Discretionary Grant Funds, 65341-65342 [2013-25890]

Download as PDF 65341 Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices within 100 days of receipt of the filed PMA application to discuss the review status of the application. With the concurrence of the applicant, a different schedule may be established. Prior to this meeting, FDA must inform the applicant in writing of any identified deficiencies and what information is required to correct those deficiencies. FDA must also promptly notify the applicant if FDA identifies additional deficiencies or of any additional information required to complete Agency review. Recordkeeping § 814.82(a)(5) and (a)(6)—Maintenance of Records The recordkeeping burden under this section requires the maintenance of records, used to trace patients and the organization and indexing of records into identifiable files to ensure the device’s continued safety and effectiveness. These records are required of all applicants who have an approved PMA. PMAs have been required since 1976, and there are 556 active PMAs that could be subject to these requirements, based on actual FDA data, and approximately 25 new PMAs are approved every year. The aggregate burden for the estimated 600 PMA holders of approved original PMAs for the next few years is estimated to be 10,200 hours. The applicant determines which records should be maintained during product development to document and/ or substantiate the device’s safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (21 CFR part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device’s continuing safety and effectiveness. In the Federal Register of July 23, 2013 (78 FR 44128), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR or FD&C act section Research conducted outside the United States (814.15(b)) PMA application (814.20) .................................................... PMA amendments and resubmitted PMAs (814.37(a)–(c) and (e)) ............................................................................. PMA supplements (814.39(a)) ............................................. Special PMA supplement—changes being affected (814.39(d)) ........................................................................ 30-day notice (814.39(f)) ..................................................... Postapproval requirements (814.82(a)(9)) ........................... Periodic reports (814.84(b)) ................................................. Agreement meeting (520(g)(7)) ........................................... Expedited review request (515(d)(5) of the FD&C Act) ...... Determination Meeting (513(1)(3)(D) of the FD&C Act) ...... Panel meeting (515(c)(3) of the FD&C Act) ........................ Day 100 meeting (515(d)(3) of the FD&C Act) ................... Total .............................................................................. 1 Number of responses per respondent Total annual responses Average burden per response Total hours 25 40 1 1 25 40 2 668 50 26,720 120 650 1 1 120 650 167 60 20,040 39,000 80 1,500 230 600 3 5 5 10 10 1 1 1 1 1 1 1 1 1 80 1,500 230 600 3 5 5 10 10 6 16 135 10 50 10 50 30 10 480 24,000 31,050 6,000 150 50 250 300 100 ........................ ........................ ........................ ........................ 148,190 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity/21 CFR section Maintenance of records (814.82(a)(5) and (a)(6)) ............... 1 There Number of records per recordkeeper 600 1 600 Average burden per recordkeeping 17 Total hours 10,200 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–25960 Filed 10–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Discretionary Grant Funds mstockstill on DSK4VPTVN1PROD with NOTICES Total annual records Health Resources and Services Administration (HRSA), HHS. AGENCY: Notice of Deviation: NonCompetitive Expansion Supplement Funds to the Healthcare Systems Bureau (HSB). ACTION: VerDate Mar<15>2010 19:21 Oct 30, 2013 Jkt 232001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 HRSA will be issuing a noncompetitive award to the Children’s Hospital of Alabama’s Regional Poison Control Center. The 11-month award for $126,144 will be made available in the form of a supplement to grant funds to the organization’s current grant, H4BHS15500. Effective October 1, 2013, the Regional Poison Control Center will be Alabama’s sole poison control center. The center’s responsibility to provide poisoning triage and treatment to half the state will be expanded to the entire state. The grant supplement will allow SUMMARY: E:\FR\FM\31OCN1.SGM 31OCN1 65342 Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices HSB to maintain its mandate to provide grant support to the poison center and ensure ready access to poison control center services. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Children’s Hospital of Alabama’s Regional Poison Control Center (Grant #H4BHS15500). Amount of the Non-Competitive Award: $126,144. CFDA Number: 93.253. Period of Supplemental Funding: 10/1/2013—8/31/2014. Authority: SECTION 1273 of the Public Health Service Act, (42 U.S.C. 300d—73), as amended by the Poison Center Support, Enhancement, and Awareness Act of 2008. Justification: HSB is legislatively mandated to fund poison centers; establish and maintain a single, national toll-free number (800–222–1222) to ensure universal access to poison center services; and implement a nationwide media campaign to educate the public and health care providers about poison prevention, poison center services, and the toll-free number. To meet the legislative mandate, HSB funds the Poison Center Support and Enhancement Grant Program (H4B) CFDA 93.253. Grantees are funded based on population. The Children’s Hospital of Alabama’s Regional Poison Control Center (H4BHS11550) was funded at $874,061 for a 5-year project period that is due to end August 31, 2014. The funding was based on providing services to 50 percent of Alabama’s population. Beginning October 1, 2013, the grantee will be responsible for providing poison center services to the state’s entire population. HSB proposes this deviation to provide a single supplement of funds in the amount of $126,144 to support the grantee’s ability to provide poison center services to the state’s entire population with the least amount of disruption. mstockstill on DSK4VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Elisa Gladstone, Director, Division of Poison Control and Healthcare Facilities, Healthcare Systems Bureau, Health Resources and Services Administration, Room 10–105, Rockville, Maryland 20857; (301) 594– 4394; Egladstone@hrsa.gov. Dated: October 24, 2013. Mary K. Wakefield, Administrator. [FR Doc. 2013–25890 Filed 10–30–13; 8:45 am] BILLING CODE 4165–15–P VerDate Mar<15>2010 19:21 Oct 30, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on Nurse Education and Practice (NACNEP). Dates and Times: November 7, 2013, 9:00 a.m.–5:00 p.m. Eastern Standard Time; November 8, 2013, 9:00 a.m.–5:00 p.m. Eastern Standard Time. Place: Webinar Format. Status: This advisory council meeting will be open to the public. Purpose: The purpose of this meeting is to identify the key issues facing nursing workforce development to respond to the Affordable Care Act and health care system redesign, and to formulate policy recommendations for Congress and the Secretary to ensure the nursing workforce is ready to meet these challenges. The objectives of the meeting are: (1) To articulate the key challenges facing nursing workforce development in meeting the health care needs of the nation; (2) to develop goals and priorities for Council action to address these challenges; and (3) to develop recommendations on the activities, initiatives, and partnerships that are critical to advancing twenty-first century public health education and practice models needed to promote the health of the public. This meeting will form the basis for NACNEP’s mandated Twelfth Annual Report to the Secretary of Health and Human Services and Congress. The meeting will include presentations and discussion focused around the purpose and objectives of this meeting. The logistical challenges of scheduling this meeting hindered an earlier publication of this meeting notice. Agenda: The Agenda will be available on the NACNEP Web site, noted below, one day prior to the meeting. Agenda items are subject to change as priorities dictate. For Further Information Contact: Further information regarding NACNEP including the roster of members, Reports to Congress, and minutes from previous meetings is available at the following Web site: http://www.hrsa. gov/advisorycommittees/bhpradvisory/ nacnep/index.html. Members of the public and interested parties may request to participate in the meeting by contacting our Staff Assistant, Jeanne Brown, to obtain access information. Access is by invitation only and will be granted on a first come, first served basis. Space is limited. For additional information regarding NACNEP, please contact Jeanne Brown, Staff Assistant, National Advisory Council on Nurse Education and Practice, Parklawn Building, Room 9–61, 5600 Fishers Lane, Rockville, Maryland 20857; email at reachDN@hrsa.gov; or telephone at (301) 443–5688. PO 00000 Frm 00079 Fmt 4703 Sfmt 9990 Dated: October 24, 2013. Jackie Painter, Deputy Director, Division of Policy and Information Coordination. [FR Doc. 2013–25891 Filed 10–30–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, October 17, 2013, 08:00 a.m. to October 17, 2013, 06:00 p.m., Renaissance Arlington Capital View Hotel, 2800 South Potomac Ave., Studio E, Arlington, VA 22202 which was published in the Federal Register on September 11, 2013, 78 FR 55752. The October 17, 2013 meeting has been changed to December 19, 2013. The meeting is closed to the public. Dated: October 25, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–25875 Filed 10–30–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Kidney, Nutrition, Obesity and Diabetes Study Section, October 10, 2013, 8:00 a.m. to October 11, 2013, 12:30 p.m., Melrose Hotel, 2430 Pennsylvania Ave. NW., Washington, DC 20037 which was published in the Federal Register on September 17, 2013, 78 FR 180, Pgs. 57169–57170. The meeting will be held at National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on December 5, 2013 at 09:30 a.m. and end on December 6, 2013 at 1:00 p.m. The meeting is closed to the public. Dated: October 25, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2013–25886 Filed 10–30–13; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65341-65342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Discretionary Grant Funds

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

ACTION: Notice of Deviation: Non-Competitive Expansion Supplement Funds 
to the Healthcare Systems Bureau (HSB).

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SUMMARY: HRSA will be issuing a non-competitive award to the Children's 
Hospital of Alabama's Regional Poison Control Center. The 11-month 
award for $126,144 will be made available in the form of a supplement 
to grant funds to the organization's current grant, H4BHS15500. 
Effective October 1, 2013, the Regional Poison Control Center will be 
Alabama's sole poison control center. The center's responsibility to 
provide poisoning triage and treatment to half the state will be 
expanded to the entire state. The grant supplement will allow

[[Page 65342]]

HSB to maintain its mandate to provide grant support to the poison 
center and ensure ready access to poison control center services.

SUPPLEMENTARY INFORMATION:
    Intended Recipient of the Award: Children's Hospital of Alabama's 
Regional Poison Control Center (Grant H4BHS15500).
    Amount of the Non-Competitive Award: $126,144.
    CFDA Number: 93.253.
    Period of Supplemental Funding: 10/1/2013--8/31/2014.

    Authority:  SECTION 1273 of the Public Health Service Act, (42 
U.S.C. 300d--73), as amended by the Poison Center Support, 
Enhancement, and Awareness Act of 2008.

    Justification: HSB is legislatively mandated to fund poison 
centers; establish and maintain a single, national toll-free number 
(800-222-1222) to ensure universal access to poison center services; 
and implement a nationwide media campaign to educate the public and 
health care providers about poison prevention, poison center services, 
and the toll-free number.
    To meet the legislative mandate, HSB funds the Poison Center 
Support and Enhancement Grant Program (H4B) CFDA 93.253. Grantees are 
funded based on population. The Children's Hospital of Alabama's 
Regional Poison Control Center (H4BHS11550) was funded at $874,061 for 
a 5-year project period that is due to end August 31, 2014. The funding 
was based on providing services to 50 percent of Alabama's population. 
Beginning October 1, 2013, the grantee will be responsible for 
providing poison center services to the state's entire population.
    HSB proposes this deviation to provide a single supplement of funds 
in the amount of $126,144 to support the grantee's ability to provide 
poison center services to the state's entire population with the least 
amount of disruption.

FOR FURTHER INFORMATION CONTACT: Elisa Gladstone, Director, Division of 
Poison Control and Healthcare Facilities, Healthcare Systems Bureau, 
Health Resources and Services Administration, Room 10-105, Rockville, 
Maryland 20857; (301) 594-4394; Egladstone@hrsa.gov.

    Dated: October 24, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-25890 Filed 10-30-13; 8:45 am]
BILLING CODE 4165-15-P