81 FR 60007 - National Advisory Committee on Rural Health and Human Services; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 169 (August 31, 2016)

Page Range		60007-60008
FR Document		2016-20911

Federal Register, Volume 81 Issue 169 (Wednesday, August 31, 2016)

[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60007-60008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20911]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Advisory Committee on Rural Health and Human Services; 
Notice of Meeting

    In accordance with Section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:

NAME:  National Advisory Committee on Rural Health and Human Services.

[[Page 60008]]


DATES AND TIMES: 
September 14, 2016, 8:30 a.m.-5:00 p.m. MT
September 15, 2016, 8:30 a.m.-5:15 p.m. MT
September 16, 2016, 8:30 a.m.-11:00 a.m. MT

PLACE: 
Albuquerque Marriott, 2101 Louisiana Boulevard NE., Albuquerque, New 
Mexico 87110, (505) 881-6800.

STATUS:  The meeting will be open to the public.

PURPOSE:  The National Advisory Committee on Rural Health and Human 
Services provides counsel and recommendations to the Secretary with 
respect to the delivery, research, development, and administration of 
health and human services in rural areas.

AGENDA:  The meeting on Wednesday, September 14, will be called to 
order at 8:30 a.m. by the Chairperson of the Committee, the Honorable 
Ronnie Musgrove. The Committee will examine the issue of social 
determinants of health in rural areas. The day will conclude with a 
period of public comment at approximately 5:00 p.m.
    The Committee will break into subcommittees and depart for site 
visits Thursday morning, September 15, at approximately 8:30 a.m. 
Subcommittees will visit the Presbyterian Medical Services Cuba Health 
Center in Cuba, New Mexico; the Laguna Pueblo, a federally recognized 
Native American tribe of the Pueblo people in Laguna, New Mexico; and 
the Guadalupe County Hospital in Santa Rosa, New Mexico. The day will 
conclude at the Albuquerque Marriott with the period of public comment 
at approximately 5:15 p.m.
    On Friday, September 16, at 8:30 a.m., the Committee will meet at 
the Albuquerque Marriott to summarize key findings from the site visits 
and develop a work plan for the next quarter.

FOR FURTHER INFORMATION CONTACT: Steve Hirsch, MSLS, Administrative 
Coordinator, National Advisory Committee on Rural Health and Human 
Services, Health Resources and Services Administration, 5600 Fishers 
Lane, 17W41D, Rockville, MD 20857, Telephone (301) 443-0835, Fax (301) 
443-2803.
    Persons interested in attending any portion of the meeting should 
contact Pierre Joseph at the Federal Office of Rural Health Policy 
(FORHP) via telephone at (301) 945-0897 or by email at 
[email protected]. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the contact person listed above at least 
10 days prior to the meeting. The Committee meeting agenda will be 
posted on the Committee's Web site at http://www.hrsa.gov/advisorycommittees/rural/.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-20911 Filed 8-30-16; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 60007

2015 when the first local transmission platelets and plasma using an FDA- This guidance is being issued
was reported in Brazil. Local approved pathogen reduction device as consistent with FDA’s good guidance
transmission of ZIKV has also been specified in the Instructions for Use of practices regulation (21 CFR 10.115).
reported in areas outside of the the device. If an FDA-approved FDA is issuing this guidance for
Americas, including the Pacific Islands pathogen reduction device becomes immediate implementation in
of Samoa, American Samoa, Marshall available for Whole Blood or red blood accordance with 21 CFR 10.115(g)(2)
Islands and Tonga, and Cape Verde in cells, blood establishments may without initially seeking prior comment
Africa, and there are now at least 50 implement pathogen reduction because the Agency has determined that
countries and territories worldwide technology for such products rather prior public participation is not feasible
with active local transmission of the than testing the donations. Blood or appropriate. The guidance represents
virus. establishments implementing these the current thinking of FDA on ‘‘Revised
The first local transmission of ZIKV in measures may discontinue providing Recommendations for Reducing the Risk
the United States was reported from donor educational material with respect of Zika Virus Transmission by Blood
Puerto Rico in December 2015, and soon to ZIKV and screening donors for ZIKV and Blood Components.’’ It does not
thereafter local transmission was also risk factors such as travel history and establish any rights for any person and
reported in American Samoa and the deferring them as previously is not binding on FDA or the public.
U.S. Virgin Islands. In July 2016, the recommended in the February 2016 You can use an alternative approach if
first cases of local transmission of ZIKV guidance. Under 21 CFR 630.10(a), if a it satisfies the requirements of the
occurring in the continental United donor volunteers a recent history of applicable statutes and regulations.
States were reported from Miami-Dade ZIKV infection, a blood establishment
County in Florida. The possibility of II. Paperwork Reduction Act of 1995
must not collect blood or blood
further geographic spread of ZIKV exists components from that donor. For such This guidance refers to previously
in regions where the Aedes aegypti, and donors, the guidance recommends a approved collections of information
possibly the Aedes albopictus, mosquito deferral period of 120 days after a found in FDA regulations. These
is present. In January 2016, ZIKV positive viral test or the resolution of collections of information are subject to
disease was added to the list of symptoms, whichever timeframe is review by the Office of Management and
nationally notifiable conditions in the longer. Budget (OMB) under the Paperwork
United States as a subtype of Arboviral Reduction Act of 1995 (44 U.S.C. 3501–
FDA recommends that blood
diseases. 3520). The collections of information in
The most common ZIKV disease establishments implement the
recommendations in the guidance as 21 CFR 601.12 have been approved
symptoms include fever, arthralgia, under OMB control number 0910–0338;
maculopapular rash, and conjunctivitis. follows: (1) Blood establishments that
collect Whole Blood and blood the collections of information in 21 CFR
In addition, neurological manifestations 606.100(b) and 606.160(b)(1) have been
and congenital anomalies have been components in U.S. States and
territories with one or more reported approved under OMB control number
associated with ZIKV disease outbreaks. 0910–0795; and the collections of
ZIKV infection has been associated with locally acquired mosquito-borne cases
of ZIKV should implement the information in 21 CFR 606.122 and
Guillain-Barré syndrome. ZIKV 630.30 have been approved under OMB
infection during pregnancy is a cause of recommendations immediately. Blood
establishments should cease blood control number 0910–0116.
microcephaly and other serious fetal
brain anomalies. Other problems have collection until testing or the use of III. Electronic Access
been detected in pregnancies and among pathogen reduction technology is Persons with access to the Internet
fetuses and infants infected with ZIKV implemented, consistent with the may obtain the guidance at either http://
before birth, such as miscarriage, recommendations in the guidance. As of www.fda.gov/BiologicsBloodVaccines/
stillbirth, absent or poorly developed the date of issuance of the guidance, the GuidanceComplianceRegulatory
brain structures, defects of the eye, recommendations applies to blood Information/Guidances/default.htm or
hearing deficits, and impaired growth; establishments that collect Whole Blood http://www.regulations.gov.
however, the full clinical spectrum of and blood components in Florida and
Puerto Rico; (2) because of their Dated: August 25, 2016.
the effects of ZIKV infection during
proximity to areas with locally acquired Leslie Kux,
pregnancy is not yet known.
FDA has identified ZIKV as a mosquito-borne cases of ZIKV or Associate Commissioner for Policy.
transfusion-transmitted infection under because of other epidemiological [FR Doc. 2016–20914 Filed 8–30–16; 8:45 am]
§ 630.3(l) and RTTI under § 630.3(h)(2). linkage to ZIKV, such as the number of BILLING CODE 4164–01–P
This determination is based on the travel-associated cases reported in a
severity of the disease, risk of State, blood establishments that collect
transfusion-transmission by blood and Whole Blood and blood components in DEPARTMENT OF HEALTH AND
blood components, the availability of Alabama, Arizona, California, Georgia, HUMAN SERVICES
appropriate screening measures, and Hawaii, Louisiana, Mississippi, New
Mexico, New York, South Carolina, and Health Resources and Services
significant incidence and prevalence
Texas should implement the Administration
affecting the potential donor population.
The guidance recommends that blood recommendations as soon as feasible, National Advisory Committee on Rural
establishments test all donations but not later than 4 weeks after the Health and Human Services; Notice of
collected in the United States and its guidance issue date; and (3) blood
mstockstill on DSK3G9T082PROD with NOTICES

Meeting
territories with an investigational establishments that collect Whole Blood
individual donor nucleic acid test (ID– and blood components in all other In accordance with Section 10(a)(2) of
NAT) for ZIKV under an investigational States and territories should implement the Federal Advisory Committee Act
new drug application (IND), or when the recommendations as soon as (Pub. L. 92–463), notice is hereby given
available, a licensed test. Alternatively, feasible, but not later than 12 weeks of the following meeting:
blood establishments may implement after the date of the issuance of this NAME: National Advisory Committee on
pathogen reduction technology for guidance. Rural Health and Human Services.

VerDate Sep<11>2014 21:59 Aug 30, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1

Document Created: 2018-02-02 12:15:00
Document Modified: 2018-02-02 12:15:00

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
Contact		Steve Hirsch, MSLS, Administrative Coordinator, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, 17W41D, Rockville, MD 20857, Telephone (301) 443-0835, Fax (301) 443-2803.
FR Citation		81 FR 60007

81 FR 60007 - National Advisory Committee on Rural Health and Human Services; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 169 (August 31, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration