Notice To Announce Project Period Extensions With Funding for Health Center Program Award Recipients in Pago Pago, American Samoa; Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts, 56460 [2019-22984]

Download as PDF 56460 Federal Register / Vol. 84, No. 204 / Tuesday, October 22, 2019 / Notices CFR 314.510). PROAMATINE is indicated for the treatment of orthostatic hypotension. PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Shire no longer markets PROAMATINE in any strength; although there are approved ANDAs referencing NDA 019815, PROAMATINE has been withdrawn from sale. We have carefully reviewed our files for records concerning the withdrawal of PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. FDA has determined under § 314.161 that PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, FDA will continue to list PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. We note that, because PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, were approved under the accelerated approval pathway, Shire was required to conduct post-approval studies to verify the clinical benefit of PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg. The clinical benefit of PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, remains subject to verification. ANDAs that refer to PROAMATINE (midodrine hydrochloride) tablets, 2.5 mg, 5 mg, and 10 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: October 15, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23014 Filed 10–21–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice To Announce Project Period Extensions With Funding for Health Center Program Award Recipients in Pago Pago, American Samoa; Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: Additional grant funds were provided to four Health Center Program SUMMARY: award recipients with project periods ending in fiscal year (FY) 2019 to extend their project periods by up to four months to ensure the ongoing delivery of services until a new award could be made. SUPPLEMENTARY INFORMATION: Recipients of the Award: Four award recipients, as listed in Table 1, in Pago Pago, American Samoa; Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts. Amount of Non-Competitive Awards: $3,066,387. Period of Supplemental Funding: FY 2019. Assistance Listings (CFDA) Number: 93.224. Authority: Public Health Service Act, Section 330, as amended (42 U.S.C. 254b, as amended). Justification: HRSA extended the FY 2019 project periods with prorated supplemental grant funds to four award recipients by up to four months until a new award is made for each service area. Continued funding to the Health Center Program award recipients ensured that individuals in the service areas received uninterrupted access to needed health care services. The approvals enabled HRSA to support consistent health care to beneficiaries, eliminate delays in funding gaps, and demonstrate administrative efficiencies. HRSA awarded approximately $3 million to the four existing Health Center Program award recipients noted in Table 1. TABLE 1—RECIPIENTS AND AWARD AMOUNTS Extension length (months) Grant No. Award recipient name City, state H80CS02470 .... American Samoa Government Department of Health. Toiyabe Indian Health Project, Inc ............... Parkwest Health Systems, Inc ...................... Community Healthlink, Inc ............................ Pago Pago, American Samoa ...................... 3 $775,917 Bishop, California .......................................... Baltimore, Maryland ...................................... Worcester, Massachusetts ........................... 4 4 4 382,549 1,326,373 581,548 H80CS26629 .... H80CS00067 .... H80CS00003 .... 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 oshockey@hrsa.gov or 301–594–4300. Dated: October 8, 2019. Thomas J. Engels, Acting Administrator. BILLING CODE 4165–15–P 17:02 Oct 21, 2019 Health Resources And Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). AGENCY: [FR Doc. 2019–22984 Filed 10–21–19; 8:45 am] VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Jkt 250001 PO 00000 Notice. Frm 00050 Fmt 4703 Sfmt 4703 Award amount HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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. SUMMARY: E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Page 56460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22984]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice To Announce Project Period Extensions With Funding for 
Health Center Program Award Recipients in Pago Pago, American Samoa; 
Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: Additional grant funds were provided to four Health Center 
Program award recipients with project periods ending in fiscal year 
(FY) 2019 to extend their project periods by up to four months to 
ensure the ongoing delivery of services until a new award could be 
made.

SUPPLEMENTARY INFORMATION: 
    Recipients of the Award: Four award recipients, as listed in Table 
1, in Pago Pago, American Samoa; Bishop, California; Baltimore, 
Maryland; and Worcester, Massachusetts.
    Amount of Non-Competitive Awards: $3,066,387.
    Period of Supplemental Funding: FY 2019.
    Assistance Listings (CFDA) Number: 93.224.
    Authority: Public Health Service Act, Section 330, as amended (42 
U.S.C. 254b, as amended).
    Justification: HRSA extended the FY 2019 project periods with 
prorated supplemental grant funds to four award recipients by up to 
four months until a new award is made for each service area. Continued 
funding to the Health Center Program award recipients ensured that 
individuals in the service areas received uninterrupted access to 
needed health care services. The approvals enabled HRSA to support 
consistent health care to beneficiaries, eliminate delays in funding 
gaps, and demonstrate administrative efficiencies. HRSA awarded 
approximately $3 million to the four existing Health Center Program 
award recipients noted in Table 1.

                                      Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
                                                                                     Extension
          Grant No.              Award recipient name          City, state            length       Award amount
                                                                                     (months)
----------------------------------------------------------------------------------------------------------------
H80CS02470...................  American Samoa            Pago Pago, American                   3        $775,917
                                Government Department     Samoa.
                                of Health.
H80CS26629...................  Toiyabe Indian Health     Bishop, California.....               4         382,549
                                Project, Inc.
H80CS00067...................  Parkwest Health Systems,  Baltimore, Maryland....               4       1,326,373
                                Inc.
H80CS00003...................  Community Healthlink,     Worcester,                            4         581,548
                                Inc.                      Massachusetts.
----------------------------------------------------------------------------------------------------------------


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 
[email protected] or 301-594-4300.

    Dated: October 8, 2019.
Thomas J. Engels,
Acting Administrator.
[FR Doc. 2019-22984 Filed 10-21-19; 8:45 am]
 BILLING CODE 4165-15-P