Funds for Leadership Training in Pediatric Dentistry's Current Grantees; One-Year Extension, 9664-9665 [2012-3792]

Download as PDF 9664 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices submissions of samples and protocols of these products may still be required for surveillance, licensing, and export purposes, or in the event that FDA obtains information that the manufacturing process may not result in consistent quality of the product. The following burden estimate is for the protocols required to be submitted with each sample. The collection of samples is not a collection of information under 5 CFR 1320.3(h)(2). Respondents to the collection of information under § 610.2 are manufacturers of licensed biological products. Respondents to the collection of information under §§ 660.6(b), 660.36(a)(2) and (b), and 660.46(b) are manufacturers of the specific products referenced previously in this document. The estimated number of respondents for each regulation is based on the annual number of manufacturers that submitted samples and protocols for biological products including submissions for lot release, surveillance, licensing, or export. Based on information obtained from FDA’s database system, approximately 77 manufacturers submitted samples and protocols in fiscal year (FY) 2011, under the regulations cited previously in this document. FDA estimates that approximately 73 manufacturers submitted protocols under § 610.2 and 2 manufacturers submitted protocols under the regulation (§ 660.6) for the other specific product. FDA received no submissions under § 660.36 or § 660.46; however, FDA is using the estimate of one protocol submission under each regulation in the event that protocols are submitted in the future. The estimated total annual responses are based on FDA’s final actions completed in FY 2011 for the various submission requirements of samples and protocols for the licensed biological products. The average burden per response is based on information provided by industry. The burden estimates provided by industry ranged from 1 to 5.5 hours. Under § 610.2, the average burden per response is based on the average of these estimates and rounded to 3 hours. Under the remaining regulations, the average burden per response is based on the higher end of the estimate (rounded to 5 or 6 hours) since more information is generally required to be submitted in the other protocols than under § 610.2. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 No. of respondents 21 CFR section No. of responses per respondent Total annual responses Average burden per response Total hours 610.2 .................................................................................... 660.6(b) ................................................................................ 660.36(a)(2) and (b) ............................................................. 660.46(b) .............................................................................. 73 2 1 1 92.9 21.5 1 1 6,782 43 1 1 3 5 6 5 20,346 215 6 5 Total .............................................................................. 77 ........................ 6,827 ........................ 20,572 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 10, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. Leadership Training in Pediatric Dentistry’s (T17) Current Grantees. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Funds for Leadership Training in Pediatric Dentistry’s Current Grantees; One-Year Extension Health Resources and Services Administration (HRSA), HHS. AGENCY: Notice of a Non-competitive One-Year Extension with Funds for ACTION: mstockstill on DSK4VPTVN1PROD with NOTICES The Health Resources and Services Administration (HRSA) will be issuing a non-competitive one-year extension with funds for the Leadership Training in Pediatric Dentistry awards to Columbia University, The Regents of the University of California and the University of Washington. Up to $196,506 per grantee will be awarded over a one-year extended project period. The Leadership Training in Pediatric Dentistry program supports a national focus on leadership training in pediatric dentistry through the support of: (1) The postdoctoral training of dentists in the primary care specialty of pediatric dentistry for leadership roles in education, research, public health, advocacy, and public service related to SUMMARY: [FR Doc. 2012–3743 Filed 2–16–12; 8:45 am] oral health programs for populations of mothers and children (infants through adolescents), particularly children with special health care needs; (2) the development and dissemination of curricula, teaching models, and other educational resources to enhance maternal and child health (MCH) oral health programs; and (3) the continuing education, consultation, and technical assistance in pediatric oral health which address the needs of the MCH community. This extension with funds will allow HRSA’s Maternal and Child Health Bureau (MCHB) to align its leadership training initiatives in oral health with HRSA’s other oral health training investments. Grantees of record and intended award amounts are: SUPPLEMENTARY INFORMATION: Grantee/organization name Grant number State Columbia University ......................................................................... The Regents of the University of California, Los Angeles ............... University of Washington ................................................................. T17MC06359 ........................ T17MC08055 ........................ T17MC00020 ........................ NY CA WA VerDate Mar<15>2010 19:08 Feb 16, 2012 Jkt 226001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17FEN1.SGM 17FEN1 FY2011 Authorized funding level $196,506 196,506 196,506 FY2012 Estimated funding level $196,506 196,506 196,506 9665 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices Maryland 20857 or email cdykton@hrsa.gov. Amount of the Award(s): Up to $196,506 per grantee over a one-year project period. CFDA Number: 93.110. Current Project Period: 7/1/2007 through 6/30/2012. Period of Supplemental Funding: 7/1/2012 through 6/30/2013. Proposed Collection: Title: A MultiCenter International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of Information Collection Request: Emergency. Need and Use of Information Collection: Incidence rates of certain lymphomas have increased in several centers in Asia thereby increasing the cancer burden in these populations, but the causes remain unknown. AsiaLymph is a multidisciplinary case-control study that will confirm and extend previous findings and yield novel insights into the causes of lymphoma in both Asia and the West. The major postulated risk factors for evaluation in this study are chemical exposures (i.e., organochlorines, trichloroethylene, and benzene) and genetic susceptibility. Other factors potentially related to lymphoma, such as viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors will also be studied. Patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions are of particular interest. Patients from 19 participating hospitals will be screened and enrolled. There will be a one-time computer-administered interview, and patients will also be asked to provide a one-time blood and buccal cell mouth wash sample and lymphoma cases will be asked to make available a portion of their pathology sample. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Newly diagnosed patients with lymphoma or patients undergoing surgery or other treatment for noncancer related medical issues who live in Hong Kong, Taiwan, and Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 3,377 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Dated: February 10, 2012. Mary K. Wakefield, Administrator. [FR Doc. 2012–3792 Filed 2–16–12; 8:45 am] BILLING CODE 4165–15–P Authority: Title V of the Social Security Act, Section 501(a)(2) (42 U.S.C. 701(a)(2)). Justification HRSA is extending funding for the Leadership Training in Pediatric Dentistry grants by one year for the following reason: MCHB has been working with leaders within HRSA involved in oral health, the Bureau of Health Professions (BHPr) on oral health training investments, and other oral health leaders in the field to align its leadership training in oral health with HRSA’s other oral health training investments. With HRSA prioritizing oral health integration in primary care, MCHB is focusing on the best possible use of its funds to continue to promote oral health training in a coordinated way related to efforts and initiatives within HRSA and the field. HRSA’s BHPr plans to hold a stakeholders meeting on oral health training in 2012 that would impact the scope and nature of all HRSA’s oral health training initiatives. To ensure coordinated and non-duplicative HRSA program planning and future oral health grant funding, it is crucial to fund MCHB’s current training program for one year to sustain MCH oral health leadership training, while developing the next MCH oral health leadership training initiative in a systemically coordinated way with other HRSA oral health training initiatives. FOR FURTHER INFORMATION CONTACT: Christopher Dykton, Health Resources and Services Administration, Maternal and Child Health Bureau, 5600 Fishers Lane, Room 18A–55, Rockville, DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Emergency Review; Comment Request: A MultiCenter International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) Summary: In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing this information collection by March 5, 2012. NCI is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NCI cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. ESTIMATES OF ANNUAL BURDEN HOURS Individuals ......... mstockstill on DSK4VPTVN1PROD with NOTICES Types of respondents Patients to be Screened ................................................... Patients with Lymphoma .................................................. Other Patients ................................................................... Study Pathologists ............................................................ Interviewers ...................................................................... 3,100 1,100 1,100 19 19 1 1 1 58 116 5/60 105/60 105/60 5/60 30/60 258 963 963 92 1102 Total ........... ........................................................................................... ........................ ........................ ........................ 3,377 Request for Comments: Written comments and/or suggestions from the VerDate Mar<15>2010 19:08 Feb 16, 2012 Jkt 226001 Number of respondents public and affected agencies should address one or more of the following PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Frequency of response Average time per response (Hours) Category of respondents Annual burden hours points: (1) Evaluate whether the proposed collection of information is E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9664-9665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3792]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Funds for Leadership Training in Pediatric Dentistry's Current
Grantees; One-Year Extension

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

ACTION: Notice of a Non-competitive One-Year Extension with Funds for
Leadership Training in Pediatric Dentistry's (T17) Current Grantees.

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

SUMMARY: The Health Resources and Services Administration (HRSA) will
be issuing a non-competitive one-year extension with funds for the
Leadership Training in Pediatric Dentistry awards to Columbia
University, The Regents of the University of California and the
University of Washington. Up to $196,506 per grantee will be awarded
over a one-year extended project period. The Leadership Training in
Pediatric Dentistry program supports a national focus on leadership
training in pediatric dentistry through the support of: (1) The
postdoctoral training of dentists in the primary care specialty of
pediatric dentistry for leadership roles in education, research, public
health, advocacy, and public service related to oral health programs
for populations of mothers and children (infants through adolescents),
particularly children with special health care needs; (2) the
development and dissemination of curricula, teaching models, and other
educational resources to enhance maternal and child health (MCH) oral
health programs; and (3) the continuing education, consultation, and
technical assistance in pediatric oral health which address the needs
of the MCH community. This extension with funds will allow HRSA's
Maternal and Child Health Bureau (MCHB) to align its leadership
training initiatives in oral health with HRSA's other oral health
training investments.

SUPPLEMENTARY INFORMATION: Grantees of record and intended award
amounts are:

----------------------------------------------------------------------------------------------------------------
FY2011 FY2012
Grantee/organization name Grant number State Authorized Estimated
funding level funding level
----------------------------------------------------------------------------------------------------------------
Columbia University..................... T17MC06359................ NY $196,506 $196,506
The Regents of the University of T17MC08055................ CA 196,506 196,506
California, Los Angeles.
University of Washington................ T17MC00020................ WA 196,506 196,506
----------------------------------------------------------------------------------------------------------------

[[Page 9665]]

Amount of the Award(s): Up to $196,506 per grantee over a one-year
project period.
CFDA Number: 93.110.
Current Project Period: 7/1/2007 through 6/30/2012.
Period of Supplemental Funding: 7/1/2012 through 6/30/2013.

Authority: Title V of the Social Security Act, Section
501(a)(2) (42 U.S.C. 701(a)(2)).

Justification

HRSA is extending funding for the Leadership Training in Pediatric
Dentistry grants by one year for the following reason: MCHB has been
working with leaders within HRSA involved in oral health, the Bureau of
Health Professions (BHPr) on oral health training investments, and
other oral health leaders in the field to align its leadership training
in oral health with HRSA's other oral health training investments. With
HRSA prioritizing oral health integration in primary care, MCHB is
focusing on the best possible use of its funds to continue to promote
oral health training in a coordinated way related to efforts and
initiatives within HRSA and the field.
HRSA's BHPr plans to hold a stakeholders meeting on oral health
training in 2012 that would impact the scope and nature of all HRSA's
oral health training initiatives. To ensure coordinated and non-
duplicative HRSA program planning and future oral health grant funding,
it is crucial to fund MCHB's current training program for one year to
sustain MCH oral health leadership training, while developing the next
MCH oral health leadership training initiative in a systemically
coordinated way with other HRSA oral health training initiatives.

FOR FURTHER INFORMATION CONTACT: Christopher Dykton, Health Resources
and Services Administration, Maternal and Child Health Bureau, 5600
Fishers Lane, Room 18A-55, Rockville, Maryland 20857 or email
cdykton@hrsa.gov.

Dated: February 10, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012-3792 Filed 2-16-12; 8:45 am]
BILLING CODE 4165-15-P

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