Pediatric Clinical Investigator Training Workshop, 23982-23983 [2014-09695]
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23982
Federal Register / Vol. 79, No. 82 / Tuesday, April 29, 2014 / Notices
‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations (§ 720.6) also are
reported on Forms FDA 2512 and FDA
2512a. When a firm discontinues the
commercial distribution of a cosmetic,
we request that the firm file Form FDA
2514, ‘‘Notice of Discontinuance of
Commercial Distribution of Cosmetic
Product Formulation’’ (§§ 720.3 and
720.6). If any of the information
submitted on or with these forms is
confidential, the firm may submit a
request for confidentiality under
§ 720.8.
FDA’s online filing system is available
on FDA’s VCRP Web site at https://
www.fda.gov/Cosmetics/
RegistrationProgram/
OnlineRegistration/ucm100241.htm.
The online filing system contains the
electronic versions of Forms FDA 2512,
2512a, and 2514, which are collectively
found within the electronic version of
Form FDA 2512.
We place cosmetic product filing
information in a computer database and
use the information for evaluation of
cosmetic products currently on the
market. Because filing of cosmetic
product formulations is not mandatory,
voluntary filings provide us with the
best information available about
cosmetic product ingredients and their
frequency of use, businesses engaged in
the manufacture and distribution of
cosmetics, and approximate rates of
product discontinuance and formula
modifications. The information assists
our scientists in evaluating reports of
alleged injuries and adverse reactions
from the use of cosmetics. We also use
the information in defining and
planning analytical and toxicological
studies pertaining to cosmetics.
Information from the database is
releasable to the public under our
compliance with the Freedom of
Information Act. We share
nonconfidential information from our
files on cosmetics with consumers,
medical professionals, and industry.
In the Federal Register of February 6,
2014 (79 FR 7196), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
No. of
respondents
Total annual
responses
Hours per
response
21 CFR Section or Part
Form no.
Total hours
Part 710 (registrations) .......
720.1 through 720.4 (ingredient statements for new
submissions).
720.6 (amendments) ...........
720.6 (notices of discontinuance).
720.8 (requests for confidentiality).
Total .............................
FDA 2511 2 .........................
FDA 2512 3 .........................
81
4,877
1
1
81
4,877
0.2
0.33
16
1,609
FDA 2512 ...........................
FDA 2512 ...........................
1,042
1,826
1
1
1,042
1,826
0.17
0.1
177
183
.............................................
1
1
1
2.0
2.0
.............................................
........................
........................
........................
........................
1,987
1 There
sroberts on DSK5SPTVN1PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and electronic Form FDA 2511 in the electronic system known as the
Voluntary Cosmetic Registration Program, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/
ucm090947.htm.
3 The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system
known as the Voluntary Cosmetic Registration Program, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/
OnlineRegistration/ucm100241.htm.
We base our estimate of the total
annual responses on paper and
electronic submissions received during
calendar years 2011, 2012 and 2013. We
base our estimate of the hours per
response upon information from
cosmetic industry personnel and our
experience entering data submitted on
paper Forms 2511, 2512, 2512a, and
2514 into the electronic system.
We estimate that, annually, 81
establishments that manufacture or
package cosmetic products will each
submit 1 registration on Form FDA
2511, for a total of 81 annual responses.
Each submission is estimated to take 0.2
hour per response for a total of 16.2
hours, rounded to 16. We estimate that,
annually, firms that manufacture, pack,
or distribute cosmetics will file 4,877
ingredient statements for new
submissions on Forms FDA 2512 and
FDA 2512a. Each submission is
estimated to take 0.33 hour per response
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16:56 Apr 28, 2014
Jkt 232001
for a total of 1,609.41 hours, rounded to
1,609. We estimate that, annually, firms
that manufacture, pack, or distribute
cosmetics will file 1,042 amendments to
product formulations on Forms FDA
2512 and FDA 2512a. Each submission
is estimated to take 0.17 hour per
response for a total of 177.14 hours,
rounded to 177. We estimate that,
annually, firms that manufacture, pack,
or distribute cosmetics will file 1,826
notices of discontinuance on Form FDA
2514. Each submission is estimated to
take 0.1 hour per response for a total of
182.6 hours, rounded to 183. We
estimate that, annually, one firm will
file one request for confidentiality. Each
such request is estimated to take 2 hours
to prepare for a total of 2.0 hours. Thus,
the total estimated hour burden for this
information collection is 1,987 hours.
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Frm 00055
Fmt 4703
Sfmt 4703
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09692 Filed 4–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Pediatric Clinical Investigator Training
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Office of
Pediatric Therapeutics (OPT) and the
Center for Drug Evaluation and Research
are announcing a 1-day public
SUMMARY:
E:\FR\FM\29APN1.SGM
29APN1
Federal Register / Vol. 79, No. 82 / Tuesday, April 29, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
workshop entitled ‘‘Pediatric Clinical
Investigator Training.’’ The purpose of
this workshop is to provide
investigators with training and expertise
in designing and conducting clinical
trials in pediatric patients that will lead
to appropriate labeling. The training
course is intended to provide
investigators with a clear understanding
of some of the challenges of studying
products in the pediatric population
when the data are intended to be used
to support product labeling, an
overview of extrapolation as it relates to
the pediatric population, a familiarity
with FDA processes and timelines that
are specific to pediatric product
development, and an overview of
ethically appropriate methods related to
the design of clinical trials in the
pediatric population.
DATES: The public workshop will be
held on September 22, 2014, from 8 a.m.
to 5:30 p.m.
ADDRESSES: The public workshop will
be held at the Pooks Hill Marriott, 5151
Pooks Hill Rd., Bethesda, MD 20814.
The hotel’s telephone number is 301–
897–9400.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Crescenzi, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–8646, FAX: 301–847–8640,
email: terrie.crescenzi@fda.hhs.gov; or
Betsy Sanford, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–8659, FAX: 301–847–8640,
elizabeth.sanford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2012, the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144) made permanent
the pediatric initiatives, Best
Pharmaceuticals for Children Act and
Pediatric Research Equity Act, which
have stimulated pediatric research over
the past 15 years. Though much
progress has been made, pediatric trials
for the purpose of developing product
use parameters and information are still
performed much less frequently than
adult trials. As such, current standards
for trials are much more oriented to
adult scientific, ethical, and clinical
processes. This situation is due, in part,
to the fact that pediatric trials have a
number of unique attributes and
requirements, which must be met if the
data are to be accepted or used by FDA.
The development of safe and effective
products in the pediatric population
presents many challenges. These
VerDate Mar<15>2010
16:56 Apr 28, 2014
Jkt 232001
challenges include trial design,
appropriate endpoints, extrapolation of
data from adults, and ethical issues. It
is extremely important that pediatric
researchers recognize and understand
the challenges and differences between
the standards for adult trials and
pediatric trials. Researchers are
responsible for ensuring the safe and
ethical treatment of pediatric patients
and obtaining adequate and reliable data
to support regulatory decisions. There is
a critical need for further pediatric
research on medical products to obtain
additional data, which will help ensure
that these products are safe and effective
in the pediatric population. We are able
to obtain data and information in older
children; however, the challenge of
obtaining data from non-verbal children
and neonates is much more difficult.
This need reinforces our responsibility
to educate clinical investigators to
assure that children are only enrolled in
research that is scientifically necessary,
ethically sound, and designed to meet
the challenges of review by FDA.
II. Participation in the Public
Workshop
A. 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, firstserved basis. Persons interested in
attending this workshop must register
online by sending an email to OPT@
fda.hhs.gov before September 8, 2014,
and include the following information:
Name, title, affiliation, email address,
and telephone number. For those
without Internet access, please contact
Terrie L. Crescenzi or Betsy Sanford (see
FOR FURTHER INFORMATION CONTACT) to
register. In the event that a minimum
number of participants have not
registered, the workshop will be
postponed. Registered participants will
be notified of any change. Registration
on the day of the public workshop will
be provided on a space available basis
beginning at 8 a.m.
Registration information, the agenda
and additional background materials
can be found at https://www.fda.gov/
NewsEvents/MeetingsConferences
Workshops/ucm392506.htm.
If you need special accommodations
due to a disability, please contact Betsy
Sanford (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance.
Persons attending the course are advised
that FDA is not responsible for
providing access to electrical outlets.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
23983
B. Videotaping
The workshop will be videotaped and
available on the Internet at https://
wcms.fda.gov/FDAgov/NewsEvents/
MeetingsConferencesWorkshops/
ucm392506.htm?ssSourceSiteId=
null&SSContributor=true,
approximately 30 days after the
workshop.
Dated: April 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09695 Filed 4–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[Funding Opportunity Number: HHS–2014–
IHS–INMED–0001; CFDA Number: 93.970]
Funding Opportunity: American
Indians Into Medicine
Announcement Type: New and
Competing Continuation.
Key Dates
Application Deadline: June 13, 2014.
Review Date: June 25, 2014.
Earliest Anticipated Start Date:
September 1, 2014.
Proof of Non-Profit Status Due Date:
June 13, 2014.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting competitive grant applications
for the Indians into Medicine Program
(INMED). This program is authorized
under the authority of 25 U.S.C. 1616g,
Indian Health Care Improvement Act,
Public Law 94–437, as amended
(IHCIA). This program is described in
the Catalog of Federal Domestic
Assistance under 93.970.
Background
The IHS, an agency within the
Department of Health and Human
Services (HHS), is responsible for
providing Federal health services to
American Indians and Alaska Natives
(AI/AN). The mission of the IHS is to
raise the physical, mental, social, and
spiritual health of AI/AN. The IHCIA
authorizes the IHS to administer
programs that are designed to attract
and recruit qualified individuals into
health professions needed at IHS
facilities. The programs administered
are designed to encourage AI/AN to
enter health professions and to ensure
the availability of health professionals
to serve AI/AN populations.
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23982-23983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Pediatric Clinical Investigator Training Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric
Therapeutics (OPT) and the Center for Drug Evaluation and Research are
announcing a 1-day public
[[Page 23983]]
workshop entitled ``Pediatric Clinical Investigator Training.'' The
purpose of this workshop is to provide investigators with training and
expertise in designing and conducting clinical trials in pediatric
patients that will lead to appropriate labeling. The training course is
intended to provide investigators with a clear understanding of some of
the challenges of studying products in the pediatric population when
the data are intended to be used to support product labeling, an
overview of extrapolation as it relates to the pediatric population, a
familiarity with FDA processes and timelines that are specific to
pediatric product development, and an overview of ethically appropriate
methods related to the design of clinical trials in the pediatric
population.
DATES: The public workshop will be held on September 22, 2014, from 8
a.m. to 5:30 p.m.
ADDRESSES: The public workshop will be held at the Pooks Hill Marriott,
5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel's telephone number
is 301-897-9400.
FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8646, FAX: 301-
847-8640, email: terrie.crescenzi@fda.hhs.gov; or Betsy Sanford, Office
of Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8659, FAX: 301-
847-8640, elizabeth.sanford@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2012, the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144) made permanent the pediatric
initiatives, Best Pharmaceuticals for Children Act and Pediatric
Research Equity Act, which have stimulated pediatric research over the
past 15 years. Though much progress has been made, pediatric trials for
the purpose of developing product use parameters and information are
still performed much less frequently than adult trials. As such,
current standards for trials are much more oriented to adult
scientific, ethical, and clinical processes. This situation is due, in
part, to the fact that pediatric trials have a number of unique
attributes and requirements, which must be met if the data are to be
accepted or used by FDA.
The development of safe and effective products in the pediatric
population presents many challenges. These challenges include trial
design, appropriate endpoints, extrapolation of data from adults, and
ethical issues. It is extremely important that pediatric researchers
recognize and understand the challenges and differences between the
standards for adult trials and pediatric trials. Researchers are
responsible for ensuring the safe and ethical treatment of pediatric
patients and obtaining adequate and reliable data to support regulatory
decisions. There is a critical need for further pediatric research on
medical products to obtain additional data, which will help ensure that
these products are safe and effective in the pediatric population. We
are able to obtain data and information in older children; however, the
challenge of obtaining data from non-verbal children and neonates is
much more difficult. This need reinforces our responsibility to educate
clinical investigators to assure that children are only enrolled in
research that is scientifically necessary, ethically sound, and
designed to meet the challenges of review by FDA.
II. Participation in the Public Workshop
A. 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 by sending an email to OPT@fda.hhs.gov
before September 8, 2014, and include the following information: Name,
title, affiliation, email address, and telephone number. For those
without Internet access, please contact Terrie L. Crescenzi or Betsy
Sanford (see FOR FURTHER INFORMATION CONTACT) to register. In the event
that a minimum number of participants have not registered, the workshop
will be postponed. Registered participants will be notified of any
change. Registration on the day of the public workshop will be provided
on a space available basis beginning at 8 a.m.
Registration information, the agenda and additional background
materials can be found at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm.
If you need special accommodations due to a disability, please
contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance. Persons attending the course are advised that FDA is
not responsible for providing access to electrical outlets.
B. Videotaping
The workshop will be videotaped and available on the Internet at
https://wcms.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm392506.htm?ssSourceSiteId=null&SSContributor=true, approximately 30
days after the workshop.
Dated: April 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09695 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P
