Submission for OMB Review; Integrity of Unit Prices, 58257-58258 [2015-24559]
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Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices
contract amount is expected to exceed
$650,000 and the service to be provided
will require meaningful numbers of
professional employees. The purpose of
the provision at FAR 52.222–46 is to
require offerors to submit for evaluation
a total compensation plan setting forth
proposed salaries and fringe benefits for
professional employees working on the
contract. Plans indicating unrealistically
low professional employees’
compensation may be assessed
adversely as one of the factors
considered in making a contract award.
B. Annual Reporting and
Recordkeeping Burden
Respondents: 12,921.
Responses per Respondent: 3.
Total Responses: 38,763.
Hours per Response: 1.333333.
Total Burden Hours: 51,684.
Public comments are particularly
invited on: Whether this collection of
information is necessary; whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0066, Professional Employee
Compensation Plan, in all
correspondence.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–24557 Filed 9–25–15; 8:45 am]
BILLING CODE 6820–EP–P
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GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[Docket 2015–0055; Sequence 19; OMB
Control No. 9000–0080]
Submission for OMB Review; Integrity
of Unit Prices
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding an extension to an
existing OMB clearance.
AGENCY:
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement concerning
Integrity of Unit Prices. A notice was
published in the Federal Register at 80
FR 35359 on June 19, 2015. One
comment was received, but was
unrelated to the subject matter.
DATES: Submit comments on or before
October 28, 2015.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
Additionally submit a copy to GSA by
any of the following methods:
• Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching the OMB control number.
Select the link ‘‘Submit a Comment’’
that corresponds with ‘‘Information
Collection 9000–0080, Integrity of Unit
Prices’’. Follow the instructions
provided at the ‘‘Submit a Comment’’
screen. Please include your name,
company name (if any), and
‘‘Information Collection 9000–0080,
Integrity of Unit Prices’’ on your
attached document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street WE,
Washington, DC 20405. ATTN: Ms.
Flowers/IC 9000–0080, Integrity of Unit
Prices.
Instructions: Please submit comments
only and cite Information Collection
9000–0080, Integrity of Unit Prices, in
SUMMARY:
C. Public Comments
Edward Loeb,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
DEPARTMENT OF DEFENSE
PO 00000
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58257
all correspondence related to this
collection. Comments received generally
will be posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr.
Edward Loeb, Procurement Analyst,
Office of Acquisition Policy, GSA, 202–
501–0650 or email edward.loeb@
gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
The clause at FAR 52.215–14,
Integrity of Unit Prices, requires offerors
and contractors under Federal contracts
that are to be awarded without adequate
price competition to identify in their
proposals those supplies which they
will not manufacture or to which they
will not contribute significant value.
The policies included in the FAR are
required by 41 U.S.C. 3503 (a)(1)(A)(for
the civilian agencies) and 10.U.S.C
2306a(b)(1)(A)(i)(for DOD and NASA).
The rule contains no reporting
requirements on contracts below the
simplified acquisition threshold,
construction and architect-engineering
services, utility services, service
contracts where supplies are not
required, commercial items, and
contracts for petroleum products.
B. Annual Reporting Burden
Respondents: 950.
Responses per Respondent: 10.
Annual Responses: 9,500.
Hours per Response: 1.
Total Burden Hours: 9,500.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary; whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
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58258
Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices
BILLING CODE 6820–EP–P
Prevention, 1600 Clifton Road NE.,
Atlanta, GA 30333, Phone: 404–639–
7028, E-Mail: Ashultz@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Alvin Shultz, MSPH, Division of
Preparedness and Emerging Infectious,
National Center for Emerging and
Zoonotic Infectious, Diseases Centers for
Disease Control and Prevention, 3311
Toledo Road, Room 4204, Hyattsville,
MD 20782 Phone: 301–458–4371, FAX:
301–458–4028, E-Mail:
NHANESgenetics@cdc.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 23, 2015.
Terrance Perry,
Director, Office of Grants Services, Centers
for Disease Control and Prevention.
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202501–4755. Please
cite OMB Control No. 9000–0080,
Integrity of Unit Prices.
Edward Loeb,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2015–24559 Filed 9–25–15; 8:45 am]
[FR Doc. 2015–24564 Filed 9–25–15; 8:45 am]
Centers for Disease Control and
Prevention (CDC)
BILLING CODE 4163–18–P
Emergency Funding for New York City
Legionella Outbreak
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
ACTION: Notice.
AGENCY:
The U.S. Centers for Disease
Control and Prevention (CDC) is
providing $1,300,000 in urgent funding
through the Epidemiology and
Laboratory Capacity for Infectious
Diseases (ELC) Cooperative Agreement
to the New York City Department of
Health (NYC HD)to combat an outbreak
of Legionella. As of August 18, 2015
NYC HD has identified 127 cases and 12
deaths associated with this public
health emergency. These funds will be
used by NYC HD to (1) create
sustainable environmental and
laboratory capacity at NYC HD to
respond to Legionella outbreak, (2)
enhance laboratory capacity of
detection, isolation, and molecular
characterization of clinical and
environmental strains at the New York
City public health laboratory, (3)
include sequence-based typing and
eventually whole genome sequencing,
and (4) allow NYC HD to characterize
the geographic distribution of Legionella
strains throughout New York City,
support the new public health
engineering program to monitor the
compliance of building owners with the
new cooling tower regulations, and
work with CDC to evaluate the impact
of these regulations.
DATES: Effective date is date of
publication in the Federal Register.
ADDRESSES: Alvin Shultz, MSPH,
Division of Preparedness and Emerging
Infectious, National Center for Emerging
and Zoonotic Infectious Diseases,
Centers for Disease Control and
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3275]
Labeling Lower-Dose Estrogen-Alone
Products for Symptoms of Vulvar and
Vaginal Atrophy
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on the topic of the
labeling for lower-dose estrogen
products delivered vaginally, intended
to treat moderate to severe symptoms of
vulvar and vaginal atrophy (VVA) due
to menopause. Lower-dose estrogen
products means products that contain
less than the 0.625 milligrams (mg) of
conjugated estrogens used in the
Women’s Health Initiative Study, and
estradiol products containing 0.0375 mg
and below. Lower-dose estrogen
products are now approved for the
treatment of moderate to severe
symptoms of VVA due to menopause,
and some in the scientific/medical
community have questioned whether
the current ‘‘Boxed Warnings’’ section
in the labeling is applicable in whole or
in part to these lower-dose estrogen
products. This meeting, a scientific
workshop, will provide an opportunity
for FDA to seek input from experts on
the Boxed Warnings section, estrogen
exposure data, and pharmacokinetic
(PK)/pharmacodynamic (PD)
relationships relative to labeling lowerdose estrogen-alone products intended
SUMMARY:
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to treat moderate to severe symptoms of
VVA due to menopause.
DATES: The public meeting will be held
on November 10, 2015, from 8:30 a.m.
to 5 p.m. Registration to attend the
meeting must be received by October 16,
2015, with onsite registration available
between 7 a.m. and 8 a.m. the day of the
meeting. See the SUPPLEMENTARY
INFORMATION section for information on
how to register for this meeting. Submit
either electronic or written comments
by October 16, 2015.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, Section A of 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 check procedures 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 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/ucm459690.htm.
FOR FURTHER INFORMATION CONTACT:
Kimberly Shiley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, Rm. 5377,
Silver Spring, MD 20993, 301–796–
2117, email:
Kimberly.Shiley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
The loss of ovarian function with
menopause leads to a drastic reduction
in circulating estrogen concentration,
which in turn leads to physiologic
changes to the vulva, vagina, and lower
urinary tract. Reduced circulating
estrogen concentration results in an
increase in vaginal pH, a thinning and
reduction of the folds of the vaginal
lining, reduction of vaginal secretions,
and loss of elasticity in vaginal tissues.
Symptoms of decreased circulating
estrogen include vaginal and vulvar
itching and/or irritation, vaginal dryness
and vaginal pain (dyspareunia), and/or
bleeding with intercourse. Not all
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58257-58258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24559]
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
[Docket 2015-0055; Sequence 19; OMB Control No. 9000-0080]
Submission for OMB Review; Integrity of Unit Prices
AGENCY: Department of Defense (DOD), General Services Administration
(GSA), and National Aeronautics and Space Administration (NASA).
ACTION: Notice of request for public comments regarding an extension to
an existing OMB clearance.
-----------------------------------------------------------------------
SUMMARY: Under the provisions of the Paperwork Reduction Act, the
Regulatory Secretariat Division will be submitting to the Office of
Management and Budget (OMB) a request to review and approve an
extension of a previously approved information collection requirement
concerning Integrity of Unit Prices. A notice was published in the
Federal Register at 80 FR 35359 on June 19, 2015. One comment was
received, but was unrelated to the subject matter.
DATES: Submit comments on or before October 28, 2015.
ADDRESSES: Submit comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: Office of Information and Regulatory Affairs
of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington,
DC 20503. Additionally submit a copy to GSA by any of the following
methods:
Regulations.gov: https://www.regulations.gov. Submit
comments via the Federal eRulemaking portal by searching the OMB
control number. Select the link ``Submit a Comment'' that corresponds
with ``Information Collection 9000-0080, Integrity of Unit Prices''.
Follow the instructions provided at the ``Submit a Comment'' screen.
Please include your name, company name (if any), and ``Information
Collection 9000-0080, Integrity of Unit Prices'' on your attached
document.
Mail: General Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F Street WE, Washington, DC 20405.
ATTN: Ms. Flowers/IC 9000-0080, Integrity of Unit Prices.
Instructions: Please submit comments only and cite Information
Collection 9000-0080, Integrity of Unit Prices, in all correspondence
related to this collection. Comments received generally will be posted
without change to https://www.regulations.gov, including any personal
and/or business confidential information provided. To confirm receipt
of your comment(s), please check www.regulations.gov, approximately two
to three days after submission to verify posting (except allow 30 days
for posting of comments submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr. Edward Loeb, Procurement Analyst,
Office of Acquisition Policy, GSA, 202-501-0650 or email
edward.loeb@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
The clause at FAR 52.215-14, Integrity of Unit Prices, requires
offerors and contractors under Federal contracts that are to be awarded
without adequate price competition to identify in their proposals those
supplies which they will not manufacture or to which they will not
contribute significant value. The policies included in the FAR are
required by 41 U.S.C. 3503 (a)(1)(A)(for the civilian agencies) and
10.U.S.C 2306a(b)(1)(A)(i)(for DOD and NASA). The rule contains no
reporting requirements on contracts below the simplified acquisition
threshold, construction and architect-engineering services, utility
services, service contracts where supplies are not required, commercial
items, and contracts for petroleum products.
B. Annual Reporting Burden
Respondents: 950.
Responses per Respondent: 10.
Annual Responses: 9,500.
Hours per Response: 1.
Total Burden Hours: 9,500.
C. Public Comments
Public comments are particularly invited on: Whether this
collection of information is necessary; whether it will have practical
utility; whether our estimate of the public burden of this collection
of information is accurate, and based on valid assumptions and
methodology; ways to enhance the quality, utility, and clarity of the
information to be collected; and ways in which we can minimize the
burden of the collection of information on those who are to respond,
through the use of appropriate technological collection techniques or
other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the
information collection documents from
[[Page 58258]]
the General Services Administration, Regulatory Secretariat Division
(MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202501-4755.
Please cite OMB Control No. 9000-0080, Integrity of Unit Prices.
Edward Loeb,
Acting Director, Federal Acquisition Policy Division, Office of
Governmentwide Acquisition Policy, Office of Acquisition Policy, Office
of Governmentwide Policy.
[FR Doc. 2015-24559 Filed 9-25-15; 8:45 am]
BILLING CODE 6820-EP-P
