Agency Information Collection Activities: Proposed Collection: Comment Request, 54447-54448 [E7-18911]
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Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Notices
yshivers on PROD1PC62 with NOTICES
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1071.
SUPPLEMENTARY INFORMATION:
I. Background
The Food and Drug Administration
(FDA) is responsible for prescribing the
conditions of safe use of food additives
under section 409 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348).
To evaluate the safety of food additives
and determine their conditions of safe
use, the agency uses various premarket
approval processes (food additive
petition process (21 CFR 171.1),
premarket notification process for food
contact substances (21 CFR 170.100),
and threshold of regulation process for
substances used in food contact articles
that migrate or may be expected to
migrate into food (21 CFR 170.39)). This
guidance provides answers to common
questions arising during the preparation
of premarket submissions that seek FDA
approval of new antimicrobial food
additives. This guidance will assist
petitioners and notifiers in designing
studies to determine whether an
antimicrobial food additive achieves its
intended technical effect. In addition,
this guidance discusses microbiological
data that may demonstrate that an
antimicrobial agent will be safe for the
intended use. This guidance applies to
all premarket approval submissions for
food additives that are intended to
control microbes in or on food,
including sources of radiation for
treating food.
The agency has adopted good
guidance practices (GGPs) that set forth
the agency’s policies and procedures for
the development, issuance, and use of
guidance documents (21 CFR 10.115).
This draft guidance is being issued as a
Level 1 guidance document consistent
with the GGPs. The draft guidance
represents the agency’s current thinking
on microbiological considerations for
antimicrobial food additive
VerDate Aug<31>2005
15:20 Sep 24, 2007
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submissions. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations. If you want to discuss
an alternative approach, contact the
FDA staff responsible for implementing
this guidance (see FOR FURTHER
INFORMATION CONTACT).
II. Paperwork Reduction Act of 1995
This draft 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 70.25, 71.1,
170.35, and 171.1 have been approved
under OMB control number 0910–0016;
the collection of information in 21 CFR
170.39 has been approved under OMB
control number 0190–0298; and the
collections of information in 21 CFR
170.101 and 170.106 have been
approved under OMB control number
0190–0495.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. If you base
your comments on scientific evidence or
data, please submit copies of the
specific information along with your
comments. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.cfsan.fda.gov/guidance.html.
Dated: September 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18816 Filed 9–24–07; 8:45 am]
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54447
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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: The Division of
Independent Review Grant Reviewer
Recruitment Form (OMB No. 0915–
0295): Extension
HRSA’s Division of Independent
Review (DIR) is responsible for carrying
out the independent and objective
review of all eligible applications
submitted to HRSA. DIR ensures that
the independent review process is
efficient, effective, economical, and
complies with statutes, regulations, and
policies. The review of applications is
performed by people knowledgeable in
the field of endeavor for which support
is requested and is advisory to
individuals in HRSA responsible for
making award decisions.
To streamline the selection and
assignment of grant reviewers to
objective review committees, HRSA
utilizes a Web-based data collection
form to gather critical reviewer
information. The Grant Reviewer Form
standardizes pertinent categories of
reviewer information, such as: Areas of
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54448
Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Notices
expertise; occupations; work settings;
reviewer experience; and allows
maximum use of drop-down menus to
simplify the data collection process. The
Web-based system also permits
reviewers to update their information as
needed. HRSA maintains a pool of
approximately 5,000 individuals that
Responses
per
respondent
Number of
respondents
Grant recruitment form
have previously served on HRSA
objective review committees.
The estimated annual burden is as
follows:
Total
responses
Hours per
response
(min.)
Total burden
hours
New reviewer .......................................................................
Updating reviewer information .............................................
1,200
3,700
1
1
1,200
3,700
45
30
900
1,850
Total ..............................................................................
4,900
........................
4,900
........................
2,750
Send comments to Susan G. Queen,
PhD., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: September 19, 2007.
Alexandra Huttinger,
Acting Director, Director, Division of Policy
Review and Coordination.
[FR Doc. E7–18911 Filed 9–24–07; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[COTP New Orleans 07–019]
Area Maritime Security Committee,
New Orleans; Vacancies
Positions Available on the Committee
Coast Guard, DHS.
Request for applications.
AGENCY:
yshivers on PROD1PC62 with NOTICES
ACTION:
SUMMARY: The Coast Guard seeks
applications for membership in the Area
Maritime Security Committee, New
Orleans. The Committee assists the
Captain of the Port, New Orleans, in
developing, reviewing, and updating the
Area Maritime Security Plan for their
area of responsibility.
DATES: Requests for membership should
reach the Captain of the Port, New
Orleans, on October 25, 2007.
ADDRESSES: Submit applications for
membership to the Captain of the Port,
New Orleans, Attn: Planning
Department, 201 Hammond Hwy.,
Metairie, La. 70005.
FOR FURTHER INFORMATION CONTACT: Mr.
Roy Ford at 504–565–5092 or Mr. James
Nolan 504–565–5085.
SUPPLEMENTARY INFORMATION:
The Committee
The Area Maritime Security
Committee, New Orleans (the
Committee), is established under, and
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15:20 Sep 24, 2007
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governed by, 33 CFR part 103, subpart
C. The functions of the Committee
include, but are not limited to, the
following:
(1) Identifying critical port
infrastructure and operations.
(2) Identifying risks (i.e., threats,
vulnerabilities, and consequences).
(3) Determining strategies and
implementation methods for mitigation.
(4) Developing and describing the
process for continuously evaluating
overall port security by considering
consequences and vulnerabilities, how
they may change over time, and what
additional mitigation strategies can be
applied.
(5) Advising and assisting the Captain
of the Port in developing, reviewing,
and updating the Area Maritime
Security Plan under 33 CFR part 103,
subpart E.
There are 8 vacancies on the
Committee. Members may be selected
from—
(1) The Federal, Territorial, or Tribal
government;
(2) The State government and political
subdivisions of the State;
(3) Local public safety, crisis
management, and emergency response
agencies;
(4) Law enforcement and security
organizations;
(5) Maritime industry, including
labor;
(6) Other port stakeholders having a
special competence in maritime
security; and
(7) Port stakeholders affected by
security practices and policies.
In support of the Coast Guard’s policy
on gender and ethnic diversity, we
encourage qualified women and
members of minority groups to apply.
background check before appointment
to the Committee.
The term of office for each vacancy is
5 years. However, a member may serve
one additional term of office. Members
are not salaried or otherwise
compensated for their service on the
Committee.
Format of Applications
Applications for membership may be
in any format. However, because
members must demonstrate an interest
in the security of the area covered by the
Committee, we particularly encourage
the submission of information
highlighting experience in maritime or
security matters.
Authority
Section 102 of the Maritime
Transportation Security Act of 2002
(Pub. L. 107–295) (the Act) authorizes
the Secretary of the Department in
which the Coast Guard is operating to
establish Area Maritime Security
Committees for any port area of the
United States. See 33 U.S.C. 1226; 46
U.S.C. 70112(a)(2); 33 CFR 103.205;
Department of Homeland Security
Delegation No. 0170.1. The Act exempts
Area Maritime Security Committees
from the Federal Advisory Committee
Act (FACA), 5 U.S.C. App. (Pub. L. 92–
463).
Dated: August 31, 2007.
L.D. Stroh,
Captain, U.S. Coast Guard, Captain of the
Port, New Orleans.
[FR Doc. E7–18886 Filed 9–24–07; 8:45 am]
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Qualification of Members
Members must have at least 5 years of
experience related to maritime or port
security operations. Applicants may be
required to pass an appropriate security
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Agencies
[Federal Register Volume 72, Number 185 (Tuesday, September 25, 2007)]
[Notices]
[Pages 54447-54448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, call the HRSA Reports Clearance
Officer on (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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: The Division of Independent Review Grant Reviewer
Recruitment Form (OMB No. 0915-0295): Extension
HRSA's Division of Independent Review (DIR) is responsible for
carrying out the independent and objective review of all eligible
applications submitted to HRSA. DIR ensures that the independent review
process is efficient, effective, economical, and complies with
statutes, regulations, and policies. The review of applications is
performed by people knowledgeable in the field of endeavor for which
support is requested and is advisory to individuals in HRSA responsible
for making award decisions.
To streamline the selection and assignment of grant reviewers to
objective review committees, HRSA utilizes a Web-based data collection
form to gather critical reviewer information. The Grant Reviewer Form
standardizes pertinent categories of reviewer information, such as:
Areas of
[[Page 54448]]
expertise; occupations; work settings; reviewer experience; and allows
maximum use of drop-down menus to simplify the data collection process.
The Web-based system also permits reviewers to update their information
as needed. HRSA maintains a pool of approximately 5,000 individuals
that have previously served on HRSA objective review committees.
The estimated annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Hours per
Grant recruitment form Number of Responses per Total response Total burden
respondents respondent responses (min.) hours
----------------------------------------------------------------------------------------------------------------
New reviewer.................... 1,200 1 1,200 45 900
Updating reviewer information... 3,700 1 3,700 30 1,850
���������������������������������
Total....................... 4,900 .............. 4,900 .............. 2,750
----------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, PhD., HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: September 19, 2007.
Alexandra Huttinger,
Acting Director, Director, Division of Policy Review and Coordination.
[FR Doc. E7-18911 Filed 9-24-07; 8:45 am]
BILLING CODE 4165-15-P