82 FR 1356 - Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 82, Issue 3 (January 5, 2017)
Office of the Secretary
Federal Register Volume 82, Issue 3 (January 5, 2017)
| Page Range | 1356-1356 | |
| FR Document | 2016-31944 |
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)] [Notices] [Page 1356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31944] ----------------------------------------------------------------------- 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] BILLING CODE 4165-15-P
![1356 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
Workers’ Compensation Programs Geographic Boundaries as amended, to impose sanctions in the
Performance Measures as it relates to form of civil monetary penalties against
Summary of Comments
the Black Lung Program, (2) to submit manufacturers that knowingly and
documents relevant to active Black Lung A few commenters expressed concern intentionally charge a 340B covered
benefits claims electronically into over how HRSA defines the service entity a price for purchase of a drug that
Claimant Online Access Link (C.O.A.L.) areas of each clinic. At least two noted exceeds the maximum applicable
and (3) to follow other procedures and that in some cases, coal miners work or ceiling price as defined by section
training related to diagnostic and reside in closer proximity to clinics in 340B(a)(1) of the PHSA. In accordance
medical providers. This last point neighboring states than to those within with section 340B(d)(1)(B)(vi)(II) of the
encompasses the learning modules the same state, but that HRSA limits PHSA, such sanctions shall not exceed
entitled ‘‘Black Lung Disability clinics’ ability to conduct outreach in $5,000 for each instance of overcharging
Evaluation and Claims Training for other states. Another commenter stated a 340B covered entity that may have
Medical Examiners’’ and available at that some clinics provide occurred. This authority may be
https://www.publichealthlearning.com/ complementary services in close redelegated. This delegation excludes
course/category.php?id=35. HRSA will proximity to one another. the authority to issue regulations.
continue to work with DOL and BLCP I have affirmed and ratified any
Response
awardees to strengthen this component actions taken by the Inspector General,
of the BLCP. In certain cases, the FY 2017 BLCP or subordinates, that involved the
FOA allows more than one BLCP exercise of the authority delegated
Pulmonary Rehabilitation awardee to provide services to coal herein prior to the effective date of the
miners in a given county, provided delegation.
Summary of Comments those awardees detail how they will This delegation became effective upon
All of the commenters agreed that avoid duplicating efforts of other black date of signature.
onsite pulmonary rehabilitation is a lung clinics. Applicants may also Authority: 42 U.S.C. 256b(d)(1)(B)(vi)
vital service. However, most propose to provide services (including
commenters expressed concerns that outreach) to coal miners in counties Sylvia M. Burwell,
this service is not widely available to other than the ones listed in the FY Secretary, Department of Health and Human
2017 BLCP FOA, including counties in Services.
miners who need it because it is costly
to operate, there are low rates of neighboring states, provided that they [FR Doc. 2016–31944 Filed 1–4–17; 8:45 am]
reimbursement, and miners often aren’t demonstrate how their services will BILLING CODE 4165–15–P
able to travel to clinics that do offer complement—rather than duplicate—
treatment. Some commenters said that existing efforts in those counties. A coal
consideration should be given for non- miner may receive services at a black DEPARTMENT OF HEALTH AND
traditional pulmonary treatment lung clinic of his or her choosing, HUMAN SERVICES
programs, such as in-home treatments, regardless of that clinic’s location or
service area designation. National Institutes of Health
and that HRSA should further research
the effectiveness of these programs. A Conclusion Center for Scientific Review; Notice of
few commenters argued that BLCP Closed Meetings
HRSA considers many of the
clinics should collaborate more with
comments received to be useful and Pursuant to section 10(d) of the
hospital-based pulmonary rehabilitation
informative to future discussions on Federal Advisory Committee Act, as
programs in multiple communities to
how to strengthen the BLCP in future amended (5 U.S.C. App.), notice is
make it more feasible for miners to
years and appreciates the interest and hereby given of the following meetings.
receive treatment. Nearly all of the
dedication of the commenters who are The meetings will be closed to the
commenters expressed concerns that
committed to serving U.S. coal miners. public in accordance with the
American Association of Cardiovascular
Any questions or concerns should be provisions set forth in sections
and Pulmonary Rehabilitation
directed to Blacklung@hrsa.gov. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(AACVPR) certification is difficult to
obtain and financially burdensome to as amended. The grant applications and
Diana Espinosa,
the clinics, and that it is not cost- the discussions could disclose
Deputy Administrator.
effective for the clinic to try to meet this confidential trade secrets or commercial
[FR Doc. 2016–32003 Filed 1–4–17; 8:45 am] property such as patentable material,
standard for additional grant funding. BILLING CODE 4165–15–P and personal information concerning
Response individuals associated with the grant
applications, the disclosure of which
In the FY 2014 BLCP FOA, BLCP DEPARTMENT OF HEALTH AND would constitute a clearly unwarranted
awardees receiving the highest level of HUMAN SERVICES invasion of personal privacy.
funding were required to provide
Office of the Secretary Name of Committee: Risk, Prevention and
AACVPR-certified pulmonary Health Behavior Integrated Review Group;
rehabilitation programs onsite. The FY Psychosocial Risk and Disease Prevention
Delegation of Authority Under Title III,
2017 BLCP FOA removes this Study Section.
Part D, Section 340B(d)(1)(B)(vi) of the
requirement and instead requires all Date: January 23–24, 2017.
Public Health Service Act (PHSA)
applicants to propose, at a minimum, Time: 8:00 a.m. to 5:00 p.m.
mstockstill on DSK3G9T082PROD with NOTICES
onsite, contracted, or referral to Notice is hereby given that I have Agenda: To review and evaluate grant
accredited Phase II or Phase III delegated to the Inspector General, applications.
pulmonary rehab services. BLCP Office of Inspector General, the Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
awardees providing AACVPR-certified authority vested in the Secretary of Contact Person: Stacey FitzSimmons,
programs to coal miners may maintain Health and Human Services under Title Ph.D., MPH, Scientific Review Officer, Center
their certification if they choose, but III, Part D, Section 340B(d)(1)(B)(vi) of for Scientific Review, National Institutes of
this is no longer a requirement. the Public Health Service Act (PHSA), Health, 6701 Rockledge Drive, Room 3114,
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Document Created: 2018-02-01 14:50:45
Document Modified: 2018-02-01 14:50:45
| 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 | |
| FR Citation | 82 FR 1356 |
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