Notice of Availability of Final Environmental Assessment (FINAL EA) and a Finding of No Significant Impact (FONSI) for Metropolitan Sewer District of Greater Cincinnati Easement on HHS/CDC/NIOSH Taft North Campus, Cincinnati, OH, 5185 [2013-01390]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 16 / Thursday, January 24, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Availability of Final
Environmental Assessment (FINAL EA)
and a Finding of No Significant Impact
(FONSI) for Metropolitan Sewer District
of Greater Cincinnati Easement on
HHS/CDC/NIOSH Taft North Campus,
Cincinnati, OH
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of Availability of Final
Environmental Assessment (FINAL EA)
and a Finding of No Significant Impact
(FONSI) for Metropolitan Sewer District
of Greater Cincinnati Easement on HHS/
CDC/NIOSH Taft North Campus,
Cincinnati, Ohio.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) is issuing this notice to
advise the public that HHS/CDC has
prepared, and signed on January 3,
2013, a Finding of No Significant Impact
(FONSI) based on the Final
Environmental Assessment (FINAL EA)
for Metropolitan Sewer District of
Greater Cincinnati Easement on the
HHS/CDC/NIOSH Taft North Campus,
Cincinnati, Ohio. HHS/CDC prepared
the final EA, dated November 2012, in
accordance with the National
Environmental Policy Act (NEPA).
DATES: The FONSI and/or Final EA are
available as of the publication date of
this notice.
ADDRESSES: Interested parties may
request copies of the FONSI and/or
Final EA, from: Mr. Sam Tarr, Centers
for Disease Control and Prevention,
Buildings and Facilities Office, 1600
Clifton Road NE., Mailstop K96, Atlanta,
GA, 30333. Telephone Number (770)
488–8170.
SUPPLEMENTARY INFORMATION: The Final
EA evaluated the granting of an
easement to the Metropolitan Sewer
District of Greater Cincinnati (MSD) for
the sole purpose of installing sanitary
sewer and storm sewer improvements to
the MSD’s existing sewer system and
the rehabilitation and expansion of an
existing storm water detention basin.
The proposed easement covers
approximately 0.64 acres located
adjacent to the intersection of Grandin
Road and Grand Beech Lane, Cincinnati,
Ohio. The EA also evaluated the
construction activities associated with
the MSD’s sanitary sewer and storm
sewer improvements. The purpose and
erowe on DSK2VPTVN1PROD with
SUMMARY:
VerDate Mar<15>2010
15:12 Jan 23, 2013
Jkt 229001
need of the proposed easement is to
provide access to MSD to implement/
construct MSD sanitary sewer and storm
sewer improvements on Federallyowned land in the custody and control
of HHS/CDC.
The Final EA has been prepared in
accordance with the National
Environmental Policy Act (NEPA) of
1969. Based on the results of the EA,
HHS/CDC has issued a Finding of No
Significant Impact (FONSI) indicating
that the proposed action will not have
a significant impact on the environment.
Minimization and mitigating measures
will include: Compliance with
applicable regulatory laws, procedures,
and permits for all construction
activities; development and
implementation of Erosion and
Sedimentation Control Plan; conduct
potential habitat survey for identified
wildlife; site review by state historic
preservation office before construction
to avoid disturbance of any site with the
potential for archeological significance;
and the application of best management
practices (BMP) to minimize short term
air quality and noise impact during
construction activities.
Dated: January 16, 2013.
J. Ronald Campbell,
Director, Division of Executive Secretariat,
Centers for Disease Control and Prevention.
[FR Doc. 2013–01390 Filed 1–23–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0847]
Guidance for Industry and Food and
Drug Administration Staff;
Humanitarian Use Device (HUD)
Designations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for the
industry and FDA staff entitled
‘‘Humanitarian Use Device (HUD)
Designations.’’ Devices are eligible for
HUD designation if they are designed to
treat or diagnose a disease or condition
that affects or is manifested in fewer
than 4,000 individuals in the United
States per year. Devices that receive
HUD designations may be eligible for
marketing approval under the
Humanitarian Device Exemption (HDE)
marketing pathway. This guidance
document is intended to assist
SUMMARY:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
5185
applicants in the preparation and
submission of HUD designation requests
and FDA reviewers in evaluating such
requests. This guidance finalizes the
draft guidance of the same title dated
December 2011.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Orphan Products (OOPD),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
5271, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling OOPD at
301–796–8660. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://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.
FOR FURTHER INFORMATION CONTACT: Eric
Chen, Office of Orphan Products
Development (OOPD), Food and Drug
Administration, Bldg. 32, Rm. 5222,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–6327,
email: eric.chen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Humanitarian Use Device
(HUD) Designations.’’ Devices are
eligible for HUD designation if they are
designed to treat or diagnose a disease
or condition that affects or is manifested
in fewer than 4,000 individuals in the
United States per year. (See section
520(m) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C.
360j(m); 21 CFR 814.102.) This guidance
document is intended to assist
applicants in the preparation and
submission of HUD designation requests
to OOPD. This guidance is also intended
to assist FDA reviewers in the
evaluation and analysis of HUD
designation requests.
Topics addressed in this guidance
include: (1) Demonstrating in HUD
designation requests that the device is
designed to treat or diagnose a disease
or condition that affects or is manifested
in fewer than 4,000 individuals in the
United States per year; (2) how this
demonstration varies depending on
whether the device is intended for
therapeutic or diagnostic purposes; (3)
E:\FR\FM\24JAN1.SGM
24JAN1
]]>Agencies
[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Page 5185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01390]
[[Page 5185]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Availability of Final Environmental Assessment (FINAL
EA) and a Finding of No Significant Impact (FONSI) for Metropolitan
Sewer District of Greater Cincinnati Easement on HHS/CDC/NIOSH Taft
North Campus, Cincinnati, OH
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of Availability of Final Environmental Assessment (FINAL
EA) and a Finding of No Significant Impact (FONSI) for Metropolitan
Sewer District of Greater Cincinnati Easement on HHS/CDC/NIOSH Taft
North Campus, Cincinnati, Ohio.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS) is issuing this
notice to advise the public that HHS/CDC has prepared, and signed on
January 3, 2013, a Finding of No Significant Impact (FONSI) based on
the Final Environmental Assessment (FINAL EA) for Metropolitan Sewer
District of Greater Cincinnati Easement on the HHS/CDC/NIOSH Taft North
Campus, Cincinnati, Ohio. HHS/CDC prepared the final EA, dated November
2012, in accordance with the National Environmental Policy Act (NEPA).
DATES: The FONSI and/or Final EA are available as of the publication
date of this notice.
ADDRESSES: Interested parties may request copies of the FONSI and/or
Final EA, from: Mr. Sam Tarr, Centers for Disease Control and
Prevention, Buildings and Facilities Office, 1600 Clifton Road NE.,
Mailstop K96, Atlanta, GA, 30333. Telephone Number (770) 488-8170.
SUPPLEMENTARY INFORMATION: The Final EA evaluated the granting of an
easement to the Metropolitan Sewer District of Greater Cincinnati (MSD)
for the sole purpose of installing sanitary sewer and storm sewer
improvements to the MSD's existing sewer system and the rehabilitation
and expansion of an existing storm water detention basin. The proposed
easement covers approximately 0.64 acres located adjacent to the
intersection of Grandin Road and Grand Beech Lane, Cincinnati, Ohio.
The EA also evaluated the construction activities associated with the
MSD's sanitary sewer and storm sewer improvements. The purpose and need
of the proposed easement is to provide access to MSD to implement/
construct MSD sanitary sewer and storm sewer improvements on Federally-
owned land in the custody and control of HHS/CDC.
The Final EA has been prepared in accordance with the National
Environmental Policy Act (NEPA) of 1969. Based on the results of the
EA, HHS/CDC has issued a Finding of No Significant Impact (FONSI)
indicating that the proposed action will not have a significant impact
on the environment. Minimization and mitigating measures will include:
Compliance with applicable regulatory laws, procedures, and permits for
all construction activities; development and implementation of Erosion
and Sedimentation Control Plan; conduct potential habitat survey for
identified wildlife; site review by state historic preservation office
before construction to avoid disturbance of any site with the potential
for archeological significance; and the application of best management
practices (BMP) to minimize short term air quality and noise impact
during construction activities.
Dated: January 16, 2013.
J. Ronald Campbell,
Director, Division of Executive Secretariat, Centers for Disease
Control and Prevention.
[FR Doc. 2013-01390 Filed 1-23-13; 8:45 am]
BILLING CODE 4163-18-P
