Health Center Program, 80365-80366 [2015-32355]
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Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the Office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 the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Deviation
Reporting for Human Cells, Tissues, and
Cellular and Tissue Based Products
Regulated Solely Under Section 361 of
the Public Health Service Act and 21
CFR part 1271; Draft Guidance for
Industry.’’ The document provides
certain establishments that manufacture
HCT/Ps, regulated solely under section
361 of the PHS Act and the regulations
under 21 CFR part 1271, with
recommendations and relevant
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examples for complying with the
requirements under 21 CFR 1271.350(b)
to report HCT/P deviations. The
examples provided in the draft guidance
are intended to illustrate those HCT/P
deviations that have been most
frequently reported to FDA, CBER.
The draft guidance does not apply to
reproductive HCT/Ps or to HCT/Ps
regulated under 21 CFR part 1270 and
recovered before May 25, 2005. The
draft guidance does not apply to health
professionals who implant, transplant,
infuse, or transfer HCT/Ps into
recipients. The draft guidance also does
not apply to HCT/Ps that are regulated
as drugs, devices, and/or biological
products under section 351 of the PHS
Act and/or the Federal Food, Drug, and
Cosmetic Act, nor does it apply to
investigational HCT/Ps subject to an
investigational new drug application or
an investigational device exemption.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on Deviation Reporting for Human
Cells, Tissues, and Cellular and Tissue
Based Products Regulated Solely Under
section 361 of the Public Health Service
Act and 21 CFR part 1271. 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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 1271 have
been approved under OMB control
number 0910–0543.
III. Other Issues for Consideration
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
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80365
Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32323 Filed 12–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Class Deviation from
Competition Requirements for the
Health Center Program; Notice of Class
Deviations from the Requirements for
Extensions, Administrative
Supplements, and for Announcing these
Deviations in the Federal Register for
the Health Center Program.
AGENCY:
In accordance with the
Awarding Agency Grants
Administration Manual (AAGAM)
Chapter 1.03.103, the Bureau of Primary
Health Care (BPHC) has been granted
class deviations from the requirements
for extensions contained in the AAGAM
Chapter 2.04.104B–4A.I.a(5)(b) and the
requirements for administrative
supplements contained in AAGAM
Chapter 2.04.104B–4A.4.b to provide
additional grant funds during extended
budget periods in excess of the allowed
maximum. The deviations prevent
interruptions in the provision of critical
health care services for a funded service
area until a new award can be made to
an eligible Service Area Competition
(SAC) applicant and to conduct an
orderly phase-out of Health Center
Program activities by the current award
recipient. BPHC has also been granted a
deviation that allows it to annually
announce via the Federal Register the
Health Center Program award recipients
that received a low cost extension and/
or administrative supplement under the
above described deviations.
SUPPLEMENTARY INFORMATION: Intended
Recipient of the Award: Health Center
Program award recipients for service
areas that are threatened with a lapse in
services due to transitioning award
recipients.
Amount of Non-Competitive Awards:
Varies annually.
Period of Supplemental Funding:
Awards made beginning in fiscal year
2016 and ongoing.
SUMMARY:
CFDA Number: 93.224
Authority: Section 330 of the Public Health
Service Act, as amended (42 U.S.C. 254b, as
amended).
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80366
Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices
Justification: Targeting the nation’s
neediest populations and geographic
areas, the Health Center Program
currently funds more than 1,300 health
centers that operate approximately
9,000 service delivery sites in every
state, the District of Columbia, Puerto
Rico, the Virgin Islands, and the Pacific
Basin. More than 23 million patients,
including medically underserved and
uninsured patients, received
comprehensive, culturally competent,
quality primary health care services
through the Health Center Program
award recipients.
Approximately one-third of current
award recipients’ service areas are
scheduled to be competed each year via
SACs. SACs are also held prior to a
current grant’s project period end date
when (1) a grant is voluntarily
relinquished or (2) a program
noncompliance enforcement action
taken by HRSA terminates the grant. If
a SAC draws no fundable applications,
BPHC may extend the current award
recipient’s budget period to conduct an
orderly phase-out of Health Center
Program activities and prepare for a new
competition for the service area.
The amount of additional grant funds
is calculated by pro-rating HRSA’s
existing annual funding commitment to
the service area. The average Health
Center Program grant amount is over $2
million. Approximately 6 months is
required to announce and conduct a
SAC. BPHC’s extensions and
administrative supplements are
generally for a minimum of 90 days,
which is at least 25 percent of the
annual grant amount, thereby typically
exceeding the allowed maximum.
Through the deviations, award
recipients receive consistent levels of
funding to support uninterrupted
primary health care services to the
nation’s most vulnerable populations
and communities during service area
award recipient transition.
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Olivia Shockey, Expansion Division
Director, Office of Policy and Program
Development, Bureau of Primary Health
Care, Health Resources and Services
Administration at 301–443–9282 or
oshockey@hrsa.gov.
Dated: December 17, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015–32355 Filed 12–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593, or visit our Web
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
SUMMARY:
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100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
November 1, 2015, through November
30, 2015. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
submit written information relevant to
the issues described above in the case of
the petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
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]]>Agencies
[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80365-80366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Health Center Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Class Deviation from Competition Requirements for the
Health Center Program; Notice of Class Deviations from the Requirements
for Extensions, Administrative Supplements, and for Announcing these
Deviations in the Federal Register for the Health Center Program.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Awarding Agency Grants Administration
Manual (AAGAM) Chapter 1.03.103, the Bureau of Primary Health Care
(BPHC) has been granted class deviations from the requirements for
extensions contained in the AAGAM Chapter 2.04.104B-4A.I.a(5)(b) and
the requirements for administrative supplements contained in AAGAM
Chapter 2.04.104B-4A.4.b to provide additional grant funds during
extended budget periods in excess of the allowed maximum. The
deviations prevent interruptions in the provision of critical health
care services for a funded service area until a new award can be made
to an eligible Service Area Competition (SAC) applicant and to conduct
an orderly phase-out of Health Center Program activities by the current
award recipient. BPHC has also been granted a deviation that allows it
to annually announce via the Federal Register the Health Center Program
award recipients that received a low cost extension and/or
administrative supplement under the above described deviations.
SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Health
Center Program award recipients for service areas that are threatened
with a lapse in services due to transitioning award recipients.
Amount of Non-Competitive Awards: Varies annually.
Period of Supplemental Funding: Awards made beginning in fiscal
year 2016 and ongoing.
CFDA Number: 93.224
Authority: Section 330 of the Public Health Service Act, as
amended (42 U.S.C. 254b, as amended).
[[Page 80366]]
Justification: Targeting the nation's neediest populations and
geographic areas, the Health Center Program currently funds more than
1,300 health centers that operate approximately 9,000 service delivery
sites in every state, the District of Columbia, Puerto Rico, the Virgin
Islands, and the Pacific Basin. More than 23 million patients,
including medically underserved and uninsured patients, received
comprehensive, culturally competent, quality primary health care
services through the Health Center Program award recipients.
Approximately one-third of current award recipients' service areas
are scheduled to be competed each year via SACs. SACs are also held
prior to a current grant's project period end date when (1) a grant is
voluntarily relinquished or (2) a program noncompliance enforcement
action taken by HRSA terminates the grant. If a SAC draws no fundable
applications, BPHC may extend the current award recipient's budget
period to conduct an orderly phase-out of Health Center Program
activities and prepare for a new competition for the service area.
The amount of additional grant funds is calculated by pro-rating
HRSA's existing annual funding commitment to the service area. The
average Health Center Program grant amount is over $2 million.
Approximately 6 months is required to announce and conduct a SAC.
BPHC's extensions and administrative supplements are generally for a
minimum of 90 days, which is at least 25 percent of the annual grant
amount, thereby typically exceeding the allowed maximum. Through the
deviations, award recipients receive consistent levels of funding to
support uninterrupted primary health care services to the nation's most
vulnerable populations and communities during service area award
recipient transition.
FOR FURTHER INFORMATION CONTACT: Olivia Shockey, Expansion Division
Director, Office of Policy and Program Development, Bureau of Primary
Health Care, Health Resources and Services Administration at 301-443-
9282 or oshockey@hrsa.gov.
Dated: December 17, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-32355 Filed 12-23-15; 8:45 am]
BILLING CODE 4165-15-P
