20232 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0471] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; User Fee Cover 

Sheet; Form FDA 3397 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

relating to Form FDA 3397, User Fee 

Cover Sheet, that must be submitted 

along with certain drug and biologic 

product applications and supplements. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 15, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information 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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comment on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

User Fee Cover Sheet; Form FDA 3397 

(OMB Control Number 0910–0297)— 

Extension 

Under the prescription drug user fee 

provisions of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

(sections 735 and 736 (21 U.S.C. 379g 

and 379h)), as amended, FDA has the 

authority to assess and collect user fees 

for certain drug and biologics license 

applications (BLAs) and supplements to 

those applications. Under this authority, 

pharmaceutical companies pay a fee for 

certain new human drug applications 

(NDAs), BLAs, or supplements 

submitted to the Agency for review. 

Because the submission of user fees 

concurrently with applications and 

supplements is required, review of an 

application by FDA cannot begin until 

the fee is submitted. The Prescription 

Drug User Fee Cover Sheet, Form FDA 

3397, is designed to provide the 

minimum necessary information to 

determine whether a fee is required for 

review of an application, to determine 

the amount of the fee required, and to 

account for and track user fees. The 

form provides a cross-reference of the 

fee submitted for an application by 

using a unique number tracking system. 

The information collected is used by 

FDA’s Center for Drug Evaluation and 

Research (CDER) and Center for 

Biologics Evaluation and Research 

(CBER) to initiate the administrative 

screening of NDAs, BLAs, and/or, 

supplemental applications to those 

applications. 

Respondents to this collection of 

information are new drug and biologics 

manufacturers. Based on FDA’s database 

system for fiscal year (FY) 2014, there 

are an estimated 290 manufacturers of 

products subject to the Prescription 

Drug User Fee Act (Pub. L. 105–115). 

The total number of annual responses is 

based on the number of submissions 

received by FDA in FY 2014. CDER 

received 3,005 annual responses that 

include the following submissions: 128 

NDAs; 7 BLAs; 1,586 manufacturing 

supplements; 1,081 labeling 

supplements; and 203 efficacy 

supplements. CBER received 705 annual 

responses that include the following 

submissions: 11 BLAs; 611 

manufacturing supplements; 64 labeling 

supplements; and 19 efficacy 

supplements. The estimated hours per 

response are based on past FDA 

experience with the various 

submissions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

FDA 3397 ............................................................................. 290 12.79 3,710 0.5 (30 min.) 1,855 

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


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20233 

Dated: March 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08618 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Joint Workshop on Drug Transporters 

in Absorption, Distribution, 

Metabolism, and Excretion: From the 

Bench to the Bedside 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Drug Transporters in 

Absorption, Distribution, Metabolism, 

and Excretion (ADME): From the Bench 

to the Bedside.’’ The public workshop is 

an American Association of 

Pharmaceutical Scientists/International 

Transporter Consortium (AAPS/ITC) 

Joint Workshop, cosponsored with 

AAPS, the American Society for Clinical 

Pharmacology and Therapeutics, and 

the European Federation for 

Pharmaceutical Sciences. The goals of 

this public workshop are to provide an 

opportunity for scientists in academia, 

industry, and regulatory agencies to 

exchange ideas about the cutting edge 

science in transporters, and to facilitate 

and enhance translational applications 

of new development in transporter 

research in drug development and 

regulatory review of new therapeutics. 

Date and Time: The public workshop 

will be held on April 20, 2015, from 

8:15 a.m. to 7 p.m.; April 21, 2015, from 

8 a.m. to 6:30 p.m.; and April 22, 2015, 

from 8 a.m. to 3:45 p.m. 

Location: The public workshop will 

be held at the Renaissance Baltimore 

Harborplace Hotel, 202 East Pratt St., 

Baltimore, MD 21202. The hotel’s phone 

number is 410–547–1200. 

Contacts: FDA: Lei Zhang, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3196, 

Silver Spring, MD 20993, 301–796– 

1635, email: leik.zhang@fda.hhs.gov. 

AAPS: For questions related to this 

event, please contact AAPS at 

registration@aaps.org. 

Registration: Workshop information 

and the registration link are posted at 

the AAPS meetings and professional 

development conference site. To register 

for the workshop, please visit http://

www.aaps.org/Meetings_and_

Professional_Development/Conference_

Mini_Sites/AAPS_WS_Transporters15/

Register/. The cost of registration is as 

follows: 

AAPS Member .......................... $1,815 

Nonmember .............................. 2,190 

Government .............................. 675 

Academic .................................. 880 

Student ..................................... 110 

The registration fee will be waived for 

50 FDA employees. If you need special 

accommodations because of a disability, 

please contact AAPS at registration@

aaps.org. Onsite registration on the day 

of the workshop will be available. 

Additional Information About the 

Workshop: The workshop agenda and 

additional background materials will be 

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

NewsEvents/ucm439157.htm to all 

registrants. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Transporters serve an important role 

in the ADME of drugs, and in turn could 

affect their safety or efficacy. The 

AAPS/ITC joint transporter workshop in 

2015 aims to continue on the success of 

preceding AAPS workshops on Drug 

Transporters meetings (2003, 2005, 

2007, 2009, 2011, 2013) and ITC 

transporter workshops (2008 and 2012) 

to provide an opportunity for scientists 

in academia, industry, and regulatory 

agencies to exchange ideas about the 

cutting-edge science. Key areas of focus 

will include the following: 

• Transporter tools of the future (e.g., 

organs-on-a-chip, humanized mouse 

models, and transporter imaging); 

• Interplay of drug metabolism and 

transporters; 

• ‘‘State of the art’’ sessions on: 

Æ Emerging transporters, 

Æ Endogenous biomarkers to assess 

transporter-mediated drug efficacy and 

toxicity or to predict drug-drug 

interactions, and 

Æ Quantitative transporter proteomics 

in translational drug metabolism and 

pharmacokinetics; 

• ‘‘Hot Topics’’ in the translation of 

transporter data to the clinic; 

• Prospective transporter substrate 

modeling; and 

• Review of comments related to 

transporters following recent guidances 

issued from the regulatory agencies, 

including FDA, European Medicines 

Agency, and Pharmaceuticals and 

Medical Devices Agency (Japan). 

II. Goals and Objectives 

• To provide a forum for open 

interchange, dissemination, and 

discussion of cutting edge science in 

transporters among scientists from 

academia, industry, and regulatory 

agencies. 

• To develop a mutual understanding 

on what needs to be done in transporter 

research and how to translate 

knowledge obtained from the bench to 

bedside. 

• To facilitate and enhance 

translational applications of new 

development in transporter research in 

drug development and regulatory 

review of new therapeutics. 

Dated: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08614 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Request for Nomination for Industry 

Representatives and Participation 

From Industry Organizations on Public 

Advisory Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on its public advisory committees 

for the Center for Drug Evaluation and 

Research (CDER) notify FDA in writing. 

FDA is also requesting nominations for 

nonvoting industry representatives to 

serve on CDER’s public advisory 

committees. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by May 15, 2015, (see sections I 

and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by May 15, 2015. 

ADDRESSES: All statements of interest 

from interested industry organizations 

interested in participating in the 

selection process of nonvoting industry 

representative nominations should be 


tkelley on DSK3SPTVN1PROD with NOTICES