Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee, 71804-71805 [2012-29165]
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Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 314 were approved under
OMB control numbers 0910–0001 and
0910–0338; the collections of
information in 21 CFR part 312 were
approved under OMB control number
0910–0014; the collections of
information in part 212 were approved
under OMB control number 0910–0667;
the collections of information in 21 CFR
parts 210 and 211 were approved under
0910–0139; and the collections of
information in 21 CFR part 207 were
approved under OMB control number
0910–0045. The guidance also refers to
collections of information associated
with submitting Form FDA 3397
(Prescription Drug User Fee Cover
Sheet), approved under OMB control
number 0910–0297.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Products.’’ The document was
published with an incorrect email
address. This document corrects that
error. Due to this error, FDA is
extending the Requests for Oral
Presentations registration date from
November 27, 2012, to December 7,
2012.
Lee
Lemley, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Silver Spring, MD 20903, 301–
796–3441, Fax: 301–847–8753, email:
CDER-AntisepticPreOpPublicMeeting@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Correction
In the Federal Register of November
21, 2012, in FR Doc. 2012–28357, on
page 69863, the following corrections
are made:
1. On page 69863, in the second
column, under Contact Person, the
email address ‘‘AntisepticPreOpPublic
Meeting@fda.hhs.gov’’ is corrected to
read ‘‘CDER-AntisepticPreOpPublic
Meeting@fda.hhs.gov’’.
2. On page 69863, in the third
column, under Requests for Oral
Presentations, the date ‘‘November 27,
2012’’ is changed to read ‘‘December 7,
2012.
Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–29166 Filed 12–3–12; 8:45 am]
BILLING CODE 4160–01–P
Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1040]
Antiseptic Patient Preoperative Skin
Preparation Products; Public Hearing;
Request for Comments; Correction
Food and Drug Administration,
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Device Good
Manufacturing Practice Advisory
Committee
HHS.
AGENCY:
Notice of public hearing; request
for comments; correction.
mstockstill on DSK4VPTVN1PROD with
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of November 21, 2012 (77 FR
69863). The document announced a
public hearing entitled ‘‘Antiseptic
Patient Preoperative Skin Preparation
SUMMARY:
VerDate Mar<15>2010
17:31 Dec 03, 2012
Jkt 229001
Section
520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as
amended, provides that the DGMPAC
shall be composed of two
representatives of interests of the device
manufacturing industry. The Agency is
requesting nominations for nonvoting
industry representatives on the
DGMPAC.
SUPPLEMENTARY INFORMATION:
I. Function of DGMPAC
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–29157 Filed 12–3–12; 8:45 am]
AGENCY:
Committee (DGMPAC) in the Center for
Devices and Radiological Health notify
FDA in writing. A nominee may either
be self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
members to represent industry interests
must send a letter stating that interest to
FDA by January 3, 2013, for the
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by January 3, 2013.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Margaret J. Ames (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Margaret J. Ames, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5234, Silver Spring,
MD 20993, 301–796–5960,
margaret.ames@fda.hhs.gov.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organization interested in
participating in the selection of
nonvoting industry representatives to
serve on the Device Good
Manufacturing Practice Advisory
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Review proposed regulations issuance
regarding good manufacturing practices
governing the methods used in, and the
facilities and controls used for
manufacture, packaging, storage,
installation, and servicing of devices,
and make recommendations regarding
the feasibility and reasonableness of
those proposed regulations. The
committee also reviews and makes
recommendations on proposed
guidelines developed to assist the
medical device industry in meeting the
good manufacturing practice
requirements, and provides advice with
regard to any petition submitted by a
manufacturer for an exemption or
variance from good manufacturing
practice regulations.
II. Qualifications
Persons nominated for the DGMPAC
should possess appropriate
qualifications to understand and
contribute to the committee’s work as
described in the committee’s function.
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within the 60 days, the
Commissioner of Food and Drugs will
select the nonvoting member to
represent industry interests.
mstockstill on DSK4VPTVN1PROD with
IV. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees, and therefore encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from device manufacturing
industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14
relating to advisory committees.
VerDate Mar<15>2010
17:31 Dec 03, 2012
Jkt 229001
Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–29165 Filed 12–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Substance Abuse
Prevention and Treatment Block Grant
Synar Report Format, FFY 2014–2016—
(OMB No. 0930–0222)—Revision
Section 1926 of the Public Health
Service Act [42 U.S.C. 300x-26]
stipulates that funding Substance Abuse
Prevention and Treatment Block Grant
(SABG) agreements for alcohol and drug
abuse programs for fiscal year 1994 and
subsequent fiscal years require states to
have in effect a law providing that it is
unlawful for any manufacturer, retailer,
or distributor of tobacco products to sell
or distribute any such product to any
individual under the age of 18. This
section further requires that states
conduct annual, random, unannounced
inspections to ensure compliance with
the law; that the state submit annually
a report describing the results of the
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Fmt 4703
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71805
inspections, the activities carried out by
the state to enforce the required law, the
success the state has achieved in
reducing the availability of tobacco
products to individuals under the age of
18, and the strategies to be utilized by
the state for enforcing such law during
the fiscal year for which the grant is
sought.
Before making an award to a State
under the SABG, the Secretary must
make a determination that the state has
maintained compliance with these
requirements. If a determination is made
that the state is not in compliance,
penalties shall be applied. Penalties
ranged from 10 percent of the Block
Grant in applicable year 1 (FFY 1997
SABG Applications) to 40 percent in
applicable year 4 (FFY 2000 SABG
Applications) and subsequent years.
Respondents include the 50 states, the
District of Columbia, the
Commonwealth of Puerto Rico, the U.S.
Virgin Islands, Guam, American Samoa,
the Commonwealth of the Northern
Mariana Islands, the Republic of Palau,
the Federated States of Micronesia, and
the Republic of the Marshall Islands.
Regulations that implement this
legislation are at 45 CFR 96.130, are
approved by OMB under control
number 0930–0163, and require that
each state submit an annual Synar
report to the Secretary describing their
progress in complying with section 1926
of the PHS Act. The Synar report, due
December 31 following the fiscal year
for which the state is reporting,
describes the results of the inspections
and the activities carried out by the state
to enforce the required law; the success
the state has achieved in reducing the
availability of tobacco products to
individuals under the age of 18; and the
strategies to be utilized by the state for
enforcing such law during the fiscal
year for which the grant is sought.
SAMHSA’s Center for Substance Abuse
Prevention will request OMB approval
of revisions to the current report format
associated with Section 1926 (42 U.S.C.
300x-26). The report format is not
changing significantly. Any changes in
either formatting or content are being
made to simplify the reporting process
for the states and to clarify the
information as the states report it; both
outcomes will facilitate consistent,
credible, and efficient monitoring of
Synar compliance across the states. All
of the information required in the new
report format is already being collected
by the states. Specific changes are listed
below:
Clarification Changes
To decrease the need for
supplemental questions and reporting,
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71804-71805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29165]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Device Good Manufacturing Practice Advisory
Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) in the Center for
Devices and Radiological Health notify FDA in writing. A nominee may
either be self-nominated or nominated by an organization to serve as a
nonvoting industry representative. Nominations will be accepted for
current vacancies effective with this notice.
DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting members to represent industry
interests must send a letter stating that interest to FDA by January 3,
2013, for the vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by January
3, 2013.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993, 301-796-
5960, margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 520 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 360j), as amended, provides that the DGMPAC
shall be composed of two representatives of interests of the device
manufacturing industry. The Agency is requesting nominations for
nonvoting industry representatives on the DGMPAC.
I. Function of DGMPAC
Review proposed regulations issuance regarding good manufacturing
practices governing the methods used in, and the facilities and
controls used for manufacture, packaging, storage, installation, and
servicing of devices, and make recommendations regarding the
feasibility and reasonableness of those proposed regulations. The
committee also reviews and makes recommendations on proposed guidelines
developed to assist the medical device industry in meeting the good
manufacturing practice requirements, and provides advice with regard to
any petition submitted by a manufacturer for an exemption or variance
from good manufacturing practice regulations.
II. Qualifications
Persons nominated for the DGMPAC should possess appropriate
qualifications to understand and contribute to the committee's work as
described in the committee's function.
[[Page 71805]]
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations, and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular committee. The interested organizations are
not bound by the list of nominees in selecting a candidate. However, if
no individual is selected within the 60 days, the Commissioner of Food
and Drugs will select the nonvoting member to represent industry
interests.
IV. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from device manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.
Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29165 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P
