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

21 CFR section No. of 

respondents 

No. of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

610.2 .................................................................................... 73 92.9 6,782 3 20,346 

660.6(b) ................................................................................ 2 21.5 43 5 215 

660.36(a)(2) and (b) ............................................................. 1 1 1 6 6 

660.46(b) .............................................................................. 1 1 1 5 5 

Total .............................................................................. 77 ........................ 6,827 ........................ 20,572 

1There 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. 

[FR Doc. 2012–3743 Filed 2–16–12; 8:45 am] 

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 

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: 

Grantee/organization name Grant number State 

FY2011 

Authorized 

funding level 

FY2012 

Estimated 

funding level 

Columbia University ......................................................................... T17MC06359 ........................ NY $196,506 $196,506 

The Regents of the University of California, Los Angeles ............... T17MC08055 ........................ CA 196,506 196,506 

University of Washington ................................................................. T17MC00020 ........................ WA 196,506 196,506 

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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 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 

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. 

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. 

ESTIMATES OF ANNUAL BURDEN HOURS

Category of 

respondents Types of respondents Number of respondents 

Frequency of 

response 

Average time 

per response 

(Hours) 

Annual burden 

hours 

Individuals ......... Patients to be Screened ................................................... 3,100 1 5/60 258 

Patients with Lymphoma .................................................. 1,100 1 105/60 963 

Other Patients ................................................................... 1,100 1 105/60 963 

Study Pathologists ............................................................ 19 58 5/60 92 

Interviewers ...................................................................... 19 116 30/60 1102 

Total ........... ........................................................................................... ........................ ........................ ........................ 3,377 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

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