80 FR 20232 - Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range		20232-20233
FR Document		2015-08618

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.

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015)

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20232-20233]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08618]



[[Page 20232]]

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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, [email protected].

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            FDA form                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FDA 3397........................             290           12.79           3,710   0.5 (30 min.)           1,855
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 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

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

DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Under the those applications. Under this authority,
HUMAN SERVICES PRA (44 U.S.C. 3501–3520), Federal pharmaceutical companies pay a fee for
Agencies must obtain approval from the certain new human drug applications
Food and Drug Administration Office of Management and Budget (NDAs), BLAs, or supplements
[Docket No. FDA–2012–N–0471] (OMB) for each collection of submitted to the Agency for review.
information they conduct or sponsor. Because the submission of user fees
Agency Information Collection ‘‘Collection of information’’ is defined concurrently with applications and
Activities: Proposed Collection; in 44 U.S.C. 3502(3) and 5 CFR supplements is required, review of an
Comment Request; User Fee Cover 1320.3(c) and includes Agency requests application by FDA cannot begin until
Sheet; Form FDA 3397 or requirements that members of the the fee is submitted. The Prescription
public submit reports, keep records, or Drug User Fee Cover Sheet, Form FDA
AGENCY: Food and Drug Administration, provide information to a third party. 3397, is designed to provide the
HHS. Section 3506(c)(2)(A) of the PRA (44 minimum necessary information to
ACTION: Notice. U.S.C. 3506(c)(2)(A)) requires Federal determine whether a fee is required for
Agencies to provide a 60-day notice in review of an application, to determine
SUMMARY: The Food and Drug the Federal Register concerning each
Administration (FDA) is announcing an the amount of the fee required, and to
proposed collection of information, account for and track user fees. The
opportunity for public comment on the including each proposed extension of an
proposed collection of certain form provides a cross-reference of the
existing collection of information, fee submitted for an application by
information by the Agency. Under the before submitting the collection to OMB
Paperwork Reduction Act of 1995 (the using a unique number tracking system.
for approval. To comply with this
PRA), Federal Agencies are required to The information collected is used by
requirement, FDA is publishing notice
publish notice in the Federal Register FDA’s Center for Drug Evaluation and
of the proposed collection of
concerning each proposed collection of Research (CDER) and Center for
information set forth in this document.
information, including each proposed With respect to the following Biologics Evaluation and Research
extension of an existing collection of collection of information, FDA invites (CBER) to initiate the administrative
information, and to allow 60 days for comment on these topics: (1) Whether screening of NDAs, BLAs, and/or,
public comment in response to the the proposed collection of information supplemental applications to those
notice. This notice solicits comments on is necessary for the proper performance applications.
the information collection requirements of FDA’s functions, including whether Respondents to this collection of
relating to Form FDA 3397, User Fee the information will have practical information are new drug and biologics
Cover Sheet, that must be submitted utility; (2) the accuracy of FDA’s manufacturers. Based on FDA’s database
along with certain drug and biologic estimate of the burden of the proposed system for fiscal year (FY) 2014, there
product applications and supplements. collection of information, including the are an estimated 290 manufacturers of
DATES: Submit either electronic or validity of the methodology and products subject to the Prescription
written comments on the collection of assumptions used; (3) ways to enhance Drug User Fee Act (Pub. L. 105–115).
information by June 15, 2015. the quality, utility, and clarity of the The total number of annual responses is
information to be collected; and (4) based on the number of submissions
ADDRESSES: Submit electronic
ways to minimize the burden of the received by FDA in FY 2014. CDER
comments on the collection of
collection of information on received 3,005 annual responses that
information to http://
respondents, including through the use include the following submissions: 128
www.regulations.gov. Submit written
of automated collection techniques, NDAs; 7 BLAs; 1,586 manufacturing
comments on the collection of
when appropriate, and other forms of supplements; 1,081 labeling
information to the Division of Dockets
information technology. supplements; and 203 efficacy
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm. User Fee Cover Sheet; Form FDA 3397 supplements. CBER received 705 annual
1061, Rockville, MD 20852. All (OMB Control Number 0910–0297)— responses that include the following
comments should be identified with the Extension submissions: 11 BLAs; 611
docket number found in brackets in the Under the prescription drug user fee manufacturing supplements; 64 labeling
heading of this document. provisions of the Federal Food, Drug, supplements; and 19 efficacy
FOR FURTHER INFORMATION CONTACT: FDA and Cosmetic Act (the FD&C Act) supplements. The estimated hours per
PRA Staff, Office of Operations, Food (sections 735 and 736 (21 U.S.C. 379g response are based on past FDA
and Drug Administration, 8455 and 379h)), as amended, FDA has the experience with the various
Colesville Rd., COLE–14526, Silver authority to assess and collect user fees submissions.
Spring, MD 20993–0002, PRAStaff@ for certain drug and biologics license FDA estimates the burden of this
fda.hhs.gov. applications (BLAs) and supplements to collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA form responses per burden per Total hours
respondents responses
respondent response
tkelley on DSK3SPTVN1PROD with NOTICES

FDA 3397 ............................................................................. 290 12.79 3,710 0.5 (30 min.) 1,855
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20233

Dated: March 8, 2015. www.aaps.org/Meetings_and_ discussion of cutting edge science in
Leslie Kux, Professional_Development/Conference_ transporters among scientists from
Associate Commissioner for Policy. Mini_Sites/AAPS_WS_Transporters15/ academia, industry, and regulatory
[FR Doc. 2015–08618 Filed 4–14–15; 8:45 am] Register/. The cost of registration is as agencies.
BILLING CODE 4164–01–P
follows: • To develop a mutual understanding
on what needs to be done in transporter
AAPS Member .......................... $1,815 research and how to translate
DEPARTMENT OF HEALTH AND Nonmember .............................. 2,190 knowledge obtained from the bench to
HUMAN SERVICES Government .............................. 675 bedside.
Academic .................................. 880 • To facilitate and enhance
Food and Drug Administration Student ..................................... 110 translational applications of new
development in transporter research in
[Docket No. FDA–2015–N–0001] The registration fee will be waived for drug development and regulatory
50 FDA employees. If you need special review of new therapeutics.
Joint Workshop on Drug Transporters accommodations because of a disability,
in Absorption, Distribution, please contact AAPS at registration@ Dated: April 8, 2015.
Metabolism, and Excretion: From the aaps.org. Onsite registration on the day Leslie Kux,
Bench to the Bedside of the workshop will be available. Associate Commissioner for Policy.
AGENCY: Food and Drug Administration, Additional Information About the [FR Doc. 2015–08614 Filed 4–14–15; 8:45 am]
HHS. Workshop: The workshop agenda and BILLING CODE 4164–01–P

ACTION: Notice of public workshop. additional background materials will be
accessible at http://www.fda.gov/Drugs/
The Food and Drug Administration NewsEvents/ucm439157.htm to all DEPARTMENT OF HEALTH AND
(FDA) is announcing a public workshop registrants. HUMAN SERVICES
entitled ‘‘Drug Transporters in SUPPLEMENTARY INFORMATION:
Absorption, Distribution, Metabolism, Food and Drug Administration
and Excretion (ADME): From the Bench I. Background [Docket No. FDA–2015–N–0001]
to the Bedside.’’ The public workshop is Transporters serve an important role
an American Association of in the ADME of drugs, and in turn could Request for Nomination for Industry
Pharmaceutical Scientists/International affect their safety or efficacy. The Representatives and Participation
Transporter Consortium (AAPS/ITC) AAPS/ITC joint transporter workshop in From Industry Organizations on Public
Joint Workshop, cosponsored with 2015 aims to continue on the success of Advisory Committees
AAPS, the American Society for Clinical preceding AAPS workshops on Drug
Pharmacology and Therapeutics, and AGENCY: Food and Drug Administration,
Transporters meetings (2003, 2005, HHS.
the European Federation for 2007, 2009, 2011, 2013) and ITC
Pharmaceutical Sciences. The goals of ACTION: Notice.
transporter workshops (2008 and 2012)
this public workshop are to provide an to provide an opportunity for scientists SUMMARY: The Food and Drug
opportunity for scientists in academia, in academia, industry, and regulatory Administration (FDA) is requesting that
industry, and regulatory agencies to agencies to exchange ideas about the any industry organizations interested in
exchange ideas about the cutting edge cutting-edge science. Key areas of focus participating in the selection of
science in transporters, and to facilitate will include the following: nonvoting industry representatives to
and enhance translational applications • Transporter tools of the future (e.g., serve on its public advisory committees
of new development in transporter organs-on-a-chip, humanized mouse for the Center for Drug Evaluation and
research in drug development and models, and transporter imaging); Research (CDER) notify FDA in writing.
regulatory review of new therapeutics. • Interplay of drug metabolism and FDA is also requesting nominations for
Date and Time: The public workshop transporters; nonvoting industry representatives to
will be held on April 20, 2015, from • ‘‘State of the art’’ sessions on: serve on CDER’s public advisory
8:15 a.m. to 7 p.m.; April 21, 2015, from Æ Emerging transporters, committees. A nominee may either be
8 a.m. to 6:30 p.m.; and April 22, 2015, Æ Endogenous biomarkers to assess self-nominated or nominated by an
from 8 a.m. to 3:45 p.m. transporter-mediated drug efficacy and organization to serve as a nonvoting
Location: The public workshop will toxicity or to predict drug-drug industry representative. Nominations
be held at the Renaissance Baltimore interactions, and will be accepted for current vacancies
Harborplace Hotel, 202 East Pratt St., Æ Quantitative transporter proteomics
effective with this notice.
Baltimore, MD 21202. The hotel’s phone in translational drug metabolism and
number is 410–547–1200. DATES: Any industry organization
pharmacokinetics;
Contacts: FDA: Lei Zhang, Food and • ‘‘Hot Topics’’ in the translation of interested in participating in the
Drug Administration, Center for Drug transporter data to the clinic; selection of an appropriate nonvoting
Evaluation and Research, 10903 New • Prospective transporter substrate member to represent industry interests
Hampshire Ave., Bldg. 51, Rm. 3196, modeling; and must send a letter stating that interest to
Silver Spring, MD 20993, 301–796– • Review of comments related to FDA by May 15, 2015, (see sections I
1635, email: leik.zhang@fda.hhs.gov. transporters following recent guidances and II of this document for further
AAPS: For questions related to this issued from the regulatory agencies, details). Concurrently, nomination
tkelley on DSK3SPTVN1PROD with NOTICES

event, please contact AAPS at including FDA, European Medicines materials for prospective candidates
registration@aaps.org. Agency, and Pharmaceuticals and should be sent to FDA by May 15, 2015.
Registration: Workshop information Medical Devices Agency (Japan). ADDRESSES: All statements of interest
and the registration link are posted at from interested industry organizations
the AAPS meetings and professional II. Goals and Objectives interested in participating in the
development conference site. To register • To provide a forum for open selection process of nonvoting industry
for the workshop, please visit http:// interchange, dissemination, and representative nominations should be

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Document Created: 2015-12-18 11:13:39
Document Modified: 2015-12-18 11:13:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by June 15, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 20232

80 FR 20232 - Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration