80_FR_80612 80 FR 80365 - Health Center Program

80 FR 80365 - Health Center Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 247 (December 24, 2015)

Page Range80365-80366
FR Document2015-32355

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.

Federal Register, Volume 80 Issue 247 (Thursday, December 24, 2015) 
[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80365-80366]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32355]


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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.

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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

Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices 80365 copies to the Division of Dockets examples for complying with the Dated: December 18, 2015. Management. If you do not wish your requirements under 21 CFR 1271.350(b) Leslie Kux, name and contact information to be to report HCT/P deviations. The Associate Commissioner for Policy. made publicly available, you can examples provided in the draft guidance [FR Doc. 2015–32323 Filed 12–23–15; 8:45 am] provide this information on the cover are intended to illustrate those HCT/P BILLING CODE 4164–01–P sheet and not in the body of your deviations that have been most comments and you must identify this frequently reported to FDA, CBER. information as ‘‘confidential.’’ Any The draft guidance does not apply to DEPARTMENT OF HEALTH AND information marked as ‘‘confidential’’ HUMAN SERVICES reproductive HCT/Ps or to HCT/Ps will not be disclosed except in regulated under 21 CFR part 1270 and Health Resources and Services accordance with 21 CFR 10.20 and other recovered before May 25, 2005. The Administration applicable disclosure law. For more draft guidance does not apply to health information about FDA’s posting of professionals who implant, transplant, Health Center Program comments to public dockets, see 80 FR 56469, September 18, 2015, or access infuse, or transfer HCT/Ps into recipients. The draft guidance also does AGENCY: Health Resources and Services the information at: http://www.fda.gov/ Administration, HHS. regulatoryinformation/dockets/ not apply to HCT/Ps that are regulated as drugs, devices, and/or biological ACTION: Notice of Class Deviation from default.htm. Competition Requirements for the Docket: For access to the docket to products under section 351 of the PHS Act and/or the Federal Food, Drug, and Health Center Program; Notice of Class read background documents or the Deviations from the Requirements for electronic and written/paper comments Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an Extensions, Administrative received, go to http:// Supplements, and for Announcing these www.regulations.gov and insert the investigational new drug application or an investigational device exemption. Deviations in the Federal Register for docket number, found in brackets in the the Health Center Program. heading of this document, into the This draft guidance is being issued ‘‘Search’’ box and follow the prompts consistent with FDA’s good guidance SUMMARY: In accordance with the and/or go to the Division of Dockets practices regulation (21 CFR 10.115). Awarding Agency Grants Management, 5630 Fishers Lane, Rm. The draft guidance, when finalized, will Administration Manual (AAGAM) 1061, Rockville, MD 20852. represent the current thinking of FDA Chapter 1.03.103, the Bureau of Primary Submit written requests for single on Deviation Reporting for Human Health Care (BPHC) has been granted copies of the draft guidance to the Office Cells, Tissues, and Cellular and Tissue class deviations from the requirements of Communication, Outreach and Based Products Regulated Solely Under for extensions contained in the AAGAM Development, Center for Biologics section 361 of the Public Health Service Chapter 2.04.104B–4A.I.a(5)(b) and the Evaluation and Research (CBER), Food Act and 21 CFR part 1271. It does not requirements for administrative and Drug Administration, 10903 New establish any rights for any person and supplements contained in AAGAM Hampshire Ave., Bldg. 71, Rm. 3128, is not binding on FDA or the public. Chapter 2.04.104B–4A.4.b to provide Silver Spring, MD 20993–0002. Send You can use an alternative approach if additional grant funds during extended one self-addressed adhesive label to it satisfies the requirements of the budget periods in excess of the allowed assist the office in processing your applicable statutes and regulations. maximum. The deviations prevent requests. The draft guidance may also be interruptions in the provision of critical obtained by mail by calling CBER at 1– II. Paperwork Reduction Act of 1995 health care services for a funded service 800–835–4709 or 240–402–8010. See area until a new award can be made to This draft guidance refers to the SUPPLEMENTARY INFORMATION section an eligible Service Area Competition previously approved collections of for electronic access to the draft (SAC) applicant and to conduct an information found in FDA regulations. guidance document. orderly phase-out of Health Center These collections of information are Program activities by the current award FOR FURTHER INFORMATION CONTACT: subject to review by the Office of Tami Belouin, Center for Biologics recipient. BPHC has also been granted a Management and Budget (OMB) under deviation that allows it to annually Evaluation and Research, Food and the Paperwork Reduction Act of 1995 Drug Administration, 10903 New announce via the Federal Register the (44 U.S.C. 3501–3520). The collections Health Center Program award recipients Hampshire Ave., Bldg. 71, Rm. 7301, of information in 21 CFR part 1271 have Silver Spring, MD 20993–0002, 240– that received a low cost extension and/ been approved under OMB control or administrative supplement under the 402–7911. number 0910–0543. SUPPLEMENTARY INFORMATION: above described deviations. III. Other Issues for Consideration SUPPLEMENTARY INFORMATION: Intended I. Background Recipient of the Award: Health Center FDA is announcing the availability of The draft guidance is being Program award recipients for service a draft document entitled ‘‘Deviation distributed for comment purposes only areas that are threatened with a lapse in Reporting for Human Cells, Tissues, and and is not intended for implementation services due to transitioning award Cellular and Tissue Based Products at this time. recipients. Regulated Solely Under Section 361 of Amount of Non-Competitive Awards: IV. Electronic Access Varies annually. mstockstill on DSK4VPTVN1PROD with NOTICES the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Persons with access to the Internet Period of Supplemental Funding: Industry.’’ The document provides may obtain the draft guidance at either Awards made beginning in fiscal year certain establishments that manufacture http://www.fda.gov/BiologicsBlood 2016 and ongoing. HCT/Ps, regulated solely under section Vaccines/GuidanceCompliance CFDA Number: 93.224 361 of the PHS Act and the regulations RegulatoryInformation/Guidances/ Authority: Section 330 of the Public Health under 21 CFR part 1271, with default.htm or http:// Service Act, as amended (42 U.S.C. 254b, as recommendations and relevant www.regulations.gov. amended). VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\24DEN1.SGM 24DEN1

80366 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices Justification: Targeting the nation’s DEPARTMENT OF HEALTH AND 100.3. This Table lists for each covered neediest populations and geographic HUMAN SERVICES childhood vaccine the conditions that areas, the Health Center Program may lead to compensation and, for each currently funds more than 1,300 health Health Resources and Services condition, the time period for centers that operate approximately Administration occurrence of the first symptom or 9,000 service delivery sites in every manifestation of onset or of significant National Vaccine Injury Compensation aggravation after vaccine state, the District of Columbia, Puerto Program; List of Petitions Received administration. Compensation may also Rico, the Virgin Islands, and the Pacific Basin. More than 23 million patients, AGENCY: Health Resources and Services be awarded for conditions not listed in Administration, HHS. the Table and for conditions that are including medically underserved and manifested outside the time periods uninsured patients, received ACTION: Notice. specified in the Table, but only if the comprehensive, culturally competent, petitioner shows that the condition was SUMMARY: The Health Resources and quality primary health care services caused by one of the listed vaccines. Services Administration (HRSA) is through the Health Center Program Section 2112(b)(2) of the PHS Act, 42 publishing this notice of petitions award recipients. received under the National Vaccine U.S.C. 300aa–12(b)(2), requires that Approximately one-third of current Injury Compensation Program (the ‘‘[w]ithin 30 days after the Secretary award recipients’ service areas are Program), as required by Section receives service of any petition filed scheduled to be competed each year via 2112(b)(2) of the Public Health Service under section 2111 the Secretary shall SACs. SACs are also held prior to a (PHS) Act, as amended. While the publish notice of such petition in the current grant’s project period end date Secretary of Health and Human Services Federal Register.’’ Set forth below is a when (1) a grant is voluntarily is named as the respondent in all list of petitions received by HRSA on relinquished or (2) a program proceedings brought by the filing of November 1, 2015, through November petitions for compensation under the 30, 2015. This list provides the name of noncompliance enforcement action Program, the United States Court of petitioner, city and state of vaccination taken by HRSA terminates the grant. If Federal Claims is charged by statute (if unknown then city and state of a SAC draws no fundable applications, person or attorney filing claim), and BPHC may extend the current award with responsibility for considering and acting upon the petitions. case number. In cases where the Court recipient’s budget period to conduct an has redacted the name of a petitioner orderly phase-out of Health Center FOR FURTHER INFORMATION CONTACT: For and/or the case number, the list reflects Program activities and prepare for a new information about requirements for such redaction. competition for the service area. filing petitions, and the Program in Section 2112(b)(2) also provides that general, contact the Clerk, United States The amount of additional grant funds the special master ‘‘shall afford all Court of Federal Claims, 717 Madison is calculated by pro-rating HRSA’s interested persons an opportunity to Place NW., Washington, DC 20005, existing annual funding commitment to submit relevant, written information’’ (202) 357–6400. For information on the service area. The average Health relating to the following: HRSA’s role in the Program, contact the 1. The existence of evidence ‘‘that Center Program grant amount is over $2 Director, National Vaccine Injury there is not a preponderance of the million. Approximately 6 months is Compensation Program, 5600 Fishers evidence that the illness, disability, required to announce and conduct a Lane, Room 11C–26, Rockville, MD injury, condition, or death described in SAC. BPHC’s extensions and 20857; (301) 443–6593, or visit our Web the petition is due to factors unrelated administrative supplements are site at: http://www.hrsa.gov/ to the administration of the vaccine generally for a minimum of 90 days, vaccinecompensation/index.html. described in the petition,’’ and which is at least 25 percent of the SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the annual grant amount, thereby typically Program provides a system of no-fault petitioner either: exceeding the allowed maximum. compensation for certain individuals a. ‘‘[S]ustained, or had significantly Through the deviations, award who have been injured by specified aggravated, any illness, disability, recipients receive consistent levels of childhood vaccines. Subtitle 2 of Title injury, or condition not set forth in the funding to support uninterrupted XXI of the PHS Act, 42 U.S.C. 300aa– Vaccine Injury Table but which was primary health care services to the 10 et seq., provides that those seeking caused by’’ one of the vaccines referred nation’s most vulnerable populations compensation are to file a petition with to in the Table, or and communities during service area the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly award recipient transition. serve a copy of the petition on the aggravated, any illness, disability, Secretary of Health and Human injury, or condition set forth in the FOR FURTHER INFORMATION CONTACT: Services, who is named as the Vaccine Injury Table the first symptom Olivia Shockey, Expansion Division respondent in each proceeding. The or manifestation of the onset or Director, Office of Policy and Program Secretary has delegated this significant aggravation of which did not Development, Bureau of Primary Health responsibility under the Program to occur within the time period set forth in Care, Health Resources and Services HRSA. The Court is directed by statute the Table but which was caused by a Administration at 301–443–9282 or to appoint special masters who take vaccine’’ referred to in the Table. oshockey@hrsa.gov. evidence, conduct hearings as In accordance with Section mstockstill on DSK4VPTVN1PROD with NOTICES appropriate, and make initial decisions 2112(b)(2), all interested persons may Dated: December 17, 2015. as to eligibility for, and amount of, submit written information relevant to James Macrae, the issues described above in the case of compensation. Acting Administrator. A petition may be filed with respect the petitions listed below. Any person [FR Doc. 2015–32355 Filed 12–23–15; 8:45 am] to injuries, disabilities, illnesses, choosing to do so should file an original BILLING CODE 4165–15–P conditions, and deaths resulting from and three (3) copies of the information vaccines described in the Vaccine Injury with the Clerk of the U.S. Court of Table (the Table) set forth at 42 CFR Federal Claims at the address listed VerDate Sep<11>2014 17:57 Dec 23, 2015 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\24DEN1.SGM 24DEN1


Document Created: 2015-12-24 02:25:17
Document Modified: 2015-12-24 02:25:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice 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.
ContactOlivia 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 [email protected]
FR Citation80 FR 80365 
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