1 453 40 18,120 

312.160(a)(3), Records pertaining to the shipment of 

drugs for investigational use in laboratory research animals or in vitro tests ....................................................... 111 1 .40 155 * 0.50 78 

312.160(c), Shipper records of alternative disposition of 

unused drugs .................................................................. 111 1 .40 155 * 0.50 78 

Total ............................................................................ ........................ .......................... ........................ ........................ 127,006 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

* Thirty (30) minutes. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04379 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–0430] 

Measuring Dystrophin in 

Dystrophinopathy Patients and 

Interpreting the Data; Public Scientific 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public scientific 

workshop; request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public scientific 

workshop to discuss dystrophin protein 

quantification methodologies for human 

tissue. This workshop is being 

cosponsored by the National Institutes 

of Health (NIH). The purpose of the 

workshop is to discuss currently 

available methodologies and to identify 

scientific knowledge gaps and 

opportunities for improving dystrophin 

protein detection in the context of drug 

development. The intended audiences 

for this workshop are scientists and 

clinicians involved in the acquisition, 

measurement, and analysis of proteins 

associated with Duchenne Muscular 

Dystrophy (DMD). 

mstockstill on DSK4VPTVN1PROD with NOTICES

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