82_FR_40323 82 FR 40160 - Notice of Supplemental Awards to the Territorial Health Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for the Zika Maternal and Child Health Services Program

82 FR 40160 - Notice of Supplemental Awards to the Territorial Health Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for the Zika Maternal and Child Health Services Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 163 (August 24, 2017)

Page Range40160-40161
FR Document2017-17883

HRSA announces the award of supplemental grants under the Zika Response and Preparedness Act to the territorial health departments of Puerto Rico, American Samoa, and U.S. Virgin Islands to address the unmet needs of women, children, and families who are or may be affected by Zika virus (ZIKV) infection.

Federal Register, Volume 82 Issue 163 (Thursday, August 24, 2017) 
[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Pages 40160-40161]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice of Supplemental Awards to the Territorial Health 
Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for 
the Zika Maternal and Child Health Services Program

AGENCY: Health Resources and Services Administration (HRSA), HHS.

[[Page 40161]]


ACTION: Notice of Supplemental Award.

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SUMMARY: HRSA announces the award of supplemental grants under the Zika 
Response and Preparedness Act to the territorial health departments of 
Puerto Rico, American Samoa, and U.S. Virgin Islands to address the 
unmet needs of women, children, and families who are or may be affected 
by Zika virus (ZIKV) infection.

SUPPLEMENTARY INFORMATION: 
    Intended Recipient of the Award: Territorial health departments of 
Puerto Rico, American Samoa, and U.S. Virgin Islands.
    Amount of Non-Competitive Awards: Approximately $1,050,000.
    CFDA Number: 93.110.
    Authority: Zika Response and Preparedness Act (Pub. L. 114-223) and 
Section 501(a)(2) of the Social Security Act (42 U.S.C. 701(a)(2)).
    Justification: The current spread of ZIKV poses a significant 
threat to public health, including the health of women, children, and 
families who are affected by ZIKV infection. ZIKV infection during 
pregnancy can cause serious birth defects, especially affecting the 
neurological system of the infant.
    Funding for these awards is available under the Zika Response and 
Preparedness Act through Special Projects of Regional and National 
Significance (SPRANS) funds.
    The needs of infants and children affected by ZIKV are complex. 
Families, health care providers, and public health professionals will 
be required to work together to assure that community-based, 
comprehensive, high quality health and social services are available to 
these children. The support system must address the medical needs of 
these children, such as regularly screening children who may not be 
symptomatic at birth; coordinate care through a medical home; finance 
care needed by children and families; link to community-based services; 
partner with families; and eventually address transition to adult 
services. Following HRSA's December 2016 grant awards to the 
territorial health departments of Puerto Rico, American Samoa, and U.S. 
Virgin Islands, recipients continued to identify pregnant women and 
infants with lab evidence of ZIKV infection that led them to refine 
their response to ZIKV. HRSA's Maternal and Child Health Bureau (MCHB) 
received information from the territorial health departments of unmet 
needs in their response to ZIKV through monitoring site visits, regular 
communication, and prior approval requests. Needs identified by 
recipients included additional equipment, personnel, and transportation 
services. With further analysis of other federal funding and the 
current epidemiologic data, MCHB confirmed additional funding is 
essential to ensure access to services and a comprehensive medical home 
for women, children, and families who are or may be affected by ZIKV 
infection. Disease burden and the significant increase in pregnant 
women and children with lab evidence of ZIKV infection in American 
Samoa and the U.S. Virgin Islands was also considered as a factor in 
determining the allocation of funds to the territories to address unmet 
needs. The period of performance of the supplemental award will be 
September 2017 through December 2019.

FOR FURTHER INFORMATION CONTACT: Maria Paz Carlos, Division of State 
and Community Health, Maternal and Child Health Bureau, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 18N104A, 
Rockville, Maryland 20857; [email protected].

------------------------------------------------------------------------
                                                              FY 2017
     Grantee/organization name            Territory        supplemental
                                                              awards
------------------------------------------------------------------------
Puerto Rico Health Department.....  Puerto Rico.........         $52,850
American Samoa Health Department..  American Samoa......         423,142
U.S. Virgin Islands Health          U.S. Virgin Islands.         574,008
 Department.
------------------------------------------------------------------------


    Dated: August 18, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017-17883 Filed 8-23-17; 8:45 am]
 BILLING CODE 4165-15-P

40160 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices Drug Administration, 5630 Fishers Submit written requests for single II. Additional Issues for Consideration: Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the Specific Request for Comments and • For written/paper comments Division of Drug Information, Center for Information submitted to the Dockets Management Drug Evaluation and Research, Food Staff, FDA will post your comment, as In addition to comments on the draft and Drug Administration, 10001 New guidance generally, FDA is requesting well as any attachments, except for Hampshire Ave., Hillandale Building, information submitted, marked and comments specifically related to the 4th Floor, Silver Spring, MD 20993– activities of private-label distributors identified, as confidential, if submitted 0002; or to the Office of as detailed in ‘‘Instructions.’’ (PLDs), and whether those activities fall Instructions: All submissions received Communication, Outreach and within the definitions under DSCSA of must include the Docket No. FDA– Development, Center for Biologics the various trading partners. FDA 2017–D–1956 for ‘‘Identifying Trading Evaluation and Research (CBER), Food considers a PLD to be an entity that Partners Under the Drug Supply Chain and Drug Administration, 10903 New owns and distributes a manufactured Security Act; Draft Guidance for Hampshire Ave., Bldg. 71, Rm. 3128, product under its own label or trade Industry; Availability.’’ Received Silver Spring, MD 20993–0002. Send name. Because there are many different comments will be placed in the docket one self-addressed adhesive label to business models for PLDs, resulting in and, except for those submitted as assist that office in processing your situations where a PLD could be ‘‘Confidential Submissions,’’ publicly requests. See the SUPPLEMENTARY considered a manufacturer, wholesale viewable at https://www.regulations.gov INFORMATION section for electronic distributor, or dispenser, we are asking or at the Dockets Management Staff access to the draft guidance document. for comments on how the different between 9 a.m. and 4 p.m., Monday business models might impact a PLD’s FOR FURTHER INFORMATION CONTACT: status as an authorized trading partner through Friday. • Confidential Submissions—To Melissa Mannion, Office of Compliance, under the DSCSA. submit a comment with confidential Center for Drug Evaluation and This draft guidance is being issued information that you do not wish to be Research, Food and Drug consistent with FDA’s good guidance made publicly available, submit your Administration, 10903 New Hampshire practices (see 21 CFR 10.115). The draft comments only as a written/paper Ave., Silver Spring, MD 20993–0002, guidance, when finalized, will represent submission. You should submit two 301–796–3130, drugtrackandtrace@ the current thinking of FDA on copies total. One copy will include the fda.hhs.gov. ‘‘Identifying Trading Partners under the information you claim to be confidential Drug Supply Chain Security Act.’’ It with a heading or cover note that states SUPPLEMENTARY INFORMATION: does not establish any rights for any ‘‘THIS DOCUMENT CONTAINS I. Background person and is not binding on FDA or the CONFIDENTIAL INFORMATION.’’ The public. You can use an alternative Agency will review this copy, including FDA is announcing the availability of approach if it satisfies the requirements the claimed confidential information, in a draft guidance for industry entitled of the applicable statutes and its consideration of comments. The ‘‘Identifying Trading Partners Under the regulations. second copy, which will have the Drug Supply Chain Security Act.’’ The claimed confidential information III. Electronic Access DSCSA (Title II of Pub. L. 113–54) redacted/blacked out, will be available establishes new requirements to develop Persons with access to the internet for public viewing and posted on and enhance drug distribution security may obtain the draft guidance at either https://www.regulations.gov. Submit by 2023. It does this, in part, by defining http://www.fda.gov/Drugs/Guidance both copies to the Dockets Management ComplianceRegulatoryInformation/ different types of entities in the drug Staff. If you do not wish your name and Guidances/default.htm, http:// supply chain as trading partners (i.e., contact information to be made publicly www.fda.gov/BiologicsBloodVaccines/ available, you can provide this manufacturers, repackagers, wholesale GuidanceComplianceRegulatory information on the cover sheet and not distributors, third-party logistics Information/Guidances/default.htm, or in the body of your comments and you providers, and dispensers). Among https://www.regulations.gov. must identify this information as other things, the DSCSA requires that trading partners of manufacturers, Dated: August 18, 2017. ‘‘confidential.’’ Any information marked wholesale distributors, dispensers, and Leslie Kux, as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 repackagers must meet the applicable Associate Commissioner for Policy. and other applicable disclosure law. For requirements for being ‘‘authorized [FR Doc. 2017–17919 Filed 8–21–17; 11:15 am] more information about FDA’s posting trading partners.’’ In addition, the BILLING CODE 4164–01–P of comments to public dockets, see 80 DSCSA outlines requirements for FR 56469, September 18, 2015, or access specific trading partners, including drug the information at: https://www.gpo.gov/ product tracing and licensure DEPARTMENT OF HEALTH AND fdsys/pkg/FR-2015-09-18/pdf/2015- HUMAN SERVICES requirements. FDA has received 23389.pdf. questions about which types of entities Docket: For access to the docket to Health Resources and Services are included in each of the trading Administration read background documents or the partner definitions and this guidance is electronic and written/paper comments intended to help clarify and explain the Notice of Supplemental Awards to the received, go to https:// rmajette on DSKBCKNHB2PROD with NOTICES relevant statutory provisions. The Territorial Health Departments of www.regulations.gov and insert the Puerto Rico, American Samoa, and guidance covers who is considered to be docket number, found in brackets in the U.S. Virgin Islands for the Zika a manufacturer, a repackager, a heading of this document, into the Maternal and Child Health Services ‘‘Search’’ box and follow the prompts wholesale drug distributor, a third-party logistics provider, and a dispenser for Program and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, purposes of certain DSCSA AGENCY:Health Resources and Services Rockville, MD 20852. requirements. Administration (HRSA), HHS. VerDate Sep<11>2014 15:29 Aug 23, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1

Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 40161 ACTION: Notice of Supplemental Award. Preparedness Act through Special site visits, regular communication, and Projects of Regional and National prior approval requests. Needs SUMMARY: HRSA announces the award Significance (SPRANS) funds. identified by recipients included of supplemental grants under the Zika The needs of infants and children additional equipment, personnel, and Response and Preparedness Act to the affected by ZIKV are complex. Families, territorial health departments of Puerto transportation services. With further health care providers, and public health analysis of other federal funding and the Rico, American Samoa, and U.S. Virgin professionals will be required to work Islands to address the unmet needs of current epidemiologic data, MCHB together to assure that community- confirmed additional funding is women, children, and families who are based, comprehensive, high quality essential to ensure access to services or may be affected by Zika virus (ZIKV) health and social services are available and a comprehensive medical home for infection. to these children. The support system women, children, and families who are SUPPLEMENTARY INFORMATION: must address the medical needs of these Intended Recipient of the Award: or may be affected by ZIKV infection. children, such as regularly screening Disease burden and the significant Territorial health departments of Puerto children who may not be symptomatic Rico, American Samoa, and U.S. Virgin increase in pregnant women and at birth; coordinate care through a Islands. children with lab evidence of ZIKV Amount of Non-Competitive Awards: medical home; finance care needed by children and families; link to infection in American Samoa and the Approximately $1,050,000. U.S. Virgin Islands was also considered CFDA Number: 93.110. community-based services; partner with families; and eventually address as a factor in determining the allocation Authority: Zika Response and of funds to the territories to address Preparedness Act (Pub. L. 114–223) and transition to adult services. Following HRSA’s December 2016 grant awards to unmet needs. The period of Section 501(a)(2) of the Social Security the territorial health departments of performance of the supplemental award Act (42 U.S.C. 701(a)(2)). Justification: The current spread of Puerto Rico, American Samoa, and U.S. will be September 2017 through ZIKV poses a significant threat to public Virgin Islands, recipients continued to December 2019. health, including the health of women, identify pregnant women and infants FOR FURTHER INFORMATION CONTACT: children, and families who are affected with lab evidence of ZIKV infection that Maria Paz Carlos, Division of State and by ZIKV infection. ZIKV infection led them to refine their response to Community Health, Maternal and Child during pregnancy can cause serious ZIKV. HRSA’s Maternal and Child Health Bureau, Health Resources and birth defects, especially affecting the Health Bureau (MCHB) received Services Administration, 5600 Fishers neurological system of the infant. information from the territorial health Funding for these awards is available departments of unmet needs in their Lane, Room 18N104A, Rockville, under the Zika Response and response to ZIKV through monitoring Maryland 20857; MCarlos@hrsa.gov. FY 2017 Grantee/organization name Territory supplemental awards Puerto Rico Health Department ................................................................ Puerto Rico .................................................................. $52,850 American Samoa Health Department ....................................................... American Samoa ......................................................... 423,142 U.S. Virgin Islands Health Department ..................................................... U.S. Virgin Islands ....................................................... 574,008 Dated: August 18, 2017. SUMMARY: In compliance with the SUPPLEMENTARY INFORMATION: When George Sigounas, requirement for opportunity for public submitting comments or requesting Administrator. comment on proposed data collection information, please include the [FR Doc. 2017–17883 Filed 8–23–17; 8:45 am] projects of the Paperwork Reduction Act information request collection title for BILLING CODE 4165–15–P of 1995, HRSA announces plans to reference, in compliance with Section submit an Information Collection 3506(c)(2)(A) of the Paperwork Request (ICR), described below, to the Reduction Act of 1995. DEPARTMENT OF HEALTH AND Office of Management and Budget Information Collection Request Title: HUMAN SERVICES (OMB). Prior to submitting the ICR to Federal Tort Claims Act (FTCA) OMB, HRSA seeks comments from the Program Deeming Applications for Health Resources and Services public regarding the burden estimate, Health Center Volunteer Health Administration below, or any other aspect of the ICR. Professionals OMB No. 0906–XXXX— DATES: Comments on this ICR must be New. Agency Information Collection Abstract: Section 224(q) of the Public received no later than September 25, Activities: Submission to OMB for Health Service (PHS) Act (42 U.S.C. 2017. Review and Approval: Public Comment 233(q)), as amended, authorizes the Request; Information Collection ADDRESSES: Submit your comments, ‘‘deeming’’ of certain individuals as Request Title: Federal Tort Claims Act including the ICR Title, to the desk PHS employees for the purposes of (FTCA) Program Deeming Applications officer for HRSA, either by email to receiving Federal Tort Claims Act for Health Center Volunteer Health OIRA_submission@omb.eop.gov or by (FTCA) coverage. Section 224(q) relates rmajette on DSKBCKNHB2PROD with NOTICES Professionals, OMB No. 0906–XXXX, fax to 202–395–5806. to volunteer health professionals (VHPs) New FOR FURTHER INFORMATION CONTACT: To of Health Center Program grantees that AGENCY: Health Resources and Services request a copy of the clearance requests have been deemed as PHS employees. Administration (HRSA), Department of submitted to OMB for review, email the The Health Center FTCA Program is Health and Human Services (HHS). HRSA Information Collection Clearance administered by HRSA’s Bureau of Officer at paperwork@hrsa.gov or call Primary Health Care (BPHC). ACTION: Notice. (301) 443–1984. Sponsoring health centers are required VerDate Sep<11>2014 15:29 Aug 23, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1


Document Created: 2018-10-24 12:35:28
Document Modified: 2018-10-24 12:35:28
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 Supplemental Award.
ContactMaria Paz Carlos, Division of State and Community Health, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18N104A, Rockville, Maryland 20857; [email protected]
FR Citation82 FR 40160 
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