Preparation for International Cooperation on Cosmetics Regulation; Public Meeting, 22993-22994 [2014-09465]
Download as PDF
<![CDATA[
22993
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR Part
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Tracking information—821.25(a) .........................................
Record of tracking data—821.25(b) ....................................
Standard operating procedures—821.25(c) 2 ......................
Manufacturer data audit—821.25(c)(3) ................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
12
12
12
12
1
46,260
1
1,124
12
555,120
12
13,488
76
1
63
1
912
555,120
756
13,488
22,000
1
22,000
1
22,000
Total ..............................................................................
........................
........................
........................
........................
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/21 CFR Part
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) .............................................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
Total ..............................................................................
........................
........................
........................
........................
23,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09467 Filed 4–24–14; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Preparation for International
Cooperation on Cosmetics Regulation;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA or we) is announcing a public
meeting entitled, ‘‘International
Cooperation on Cosmetics Regulation
(ICCR)—Preparation for ICCR–8
Meeting.’’ The purpose of the meeting is
to invite public input on various topics
pertaining to the regulation of
cosmetics. We may use this input to
help us prepare for the ICCR–8 meeting
that will be held in Canada from July 8
to 10, 2014.
Date and Time: The meeting will be
held on June 4, 2014, from 2 p.m. to 4
p.m.
Location: The meeting will be held at
the Food and Drug Administration,
VerDate Mar<15>2010
16:57 Apr 24, 2014
Jkt 232001
Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Pkwy.,
Wiley Auditorium (first floor), College
Park, MD 20740.
Contact Person: If you intend to
participate in the meeting, you should
register with Maria Rossana (Rosemary)
Cook, Office of Cosmetics and Colors,
Food and Drug Administration, 4300
River Rd., College Park, MD 20740,
email: maria.cook@fda.hhs.gov or FAX:
301–436–2975.
Registration and Requests for Oral
Presentations: Send registration
information (including your name, title,
firm name, address, telephone number,
fax number, and email address), written
material, and requests to make an oral
presentation, to the contact person by
May 20, 2014.
If you need special accommodations
due to a disability, please contact Maria
Rossana (Rosemary) Cook (see Contact
Person) by May 28, 2014.
SUPPLEMENTARY INFORMATION: You may
present proposals for future ICCR
agenda items, data, information, or
views orally or in writing, on issues
pending at the public meeting. Time
allotted for oral presentations may be
limited to 10 minutes or less for each
presenter. If you wish to make an oral
presentation, you should notify the
contact person by May 20, 2014, and
submit a brief statement of the general
nature of the evidence or arguments that
you wish to present, your name,
address, telephone number, fax number,
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
and email address, and indicate the
approximate amount of time you need
to make your presentation.
Transcripts: As soon as a transcript is
available, it will be accessible at
https://www.regulations.gov. It also may
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20850. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. You
should send written requests for a
hardcopy or CD–ROM transcript to the
Division of Freedom of Information,
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
The Purpose of the Multilateral
Framework on the ICCR: The purpose of
the multilateral framework on the ICCR
is to pave the way for the removal of
regulatory obstacles to international
trade while maintaining global
consumer protection.
ICCR is a voluntary international
group of cosmetics regulatory
authorities from the United States,
Japan, the European Union, and Canada.
These regulatory authority members
will enter into constructive dialogue
with their relevant cosmetics industry
trade associations and public advocacy
groups. Currently, the ICCR members
are: Health Canada; the European
Directorate General for Health and
Consumers; the Ministry of Health,
E:\FR\FM\25APN1.SGM
25APN1
22994
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
Labor and Welfare of Japan; and the U.S.
Food and Drug Administration. All
decisions made by consensus will be
compatible with the laws, policies,
rules, regulations, and directives of the
respective administrations and
governments. Members will implement
and/or promote actions or documents
within their own jurisdictions and seek
convergence of regulatory policies and
practices. Successful implementation
will need input from stakeholders.
We will make the agenda for the
public meeting available on the Internet
at: https://www.fda.gov/Cosmetics/
InternationalActivities/
ConferencesMeetingsWorkshops/
InternationalCooperationonCosmetics
RegulationsICCR/default.htm.
Depending on the number of requests
for oral presentations, we intend to have
an agenda available by May 30, 2014.
We may use the information that you
provide to us during the public meeting
to help us prepare for the July 8 to 10,
2014, ICCR–8 meeting.
HHS.
The public meeting will be held
on June 10, 2014, from 9 a.m. to 1 p.m.
Registration to attend the meeting must
be received by May 27, 2014 (see the
SUPPLEMENTARY INFORMATION section for
instructions).
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security checks will be performed. For
more information on parking and
security procedures, please refer to
https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit either electronic or written
comments by August 11, 2014. Submit
electronic comments to
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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FDA will post the agenda
approximately 5 days before the meeting
at:https://www.fda.gov/Drugs/
NewsEvents/ucm387057.htm.
FOR FURTHER INFORMATION CONTACT:
Pujita Vaidya, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1170,
Silver Spring, MD 20993, 301–796–
0684, FAX: 301–796–0684, email:
Pujita.Vaidya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ACTION:
Notice of public meeting;
request for comments.
I. Background on Patient-Focused Drug
Development
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting and an
opportunity for public comment on
Patient-Focused Drug Development for
neurologic manifestations of inborn
errors of metabolism. Patient-Focused
Drug Development is part of FDA’s
performance commitments made as part
of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to
allow FDA to obtain patient
perspectives on the impact of neurologic
manifestations of inborn errors of
metabolism on daily life as well as
patient views on treatment approaches
for neurologic manifestations of inborn
errors of metabolism.
FDA has selected neurologic
manifestations of inborn errors of
metabolism as the focus of a public
meeting under Patient-Focused Drug
Development, an initiative that involves
obtaining a better understanding of
patients’ perspectives on the severity of
the disease and the available therapies
for the condition. Patient-Focused Drug
Development is being conducted to
fulfill FDA performance commitments
that are part of the authorization of
PDUFA V under Title I of the Food and
Drug Safety and Innovation Act
(FDASIA) (Pub. L. 112–144). The full set
of performance commitments is
available on the FDA Web site at
https://www.fda.gov/downloads/
forindustry/userfees/
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09465 Filed 4–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0396]
Public Meeting on Patient-Focused
Drug Development for Neurologic
Manifestations of Inborn Errors of
Metabolism
AGENCY:
Food and Drug Administration,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:57 Apr 24, 2014
Jkt 232001
DATES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
prescriptiondruguserfee/
ucm270412.pdf.
FDA committed to obtain the patient
perspective on 20 disease areas during
the course of PDUFA V. For each
disease area, the Agency will conduct a
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
communities, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice (78 FR 08441) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FYs) 2013–
15, the first 3 years of the 5-year PDUFA
V timeframe. The Agency used several
criteria outlined in the April 11, 2013,
notice to develop the list of disease
areas. FDA obtained public comment on
the Agency’s proposed criteria and
potential disease areas through a public
docket and a public meeting that was
convened on October 25, 2012. In
selecting the set of disease areas, FDA
carefully considered the public
comments received and the perspectives
of review divisions at FDA. By the end
of FY 2015, FDA will initiate a second
public process for determining the
disease areas for FY 2016–17. More
information, including the list of disease
areas and a general schedule of
meetings, is posted on FDA’s Web site
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused
Drug Development meeting is to obtain
input on the symptoms and other
impacts of neurologic manifestations of
inborn errors of metabolism that matter
most to patients, as well as perspectives
on current approaches to treating
neurologic manifestations of inborn
errors of metabolism. FDA expects that
this information will come directly from
patients, caregivers, and patient
advocates. Inborn errors of metabolism
include a range of genetic disorders in
which the body has an enzyme
deficiency, which causes buildup of
harmful metabolites. Examples of
inborn errors of metabolism include
phenylketonuria, lysosomal storage
disorders, Wilson disease, and many
others. Symptoms vary depending on
the condition and can be acute or
chronic. Neurologic symptoms are
common. For most inborn errors of
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22993-22994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Preparation for International Cooperation on Cosmetics
Regulation; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA or we) is announcing a public
meeting entitled, ``International Cooperation on Cosmetics Regulation
(ICCR)--Preparation for ICCR-8 Meeting.'' The purpose of the meeting is
to invite public input on various topics pertaining to the regulation
of cosmetics. We may use this input to help us prepare for the ICCR-8
meeting that will be held in Canada from July 8 to 10, 2014.
Date and Time: The meeting will be held on June 4, 2014, from 2
p.m. to 4 p.m.
Location: The meeting will be held at the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5100
Paint Branch Pkwy., Wiley Auditorium (first floor), College Park, MD
20740.
Contact Person: If you intend to participate in the meeting, you
should register with Maria Rossana (Rosemary) Cook, Office of Cosmetics
and Colors, Food and Drug Administration, 4300 River Rd., College Park,
MD 20740, email: maria.cook@fda.hhs.gov or FAX: 301-436-2975.
Registration and Requests for Oral Presentations: Send registration
information (including your name, title, firm name, address, telephone
number, fax number, and email address), written material, and requests
to make an oral presentation, to the contact person by May 20, 2014.
If you need special accommodations due to a disability, please
contact Maria Rossana (Rosemary) Cook (see Contact Person) by May 28,
2014.
SUPPLEMENTARY INFORMATION: You may present proposals for future ICCR
agenda items, data, information, or views orally or in writing, on
issues pending at the public meeting. Time allotted for oral
presentations may be limited to 10 minutes or less for each presenter.
If you wish to make an oral presentation, you should notify the contact
person by May 20, 2014, and submit a brief statement of the general
nature of the evidence or arguments that you wish to present, your
name, address, telephone number, fax number, and email address, and
indicate the approximate amount of time you need to make your
presentation.
Transcripts: As soon as a transcript is available, it will be
accessible at https://www.regulations.gov. It also may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20850. A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. You should send written requests for
a hardcopy or CD-ROM transcript to the Division of Freedom of
Information, (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
The Purpose of the Multilateral Framework on the ICCR: The purpose
of the multilateral framework on the ICCR is to pave the way for the
removal of regulatory obstacles to international trade while
maintaining global consumer protection.
ICCR is a voluntary international group of cosmetics regulatory
authorities from the United States, Japan, the European Union, and
Canada. These regulatory authority members will enter into constructive
dialogue with their relevant cosmetics industry trade associations and
public advocacy groups. Currently, the ICCR members are: Health Canada;
the European Directorate General for Health and Consumers; the Ministry
of Health,
[[Page 22994]]
Labor and Welfare of Japan; and the U.S. Food and Drug Administration.
All decisions made by consensus will be compatible with the laws,
policies, rules, regulations, and directives of the respective
administrations and governments. Members will implement and/or promote
actions or documents within their own jurisdictions and seek
convergence of regulatory policies and practices. Successful
implementation will need input from stakeholders.
We will make the agenda for the public meeting available on the
Internet at: https://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm.
Depending on the number of requests for oral presentations, we intend
to have an agenda available by May 30, 2014. We may use the information
that you provide to us during the public meeting to help us prepare for
the July 8 to 10, 2014, ICCR-8 meeting.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09465 Filed 4-24-14; 8:45 am]
BILLING CODE 4160-01-P
