Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11135 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. The Paperwork Reduction Act of 

1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910–0701. 

The guidance also refers to previously 

approved collections of information 

found in FDA’s adverse event reporting 

requirements in 21 CFR 310.305, 314.80, 

314.98, 600.80, 606.170, 640.73, 

1271.350, and 21 CFR part 803. These 

regulations contain collections of 

information that are subject to review by 

OMB under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520) and 

are approved under OMB control 

numbers 0910–0116, 0910–0291, 0910– 

0230, 0910–0308, 0910–0437, and 0910– 

0543. In addition, the guidance also 

refers to adverse event reports for 

nonprescription human drug products 

marketed without an approved 

application and dietary supplements 

required under sections 760 and 761 of 

the FD&C Act (21 U.S.C. 379aa and 

379aa–1), which include collections of 

information approved under OMB 

control numbers 0910–0636 and 0910– 

0635. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov/MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/

default.htm, http://www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/GuidanceDocuments/

default.htm, or http://

www.regulations.gov. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4288 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request: STAR METRICS 

(Science and Technology for 

America’s Reinvestment: Measuring 

the EffecTs of Research on Innovation, 

Competitiveness and Science) 

Summary: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Director, National Institutes of Health 

(NIH) has submitted to the Office of 

Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on Oct 5, 2011 and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 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: STAR 

METRICS (Science and Technology for 

America’s Reinvestment: Measuring the 

EffecTs of Research on Innovation, 

Competitiveness and Science). Type of 

Information Collection Request: 

Extension of OMB number 0925–0616, 

expiration date 03/31/2012. Need and 

Use of Information Collection: The aim 

of STAR METRICS is twofold. The goal 

of STAR METRICS is to continue to 

provide mechanisms that will allow 

participating universities and Federal 

agencies with a reliable and consistent 

means to account for the number of 

scientists and staff that are on research 

institution payrolls, supported by 

federal funds. In subsequent generations 

of the program, it is hoped that STAR 

METRICS will allow for measurement of 

science impact on economic outcomes 

(such as job creatfon), on knowledge 

generation (such as citations, and 

patents) as well as on social and health 

outcomes. 

Frequency of Response: Quarterly.∼ 

Affected Public: Universities and 

other research institutions. 

Type of Respondents: University 

administrators. 

The annual reporting burden is as 

follows: 

Estimated Number of Respondent: 

100. 

Estimated Number of Responses per 

Respondent: 4. 

Average Burden Hours per Response: 

2.5. 

Estimated Total Annual Burden 

Hours Requested: 1,315. 

The annualized cost to respondents is 

estimated to be $65,750. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS

Number of 

respondents 

Frequency 

of response 

Average time 

per response 

(in hours) 

Annual hour 

burden 

Stage I: One time data input ........................................................................... 7 1 45 315 

Stage 2: Ongoing quarterly data input ............................................................ 100 4 2.5 1,000 

Total .......................................................................................................... ........................ ........................ ........................ 1,315 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the functioning of the 

National Cancer Institute, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 


srobinson on DSK4SPTVN1PROD with NOTICES
11136 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: George 

Chacko, Office of Planning, Analysis, 

and Evaluation, Center for Scientific 

Review, 6701 Rockledge Drive, Suite 

3030, Bethesda, MD 20892 or call nontoll-free at 301–435–1111 or email your 

request, including your address to: 

chackoge@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

George Chacko, 

Director, Office of Planning, Analysis, and 

Evaluation, Center for Scientific Review, 

National Institutes of Health. 

[FR Doc. 2012–4271 Filed 2–23–12; 8:45 am] 

BILLING CODE 4104–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; a Multi-Center International 

Hospital-Based Case-Control Study of 

Lymphoma in Asia (AsiaLymph) (NCI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

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 

the United States and in many other 

parts of the world. The contribution of 

environmental, occupational, and 

genetic factors to the cause of 

lymphoma has generated a series of 

novel findings from epidemiological 

studies conducted in the United States 

that have attempted to explain this 

increase. However, none of the chemical 

associations have been conclusively 

established and the identification of the 

key, functional alleles in gene regions 

associated with risk of NHL requires 

further elucidation. Further, the ability 

to follow-up, confirm, and extend these 

observations in the United States is 

limited by the low prevalence and 

limited range of several important 

chemical and viral exposures and the 

high to complete linkage disequilibrium 

among key candidate genetic loci in 

Western populations. To optimize the 

ability to build on and clarify these 

findings, it is necessary to investigate 

populations that differ from those in the 

West in both exposure patterns and 

underlying genetic structure. A 

multidisciplinary case-control study of 

lymphoma in Asia, where lymphoma 

rates have also risen, provides an 

opportunity to replicate and extend 

recent and novel observations made in 

studies in the West in a population that 

is distinctly different with regard to 

patterns of key risk factors, including 

range of exposures, prevalence of 

exposures, correlations between 

exposures, and variation in gene regions 

of particular interest. It will also 

improve the ability to understand the 

causes of certain types of rare 

lymphoma tumors in the United States 

that occur at much higher rates in Asia. 

As such, AsiaLymph will confirm and 

extend previous findings and yield 

novel insights into the causes of 

lymphoma in both Asia and in the 

United States. 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. 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 Taiwan and in Hong Kong, Chengdu 

and Tianjin, China will be enrolled at 

treating hospitals. The annual reporting 

burden is estimated at 5,302 hours (see 

Table below). There are $77,000 in 

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 

(minutes/hour) 

Annual 

burden hours 

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

Patients with Lymphoma .................. 1,100 1 105/60 1,925 

Other Patients .................................. 1,100 1 105/60 1,925 

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

Interviewers ...................................... 19 116 30/60 1,102 

Total ........................................... ........................................................... ........................ ........................ ........................ 5,302 


srobinson on DSK4SPTVN1PROD with NOTICES