Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public Hearing, 68854-68855 [2013-27359]
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emcdonald on DSK67QTVN1PROD with NOTICES
68854
Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices
international scale in a pilot program
starting in January 2014. The
international partners for the MDSAP
pilot, Therapeutic Goods
Administration of Australia, Brazil’s
ˆ
ˆ
Agencia Nacional de Vigilancia
´
Sanitaria, Health Canada, FDA, and
Japan’s Ministry of Health, Labour and
Welfare and Pharmaceuticals and
Medical Devices Agency, are official
observers and active participants in the
pilot program’s Regulatory Authority
Council and subject matter expert
groups.
The mission of the participants in the
MDSAP International Coalition is to
jointly leverage regulatory resources to
manage an efficient, effective, and
sustainable single audit program
focused on the oversight of medical
device manufacturers. The development
of the MDSAP includes the use of third
party auditors, much like some current
regulatory audit programs, as well as
regulatory inspectorates. Recognizing
the increasingly global nature and
number of medical device
manufacturers, the use of third party
auditors in addition to regulatory
authority inspectorates, allows greater
coverage in auditing manufacturers as
opposed to relying solely on the
government resources of individual
countries. The government resources
can then be focused on high risk or
problematic medical devices,
manufacturers that are not in
compliance with the regulations, and
oversight of the third party auditing
organizations. The MDSAP Pilot is
intended to allow MDSAP-recognized
auditing organizations to conduct a
single audit of a medical device
manufacturer that will satisfy the
relevant requirements of the medical
device regulatory authorities
participating in the pilot.
The regulatory authorities involved in
the pilot will base their recognition and
assessment process on the following
final IMDRF MDSAP documents:
• IMDRF MDSAP WG N3—
‘‘Requirements for Medical Device
Auditing Organizations for Regulatory
Authority Recognition;’’
• IMDRF MDSAP WG N4—
‘‘Competence and Training
Requirements for Auditing
Organizations;’’
• IMDRF MDSAP WG N5—
‘‘Regulatory Authority Assessment
Method for the Recognition and
Monitoring of Medical Device Auditing
Organizations;’’ and
• IMDRF MDSAP WG N6—
‘‘Regulatory Authority Assessor
Competency and Training
Requirements.’’
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Each of these documents was
proposed in draft by the IMDRF and
comments were solicited. IMDRF is in
the process of revising these documents
based on comments received. The
IMDRF MDSAP Working Group has
submitted the four proposed final
documents for the IMDRF Management
Committee meeting in Brussels on
November 12 to14, 2013.
The proposed drafts for each
document are not available during the
revision process. When final, these
documents will be available on the
IMDRF Web site (see https://
www.imdrf.org/).
In addition, the MDSAP International
Coalition has also developed several
documents in order to implement the
pilot. As documents are finalized by the
MDSAP International Coalition
Regulatory Authority Council, the
documents will be posted on FDA’s
Web site.
The MDSAP audit process was
designed and developed to ensure a
single audit will provide efficient yet
thorough coverage of the requirements
of medical devices. FDA will accept the
MDSAP audit reports as a substitute for
routine Agency inspections. Inspections
conducted ‘‘For Cause’’ or ‘‘Compliance
Followup’’ by FDA will not be affected
by this program. Moreover, this MDSAP
Pilot would not apply to any necessary
preapproval or postapproval inspections
for Premarket Approval (PMA)
applications or to decisions under
section 513(f)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360c(f)(5)) concerning the classification
of a device.
III. Electronic Access
Additional information on the IMDRF
MDSAP can be found at: https://
www.imdrf.org/ and at https://
www.fda.gov/MedicalDevices/.
V. Comments
Interested persons may submit either
electronic comments regarding the
MDSAP International Coalition Pilot
Program to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
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Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27358 Filed 11–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1038]
Over-the-Counter Ophthalmic Drug
Products—Emergency Use Eyewash
Products; Rescheduling of Public
Hearing
AGENCY:
Food and Drug Administration,
HHS.
Notice; rescheduling of public
hearing.
ACTION:
The Food and Drug
Administration (FDA) is rescheduling a
December 4, 2013, public hearing to
obtain information on the formulation,
manufacturing, and labeling of currently
marketed over-the-counter (OTC)
emergency use eyewash products,
announced in the Federal Register of
Wednesday, September 18, 2013. Based
on a request received by the Agency, we
are rescheduling the public hearing to
March 7, 2014, and updating the related
procedural dates that appeared in the
September 18, 2013, notice.
DATES: The public hearing will be held
on March 7, 2014, from 9 a.m. to 5 p.m.
Submit electronic or written requests to
make oral presentations and comments
by February 14, 2014. If you wish to
attend the hearing or make an oral
presentation during the hearing, you
must register by submitting an
electronic request to
CDEREYEWASHMEETING@fda.hhs.gov
by close of business on February 14,
2014. For those unable to attend in
person, FDA will provide a Webcast to
the meeting; additional information
about the Webcast location will be
posted on the Web page at https://
www.fda.gov/Drugs/NewsEvents/
ucm356526.htm prior to March 7, 2014.
Electronic or written comments will be
accepted after the hearing until June 6,
2014.
FOR FURTHER INFORMATION CONTACT:
Mary C. Gross, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–3519, FAX: 301–847–
8753, mary.gross@fda.hhs.gov; or Elaine
Abraham, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
SUMMARY:
E:\FR\FM\15NON1.SGM
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Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices
Ave., Silver Spring, MD 20903, 301–
796–0843, FAX: 301–796–9899,
elaine.abraham@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 18, 2013
(78 FR 57397), FDA announced that it
would hold a public hearing on
December 4, 2013, to obtain information
on the formulation, manufacturing, and
labeling of currently marketed OTC
emergency use eyewash products. Based
on a request received by the Agency, we
are rescheduling the public hearing to
March 7, 2014. Because we are
rescheduling the hearing, we are also
rescheduling the procedural dates (see
DATES) that appeared in the September
18, 2013, notice. For additional
information about the purpose and
scope of the hearing, see the September
18, 2013, notice available on FDA’s Web
site at https://www.fda.gov/Drugs/
NewsEvents/ucm356526.htm.
Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27359 Filed 11–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
emcdonald on DSK67QTVN1PROD with NOTICES
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Advisory Committee to the Director,
National Institutes of Health.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: December 5–6, 2013.
Time: December 05, 2013, 9:00 a.m. to 5:00
p.m.
Agenda: NIH Director’s report; ACD
Working Group Implementation Team
reports, NIH updates, and other business of
the Committee.
Place: National Institutes of Health,
Building 31, C Wing, 6th Floor, Conference
Room 6, 31 Center Drive, Bethesda, MD
20892.
Time: December 06, 2013, 9:00 a.m. to
12:00 p.m.
Agenda: ACD Working Group
Implementation Team reports, NIH updates,
and other business of the Committee.
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Place: National Institutes of Health,
Building 31, C Wing, 6th Floor, Conference
Room 6, 31 Center Drive, Bethesda, MD
20892.
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 103, Bethesda, MD 20892,
301–496–4272, woodgs@od.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit. Information is also available on the
Institute’s/Center’s home page: https://
acd.od.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: November 8, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–27348 Filed 11–14–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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68855
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Resource Related
Research Projects (R24).
Date: December 11, 2013.
Time: 11:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Sujata Vijh, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–594–
0985, vijhs@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: November 8, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–27350 Filed 11–14–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Musculoskeletal Diseases.
Date: December 6, 2013.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Yanming Bi, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\15NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68854-68855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1038]
Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash
Products; Rescheduling of Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; rescheduling of public hearing.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is rescheduling a
December 4, 2013, public hearing to obtain information on the
formulation, manufacturing, and labeling of currently marketed over-
the-counter (OTC) emergency use eyewash products, announced in the
Federal Register of Wednesday, September 18, 2013. Based on a request
received by the Agency, we are rescheduling the public hearing to March
7, 2014, and updating the related procedural dates that appeared in the
September 18, 2013, notice.
DATES: The public hearing will be held on March 7, 2014, from 9 a.m. to
5 p.m. Submit electronic or written requests to make oral presentations
and comments by February 14, 2014. If you wish to attend the hearing or
make an oral presentation during the hearing, you must register by
submitting an electronic request to CDEREYEWASHMEETING@fda.hhs.gov by
close of business on February 14, 2014. For those unable to attend in
person, FDA will provide a Webcast to the meeting; additional
information about the Webcast location will be posted on the Web page
at https://www.fda.gov/Drugs/NewsEvents/ucm356526.htm prior to March 7,
2014. Electronic or written comments will be accepted after the hearing
until June 6, 2014.
FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903, 301-796-3519, FAX: 301-847-
8753, mary.gross@fda.hhs.gov; or Elaine Abraham, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire
[[Page 68855]]
Ave., Silver Spring, MD 20903, 301-796-0843, FAX: 301-796-9899,
elaine.abraham@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 18,
2013 (78 FR 57397), FDA announced that it would hold a public hearing
on December 4, 2013, to obtain information on the formulation,
manufacturing, and labeling of currently marketed OTC emergency use
eyewash products. Based on a request received by the Agency, we are
rescheduling the public hearing to March 7, 2014. Because we are
rescheduling the hearing, we are also rescheduling the procedural dates
(see DATES) that appeared in the September 18, 2013, notice. For
additional information about the purpose and scope of the hearing, see
the September 18, 2013, notice available on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/ucm356526.htm.
Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27359 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P
