Notice of Supplemental Awards to the Territorial Health Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for the Zika Maternal and Child Health Services Program, 40160-40161 [2017-17883]
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40160
Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–1956 for ‘‘Identifying Trading
Partners Under the Drug Supply Chain
Security Act; Draft Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
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fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
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VerDate Sep<11>2014
15:29 Aug 23, 2017
Jkt 241001
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Melissa Mannion, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Identifying Trading Partners Under the
Drug Supply Chain Security Act.’’ The
DSCSA (Title II of Pub. L. 113–54)
establishes new requirements to develop
and enhance drug distribution security
by 2023. It does this, in part, by defining
different types of entities in the drug
supply chain as trading partners (i.e.,
manufacturers, repackagers, wholesale
distributors, third-party logistics
providers, and dispensers). Among
other things, the DSCSA requires that
trading partners of manufacturers,
wholesale distributors, dispensers, and
repackagers must meet the applicable
requirements for being ‘‘authorized
trading partners.’’ In addition, the
DSCSA outlines requirements for
specific trading partners, including drug
product tracing and licensure
requirements. FDA has received
questions about which types of entities
are included in each of the trading
partner definitions and this guidance is
intended to help clarify and explain the
relevant statutory provisions. The
guidance covers who is considered to be
a manufacturer, a repackager, a
wholesale drug distributor, a third-party
logistics provider, and a dispenser for
purposes of certain DSCSA
requirements.
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II. Additional Issues for Consideration:
Specific Request for Comments and
Information
In addition to comments on the draft
guidance generally, FDA is requesting
comments specifically related to the
activities of private-label distributors
(PLDs), and whether those activities fall
within the definitions under DSCSA of
the various trading partners. FDA
considers a PLD to be an entity that
owns and distributes a manufactured
product under its own label or trade
name. Because there are many different
business models for PLDs, resulting in
situations where a PLD could be
considered a manufacturer, wholesale
distributor, or dispenser, we are asking
for comments on how the different
business models might impact a PLD’s
status as an authorized trading partner
under the DSCSA.
This draft guidance is being issued
consistent with FDA’s good guidance
practices (see 21 CFR 10.115). The draft
guidance, when finalized, will represent
the current thinking of FDA on
‘‘Identifying Trading Partners under the
Drug Supply Chain Security Act.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17919 Filed 8–21–17; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Awards to the
Territorial Health Departments of
Puerto Rico, American Samoa, and
U.S. Virgin Islands for the Zika
Maternal and Child Health Services
Program
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
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40161
Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
ACTION:
Notice of Supplemental Award.
HRSA announces the award
of supplemental grants under the Zika
Response and Preparedness Act to the
territorial health departments of Puerto
Rico, American Samoa, and U.S. Virgin
Islands to address the unmet needs of
women, children, and families who are
or may be affected by Zika virus (ZIKV)
infection.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Territorial health departments of Puerto
Rico, American Samoa, and U.S. Virgin
Islands.
Amount of Non-Competitive Awards:
Approximately $1,050,000.
CFDA Number: 93.110.
Authority: Zika Response and
Preparedness Act (Pub. L. 114–223) and
Section 501(a)(2) of the Social Security
Act (42 U.S.C. 701(a)(2)).
Justification: The current spread of
ZIKV poses a significant threat to public
health, including the health of women,
children, and families who are affected
by ZIKV infection. ZIKV infection
during pregnancy can cause serious
birth defects, especially affecting the
neurological system of the infant.
Funding for these awards is available
under the Zika Response and
SUMMARY:
Preparedness Act through Special
Projects of Regional and National
Significance (SPRANS) funds.
The needs of infants and children
affected by ZIKV are complex. Families,
health care providers, and public health
professionals will be required to work
together to assure that communitybased, comprehensive, high quality
health and social services are available
to these children. The support system
must address the medical needs of these
children, such as regularly screening
children who may not be symptomatic
at birth; coordinate care through a
medical home; finance care needed by
children and families; link to
community-based services; partner with
families; and eventually address
transition to adult services. Following
HRSA’s December 2016 grant awards to
the territorial health departments of
Puerto Rico, American Samoa, and U.S.
Virgin Islands, recipients continued to
identify pregnant women and infants
with lab evidence of ZIKV infection that
led them to refine their response to
ZIKV. HRSA’s Maternal and Child
Health Bureau (MCHB) received
information from the territorial health
departments of unmet needs in their
response to ZIKV through monitoring
site visits, regular communication, and
prior approval requests. Needs
identified by recipients included
additional equipment, personnel, and
transportation services. With further
analysis of other federal funding and the
current epidemiologic data, MCHB
confirmed additional funding is
essential to ensure access to services
and a comprehensive medical home for
women, children, and families who are
or may be affected by ZIKV infection.
Disease burden and the significant
increase in pregnant women and
children with lab evidence of ZIKV
infection in American Samoa and the
U.S. Virgin Islands was also considered
as a factor in determining the allocation
of funds to the territories to address
unmet needs. The period of
performance of the supplemental award
will be September 2017 through
December 2019.
FOR FURTHER INFORMATION CONTACT:
Maria Paz Carlos, Division of State and
Community Health, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18N104A, Rockville,
Maryland 20857; MCarlos@hrsa.gov.
FY 2017
supplemental
awards
Grantee/organization name
Territory
Puerto Rico Health Department ................................................................
American Samoa Health Department .......................................................
U.S. Virgin Islands Health Department .....................................................
Puerto Rico ..................................................................
American Samoa .........................................................
U.S. Virgin Islands .......................................................
Dated: August 18, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017–17883 Filed 8–23–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rmajette on DSKBCKNHB2PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval: Public Comment
Request; Information Collection
Request Title: Federal Tort Claims Act
(FTCA) Program Deeming Applications
for Health Center Volunteer Health
Professionals, OMB No. 0906–XXXX,
New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
15:29 Aug 23, 2017
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than September 25,
2017.
SUMMARY:
Jkt 241001
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
ADDRESSES:
PO 00000
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$52,850
423,142
574,008
When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Federal Tort Claims Act (FTCA)
Program Deeming Applications for
Health Center Volunteer Health
Professionals OMB No. 0906–XXXX—
New.
Abstract: Section 224(q) of the Public
Health Service (PHS) Act (42 U.S.C.
233(q)), as amended, authorizes the
‘‘deeming’’ of certain individuals as
PHS employees for the purposes of
receiving Federal Tort Claims Act
(FTCA) coverage. Section 224(q) relates
to volunteer health professionals (VHPs)
of Health Center Program grantees that
have been deemed as PHS employees.
The Health Center FTCA Program is
administered by HRSA’s Bureau of
Primary Health Care (BPHC).
Sponsoring health centers are required
SUPPLEMENTARY INFORMATION:
E:\FR\FM\24AUN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Pages 40160-40161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Awards to the Territorial Health
Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for
the Zika Maternal and Child Health Services Program
AGENCY: Health Resources and Services Administration (HRSA), HHS.
[[Page 40161]]
ACTION: Notice of Supplemental Award.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of supplemental grants under the Zika
Response and Preparedness Act to the territorial health departments of
Puerto Rico, American Samoa, and U.S. Virgin Islands to address the
unmet needs of women, children, and families who are or may be affected
by Zika virus (ZIKV) infection.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Territorial health departments of
Puerto Rico, American Samoa, and U.S. Virgin Islands.
Amount of Non-Competitive Awards: Approximately $1,050,000.
CFDA Number: 93.110.
Authority: Zika Response and Preparedness Act (Pub. L. 114-223) and
Section 501(a)(2) of the Social Security Act (42 U.S.C. 701(a)(2)).
Justification: The current spread of ZIKV poses a significant
threat to public health, including the health of women, children, and
families who are affected by ZIKV infection. ZIKV infection during
pregnancy can cause serious birth defects, especially affecting the
neurological system of the infant.
Funding for these awards is available under the Zika Response and
Preparedness Act through Special Projects of Regional and National
Significance (SPRANS) funds.
The needs of infants and children affected by ZIKV are complex.
Families, health care providers, and public health professionals will
be required to work together to assure that community-based,
comprehensive, high quality health and social services are available to
these children. The support system must address the medical needs of
these children, such as regularly screening children who may not be
symptomatic at birth; coordinate care through a medical home; finance
care needed by children and families; link to community-based services;
partner with families; and eventually address transition to adult
services. Following HRSA's December 2016 grant awards to the
territorial health departments of Puerto Rico, American Samoa, and U.S.
Virgin Islands, recipients continued to identify pregnant women and
infants with lab evidence of ZIKV infection that led them to refine
their response to ZIKV. HRSA's Maternal and Child Health Bureau (MCHB)
received information from the territorial health departments of unmet
needs in their response to ZIKV through monitoring site visits, regular
communication, and prior approval requests. Needs identified by
recipients included additional equipment, personnel, and transportation
services. With further analysis of other federal funding and the
current epidemiologic data, MCHB confirmed additional funding is
essential to ensure access to services and a comprehensive medical home
for women, children, and families who are or may be affected by ZIKV
infection. Disease burden and the significant increase in pregnant
women and children with lab evidence of ZIKV infection in American
Samoa and the U.S. Virgin Islands was also considered as a factor in
determining the allocation of funds to the territories to address unmet
needs. The period of performance of the supplemental award will be
September 2017 through December 2019.
FOR FURTHER INFORMATION CONTACT: Maria Paz Carlos, Division of State
and Community Health, Maternal and Child Health Bureau, Health
Resources and Services Administration, 5600 Fishers Lane, Room 18N104A,
Rockville, Maryland 20857; MCarlos@hrsa.gov.
------------------------------------------------------------------------
FY 2017
Grantee/organization name Territory supplemental
awards
------------------------------------------------------------------------
Puerto Rico Health Department..... Puerto Rico......... $52,850
American Samoa Health Department.. American Samoa...... 423,142
U.S. Virgin Islands Health U.S. Virgin Islands. 574,008
Department.
------------------------------------------------------------------------
Dated: August 18, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017-17883 Filed 8-23-17; 8:45 am]
BILLING CODE 4165-15-P
