Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications, 20924-20925 [2013-08012]
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20924
Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1140.32 ................................................................................
1
1
1
1
1
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding pharmaceutical advertising
and cigarette and smokeless tobacco
product advertising expenditures. The
burden collection does not include
reporting burdens associated with
providing established names on labels
and statements of intended use because
section 102 of the Tobacco Control Act
required that these provisions be struck
from the reissued final rule (previously
included in §§ 897.24 and 897.32(c)).
Section 1140.30 requires
manufacturers, distributors, and
retailers to observe certain format and
content requirements for labeling and
advertising, and requires manufacturers,
distributors, and retailers to notify FDA
if they intend to use an advertising
medium that is not listed in the
regulations. The concept of permitted
advertising in § 1140.30 is sufficiently
broad to encompass most forms of
advertising. FDA estimates that
approximately 300 respondents will
submit an annual notice of alternative
advertising, and the Agency has
estimated it should take 1 hour to
provide such notice.
For the recordkeeping and disclosure
requirements, § 1140.32 requires
competent and reliable survey evidence
to establish whether a newspaper,
magazine, periodical, or other
publication qualifies as an ‘‘adult’’
publication. Section 1140.32 also
requires the use of a black text on a
white background for labeling and
advertising. The respondent and hourly
burden for recordkeeping and disclosure
under this section (2 burden hours total)
reflect placeholders for the number of
manufacturers who would keep records
under this section.
During the next 3 years, FDA does not
intend to enforce the recordkeeping and
disclosure requirements of § 1140.32
and has revised the burden to act as a
placeholder in the event FDA exercises
its authority to enforce the requirements
of this section in the future.
FDA estimates that the total time
required for this collection of
information is 302 hours.
VerDate Mar<15>2010
20:02 Apr 05, 2013
Jkt 229001
Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08034 Filed 4–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0248]
Center for Biologics Evaluation and
Research eSubmitter Pilot Evaluation
Program for Investigational New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is announcing an invitation to
sponsors of investigational new drug
(IND) applications to participate in a
pilot evaluation program for CBER’s
eSubmitter Program (eSubmitter).
CBER’s eSubmitter is a computerassisted automated program that has
been customized to facilitate the
creation of IND applications in
electronic format, including a template
specifically for IND applications related
to antivenom drugs/antivenins.
Participation in the pilot program is
open to sponsors that submit IND
applications to the Office of Blood
Research and Review, the Office of
Cellular, Tissue and Gene Therapy, or
the Office of Vaccines Research and
Review in CBER. CBER will only accept
participation from up to nine sponsors.
The pilot program is intended to
provide industry and CBER regulatory
review staff with an opportunity to
evaluate the eSubmitter system and
determine if it facilitates the IND
submission process. The purpose of this
notice is to invite sponsors of IND
applications to contact CBER for more
information if they are interested in
participating in this pilot program.
DATES: Submit an electronic request for
participation in this program by July 8,
2013.
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
If you are interested in
participating in this program, you
should submit an electronic request to
CBER_eSubmitter_program
@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Lore
Fields, Office of Blood Research and
Review, Center for Biologics Evaluation
and Research (HFM–375), Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448, 301–827–6143, FAX: 301–827–
3534, email: lore.fields@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
CBER regulates certain biological
products and is committed to advancing
the public health through innovative
activities that help ensure the safety,
effectiveness, and timely delivery of
these products to patients. Further,
CBER seeks to continuously enhance
and update the efficiency and quality of
its regulatory review process and to
facilitate its interaction with
stakeholders by providing CBER staff
and industry with improved processes.
In support of this goal, CBER has
participated in FDA’s development of
eSubmitter to improve the process for
providing certain regulatory
submissions to FDA.
II. eSubmitter Pilot Evaluation Program
Expectations
The eSubmitter pilot evaluation
program is expected to last
approximately 6 months. During this
period of time, participants will
complete their IND application
submissions using the eSubmitter
template developed by FDA that has
been specifically designed for use by
IND sponsors. eSubmitter was
developed using the same criteria for
applications that are currently used in
the IND application review process at
CBER. To create the IND application,
the participant will enter the requested
information into the eSubmitter tool and
attach requested documents as an
Adobe document (pdf format). This
information will be saved onto a CD–
ROM by the sponsor and mailed to
CBER for review. Paper copies of
submissions will not be required. CBER
will review the information provided on
E:\FR\FM\08APN1.SGM
08APN1
Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices
the CD–ROM and the attachments
according to current managed review
procedures. Only new IND applications
and their amendments will be eligible
for participation in the pilot program.
During the IND application process,
CBER staff will be available to answer
any questions or concerns that may
arise. As each application is completed,
the users will be asked to comment on
the eSubmitter program. These
comments and discussions will assist
CBER in the final development and
release of this electronic program for use
by industry.
III. Requests for Participation
Requests to participate in the
eSubmitter Pilot Evaluation Program
should be sent electronically to
CBER_eSubmitter_program
@fda.hhs.gov. You should include the
following information in your request:
Contact name, contact phone number,
email address, name of the facility,
address, and registration number (if
applicable). Once requests for
participation are received, FDA will
contact interested sponsors to discuss
the pilot program.
Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08012 Filed 4–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Draft and Revised Draft Guidances for
Industry Describing Product-Specific
Bioequivalence Recommendations;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of additional draft and
revised draft product-specific
bioequivalence (BE) recommendations.
The recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of June 11, 2010 (75 FR 33311),
FDA announced the availability of a
guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
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SUMMARY:
VerDate Mar<15>2010
20:02 Apr 05, 2013
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20925
site. The BE recommendations
identified in this notice were developed
using the process described in that
guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on these draft
and revised draft guidances before it
begins work on the final versions of the
guidances, submit either electronic or
written comments on the draft and
revised draft product-specific BE
recommendations listed in this notice
by June 7, 2013.
ADDRESSES: Submit written requests for
single copies of the individual BE
guidances 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 draft
guidance recommendations.
Submit electronic comments on the
draft product-specific BE
recommendations 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.
FOR FURTHER INFORMATION CONTACT: Kris
´
Andre, Center for Drug Evaluation and
Research (HFD–600), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9326.
SUPPLEMENTARY INFORMATION:
recommendations within 60 days of
their announcement in the Federal
Register. FDA considers any comments
received and either publishes final
recommendations or publishes revised
draft recommendations for comment.
Recommendations were last announced
in the Federal Register of December 17,
2012 (77 FR 74669). This notice
announces draft product-specific
recommendations, either new or
revised, that are being posted on FDA’s
Web site concurrently with publication
of this notice.
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that
guidance, FDA adopted this process as
a means to develop and disseminate
product-specific BE recommendations
and provide a meaningful opportunity
for the public to consider and comment
on those recommendations. Under that
process, draft recommendations are
posted on FDA’s Web site and
announced periodically in the Federal
Register. The public is encouraged to
submit comments on those
H
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Fmt 4703
Sfmt 4703
II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing new draft
product-specific BE recommendations
for drug products containing the
following active ingredients:
A
Albuterol sulfate (multiple RLDs)
Amoxicillin
C
Cefixime
D
Desipramine hydrochloride
Desvenlafaxine
Dutasteride; tamsulosin hydrochloride
E
Estramustine phosphate sodium
Ethinyl estradiol, etonogestrel
Ethionamide
Ezogabine
F
Flutamide
Hydrocortisone
I
Icosapent ethyl
K
Ketorolac tromethamine
L
Loratadine
M
Miconazole
Minocycline hydrochloride
Mitotane
N
Nevirapine
P
Phentermine hydrochloride; topiramate
R
Rimexolone
Rizatriptan benzoate
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20924-20925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0248]
Center for Biologics Evaluation and Research eSubmitter Pilot
Evaluation Program for Investigational New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing an invitation to
sponsors of investigational new drug (IND) applications to participate
in a pilot evaluation program for CBER's eSubmitter Program
(eSubmitter). CBER's eSubmitter is a computer-assisted automated
program that has been customized to facilitate the creation of IND
applications in electronic format, including a template specifically
for IND applications related to antivenom drugs/antivenins.
Participation in the pilot program is open to sponsors that submit IND
applications to the Office of Blood Research and Review, the Office of
Cellular, Tissue and Gene Therapy, or the Office of Vaccines Research
and Review in CBER. CBER will only accept participation from up to nine
sponsors. The pilot program is intended to provide industry and CBER
regulatory review staff with an opportunity to evaluate the eSubmitter
system and determine if it facilitates the IND submission process. The
purpose of this notice is to invite sponsors of IND applications to
contact CBER for more information if they are interested in
participating in this pilot program.
DATES: Submit an electronic request for participation in this program
by July 8, 2013.
ADDRESSES: If you are interested in participating in this program, you
should submit an electronic request to CBER_eSubmitter_program@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Lore Fields, Office of Blood Research
and Review, Center for Biologics Evaluation and Research (HFM-375),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6143, FAX: 301-827-3534, email:
lore.fields@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological products and is committed to
advancing the public health through innovative activities that help
ensure the safety, effectiveness, and timely delivery of these products
to patients. Further, CBER seeks to continuously enhance and update the
efficiency and quality of its regulatory review process and to
facilitate its interaction with stakeholders by providing CBER staff
and industry with improved processes. In support of this goal, CBER has
participated in FDA's development of eSubmitter to improve the process
for providing certain regulatory submissions to FDA.
II. eSubmitter Pilot Evaluation Program Expectations
The eSubmitter pilot evaluation program is expected to last
approximately 6 months. During this period of time, participants will
complete their IND application submissions using the eSubmitter
template developed by FDA that has been specifically designed for use
by IND sponsors. eSubmitter was developed using the same criteria for
applications that are currently used in the IND application review
process at CBER. To create the IND application, the participant will
enter the requested information into the eSubmitter tool and attach
requested documents as an Adobe document (pdf format). This information
will be saved onto a CD-ROM by the sponsor and mailed to CBER for
review. Paper copies of submissions will not be required. CBER will
review the information provided on
[[Page 20925]]
the CD-ROM and the attachments according to current managed review
procedures. Only new IND applications and their amendments will be
eligible for participation in the pilot program.
During the IND application process, CBER staff will be available to
answer any questions or concerns that may arise. As each application is
completed, the users will be asked to comment on the eSubmitter
program. These comments and discussions will assist CBER in the final
development and release of this electronic program for use by industry.
III. Requests for Participation
Requests to participate in the eSubmitter Pilot Evaluation Program
should be sent electronically to CBER_eSubmitter_program@fda.hhs.gov.
You should include the following information in your request: Contact
name, contact phone number, email address, name of the facility,
address, and registration number (if applicable). Once requests for
participation are received, FDA will contact interested sponsors to
discuss the pilot program.
Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08012 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P
