80 FR 58258 - Emergency Funding for New York City Legionella Outbreak

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)

Federal Register Volume 80, Issue 187 (September 28, 2015)

Page Range		58258-58258
FR Document		2015-24564

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.

Federal Register, Volume 80 Issue 187 (Monday, September 28, 2015)

[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Page 58258]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)


Emergency Funding for New York City Legionella Outbreak

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (DHHS).

ACTION: Notice.

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SUMMARY: 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 Prevention, 1600 Clifton Road 
NE., Atlanta, GA 30333, Phone: 404-639-7028, E-Mail: [email protected].

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: [email protected].

    Dated: September 23, 2015.
Terrance Perry,
Director, Office of Grants Services, Centers for Disease Control and 
Prevention.
[FR Doc. 2015-24564 Filed 9-25-15; 8:45 am]
BILLING CODE 4163-18-P

58258 Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices

the General Services Administration, Prevention, 1600 Clifton Road NE., to treat moderate to severe symptoms of
Regulatory Secretariat Division (MVCB), Atlanta, GA 30333, Phone: 404–639– VVA due to menopause.
1800 F Street NW., Washington, DC 7028, E-Mail: Ashultz@cdc.gov. DATES: The public meeting will be held
20405, telephone 202501–4755. Please FOR FURTHER INFORMATION CONTACT: on November 10, 2015, from 8:30 a.m.
cite OMB Control No. 9000–0080, Alvin Shultz, MSPH, Division of to 5 p.m. Registration to attend the
Integrity of Unit Prices. Preparedness and Emerging Infectious, meeting must be received by October 16,
Edward Loeb, National Center for Emerging and 2015, with onsite registration available
Zoonotic Infectious, Diseases Centers for between 7 a.m. and 8 a.m. the day of the
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide Disease Control and Prevention, 3311 meeting. See the SUPPLEMENTARY
Acquisition Policy, Office of Acquisition Toledo Road, Room 4204, Hyattsville, INFORMATION section for information on
Policy, Office of Governmentwide Policy. MD 20782 Phone: 301–458–4371, FAX: how to register for this meeting. Submit
[FR Doc. 2015–24559 Filed 9–25–15; 8:45 am] 301–458–4028, E-Mail: either electronic or written comments
NHANESgenetics@cdc.gov. by October 16, 2015.
BILLING CODE 6820–EP–P
ADDRESSES: The meeting will be held at
Dated: September 23, 2015.
the FDA White Oak Campus, 10903
Terrance Perry,
New Hampshire Ave., Bldg. 31
DEPARTMENT OF HEALTH AND Director, Office of Grants Services, Centers Conference Center, Section A of the
HUMAN SERVICES for Disease Control and Prevention.
Great Room (Rm. 1503), Silver Spring,
[FR Doc. 2015–24564 Filed 9–25–15; 8:45 am]
Centers for Disease Control and MD 20993. Entrance for the public
BILLING CODE 4163–18–P meeting participants (non-FDA
Prevention (CDC)
employees) is through Building 1, where
Emergency Funding for New York City routine security check procedures will
DEPARTMENT OF HEALTH AND be performed. For more information on
Legionella Outbreak HUMAN SERVICES parking and security procedures, please
AGENCY: Centers for Disease Control and refer to http://www.fda.gov/AboutFDA/
Prevention (CDC), Department of Health Food and Drug Administration
WorkingatFDA/BuildingsandFacilities/
and Human Services (DHHS). WhiteOakCampusInformation/
ACTION: Notice. [Docket No. FDA–2015–N–3275] ucm241740.htm.
Submit electronic comments to
SUMMARY: The U.S. Centers for Disease Labeling Lower-Dose Estrogen-Alone
www.regulations.gov. Submit written
Control and Prevention (CDC) is Products for Symptoms of Vulvar and
comments to the Division of Dockets
providing $1,300,000 in urgent funding Vaginal Atrophy
Management (HFA–305), Food and Drug
through the Epidemiology and AGENCY: Food and Drug Administration, Administration, 5630 Fishers Lane, Rm.
Laboratory Capacity for Infectious HHS. 1061, Rockville, MD 20852. All
Diseases (ELC) Cooperative Agreement comments should be identified with the
to the New York City Department of ACTION: Notice of public meeting;
request for comments. docket number found in brackets in the
Health (NYC HD)to combat an outbreak heading of this document.
of Legionella. As of August 18, 2015 SUMMARY: The Food and Drug FDA will post the agenda
NYC HD has identified 127 cases and 12 Administration (FDA) is announcing a approximately 5 days before the meeting
deaths associated with this public public meeting and an opportunity for at http://www.fda.gov/Drugs/
health emergency. These funds will be public comment on the topic of the NewsEvents/ucm459690.htm.
used by NYC HD to (1) create labeling for lower-dose estrogen FOR FURTHER INFORMATION CONTACT:
sustainable environmental and products delivered vaginally, intended Kimberly Shiley, Center for Drug
laboratory capacity at NYC HD to to treat moderate to severe symptoms of Evaluation and Research, Food and
respond to Legionella outbreak, (2) vulvar and vaginal atrophy (VVA) due Drug Administration, 10903 New
enhance laboratory capacity of to menopause. Lower-dose estrogen Hampshire Ave. Bldg. 22, Rm. 5377,
detection, isolation, and molecular products means products that contain Silver Spring, MD 20993, 301–796–
characterization of clinical and less than the 0.625 milligrams (mg) of 2117, email:
environmental strains at the New York conjugated estrogens used in the Kimberly.Shiley@fda.hhs.gov.
City public health laboratory, (3) Women’s Health Initiative Study, and SUPPLEMENTARY INFORMATION:
include sequence-based typing and estradiol products containing 0.0375 mg
eventually whole genome sequencing, and below. Lower-dose estrogen I. Introduction
and (4) allow NYC HD to characterize products are now approved for the The loss of ovarian function with
the geographic distribution of Legionella treatment of moderate to severe menopause leads to a drastic reduction
strains throughout New York City, symptoms of VVA due to menopause, in circulating estrogen concentration,
support the new public health and some in the scientific/medical which in turn leads to physiologic
engineering program to monitor the community have questioned whether changes to the vulva, vagina, and lower
compliance of building owners with the the current ‘‘Boxed Warnings’’ section urinary tract. Reduced circulating
new cooling tower regulations, and in the labeling is applicable in whole or estrogen concentration results in an
work with CDC to evaluate the impact in part to these lower-dose estrogen increase in vaginal pH, a thinning and
of these regulations. products. This meeting, a scientific reduction of the folds of the vaginal
DATES: Effective date is date of
tkelley on DSK3SPTVN1PROD with NOTICES

workshop, will provide an opportunity lining, reduction of vaginal secretions,
publication in the Federal Register. for FDA to seek input from experts on and loss of elasticity in vaginal tissues.
ADDRESSES: Alvin Shultz, MSPH, the Boxed Warnings section, estrogen Symptoms of decreased circulating
Division of Preparedness and Emerging exposure data, and pharmacokinetic estrogen include vaginal and vulvar
Infectious, National Center for Emerging (PK)/pharmacodynamic (PD) itching and/or irritation, vaginal dryness
and Zoonotic Infectious Diseases, relationships relative to labeling lower- and vaginal pain (dyspareunia), and/or
Centers for Disease Control and dose estrogen-alone products intended bleeding with intercourse. Not all

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Document Created: 2018-02-26 10:22:08
Document Modified: 2018-02-26 10:22:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective date is date of publication in the Federal Register.
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: [email protected]
FR Citation		80 FR 58258

80 FR 58258 - Emergency Funding for New York City Legionella Outbreak

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention (CDC)

Federal Register Volume 80, Issue 187 (September 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)