Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA), 1356 [2016-31944]
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Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
Workers’ Compensation Programs
Performance Measures as it relates to
the Black Lung Program, (2) to submit
documents relevant to active Black Lung
benefits claims electronically into
Claimant Online Access Link (C.O.A.L.)
and (3) to follow other procedures and
training related to diagnostic and
medical providers. This last point
encompasses the learning modules
entitled ‘‘Black Lung Disability
Evaluation and Claims Training for
Medical Examiners’’ and available at
https://www.publichealthlearning.com/
course/category.php?id=35. HRSA will
continue to work with DOL and BLCP
awardees to strengthen this component
of the BLCP.
Pulmonary Rehabilitation
Summary of Comments
All of the commenters agreed that
onsite pulmonary rehabilitation is a
vital service. However, most
commenters expressed concerns that
this service is not widely available to
miners who need it because it is costly
to operate, there are low rates of
reimbursement, and miners often aren’t
able to travel to clinics that do offer
treatment. Some commenters said that
consideration should be given for nontraditional pulmonary treatment
programs, such as in-home treatments,
and that HRSA should further research
the effectiveness of these programs. A
few commenters argued that BLCP
clinics should collaborate more with
hospital-based pulmonary rehabilitation
programs in multiple communities to
make it more feasible for miners to
receive treatment. Nearly all of the
commenters expressed concerns that
American Association of Cardiovascular
and Pulmonary Rehabilitation
(AACVPR) certification is difficult to
obtain and financially burdensome to
the clinics, and that it is not costeffective for the clinic to try to meet this
standard for additional grant funding.
Geographic Boundaries
Summary of Comments
A few commenters expressed concern
over how HRSA defines the service
areas of each clinic. At least two noted
that in some cases, coal miners work or
reside in closer proximity to clinics in
neighboring states than to those within
the same state, but that HRSA limits
clinics’ ability to conduct outreach in
other states. Another commenter stated
that some clinics provide
complementary services in close
proximity to one another.
Response
In certain cases, the FY 2017 BLCP
FOA allows more than one BLCP
awardee to provide services to coal
miners in a given county, provided
those awardees detail how they will
avoid duplicating efforts of other black
lung clinics. Applicants may also
propose to provide services (including
outreach) to coal miners in counties
other than the ones listed in the FY
2017 BLCP FOA, including counties in
neighboring states, provided that they
demonstrate how their services will
complement—rather than duplicate—
existing efforts in those counties. A coal
miner may receive services at a black
lung clinic of his or her choosing,
regardless of that clinic’s location or
service area designation.
Conclusion
HRSA considers many of the
comments received to be useful and
informative to future discussions on
how to strengthen the BLCP in future
years and appreciates the interest and
dedication of the commenters who are
committed to serving U.S. coal miners.
Any questions or concerns should be
directed to Blacklung@hrsa.gov.
Diana Espinosa,
Deputy Administrator.
[FR Doc. 2016–32003 Filed 1–4–17; 8:45 am]
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Response
In the FY 2014 BLCP FOA, BLCP
awardees receiving the highest level of
funding were required to provide
AACVPR-certified pulmonary
rehabilitation programs onsite. The FY
2017 BLCP FOA removes this
requirement and instead requires all
applicants to propose, at a minimum,
onsite, contracted, or referral to
accredited Phase II or Phase III
pulmonary rehab services. BLCP
awardees providing AACVPR-certified
programs to coal miners may maintain
their certification if they choose, but
this is no longer a requirement.
VerDate Sep<11>2014
21:06 Jan 04, 2017
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authority Under Title III,
Part D, Section 340B(d)(1)(B)(vi) of the
Public Health Service Act (PHSA)
Notice is hereby given that I have
delegated to the Inspector General,
Office of Inspector General, the
authority vested in the Secretary of
Health and Human Services under Title
III, Part D, Section 340B(d)(1)(B)(vi) of
the Public Health Service Act (PHSA),
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
as amended, to impose sanctions in the
form of civil monetary penalties against
manufacturers that knowingly and
intentionally charge a 340B covered
entity a price for purchase of a drug that
exceeds the maximum applicable
ceiling price as defined by section
340B(a)(1) of the PHSA. In accordance
with section 340B(d)(1)(B)(vi)(II) of the
PHSA, such sanctions shall not exceed
$5,000 for each instance of overcharging
a 340B covered entity that may have
occurred. This authority may be
redelegated. This delegation excludes
the authority to issue regulations.
I have affirmed and ratified any
actions taken by the Inspector General,
or subordinates, that involved the
exercise of the authority delegated
herein prior to the effective date of the
delegation.
This delegation became effective upon
date of signature.
Authority: 42 U.S.C. 256b(d)(1)(B)(vi)
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–31944 Filed 1–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Risk and Disease Prevention
Study Section.
Date: January 23–24, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Stacey FitzSimmons,
Ph.D., MPH, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
E:\FR\FM\05JAN1.SGM
05JAN1
]]>Agencies
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Page 1356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31944]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Delegation of Authority Under Title III, Part D, Section
340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA)
Notice is hereby given that I have delegated to the Inspector
General, Office of Inspector General, the authority vested in the
Secretary of Health and Human Services under Title III, Part D, Section
340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA), as amended,
to impose sanctions in the form of civil monetary penalties against
manufacturers that knowingly and intentionally charge a 340B covered
entity a price for purchase of a drug that exceeds the maximum
applicable ceiling price as defined by section 340B(a)(1) of the PHSA.
In accordance with section 340B(d)(1)(B)(vi)(II) of the PHSA, such
sanctions shall not exceed $5,000 for each instance of overcharging a
340B covered entity that may have occurred. This authority may be
redelegated. This delegation excludes the authority to issue
regulations.
I have affirmed and ratified any actions taken by the Inspector
General, or subordinates, that involved the exercise of the authority
delegated herein prior to the effective date of the delegation.
This delegation became effective upon date of signature.
Authority: 42 U.S.C. 256b(d)(1)(B)(vi)
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-31944 Filed 1-4-17; 8:45 am]
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